I write this from Michigan, where legislation prevents its citizens from pursuing litigation for injuries, disabilities or death caused by any drug that has been FDA approved. In other words, if a drug is good enough for the FDA, it is good enough for the Michigan legislature and good enough for its citizens. If the drug has been FDA approved, regardless of how dangerous it is or what has been discovered about it after approval, a Michigan citizen who has been seriously injured by the drug cannot pursue its manufacturer for damages.
As a former trial lawyer, naturally, I vehemently disagree with this legislation. I was surprised to find that I have an unlikely ally, doctors! The New England Journal of Medicine has filed a friend of the court brief to the United States Supreme Court in the case of Wyeth v. Levine, stating that the “Food and Drug Administration is in no position to guarantee drug safety” and that “lawsuits can serve as a vital deterrent and protect consumers if drug companies don’t disclose risks”. You read that correctly folks; lawyers didn’t say it, doctors did.
“The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety. Without the discoveries dredged up by plaintiffs’ lawyers through liability litigation, the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct,” the doctors argued in their brief.
47 state attorneys general and two former FDA commissioners – David Kessler and Donald Kennedy support the Journal’s position. We will watch closely to see what the Supreme Court does with this case, but the support of the Journal and the doctors is certainly welcomed and appreciated.
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