Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.
Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy. The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency’s resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic. H.R. 6381 garnered 62 co-sponsors last time. Officials for the “American Association for Justice” f/k/a ATLA, recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.