Taxotere Lawsuit Update

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