DOES COMPLYING WITH THE FDA’S PREMARKET APPROVAL PROCESS PREVENT A PRODUCT LIABILITY CLAIM FOR INJURIES ARISING FROM A DEFECTIVELY DESIGNED MEDICAL DEVICE?

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.

Troutman v. Curtis, 286 Kan. 452, 185 P.3d 930 (2008).

This case addresses the following issue:

Does complying with the FDA’s premarket approval process prevent a product liability claim for injuries arising from a defectively designed medical device?

This case arose from a product liability claim concerning a suturing device used in heart procedures. Id. at 453. The device manufacturer had complied with a premarket approval process set out by the Food and Drug Administration (FDA). Id. The manufacturer argued that by complying with this process, federal law preempted any claim for defective design under the produce liability law of Kansas. Id. After reviewing a recent United States Supreme Court decision, the court determined that a product liability claim based on defective designed for such a device can only exist if based on the failure to comply with the FDA’s process and procedures. Id. at 456.

Plaintiff in this case suffered injuries from a suturing device used by Defendant in his heart operation. Id. at 453. Plaintiff filed suit for his injuries, alleging the product had been defectively designed. Id. Defendant had participated in a program with the FDA, whereby its product was tested and approved prior to being placed on the open market. Id. at 454. Defendant, in discovery, had asked Plaintiff if the design defective was based on failing to comply with any regulation or law, to which the Plaintiff had answered it was not. Id. at 455. Defendant then raised the defense of federal preemption of Plaintiff’s claim, which the trial court agreed with, granting summary judgment for the Defendant. Id. at 453.

In the United States, federal and state laws generally co-exist, and companies must comply with both. Id. at 454. However, occasionally these laws can conflict, in which case the federal law always prevails pursuant to the Supremacy Clause of the Constitution. Id. An example of this is when the FDA creates regulations that outlines the requirements of a medical device. Id. at 455. To allow both of these obligations to exist—according to the courts—would place manufacturers of medical devices in a position to withhold useful medical devices from certain states based on the state’s product liability law. Id.

The FDA’s premarket approval program had found the medical device at issue here to be sufficiently safe in its design. Id. at 456. Thus, the court found, there was only one potential design defect that could exist: failure to comply with the design requirements of the program itself. Id. Product liability claims could still exist for manufacturing defects—an unintended variance on the design of the product—but not for the design itself being inadequate. Id. Because Plaintiff in this case directly admitted that there was no allegation of noncompliance with the program, so Defendant was entitled to judgment on the defense of preemption. Id.