Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer responsibility for defective medical devices. This law will overturn the holding in the U.S. Supreme Court case of Reigel v. Medtronic decided two years ago. Background on that case can be found at the author’s website.
Though the opposition claims that this law will give unsophisticated juries more authority than the FDA experts, the FDA has conceded for years that it does not have the wherewithall to monitor and control the medical product performances in the field. The FDA has relied on state court actions brought by injured consumers as a "complimentary review" of the medical devices it authorizes into the marketplace.
Following the Reigel decision, the FDA has had to rely on manufacturers to correct defects in their products, something that manufacturers are naturally reluctant to do. Contrary to the opposition’s view, profit most often motivates the actions of the manufacturers. The "initiative" and "inventiveness" that the opposition claims will be stifled by the law seldom overrules the profit motive in favor of safety innovations. This is particularly true when the manufacturer is made completely immune from responsibility to those hurt by its defective products.
We commend Congress for its work to correct the "black hole" that the Supreme Court created, and to return responsibility to those that place defective medical products into the medical marketplace and our bodies.