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Taxotere Lawsuit Update

The latest Taxotere lawsuit news and updates.

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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