On Tuesday, August 4, 2009, the Senate Committee on Health, Education, Labor and Pensions met for a hearing called "Protecting Patients from Defective Medical Devices" regarding Senate Bill 540, a companion bill to the House bill, H.R. 1346, the "Medical Device Safety Act of 2009." The House Subcommittee on Health, of the Committee on Energy and Commerce also met earlier this year on this issue, with some of the same speakers.
S. 150 and H.R. 1346 seek to overturn the Supreme Court's important ruling in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that the PMA approval process for Class III devices imposes federal requirements that preempt state tort claims which would impose additional or different "requirements" regarding the safety and efficacy of the device, pursuant to the express preemption clause found in the Medical Devices Amendment of 1976.
Speaking in support of the bill were William Maisel, Director of the Medical Device Safety Institute, Thomas McGarity, Professor at the University of Texas School of Law, and Michael Mulvihill, a patient who was formerly implanted with a medical device. The arguments they presented echoed those of preemption opponents.
Dr. Maisel's testimony came from the perspective of a medical practitioner, and while he praised the work of the FDA as a "preeminent medical regulatory system," it was his opinion that the FDA nevertheless could not regulate all safety and effectiveness issues that arise regarding PMA approved devices. Dr. Maisel also was of the opinion that medical device manufacturers fail to properly report medical device adverse events that in turn allegedly restricted the FDA's ability to properly regulate the industry, and in his view tort liability was an additional safeguard that Congress should restore. Professor McGarity echoed this perspective from a legal standpoint and suggested that innovation would not suffer (although he did not offer any objective support for this theory). Patient Mulvihil provided his thoughts about an allegedly defective lead he received.
Speaking in opposition to the bill were former Chief Counsel for the FDA, Peter Barton Hutt, and medical device patient Michael G. Roman. Mr. Hutt gave a historical account of how the Medical Devices Amendments of 1976, which included the express preemption clause in question, came to fruition. As Chief Counsel during 1971-1975, he came before the House Subcommittee on Public Health and Environment of the Committee on Interstate and Foreign Commerce at that time to support national uniform standards for medical devices in order to "strengthen the integrity, credibility, and primary jurisdiction of the agency." From this sub-committee hearing, "all medical device legislation considered in the House and Senate included some form of national uniformity requirement." Mr. Hutt warned that if the current Senate reverses the standards put in place through the 1976 Medical Device Amendments, judges and juries in product liability cases would make decisions inconsistent with FDA decisions to approve devices for market. Mr. Hutt also went on to describe the rigor of the PMA approval process that is applicable only for less than 1/2 of 1% of medical devices on the market.
The last witness of the day was patient Michael Roman, who testified about the importance of medical device innovation and availability from his personal experience. After multiple surgeries to repair a torn knee ligament that resulted in a staph infection and later progressive amputations of his right leg, Mr. Roam testified that prior to his medical device, he was under so much pain that he could not remember ten years of his children's' lives. Mr. Roman also testified that he was only able to live with large amounts of pain medication, radiation and injections to no avail. It was only after the implantation of a spinal cord stimulator (which delivers certain electrical impulses through leads to his spinal cord) that his pain has been managed effectively. He currently works with Boston Scientific in speaking out about the debilitating nature of pain and how medical technologies could assist patients in living full lives. His focus was that safe, innovative products should be approved through a more robust FDA, not through the vagaries of litigation that would result from the passage of the bill.
The limited time available during these hearings means that the witnesses often can only scratch the surface, and there is so much more to be said about why the Medical Device Safety Act of 2009 is a bad idea. For a more detailed perspective, it is worth reading “The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology’s Sloan School of Management.