It is relatively rare these days for average folks to defeat business interests before the U.S. Supreme Court. That's why the ruling Wednesday that kept the door open for patients to sue drugmakers in state court was an encouraging victory. The high court said that the Food and Drug Administration's approval of a drug and its label does not preclude injured patients from bringing personal injury suits.
Giving consumers the power to seek compensation for injuries from unsafe or mislabeled drugs will make drug companies more responsive to dangers posed by their products. The ruling also will likely have consumer protection implications beyond pharmaceuticals, to other manufactured products.
In Wyeth vs. Levine, the drug company Wyeth sought to have set aside a $6.7 million judgment won by a Vermont woman who lost part of her arm because an antinausea drug was improperly injected. The money was awarded because the drug was found to have insufficient warnings. But Wyeth said that because the FDA approved the warning label, the company was shielded from injury lawsuits in state court.
To the relief of consumers and patients, the Supreme Court ruled 6-3 that drug companies could not hide behind the actions of the federal regulatory agency. Justice John Paul Stevens, writing for the majority, noted that until the Bush administration changed course, the FDA supported the ability of consumers to sue in state courts as a complement to its regulatory powers. He noted that this change of policy occurred despite the FDA's "limited resources to monitor the 11,000 drugs on the marketplace."
Last year, the Supreme Court ruled 8-1 that makers of FDA-approved medical devices were immune from state lawsuits. In that case, the high court found that the 1976 federal law giving the FDA the power to regulate devices such as pacemakers and heart stents also included a bar on product liability suits against the manufacturers. In the Wyeth case, there was nothing explicitly in statute, and the issue was whether an "implied pre-emption" flows from all FDA warning label approvals.
It doesn't make sense for patients injured by a dangerous drug to have access to the courts while those hurt by a medical device do not. Members of Congress are already pushing legislation that would bring medical devices in line with the law that now controls pharmaceuticals, giving all injured consumers the opportunity to sue.
The Wyeth case will encourage manufacturers to be extra cautious, since they retain the responsibility to produce safe products or face the legal consequences.
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