The president of the ABA recently wrote to leaders of the House and Senate to express his personal support for H.R. 6381, the so-called “Medical Device Safety Act” that was introduced in the 110th Congress. The letters urged Congress to reintroduce in 2009 this legislation, which is designed to overturn the Supreme Court’s decision in Riegel v. Medtronic that a product liability lawsuit filed against Medtronic in state court was pre-empted because the device had received approval from the FDA.
Among the inaccurate and misleading statements in the letters is the claim that the plea is “on behalf of the American Bar Association and its over 400,000 members.” In fact, MassTortDefense knows a number of members of the ABA who understand the appropriate role of the preemption doctrine, its constitutional basis, and the need for a national test balancing risks and benefits.
As the Supreme Court has noted, state tort law that requires a manufacturer’s catheters to be “safer” in the eyes of a lay jury may require them to be less effective than the model the FDA has approved. State court juries do not ask how many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm. A jury sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. Why is it that the understandable solicitude for those few injured by FDA-approved devices must necessarily overcome a solicitude for those many patients who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations?