Epstein: A Sickly Medical Device Safety Act

A Sickly Medical Device Safety Act
Richard A. Epstein
August 11, 2009

Congressional mischief comes in large packages, like health care reform, and in small bundles, like the ill-advised Medical Device Safety Act of 2009 (MDSA) which is now moving forward in both the House and Senate. This short bill will overrule, retroactively for all pending cases, the Supreme Court's 2008 decision in Riegel v. Medtronic, Inc., which held that a specific statutory provision in the 1976 Medical Device Act explicitly blocked (or "expressly preempted" in technical jargon) state courts from allowing personal injury litigation to attack any device's design or warnings to which the FDA has given, after exhaustive inspection, its pre-market approval.

If passed, the MDSA would allow the same type of tort suits against medical device manufacturers to be brought against drug manufacturers. Furthermore, the 2009 Supreme Court decision in Wyeth v. Levine finally set to rest the controversial use of the doctrine of "implied preemption" to protect drug manufacturers against state law damage suits that attack FDA-approved drug warnings Justice Stevens noted that's how it was 70 years ago when the Food, Drug and Cosmetic Act became law. He concluded that's how it should be today, unless Congress explicitly brings these cases to a halt.

Why not, the defenders of the MDSA ask, require drug and device manufacturers to answer, in damages, for the harm that their bad products wrongfully inflict on consumers? Nothing is amiss--if you use the right definitions of "bad" and "wrongful." Seventy years ago, "bad" covered contaminated products, frayed wires and mislabeled or misbranded products. But in today's heady tort world, a bad product includes a good product that downstream health care professionals horribly misuse. Facts really matter, and both Riegel and Wyeth replicate this depressing pattern.

Richard A. Epstein