Congress appears ready to put the preemption issue to bed, once and for all. But first a little history. In Riegel, the Supreme Court ruled that a medical device manufacturer can’t be sued under state laws for harm caused by a device that received FDA approval.
Sadly, because of this unfair preemption decision, many patients have been thrown out of court. Interestingly, a recent New England Journal of Medicine editorial concluded that preemption results in medical devices that are less safe. They explain that patient safety can be insured only when the makers of drugs and devices fully and openly disclose both benefits and potential adverse effects. They note that that the FDA opposed preemption until 2003, at which time it inexplicably did an “about-face” and took the position that the approval of a medical device should be regarded as the final word and should immunize companies against legal liability.
In 2006, the FDA took the same position regarding drugs. Fast forward to Levine decision just weeks ago, where the Supreme Court dismissed the manufacturer’s argument that failure to warn suits against drug companies are preempted by FDA approval .
Great ruling for patients, correct? But, device recipients still have to contend with Riegel. So, we are currently faced with a strange situation where failure to warn and design defect lawsuits may be preempted for medical devices, but not drugs.
Fortunately, legislation may come to the rescue. The currently proposed Medical Device Safety Act would undo the damage done by Riegel and make it clear that the law does not preempt suits dealing with device devices. This would give the device cases the same status as drug cases. The Editorial in the New England Journal of Medicine urges Congress to swiftly pass this legislation and allow lawsuits by injured patients which, they explain, has been an important part of the regulatory framework and very effective in keeping medical devices safe. We agree and are pleased to see that many recognize the important safety net provided by our tort system.
Richard J. Arsenault, 2011
