Medical Device Link.

GOVERNMENTAL & LEGAL AFFAIRS

Return to Article: Preemption for PMA Devices

Beyond the pending U.S. Supreme Court hearing of Riegel v. Medtronic, the issue of federal preemption for medical devices also arose this past summer as the House Committee on Energy and Commerce’s subcommittee on health was finalizing its work on a bill reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). In June, a discussion draft of the legislation emerged that drew sharp criticism from the medtech industry. The area of greatest concern was a provision that would have placed limits on federal preemption defenses in liability cases involving medical devices, including those that have gone through FDA’s rigorous PMA process.

The proposed legislation would have negated federal preemption in stating, “Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law).”

Steven Ubl, president and CEO of industry association AdvaMed (Washington, DC), provided the subcommittee with written testimony in which he stated, “Device-specific reviews, such as a PMA, entail a comprehensive review of safety and effectiveness by FDA’s expert scientists, physicians, and other analysts.” In a subsequent news release, Ubl added, “Elevating individualized state actions and decisions through tort lawsuits over FDA’s expert science-based determinations of safety and effectiveness would undercut the agency’s authority and create a disincentive for companies’ research and development efforts.”

Ubl did not mince words in voicing AdvaMed’s concern over the federal preemption provision and its impact on MDUFMA. “This would be the end of the program—period,” he said. “Neither FDA nor industry would ever support this provision.”

Indeed, FDA’s deputy commissioner for policy, Randall Lutter, MD, said, “We believe that state law actions that can conflict with the agency’s conclusions and frustrate the agency’s implementation of its public health mandate should not be endorsed in federal laws.”

John Engler, former three-term governor of Michigan and current president and CEO of the National Association of Manufacturers (Washington, DC), called the proposed change in the federal preemption clause a “judicial prescription for disaster.” In an op-ed piece in The Detroit News, Engler wrote, “Current regulations prevent states from imposing requirements that are ‘different from or in addition to’ the FDA rules that ensure safety and effectiveness. Manufacturers depend on this single standard—a very high standard—to produce the drugs and medical devices that save people’s lives. Dealing with 50 different requirements, enforced by state courts and regulators, would be an expensive, bureaucratic nightmare only benefiting thousands of trial lawyers in the hunt for a big payoff.”

Efforts to remove what the industry considered to be onerous provisions—including those negating preemption—proved to be largely successful. The bill that emerged from the House on the final day of markups was much more in line with the Senate bill, with which the device industry is generally pleased.