In today’s DC Examiner, Ted Frank of the American Enterprise Institute reports the story of a man who gambled, started taking a drug to control his Parkinson’s, continued gambling, stopped taking the drug, still gambled and eventually, four years on, gambled compulsively on the Internet and lost lots of money. He then sued the drug manufacturer.
A jury awarded Gary Charbonneau $204,000 to reimburse him for his gambling losses, $175,000 for “pain and suffering” and $7.8 million in punitive damages. The manufacturer had failed to provide enough warnings about side effects, or so they concluded.
All drugs from aspirin on up have side effects; doctors prescribe them because the benefits outweigh the costs. There can always be “more” warnings, and can always be accusations that the additional warnings weren’t sufficient.
After all, if the doctor knew the patient was going to have a side effect, she would not have prescribed the drug, so the warning must not have been good enough. The manufacturer can solve the problem only by taking every drug off the market, making everyone worse off.
Thus, the Food and Drug Administration says that courts should not permit such “failure-to-warn” lawsuits. Lawsuits can destroy the effectiveness of warning labels.
The trial bar wants to undermine the federal regime of drug regulation, preferring to sue in state courts where juries are more liable to make outrageous awards like those cashed in by Mr. Charbonneau. This “preemption issue” of federally regulated labeling was addressed by the U.S. Supreme Court in the Riegel v. Medtronic decision about medical devices, which limited tort claims in state courts when the manufacturer met federal labeling standards. In the fall the court will consider Wyeth v. Levine, concerning the regulation of drugs (in this case, an anti-nausea drug treatment). In the meantime, preemption is coming under attack in Congress. (For example, this medical device legislation, H.R.6381.)
As Frank concludes: “As even Clinton appointee Justice Stephen Breyer pointed out in a February 8-1 Supreme Court decision about medical devices, if we are to have meaningful safety regulation, those standards should be determined by federal regulators, not by untrained juries who hear only the sad stories of side effects in hindsight without considering the larger policy issues. ”
- WSJ Law Blog post on preempton and Wyeth v. Levine
- WSJ editorial on legislation to overturn Riegel v. Medtronic, “Devices for Lawyers“
- U.S. Solicitor General’s amicus brief in support of Wyeth and preemption in Wyeth v. Levine
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