On June 18, 2009, the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). The Act, if passed, would reverse the United States Supreme Court's decision in Riegel v. Medtronic handed down last year. As a result of that case, injured patients are barred from suing medical device makers for injuries caused by faulty devices. The hearing tomorrow is titled, "Medical Devices: Are Current Regulations Doing Enough For Patients?"
This hearing is a follow-up to the May 12, 2009 hearing on the Act. The June 18, 2009 hearing is coming on the heels of reports from the Wall Street Journal that new FDA Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency's medical device division.
Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal.
The passing of the Medical Device Safety Act of 2009 would clear the way for the thousands of individuals seriously injured by recalled Medtronic Sprint Fidelis Leads to pursue their claims against the manufacturer. Given that these devices were approved during a self-titled "dysfunctional" period of the FDA, allowing injured paitents recourse in a court of law only seems fair.