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Sanofi-Aventis currently faces about 7,500 product liability lawsuits in the federal court system, each raising similar allegations that women were left with permanent hair loss from Taxotere, indicating that the manufacturers of the breast cancer drug failed to provide adequate warnings about the risk, which is not seen with other, equally effective treatment options.
Given similar questions of fact and law raised in cases brought on behalf of women nationwide, all federal Taxotere lawsuits are centralized before U.S. District Judge Kurt Engelhardt in the Eastern District of Louisiana, as part of a federal Multidistrict Litigation, or MDL, which is designed to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.
According to a joint report (PDF) last week, the litigation has grown from about 28 cases in October 2016, to approximately 7,500 cases pending as of December 12. In addition, as lawyers continue to review and file additional claims on behalf of women left with permanent hair loss following Taxotere breast cancer treatments, the size of the MDL is expected to increase further in the coming months and years.
Although hair loss is a known and accepted part of chemotherapy, women involved in the lawsuits allege that the drug maker provided false and misleading information that suggested their hair would regrow following Taxotere treatment, which is often not the case, leaving women with thinning hair or bald spots that may be permanent. If warnings had been provided about this known risk associated with Taxotere, plaintiffs indicate that they would have elected to receive different breast cancer treatments that do not carry the same permanent hair problems.
As part of the coordinated proceedings in the Taxotere MDL, Judge Engelhardt has established a “bellwether” process, which will prepare small groups of cases for early trial dates to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.
In July, Judge Engelhardt identified ten claims that will be eligible for the first bellwether trial, which is scheduled to begin on September 24, 2018. Four additional jury trials are expected throughout 2019, with cases set to begin on January 28, April 8, July 15, and November 4, 2019.
Taxotere Hair Loss Problems
Taxotere (docetaxel) is a high potency taxane-based cancer drug, which was introduced by Sanofi-Aventis in 1996 as a superior alternative to existing low-potency taxanes, such as Taxol. However, lawsuits allege that the drug is actually no more effective at treating breast cancer, yet carries a risk of permanent hair loss, or alopecia, which has not been associated with low-potency taxanes.
According to allegations raised in Taxotere hair loss cases filed in U.S. District Courts nationwide, Sanofi-Aventis provided false and misleading information for consumers and physicians in the United States, withholding reports of on-going hair problems experienced by users of the high-potency taxane.
Plaintiffs maintain that Sanofi-Aventis knew or should have known about the link between Taxotere and hair loss problems that continue for years following treatment, yet placed their desire for profits before consumer safety.
As early as 2005, studies have found that women face a substantial risk of permanent hair loss with Taxotere, including findings that indicate one out of every 10 patients treated with Taxotere suffered hair loss that lasted up to 10 years and five months following chemotherapy, and in some cases longer.
While Taxotere warnings in several other countries included information about the permanent alopecia risk, that same information was not provided to American women or doctors.
Judge Engelhardt has directed the parties to meet and confer this summer for a Taxotere settlement conference, to discuss potential resolutions for the litigation. However, if the cases are not settled following the MDL bellwether trials, thousands of individual cases may be remanded back to U.S. District Courts nationwide for separate trial dates in the future.