Rapid advances in medical science are bringing an astonishing array of new therapies to patients. At the same time, those advances raise significant questions about how to strike an appropriate balance between patient safety and the availability of potentially lifesaving drugs and medical devices. In its recent decision in Riegel v. Medtronic Inc., the U.S. Supreme Court explored the complicated issue of who is best positioned to weigh the benefits and costs of new treatments, while reconciling the interest in protecting public safety with the sometimes competing interest in protecting the market for new devices.
At issue in the case was the meaning of the pre-emption clause in the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetics Act, which bars any state from establishing a requirement for a device "which is different from, or in addition to, any requirement" established under the MDA. Specifically, the court addressed the question of whether the clause precludes consumers from bringing state personal-injury suits challenging the safety and effectiveness of a very small number (roughly 1 %) of the most sophisticated devices that receive FDA premarket approval.
The case originated in 1996 when an FDA-approved balloon catheter burst while Charles Riegel was undergoing an angioplasty. As a result, Riegel suffered a complete heart blockage, necessitating emergency coronary bypass surgery. Riegel later sued Medtronic Inc., the manufacturer of the catheter, claiming that the device was negligently designed, manufactured and mislabeled under New York state law. The U.S. district court dismissed most of Riegel's claims on the ground that they were pre-empted by the MDA. The 2d U.S. Circuit Court of Appeals upheld that ruling, and the case was appealed to the Supreme Court.
The Supreme Court decision in the case turned on the question of what constitutes federal and state requirements under the MDA. In denying Riegel's claims against Medtronic, the court asserted that the catheter had been subject to an intensive approval process resulting in detailed federal requirements relating to the design, manufacture and labeling of the device. And, following its own reasoning in a prior pre-emption decision involving the MDA (Medtronic v. Lohr), the court asserted that a successful state tort suit would effectively impose separate and competing design, manufacturing and labeling requirements on manufacturers of medical devices.
But the court's analysis ran deeper, to a consideration of whether the FDA or a state court was best suited to realize the public good of having available safe and effective medical devices. Medtronic's balloon catheter was subject to an exhaustive premarket approval (PMA) process, under which manufacturers submit results of clinical studies and other extensive documentation for FDA review. Further, a device company submits an application for PMA typically only after investing thousands of hours and millions of dollars in developing and testing its new device. In turn, the FDA's internal scientists and engineers spend on average 1,200 hours assessing the device, may refer the application to a panel of outside experts and frequently request additional data from the manufacturer before granting PMA.
As the court reasoned in its 8-1 opinion, it defies all logic that a jury of six or 12 laypeople is better positioned to render a decision about the appropriate design and labeling of a complex medical device based upon evidence involving a single plaintiff presented over a two-to-three week period rather than scores of FDA experts assessing evidence that involves hundreds of patients culled from multiyear clinical trials. As Justice Antonin Scalia, who wrote the court's opinion, stated during oral arguments in Riegel, "because of the judgment of that one jury, the manufacturer is placed at risk in selling a device that scientists at the FDA have said is okay. I find that extraordinary."
The Supreme Court's ruling also recognizes that the environment in which medical device companies operate has changed dramatically since Congress passed the MDA in 1976. The number of suits against device manufacturers has proliferated, and Internet advertising has greatly aided well-financed plaintiffs' attorneys in "collecting" unrelated clients for so-called "mass tort" litigation. Absent federal pre-emption, companies could face verdicts dictating design, manufacturing and labeling standards that differ in each of the 50 states — hardly a formula for bringing safe and effective devices to a national market.
The FDA-centered process for approving new devices and drugs may not be perfect, but that does not justify allowing litigants to effectively set up an alternative regulatory process through the courts. Rather than rushing to amend the MDA to overturn the court's decision, Congress would better serve the public interest in protecting patient safety by addressing funding deficiencies at the FDA and strengthening the FDA's resources for reviewing new devices.
But surely the proper remedy for an overworked FDA is not empowering a panel of ordinary citizens to make complex scientific judgments based upon a cursory review of a narrow band of evidence.
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