I don’t want to jinx it, but the 2009 Medical Device Safety Act looks like it may be approved. The legislation, designed to void Riegel v. Medtronic, was the focus of witness testimony before the US Senate Health, Education, Labor and Pensions Committee. Key witnesses who testified in support of the Act included Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Maisel also chairs the FDA’s Circulatory Advisory Committee. Maisel, an influential voice in the industry, testified that FDA approval does not guarantee that the medical device is safe.
Essentially, that’s the problem with the Riegel v. Medtronic ruling. This court decision exempted medical device manufacturers from state civil suits if the device had received prior FDA approval.
Another witness testifying before the Senate committee spoke of the suffering he endured after being injured by multiple shocks from a defective Sprint Fidelis defibrillator whose wires malfunctioned causing the medical device to continuously shock the victim. The 2009 Medical Device Safety Act would allow such victims to pursue claims against the manufacturers of such defective medical devices.
Currently, failure to warn and design defect lawsuits are preempted for faulty medical devices but not for drugs. The 2009 Medical Device Safety Act is designed to correct this inequity in the law. Let’s hope it passes and becomes the law of the land.