April 17, 2024

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Sanofi is in trouble: Chemotherapy drugs are suspected of false advertising

Sanofi is in trouble: Chemotherapy drugs are suspected of false advertising


Sanofi is in trouble: Chemotherapy drugs are suspected of false advertising, misleading patients

Sanofi believes it has finally won its first victory in thousands of lawsuits against the chemotherapy drug Taxotere . But recently, according to federal officials, the court overturned the jury’s verdict, ordered a retrial and pressured the drug company.


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The lawsuit was filed in 2016 by a breast cancer patient named Barbara Earnest . She underwent several courses of chemotherapy after a lumpectomy , including Taxotere. Although the cancer has been successfully cured, her hair has never grown back.


Earnest believes the damage is permanent, so she sued Sanofi for failing to warn of the potential risk .


Earnest wrote in the original complaint: “Through its publications and advertising, the defendants misled the plaintiffs, the public, and the medical community. To convince everyone that Taxotere, unlike other chemotherapy drugs, can regrow hair in patients. .”


This case is one of more than 12,000 lawsuits against the French pharmaceutical company. U.S. District Judge Jane Triche Milazzo for New Orleans consolidated the cases into a cross-district proceeding.


Sanofi insists that the 2019 trial could prove that patients are unlikely to experience permanent hair loss with Taxotere. The company has two witnesses, former Sanofi deputy general manager Michael Kopreski and UCLA professor John Glaspy . They were able to demonstrate that only 4.2% of patients treated with Taxotere experienced “persistent” hair loss, and fewer suffered “permanent” hair loss. This argument is largely based on Kopreski’s research report, which re- analyzed the results of experiments they had previously submitted to the FDA for review .


Although Sanofi says their products are unlikely to cause permanent hair loss, in 2015 the FDA asked them to change the label to warn patients of the possibility of “permanent, irreversible hair loss. ” In 2020, Reuters reported that Milazzo dismissed nearly 200 lawsuits against Sanofi, announcing that a change in its label had made the potential risk clear.


In Earnest’s case, the jury was unanimous on Sanofi’s side. But recently, the U.S. Court of Appeals for the Fifth Circuit overturned the ruling.

The court ruled that because Kopreski was not qualified to give an expert opinion and Glaspy did not personally verify the veracity of the Kopreski trial data , their actions “seriously prejudice” Earnest’s interests.


Circuit Judge Cory Wilson wrote: “The duty of expert investigation is based on discovery and the rules of evidence. Sanofi defended itself by providing Dr. Kopreski’s non-expert testimony, and with this unacceptable testimony, from Dr. Glaspy More expert testimony was drawn there. It then relied on the testimony of its only two witnesses, closing the case arguing that the plaintiff’s “ whole case was lost. “


Earnest’s lawyer Attorney Chris Coffin said the court’s decision was a “very good outcome” for the plaintiffs. “Barbara Earnest did not get a fair trial because Sanofi violated the federal rules of evidence. The Fifth Circuit has agreed to retry her case, and this result is a huge victory for her and all plaintiffs,” he said.


Taxotere belongs to the taxane class of antitumor drugs , which are widely used in chemotherapy. Taxotere was originally a high-potency paclitaxel that was approved by the FDA in 1996.

To expand its use as an adjuvant therapy to improve the efficacy of other chemotherapy drugs , Sanofi initiated a 10-year Phase 3 clinical trial called the TAX316 trial (the interim results of this trial were Kopreski’s reanalysis of previous experiments) basis of the data).

In August 2004, the FDA approved Taxotere in combination with doxorubicin and cyclophosphamide as an adjuvant drug for chemotherapy.


Back in 2009, the drug received a warning letter from the FDA saying the claim that Taxotere was superior to paclitaxel was misleading.


Earnest received four courses of doxorubicin and cyclophosphamide , and started losing hair after the second course, according to the complaint. After that, the doctor started giving her Texote.


A Sanofi spokesperson wrote in a response email: “Taxotere, a life-saving chemotherapy, was an integral part of Ms. Earnest’s breast cancer treatment regimen. The jury found that Ms. Earnest was unable to prove her We are very disappointed that the jury was overturned in the verdict that the alopecia was caused by Texotee.”


Coffin responded that no date has been set for the retrial.







Sanofi is in trouble: Chemotherapy drugs are suspected of false advertising

(source:internet, reference only)

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