Taxotere Lawsuit Update | TheLawFirm.com

Taxotere Lawsuit Update

The latest Taxotere lawsuit news and updates.

Taxotere Lawsuit (MDL) UpdatE

May 11, 2020
Author: Jeremy Fietz

Seeking justice against Big Pharma takes time. A LOT of time. The Taxotere litigation is no different, despite some early indications by the Court that it wanted this case to be handled more quickly than a typical mass tort case.

So far out of the thousands of women that have brought claims that the chemotherapy drug Taxotere caused permanent hair loss (alopecia), only one case was brought to trial (in September of 2019). In that case, the jury concluded that that particular woman (Barbara Earnest) did not suffer permanent hair loss caused by Taxotere. The Court recently denied a motion for a new trial in that case so that one case is pretty much decided:

But that is just one case among thousands. A second “bellwether” trial was supposed to commence March 23, 2020, but was recently postponed (continued) due to the corona virus pandemic.

So what’s next for the litigation and the thousands of other women waiting for justice?

Well for one thing, over a dozen cases have been selected by the Court to be worked up for more bellwether trials. Bellewether trials are trials that are meant to be seen as examples of what evidence is relevant and admissible and what juries think of that evidence. The trials are case-specific so they are not binding on anyone except the particular victims involved. That said, they are used by the Court and both sides (Plaintiff and Defense) to inform the potential settlement of the litigation as a whole. In other words, if all of the cases that go to trial lose, then the motivation of the giant pharmaceutical company to pay to settle the remaining cases will be low. By the same token if all of the trials win then the victims’ side will expect high settlement values. What is more likely is that some cases win and some lose and that depending on many factors, that will influence what a settlement may look like. 


Unfortunately, this takes time and the next bellwether trial is not expected to happen until October 2020 and another in February of 2021.

Jeremy Fietz, managing partner of TheLawFirm.com, recently talked about another issue that is happening in the Taxotere litigation: “The defense is trying to limit how big the case really is. Sanofi [the giant French pharmaceutical company behind Taxotere] brought a huge motion before Judge Milazzo [the Federal Court Judge overseeing the Taxotere litigation]. In the motion, Sanofi requested that the Court dismiss all cases involving victims who used Taxotere after December 2015. This is because in December 2015, Taxotere published a warning about the potential for hair loss. The outcome of this motion will help determine just how many thousands of women need to be considered potential claimants in a global settlement of the cases. I suspect Sanofi won’t discuss resolution until that issue is resolved, and there are more bellwether trial results.”

In short, justice takes time. It will be a long haul and victims and their lawyers need to realize that it is a marathon, not a sprint.

Sources

laed.uscourts.gov

laed.uscourts.gov

Taxotere Lawsuit (MDL) Update: Taxotere MDL: Judge Dismisses Case Of One Bellwether Plaintiff, Denies Two Requests To Toss Another

March 26, 2020
Author: Daniel Gala

  On March 23, the district judge overseeing multidistrict litigation (MDL) over the cancer drug Taxotere ruled on defense motions to dismiss the cases of two plaintiffs scheduled to participate in the MDL’s upcoming second bellwether trial, tossing the case of one plaintiff while denying two motions for summary judgment with regards to the other. 

United States District Judge Jane Triche Milazzo, writing for the Eastern District of Louisiana, denied motions for summary judgment against plaintiff Elizabeth Kahn based on warnings causation and statute of limitations. However, she granted a similar motion for plaintiff June Phillips, based on warnings causation. 

As a result, “Plaintiff June Phillips’ case is dismissed with prejudice,” Judge Milazzo wrote in her brief, one-page order of March 23, which did not provide the reasoning behind her rulings.

"Written reasons will follow,” the order said.

As of the close of business on March 25, no such explanatory document—typically filed as an Order and Reasons—had yet been posted to the Taxotere MDL docket.

However, in its memorandum supporting its motion for summary judgment against plaintiff June Phillips, defendant Sanofi had argued that the plaintiffs claims should be dismissed because she “cannot establish warnings causation under the Fifth Circuit’s two-pronged test” for warnings causation. 

“Plaintiff June Phillips claims Sanofi failed to provide an adequate warning concerning the risk of permanent alopecia and Taxotere,” said Sanofi’s memorandum in support. “Among the many elements of that claim, the Plaintiff must prove warnings causation.”

In other words, in bringing her failure to warn claim under Louisiana law, plaintiff Phillips had to prove that, had Sanofi provided the argued-for warning, it would have made a difference in her doctor’s recommendation as to the suggested course of treatment. This is the so-called first prong of the Fifth Circuit’s warnings causation test. 

“First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician,” said Sanofi’s memorandum in support, quoting the Fifth Circuit’s decision in Stahl. 

Sanofi argued that Phillips could not establish this prong because, despite the lack of a warning on the drug label, her doctor already was aware of the risk of permanent hair loss associated with Taxotere and yet prescribed that course of treatment regardless. 

“By [the time of his prescribing plaintiff Phillips’ Taxotere-containing treatment regimen], Dr. Sonnier already knew that '[p]ermanent chemotherapy-induced alopecia is a rare but, none the less, possible side effect associated with many chemotherapy regimens,'” the defense argued.

In granting this motion for summary judgment and dismissing the case of plaintiff June Phillips with prejudice, the court appears to have agreed with this line of reasoning, though we will have to wait for the court to release its order and reasons before we can know with certainty what analysis lies behind the court’s decision. Similarly, we will have to wait for the court’s order and reasons to learn why the court ruled differently in the case of plaintiff Elizabeth Kahn, particularly when the defendant’s arguments and the factual circumstances are largely similar in both cases.

Established in October 2016, the Taxotere MDL centralized federal products liability lawsuits filed by plaintiffs alleging that defendant Sanofi failed to adequately warn patients and physicians in the United States about the risk of permanent hair loss associated with the cancer drug Taxotere. Based in the Eastern District of Louisiana at New Orleans, the MDL has grown to become one of the largest active MDL’s in the country by number of cases. 

Held in September 2019, the Taxotere MDL’s highly-anticipated first bellwether trial resulted in a verdict for the defense, with the jury finding that the plaintiff had failed to prove that Taxotere was the cause of her permanent hair loss. 

The second bellwether trial, originally scheduled to begin in late March, was subsequently postponed when Sanofi succeeded in having the plaintiff’s claims dismissed on statute of limitations grounds—a tactic which they tried, and failed, to use against plaintiff Elizabeth Kahn, who after the dismissal of the case of June Phillips, presently is slated to be the sole plaintiff in the second bellwether, now scheduled to begin August 10. 

Have you or a loved one suffered permanent hair loss after undergoing a Taxotere-containing treatment regimen? If so, contact the experienced team of attorneys at TheLawFirm.com today for a free consultation with a licensed attorney! 

Sources:

United States District Court Eastern District of Louisiana. (23 March 2020). Order. Case 2:16-md-02740-JTM-MBN. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Accessed 25 March 2020). Docket Entries for Case 2:16-md-02740-JTM-MBN. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (14 February 2020). Defendants’ Memorandum of Law in Support of Their Motion for Summary Judgment on Warnings Causation. Case 2:16-md-02740-JTM-MBN. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. June Phillips, 2:16-cv-15397

Taxotere Lawsuit (MDL) Update: Taxotere MDL: Parties Agree To Amend Pretrial Deadlines Due To Coronavirus; Bellwether Start Dates Unchanged

March 24, 2020
Author: Daniel Gala

  The parties involved in multidistrict litigation (MDL) over the cancer drug Taxotere have agreed to postpone several deadlines related to pretrial discovery by roughly a month due to the coronavirus, according to an order issued March 19].  

“Because the Federal and State Governments have declared emergencies in response to the COVID-19 pandemic, the parties have agreed to amend [a previous court management order],” says the order signed by US District Judge Jane Triche Milazzo.  

Specifically, the order pushes back four pretrial deadlines.   

First, the “deadline for Plaintiffs’ expert disclosures (for all experts, including dermatologist/dermapathologist) as to Accord, Hospira, and Sandoz is extended from March 16, 2020 to April 15, 2020”; second, the “deadline for Plaintiff expert depositions is extended from April 16, 2020 to May 18, 2020”: third, the “deadline for all of Defendants’ expert disclosures (for all experts) is extended from April 24, 2020 to May 26, 2020; and, fourth, the “deadline for Defendant expert depositions is extended from May 22, 2020 to June 22, 2020.”   

The Taxotere MDL, based in New Orleans, has centralized thousands of federal lawsuits filed by women alleging that the makers of Taxotere failed to adequately warn doctors and plaintiffs about the risk of permanent hair loss associated with Taxotere-containing cancer-treatment regimens.  

The MDL’s first bellwether trial, held in September 2019, resulted in a verdict for the defendant drugmaker Sanofi, with the jury finding that Taxotere was not responsible for the plaintiff’s permanent hair loss. The second bellwether trial, previously scheduled to begin in late March, was postponed until August after the original plaintiff had her case dismissed for failure to file her claim in a timely manner.   

The March 19 order amends the schedule established earlier by Case Management Order No. 14E. Filed February 21, the previous order outlined detailed schedules for the second, third, fourth, and fifth Taxotere bellwether trials.   

While the March 19 order does not reference a particular bellwether trial or case to which the changes apply, based on the dates stated, the delays appear to involve pretrial discovery for the third bellwether trial, which is still scheduled to begin October 13, 2020.   

Given that the court’s February 21 scheduling order established more than 100 different deadlines across the four upcoming bellwethers, the fact that the March 19 order amends only four deadlines shows that, to date at least, the coronavirus pandemic is not expected to greatly impact the proceedings.   

Presently, the second Taxotere bellwether is slated to begin August 10; the third bellwether is scheduled for October 13; the fourth is set for February 1, 2021; and the fifth is calendared for April 19, 2021.   

If you or a loved one has suffered permanent hair loss after undergoing a Taxotere-containing cancer treatment, contact the experienced team of attorneys at TheLawFirm.com today to schedule a free legal consultation with a licensed attorney!   

Sources:   

United States District Court Eastern District of Louisiana. (19 March 2020). Case Management Order No. 14F. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (21 February 2020). Case Management Order No. 14E (Amendment to Trial Schedules). In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit (MDL) Update: Sanofi Pushes For Summary Judgment Against Two More Taxotere Bellwether Plaintiffs 

March 15, 2020
Author: Daniel Gala

  Pharmaceutical giant Sanofi continues to push for the dismissal of claims brought by two plaintiffs slated to participate in a forthcoming bellwether trial in multidistrict litigation (MDL) over its cancer drug Taxotere, the latest move in the defendant drugmaker’s efforts to have as many claims as possible dismissed prior to reaching a jury.   

On March 6, Sanofi filed three separate replies in support of its various motions for summary judgment against plaintiffs Elizabeth Kahn and June Philips, the court docket shows [https://ecf.laed.uscourts.gov/cgi-bin/mobile_query.pl?search=dktEntry&caseid=189312&caseNum=2:16-md-02740-JTM-MBN]. Kahn faces two motions for summary judgment, one based on warnings causation and the other brought on statute of limitations grounds. Philips faces a single motion based on warnings causation.   

The Taxotere MDL has centralized thousands of federal lawsuits filed by women accusing defendant Sanofi of having failed to adequately warn patients and doctors about the risk of permanent hair loss associated with its highly profitable cancer drug.   

The MDL’s first bellwether trial, held in September 2019, resulted in a verdict for the defense, and the previously scheduled second bellwether trial—which had been slated to begin in late March—was postponed after Sanofi succeeded in having the plaintiff’s case dismissed.   

Now, Sanofi is employing the same tactic against plaintiffs Kahn and Philips, both having been selected as future bellwether plaintiffs.   

Summary Judgment Based on Warnings Causation   

In a number of cases within the Taxotere MDL, defendant Sanofi has argued that the plaintiff’s claims should be dismissed based on “warnings causation”. But what exactly does that mean?   

The legal concept of “warnings causation” arises in cases based on an alleged failure to warn. In this instance, plaintiffs in the Taxotere MDL have accused Sanofi of failing to adequately warn them and their doctors about the risk of permanent hair loss associated with a Taxotere-containing treatment regimen. In many jurisdictions, courts have decided that, in order to prevail on such claims, a plaintiff must show that, had the argued-for warning been in place, it would have caused the treating physician to recommend an alternative course of treatment and/or it would have resulted in the patient pursuing such an alternative.   

United States District Judge Jane Triche Milazzo, presiding over the Taxotere MDL, has established a four-prong test for determining whether this standard has been satisfied.   

"For failure-to-warn cases involving chemotherapy drugs, this Court has articulated a framework that contemplates a vigorous, albeit hypothetical, discussion between patients and their prescribing physicians,” defendant Sanofi’s March 6 reply on warnings causation involving plaintiff Kahn states, summarizing the court’s previously-held position. “This analysis requires Plaintiff to come forward with evidence supporting each of four scenarios: ‘[1] whether and how the doctor would have advised the patient of the risk of permanent alopecia associated with Taxotere, [2] whether the patient would have inquired about other options, [3] what the doctor would have recommended, and [4] what decision the plaintiff would have ultimately made.”   

Sanofi argues that the plaintiff Kahn fails on each of these four elements, citing her own testimony and that of her doctor, as well as a lack of contemporaneous evidence to the contrary presented by the plaintiff.   

“Plaintiffs in this litigation cannot satisfy their burden to show ‘what decision [they] would have ultimately made’ by simply declaring, in hindsight, that they would not have taken Taxotere had they known that their hair would not return exactly as before,” the defendant Sanofi argues.   

Sanofi’s arguments in favor of summary judgment on warnings causation in the case of plaintiff June Phillips largely mirror those presented in the Kahn case, with the defendant drugmaker arguing that Phillips has failed to show either that her doctor would have recommended an alternative treatment or that Phillips would have requested one had the allegedly absent warning been in place at the time.   

Summary Judgment On Statute Of Limitations Grounds   

Sanofi’s arguments in seeking the dismissal of plaintiff Kahn’s case on statute of limitations grounds mirror those the defendant drugmaker deployed in having the case of the prior second bellwether plaintiff dismissed for failure to file her claims in a timely manner.   

Under Louisiana law, which governs in many Taxotere MDL cases, plaintiffs are allowed only a brief one-year window after the alleged injury takes place in which they may file their lawsuits. With the alleged injury suffered by plaintiffs in the Taxotere MDL being permanent hair loss, one of the key subjects of dispute in the litigation has been defining when this injury occurred.     

In defining permanent hair loss in the MDL’s master complaint, plaintiffs cited an expert as saying that clinical permanent hair loss is deemed to have occurred when hair has not regrown six months after the conclusion of a patient’s last cancer treatment. Defendant Sanofi has pounced on this description, arguing that the clock starts running on the one-year window six months after the plaintiff has completed her Taxotere-containing treatment regimen.     

In a setback for plaintiffs, the court largely has expressed agreement with this argument while rebuffing requests by plaintiffs to amend the master complaint in order to revise their definition of the plaintiffs’ alleged injuries.   

“Ms. Kahn asserts that Sanofi bases the definition of her injury on a misreading of the Master Complaint,” the defendant’s reply in support of summary judgment says. “The Court, however, has already rejected this argument because the Master Complaint defines all Plaintiffs’ injury as occurring six months after the completion of chemotherapy.”   

Sanofi further argues that none of the exceptions to the statute of limitations argued by the plaintiff apply to her case.   

“Ms. Kahn must establish an exception to prescription under contra non valentem,” Sanofi’s reply states, referring to the legal principle that, in part, holds that the statute of limitations may not run against a plaintiff that has no way of knowing of the existence of a legal claim. “But she has not shown that she lacked knowledge sufficient to excite the attention of a reasonable person to inquire into whether she had a cause of action.”   

With plaintiff Kahn’s claims facially barred by the statute of limitations and no exceptions applicable to her case, Sanofi argues, her lawsuit should be dismissed.   

Conclusion   

The motions for summary judgment filed by Sanofi against plaintiffs Kahn and Phillips represent a furthering of the defendant drugmaker’s strategy of having as many cases as possible dismissed prior to reaching trial. Relying on plaintiffs’ own definition of permanent hair loss, Sanofi thus far has succeeded in convincing the court that a Taxotere plaintiff should have only 18 months from the time of her last cancer treatment in order to file her claim.   

However, with the Taxotere MDL remaining one of the largest active MDLs in the country by number of cases, Sanofi still has a hard legal slog ahead of it.   

If you or a loved one has suffered permanent hair loss after undergoing a Taxotere-containing treatment regimen, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation!   

  Sources:   

United States District Court Eastern District of Louisiana. (6 March 2020). Defendants’ Reply In Support Of Their Motion For Summary Judgment On Warnings Causation. Elizabeth Kahn, Case No. 2:16-cv-17039. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (6 March 2020). Defendants’ Reply In Support Of Their Motion For Summary Judgment On Warnings Causation. June Phillips, Case No. 2:16-cv-15397. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (6 March 2020). Defendants’ Reply In Support Of Their Motion For Summary Judgment On Statute Of Limitations Grounds Against Plaintiff Elizabeth Kahn. Elizabeth Kahn, Case No. 2:16-cv-17039. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit (MDL) Update: Sanofi Succeeds In Having Another Case Tossed From Taxotere MDL

March 7, 2020
Author: Daniel Gala

Defendant drugmaker Sanofi has succeeded in having another lawsuit tossed from multidistrict litigation (MDL) over its cancer drug Taxotere, with the presiding judge issuing on March 3 a judgment dismissing with prejudice the case of plaintiff Kelly Gahan.   

Thousands of plaintiffs have sued Sanofi alleging that the company failed to adequately warn doctors and patients in the United States about the risk of permanent hair loss—or alopecia—associated with the cancer drug. Federal Taxotere lawsuits have been centralized as multidistrict litigation (MDL) in the Eastern District of Louisiana, located at New Orleans.   

Despite several individual cases recently having been dismissed, the Taxotere litigation remains one of the largest active MDLs in the country by number of cases.   

At issue in defendant Sanofi’s motion for summary judgment were the plaintiff Gahan’s claims based on failure to warn and fraud, which were brought under Colorado law. We’ll take a look at each in turn.   

Failure To Warn   

With regards to the plaintiff’s failure to warn claims, defendant Sanofi argued that the plaintiff Gahan failed to demonstrate that a change in the warnings associated with Taxotere would have caused her and her doctor to make a different decision as to the appropriate course of treatment.   

“Relying in part on the learned intermediary doctrine, Defendants argue that Plaintiff has failed to introduce evidence that a different warning from Defendants would have led Dr. Gahan’s oncologist, Dr. Virginia Borges, to change her prescribing decision,” US District Judge Jane Triche Milazzo summarized in the Order and Reasons accompanying the Judgment.   

As the judge explained later, the “learned intermediary doctrine provides that in cases involving prescription drugs, the manufacturer’s duty to warn runs to the prescribing physician, not the ultimate user…Under this doctrine, Colorado law permits the granting of summary judgment in cases where manufacturer provided an adequate warning to the prescribing physician.”   

While the plaintiff Gahan argued that Sanofi failed to provide adequate warning because the Taxotere warning label did not specifically reference alopecia as a risk, Sanofi countered that Dr. Borges already was aware of the risk of permanent hair loss associated with Taxotere by other means but chose to recommend the treatment regardless.   

“Defendants aver that Dr. Borges had prior independent knowledge of the risk of permanent alopecia associated with Taxotere and nonetheless prescribed a Taxotere regimen to Plaintiff Gahan,” Judge Milazzo wrote.   

In the end, Judge Milazzo agreed with the defendants’ conclusions, though not for precisely the reasons they asserted.   

“Defendants emphasize that no label change would have altered Dr. Borges’s recommendation that Gahan use a Taxotere regimen,” Judge Milazzo wrote. “However this Court does not view this issue so narrowly. This Court has previously ruled in this MDL that a plaintiff must show that an adequate warning would have changed her doctor’s prescribing decision.”   

In her analysis, Judge Milazzo notes that the context of cancer treatment is somewhat unique in that a patient must give informed consent to undergoing a particular course of treatment. In the instant case, Judge Milazzo found that both the doctor and patient were aware of the risk of permanent hair loss associated with Taxotere despite such information being absent from the Taxotere warning label.   

And, as Judge Milazzo noted, in the case of the plaintiff Gahan, an emergency-room physician, the patient also was a doctor in her own right.   

“Here, the uncontroverted evidence shows that Dr. Borges had the following information—she had three prior patients who suffered permanent hair loss after taking Taxotere, and she read numerous articles in dermatology publications, as well as an article by Dr. Scot Sedlacek describing the risk of permanent alopecia associated with Taxotere,” Judge Milazzo wrote. “Defendants’ Motion reveals that this information was shared with Dr. Gahan. Despite this knowledge, Dr. Gahan chose to proceed with a Taxotere-containing regiment as recommended and ultimately prescribed by Dr. [Borges].”   

The court further took note that, if the plaintiff Gahan had selected an alternative course of treatment, Dr. Borges would have prescribed that treatment, placing a particular onus on the patient in this instance.   

“While Dr. Borges recommended the Taxotere-containing regimen, the evidence supports the inference that she would have prescribed Gahan a non-Taxotere treatment if Gahan had preferred,” Judge Milazzo wrote.   

Consequently, having found that the plaintiff Gahan failed to adequately demonstrate a causal connection between the defendant Sanofi’s alleged failure to warn and Gahan and her doctor’s ultimate decision to proceed with the Taxotere-containing regimen, Judge Milazzo granted Sanofi’s motion for summary judgment on Gahan’s failure to warn claims.   

Fraud   

At the time of defendant Sanofi filed its motion for summary judgment, plaintiff Gahan’s lawsuit contained three surviving fraud-based claims: fraudulent misrepresentation, fraudulent concealment, and fraud and deceit. Judge Milazzo took little time in dispensing with these claims.   

“Plaintiff Gahan cannot show that she relied on a misrepresentation by Defendants,” Judge Milazzo concluded succinctly, citing an element necessary to proving Gahan’s claims under Colorado law. “As discussed herein, Dr. Gahan had knowledge of the risk of permanent alopecia associated with Taxotere yet chose to take a Taxotere regimen anyway. She did not rely on Defendants’ allegedly inadequate warning label.”   

Being unable to show that she relied on defendant Sanofi’s alleged misrepresentations in reaching her decision on which course of treatment to pursue, plaintiff Gahan was unable to sustain her fraud-based claims, Judge Milazzo ruled.   

Conclusion   

Despite defendant Sanofi’s having succeeded of late in having multiple cases tossed from the Taxotere MDL, thousands of such cases remain, and the court is continuing with pretrial proceedings paving the way for forthcoming bellwether trials. However, by taking a closer look at the legal arguments presented by defendant Sanofi as well as the court’s responses to them, we can reach a better understanding of the legal contours of the Taxotere MDL and the course the litigation is likely to take.   

If you or a loved one has suffered permanent hair loss after undergoing a Taxotere-containing cancer-treatment regimen, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation!  

Sources:   

United States District Court Eastern District of Louisiana. (3 March 2020). Judgment. Kelly Gahan, No. 16-15283. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (3 March 2020). Order and Reasons. Kelly Gahan, No. 16-15283. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit (MDL) Update: Court Narrows List Of Potential Plaintiffs For Fourth Bellwether

March 7, 2020
Author: Daniel Gala

Taxotere MDL: Court Narrows List Of Potential Plaintiffs For Fourth Bellwether  

The judge presiding over multidistrict litigation (MDL) involving the cancer drug Taxotere has narrowed the list of prospective plaintiffs for the MDL’s fourth bellwether trial to twelve, pursuant to an order dated February 18.  

The twelve plaintiffs now will begin the pretrial discovery process as the court paves the way for subsequent bellwether trials.  

The court recently had been forced to reschedule the MDL’s forthcoming bellwether trials after the plaintiff selected to participate in the second Taxotere bellwether had her case dismissed for failure to file her claim in a timely manner.  

The second bellwether originally had been slated to begin March 23. Postponed indefinitely after the plaintiff’s case was dismissed, the second bellwether now is set to begin August 10, pursuant to a February 21 scheduling order.  

According to the same order, the Taxotere MDL’s third bellwether trial now is scheduled to begin Tuesday, October 13, with the fourth calendared for February 1, 2021, and the fifth bellwether set for April 19, 2021.  

The MDL’s highly anticipated first bellwether trial was held in September 2019 and resulted in a jury verdict for the defendant drugmaker Sanofi. US District Judge Jane Triche Milazzo, presiding over the MDL, recently rejected a request for new trial submitted by the plaintiff in the first bellwether.  

Thousands of plaintiffs have sued Sanofi alleging that the company failed to adequately warn doctors and patients about the risk of permanent hair loss—or alopecia—associated with Taxotere, making the litigation one of the largest active MDLs in the United States by number of cases.  

Federal products liability lawsuits over Taxotere have been centralized as an MDL in the Eastern District of Louisiana since October 2016.  

Presently, oral arguments are scheduled to take place on March 11 and 25, with a general status conference and show cause hearing set for March 24, according to the court’s calendar.  

Sources:  

United States District Court Eastern District of Louisiana. (18 February 2020). Case Management Order No. 23. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (21 February 2020). Case Management order No. 14E (Amendment To Trial Schedules). MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (Accessed 6 March 2020). Calendar. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation.

Taxotere Lawsuit (MDL) Update: Taxotere MDL Judge Issues New Bellwether Trial Schedule

February 27, 2020
Author: Daniel Gala

Following the indefinite postponement earlier this month of the second bellwether trial in multidistrict litigation (MDL) over Sanofi’s cancer drug Taxotere, the presiding judge issued on February 21 an order revising the schedule for four upcoming bellwether trials. 

Pursuant to the February 21 order issued by US District Judge Jane Triche Milazzo, the Taxotere MDL’s second bellwether now is scheduled to commence Monday, August 10, 2020. 

The third bellwether trial is slated to begin Tuesday, October 13; the fourth is calendared for February 1, 2021; and the fifth presently is set for April 19, 2021.

The Taxotere MDL has centralized thousands of federal lawsuits alleging that defendant drugmaker Sanofi failed to adequately warn patients and doctors about the risk of permanent hair loss—or alopecia—associated with the cancer drug. It presently is one of the largest active MDLs in the country by number of cases. 

The second Taxotere bellwether, originally scheduled to begin March 23, was postponed indefinitely on February 4 after the intended plaintiff had her case dismissed. 

Plaintiff Cynthia Thibodeaux, who had been selected to participate in the MDL’s second bellwether trial, had her case thrown out January 23 supporting her decision, Judge Milazzo voiced her agreement with Sanofi’s argument that the plaintiff Thibodeaux had failed to file her claim within the one-year window provided under Louisiana law, which governed in her case. 

The judge’s ruling in the Thibodeaux case hinged on the issue of when the plaintiff first became aware, or should have become aware, of her injury. Using plaintiffs’ own definition for alopecia—which an expert for the plaintiffs has said begins six months after hair has failed to regrow following cancer treatment—defendants argued that Thibodeaux, starting six months after she had concluded her cancer treatment, had one year to file her lawsuit.

In a ruling that could have repercussions for numerous other cases in the MDL, Judge Milazzo agreed, dismissing the case for not having been filed in a timely manner. (Thibodeaux did not file her lawsuit until some six years after the conclusion of her cancer treatment, when she saw an attorney advertisement on television explaining the alleged connection between Taxotere and permanent hair loss.) 

The MDL’s first bellwether trial was held in September 2019 and resulted in a verdict for defendant Sanofi. Judge Milazzo recently denied that plaintiff’s request for a new trial. The first bellwether plaintiff had argued that certain improprieties relating to the testimony of defense experts warranted a new trial, but the court disagreed that any such errors had taken place and also found, in the alternative, that even if the plaintiff’s argument were valid, the alleged improprieties did not rise to the level of requiring a new trial. 

The court also issued on February 21 an order reaffirming the schedule for upcoming hearings. On March 11, the court will hear oral arguments on four separate motions, including three motions for summary judgment filed by defendant Sanofi. Two of these motions to dismiss involve the replacement plaintiffs in the rescheduled second bellwether trial. 

Sources: 

United States District Court Eastern District of Louisiana. (21 February 2020). Case Management order No. 14E (Amendment To Trial Schedules). MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

  United States District Court Eastern District of Louisiana. (Filed 4 February 2020). Case Management Order No. 22. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 23 January 2020). Judgment. Cynthia Thibodeaux, No. 16-15859. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 23 January 2020). Order and Reasons. Cynthia Thibodeaux, No. 16-15859. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (14 February 2020). Order and Reasons. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (21 February 2020). Order. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit (MDL) Update: No New Trial For Plaintiff In First Taxotere Bellwether, MDL Judge Rules 

February 20, 2020
Author: Daniel Gala

The judge presiding over multidistrict litigation (MDL) involving the cancer drug Taxotere has denied the motion for new trial submitted by the plaintiff in the MDL’s first bellwether, which was conducted in September 2019 and resulted in a jury verdict in favor of the defendant drugmaker Sanofi. 

“Plaintiff has failed to show that a new trial is warranted,” United States District Judge Jane Triche Milazzo ruled in an order filed February 14, refuting plaintiff’s contention that the defense had violated the judge’s own evidentiary rulings with regards to the testimony of on its experts. 

The Taxotere MDL has centralized thousands of federal lawsuits filed by plaintiffs alleging that Sanofi failed to adequately warn patients and doctors about the risk of permanent hair loss—or alopecia—associated with Taxotere, a popular and highly profitable cancer medication. It is one of the largest active MDLs in the country by number of pending cases. 

Bellwether plaintiff Barbara Earnest moved for a new trial shortly after the jury returned its verdict finding that, in the word’s of Judge Milazzo’s order, plaintiff Earnest “did not have permanent chemotherapy-induced alopecia caused by Taxotere.” Earnest's October 25 motion for a new trial alleged problems with expert testimony and evidence presented by defendant Sanofi, claiming certain aspects were in violation of the court’s prior discovery rulings. It also accused Sanofi lawyers of presenting different data to the jury than the company had provided to the US Food and Drug Administration (FDA), the country’s top pharmaceutical regulator. 

“In the instant Motion, Plaintiff asks the Court to vacate the judgement against Earnest,” Judge Milazzo’s February 14 order summarizes. “Plaintiff avers that the Court erroneously admitted certain evidence from Defendants’ expert, Dr. John Glaspy, and that his admission violated Earnest’s substantial rights.” 

Judge Milazzo continues: 

“Plaintiff takes issue with Dr. Glaspy’s reliance upon a certain analysis that Dr. Michael Kopreski performed. As this Court explained in a prior ruling, Dr. Kopreski is a former employee of Defendant Sanofi. Dr. Kopreski was not proffered as an expert for the Earnest trial, but Dr. Glaspy relied on Dr. Kopreski’s analysis of a clinical study called the TAX 316 study.” 

The TAX 316 trial involved tracking subjects for ten years after they underwent breast-cancer treatment using Taxotere. At the time, the study concluded that approximately 4% of study participants experienced “persistent alopecia". This is the figure that Sanofi has reported to the FDA. Subsequently, the Sanofi employee Dr. Kopreski performed a re-analysis of the TAX 316 data and concluded that incidence of “persistent alopecia” actually was closer to 1%. 

When Dr. John Glaspy testified for defendant Sanofi at trial, he relied on Dr. Kopreski’s re-analysis of the TAX 316 data even though Dr. Glaspy admittedly had not confirmed Dr. Kopreski’s re-analysis for himself. The plaintiff Earnest had argued that this violated the court’s own rulings on the matter. 

“Plaintiff avers that this Court’s [pretrial evidentiary] Order set ‘ground rules’ that were not followed,” Judge Milazzo writes. “They argue that Defendants’ experts were required to independently verify Dr. Kopreski’s work, and they did not. Because of this, Plaintiff avers that a new trial is warranted.” 

However, Judge Milazzo does not agree with this position. 

“This Court remains convinced that Dr. Glaspy’s testimony was appropriate for the jury,” her order states, adding later, “Dr. Glaspy was not required to check every aspect of Dr. Kopreski’s work for his reliance on the work to be reasonable.” 

Judge Milazzo further asserts that the plaintiff had adequate opportunity to present these issues at trial and allow the jury to decide the matter for itself. 

“[I]n its Order allowing Defendants’ experts to rely on Dr. Kopreski’s work, the Court wrote that Plaintiff would have the chance to show the jury that Defendants’ experts relied on Dr. Kopreski’s re-analysis,” the judge explains. “The Court wrote that Plaintiff could ask the experts to explain why such reliance was warranted, and ’the jury can decide whether to credit the experts’ testimony.’ Plaintiff had this opportunity at trial. Not only did Plaintiff cross-examine Dr. Glaspy about his reliance on Dr. Kopreski’s work, but the jury saw Plaintiff’s counsel ask Dr. Kopreski about his re-analysis.” 

Judge Milazzo further reasons that, even if the plaintiff’s argument were correct, she still would have failed to meet the high legal standard required to demonstrate the need for a new trial. 

“Lastly, even if the Court erred in allowing Dr. Glaspy to rely on Dr. Kopreski’s re-analysis, Plaintiff has not shown ‘manifest injustice’ to warrant a new trial,” Judge Milazzo's order states, concluding a few sentences later that, “Accordingly, the Court sees no reason to grant a new trial.” 

While the ruling denying a new trial represents an enormous disappointed for the plaintiff Barbara Earnest, her family, and her legal team, as well as a setback for Taxotere plaintiffs more broadly, the massive MDL continues, making its way through pretrial proceedings toward additional bellwether trials, ensuring that the defense verdict in the first bellwether trial will hardly be the last word in Taxotere litigation. 

Sources:

United States District Court Eastern District of Louisiana. (14 February 2020). Order and Reasons. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Memorandum of Law in Support of Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

Taxotere Lawsuit (MDL) Update: Sanofi Asks Court To Toss Claims Of Another Bellwether Plaintiff

February 19, 2020
Author: Daniel Gala

Just weeks after defendant pharmaceutical maker Sanofi succeeded in having the second bellwether trial in multidistrict litigation (MDL) over its cancer drug Taxotere postponed indefinitely by having the intended plaintiff’s lawsuit dismissed, the company has filed multiple motions attempting to have the claims of another prospective bellwether plaintiff tossed as well.   

On February 14, defendant Sanofi filed two separate motions for summary judgment in the case of plaintiff Elizabeth Kahn, who is slated to be a plaintiff in one of the MDL’s upcoming bellwether trials. That trial presently is schedule to begin August 10.   

Sanofi’s Statute of Limitations Argument   

Pursuing what has become one of the MDL’s central lines of argument, Sanofi’s first motion for summary judgment seeks to have plaintiff Kahn’s case dismissed based on the applicable statute of limitations, arguing that she waited too long to file her claim.  

“[T]he Court should grant Sanofi’s Motion because Ms. Kahn’s claims are barred by Louisiana’s one-year statute of limitations,” the defense motion argues. “In brief, Ms. Kahn sustained her alleged injury and was aware of a potential relationship of her Taxotere chemotherapy regimen in January 2010. But Ms. Kahn waited more than six years to file suit in December 2016.”  

Sanofi previously has succeeded in having other cases dismissed from the Taxotere MDL based on a similar argument, including a lawsuit brought by Cynthia Thibodeaux, who had been selected to serve as plaintiff in the MDL’s second bellwether trial. That trial was scheduled to begin March 23 but has since been postponed indefinitely.   

Given the brief one-year window that Louisiana state law allows for the filing of personal-injury claims such as those at issue in the Taxotere MDL, a key matter of contention in Taxotere litigation has been the question of when the clock should begin running on that one-year term. With the MDL being based in US District Court for the Eastern District of Louisiana, in New Orleans, Louisiana state law governs many of the cases.   

Attempting to use the plaintiffs’ own definition of alopecia—or permanent hair loss—against them, defendant Sanofi has argued that the clock should start running six months after the plaintiff in question stopped Taxotere treatment.   

The Taxotere MDL has centralized thousands of lawsuits alleging that Sanofi improperly concealed from doctors and patients in the United States the risk of permanent hair loss associated with its popular and highly profitable cancer drug. In the MDL’s master complaint, plaintiffs define alopecia as occurring when hair has failed to grow back for a period of at least six months.  

Sanofi has argued that, if the plaintiffs’ alleged injury—permanent hair loss—begins at this six-month juncture, then plaintiffs should be allowed one year from that date to file their lawsuits.   

Plaintiffs have pushed back, saying that there is no hard and fast definition of when “permanent” hair loss begins, but the court thus far has shown itself amenable to Sanofi’s argument, having dismissed several cases on that basis already, including that of the would-be second bellwether plaintiff Thibodeaux.   

In response, plaintiffs including Kahn have requested the court’s permission to amend their individual short-form complaints as well as the MDL’s long-form master complaint in order to buttress their arguments against being time-barred, but, to date, the presiding judge has largely rebuffed those efforts, as well.   

“This Court agrees with Defendants that an amendment to the Long-Form Complaint would be inappropriate at this time,” District Judge Jane Triche Milazzo wrote in a December 12 order denying the plaintiffs’ request to amend the master long-form complaint. “The parties and the Court have been operating under Plaintiffs’ original definition of their alleged injury since Plaintiffs adopted it in their original master complaint filed on March 31, 2017. Magistrate Judge North used the definition in resolving certain discovery disputes.”   

Later, Judge Milazzo laid bare what she sees as the plaintiffs’ motivation for wanting to change the language in their lawsuits, giving little hope that she will reconsider her stance.  

“It is apparent that the main reason Plaintiffs wish to amend the Long-Form Complaint at this juncture is to save cases that are otherwise subject to dismissal for being too late,” she wrote. “Presumably, Plaintiffs made an informed decision to define their injury the way they originally did. The Court will not allow Plaintiffs at this point in the MDL to backtrack on that decision.”   

Still, this did not deter the prospective bellwether plaintiff Kahn from filing on January 31 her own motion, along that of plaintiff June Phillips, requesting leave to amend their short form complaints. On February 11, defendant Sanofi filed its opposition in arguing that “Plaintiffs’ untimely amendments to their SFCs [Short-Form Complaints] are an ‘effort to save cases that are otherwise subject to being time-barred.’”   

The court has yet to rule on the requests by plaintiffs Kahn and Phillips to amend their lawsuits, but given Judge Milazzo’s prior rulings, it does not seem likely that she will decide in their favor.   

Sanofi’s Warnings Causation Argument   

Sanofi’s second motion for summary judgment against plaintiff Kahn, also filed February 14, is based on the argument that she has failed to establish all of the necessary elements to support her claim that Sanofi failed to adequately warn her and her doctor about the risk of permanent hair loss associated with Taxotere treatment.  

Specifically, Sanofi argues that Kahn’s case does not satisfy the element of “warnings causation,” which requires a plaintiff to demonstrate both that her doctor would not have prescribed the treatment in question had he or she known about the undisclosed risk and that the alleged injury would not have occurred but for the plaintiff’s having been administered such treatment. Sanofi contends that Kahn’s case falls short on both fronts and should be dismissed as a result.   

First, Sanofi contends that, even had the plaintiff’s doctor been aware of the risk of permanent hair loss at the time, he still would have prescribed his patient the same Taxotere treatment.   

“Here, it is undisputed that the allegedly non-disclosed risk of permanent alopecia would not have changed [plaintiff’s treating physician] Dr. Kardinal’s decision to prescribe Taxotere to Plaintiff—even knowing what he knows today about Taxotere,” Sanofi argues in its memorandum in support of its motion for summary judgment.  

Second, Sanofi says that the plaintiff Kahn has failed to show that she would have avoided the alleged injury by undergoing an alternative cancer treatment.   

“Plaintiff adduced no evidence that choosing another chemotherapy regime without Taxotere would have avoided her alleged injury,” the defendant’s memorandum says. “Dr. Kardinal, who prescribed Plaintiff’s chemotherapy, and Dr. Zoe Larned, who took over Plaintiff’s treatment after her first Taxotere infusion, testified that they had patients who experienced ‘permanent chemotherapy-induced alopecia’ on other ’standard of care’ drugs used to treat Plaintiff’s type of cancer. Dr. Larned further testified that incidence of persistent hair loss with Taxotere is low compare to other chemotherapy drugs.”   

As of publication, the court had yet to rule on either of Sanofi’s motions for summary judgment in the Kahn case.   

Conclusion  

That defendant Sanofi continues to file multiple motions for summary judgment against prospective bellwether plaintiffs demonstrates its strategy of having as many cases as possible dismissed without having to reach a jury trial on the actual merits. However, with thousands of cases pending in one of the largest active MDLs in the United States, plaintiffs undoubtedly will persist in their fight despite momentary setbacks.   

If you or a loved one has suffered permanent hair loss after being treated with Taxotere, contact TheLawFirm.com today for a free consultation!  

Sources:   

United States District Court Eastern District of Louisiana. (14 February 2020). Defendants’ Motion for Summary Judgment Based on the Statute of Limitations. Document 9295. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (12 December 2019). Order and Reasons. Document 8702. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (14 February 2020). Defendants’ Motion for Summary Judgment Based on Warnings Causation. Document 9300. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (31 January 2020). Plaintiffs’ Motion for Leave to File Amended Short Form Complaints of Bellwether Trial Plaintiffs, Elizabeth Kahn and June Phillips. Document 9300. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation  

United States District Court Eastern District of Louisiana. (14 February 2020). Defendants’ Memorandum of Law in Support of Their Motion for Summary Judgment on Warnings Causation. Document 9300-2. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Taxotere MDL’s 2nd Bellwether Trial Postponed Indefinitely After Plaintiff’s Case Dismissed

February 14, 2020
Author: Daniel Gala

The second bellwether trial in federal multidistrict litigation (MDL) over the cancer drug Taxotere (docetaxel) has been postponed indefinitely, per a court order filed February 4. The order does not set a new date for the trial, which had been scheduled to begin in spring 2020.   

“It is ordered that the second bellwether trial previously set for March 23-April 3, 2020, is continued,” states the case management order signed by United States District Judge Jane Triche Milazzo, who is presiding over the Taxotere MDL. “At a later time, the Court will issue a Case Management Order setting a new trial date.”    

While the brief, one-paragraph order also is silent on the reason for the indefinite postponement, it follows the January 23 dismissal of the case of plaintiff Cynthia Thibodeaux, who previously had been selected as the plaintiff for the second bellwether trial.    

Formed in October 2016, the Taxotere MDL has centralized thousands of federal lawsuits accusing the defendant drugmaker Sanofi of failing to adequately warn patients and doctors in the United States about the risk of alopecia, or permanent hair loss, associated with its widely used cancer medication. The MDL’s first bellwether, which was held during September 2019, resulted in a verdict for the defendant drugmaker Sanofi.    

The parties to the Taxotere MDL recently have been embroiled in significant legal wrangling over statute-of-limitations issues, with defendant Sanofi attempting to have broad swathes of cases dismissed for an alleged failure by plaintiffs to file their claims in a timely manner.  For their part, plaintiffs have been seeking the court's permission to amend both individual complaints and the MDL’s master complaint to better protect vulnerable cases from dismissal.    

One such case that recently has been dismissed for a failure to file by the required deadline is that of plaintiff Cynthia Thibodeaux, also known as the previously-selected plaintiff for Taxotere bellwether trial number two.    

The Case Of Would-Be Bellwether Plaintiff Cynthia Thibodeaux    

The arguments made by defendant Sanofi in its motion for summary judgment against plaintiff Cynthia Thibodeaux mirror those the drugmaker is seeking to assert across potentially thousands of cases in the Taxotere MDL. And, worryingly for many Taxotere plaintiffs, US District Judge Milazzo appears to agree with Sanofi on a number of key points.    

For example, in the court’s Order and Reasons for granting Sanofi’s motion for summary judgment in the Thibodeaux case, Judge Milazzo says she agrees with Sanofi’s argument that the allotted time period for the plaintiff to file her claim began running six months after she initially lost her hair due to cancer treatment.    

This interpretation stems from the definition for permanent hair loss provided by an expert witness for the plaintiffs and subsequently relied upon by plaintiffs in the MDL’s master complaint as well as many individual complaints.    

“Defendants’ point to the Master Complaint in the MDL, defining permanent chemotherapy-induced alopecia (‘PCIA’) as ‘an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy,’” the court explains in its Order and Reasons. “Highlighting the fact that in her short Short Form Complaint, Thibodeaux incorporated the Master Complaint by reference, Defendants aver that the prescriptive period began to run six months after Thibodeaux completed chemotherapy.”    

As Judge Milazzo explains, Louisiana state law, which governed in the Thibodeaux case, allows only a short, one-year period in which products liability claims like the ones at issue in the Taxotere MDL may be filed.    

“Under Louisiana Civil Code article 3492, the prescriptive period for products liability claims is one year,” Judge Milazzo writes. “Generally the period begins to run from the day the injury or damage is sustained.”    

Ultimately, the judge sides with Sanofi’s argument that Thibodeaux’s case should be dismissed.    

“This Court agrees with Defendants that Plaintiff’s case is prescribed on the face of the pleadings,” Judge Milazzo explains, following a line of reasoning that may ultimately prove fatal to thousands of Taxotere cases. “Plaintiff identifies her injury as permanent chemotherapy-induced alopecia (‘PCIA’). In her Short Form Complaint, she incorporates the Master Complaint, which defines PCIA as ‘an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy.’ Thibodeaux completed her chemotherapy treatment in June 2009, which means that the one-year prescriptive period began in January 2010 and ended in January 2011. On the face of the pleadings, when Thibodeaux filed her complaint in October 2016, her case had prescribed.”    

Ultimately, Judge Milazzo granted Sanofi’s request for summary judgment and dismissed Thibodeaux’s case with prejudice, leading to the indefinite postponement of the MDL’s second bellwether trial.    

"Sanofi’s Summary Judgment Motion Is Premised On a Falsehood”: The Defense’s Other Early-Dismissal Strategy    

Meanwhile, in addition to seeking to have cases like Thibodeaux’s dismissed for allegedly failing to file by the legally imposed deadline, defendant Sanofi also has urged the court to dismiss all cases involving plaintiffs whose Taxotere treatment began prior to December 15, 2006, arguing that the company had no reason to be aware of certain risks posed by its blockbuster drug before that time.    

In a response filed February 7, plaintiffs presented their arguments against such dismissals, which they say potentially could affect the cases of more than 1,000 women.    

The plaintiffs’ opposition filing opens unequivocally:   

“Sanofi’s summary judgment motion is premised on a falsehood: that Dr. Kessler has opined that the earliest Sanofi knew or could have known that Taxotere causes permanent hair loss is December 15, 2006—the date of Dr. Sedlacek’s report,” the plaintiffs assert. "That is not Dr. Kessler’s opinion; it is a distortion of what he said.”    

The plaintiffs here are referencing of one their own expert witnesses—Dr. David Kessler—as well as a landmark report by Dr. Sedlacek demonstrating the risk of permanent hair loss associated with Taxotere, which first was published December 15, 2006.    

Defendant Sanofi’s motion for summary judgment, filed January 7, argues that plaintiffs’ whose treatment began before that date should have their cases dismissed as a matter of law.    

“In brief, the overwhelming majority of jurisdictions recognize that a prescription drug manufacturer has a duty to warn of risks that the manufacturer knew or should have known of at the time of manufacture,” Sanofi’s January 7 motion for summary judgment argues. “The Plaintiffs’ Steering Committee (‘PSC’) has provided no evidence that Sanofi knew or should have known of a possible causal connection between Taxotere and permanent hair loss before December 15, 2006.”    

In support of this claim, Sanofi argues that the “PSC’s evidence, in fact, confirms Sanofi’s position” because, according to Sanofi,  “PSC’s regulatory expert, Dr. David Kessler, has consistently testified that reasonable evidence of a causal association between Taxotere and permanent hair loss extend no earlier than” the publcation of Dr. Sedlacek’s report.   

Not so, retort the plaintiffs in their February 7 filing.    

“Dr. Kessler has never offered an opinion for any Plaintiff in this MDL who was administered Taxotere before December 15, 2006,” the plaintiffs argue. “Rather, he ‘reserve[d] the right to study the issues at both earlier and later dates,’” they say, quoting Dr. Kessler’s report directly, with emphasis added by plaintiffs’ counsel.     

The plaintiffs similarly cast doubts on defendant Sanofi’s claim that it was unaware of the risk of permanent hair loss associated with Taxotere prior to the publication date of Dr. Sedlacek’s report.    

“What Sanofi fails to tell the Court, however, is that the company knew of Dr. Sedlacek’s findings before that date,” the plaintiffs’ opposition filing alleges. “That evidence easily defeats Sanofi’s request for judgment as of December 2006.”    

Pursuant to an order filed February 12, the court has scheduled oral argument on this matter for March 25.    

Conclusion - Where The Taxotere MDL Goes From Here   

Despite the dismissal of the case previously selected for the second bellwether trial, the Taxotere MDL continues to make its way through pretrial proceedings en route to subsequent bellwethers. On February 6, Judge Milazzo signed an order filed order scheduling the MDL’s next general status conference for March 24, one day after the second bellwether trial had been slated to begin.    

The following day, March 25, the court is scheduled to hear oral arguments on a number of motions in addition to Sanofi’s request to dismiss the cases of all plaintiffs who began taking Taxotere prior to December 15, 2006. The additional motions slated for oral argument that day include Defendants’ Motion for Summary Judgment on the Claims of Plaintiffs Whose Taxotere Treatment Started After December 11, 2015 and Plaintiffs’ Motion for Partial Summary Judgment on Affirmative Defenses Under Louisiana Law.    

Stay tuned to TheLawFirm.com for the latest updates on the Taxotere MDL! If you or a loved one has suffered permanent hair loss after taking Taxotere, contact the experienced team of attorneys at TheLawFirm.com now for a free legal consultation!    

Sources:     

United States District Court Eastern District of Louisiana. (Filed 4 February 2020). Case Management Order No. 22. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (Filed 7 February 2020). Plaintiffs’ Opposition to Defendants’ Motion for Summary Judgment (Pre-December 15, 2006).  MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (Filed 7 January 2020). Defendants’ Motion for Summary Judgment on the Claims of Plaintiffs Whose Taxotere Treatment Started Before December 15, 2006.  MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (Filed 23 January 2020). Judgment. Cynthia Thibodeaux, No. 16-15859. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (Filed 23 January 2020). Order and Reasons. Cynthia Thibodeaux, No. 16-15859. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (Filed 12 February 2020). Order. MDL No. 16-2740. In re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Taxotere MDL Judge Upholds Dismissal Of Two Cases, Grants Summary Judgment In Third

January 29, 2020
Author: Daniel Gala

In what is shaping up to be an issue central to litigation over claims that pharmaceutical-maker Sanofi failed to warn patients and doctors about the risk of permanent hair loss associated with its cancer drug Taxotere, at least three cases recently have been dismissed on the basis that they were not filed within the time period allowed by law. Worryingly, these dismissals were based on timelines established in plaintiffs’ own definition of their alleged injuries.    

Plaintiff Thibodeaux    

First, on January 23, US District Judge Jane Triche Milazzo issued an order granting a defense motion for summary judgment in the case of plaintiff Cynthia Thibodeaux, ruling that, by filing her lawsuit "more than six years after she completed chemotherapy and lost her hair,” Thibodeaux had failed to meet the one-year deadline allowed for the filing of such claims under Louisiana law, which governs in her case.    

The case is part of multidistrict litigation (MDL) presently taking place in federal court in the Eastern District of Louisiana at New Orleans, and the issue of timing is one that is proving to be central to many cases in the massive litigation. Defining the condition of alopecia—or permanent hair loss—in the master complaint, plaintiffs relied on testimony of their expert in saying that permanent hair loss essentially begins as a clinical diagnosis when hair still has not regrown six months after initial hair loss.    

The defendant Sanofi has used this definition as a basis to argue that the one-year period Louisiana law provides in which plaintiffs may file a claim should begin six months after a plaintiff first suffered from hair loss. Under this view, many of the MDL’s plaintiffs are at risk of having their cases similarly dismissed for failure to file their claim in a timely manner.    

In an effort to revise this six-month definition, plaintiffs have requested leave from the court to amend both the master complaint and the short-form complaints relating to individual cases, but to date the court has rebuffed those efforts, refusing to give plaintiffs an additional opportunity to amend their complaints at this late date.    

Without an amendment, many plaintiffs risk the same fate as Thibodeaux.    

“The Court agrees with Defendants that Plaintiff’s case is prescribed on the face of the pleadings,” Judge Milazzo wrote in her order granting summary judgment in Thibodeaux’s case. “Plaintiff identifies her injury as permanent chemotherapy-induced alopecia (‘PCIA’). In her Short Form Complaint, she incorporates the Master Complaint, which defines PCIA as ‘an absence of or incomplete hair growth six months beyond the completion of chemotherapy.’ Thibodeaux completed her chemotherapy treatment in June 2009, which means that the one-year prescriptive period began in January 2010 and ended in January 2011. On the face of the pleadings, when Thibodeaux filed her complaint in October 2016, her case had prescribed.”    

While the plaintiff argued “that she reasonably believed her hair would grow back until she saw the attorney advertisement in 2016,” the court rejected this argument, instead relying on the six-month period as defined in the master complaint.    

Plaintiffs Johnson and Francis    

Similarly, also on January 23, Judge Milazzo issued a separate order denying a request made by two other plaintiffs to reconsider the court’s decision in July 2019 to dismiss their cases, also for not having been filed in a timely manner for reasons similar to those provided in Thibodeaux’s case.    

Namely, relying on the master complaint’s definition of permanent hair loss as beginning six months after hair has not regrown, the court found that those cases had no been filed in a timely manner, as well.    

“In its Order and Reasons dated July 9, 2019, the Court held that the claims of Plaintiffs Deborah Johnson and Tanya Francis were prescribed,” Judge Milazzo wrote in her January 23 order. “To make this decision, the Court had to consider when their injuries manifested—or when their hair loss became permanent. The Court looked to the Plaintiffs’ Master Complaint in the MDL, which alleges that permanent chemotherapy induced alopecia (‘PCIA’) ‘is defined as an absence or incomplete hair regrowth six months beyond the completion of chemotherapy.’ Notably, both Johnson and Francis incorporated the allegations of the Master Complaint into their Short Form Complaints, and several experts in this MDL have defined PCIA in the same way as the Master Complaint.”    

In asking the court to reconsider its ruling, “Plaintiffs argue that the Court inappropriately relied on the definition of permanent alopecia set forth in the Master Complaint.”    

However, the court rejects this contention, writing, “Plaintiffs fail to point to any manifest error in the Court’s reasoning.”    

Conclusion    

The willingness of the Taxotere MDL judge to dismiss cases for failure to file in a timely manner based on the six-month definition of the onset of permanent hair loss poses a potentially serious problem for a number of plaintiffs in the litigation, with Sanofi clearly adopting a strategy of having as many cases tossed out on summary judgment as possible, without ever reaching a decision on the merits of the case. That the court has shown reluctance thus far to allow either the plaintiffs’ steering committee or individual plaintiffs to amend their complaints to address the issue presents an additional challenge for plaintiffs seeking to overcome this legal hurdle.    

The situation also serves as a reminder of the importance of brining a legal claim as soon as possible after one learns of the potential for legal action, with defendants quick to have cases tossed for, they argue, failing to meet the required filing deadlines.    

Don’t let your right to bring legal action expire before you file your claim! Contact the experienced team of attorneys at TheLawFirm.com right away for a free legal consultation!    

  Sources:   

United States District Court Eastern District of Louisiana. (23 January 2020). Order and Reasons. Cynthia Thibodeaux, No. 16-15859. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation    

United States District Court Eastern District of Louisiana. (23 January 2020). Order and Reasons. Deborah Johnson, 16-cv-15607. Tanya Francis, 16-cv-17410. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Taxotere MDL Court Sets Deadlines For Plaintiffs To Remedy ‘Deficient’ Discovery Responses

January 13, 2020
Author: Daniel Gala

Certain plaintiffs accused by defendant Sanofi of submitting “deficient” responses to pretrial discovery requests in multidistrict litigation (MDL) over the cancer drug Taxotere have been given a mid-February deadline to correct such deficiencies or explain to the court why such alleged deficiencies do not exist, according to a January 10 minute entry.   

The entry, signed by US Magistrate Judge Michael B. North, followed a docket conference call also held January 10. During the conference call and the subsequent minute entry, the court established a procedure by which it aims to resolve ongoing discovery disputes in an orderly and timely manner.   

Specifically, the discovery disputes at issue involve plaintiffs’ production of electronically stored information, or ESI. The defendant Sanofi has taken issue with the format in which some plaintiffs have produced ESI related to their cases.   

“As to the remaining Plaintiffs listed on Sanofi’s January 10, 2020 deficiencies spreadsheet, each such Plaintiff shall have until February 10, 2020 to cure any remaining deficiencies,” the minute entry states. “To the extent that Sanofi has a reasonable belief that any Plaintiff has not completely complied with the obligation to produce ESI in the proper format, Sanofi’s counsel is to confer with counsel for the Plaintiff to discuss any perceived shortcomings in an attempt to finally resolve the matter as to that Plaintiff.”   

Once these conferences have been held, the court then expects the defense to file a single document summarizing any remaining conflicts.   

“Following such conference(s), to the extent any disputes remain concerning the completeness of a particular Plaintiff’s ESI production, Sanofi shall submit to the Court a single statement explaining its position as to the alleged deficiencies, limited to a short paragraph per Plaintiff,” the minute entry states.   

After this filing by the defense, plaintiffs then will have 21 days to respond, providing “a similarly brief explanation setting forth why counsel believes Plaintiff’s discovery response is complete,” at which time the “Court will determine how to proceed thereafter upon receipt of said submissions.”   

Additionally, the minute entry covers a number of plaintiffs who have submitted ESI related to their cases only in PDF, purportedly because it was the only format in which the ESI is presently available.   

“As to the eight Plaintiffs identified by Sanofi who have produced only PDF versions of documents/photographs in response to this Court’s November 6, 2019 order, within 14 days counsel for those Plaintiffs are to submit to Sanofi a Rule 26 certification that the underlying ESI has been lost,” the entry states.   

The Taxotere MDL has centralized thousands of federal products liability lawsuits accusing drugmaker Sanofi of failing to adequately disclose to patients and doctors in the United States the risk of permanent hair loss associated with its cancer drug Taxotere. While the MDL’s highly anticipated first bellwether trial—held in September 2019—resulted in a verdict for defendant Sanofi, the court already is far along in preparations for additional bellwethers, which are scheduled in commence in 2020.   

If you or a loved one has suffered from permanent hair loss after taking the cancer drug Taxotere (docetaxel), contact TheLawFirm.com for a free consultation with a licensed attorney!   

Source:   

United States District Court Eastern District of Louisiana. (10 January 2020). Minute Entry for proceedings held before Magistrate Judge Michael North. Document 9026. Case 2:16-md-02740-JTM-MBN. MDL 2740. In re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update - Taxotere MDL: Defendants Move To Dismiss All Cases In Which Taxotere Use Began Before December 2006

January 10, 2020
Author: Daniel Gala

In multidistrict litigation (MDL) over allegations that Big Pharma defendant Sanofi failed to warn patients and their doctors about the risk of permanent hair loss associated with the cancer drug Taxotere, the defense has moved to dismiss all cases in which the plaintiffs’ use of the drug began prior to December 15, 2006, saying that Sanofi had no reason to know of the alleged risks prior to that time.    

According to an exhibit submitted by Sanofi in support of its motion to dismiss, if granted, the request could cause nearly 1,400 cases to be tossed from the MDL.    

“In brief, the overwhelming majority of jurisdictions recognize that a prescription drug manufacturer has a duty to warn of risks that the manufacturer knew or should have known at the time of manufacture,” argues Sanofi’s motion for summary judgement, filed January 7. “The Plaintiffs’ Steering Committee (‘PSC’) has provided no evidence that Sanofi knew or should have known of a possible causal association between Taxotere and permanent hair loss before December 15, 2016.”    

In establishing this date as the time at which the risk of permanent hair loss posed by Taxotere arguably became knowable, Sanofi relies on the testimony of the plaintiffs’ own expert.    

“Specifically, the PSC’s regulatory and label expert, Dr. David Kessler, testified that ‘by as early as 2009,’ and no earlier than December 15, 2006, there first existed reasonable evidence of a causal association between Taxotere and permanent hair loss requiring Sanofi to change the Taxotere label,” states the memorandum in support of Sanofi’s motion. “No expert offered by the PSC has or will testify that Sanofi had actual or constructive knowledge of such evidence (or a corresponding duty to warn) any earlier than this date.”    

The date December 15, 2006 is significant because that is the day on which “an abstract by Dr. Scot Sedlacek was presented at the San Antonio Breast Cancer Symposium,” according to a footnote contained in Sanofi’s memorandum.    

“‘Sedlacek’s date in 2006 the bells should be going off,’” Sanofi quotes plaintiffs’ expert Dr. Kessler, a former commissioner for the US Food and Drug Administration (FDA), as testifying. “‘[T]his data was publicly available, it was at the major breast conference, it was put out in 2006, but in 2006 this was over, as far as causation.’”    

In Exhibit A to its memorandum in support of its motion for summary judgment, defendant Sanofi provides the court with a list of all the cases it believes should be dismissed because the plaintiff’s Taxotere treatment began prior to December 15, 2016. Listed by order of the date of the plaintiff’s first Taxotere treatment, this list covers 36 single-spaced pages and contains roughly 1,370 cases, according to an analysis conducted by TheLawFirm.com.    

Some plaintiffs appear to have missed what Sanofi is seeking to establish as the deadline by mere days, with one having commenced treatment on December 13, 2006 and another on December 12. Some plaintiffs are listed as having begun Taxotere treatment as early as the late 1990s.    

As of December 16, 2019, the Taxotere MDL was the fourth largest active MDL in the United States with 11,971 actions pending and 14,187 total cases having taken part in the ongoing litigation, according to the Judicial Panel on Multidistrict Litigation (JPML).    

This means that, in its motion for summary judgment, Sanofi is asking the court to toss over 10% of the MDL’s active cases.    

When a party to litigation seeks summary judgment, that party essentially is telling the court that, even assuming for the sake of argument that the facts as presented by the opposing party are true, the opposing party still has not stated a sufficient basis to support its legal arguments. Therefore, the party moving for summary judgment argues, the case should be dismissed, as there are no facts to be decided and, consequently, no reason to hold a trial.    

The Taxotere MDL was established in October 2016 by order of the JPML. The MDL’s highly anticipated first bellwether trial, which was held in September 2019, resulted in a verdict for the defense, but the plaintiff has since requested a new trial. Subsequent bellwethers are scheduled to commence in 2020.    

  Source:     

United States District Court Eastern District of Louisiana. (7 January 2019). Defendants’ Motion For Summary Judgment On The Claims Of Plaintiffs’ Whose Taxotere Treatment Started Before December 15, 2006. Case 2:16-md-02740-JTM-MBN. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (7 January 2019). Defendants’ Memorandum Of Law In Support Of Their Motion For Summary Judgment On The Claims Of Plaintiffs’ Whose Taxotere Treatment Started Before December 15, 2006. Case 2:16-md-02740-JTM-MBN. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States District Court Eastern District of Louisiana. (7 January 2019). Exhibit A To Defendants’ Motion For Summary Judgment On The Claims Of Plaintiffs’ Whose Taxotere Treatment Started Before December 15, 2006. Case 2:16-md-02740-JTM-MBN. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation   

United States Judicial Panel on Multidistrict Litigation (JPML). (16 December 2019). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending

Taxotere Lawsuit Update: Taxotere MDL Judge Grants In Part Plaintiffs’ Motion To Amend Third Bellwether Complaints, Denies Changes To Master Complaint

December 20, 2019
Author: Daniel Gala

The judge overseeing multidistrict litigation (MDL) over the cancer drug Taxotere (docetaxel) on December 12 granted in part and denied in part a motion filed by three prospective plaintiffs in the MDL’s forthcoming third bellwether trial requesting permission to amend their lawsuits. On the same day, the judge also denied in full a motion to amend the MDL’s master long-form complaint.

The Taxotere MDL has centralized thousands of federal lawsuits alleging that the cancer medication caused permanent hair loss in a significant percentage of patients, a fact that plaintiffs allege defendant drug company Sanofi-Aventis knew but failed to disclose to US regulators, doctors, or patients.

“Plaintiffs in this multidistrict litigation (‘MDL’) are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel, that Plaintiffs were administered for the treatment of breast cancer and other forms of cancer,” United States District Judge Jane Triche Milazzo summarized in her order denying plaintiffs’ motion to amend their master complaint. “Plaintiffs allege that the drug caused permanent alopecia—in other words, permanent hair loss. Plaintiffs bring claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more.”

Plaintiffs’ Request To Amend The Master Complaint

Judge Milazzo’s orders on the plaintiffs’ requests to amend the complaints for the third bellwether trial and the master complaint arise from rulings reached in the runup to the MDL’s first bellwether trial, which took place from September 16 through September 26 and resulted in a verdict for the defendant drugmaker Sanofi.

Judge Milazzo explains:

“Notably, before the first bellwether trial, the Court ruled on Defendants’ summary judgment motions asserting statute-of-limitations defenses. In its rulings, the Court had to decide when Plaintiffs injuries manifested and when prescription began to run. The Court looked to Plaintiffs’ complaint, which alleged that their hair loss became permanent when it had not grown back six months after the completion of chemotherapy. Accordingly, the Court found that generally prescription begins to run after six months of hair loss.”

That is, in the lead-up to the first bellwether trial, the court was faced with the question of when the statute of limitations should begin to take effect for the purposes of the plaintiff’s claims. This is a very important consideration because the law gives plaintiffs only a limited time period, often just a few years, in which to file a lawsuit once the claim has become valid.

Relying on information contained in the plaintiffs’ master complaint, the court ruled that the time allotted by the applicable statute of limitations would run starting six months after a plaintiff first experienced permanent hair loss. As this ruling would time-bar many of the MDL’s existing cases, and arguably relied on a misinterpretation of the clinical diagnosis of permanent hair loss, plaintiffs’ have sought to revise the relevant language contained in their master complaint.

Again, Judge Milazzo summarizes:

“In the Motion before the Court, Plaintiffs seek to amend the Long-Form Complaint to no longer define their injury as manifesting six months after chemotherapy. Instead, the proposed amended complaint alleges that ‘[t]here is no single definition for Permanent Chemotherapy Induced Alopecia and the amount of time to establish permanent hair loss varies from patient to patient, including among Plaintiffs.’”

However, despite the law granting district courts wide discretion in determining whether or not to allow a party to amend its pleadings, Judge Milazzo finds that, given the particular circumstances, the requested revisions to the master complaint are unwarranted.

“This Court agrees with Defendants that an amendment to the Long-Form [Master] Complaint would be inappropriate at this time,” Judge Milazzo writes. “The parties and the Court have been operating under Plaintiff’s original definition of their alleged injury since Plaintiffs adopted it in their original master complaint filed on March 31, 2017. Magistrate Judge North used the definition in resolving certain discovery disputes.”

After citing several specific instances in which the court has relied on plaintiffs’ existing definition of permanent alopecia in making key rulings, Judge Milazzo determines that it would unfairly impact the defendants to allow a revision at this time.

“The Fifth Circuit has held that a defendant is unduly prejudiced by granting leave to amend if the changes to the complaint would require additional discovery and the defendant to prepare a different defense,” the order states. “If the Court were to allow Plaintiffs to amend at this late stage, this would negate a significant amount of the work that has been done in this MDL. Defendants would undoubtedly want to revise certain expert reports and conduct supplemental depositions, and certain rulings from the Court would be mooted.”

In addition to naming the numerous ways in which the MDL would be forced, in essence, to backtrack to accommodate the plaintiffs’ requested revisions to the master complaint, Judge Milazzo also calls out directly what she sees as the plaintiffs’ motives for requesting such change. “It is apparent that the main reason Plaintiffs wish to amend the Long-Form Complaint at this juncture is to save cases that are otherwise subject to dismissal for being filed too late,” Judge Milazzo says.

It is unclear how many of the MDL’s thousands of cases might be impacted by the court’s ruling not to allow the requested amendments to plaintiffs’ master complaint.

Request To Amend Complaints For Third Bellwether Trial

Separately from the question of whether the court would permit the MDL’s plaintiffs to amend the master complaint affecting all cases, Judge Milazzo also ruled December 12 on a motion filed by three prospective plaintiffs for the third bellwether trial seeking to amend their short-form complaints. As the judge explains, one of these three plaintiffs ultimately will be selected as the plaintiff in that trial.

“These are the three Plaintiffs that the Court selected on October 31, 2019, to proceed with discovery in connection with the third bellwether trial,” Judge Milazzo writes. “In other words, the Court ruled that these three cases should continue being developed with an eye toward trial, as any of them could be selected as the bellwether plaintiff for the third trial.”

The plaintiffs’ proposed amendments would, in the words of the court “eliminate certain causes of action, add a failure to warn claim under the Louisiana Products Liability Act (‘LPLA’), and revise and add several allegations.”

In response, the court granted in part and denied in part the plaintiffs’ requests, allowing plaintiffs’ proposed changes with regards to “removing certain causes of action and adding inadequate warning claims under the LPLA” but not the plaintiffs’ requests to “revise and add several allegations.”

The court makes quick work of the question of removing of certain causes of action and adding the LPLA claim, as these amendments were not contested by defendants.

“Insofar as Plaintiffs seek to eliminate certain legal counts not recognized by Louisiana law, Defendants do not oppose the Motion,” Judge Milazzo writes. “Defendants also do not oppose Plaintiffs’ addition of an inadequate warning claim under the LPLA. Plaintiff’s Motion is granted in these respects.”

However, the three prospective plaintiffs’ next requested amendments are the same as those sought on behalf of all of the MDL’s plaintiffs with regards to the master complaint, and the court reaches an identical conclusion for identical reasons.

“Essentially, Plaintiffs move the Court to adopt and incorporate the amended Long-Form [Master] Complaint that was the subject of the Plaintiffs’ Motion to Amend the Long-Form Complaint [citation omitted], which the Court denied,” Judge Milazzo writes. “For the reasons explained in the Court’s order denying that Motion, the Court will not allow Plaintiffs to alter allegations in their Short-Form Complaints to parallel the proposed Long-Form [Master] Complaint.”

The court also denies two additional amendments proposed by the plaintiffs, the first of which would have added additional allegations “regarding Sanofi, a manufacturer that is not a Defendant in the case of the three Plaintiffs bringing the instant Motion.” Bluntly, the court finds that “Plaintiffs offer no basis for including these allegations in their complaints.”

Finally, the court rejects a similar change that would have eliminated a date for the onset of “Hair Loss and Thinning” in reference to one of the plaintiffs, again noting that “it is apparent that Plaintiffs seek to revise their allegations to buttress their claims against statute-of-limitations defendants.”

Conclusion

The multiple motions filed by both the plaintiffs steering committee and the individual prospective bellwether plaintiffs highlights the concerns plaintiffs and their lawyers have over potential statute-of-limitations defenses posed by the defendants. Pretrial discovery rulings in the leadup to the MDL’s first bellwether, which appear to have prompted the plaintiffs’ motions to amend, may ultimately prove critical to thousands of Taxotere and docetaxel cases that may end up being time-barred as a result.

While it is not apparent that individual plaintiffs will be held to the same general rule that the time allotted to file a claim under the requisite statute of limitations begins six months after the plaintiff first experienced hair loss, given the nature of MDLs, in which a relative few bellwether trials are intended to lay the groundwork for broader settlement negotiations, it is unlikely that every individual plaintiff will have the opportunity to argue the specifics of her case at trial.

Meanwhile, although one of the orders issued December 12 dealt directly with the third bellwether, the court continues to make its way toward the MDL’s second trial, presently scheduled to commence March 23, 2020.

Sources:

United States District Court Eastern District of Louisiana. (12 December 2019). Order and Reasons. (Re: Motion for Leave to File Amended Short-Form Complaints For The Third Bellwether Trial Plaintiffs [Doc. 8577]). MDL No. 16-2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (12 December 2019). Order and Reasons. (Re: Motion for Leave to File Plaintiffs’ Third Amended Master Long-Form Complaint and Jury Demand [Doc. 8334]). MDL No. 16-2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability

Taxotere Lawsuit Update: Taxotere MDL Judge Hears Oral Arguments On Plaintiff’s Request For New Trial

December 7, 2019
Author: Daniel Gala

The judge presiding over multidistrict litigation (MDL) involving the cancer drug Taxotere heard on December 5 oral arguments pertaining to a number of key issues, including a request for a new trial made by the plaintiff in the MDL’s first bellwether.

The issues argued at the hearing, which took place between 9:30 am and 11:00 am, also included a motion by the plaintiffs steering committee to amend the MDL’s master long-form complaint as well as the short-form complaints for the plaintiffs in the upcoming third bellwether trial, court documents show.

No final rulings have been made on the issues argued. Pursuant to an order issued December 6, the next general status conference is scheduled for January 9, 2020 at 9:30 am.

The Taxotere MDL has centralized thousands of lawsuits filed on behalf of plaintiffs who allege that the defendant pharmaceutical makers, primarily Taxotere-maker Sanofi-Aventis, failed to adequately warn patients and doctors about the known risk of permanent hair loss associated with their drugs. Plaintiffs also accuse Sanofi of overstating Taxotere’s benefits as compared to other available treatment options.

The Taxotere MDL’s long-awaited first bellwether trial concluded in September with a verdict for the defendant Sanofi, the jury having found for the defense on the threshold question of whether or not Taxotere was responsible for the plaintiff’s permanent hair loss. Having found that Taxotere was not the cause, the jury did not even reach later questions as to Sanofi’s potential liability on failure-to-warn claims.

Roughly a month after the jury’s verdict was handed down in late September, on October 25, plaintiff Barbara Earnest filed a motion requesting a new trial on the basis of certain alleged improprieties pertaining to the testimony of Sanofi’s expert witness. Sanofi filed its response November 20, characterizing the plaintiff, a cancer survivor now suffering from permanent hair loss, as “rehashing her baseless challenge to the expert testimony.”

Meanwhile, Sanofi is seeking from the plaintiff Ms. Earnest reimbursement for certain costs associated with the litigation, including expenses related to the very expert testimony at issue in the plaintiff’s request for a new trial.

United States District Judge Jane Triche Milazzo, overseeing the MDL in the Eastern District of Louisiana at New Orleans, might issue her rulings on the matters discussed at the December 5 oral argument at any time.

Sources:

United States District Court Eastern District of Louisiana. (5 December 2019). Minute Entry. MDL No. 16-2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (6 December 2019). Pretrial Order No. 101. MDL No. 16-2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (20 November 2019). Defendants Sanofi-Aventis U.S. LLC And Sanofi US Services Inc.’s Response In Opposition To Plaintiff Barbara Earnest’s Motion For A New Trial. Case No. 2:16-cv-17144. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Taxotere MDL: Defendants Fight Plaintiffs’ Request To File Amended Complaint For Third Bellwether

December 3, 2019
Author: Daniel Gala

Defendant pharmaceutical companies embroiled in multidistrict litigation (MDL) over the cancer drug Taxotere have taken aim at a request by the plaintiffs steering committee (PSC) to file amended complaints for the plaintiffs in the MDL’s forthcoming third bellwether trial, filing their opposition with the court November 26.

Oral arguments on the issue are scheduled for December 5.

While third-bellwether defendants Sandoz, Inc.; Hospira Worldwide, Inc.; and Accord Healthcare, Inc. did accede to certain changes in the plaintiffs’ short-form complaints, they urged the court not to allow others.

“Plaintiffs Wanda Stewart, Dora Sanford, and Alice Hughes seek permission from the Court to amend their respective Short Form Complaints (‘SFCs’) to: eliminate some of the legal counts not recognized by Louisiana Law; add a failure-to-warn claim under the Louisiana Products Liability Act (‘LPLA’); and revise and add numerous allegations that are either inconsistent with their prior allegations and sworn testimony or are irrelevant to these Defendants,” the filing states. “Defendants do not oppose the Motion for leave to amend to the extent that Plaintiffs seek to eliminate causes of action not permitted by Louisiana law and to add a failure-to-warn claim under the LPLA. Defendants otherwise oppose the Motion.”

Defendants’ First Argument

First, the defendants argue, because Louisiana law will apply to the plaintiffs in that case, the third bellwether plaintiffs should not be permitted to amend their complaint merely to add a claim under the Louisiana Products Liability Act, but should be required to replace similar claims stated in the MDL’s master complaint.

“Plaintiffs should be directed to substitute their LPLA cause of action for their generic Master Complaint Count I,” the defendants argue. “They cannot pursue both.”

Defendants’ Second Argument

Second, the defendant pharmaceutical company say that the PSC should not be denied their request to amend the third bellwether plaintiffs’ short-form complaint to the extent that, as the defendants accuse, the PSC is attempting to use it as a back-door method for amending the MDL’s master complaint.

“The purpose of the Short Form Complaint is to tailor the general allegations in the Master Complaint to fit the specific facts of each case,” reads the defendants’ opposition. “Instead, Plaintiffs are attempting to use their SFCs to do the opposite—to expand the general, non-case-specific allegations in the Master Complaint.”

The defendant pharmaceutical companies previously had opposed the PSC’s efforts to revise the master complaint for reasons “including Plaintiffs’ undue delay and the prejudice and futility of the requested amendments.”

To support this contention, the defendants’ note that the plaintiffs’ request “proposes to add dozens of allegations that relate only to Sanofi, a non-party [in the third bellwether trial], and not to any of the…Defendants named in these three cases.”

Defendants’ Third Argument

Finally, the defendants’ third argument for the court to deny certain proposed amendments to the short form complaint refers to a specific plaintiff in the third bellwether trial, Alice Hughes.

“Third, Plaintiffs’ Motion should be denied as to Plaintiff Hughes’s attempt to amend her case-specific factual allegations to delete her previously-alleged date of onset of injury,” the opposition says.

The date of onset of the injury is significant as it can impact how much time a plaintiff has to file his or her lawsuit.

The Taxotere MDL

Since October 4, 2016, federal products liability lawsuits over Taxotere have been centralized in the Eastern District of Louisiana. Plaintiffs allege that the pharmaceutical company Sanofi-Aventis and other defendants purposefully concealed the risk of permanent hair loss associated with Taxotere while also overplaying its benefits as compared to competing treatments.

The long-awaited first bellwether trial ended in September with a jury verdict for defendant Sanofi-Aventis, but the plaintiff has requested a new trial, alleging improprieties with the testimony of the expert witness for the defense.

The MDL’s second and third bellwether trials are slated to begin during the first half of 2020.

Sources:

United States District Court Eastern District of Louisiana. (26 November 2019). Sandoz, Hospira, and Accord Defendants’ Response To PSC’s Motion For Leave To File Amended Short Form Complaints For Third Trial Plaintiffs. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: JPML Transfers Another Case To Taxotere MDL As Parties Exchange Preliminary Witness Lists

November 26, 2019
Author: Daniel Gala

The Judicial Panel on Multidistrict Litigation (JPML) on November 22 issued an order transferring an additional case to multidistrict litigation (MDL) over allegations that drugmaker Sanofi-Aventis failed to adequately disclose to patients and doctors the risk of permanent hair loss associated with its cancer drug Taxotere.

Meanwhile, on November 21, parties in three of the MDL’s cases exchanged preliminary witness lists in preparation for upcoming bellwether trials. The Taxotere MDL’s long-awaited first bellwether trial concluded on September 26 with a verdict in favor of the defendant drugmaker.

“On October 4, 2016, the Panel transferred 28 civil action(s) to the United States District Court for the Eastern District of Louisiana for coordinated or consolidated pretrial proceedings,” the JPML’s November 22 conditional transfer order states. “Since that time, 357 additional action(s) have been transferred to the Eastern District of Louisiana.”

The November 22 transfer order included a single case from the District of New Jersey.

According to a JPML statistics report, the Taxotere MDL was already the fourth largest active MDL in the United States, with 11,784 actions pending as of November 19. The MDL has included 13,927 total cases.

Meanwhile, three separate plaintiffs and three different defendants submitted preliminary witness lists to the court on November 21. The defendants to submit preliminary witness lists include Sandoz, Inc.; Hospira, Inc.; and Accord Healthcare, Inc., each facing a different plaintiff.

At the same time, District Judge Jane Triche Milazzo, presiding over the MDL, is weighing a request for a new trial submitted to the court by the plaintiff from the MDL’s first bellwether. The plaintiff alleges certain improprieties relating to the testimony of the defendant pharmaceutical maker’s expert witness. Meanwhile, the victorious defendant Sanofi-Aventis, defendant in the first Taxotere bellwether, is seeking certain costs, including expert witness expenses, from the plaintiff in that case.

A hearing on the subject of a new trial in the first Taxotere bellwether is scheduled to take place on December 5.

The next bellwether trials are scheduled to commence in 2020.

Sources:

United States District Court Eastern District of Louisiana. (21 November 2019). The Hospira Defendants’ Preliminary Witness List. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Dora Sanford v. Hospira, Inc. et al, Civil Case No. 2:17-cv-09417

United States District Court Eastern District of Louisiana. (21 November 2019). Defendant Sandoz Inc.’s Preliminary Witness List. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Wanda Stewart v. Sandoz Inc. Civil Case No. 2:17-cv-10817

United States District Court Eastern District of Louisiana. (21 November 2019). Defendant Accord Healthcare, Inc.’s Preliminary Witness List. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Alice D. Hughes Case No. 2:17-cv-11769

Judicial Panel on Multidistrict Litigation (JPML). (19 November 2019). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending

Taxotere Lawsuit Update: Sanofi Files Response To Taxotere Bellwether Plaintiff’s Request For New Trial

November 25, 2019
Author: Daniel Gala

Nearly a month after the plaintiff in the first bellwether trial in multidistrict litigation (MDL) over the cancer drug Taxotere filed a motion requesting a new trial, citing problems with the defense’s expert testimony, defendant Sanofi-Aventis filed its response November 20, urging the court to deny the plaintiffs’ request and reject her “baseless challenge to the expert testimony of Dr. John Glaspy.”

The request for a new trial follows a verdict delivered September 26, in which the jury found that Taxotere was not responsible for the permanent hair loss suffered by plaintiff Barbara Earnest. The trial was the first bellwether in multidistrict litigation (MDL) that has centralized thousands of federal Taxotere lawsuits.

In a motion filed October 25, the plaintiff Earnest requested that the court grant a new trial on the basis of certain improprieties relating to the testimony of the single expert witness to testify for Sanofi-Aventis at trial. Specifically, the plaintiff argues that defense expert Dr. John Glaspy improperly relied on a controversial re-analysis of clinical data conducted by Dr. Michael Kopreski without confirming its conclusions for himself, as the plaintiff argues was required by rules established by the court during pretrial proceedings.

“The Court permitted Sanofi’s expert witnesses to rely on Dr. Kopreski’s re-analysis at trial—but only because the Court credited Sanofi’s representation that its experts would testify that they had independently reviewed Dr. Kopreski’s work,” the plaintiff’s memorandum in support of its request for a new trial says. “At trial, however, Dr. John Glaspy, Sanofi’s sole testifying expert—stated unequivocally that he could not independently verify Dr. Kopeski’s re-analysis.”

However, in its November 20 response, defendant Sanofi-Aventis paints the plaintiff’s request for a new trial as being based on a tired retread of arguments already dismissed by the court.

“Plaintiff now seeks a new trial by rehashing her baseless challenge to the expert testimony of Dr. John Glaspy,” the defendant’s response says. “Plaintiff’s Motion for a New Trial is an attempt to revive the same flawed claim, premised on a selective and misleading recitation of the trial record and this Court’s prior decisions. This Court has already considered and correctly rejected Plaintiff’s arguments.”

Attorneys for Sanofi-Aventis also argued that there was sufficient evidence beyond the expert testimony to support the jury’s verdict.

“In any event, the trial record, including testimony by Plaintiff’s own experts provided substantial evidence, independent of any testimony by Dr. Glaspy, that supported the jury’s verdict that Taxotere did not cause Mrs. Earnest’s permanent alopecia,” the defendant’s response says. “Mrs. Earnest lost her hair before ever taking Taxotere in 2011. Evidence showed that the chemotherapy drugs Mrs. Earnest took before taking Taxotere—Adriamycin and Cytoxan—carry reports of permanent hair loss. Further, since receiving chemotherapy, Mrs. Earnest has taken Arimidex, a hormone suppression therapy also associated with reports of persistent hair loss.”

Defendant Sanofi-Aventis’ response was filed pursuant to an October 31 order that gave the drugmaker until November 20 to file its response to the plaintiff’s request for a new trial. According to the same order, oral arguments on the issue of a new trial are to be held December 5 at 9:30 am.

Meanwhile, the MDL continues to make its way toward subsequent bellwether trials, meaning that, whatever the outcome of plaintiff Barbara Earnest’s request for a new trial, the September 26 verdict for the defense will not be the final word in Taxotere litigation.

Sources:

United States District Court Eastern District of Louisiana. (20 November 2019). Defendants Sanofi-Aventis U.S. LLC And Sanofi US Services Inc.’s Response In Opposition To Plaintiff Barbara Earnest’s Motion For A New Trial. Case No. 2:16-cv-17144. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Memorandum of Law in Support of Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (Filed 31 October 2019). Order. This document applies to all cases. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Section: “H”

Taxotere Lawsuit Update: Sanofi Continues Push To Collect Costs From First Bellwether Plaintiff ‘Of Limited Means’

November 15, 2019
Author: Daniel Gala

Multi-billion-dollar pharmaceutical giant Sanofi continues to persist in its efforts to collect more than $50,000 in litigation costs from a plaintiff “of limited means” who took on Sanofi in the first bellwether trial over the company’s cancer drug Taxotere, despite the court having yet to make a determination on the plaintiff’s request for a new trial based on alleged improprieties in the testimony of Sanofi’s expert witness.

On September 26, a jury found that Taxotere was not responsible for the plaintiff’s permanent hair loss, but the plaintiff has requested a new trial, arguing that the defense violated pretrial rulings governing the testimony of its expert witness.

Though the issue of a new trial remains open, according to a bill of costs submitted October 10, Sanofi is seeking nearly $57,000 from the plaintiff Earnest, who sued Sanofi alleging that Taxotere caused her to suffer from permanent disfigurement in the form of lifelong hair loss. Among the costs being sought are $1,760.68 in "Expert Witness Costs” for Dr. John Glaspy, whose testimony is at the heart of the plaintiff’s request for a new trial.

In an order issued November 14, United States District Judge Jane Triche Milazzo granted defendant Sanofi’s request to enter Sanofi’s Reply in Support of Motion to Tax Costs Against Plaintiff, Barbara Earnest, into the court’s docket.

The court’s November 14 order was in response to a motion filed November 6 by Sanofi asking for the opportunity to respond the plaintiff’s argument against taxing costs while the issue of a new trial is pending.

In the filing that now has been entered into the docket, Sanofi argues that the law supports its ability to collect certain costs, saying that the plaintiff’s arguments that the court should consider the relative financial position of the parties and that costs should not be awarded where a new trial has been requested are not supported by the relevant legal authorities.

“The Fifth Circuit has made clear that under Rule 54(d)(1) there is a ‘strong presumption’ that the prevailing party will be awarded costs and a denial is appropriate only in special circumstances—none of which is present here,” Sanofi’s Reply Brief In Support Of Its Motion To Tax Costs Against Plaintiff Barbara Earnest argues. “Plaintiff’s Opposition does nothing to overcome this heavy burden and instead misstates precedent to argue costs should be withheld.” Putting aside any considerations of fairness, Sanofi’s lawyers cite legal precedent they say supports their position that the relative financial positions of the parties are irrelevant to the court’s consideration in awarding costs to a prevailing party.

“As to the alleged disparity of resources between Plaintiff and Sanofi…Plaintiff alleges she is ‘of limited means’ and that Sanofi has ‘significant financial resources,’” Sanofi says in its reply. “The Fifth Circuit holds, however, that ‘reducing or eliminating a prevailing party’s costs award based on its wealth—either relative or absolute—is impermissible as a matter of law,’ [citations omitted] and that the ‘limited resources’ of the losing party cannot provide a basis for denying costs.”

In the alternative, Sanofi’s attorneys argue that it is likely that the plaintiff would not be bearing the costs herself.

“Even if this Court could consider Ms. Earnest’s financial status—which the Fifth Circuit holds it cannot—based on standard contingency fee practice, it is likely that Plaintiff’s counsel is the one who bears the costs where, as here, the case resulted in a defense verdict.”

As for the plaintiff’s argument that the awarding of costs should be postponed pending a determination on plaintiff’s request for a new trial, Sanofi says that this too is unsupported by legal precedent.

“Plaintiff argues that Sanofi’s Motion is premature because she has filed a motion for new trial, which remains pending,” Sanofi’s reply states. “Plaintiff, however, offers no case which suggests a court’s ruling on a motion to tax costs should be deferred under these circumstances. Moreover, Sanofi should not be deprived of its statutory right to recover its costs, where a ruling on the motion for new trial and any appeal could take months, if not years, before resolution.” While District Judge Milazzo granted Sanofi’s request to add its reply to the record, the court has not yet rendered a judgement on Sanofi’s request to collect costs from Ms. Earnest, and it is unclear when a decision can be expected.

Meanwhile, the MDL continues to make its way toward additional bellwether trials. Pursuant to a November 13 order, the MDL’s next discovery conference is scheduled to take place on December 5, with a docket conference call set for January 10, 2020. The bellwether trial was conducted as part of multidistrict litigation (MDL) that, since 2016, has centralized thousands of federal products liability claims filed by plaintiffs alleging that Sanofi failed to adequately warn them and their doctors about the risk of permanent hair loss associated with Taxotere, while overstating the drug’s benefits as compared to other available treatments.

Sources:

United States District Court Eastern District of Louisiana. (14 November 2019). Order. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest, Case No. 2:16-cv-17144. Barbara Earnest, Case No. 2:16-cv-17144

United States District Court Eastern District of New Orleans. (10 October 2019). Bill Of Costs. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest, Case No. 2:16-cv-17144. Barbara Earnest, Case No. 2:16-cv-17144

United States District Court Eastern District of Louisiana. (6 November 2019). Sanofi’s Motion For Leave To File Reply In Support Of Its Motion To Tax Costs Against Plaintiff Barbara Earnest. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest, Case No. 2:16-cv-17144

United States District Court Eastern District of Louisiana. (6 November 2019). Sanofi’s Reply Brief In Support Of Its Motion To Tax Costs Against Plaintiff Barbara Earnest. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest, Case No. 2:16-cv-17144

United States District Court Eastern District of Louisiana. (13 November 2019). Order. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: In Seeking Costs For First Taxotere Bellwether, Sanofi Wants Plaintiff To Pay For Expert At Heart Of Motion For New Trial

November 7, 2019
Author: Daniel Gala

Even as plaintiff Barbara Earnest seeks a new trial following a jury verdict finding Sanofi not liable for her permanent hair loss, the defendant pharmaceutical company is pushing ahead in its efforts to force Earnest to pay for certain legal costs associated with the first bellwether trial in multidistrict litigation (MDL) over Sanofi’s cancer drug Taxotere.

Ironically, the expenses for which Sanofi is seeking reimbursement include costs related to an expert witness whose testimony is at the heart of the plaintiff’s request for a new trial.

On October 29, plaintiff Barbara Earnest filed her response to Sanofi’s motion seeking reimbursement of certain costs, calling the company’s request “unwarranted under the circumstances, not supported by proper documentation, and premature.”

Earnest’s lawyers emphasized that “Sanofi is a large, multinational pharmaceutical corporation with significant financial resources and will not be unduly burdened by the costs expended in this matter.” Meanwhile, “Mrs. Earnest is a cancer survivor of limited means” who “has not been employed since 2005 and relies upon the retirement income provided by her husband.”

Additionally, the plaintiff’s response highlights that, as the first bellwether in a large, complex, long-running MDL, her case performed a valuable public service and was not brought in bad faith.

Finally, Earnest’s lawyers argue that the bill of costs submitted by the defendant does not meet the applicable standards for specificity.

“Defendants have not itemized the costs so it is impossible to determine whether the transcripts were expedited or whether the airfare and local transportation costs are proper,” the plaintiff’s filing states. “For example, the cost associated with first class travel is not taxable because travel must be at the ‘most economical rate available.’…Defendants have not met the burden of supporting the costs requested with particularity and should not be entitled to reimbursement of those costs.”

On September 26, a jury found Sanofi not liable, determining that Taxotere had not been the cause of the plaintiff’s permanent hair loss.

On October 10, Sanofi filed a motion seeking to collect from Earnest nearly $57,000 in trial-related expenses, including $1,760.68 in “Expert Witness Costs” for Dr. John Glaspy, according to a bill of costs submitted by the defense.

On October 25, Earnest filed a motion seeking a new trial, claiming that Sanofi had not followed rules governing the testimony of its expert witnesses that had been established during pretrial proceedings.

The plaintiff’s argument centers on a controversial statistical re-analysis performed by former Sanofi employee Dr. Michael S. Kopreski, MD, on data derived from a long-term clinical trial known as TAX 316. Following a ten-year study, the researchers conducting TAX 316 found permanent hair loss to be a “common side effect” occurring in 4 percent of patients taking Sanofi’s cancer drug Taxotere. However, conducting a re-analysis based on a vastly incomplete data set, Dr. Kopreski claimed he was able to show that the incidence of permanent hair loss had been vastly overstated.

During pretrial proceedings, the court determined that expert witnesses for Sanofi could testify as to Dr. Kopreski’s “re-analysis” only if the experts themselves had been able to recreate his findings.

“At trial, however, Dr. John Glaspy—Sanofi’s only testifying expert—stated unequivocally that he could not independently verify Dr. Kopreski’s re-analysis,” the plaintiff’s motion for a new trial says before quoting Dr. Glaspy’s testimony directly: “ ‘I will say again that if the data that Dr. Kopreski put in that table isn’t accurate, then my analysis is flawed. If it is accurate, I will stand by it.’”

Now, it is the same Dr. Glaspy for whom the defendant Sanofi wants the retired, cancer-survivor plaintiff Barbara Earnest to pay almost $1,800 in lodging ($159), airfare ($1,171.08), local transportation ($350.06), and attendance ($80).

While there is no word on when a ruling can be expected on the issue of whether Earnest will be charged for Sanofi’s costs, a hearing will be held December 5 to determine if a new trial is warranted, according to an October 31 order issued by US District Judge Jane Triche Milazzo.

Sources:

United States District Court Eastern District of New Orleans. (10 October 2019). Bill Of Costs. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of New Orleans. (25 October 2019). Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. In re: Taxotere (Docetaxel) Products Liability Litigation. MDL No. 2740. Section

United States District Court Eastern District of New Orleans. (31 October 2019). Order. MDL No. 16-2740. Section “H”. In re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Plaintiff In First Taxotere Bellwether Seeks New Trial, Alleges Problems With Sanofi Experts

November 1, 2019
Author: Daniel Gala

The plaintiff in the first bellwether trial over the cancer drug Taxotere has petitioned” the court for a new trial, citing problems with expert testimony provided by the defense.

The long-awaited trial, part of federal multidistrict litigation (MDL) involving claims that Taxotere-maker Sanofi failed to adequately warn patients in the US about the risk of permanent hair loss associated with the drug, resulted in a verdict for the defense, delivered September 26 after a nine-day trial.

However, in a motion and supporting memorandum filed October 25, attorneys for plaintiff Barbara Earnest argue that a new trial should be granted on the basis of the defendant’s alleged violation of the court’s rules regarding expert witnesses.

Sanofi Used Different Data In Court Than It Provided To FDA, Plaintiff Says

At issue is a re-analysis of Taxotere data conducted by Dr. Michael S. Kopreski, M.D., a former Sanofi employee. Dr. Kopreski took a second look at data derived from a long-term clinical study known as TAX 316 and found that reports of permanent hair loss associated with Taxotere use had been overstated.

“In the CSR [Clinical Study Report] for TAX 316, Sanofi reported 29 patients in the Taxotere-arm that had alopecia ongoing at the end of the 10-year study,” the plaintiff’s memorandum states. “When deposed on this topic, however, Dr. Kopreski testified that he had performed a re-analysis of the TAX 316 data that, in his view, eliminated 22 of the 29 originally reported experiences of ‘ongoing’ alopecia in the Taxotere-arm.”

As the plaintiff’s memorandum points out, however, Sanofi never felt the need to share this supposed new data with the United States Food and Drug Administration (FDA), with which it had been sharing TAX 316 developments:

“Periodically since 2010 and as recently as 2018, Sanofi has reported to the FDA that about 4 percent of patients receiving Taxotere, who were followed for ten years as part of a clinical trial called TAX 316, had experienced ‘ongoing alopecia.’…At 4 percent, persistent alopecia is considered a common side effect of Taxotere.’” “After Plaintiff filed this failure-to-warn suit, however, Sanofi decided this percentage is wrong for a jury—even as it remains right for the FDA and the company’s drug label,” the plaintiff’s memorandum continues. “In fact, Sanofi has never told the FDA that its final clinical trial data—as conclusively analyzed under the company’s own protocols—is somehow wrong. Nevertheless, it has argued before this Court that Dr. Kopreski’s re-analysis is reliable evidence, and also Sanofi’s experts can independently verify this re-analysis.”

Dr. Kopreski’s Re-Analysis Was Flawed, Done In Coordination With Sanofi’s Lawyers, Plaintiff Says

According to lawyers for the plaintiff, Dr. Kopreski’s so-called re-analysis was conducted outside Sanofi’s normal research stream, and Dr. Kopreski was not involved in preparing TAX 316 clinical data for submission to the FDA. Instead, Dr. Kopreski was hired directly by Sanofi lawyers.

“At his deposition, Dr. Kopreski admitted that he was not involved in the data analysis effort in the TAX 316 study before the study’s final submission to the FDA,” the plaintiff’s memorandum says. “He also admitted that his re-analysis of TAX 316 was not done as part of any regulatory submission to the FDA…Rather, Dr. Kopreski undertook such efforts at the behest of Sanofi’s attorneys at Shook, Hardy & Bacon.”

As part of these efforts, according to plaintiff’s counsel, Dr. Kopreski was not given a complete data set to work from.

“Regarding the Taxotere (or “TAC”) arm of TAX 316, Dr. Kopreski acknowledged that the only patient data he was given pertained to the 29 reports of ongoing alopecia, and not the full 744 participants,” the plaintiff’s memorandum says. “And even as to those 29 patients, he could not verify the completeness of the data given to him.”

“In other words, the limited documentation and data he reviewed was restricted to those that Sanofi’s lawyers cherry-picked,” the memorandum claims.

Sanofi’s Other Expert Could Not Independently Verify Dr. Kopreski’s Re-Analysis, As The Court Had Required, Plaintiff Claims

In addition to allegedly presenting different data for permanent alopecia rates at trial than had been reported to the FDA, attorneys for the plaintiff also accuse Sanofi of violating rules pertaining to expert testimony, as established by the court during pretrial proceedings.

“The Court permitted Sanofi’s expert witnesses to rely on Dr. Kopreski’s re-analysis at trial—but only because the Court credited Sanofi’s representation that its experts would testify that they had independently reviewed Dr. Kopreski’s work,” the plaintiff’s memorandum says. “The ability of such experts ‘to testify of [their] knowledge as to the nature and extent of the source from which the statistics were gathered,’ and to be cross-examined on their own knowledge, was the lynchpin of this Court’s Daubert ruling.” That is, in order for a defense witness to properly testify as an expert while relying on Dr. Kopreski’s re-analysis, he or she would need to be able to independently verify Dr. Kopreski’s data and analysis, not merely relying on Dr. Kopreski’s figures as presented. However, plaintiff’s counsel argues that this was not the case. “At trial, however, Dr. John Glaspy, Sanofi’s sole testifying expert—stated unequivocally that he could not independently verify Dr. Kopreski’s re-analysis,” the plaintiff’s memorandum asserts before quoting Dr. Glaspy’s testimony directly:

“‘I will say again that if the data that Dr. Kopreski put in the table isn’t accurate, then my analysis is flawed. If it is accurate, I will stand by it.’”

Why It Matters

So why does all of this rise to the level of requiring a new trial? According to the plaintiff, these acts by the defense and its expert witness violated the court’s own pretrial rulings as well as established evidentiary rules governing expert testimony. In doing so, the plaintiff contends, the defense misled jurors into believing that the incidence of permanent alopecia associated with Taxotere was significantly less than the rate Sanofi has reported to the US FDA.

The question of whether and at what rate Taxotere causes permanent hair loss was central to the trial’s outcome, with jurors finding that Taxotere was not the cause of plaintiff Barbara Earnest’s permanent alopecia.

On the verdict form returned September 26, the jury representative checked “No” for the threshold question, “Do you find by a preponderance of evidence that Barbara Earnest has permanent chemotherapy-induced alopecia caused by Taxotere?”

With jurors answering in the negative, they did not even reach subsequent questions about whether the plaintiff or her doctor were adequately warned about the risk.

Consequently, attorneys for the plaintiff believe jurors were improperly swayed to believe the incidence of permanent alopecia associated with Taxotere is lower than has been reported to regulatory bodies, which then led the jury to conclude that Taxotere had not been the cause of the plaintiff’s permanent hair loss.

What Happens Next

In response to the plaintiff’s motion seeking a new trial, US District Judge Jane Triche Milazzo issued on October 31 an order giving Sanofi until November 20 to file its response and scheduling an oral argument on the matter for December 5 at 9:30 am. According to the order, each side will be allotted seven minutes to argue why or why not the plaintiff Barbara Earnest should be granted a new trial.

Meanwhile, the court continues to pave the way for multiple subsequent bellwethers, so even if the contested verdict from the first bellwether stands, it will hardly be the final word on the Taxotere MDL.

Sources:

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Memorandum of Law in Support of Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (Filed 25 October 2019). Memorandum of Law in Support of Plaintiff Earnest’s Motion for New Trial. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (Filed 31 October 2019). Order. This document applies to all cases. MDL No. 16-2740. Section: “H”

United States District Court Eastern District of Louisiana. (Filed 27 September 2019). Judgment. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

United States District Court Eastern District of Louisiana. (Filed 26 September 2019). Verdict Form. Case No. 2:16-cv-17144. MDL No. 2740. Section “H”

Taxotere Lawsuit Update: Sanofi MDL Judge Holds Status Conference As Parties Start Prep For Next Bellwether

October 21, 2019
Author: Daniel Gala

The judge presiding over multidistrict litigation (MDL) involving the cancer drug Taxotere held on October 18 a status conference with counsel from both parties, with the next general status conference being scheduled for November 7, court documents show.

The three-year-old MDL is just coming off its highly anticipated first bellwether trial, in which the jury found Taxotere-maker Sanofi not liable for the plaintiff’s permanent hair loss. Thousands of plaintiffs have sued Sanofi alleging that the drugmaker failed to adequately warn patients about the risk of permanent alopecia, or hair loss, associated with Taxotere.

However, according to the verdict form returned September 26, jurors failed to find that Taxotere had been the cause of the plaintiff’s permanent hair loss, rendering further questions about Sanofi’s liability for failure to warn and other claims moot.

With the Taxotere MDL’s first bellwether having been some three years in the making, parties now have only a few months to gear up for the MDL’s second trial, scheduled to begin March 23, 2020, according to a June scheduling order. The third MDL is slated to follow on August 10.

Additionally, in a July case management order, the court released its list of "initial selections for the trial pool for the fourth and fifth bellwether trials.”

All of which serves as a reminder that the outcome in the first bellwether trial is hardly the final word on Sanofi’s Taxotere liability or the MDL’s ultimate outcome.

Sources:

United States District Court Eastern District of Louisiana. (18 October 2019). Minute Entry. In Re: Taxotere (Docetaxel) Products Liability Litigation. MDL No. 16-2740. Section H

United States District Court Eastern District of Louisiana. (18 October 2019). Pretrial Order No. 100. In Re: Taxotere (Docetaxel) Products Liability Litigation. MDL No. 16-2740. Section H

United States District Court Eastern District of Louisiana. (26 September 2019). Verdict Form. Barbara Earnest v. Sanofi Aventis U.S. LLC and Sanofi US Services, Inc. Civil Action No. 16-17144. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Following Taxotere Bellwether Win, Sanofi Seeks Costs From Plaintiff

October 12, 2019
Author: Daniel Gala

In late September, a Louisiana jury found drugmaker Sanofi not liable in the first bellwether trial in multidistrict litigation (MDL) over its cancer drug Taxotere. Now, Sanofi is seeking to extract the costs of its legal defense from the plaintiff.

On October 10, Sanofi filed a motion asking the court to force plaintiff Barbara Earnest to reimburse the pharmaceutical giant for more than $55,000 in costs, including court costs, transcript fees, and expert witness costs.

“On September 26, 2019, this Court entered the jury’s verdict in favor of Sanofi,” the defendant company’s Memorandum in Support of Bill of Costs states. “Sanofi now respectfully moves and urges that all costs incurred in the defense of this matter…be assessed against Plaintiff Barbara Earnest.”

Earnest and thousands of other plaintiffs have sued Sanofi alleging that the company failed to adequately disclose the risk of permanent hair loss associated with the cancer drug.

“As a result of Defendants’ wrongful conduct, Plaintiff has continued to suffer and will suffer in the future from disfiguring permanent alopecia as a result of receiving chemotherapy with docetaxel (TAXOTERE) and/or a generic non-bioequivalent of same,” Earnest’s lawsuit alleged. “Defendants’ labeling of docetaxel (TAXOTERE) was defective because it failed to adequately warn of the risk of disfiguring permanent alopecia.”

However, on the threshold question of whether Earnest’s permanent hair loss was caused by Taxotere, jurors were unconvinced, finding Sanofi not responsible.

Now, Sanofi is seeking $56,881.91 in costs including approximately $1,800 in expert witness costs; $27,000 in trial transcript fees; $28,000 in deposition transcript fees; and $20 in court costs, according to Sanofi’s bill of costs, submitted with its October 10 motion.

Though a setback for plaintiffs, the verdict in the first bellwether is hardly the last word in the Taxotere MDL. Multiple additional bellwethers presently are in the pipeline, with the second trial scheduled to begin in March 2020, and the third bellwether set to begin in July of that year, according to a June case management order.

Sources:

United States District Court Eastern Disrtict of Louisiana. (10 October 2019). Bill Of Costs. Case No. 2:16-cv-17144. MDL No. 2740. In Re: Taxotere (Doxetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (12 December 2016). Complaint & Jury Demand. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest v. Sanofi, S.A., et al

United States District Court Eastern District of Louisiana. (17 June 2019). Case Management Order No. 14D (Amendment to CMO 14 and 14A Regarding Trials 2 and 3). MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Jury Finds Sanofi Not Liable In First Taxotere MDL Bellwether Trial

September 30, 2019
Author: Daniel Gala

More than three years in the making, the first bellwether trial in multidistrict litigation (MDL) over the cancer drug Taxotere ultimately lasted less than two weeks, with the jury returning on September 26 a verdict finding defendant drugmaker Sanofi not liable on claims that it had misrepresented the risk of permanent hair loss associated with Taxotere. Jurors required fewer than three hours of deliberations to reach their decision, court documents show.

“Considering the verdict of the jury rendered on September 26, 2019; it is hereby ordered, adjudged, and decreed that Judgement be entered in favor of defendants Sanofi-Aventis U.S. LLC & Sanofi US Services Inc. (formerly known as Sanofi-Aventis U.S. Inc.) and against plaintiff Barbara Earnest,” the judgment signed by US District Judge Jane Triche Milazzo orders.

The case was the first to reach trial in an MDL that, as of September 28, contained over 13,700 cases, according to a count of member cases conducted by TheLawFirm.com. The MDL is located in the Eastern District of Louisiana.

The Plaintiff And Her Claims

The nine-day bellwether trial featured the claims of plaintiff Barbara Earnest, who alleged that, following a breast-cancer diagnosis in 2011, she was given “TAXOTERE and/or a generic non-bioequivalent of same” in conjunction with multiple rounds of chemotherapy. At the time, Earnest’s lawsuit claimed , “Neither Plaintiff nor her treating healthcare providers were aware of or informed by Defendants that disfiguring permanent alopecia [hair loss] can occur following treatment with docetaxel (TAXOTERE) and/or a generic non-bioequivalent of same” despite prior research demonstrating the existence of such a risk.

“As a result of Defendants’ wrongful conduct, Plaintiff has continued to suffer and will suffer in the future from disfiguring permanent alopecia as a result of receiving chemotherapy with docetaxel (TAXOTERE) and/or a generic non-bioequivalent of same,” Earnest’s lawsuit alleges. “Defendants’ labeling of docetaxel (TAXOTERE) was defective because it failed to adequately warn of the risk of disfiguring permanent alopecia.”

Earnest further argued that the defendant drugmakers had confirmed its own knowledge of the alopecia risk in statements to foreign regulatory bodies.

“Despite the fact that all Defendants disclosed risks associated with docetaxel (TAXOTERE) and/or the generic non-bioequivalents of same of permanent alopecia to patients and regulatory agencies in other countries, all Defendants failed to either alert Plaintiff, the public, and the scientific community in the United States or perform further investigation into the safety of docetaxel (TAXOTERE) and/or the generic bio-equivalents of same regarding the side effect of disfiguring permanent alopecia,” Earnest's complaint alleges.

The nine claims asserted in Earnest’s lawsuit included: (1) design defect; (2) strict products liability; (3) inadequate warning; (4) breach of express warranty; (5)breach of implied warranty; (6)fraudulent misrepresentation; (7) fraudulent concealment; (8) negligent misrepresentation; and (9) strict product liability for misrepresentation.

The Verdict Form

Despite the long-awaited bellwether trial and verdict, which were intended to help sort out many of the legal and factual issues underlying the Taxotere products liability litigation, many open questions remain. This is because the jury’s verdict never reached many of the MDL’s central allegations, with jurors failing to find in favor of the plaintiff on the threshold question of whether she suffered from permanent hair loss as a result of taking Taxotere, rendering all of the plaintiff’s claims invalid.

“Do you find by a preponderance of the evidence that Barbara Earnest has permanent chemotherapy-induced alopecia caused by Taxotere?” asked the first question on the verdict form, providing a space for checking either “Yes” or “No”. The form then continues, “If the answer to Question 1 is ’No,’ please sign the Verdict Form and return to the courtroom. If the answer to Question 1 is ‘Yes,’ please proceed to Question 2.” The jury representative placed an “X” beside ’No’ and returned the verdict form to the court, leaving the remainder of the form’s five questions unanswered.

These questions included:

“2. Do you find by the preponderance of the evidence that Sanofi inadequately warned [plaintiffs’ doctor] Dr. Carinder of the risk of permanent chemotherapy-induced alopecia associated with Taxotere?”

“3. Do you find by the preponderance of the evidence the Defendants’ failure to warn Dr. Carinder was the proximate cause of Barbara Earnest’s injuries?”

“4. Do you find by the preponderance of the evidence that Barbara Earnest lacked actual or constructive knowledge of facts indicating that she was a victim of a tort prior to December 12, 2015?”

“5. What amount do you find by a preponderance of the evidence is appropriate to fairly and adequately compensate Barbara Earnest for her injuries?”

Question five then included a space to write in dollar amounts for “[p]ermanent disfigurement” and “mental anguish and loss of enjoyment of life, past, present and future.”

However, with plaintiff’s counsel having failed to convince jurors that Barbara Earnest suffers from permanent hair loss caused by her having taken Taxotere, all of these questions remained unanswered.

The Last Day Of Trial

Day nine, the final day of trial, saw a flurry of courtroom activity, beginning with a series of motions and arguments made outside the presence of the jury, including a motion by plaintiff to reopen evidence as to the testimony of Barbara Earnest, which was denied by the court. A plaintiff motion requesting declaration of a mistrial on the basis of defendants’ alleged violations of the court’s motion in limine rulings also was denied by the court, while a motion by the defense for judgment as a matter of law was deferred for consideration until after the jury verdict, court documents show.

Throughout the trial, defendants had moved multiple times for judgement as a matter of law, including at the conclusion the plaintiff’s case, the court docket shows.

After motions were heard and ruled upon, jurors re-entered the courtroom, where they heard closing arguments from both parties. At 12:06 pm, court records indicate that jurors exited the courtroom to begin deliberations, returning with a verdict fewer than three hours later, at 2:47 pm. The verdict was read to the court, with the court adjourned at 3:00 pm.

Where The Taxotere MDL Goes From Here

While the first bellwether trial was long-awaited and therefore highly anticipated, it hardly represents the final word on the Taxotere MDL, with pretrial proceedings already well underway in preparation for several additional bellwethers.

According to a case management order issued in June, the second bellwether trial is scheduled to commence on March 23, 2020, with the third bellwether slated to being on July 28, 2020. And, in July of this year, the court released its list trial pool of plaintiffs for the fourth and fifth bellwethers.

With these additional trials in the works and nearly 14,000 cases now centralized in the MDL, the Taxotere litigation saga is far from over.

Sources:

United States District Court Eastern District of Louisiana. (27 September 2019). Judgment. Barbara Earnest, 16-17144. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (26 September 2019). Verdict Form. Barbara Earnest v. Sanofi Aventis U.S. LLC and Sanofi US Services, Inc. Civil Action No. 16-17144. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (12 December 2016). Complaint & Jury Demand. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest v. Sanofi, S.A., et al

United States District Court Eastern District of Louisiana. (26 September 2019). Jury Trial - Day 9 (FINAL) Judge Jane Triche Milazzo presiding. Civil Action: 16-17144 ”

United States District Court Eastern District of Louisiana. (Accessed 28 September 2019). Civil Docket for Case #: 2-16-md-02740-JTM-MBN. In Re: Taxotere (Doxetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (17 June 2019). Case Management Order No. 14D (Amendment to CMO 14 and 14A Regarding Trials 2 and 3). MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Experts Hit The Stand As Taxotere MDL’s First Bellwether Commences

September 27, 2019
Author: Daniel Gala

The first bellwether trial to take place in multidistrict litigation (MDL) over the cancer drug Taxotere got underway September 16 with the selection of jurors and opening statements, according to a court entry summarizing the day’s proceedings. Throughout the first week of trial, attorneys for plaintiff Barbara Earnest called to the stand a number of witnesses intended to substantiate her claim that she, like thousands of other plaintiffs, has suffered lifelong disfigurement in the form of permanent hair loss as a result of taking Sanofi’s cancer drug Taxotere, a risk for which she and her healthcare providers allegedly were not adequately warned by the drugmaker.

The MDL is taking place in the US District Court for the Eastern District of Louisiana, located in New Orleans.

Before lunch on day one of the first Taxotere bellwether, a jury of eight individuals was selected through voire dire examination, sworn in, and instructed. In the afternoon session, the freshly selected jurors heard opening statements from both parties, followed by a videotaped deposition, court documents show.

Over the course of subsequent days, additional court entries show that the court heard from several expert witnesses, including Dr. David Kessler, MD, JD, who “is accepted by the Court as an expert in the fields of FDA regulation, drugs standards and labeling of drugs and medical devices, as well as a medical expert in the fields of epidemiology and biostatistics,” and Dr. Antonella Tosti, MD, “an expert in the fields of dermatology, hair, hair disorders, lack of hair regrowth, [and] diagnoses of permanent chemotherapy induced alopecia.”

The case selected for the first bellwether is that of plaintiff and Louisiana resident Barbara Earnest, whose complaint originally was filed in December 2016. Earnest alleges that Sanofi and other drugmaker defendants failed to adequately disclose information related to known risks associated with Taxotere and bioequivalent drugs.

“Although alopecia, or permanent hair loss, is a common side effect related to chemotherapy drugs, permanent alopecia is not,” the complaint says. “Defendants, through their publications and marketing materials misled Plaintiff, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back.”

The complaint continues: “Defendants knew or should have known that the rate of permanent alopecia related to docetaxel (TAXOTERE) and/or a generic bioequivalent of same was far greater than with other products available to treat the same condition as Defendants’ product.”

The plaintiff’s lawsuit cites several studies of which defendants either were aware or should have been aware showing relatively high rates of permanent hair loss among those having taken Taxotere. The studies referenced were published as early as 2005 and include a study known as “GEICAM 9805” that showed “9.2% of patients who took docetaxel (TAXOTERE) had persistent alopecia, or hair loss, for up to 10 years and 5 months, and in some cases longer, after taking docetaxel (TAXOTERE).”

Additionally, the lawsuit references “a 2006 study by a Denver-based oncologist in the United States [who] had observed that an increased percentage (6.3%) of his patients who had taken docetaxel (TAXOTERE) suffered from permanent disfiguring hair loss for years after the patients had stopped taking” the drug.

“Defendants chose to withhold this information in the United States despite advising physicians, patients, and regulatory agencies in other countries, including the European Union and Canada, that docetaxel (TAXOTERE) and/or a generic bioequivalent of same causes an increased risk of permanent disfiguring hair loss,” the complaint alleges. “Defendants instead continued to warn or advise physicians, healthcare providers, patients, and Plaintiff in the United States only with the generic, vague, and insufficient warning that ‘hair generally grows back’ after taking docetaxel (TAXOTERE) and/or a generic bioequivalent of same.”

According to her lawsuit, in April 2011, Barbara Earnest received a diagnosis of breast cancer in her left breast, with her doctor prescribing chemotherapy as the treatment. Earnest underwent four rounds of chemotherapy beginning in June 2011 and ending in August of that year, during which time Earnest was given “TAXOTERE and/or a generic non-bioequivalent of same.” At the time, “[n]either patient nor her treating healthcare providers were aware of or informed by Defendants that disfiguring permanent alopecia can occur following treatment with docetaxel (TAXOTERE) and/or a generic non-bioequivalent of same.”

Now, Earnest says , as a result of the defendant drugmakers’ wrongful conduct, she “has continued to suffer and will suffer in the future from disfiguring permanent alopecia.”

“Defendants’ labeling of docetaxel (TAXOTERE) was defective because it failed to adequately warn of the risk of disfiguring permanent alopecia,” the complaint summarizes.

The nine claims asserted in Earnest’s lawsuit include: (1) design defect; (2) strict products liability; (3) inadequate warning; (4) breach of express warranty; (5)breach of implied warranty; (6)fraudulent misrepresentation; (7) fraudulent concealment; (8) negligent misrepresentation; and (9) strict product liability for misrepresentation.

Earnest seeks “an amount to be determined at trial”. Beyond Sanofi, other named defendants include pharmaceutical makers Aventis, Hospira, Sun Pharma, McKesson, Sandoz, Accord Healthcare, Apotex, Pfizer, Northstar RX, and Eagle Pharmaceuticals.

“Defendants prayed on one of the most vulnerable groups of individuals at the most difficult time in their lives,” Earnest's lawsuit asserts. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to normal life.”

Sources:

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 1 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section: “H”.

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 2 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section: “H”.

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 3 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section:

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 4 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section: “H”.

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 5 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section:

United States District Court Eastern District of Louisiana. (19 September 2019). Jury Trial - Day 6 Judge Janet Triche Milazzo presiding. Civil Action: 16-17144 Barbara Earnest v. Sanofi S.A. et al. MDL No. 16-2740. Section: “H”.

United States District Court Eastern District of Louisiana. (12 December 2016). Complaint & Jury Demand. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Barbara Earnest v. Sanofi, S.A., et al

Taxotere Lawsuit Update: As Taxotere MDL Set To Begin First Trial, Judge Grants Sanofi Request To Bar FDA Warning Letter From Evidence

September 16, 2019
Author: Daniel Gala

With the first bellwether trial in multidistrict litigation (MDL) over the cancer drug Taxotere scheduled to begin in mid-September, the presiding judge has granted defendant Sanofi’s motion to bar from evidence a 2011 warning letter from the United States’ Food and Drug Administration (FDA) identifying alleged compliance issues at a Sanofi production facility.

In an order issued September 11, United States District Judge Jane Triche Milazzo granted defendant Sanofi’s Motion in Limine to Preclude Evidence Concerning FDA’s January 2011 Warning Letter and Corresponding 483 Inspection, apparently agreeing with the defendant company’s contention that the potential prejudicial impact of the evidence on jurors outweighed its probative value.

The ruling means that, unless “the door is opened” as Judge Milazzo’s order puts it, jurors will not hear about the January 28, 2011 warning letter from the FDA’s Public Health Service, in which “FDA concludes that Sanofi has engage in prohibited acts in violation” of Postmarketing Adverse Drug Experience (PADE) reporting requirements mandated by law.

Jurors further will not learn about how the FDA found that Sanofi’s “corrective action plan does not adequately address procedural deficiencies” or how the FDA has accused Sanofi of “[f]ailure to include all other postmarketing studies in Annual Reports” to the FDA, meaning that the company’s “Annual Reports submitted to FDA for marketed drug products were incomplete.”

In arguing for the FDA warning letter to be barred from evidence, attorneys for Sanofi contended in their motion in limine submitted July 16 that the letter “is not relevant to any element of Plaintiff’s claim…and any probative value from these opinions is substantially outweighed by the danger of unfair prejudice, confusing the issues, misleading the jury, and wasting time.”

Judge Milazzo apparently agreed, granting Sanofi’s motion with the caveat that “if the door is opened, a conference with the Court should be held.”

In the same September 11 order, Judge Milazzo also deferred a decision on the admissibility of adverse event reports involving patients other than the plaintiff.

“Individual adverse event reports are inadmissible,” the order states. “However, if they are referenced in depositions, the jury may need context, in which case a conference with the Court should be held.”

The MDL, based in the Eastern District of Louisiana, centralized federal claims alleging that Sanofi overstated the benefits of Taxotere as compared to other available treatment options while concealing the risk of lifelong disfigurement in the form of permanent hair loss.

The first bellwether trial is scheduled to commence Monday, September 16. In preparation for such, on September 11, the parties also submitted their final witness lists.

Sources:

United States District Court Eastern District of Louisiana. (11 September 2019). Order. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States Food and Drug Administration (FDA) Public Health Service. (28 January 2011). Warning Letter Addressed To Gregory Irace President and Chief Executive Officer (CEO) Sanofi-Aventis US LLC. United States District Court Eastern District of Louisiana. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Exhibit A to Defendants’ Motion in Limine No. 28: Motion to Preclude Evidence or Argument Concerning FDA’s January 2011 Warning Letter And Corresponding 483 Action

United States District Court Eastern District of Louisiana. (16 July 2019). Defendants’ Motion in Limine No. 28: Motion to Preclude Evidence or Argument Concerning FDA’s January 2011 Warning Letter And Corresponding 483 Action. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Taxotere MDL Plaintiff Gets Green Light To Call Former FDA Commissioner To Testify In Upcoming First Bellwether

September 5, 2019
Author: Daniel Gala

As the September 16 scheduled start date for the first bellwether trial in multidistrict litigation (MDL) over Sanofi’s cancer drug Taxotere fast approaches, the presiding judge has issued an order giving the go-ahead for a former commissioner of the United States Food and Drug Administration (FDA) to testify for the plaintiff, Bloomberg Law reported September 4.

Former FDA Commissioner David A. Kessler will be permitted to testify as to pharmaceutical companies’ legal obligations under the FDA’s regulatory regime, with US District Judge Triche Milazzo having rejected defendant Sanofi’s contention that his testimony had the potential to confuse jurors.

Trained in both medicine and law, Kessler was nominated to be FDA Commissioner by then-President George H.W. Bush in 1990, prior to which he had served as medical director of the Albert Einstein College of Medicine in New York while also teaching food and drug law at Columbia University Law School. At the time of his initial nomination, Kessler was just 39 years old. Though confirmed on a bipartisan basis, Kessler soon gained more popularity among Democrats than Republicans for his efforts to more fully exert the FDA’s regulatory powers in the area of consumer protection, a move lauded by some but condemned by others as anti-business.

In one famous example, in 1991, Kessler’s FDA seized 2,000 cases of Citrus Hill Fresh Choice orange juice, saying that labeling the product “fresh” was misleading to consumers, as the juice was made from reconstituted orange-juice concentrate.

“In an unusual action against a large food company, the Food and Drug Administration moved today to stop the distribution of a leading brand of orange juice, saying it was falsely labeled as ‘fresh,’” the New York Times reported at the time. “Federal inspectors seized 2,000 cases of the product, Citrus Hill Fresh orange juice, from a Minnesota warehouse in a labeling dispute between the agency and the Proctor & Gamble Company, which makes the juice.”

Kessler was renominated for the position by President Bill Clinton and subsequently reaffirmed by congress. He is widely remembered for his efforts to use the FDA’s regulatory authority to reign in the tobacco industry, efforts that famously were struck down by the United States Supreme Court in the case FDA v. Brown & Williamson Tobacco Corp.

The Taxotere MDL at which Kessler now has been cleared to testify was established in October 2016 by order of the Judicial Panel on Multidistrict Litigation (JPML), centralizing federal lawsuits filed by plaintiffs alleging that the makers of Taxotere had failed to adequately disclose the risk of lifelong disfigurement in the form of permanent hair loss while overstating the benefits of Taxotere as compared to other available treatments. It presently includes over 11,000 cases.

“All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marked Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss,” the JPML’s 2016 Transfer Order states.

In addition to the federal MDL, the New Jersey Supreme Court in August 2018 established mutlicounty litigation (MCL) to handle Taxotere products liability claims filed in New Jersey state court.

Sources:

Bloomberg Law. (4 September 2019). Former FDA Head Kessler May Testify in Sanofi Taxotere Trial

United States Judicial Panel on Multidistrict Litigation (JPML). (4 October 2016). Transfer Order. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Acting Administrative Director of the Courts. (15 August 2018). Notice to the Bar. Multicounty Litigation - Designation of Taxotere Litigation as MCL. MCL Website

Anderson, S. H. (13 October 1990). Chronicle. The New York Times

Wikipedia. (Accessed 4 September 2019). FDA v. Brown & Williamson Tobacco Corp

Wikipedia. (Accessed 4 September 2019). David A. Kessler

Taxotere Lawsuit Update: Judge’s Ruling Clears Way For Plaintiff Experts To Testify At First Taxotere Bellwether Trial

September 3, 2019
Author: Daniel Gala

As multidistrict litigation (MDL) over the cancer drug Taxotere nears its first bellwether trial, scheduled to begin in September, attorneys representing plaintiffs earned a key pretrial victory August 24 when the presiding judge dismissed an effort by defendant Sanofi SA to have two of the plaintiffs’ expert witnesses barred from testifying, Reuters reported.

The ruling comes on the heels of an August 15 evidentiary ruling in favor of Sanofi. In that ruling, US District Judge Jane Triche Milazzo said she would allow Sanofi to present at trial new research that suggests the incidence of Taxotere-related alopecia may be less common than previously suspected.

The two experts whose testimony Judge Milazzo allowed in the August 24 ruling both will speak to the issue of Taxotere’s link to alopecia, or permanent hair loss, according to Reuters.

The recent evidentiary rulings will prove integral during the first bellwether trial, which is scheduled to begin September 16, according to an April 16 scheduling order. Additional bellwethers presently are scheduled to commence in 2020.

The Taxotere MDL, formed in October 2016, centralized federal products liability lawsuits filed by patients alleging that Sanofi both overstated the benefits of Taxotere as compared to competing treatments and failed to disclose the risk of permanent hair loss associated with the drug. The MDL is being conducted at the US District Court for the Eastern District of Louisiana in New Orleans.

In addition to the federal MDL, the New Jersey Supreme Court in 2018 established multicounty litigation (MCL) to centralize Taxotere-related claims filed against Sanofi in New Jersey state court.

Sources:

Raymond, N. (26 August 2019). Judge rejects Sanofi bid to exclude experts in Taxotere hair loss cases. Reuters

United States District Court Eastern District of Louisiana. (16 April 2019). Case Management Order No. 14B (Amendment to CMO 14 and CMO 14A Regarding Trial I). MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Sanofi U.S. (Accessed 30 August 2019). About Us

Taxotere Lawsuit Update: With First Bellwether Just Weeks Away, Taxotere MDL Judge Rules Sanofi May Present New Hair-Loss Analysis

August 26, 2019
Author: Daniel Gala

As multidistrict litigation (MDL) over the cancer medication Taxotere continues to make its way toward its first bellwether trial, presently scheduled to begin September 16, the presiding judge has issued a ruling in favor of defendant Sanofi SA, allowing the company to present expert testimony on new research suggesting that the risk of lifelong disfigurement in the form of permanent hair-loss may not be as great as previous studies had suggested. Attorneys for plaintiffs suing the pharmaceutical giant had sought to have such testimony excluded from trial.

The ruling came on Wednesday, August 15, according to a report by Reuters. The court’s calendar shows a “show cause” hearing scheduled for 2:00 pm on that date, and a minute entry dated August 15 confirms that a status conference was held with members of the settlement committee that day, as well, though the document does not contain any details as to the substance of the conference.

According to an April 16 scheduling order, the first bellwether trial is scheduled to commence September 16. The bellwether originally was calendared to begin in May.

A number of other bellwethers are in the pipeline, as well. The court presently is in the process of narrowing down the potential plaintiffs for the MDL's fourth and fifth bellwethers, with the judge having issued a list of 20 potential plaintiffs on July 29. The parties had until August 9 to make any objections.

The MDL is based in the US District Court for the Eastern District of Louisiana, located in New Orleans, and is being presided over by US District Judge Jane Triche Milazzo. The MDL has been ongoing since the fall of 2016.

The MDL centralized federal products liability claims alleging that Sanofi overstated the benefits of Taxotere as compared to other cancer treatments while also failing to adequately disclose the risk of permanent hair-loss.

Additionally, in 2018, the New Jersey Supreme Court established multicounty litigation (MCL) to hear state-court Taxotere claims.

Sources:

Raymond, N. (15 August 2019). Sanofi beats bid to exclude expert ’Trojan horse’ testimony on Taxotere risk. Reuters

United States District Court Eastern District of Louisiana. (Accessed 23 August 2019). Calendar. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (16 April 2019). Case Management Order No. 14B (Amendment to CMO 14 and CMO 14A Regarding Trial I). MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (29 July 2019). Case Management Order No. 20. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (22 March 2019). Case Management Order No. 18. MDL No. 16-2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Grant, G. A. (15 August 2018). Notice to the Bar. Multicounty Litigation - Designation of Taxotere Litigation as MCL. Acting Administrative Director of the Courts

Taxotere Lawsuit Update: Attys For Taxotere Plaintiffs Ask Judge To Bar Talk of Ads From First Bellwether

July 19, 2019
Author: Daniel Gala

Lawyers representing plaintiffs suing pharmaceutical-maker Sanofi-Aventis US LLC over its cancer drug Taxotere have asked the judge presiding over federal multidistrict litigation (MDL) to exclude from the first bellwether trial any evidence or testimony relating to plaintiff attorneys’ advertisements or public appearances, including “whether Plaintiff’s counsels’ advertisements, websites, public appearances, or other representations may have caused a spike in adverse event reporting relating to Taxotere,” according to a memorandum filed July 16.

“Plaintiff anticipates that Sanofi may attempt to alienate the jury by converting the trial into a referendum on lawful practices by plaintiff attorneys, while suggesting to the jury that these types of advertisements are actually harmful and persuade persons to go off their medication or cause a spike in Taxotere adverse events,” the brief, filed with the US District Court for the Eastern District of Louisiana, argues.

The motion shows that attorneys representing plaintiffs already are anticipating efforts by defense counsel to distract jurors from the core facts at issue in the case.

“The introduction of such testimony and argument has no probative value because it is based on a false premise and is substantially and unfairly prejudicial,” the memorandum argues.

Since May 2017, federal products liability claims involving Sanofi’s Taxotere have been centralized as multidistrict litigation (MDL) in the Eastern District of Louisiana. The first bellwether trial is scheduled to begin in September.

Thousands of state and federal lawsuits have been filed alleging that Sanofi overplayed the benefits while understating the risks of Taxotere as compared to other cancer drugs. The breast-cancer medication has been linked to permanent disfigurement in the form of permanent hair loss. Plaintiffs contend that they had been told the hair loss would be only temporary and that they were misled into not choosing competing medications with similar efficacy rates but without the risk of permanent hair loss.

In addition to the federal MDL, Sanofi also faces multicounty litigation (MCL) centralizing New Jersey state law claims.

Source:

United States District Court Eastern District of Louisiana. (16 July 2019). Memorandum In Support Of Motion In Limine To Preclude Testimony And Argument Regarding Plaintiff Counsel Advertisements (Motion in Limine No. 4). In Re: Taxotere (Docetaxel) Products Liability Litigation. MDL No. 2740

Taxotere Lawsuit Update: Taxotere MDL Judge Amends 2020 Start Dates For Second and Third Bellwethers

July 2, 2019
Author: Daniel Gala

The federal judge presiding over multidistrict litigation (MDL) involving the cancer drug Taxotere issued in mid-June a pair of orders amending the schedules for the second and third bellwether trials and affecting the selection of the cases to be tried as the fourth and fifth bellwethers.

The MDL has centralized federal products liability claims filed by plaintiffs alleging that Taxotere maker Sanofi failed to adequately warn of the risk of permanent disfigurement, including permanent hair loss, when taking the drug. The MDL is being conducted in the United States District Court for the Eastern District of Louisiana, located in New Orleans.

Taxotere is the brand name for the cancer drug docetaxel.

Case Management Order 19, the first of the two orders to be issued, states that the court will select the pool of plaintiffs to be considered for the fourth and fifth bellwethers by July 19, with the parties then having until August 2 to raise any objections. After consideration of these objections, the court then will reduce the number of potential plaintiffs to 20.

Issued a few days later on June 17, Case Management Order 14D amends the schedules for the second and third bellwether trials, setting the start date of the second bellwether for March 23, 2019 and start date of the third bellwether for August 10, 2020.

The first bellwether trial is set to begin in September, nearly three years into the MDL, which dates back to October 2016.

“On the basis of the papers filed and hearing session held, we find that these actions involve common questions of fact,” the Judicial Panel on Multidistrict Litigation (JPML) wrote in its October 4, 2016 Transfer Order, which established the Taxotere MDL. “All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more affective than other chemotherapy drugs when other drugs were equally effective without the associate permanent hair loss.”

A general status conference for the MDL presently is scheduled to take place July 11, according to the court calendar.

Sources:

United States District Court Eastern District of Louisiana. (17 June 2019). Case Management Order No. 14D (Amendment to CMO 14 and 14A Regarding Trials 2 and 3). MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Court website

United States District Court Eastern District of Louisiana. (13 June 2019). Case Management Order No. 19. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Court website

United States District Court Eastern District of Louisiana. (Accessed 2 July 2019). Calendar. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. Court website

United States Judicial Panel on Multidistrict Litigation (JPML). (4 October 2016). Transfer Order. MDL No. 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation. JPML Website

Taxotere Lawsuit Update: Judge Revises Bellwether Schedule In Taxotere MDL

May 9, 2019
Author: Daniel Gala

On April 16 and 22, the United States District Court for the Eastern District of Louisiana issued a pair of case management orders revising the schedule for the first bellwether trial and associated pretrial proceedings in multidistrict litigation (MDL) over the cancer drug Taxotere. The April 22 order also revised the procedures pertaining to the selection of trial pool cases, allowing the parties to select a combined total of 20 new trial pool plaintiffs.

Under the two orders, the parties have until June 19 to submit their additional trial pool selections, with the first bellwether scheduled to start September 16.

The Taxotere MDL has centralized federal products liability claims brought by plaintiffs suing over the cancer medication, saying that its maker failed to adequately warn of the drug’s risks, including that it could cause disfigurement in the form of permanent hair loss.

Issued by United States District Judge Jane T. Milazzo, the April 16 case management order lays out an updated schedule for the first bellwether trial, as well as providing a sort of roadmap as to where the pretrial proceedings presently stand.

On the updated Trial I schedule, the following items are marked as “Completed”: phase II discovery, plaintiff expert reports, plaintiff expert depositions, defendant expert depositions, motions and briefs, and opposition briefs.

The revised Trial I schedule contained in the April 16 order further indicates that reply briefs were to be handed in by April 16 and that plaintiffs’ expert supplemental depositions were to be completed by April 26.

The court anticipates commencing jury selection for the first bellwether trial this summer, with jury questionnaires on July 12 and motions in limine on July 16.

The April 22 order amends the trial pool selection process, allowing plaintiffs to select an additional eight trial pool cases and defendants another 12 by the June 19 deadline.

Sources:

United States District Court Eastern District of Louisiana. (22 April 2019). Case Management Order No. 14C (Amendment to Trial Pool Selection). MDL No. 2740 In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (16 April 2019). Case Management Order No. 14B (Amendment To CMO 14 And CMO 14A Regarding Trial I). MDL No. 2740 In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Judge Orders Plaintiff To Turn Over Google Group Data In Taxotere MDL

April 24, 2019
Author: Daniel Gala

Despite protests from the plaintiff, a magistrate judge involved in federal multidistrict litigation (MDL) over the cancer drug Taxotere has ordered that electronically stored information relating to a Google group known as “Taxotears” be handed over to defendant Sanofi, according to a minute entry issued April 8.

United States Magistrate Judge Michael B. North issued the order following a telephonic discovery conference in which representatives for plaintiff Debra Cantwell argued against having to turn over the materials, which the minute entry gave the plaintiff just 24 hours to produce.

The Taxotere MDL, located in the Eastern District of Louisiana, centralized federal products liability claims alleging that the drug caused permanent hair loss in women taking it as a treatment for breast cancer.

“All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss,” read the Transfer Order issued by the Judicial Panel on Multidistrict Litigation (JPML) in October 2016, which created the MDL.

In a separate order issued April 5, United States District Judge Jane Triche Milazzo set the next general status conference for May 21, 2019. 


Sources:

United States District Court Eastern District of Louisiana. (8 April 2019). Minute Entry. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

United States District Court Eastern District of Louisiana. (5 April 2019). Pretrial Order No. 95. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Judicial Panel on Multidistrict Litigation (JPML). (4 October 2016). Transfer Order. MDL 2740. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: Start Date For First Taxotere Bellwether Pushed Back To September

April 3, 2019

The judge overseeing multidistrict litigation (MDL) involving the cancer medication Taxotere has ordered the start date of the first bellwether trial to be postponed until September 2019, per an order issued March 22. The first bellwether previously had been scheduled to begin in May.

“It is ordered that the first bellwether trial previously set for May 13-24, 2019, is continued to September 16-27, 2019,” the brief case management order, signed by United States District Judge Jane Triche Milazzo, stated in its entirety.

Although the order did not state a specific reason for the delay, other recent court orders show the Taxotere MDL still to be in the early stages of the pretrial process, with the postponement being a recognition by Judge Milazzo that the court will not be prepared to begin a trial in a little over one month’s time.

Still, with the MDL approximately half way through its third year, the order represents yet another delay in the long-running litigation.

In its transfer order issued October 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized federal Taxotere lawsuits that “share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.”

The next status conference is scheduled to take place April 4.

Sources:

United States District Court Eastern District of Louisiana. (22 March 2019). Case Management Order No. 18. MDL No. 16-2740 In Re: Taxotere (Docetaxel) Products Liability Litigation

Judicial Panel on Multidistrict Litigation (JPML). (4 October 2016). Transfer Order. MDL No. 2740 In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: NJ Taxotere MCL Will Use Same Common Benefit Rules As Taxotere MDL, Judge Orders

April 3, 2019

When it comes to the administration of common benefit attorneys’ fees, the same rules governing federal multidistrict litigation (MDL) over the cancer medication Taxotere will apply to multicounty litigation (MCL) in New Jersey state court, the judge overseeing the MCL ruled in an order issued March 22.

In the order, the court also appoints as Common Benefit Liaison Counsel Rayna Kessler and Karen Beyea-Schroeder, “recognizing that Ms. Kessler and Ms. Beyea-Schroeder have guided this litigation from its inception, and have the most detailed knowledge of the work performed, expenses paid, interaction and involvement with related litigation around the country, and the value of the work in advancing the litigation on behalf of all plaintiffs,” Judge James F. Hyland wrote for the Superior Court of New Jersey in Middlesex County.

Like the federal Taxotere MDL taking place in Louisiana district court, the New Jersey Taxotere MCL involves products liability claims over the cancer medication, including allegations that women taking Taxotere (Docetaxel) as a treatment for breast cancer have suffered permanent hair loss.

According to the most recent available case list, updated February 14, 2019, the New Jersey state MCL contains 184 total cases, with a new case having been filed as recently February 2.

The relatively young MCL was created in July 2018 by order of the Supreme Court of New Jersey. It continues to make its way through the pretrial process, with the next case management conference scheduled for April 18, 2019.

Sources:

Superior Court of New Jersey Law Division – Middlesex County. (22 March 2019). Case Management Order No. __ [sic] (Intent to Enter Common Benefit Order, Time and Expense Rules, and Related Issues). MCL No. 628. In Re: Taxotere (Docetaxel) Products Liability Litigation

Superior Court of New Jersey Law Division – Middlesex County. (Last updated 14 February 2019). Taxotere Case List Updated February 14, 2019. MCL No. 628. In Re: Taxotere (Docetaxel) Products Liability Litigation

Taxotere Lawsuit Update: NJ Supreme Court Grants Multicounty Litigation For Taxotere Lawsuits

August 23, 2018

The New Jersey Supreme Court has granted a request to consolidate state-court lawsuits involving the chemotherapy drug Taxotere, paving the way for centralized proceedings in approximately 350 active claims within the state. The lawsuits allege that the makers of Taxotere failed to adequately warn patients of the risk of permanent hair loss that could result from their taking the medication.

According to Law360, which reported the decision on August 21, 2018, the New Jersey Supreme Court approved consolidation of the claims as multicounty legislation sometime during July, but the decision was not made public until a notice was released August 15.

The centralization petition, which was filed by attorneys representing patients who took Taxotere, sought consolidation of the cases involving out-of-state plaintiffs from Connecticut, Maryland, Ohio, and Pennsylvania. The petition urged that in-state New Jersey plaintiffs should retain the option of bringing suit in their home counties.

Arguing for centralization, attorneys for plaintiffs cited the high number of total lawsuits and the similarity of the issues involved. They also argued that consolidation of the New Jersey state-court claims would allow for better coordination with federal Taxotere proceedings being conducted at a district court in Louisiana.

“[A]ll of the actions proposed for designation allege substantially similar violations of law and are based upon the same or substantially similar underlying claims surrounding the safety profile of Taxotere,” the patients’ petition for multicounty designation read, according to Law360.

Attorney Rayna E. Kessler, who represents several women presently suing drug makers over Taxotere, expressed satisfaction with the decision to approve consolidation as multicounty litigation, as well as with the judge who will oversee the centralized proceedings.

“We are particularly looking forward to having these cases heard in New Jersey, where many women throughout the state suffered as a result of using Taxotere,” Kessler told Law360.

The lawsuits have been consolidated in Middlesex County, which already was the venue for over 330 Taxotere cases. The proceedings will be conducted by Judge James F. Hyland.

Defendants in the Taxotere lawsuits include Sanofi U.S. Services Inc., Sanofi-Aventis U.S. LLC, Sandoz Inc., and Actavis LLC. Teva Pharmaceuticals USA Inc., which acquired Actavis, also has been drawn into the litigation.

Plaintiffs accuse the defendant drug makers of wrongful conduct with regards to the design, manufacture, distribution, labeling, advertising, marketing, promotion, and sale of Taxotere.

If you or a loved one has suffered harm as a result of taking a prescription drug such as Taxotere, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation with an actual lawyer! The law places strict time limits on your ability to file a claim, so don’t delay, contact TheLawFirm.com today!

Source: Law 360

Taxotere Lawsuit Update: Sanofi ordered to trun over hundreds of docs in Taxotere case

May 25, 2018

In a blow to drug-maker Sanofi in litigation over its cancer drug Taxotere, on May 22, a federal judge in Pennsylvania ordered the company to hand over hundreds of documents related to False Claims Act (FCA) litigation over Sanofi’s alleged marketing of Taxotere for off-label uses. Sanofi had sought to conceal the documents under the guise of attorney-client privilege, but the court found, based largely on whistleblower testimony, that the privilege did not apply.

Former-employee-turned-whistleblower Yoash Gohil, who has been pursuing the case in various forms since 2002, alleges that Sanofi—under its old name Aventis Pharmaceuticals—paid kickbacks to doctors who engaged with the company in a scheme to prescribe Sanofi to patients for uses that had not been approved by the US Food and Drug Administration (FDA). When the company then sought reimbursement from Medicare and Medicaid for these drugs, Gohil argues, it was in violation of the FCA.

Sanofi now will be forced to reveal a trove of documents related to one of its Taxotere marketing programs, including information related to reimbursements and any efforts to destroy or otherwise conceal damaging evidence.

Whistleblower Gohil had asserted to the court that Sanofi was using the guise of attorney-client privilege to withhold relevant information, arguing that many of the documents were email correspondence that had merely been forwarded to an attorney, hardly grounds for asserting the privilege.

The documents unearthed by the new court orders may impact not only the instant case but also consolidated suits presently making their way through the Louisiana court system. Stay tuned to the TheLawFirm.com for the latest Taxotere litigation information.

Source: Law 360

Taxotere Lawsuit Update: Over 1000 Taxotere MDL's Filed

May 19, 2018

There are now over 1000 lawsuits filed in the Taxotere MDL. About half of these cases involve generic and quasi-generic manufacturers. The attorneys at TheLawFirm.com have written before about the challenges that generic drugs can pose. We have now learned that the U.S. Judicial Panel on Multidistrict Litigation (JPMDL) has allowed claims involving generic docetaxel to be included in the Taxotere MDL.

Judge Sarah S. Vance, Chair of the JPMDL, stated in a letter that the consolidated litigation does include lawsuits against both name-brand and generic forms of the drug. Taxotere, manufactured by Sanofi, lost its patent protection in late 2010. The plaintiffs charge that they experienced permanent hair loss following treatment with Taxotere. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label.

While hair loss is a common side effect of chemotherapy, the plaintiffs allege that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to cancer patients in Canada and Europe. However, Taxotere’s U.S. label only included a warning that “hair generally grows back.” The plaintiffs allege that this warning is vague and insufficient.

The Taxotere lawyers at TheLawFirm.com are hopeful that the defense will focus less on preparing for trial and more on resolving the cases. If you took Taxotere and suffered permanent hair loss as a result, contact us for a free consultation.

Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article. 

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