Sanofi Loses Summary Judgment Motion Reconsideration on Taxotere Bellwether

Sanofi, a manufacturer of the chemotherapy drug Taxotere, lost a reconsideration of a previously denied motion for summary judgment.

Anjelica Cappellino, J.D.

Written by
— Updated on August 18, 2021

Sanofi Loses Summary Judgment Motion Reconsideration on Taxotere Bellwether

The motion sought dismissal of the case, Elizabeth Kahn v. Sanofi S.A., et al., 16-CV-17039. This case is part of multidistrict litigation pending before the District Court in the Eastern District of Louisiana against Sanofi and other drugmakers. The Kahn case will be the second bellwether trial in the MDL of In re Taxotere (Docetaxel) Products Liability Litigation, 16-md-02740.

The summary judgment motion hinged on whether the plaintiff’s doctor would’ve made a different prescribing decision if warned the drug could cause hair loss. However, the court determined there was still a question of material fact. The question was whether the doctor would have discussed alternative treatments if warned of Taxotere’s side effects.

The Lawsuit’s Allegations in Taxotere Lawsuit

The plaintiff in Kahn alleges that for years, the manufacturers of Taxotere, Docetaxel, and Docefrez have known that these chemotherapy drugs (used to treat breast cancer) cause permanent hair loss. Thousands of other plaintiffs in similar cases claim the same.

The plaintiffs are women who underwent chemotherapy treatment with the drugs in question for their breast cancer. They suffered from permanent hair loss, known as alopecia, a side effect for which they were completely unprepared and unwarned. In an Amended Master Long Form Complaint of common allegations, the plaintiffs allege that because of this undisclosed side effect, they “have struggled to return to normalcy, even after surviving cancer because an integral element of their identities, their hair, never returned. Plaintiffs are stigmatized with the universal cancer signifier—baldness—long after they underwent cancer treatment, and their hair loss acts as a permanent reminder that they are cancer victims.”

The plaintiffs further allege the defendants knew that their drugs caused long-term alopecia, as per various studies. Furthermore, the plaintiffs claim the defendants failed to report these findings to the U.S. Food & Drug Administration. According to the plaintiffs, the defendants continued to market Taxotere without warning patients nor doctors of these side effects. The plaintiffs advance strict product liability claims in connection to the defendant’s misrepresentations and their failure to warn. Additionally, they advanced claims of negligence, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, fraud and deceit, and breach of express warranty.

Sanofi’s Motion for Summary Judgment

In its first motion for summary judgment in the Taxotere lawsuit, Sanofi cited the medical testimony of the plaintiff’s oncologist, Carl Kardinal. The oncologist asserted that he would have still recommended Taxotere to Ms. Kahn despite any side effects of hair loss. The defendants cited Louisiana’s “learned intermediary” doctrine. The doctrine holds that their duty to warn of any effects was to a patient’s doctor, not to the patient. Kahn’s doctor’s decision would have been the same. Because of this, Sanofi argued that their alleged failure to warn could not have caused Kahn’s hair loss.

The court considered whether Dr. Kardinal would have warned Kahn of a risk of permanent hair loss if he had known of it. Moreover, the court noted that he would have discussed it along with other treatment options, had Kahn decided against Taxotere. Kahn would have asked about other options if Dr. Kardinal had told her about the risks of Taxotere. Thus, the court determined there existed a genuine issue of fact as to causation.

In its renewed motion, the defendants cite a recent Fifth Circuit decision related to another case in the instant MDL—June Phillips v. Sanofi U.S. Services, et al., No. 20-30405, 2021 WL 1526429 (5th Cir. Apr. 19, 2021). This case discussed applying the intermediary doctrine in the context of chemotherapy drugs. The court held that “causation analysis must focus ‘on the prescribing physician’s decision to prescribe the drug.’” In Phillips, the court found that a warning of permanent hair loss would not have altered the physician’s risk-benefit assessment. In addition, there was no evidence that the plaintiff would have steered the conversation to different treatment options if warned.

Contrasting Opinion

In contrast, the court in Kahn found that, even if Dr. Kardinal would not have changed his Taxotere recommendation, he did testify that discussions with the patients would have included the risk. Dr. Kardinal further testified other viable alternatives existed if a patient rejected Taxotere for its hair loss risks. As such, the court held that the jury had to decide whether Kahn’s oncologist would have changed his recommendation upon discussions about hair loss risks.

Future Litigation in Taxotere Lawsuit

Elizabeth Kahn’s trial is scheduled to begin on August 23, 2021. This will be the second bellwether case to go to trial. In September 2019, Sanofi won its first bellwether trial, with the jury finding in the company’s favor. Currently, there are still more than 12,000 product liability cases pending against Sanofi and other Taxotere distributors. The court’s rulings on defendants’ summary judgment motions will almost certainly affect the pre-trial motion practice of any additional bellwether trials.

Leave a Reply

Your email address will not be published.

I am an