As reported in the Pharmalot blog and the Patent Doc blog, six Fabry patients are now suing Genzyme and Mt. Sinai hospital as individuals and as a class for their failure to provide Fabrazyme to treat their disease. Previously these patients had asked HHS to exercise march-in rights to find another manufacturer for the product and they have also sued to force thr rationed drug to be sold in the US first before being shipped overseas as the inventions allowing the drug to be made were paid for by US tax dollars.
C. Allen Black, Jr., who represents the Fabry patients in this case, said in a press release that "for the first time, the courts will be asked to determine whether patients who are guaranteed access to tax-payer funded inventions under the Bayh-Dole act may recover individual damages under the statute when a contractor misuses the invention or withholds it from the public."
Black states further, “It defies belief that, even though US tax dollars paid for the invention of the drug and its development, American citizens are now told that they must suffer and die while paying almost $240,000 a year for a dose of drug that is untested, dangerous, and too low to even help them. Worse, some of my clients were diagnosed after June 2009, so Genzyme simply bans those Americans from receiving any drug at all.”
Fabry patients have requested compensation and punitive damages for lack of adequate treatment and Genzyme's failure to take adequate precautions including keeping a reserve inventory and providing second sources of manufacturing.