beau darley Rare ruling in Taxotere MDL allows claims against genericsThe Taxotere multidistrict litigation (MDL) has reached 1,000 claims against the French drugmaker, Sanofi Aventis, according to Lawyers and Settlements. The number of claims is expected to continue climbing, especially following a recent, rare ruling by the U.S. Judicial Panel on Multidistrict Litigation (JPML). The ruling allows claims against manufacturers of generic versions of the drug to be included in the MDL.

As Beasley Allen previously reported, the FDA approved Taxotere in 1996. Sanofi was aware of the risks after its own trials in the 1990s showed women with breast cancer who took Taxotere had persistent hair loss. Further, Sanofi studies published in 2007 and again in 2010 showed risks of permanent hair loss.

Typically, manufacturers of generic versions of brand-name drugs are not held accountable in lawsuits that claim that the manufacturer failed to warn of a drug’s defect, like those combined under the MDL. This is because, in most cases, the generic drug manufacturer must match its label to the branded drug’s.

However, there are some generic versions of Taxotere, sold as docetaxel, which entered the market through one of the U.S. Food and Drug Administration’s (FDA) fast-track approval processes known as the 505(b)(2). The 505(b)(2) approval process is actually a form of new drug application (NDA), rather than the abbreviated new drug application (ANDA) used by most generic drug manufacturers. The process does not require similar versions of already approved drugs to complete the same health and safety testing. Instead, drug companies are allowed to rely on safety and efficacy studies not conducted by or for the drug company.

Because it is an NDA, drug companies with 505(b)(2)-approved medications face the same labeling obligations as the brand-name drug makers. The JPML’s ruling is not a determination that these quasi-generic manufacturers can be held liable for failure to warn, but it is a step in the right direction.

The FDA did not approve generic versions of Taxotere until between 2011 and 2016, meaning that all eight manufacturers of the generic and quasi-generic versions would likely have known about the risk of permanent hair loss prior to putting their products on the market. Sanofi began warning patients outside of the U.S. in 2005, but did not provide similar warnings to patients in the U.S. until a decade later when the FDA forced it to update the drug’s warning label.

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Lawyers at Beasley Allen are currently investigating potential cases involving individuals who have suffered permanent hair loss following chemotherapy with Taxotere. For more information on this subject, contact Beau Darley or Melissa Prickett, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Beau.Darley@beasleyallen.com or Melissa.Prickett@beasleyallen.com.

Sources:
Lawyers and Settlements
National Center for Biotechnology Information
Beasley Allen



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