Thomas C. Novelli03.31.09
On the Hill: Device Safety Act Could Have Hodgepodge Effect
Thomas C. Novelli
Under the medical device approval laws, a provision exists that protects the scientific and highly regulated process from competing regulatory challenges. Recently, the U.S. Supreme Court clarified and reaffirmed this provision. However, a year later, the same court reversed its position in a case that reviewed a parallel legal principle involving drug approvals.
Both cases focused on the legal principle of federal preemption of tort liability claims in state courts. While the cases were similar in theory, the court issued mixed signals in its rulings. The political fallout from the decisions is being felt, with activist members of Congress moving quickly to enact legislation that could change the landscape for medical device manufacturers.
In the 2008 case Riegel v. Medtronic, the Supreme Court issued an opinion supporting the legal principle of federal preemption. At issue in the case was whether the U.S. Food and Drug Administration (FDA) approval process for premarket approval (PMA) of classified products preempted claims of tort liability in state courts. The case evolved from a defective balloon catheter used during an angioplasty procedure.
The plaintiffs in the case argued that the device was designed, labeled and manufactured in a manner that violated New York common law.However, both the District and Federal Circuit courts, prior to the Supreme Court’s decision, ruled that the federal preemption clause barred any claims against the safety and effectiveness of a device made under state common law claims. The Supreme Court affirmed these lower court decisions.
History of Preemption Laws
In 1976, Congress amended the Federal Food, Drug and Cosmetic Act to include regulation of medical devices.Previously, the FDA did not possess the statutory authority for premarket approval, review or testing. The agency could, however, determine whether a product was safe and effective for human use. In addition, the agency did possess the ability to bring charges against manufacturers who mis-branded products or sold unadulterated products. The authority granted to the agency with respect to medical devices was analogous to general “policing” powers.The FDA maintained greater authority once a product was on the market.
Unlike devices, prescription drugs underwent a more rigorous review process prior to the current device regulation framework. To bring greater parity between the regulation of drugs and devices, Congress passed the Medical Device Amendments of 1976 (MDA). In short, the legislation created the framework for the FDA regulatory scheme, as it is known today. Given the need to have a strict regiment in place to ensure patient safety and product effectiveness, legislators aimed to craft legislation that would not allow the FDA process to be challenged at multiple levels.
To this end, Congress included a provision in the MDA to ensure that uniformity in the regulatory system was maintained. Specifically, Congress created a provision for the PMA process to preempt any attempts by state courts to create additional requirements to determine a product’s safety and effectiveness. The rationale behind this inclusion was to avoid a patchwork of competing regulatory schemes that could lead to inconsistency and confusion.
A Wrinkle in Federal Preemption Theory
After the opinion in Riegel was issued, policymakers have closely followed a second preemption case involving pharmaceutical products.In that case, Wyeth vs. Levine, the court took a different approach regarding the theory of preemption. In this instance, the court ruled against the manufacturer and ruled that the FDA approval process for drugs did not preempt tort liability claims in state courts. In short, the court widened the liability target on drug makers. The result of the Wyeth case has now become fodder for lawmakers looking to device manufacturers.
Since the Wyeth decision, lawmakers have rushed to introduce legislation that would, in effect, overturn the Supreme Court’s decision in Riegel. In the House of Representatives, Congressmen Frank Pallone, Jr. (D-N.J.), chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-Calif.), chairman of the Energy and Commerce Committee, introduced the Medical Device Safety Act of 2009. Likewise in the Senate, Edward Kennedy (D-Mass.), chairman of the Senate Health, Education, Labor and Pensions Committee, introduced similar legislation to reverse the court’s decision.
The legislation would amend the MDA preemption provisions by adding the following caveat: “No Effect on Liability Under State Law—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”
The addition of this provision would subsequently overturn the court’s ruling by allowing safety and effectiveness to be considered and reviewed by a lay jury in a state court. Should this legislation move forward, it likely would affect the way device manufacturers innovate and develop new technologies.
Unintended Consequences
The Medical Device Safety Act has the potential to undue years of statutory intent while concurrently producing unintended consequences that will affect both patients and innovators. For starters, the proposal assumes that the 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” (juries). However, the legislative statutes the proposal seeks to amend (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.Prior to the inclusion of the 1976 MDA, the FDA did not possess real authority to determine whether a product was safe or effective prior to approval. Instead, the agency employed police authority to determine safety and efficacy ex post facto of a device approval. The overall consequence of the Medical Device Safety Act would be the ability of state courts and lay juries to challenge, and perhaps determine, whether a medical device is safe or effective.
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 ensuring medical device safety and efficacy. This reputation is built on the nearly 1,000 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. Developers of medical technologies may become hesitant to innovate if there is a cloud of liability-related uncertainty overhead. 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 the government should be encouraging innovation and entrepreneurship, it is instead putting up a barricade.
Despite these concerns, many in Congress are listening to constituencies who seek to benefit from increased device-related litigation and seem to have little concern for innovation in the device industry. Given the current dynamics in Congress, it could be very likely that this legislation easily moves through both chambers of Congress and the president will accordingly sign. Whether or not the potential unintended consequences of the Medical Device Safety Act are given full consideration remains to be seen.
Thomas C. Novelli is director of Federal Affairs for the Medical Device Manufacturers Association in Washington, D.C. From 2003 to 2007, he served on the Senate Committee on Finance, where he worked on several areas directly affecting the medical device and pharmaceutical industries, including reimbursement, drug and device safety and approval and fraud and abuse in the Medicare and Medicaid programs. Novelli received his undergraduate degree in political science from the University of Dayton in Ohio, and a Master of Arts in policy from the Catholic University of America in Washington, D.C.