Authors

George Horvath, University of California College of Law, San Francisco

Medical Device Dangers: Choosing Ignorance in the Courts and at the FDA

Abstract

Medical devices save lives and improve well-being but have caused as many as 83,000 deaths and 1.7 million injuries in a recent decade. Decisions of critical importance—patients’ decisions whether to have a device implanted, doctors’ decisions about which device to use, insurers’ decisions whether to reimburse for those devices—depend on information about risk that is provided by manufacturers. But producing this information is costly. Injured patients, through private lawsuits under state products liability theories, can incentivize device manufacturers to incur these costs and to produce and disclose information about device risk. Unfortunately, courts are making it increasingly unlikely that this will occur. Using a new empirical analysis of cases that have interpreted “comment k,” a sixty-year-old liability shield set out in the Restatement (Second) of Torts, this Article shows that over the past quarter-century courts have aggressively limited device manufacturers’ exposure to liability and thus have reduced one of their main incentives to invest in the production of information about device risk. And worse, these courts’ decisions have not been required by statute or by precedent; rather, courts have been choosing to interpret comment k in ways that keep us ignorant of the dangers posed by medical devices. These decisions have a synergistic effect with the Supreme Court’s decisions that have preempted state law actions against many devices and with the limits on the FDA’s ability to require manufacturers to produce information about risk. As a result, patients and physicians, as well as insurers, regulators, courts, and juries, are all being forced to make decisions based on unnecessarily limited information.

Unfortunately, straightforward solutions, such as Congress augmenting the FDA’s authority to require clinical trials or courts changing the way in which they are interpreting comment k, are unlikely to succeed. This Article evaluates an alternative set of potential solutions that may help put critical medical decisions on more solid ground.

Repository Citation

George Horvath, Medical Device Dangers: Choosing Ignorance in the Courts and at the FDA, 67 Wm. & Mary L. Rev. 669 (2026), https://scholarship.law.wm.edu/wmlr/vol67/iss3/3