NEJM Supports Medical Device Safety Act of 2009
Passage would hold medical device manufacturers to same legal standards as drug manufacturers
THURSDAY, March 19 (HealthDay News) -- Passage of the Medical Device Safety Act of 2009 would nullify the U.S. Supreme Court's 2008 Riegel v. Medtronic decision -- which shielded medical device manufacturers from the potential consequences of failing to adequately disclose risks -- and significantly improve patient safety, according to an editorial published online March 18 in the New England Journal of Medicine.
Gregory D. Curfman, M.D., and colleagues cited the consequences of Riegel v. Medtronic, including the recent dismissal of more than 1,000 cases filed against Medtronic in U.S. District Court in Minnesota after the failure of its Sprint Fidelis implantable cardioverter-defibrillator lead, which was withdrawn from the market in 2007.
The authors argue that Riegel v. Medtronic was based on a point of statutory law instead of patient-safety considerations, leading to a legal situation in which failure-to-warn and design-defect lawsuits are preempted for medical devices but not for drugs.
"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard," the authors conclude. "We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides."