Preemption Trouble Ahead: Proposed Legislation Brings Possible Turmoil

The development of new and innovative medical technologies is often a costly and lengthy process. Navigating the rigorous FDA requirements for premarket approval (PMA) can take years and tens of millions of dollars. Yet some on Capitol Hill are challenging the robustness of the current PMA review process. They would rather have a medical product's safety and efficacy be determined by a layperson in a jury than by FDA engineers and scientists who have spent years reviewing clinical data about the device. If this change were to occur, it would undermine the current regulatory process and stifle innovation.

The principle of federal preemption over state laws is driving a debate in Washington about whether injured parties should be permitted to bring liability suits against PMA devices in state courts. The principle of preemption is generally defined as federal law preempting, or being supreme over, state laws or regulations. This was the issue at stake in a recently decided Supreme Court case involving a device manufacturer.

The Supreme Court addressed the preemption doctrine head-on in the case of Riegel v. Medtronic. In the Riegel case, plaintiffs brought suit alleging that a Medtronic catheter was negligently designed and manufactured. The plaintiff's contention was that Medtronic was explicitly liable for injuries incurred because of the product's design.

The overall issue, however, was the legal doctrine of federal preemption. As the doctrine relates to the case, the conflict focused on whether claims of product liability under various state tort liability laws were preempted by the PMA process under the Federal Food, Drug, and Cosmetic Act. In an 8–1 decision, the Court held that the PMA process preempts competing state tort laws and thereby limits the liability that companies can face in a product liability lawsuit.

Where the Trouble Lurks

While the Supreme Court's decision was welcome news for many in the medical technology industry, opponents of the decision quickly denounced the ruling and began setting the stage for dissenting action. In May, Representative Henry Waxman (D–CA), as chairman of the House Committee on Oversight and Government Reform, called a hearing to examine the implications of preemption of state liability laws. The highly publicized event specifically examined the central question of the Riegel decision, focusing on whether FDA regulation of drugs and devices should bar injured patients from compensation under state law. Following the hearing, Waxman requested documents related to FDA's position on preemption of state liability lawsuits for both drugs and devices.

These actions culminated in the June introduction of the Medical Device Safety Act of 2008 (HR 6381) in the House of Representatives, and the July introduction of a Senate bill of the same name (S 3398). The legislative proposal aptly states, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” Notwithstanding possible constitutional challenges to this legislation itself, the proposal, in effect, negates the Supreme Court's holding and would allow for seemingly endless litigation against PMA products—no matter how rigorous the federal approval process might be.

The Medical Device Safety Act maintains a thinly coded shell of self-righteousness that barely covers the inherent and substantial flaws of the policy it seeks to advance. To begin, the proposal assumes that FDA's rigorous PMA process is flawed and should, without debate, be subject to the second guessing of the medical ‘expertise' of hundreds of different and competing authorities (aka juries). However, the legislative statutes the proposal attacks (the Medical Device Amendments of 1976) have prevented, and continue to prevent, the safety problems the proposal's authors believe are inherent in the current law. The PMA process was incorporated into the Federal Food, Drug and Cosmetic Act by way of the Medical Device Amendments of 1976. Prior to this change, the FDA did not possess any real authority to determine whether a product was safe or efficacious prior to approval. Instead, the agency employed police authority to determine safety and efficacy ex post facto of a device approval. In turn, if a product was neither effective nor safe, the FDA could seek legal recourse for possible product misbranding or adulteration. The overall consequence of the Medical Device Safety Act essentially would be the ability of state courts to challenge, and perhaps determine, whether a medical device is safe or efficacious.

What existed prior to the 1976 device amendments was a mélange of competing, and often conflicting, state regulations established to determine the safety and efficacy of a medical device. As it became apparent that innovations in the device industry were pervasive and that the industry itself was burgeoning, Congress rightly acted to establish a single, consistent and risk-based system to determine whether a device was safe and efficacious prior to that product entering the stream of commerce. The Medical Device Safety Act will, in effect, ignore what Congress sought to establish to deal with potentially unsafe products regulated at the state level. The proposal will allow for numerous state courts to question the validity of the PMA process and, ultimately, the very mission of the FDA. The agency and its Center for Devices and Radiological Health continue to be the “gold standard” in the world in ensuring medical device safety and efficacy. This reputation is built on the nearly 1000 scientists, researchers, physicians and engineers who devote their career to the agency's mission. Absent this single national authority, we are left with the mélange of conflicting state regulations that was problematic to the pre-device amendments era.

The authors of the Medical Device Safety Act continually argue that the legislation is about preserving and improving patient safety. However, the outcome of the legislation, if passed, could have the opposite effect. The hodgepodge effect of a medical device's safety and efficacy being challenged at numerous state levels significantly undermines the tried and true PMA process. In turn, patient access to innovative and lifesaving medical devices could be limited, resulting in greater negative clinical outcomes and substantial increases in overall healthcare spending. At a time when our country should be encouraging the development of new technologies, the passage of this legislation would have opposite outcome.

A Flawed Proposal

Questioning the motivation of the creation of legislation such as the Medical Device Safety Act almost seems to be sacrosanct. Through a convoluted cloud of sanctimonious rhetoric, the stated intent of the legislation is to protect patient safety. Again, the bill's authors assume that patient safety is ignored under the current approval scheme. In constructing their argument, legislators claim that patients injured by a device can seek no other legal recourse in pursuing damages for their injuries. This is a false claim, as the court's decision in Riegel does not deny a plaintiff complete legal recourse. Rather, it simply conveys a long-held constitutional principle of implied preemption of federal law. The Supreme Court rightly concluded that impracticalities that could arise from a patchwork of competing state courts would significantly undermine the authority of a single, scientific authority. Given the obvious flow of commerce from state to state, the PMA process provides such a scientific authority and has been proven to be the best facility to ensure device safety and efficacy. What appears to be a chivalrous and cavalier advancement for patient safety is more akin to the motivations of plaintiffs' attorneys.

The passage of this legislation remains unclear for the remainder of 2008. Congress has a plateful of other non-health-related issues to address prior to its adjournment. The fact that 2008 is an election year also will dampen most legislators' appetites to address any controversial issue. Many experts speculate that 2009 will be a watershed year for health reform, and possibly, an opportunity will exist to pass the Medical Device Safety Act. For innovation's sake, let's hope there are more motivated engineers and innovators than there are trial attorneys.

Thomas C. Novelli is director of federal affairs for the Medical Device Manufacturers Association (Washington, DC). He can be reached by phone at 202/354-7175 or via e-mail at [email protected].

© 2008 Canon Communications LLC

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