Manufacturer of chemotherapy drug targeted by Louisiana law firm in lawsuit

By Noell Wolfgram Evans | Dec 18, 2016

NEW ORLEANS — A New Orleans-based law firm is currently reviewing lawsuits of more than 30 claimants who claim they suffered permanent hair loss, also known as alopecia, allegedly caused by the chemotherapy drug Taxotere.

For years, a commonly accepted side-effect of chemotherapy treatment has been hair loss. In most cases, it has been temporary.

"Alopecia is one of the most commonly reported adverse reactions associated with some chemotherapy treatments, including across all Taxotere indications. Sanofi has disclosed that this is a Taxotere side effect since the product was first approved in the U.S. in 1996," Carrie Brown, a spokesperson for Sanofi-Aventis, the manufacturer of Taxotere, told the Louisiana Record.

Brown said the company has regularly provided safety information to the Food and Drug Administration (FDA).

“Since its approval, Sanofi has submitted safety information to FDA on an ongoing basis as part of post-marketing regulations, including information concerning persisting and/or permanent alopecia," Brown said.

Taxotere has been used in Europe and Canada where, since 2005, it has come with a warning regarding the potential of permanent hair loss. That warning was not placed on labels until 2015 in the United States.

“In December 2015, following discussion between FDA and Sanofi, the label was updated to reflect that cases of permanent alopecia have been reported following use of Taxotere, although at an unknown frequency," Brown said. "All prescribing decisions are made by treating physicians who understand their patient’s needs and weigh the risks and benefits of treatment options. “

However, M. Palmer Lambert, an associate with Gainsburgh, Benjamin, David, Meunier & Warshauer LLC, who is also participating in the MDL, told the Louisiana Record the warning label came too late.

“Despite Sanofi’s knowledge of this significant risk of permanent hair loss as early as 2004, the drug’s U.S. warning label controlled by Sanofi never mentioned such a risk until December 2015. Other equally effective treatment options are available to be prescribed by oncologists that do not carry this risk of permanently bearing the mark of cancer," Lambert said.

The review began Nov. 17 when The Lambert Firm attorney Emily Jeffcott was appointed to the Taxotere plaintiffs' steering committee (PSC) by the Multi-District Litigation (MDL) Court.

This action was initiated by U.S. District Judge Kurt D. Engelhardt of the Eastern District of Louisiana. Engelhardt made the appointments to the Plaintiffs’ Liaison Counsel, Defendants’ Liaison Counsel and PSC under Pretrial Order 2.

The PSC is charged with overseeing the discovery stage of the litigation process as it works with each defendant’s lawyer or committee. MDLs are established when there are multiple civil claims cases that are similar in nature, but which are filed in differing judicial districts. The MDL steps up to facilitate the pre-trial processes.

“As court-appointed counsel, [I] and 15 other attorneys from nine states will take a lead role in advancing claims that France-based pharmaceutical company Sanofi-Aventis’ failed to warn women across the United States (and their physicians) that its breast cancer chemotherapy drug Taxotere causes permanent hair loss at a significant rate," Lambert said.

It is estimated that the PSC will be performing its review until 2018.

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Organizations in this Story

Gainsburgh, Benjamin, David, Meunier, & Warshauer LLC U.S. District Court for the Eastern District of Louisiana U.S. Food and Drug Administration (FDA)

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