Originally published August 1996
According to device manufacturers, industry innovation may be the primary victim of the Supreme Court's ruling in the Medtronic, Inc. v. Lohr case issued on June 26.
In a 5-4 decision, the Court disallowed Medtronic's claim for federal preemption against the state suit filed by Lora Lohr, clearing the way for the case to be heard in the Florida courts. Lohr's suit, which stems from the failure of her pacemaker lead in 1990, alleges that Medtronic is liable for negligent design, negligent manufacturing, and failure to warn, and seeks to recover $1 million in damages.
Industry associations were quick to voice their disappointment. Alan Magazine, president of the Health Industry Manufacturers Association, commented that the ruling "may present a potential step backwards for medical device innovation." On behalf of the Medical Device Manufacturers Association, Wayne Barlow, the association's vice chairman and president and CEO of Wescor, Inc. (Logan, UT), said the high court's decision "is a setback for medical device innovation, and will likely change some elements of research and development for small, entrepreneurial companies."
Officials at Medtronic echo industry sentiment. "We're concerned about the long-term impact on innovation that any complication in regulatory standards would create," says Medtronic spokesman Dick Reid. "If, as a result of this decision, verdicts and settlements in state liability suits tended to set standards--in other words, if one state said that a characteristic of a medical device was inadequate while another state said it was adequate--industry would have to design its devices to meet a very complicated set of standards. It would become more difficult to design new devices, and more difficult to improve the ones we have."
Meanwhile, industry attorneys are poring over the justices' opinions to determine how they will be applied in future cases. "There will be debate over how broadly the decision is read," says Jeffrey Shapiro, a medical device attorney with the firm of Hogan & Hartson (Washington, DC). "Plaintiffs' attorneys will argue that this decision means there is no more federal preemption, and company attorneys will take the opposite view. Neither position will be completely correct. On the one hand, it is clear that product liability claims against a 510(k) device will no longer be preempted. On the other hand, it looks possible--though not certain--that a majority of the justices would be predisposed to find design, manufacturing, and labeling claims preempted for a PMA device."
The remaining uncertainty stems from the fact that the high court justices offered three separate opinions in the case. Justice Stephen Breyer concurred with the judgment of the Court, but offered a separate opinion that split the difference between the other eight justices. Breyer concluded that the Medical Device Amendments of 1976 "will sometimes preempt a state-law tort suit," but did not specify under what circumstances such preemption could be expected.
"In terms of future cases, Justice Breyer is clearly the swing vote," observes Shapiro. "In the past, the circuit courts were split on the issue of preemption for 510(k) devices. The Court's decision in this case denied preemption of claims related to the design, manufacture, or labeling of a 510(k) device, but Justice Breyer's opinion left the door open to preemption for PMA devices.
"Justice Breyer believes that preemption should be granted if FDA's requirements for a device are specific enough. He did not feel that the agency's substantial equivalence process, GMP regulations, or labeling regulations were specific enough to sustain a preemption claim for a 510(k) device. But his opinion suggests that he might rule differently for PMA requirements, which are much more device-specific."
"The closeness of the vote--a 4-1-4 plurality--makes it apparent that the justices could not agree," says Medtronic's Reid. "But once you include the opinion of Justice Breyer, a majority believes that preemption should be upheld in certain cases. And we interpret that as meaning that devices subject to the premarket approval process would fit the requirements for such a case."
"On the whole," says Shapiro, "manufacturers are in much the same situation after the Lohr decision as they were before, in the sense that they can still litigate such cases on their merits. It would have been more surprising if the Court had gone the other way and found in favor of a sweeping preemption, because that would have outlawed virtually all state legal remedies for plaintiffs in cases involving allegedly defective devices. The current decision is closer to preserving the status quo."
With the apparent uncertainty of the high court's decision over when preemption can be claimed, manufacturers will be turning their attention to the case of Mitchell v. Collagen, which raises the preemption question for a PMA product. That case is now before the Seventh Circuit Court of Appeals (Chicago). "If Mitchell v. Collagen eventually comes to the Supreme Court, and the Court agrees to consider it, that could close the loop," says Reid. "Then we would know exactly where we stood, for both 510(k) and PMA devices. Right now, we still don't know."--Steven Halasey