March 04, 2009Preemption Shot Down By Supreme CourtNews is just out that US Supreme Court has ruled against Wyeth in a landmark case wherein the drug and device maker had sought to have federal preemption rules override state laws on injuries caused by drugs and devices. Preemption basically holds that if the FDA has approved a drug or device as safe, then a pharma company couldn't be held liable for an unsafe product under state laws. The USSC didn't buy it, however, and shot down Wyeth's case 6 to 3. Preemption has been Big Pharma's wet dream for ages. Looks like Big Pharma needs a new dream. Posted by Philip Dawdy at March 4, 2009 09:26 AM
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As someone who was named in one of the amicus briefs I am of course pleased that our side won. It certainly was not a slam dunk. The essence of the victory is this: “It is a central premise of the Food, Drug and Cosmetic Act and the F.D.A.’s regulations that the manufacturer bears responsibility for the content of its label at all times.” Certainly I supported pre-emption because I believe that the pharmaceutical companies must bear responsibility for the dangers of their products and not pass the buck to the FDA who simply have not demonstrated they can live up even to the limited responsibility they do have. Posted by: Sara at March 4, 2009 01:42 PMWoops I mean I was against pre-emption because . . . Posted by: Sara at March 4, 2009 01:44 PM"A Vermont jury awarded $7 million in legal damages to a guitarist, Diana Levine. Part of her arm had to be amputated after she was improperly injected with the anti-nausea drug Phenergan made by Wyeth as part of treatment for a migraine." "Stevens said Levine presented evidence of at least 20 incidents before her injury in which a Phenergan injection resulted in gangrene and an amputation. As the amputations mounted, Wyeth could have analyzed the accumulating data and added a stronger warning, he said." This is the case. I took this in pills. Post a comment
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