Risk Management

Will FDA Regulations Preempt Personal Injury Suits?

By Elizabeth C. Moran, JD

[Digest, Winter, 1996]

In January 1996, the U.S. Supreme Court agreed to decide whether FDA regulation of medical devices precludes patients from bringing strict liability, negligence, and other common law claims for injuries caused by improper design, manufacture, or labeling of medical devices.

In Lohr v. Medtronics, Inc., the plaintiff claimed she was injured by an unsafe pacemaker, a Class III device which had been marketed under the abbreviated Section 510(k) procedure as “substantially equivalent” to previous pacemakers.

Applying the Medical Device Amendments of the Food, Drug and Cosmetic Act, which prohibit states from imposing regulations on medical devices that are “different from or in addition to” federal regulations, the U.S. Court of Appeals for the Eleventh Circuit determined that because the FDA imposed specific regulations on the manufacture and labeling of the device, injured patients cannot sue the manufacturers for manufacturing defects or inadequate warnings. The Court held, however, that claims relating to improper design of the pacemaker still could be pursued because the FDA had not imposed any specific requirements governing design.

Over the past several years, the courts have issued widely divergent and conflicting decisions in this area. For example, the Ninth Circuit recently held, in Kennedy v. Collagen Corp., that the Medical Device Amendments do not preclude personal injury suits at all but are intended to prevent states from enacting statutes and regulations that apply specifically to medical devices.

Some courts have held that certain kinds of injury claims are preempted for Class III devices that have gone through full Pre-Market Approval, but not for devices, such as Class II devices, that are subject to lesser regulation. Other courts have held that there is no preemption unless the FDA has enacted regulations specific to a particular device, such as the specific requirements for warnings on tampons and hearing aids. Still others have applied the doctrine of preemption broadly, concluding that the FDA’s general requirements for manufacturing procedures and labeling, which apply to all medical devices regardless of classification, preclude most, if not all, common law injuries.

The Supreme Court’s decision will have a profound effect upon the scope of litigation involving medical devices.

If the Court applies preemption broadly, as many lower courts have done, device manufacturers will be largely insulated from liability. However, the physician who uses the device remains a potential defendant — perhaps the only “deep pocket” — under theories of medical negligence and lack of informed consent.