Op-Ed: Medical Device Makers Should Not be Shielded From State Lawsuits

In an op-ed in the New England Journal Of Medicine Gregory Curfman, M.D., Stephen Morrissey, Ph.D. and Jeffrey Drazen, M.D. wrote, "Major stakeholders throughout our health care system agree that every step must be taken to ensure that medical interventions, used with the intention of improving patients' health, are as safe as possible." However, "every medical intervention has benefits and risks." They say, "Unfortunately, one major stakeholder, the medical-device industry, has been shielded from the potential consequences of failing to adequately disclose risks." After "the Supreme Court ruling in Riegel, thousands of lawsuits against medical-device manufacturers have been tossed out of court by judges following the Court's lead in deeming such lawsuits to be preempted" and "we contend that preemption will result in medical devices that are less safe for the American people." Concluding, they say, "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."