Taxotere Lawsuit Alleging Off-Label Marketing Will Go Forward

Published on January 17, 2017 by Sandy Liebhard

A Taxotere lawsuit that accuses Sanofi-Aventis of marketing the chemotherapy medication for off-label use will go forward, despite the company’s contention that it should be dismissed. According to Reuters, a federal judge in Philadelphia, Pennsylvania ruled last week that the marketing claims at the center of the case are not necessarily protected under the 1st Amendment’s free speech guarantees.

Court records indicate that the whistleblower complaint was filed by a former Sanofi-Aventis employee who claims that the company paid doctors illegal kickbacks to promote Taxotere as for uses outside of its approved indications.

“As a result,” the lawsuit asserts, “Aventis’ fraudulent marketing scheme allegedly caused a substantial number of health care providers to submit claims for reimbursement to governmental medical reimbursement systems for the use of Taxotere, which would not have otherwise been paid had the government reimbursement programs known of Aventis’ fraudulent marketing scheme.”

Sanofi-Aventis had been seeking to have the claim dismissed on both statute of limitations and 1st Amendment grounds. However, U.S. District Judge Lawrence F. Stengel of the Eastern District of Pennsylvania rejected the company’s arguments, finding, among other things, that marketing claims are not protected speech if they are false and misleading. Whether or not Sanofi-Aventis utilized false and misleading statements in marketing Taxotere remains a question for a jury to decide, Judge Stengel wrote.

The Taxotere whistleblower lawsuit is being supported by the U.S. Department of Justice, which would collect compensation on behalf of U.S. taxpayers if it is successfully litigated

Taxotere Hair Loss Litigation

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

In addition to the whistleblower case, Sanofi-Aventis is named a defendant in more than 260 Taxotere lawsuits filed on behalf of patients who allegedly experienced permanent alopecia related to its use. While chemotherapy drugs typically cause temporary hair loss, plaintiffs pursuing these lawsuits claim that Taxotere alopecia is far more likely to be permanent. Among other things, they point out that Sanofi-Aventis has long provided information regarding the potential for permanent alopecia to individual patients and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Federally-filed Taxotere hair loss claims have been centralized in a multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana.

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