Another Voice / Health care
Peter Pitts: Supreme Court ruling could prove disastrous
President Obama has promised to reform the American health care system by expanding access to care and lowering costs. A recent Supreme Court decision just made his job a whole lot harder.
In Wyeth v. Levine, the justices upheld a $6.7 million award to a Vermont woman who lost her lower arm because of a botched injection of the anti-nausea drug Phenergan. The verdict will impact not just the case’s plaintiff, Diana Levine, and its defendant, Wyeth Pharmaceuticals. It has the potential to unleash a flood of frivolous lawsuits.
Levine’s story is sad. She was admitted to a clinic in 2000 with a migraine headache. A physician’s assistant gave her a painkiller and then administered Phenergan to combat nausea brought on by the medicine. The aide didn’t inject the Phenergan properly, and Levine contracted gangrene.
Phenergan’s label contained several prominent warnings about the risk of gangrene associated with a faulty injection. The label was also approved by the Food and Drug Administration, which has the final say on all matters of drug safety, including warning labels.
Levine sued the physician, the physician’s assistant and the clinic. All three parties settled. But Levine also sued Wyeth for failing to warn about the risks of injecting Phenergan. Her lawyers argued that Wyeth should have prohibited injection altogether, despite a green light from the FDA.
The Supreme Court agreed and declared that federal approval of a drug and its label does not protect a drug company from liability in state courts.
This verdict will have a chilling effect on health care. Effectively, the Wyeth decision allows all 50 states to set their own standards for pharmaceutical safety. What was once the job of a single, national body, the FDA, is now the province of trial lawyers, judges and non-expert juries. Universal, federally regulated drug labels will become a thing of the past. That’s a scary thought.
But Wyeth need not be the final word on drug regulation in this country. Policymakers can take several steps to save our health system from enterprising trial lawyers.
First, federal lawmakers should clearly define the legal liability of drug companies. Firms should, of course, be held to account for fraud and other egregious wrongdoing, but it makes no sense to hold them responsible for physician error, as the Levine case did.
Policymakers should also create a uniform standard for drug labeling that applies in all 50 states. Such a standard would ensure the safety of our medicines while keeping the costs of those medicines down.
In addition, state courts should establish clear guidelines for warning labels. In the absence of plainly defined rules, trial lawyers will be able to file suit after suit with impunity.
If they’re to successfully lower health costs, lawmakers must mitigate the effects of this wrongheaded decision.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
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