In her wrongful death lawsuit, Janet Schubert maintains that her deceased husband, William, was diagnosed with Fabry disease, a rare, but life-threatening genetic condition, in 2005 and was in acceptable health until mid-2009, when Genzyme began rationing its drug. And she attributed his March 2010 death to the insufficient dosing the biotech imposed on patients.
Specifically, Schubert points to viral contamination that emerged at a Genzyme facility as well as an episode in which glass, rubber and steel particles were found. The ongoing manufacturing problems eventually prompted Genzyme to sign a consent decree with the FDA and dampened its stock price to the point where Sanofi later decided the biotech was a good deal (see here, here and here).
Genzyme was "aware that the lower dose of Fabrazyme posed a deadly risk to patients and consumers," the lawsuit charges. The biotech "grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals and the public of the lethal risk presented due to inherent and customary manufacturing defects and imperfections in the product" (here is the lawsuit).
This is not the first time that Genzyme has been sued over Fabrazyme shortages. A lawsuit that was filed last year by several Fabry patients mentioned that at least three people may have died as a result of the rationing (look here). But this appears to be the first time that a wrongful death lawsuit has been filed over the manufacturing problems.
A common thread, however, is the contention that Genzyme never tested to determine whether the reduced dosage was safe or effective for treating Fabry disease, and failed to warn about the risks associated with dosages that were lower than what was originally approved by the FDA. We asked Genzyme for comment and will update you accordingly. Also named as defendants are Sanofi and Mt. Sinai School of Medicine, which was awarded an NIH grant and invented Fabrazyme.
[UPDATE: A Genzyme spokeswoman send us this: "We have shared the patient community’s desire to return to normal supply of Fabrazyme, and we announced last week that patients in the U.S. have resumed to their normal dosing. While we understand the challenges the supply shortages have made for both patients and physicians, we cannot comment on specific patient experiences or on litigation.]
Meanwhile, Sanofi ceo Chris Viehbacher two days ago said that Fabrazyme production should double by the end of this year. His comments came a few weeks after the FDA and the European Medicines Agency approved a new plant in Framingham, Massachusetts, a move that Sanofi has been counting on to validate its $20 billion Genzyme purchase (see this).
Last month, by the way, more than two dozen people who suffered Fabrazyme shortages filed a lawsuit against the US Department of Health and Human Services, the FDA and the National Institutes of Health, arguing their rights were violated because the federal government failed to take adequate enforcement actions against Genzyme or allow for alternative means to protect supplies (read here).