In a development that is highly unusual in drug litigation, eight pharmaceutical companies involved in the manufacture and marketing of generic Taxotere (docetaxel) are now being named as defendants in current multi-district litigation moving forward in a Louisiana federal court. So far, 1,000 women who have suffered hair loss from Taxotere treatments have filed suit against French drugmaker Sanofi-Aventis. Now that generic manufacturers are being targeted, the number of plaintiffs is expected to rise significantly.
What makes this situation unique from a legal perspective is that when a brand-name medication is a cause of action in litigation, generic versions of the same drug are normally excluded. The decision to include generic doxetaxel in the current MDL represents an unusual move by the Judicial Panel. One attorney involved in the litigation said this is the first time he has ever heard of such a decision.
Lawsuits against Sanofi-Aventis began last year by cancer patients who had been treated with Taxotere and suffered permanent alopecia (hair loss) as a result. Plaintiffs allege that the company was aware of that risk based on its own internal research and failed to warn patients. The drug itself was first approved by the FDA in 1996, but warnings about the possibility of permanent alopecia did not appear on packaging until twenty years later.
Generic versions of brand name medications such as Taxotere are usually approved under the FDA 505(b)(2) process. This is similar to the infamous 510(k) Pre-Market Clearance process that allows drug makers and medical device manufacturers to bypass rigorous clinical trials and testing if they can demonstrate that the new product is “substantially similar” to a previously-approved one. Under 505(b)(2), the FDA recognizes that the generic drug is virtually identical to the brand-name version – so approval is granted without requiring any new testing. There is a difference, however; while the manufacturer of a drug or a device approved under 510(k) can be held liable for design defects, those who put out generic drugs are generally immune from lawsuits affecting the name brand equivalent. In the past, plaintiffs who have brought complaints against a generic drug have had their cases dismissed.
What is different in this case is that claimants against generic docetaxel manufacturers point out that their versions were approved after research on hair loss had been published. The results of that study were published in the Annals of Oncology in 2006 and the New England Journal of Medicine in 2010, while generic versions of Taxotere started in 2011. Therefore, these drugmakers should have known about the alopecia risk, and failed to warn patients.