Taxotere Whistleblower Lawsuit Proceeds

A Taxotere whistleblower lawsuit will proceed,  a judge ruled in January 2017. The Taxotere whistleblower lawsuit accuses Sanofi-Aventis of marketing Taxotere “off-label.” The case will go forward because the judge refused the company’s petition to have it dismissed. The “off-label” marketing accusation says the company illegally marketed the drug to doctors and hospitals.

Illegal Kickbacks for Taxotere Sales

Reuters reported that a federal judge in Philadelphia ruled marketing claims in the case are not protected under the 1st Amendment’s free speech guarantees. Court records show a former Sanofi-Aventis employee filed the whistleblower complaint. The petition claims the company paid doctors illegal kickbacks to promote Taxotere for uses outside its FDA-approved indications.

Taxotere Whistleblower Lawsuit
The whistleblower lawsuit charges that Aventis’ fraudulent marketing scheme caused several health care providers to submit claims for reimbursement to governmental medical reimbursement systems. The petition says these claims would not have been paid “had the government reimbursement programs known of Aventis’ fraudulent marketing scheme” for Taxotere.

Sanofi-Aventis fails to have case dismissed
Sanofi-Aventis had sought dismissal of the whistleblower lawsuit on statute of limitations and 1st Amendment grounds. U.S. District Judge Lawrence F. Stengel of the Eastern District of Pennsylvania rejected those arguments. Judge Stengel ruled marketing claims are not protected speech if they are false and misleading. Whether or not Sanofi-Aventis used false and misleading marketing statements remains a question for a jury, the judge wrote.

The U.S. Department of Justice is supporting the Taxotere whistleblower lawsuit. If successful, the department would collect compensation on behalf of U.S. taxpayers.

What is Taxotere?
Taxotere is a drug used in conjunction with chemotherapy. It was approved by the U.S. Food & Drug Administration in 1996 to treat breast cancer. Taxotere is now indicated to treat other malignancies, including head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer.

Taxotere Hair Loss Lawsuits

Sanofi-Aventis is also named as a defendant in some 1,000 Taxotere lawsuits filed for women who say they suffer permanent hair loss – or alopecia – related to Taxotere use. While chemotherapy drugs often cause hair loss, Taxotere used with chemotherapy often makes hair fall out and not grow back. Other chemo drugs cause only temporary hair loss. Plaintiffs pursuing Taxotere lawsuits claim Taxotere alopecia is much more likely to be permanent, compared with similar chemo drugs.

Europeans Warned, Americans Not Warned
Plaintiffs point out that Sanofi-Aventis has long provided information regarding the potential for permanent alopecia to individual patients and regulatory agencies overseas. Taxotere’s U.S. label, however, included only generic, vague, insufficient warnings that “hair generally grows back.” That is the crux of this case and most drug cases, that the manufacturer failed to adequately warn of the drug’s actual “side effects,” though it was legally bound to do so.

Federal Taxotere Lawsuits
Taxotere lawsuits filed in federal court have been centralized in multi-district litigation court in the U.S. District Court (MDL) in Eastern District of Louisiana.