Could a drugmaker be held responsible for the death of a patient because of a drug shortage? A new lawsuit will test the claim: An Idaho widow has sued Genzyme and its parent company, Sanofi ($SNY), saying that a shortage of Fabrazyme--which prompted rationing and partial dosing--killed her husband. The Mount Sinai School of Medicine, which holds the patents for Fabrazyme, was also named as a defendant in the lawsuit.
The shortage began after viral contamination forced a shutdown at Genzyme's Boston-area plant. While the company worked to fix its manufacturing problems there--problems that eventually led to an FDA consent decree--it set up a rationing program for Fabry disease patients. And it's this program that Janet Schubert blames for her husband's death.
"Genzyme's rationing scheme was undertaken despite their knowledge that less than a full dosage would not be effective and many patients would suffer catastrophic health deterioration and even death," the lawsuit claims (as quoted by Courthouse News Service).
The lawsuit comes as Genzyme has begun shipping new Fabrazyme supplies from its recently FDA-approved plant in Framingham, MA. Sanofi CEO Chris Viehbacher said last week that Fabrazyme supplies should double by year's end.
"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," a Genzyme spokeswoman told Pharmalot, adding that the company can't comment on specific patients or on litigation.
Schubert's lawsuit, which was filed in Salt Lake County Court in Utah, follows another patient action in federal court. Two dozen patients, including a lead plaintiff who uses Fabrazyme, allege that the FDA allows drug companies to discriminate against U.S. citizens, citing Genzyme's decision to ration U.S. Fabrazyme supplies more severely than European supplies. Another patient group sued last year over Genzyme's handling of the shortage.