Increasingly, consumers who feel that they've been injured by drugs are taking their case to state courts. Their adversaries, the pharmaceutical companies, have long contended that the cases had no place in state proceedings, at least in the case of drugs that had been approved by the FDA, suggesting that federal law should govern such cases. For decades, courts disagreed with the pharmas, but of late, things are turning around. Some observers say that if state courts don't put pressure on the pharmas, they'll have little incentive to disclose post-approval adverse drug effects--but the FDA disagrees.
Now, it seems that the Supreme Court may have the final word. Recently, the Court ruled that many states' suits against medical device makers are pre-empted by federal law. They'll soon rule on a similar case that could make pre-emption the standard for drug cases, too. This could have a dramatic effect on actions such as the flood of state suits against Johnson & Johnson, which has been sued by more than 3,000 women and their families, all claiming that its FDA-approved Ortho Evra patch caused harm by delivering much more estrogen than expected.
To learn more about this trend:
- read this New York Times piece
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