The Senate Committee on the Judiciary recently held a hearing entitled “Short-Change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.”
On June 11, 2008, the Committee discussed recent preemption decisions by the Supreme Court, and heard from several witnesses including consumers, academics, a representative of the United States Chamber of Commerce, and attorneys. See details here.
Committee Chair Senator Leahy (D. Vt.) took up the cry of Democrats who have suggested that the Supreme Court has narrowly interpreted the laws designed to protect Americans who rely on medical devices to keep them alive. This Supreme Court interpretation has transformed the law, he said, into one that takes away protections from people by extinguishing long-standing state law remedies which hold corporations accountable when they are aware of potential dangers but hide them from consumers. As a result, Americans are allegedly not only deprived of a remedy under state law but are offered no replacement remedy under Federal law.
Sen. Orrin Hatch’s questioning brought out the U.S. Supreme Court’s decision in Riegel v. Medtronic, preempting state law claims relating to FDA approval of certain medical devices, was correctly decided. FDA approval of a device pre-marketing-approval application constitutes approval of the physical aspects of a device and its labeling, which results from a comprehensive review of the scientific and medical information relevant to the effectiveness and safety of the particular device. It also reflects FDA’s detailed resolution of tensions between aspects of the device that confer therapeutic benefits and aspects that present risks to safety.
Where the FDA has weighed the advantages and disadvantages of, and has approved, the design and labeling of a particular product, decision-makers applying state law should not be permitted to second-guess FDA’s approval, or re-weigh benefits and risks, or revise trade-offs FDA has already found acceptable, by finding the product’s design or labeling inadequate, Hatch was told.
Hatch noted that it would be difficult to characterize the Supreme Court’s 8-1 decision as a ruling by an “activist” court. The court’s decision was foreshadowed by prior Supreme Court and federal appeals court rulings.
The hearing was cut off before all witnesses testified live due to procedural issues in the Senate. Clearly, however, certain members of Congress are paying attention to the preemption issues.