Supreme Court to Consider Preemption

BUSINESS NEWS

In June, the Supreme Court announced that it would review the case of Riegel v. Medtronic. According to James Beck, counsel in the mass torts and product liability group of Dechert LLP (Philadelphia) and coauthor of the Drug and Device Law blog (www.druganddevicelaw.blogspot.com), the Court's action will likely provide a definitive resolution to the issue of federal preemption for FDA- approved medical devices.

Federal preemption is a legal concept that gives federal laws and regulations precedence over state laws and regulations in the same area.

In Riegel, a trial court dismissed a product liability suit concerning a Medtronic balloon catheter. The court ruled that the patient was not entitled to state law remedies in light of the prior FDA approval of the device. The Second Circuit Court of Appeals upheld that decision.

Seven of the eight federal circuit courts have consistently upheld the doctrine of federal preemption for medical devices. The High Court is expected to hear the case in October.

The issue of preemption also arose 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). 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 devices that have gone through FDA's rigorous premarket approval (PMA) process.

The proposed legislation would have negated such a concept 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)."

Steve 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 evisceration of the concept of federal preemption 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, Randall Lutter, MD, FDA's deputy commissioner for policy, 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."

Efforts to remove what the industry considered to be onerous provisions 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.

Commenting on the final House bill re-authorizing MDUFMA, AdvaMed's Ubl said, "We are especially pleased that the committee removed a proposal to limit the preemptive effect of FDA's device-specific actions, which potentially would have created hundreds of standards for medical technology manufacturers."