What the brief says

The brief, or legal document, which was recently submitted to the U.S. Supreme Court on behalf of the NEJM’s top medical analysts basically tells the court that allowing injured consumers to sue drug manufacturers is necessary to keep the overall process in check. The writers say that the FDA simply can’t do its job adequately due to the number of new drugs that seek FDA approval each year – something that the FDA itself has admitted.

However, the Bush Administration doesn’t agree and has stated that the FDA can do its job adequately and that drug manufacturers should not be held accountable for the safety of their drugs. The issue, known as preemption, is a hot topic for consumers, courts and regulators. It says that if the FDA had the final say on whether a drug should be approved, then anyone injured by that drug cannot sue the pharmaceutical company who manufactured the drug.

Critics say that too many Americans are seriously injured or die each year because drug companies simply don’t do enough research on new drugs or fully disclose the research that has been done to the FDA – especially when that research isn’t consumer-friendly. The writers of the NEJM brief point to the numerous drugs that have been taken off the market due to safety concerns – concerns that the FDA couldn’t adequately manage.

All eyes on Wyeth vs. Levine

All eyes are now on a case known as Wyeth vs. Levine which deals with the pre-emption issue as it relates to drug companies. In that case, Diana Levine was a musician who lost her arm after taking Wyeth’s nausea drug Phenergan. She claimed that Wyeth did not adequately disclose the drug’s risks and was awarded $6.8 million. Wyeth appealed – all the way to the Supreme Court.

The same court recently upheld the pre-emption argument as it relates to medical devices. In that case, a man was severely injured when a balloon catheter exploded during an angioplasty. He and his family sued the manufacturer, Medtronic Inc. However, the court ruled in favor of the manufacturer – reasoning that the FDA was responsible for the final approval of the device.

The U.S. Supreme Court will decide the Wyeth case in the fall of 2008.