CAN VIOLATION OF AN FDA REGULATION CONSTITUTE A CLAIM FOR NEGLIGENCE PER SE?

Sometimes the black letter law passed by the legislature is unclear. The legislature can’t anticipate every possible fact scenario when they pass a law, so it lay to the courts to interpret the law and give guidance to what it means. This interpretation is called case law. When the court decides a certain meeting to the law it essentially answers a legal question. Lawyers and other courts then can rely on that ruling when they have a similar issue in their case. The following case answers the question above.

Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

This case addresses the following issue:

Can violation of an FDA regulation constitute a claim for negligence per se?

A state law claim for negligence per se is based on the violation of law that resulting in injury to an individual. Id. at 352. Though most laws are available for such a claim, not every law can be used to establish such a claim. Id. In this case, Petitioner argued that a violation of the Food, Drug and Cosmetic Act (FDCA) was preempted from establishing a negligence per se claim because the FDCA already contains its own policing procedure. Id. at 353. The Court agreed, holding the federal law preempted any state law claim for personal injuries. Id.

The FDCA generally requires a new medical device to be approved as adequately safe in its design. Id. at 345. However, an exception exists when a device is shown to be substantially similar to an already approved device. Id. In this case, Petitioner had designed a bone screw device for use in spinal surgeries. Id. at 346. Petitioner asked the Food and Drug Administration (FDA) to approve the device under the exception, but the request was denied. Id. Petitioner provided additional information, but the application was again denied. Id. Petitioner then filed a third application, where it applied for an exception for each of the part of the device and noted the anticipated use was for arms and legs. Id. This application was approved, but the device ultimately caused severe injuries when used in spinal surgeries. Id. The FDCA contains a provision which requires the FDA to investigate and prosecute frauds upon the agency in relation to requirements of the FDCA. Id. at 347.

The Court began by noting federal laws can either expressly preempt state law or preempt state laws by implication. Id. at 348. Preemption is implied when the federal and state law directly conflict, creating competing obligations on a party. Id. Looking at the laws at issue here, the Court focused on the enforcement provision of FDCA. Id.

By granting enforcement responsibilities to the FDA, Congress recognized the “somewhat delicate balance of statutory objectives.” Id. If the FDA fails to prosecute any fraud at all, the FDCA has no meaning at all—manufacturers are free to completely disregard it. Id. If the FDA is too aggressive in prosecuting, particularly in deciding if a fine or a mandatory recall is the appropriate punishment, valuable medical devices could be kept away from patients for too longer, costing patients their health. Id. at 349-50. The FDA is entrusted with striking the appropriate balance; however, individuals can report violations and even petition the FDA to prosecute a violation—but the final call is always one that belongs to the FDA. Id.

With this purpose in mind, the Court found that the FDCA preempt claims based upon its own violation. Id. at 353. If Congress had intended for a private cause of action to exist, it would have added such an action rather than granting prosecution only to the FDA. Id. Thus, Respondent’s claim for negligence per se was preempted and could not be brought. Id.