CAN A MEDICAL DEVICE BE DEFECTIVELY DESIGNED EVEN IF THE MANUFACTURER GOT APPROVAL OF THE DESIGN FROM THE FDA?
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.
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
This case addresses the following issue:
Can a medical device be defectively designed even if the manufacturer got an approval of the design from the FDA?
This case dealt with how state and federal laws interact. Id. at 314. Normally, these laws both apply without issue. Id. However, sometimes these laws conflict, seeming to impose two competing obligations. Id. In such situations, the federal law always prevails because the U.S. Constitution declares federal law the “supreme law of the land.” Id. at 315. This case dealt with a situation where federal law declared a medical device adequately designed, but state law attempted to find the device defectively designed. Id. The Court ultimately found that when federal law is complied with, no state law can be imposed to make a designed safer to avoid liability. Id.
This case dealt with a cardiovascular catheter that ruptured during a heart surgery, causing great injury to the Petitioner. Id. at 318. Prior to being released, Respondent had submitted the device to the Food and Drug Administration (FDA) for premarket approval. Id. at 315. This process is provided for by the Medical Device Amendments of 1976 (MDA). Id. Essentially, the FDA reviews the medical device’s design and administers several tests to ensure the device is adequately safe. Id. This process is rigorous and averages approximately 1,200 hours of research per device. Id. The trial court found that, by complying with premarket approval process, Respondent could not be found liable under New York state law for defectively designing the device. Id. at 316. This was because the MDA preempted state laws concerning the adequacy of the design. Id.
Unlike “simpler” cases of preemption, the two laws at issue here didn’t directly conflict with one another. Id. at 319. However, federal law can still preempt state law when Congress has expressed an intention to “completely occupy a field of law.” Id. Looking at the MDA and premarket approval process, the Court weighed the reasoning behind Congress passing the MDA. Id. at 320. When states are left to determine what constitutes an adequately safe design, a medical device manufacturer could have 50 competing standards. Id. This would make designing a product both difficult and liabilities virtually endless. Id.
Further, allowing states to impose additional requirements, beyond what the MDA requires, would have adverse effects contrary to the intentions of Congress. Id. at 321. For example, citizens of states with more demanding product liability laws would not have access to medical devices that citizens of other states would. Id. This directly conflicts with what Congress had hoped to achieved with the MDA—a uniform set of standards that encouraged development of cutting-edge medical devices for citizens of all states. Id.
Looking at these facts, the Court found that there was sufficient evidence to support a finding that Congress intended to preempt state laws attempting to impose additional requirements on designing medical devices. Id. at 322. Thus, the trial court was correct to find for Respondent because New York’s product liability law was preempted for claims of defective design. Id. However, there was one important caveat: when the design defect is based upon a failure to comply with the MDA or premarket approval process, federal law and state law are in agreement, and thus, a state law claim can exist because the laws are in harmony, not opposition. Id.