Supreme Court Shields Medical-Device Makers

By Gregory P. Brummett, Esq.

In its February 20, 2008, decision in Riegel v Medtronic, Inc., the U.S. Supreme Court ruled that The Medical Devices Act of 1976 (“MDA”) was sufficient to preempt any State law that purported to “establish or continue … any requirement … which is different from, or in addition to, any requirement” under relevant federal law.  The MDA, passed in response to widespread lawsuits over the Dalkon shield, provides for Food and Drug Administration (“FDA”) oversight of medical devices with the degree of scrutiny depending on the type of device at issue.  The most extensive oversight is applied to those medical devices designated as Class III devices.  Such devices are subject to a premarket approval process during which the FDA reviews their design, labeling, and manufacturing specifications and determines whether or not those specifications provide a reasonable assurance of safety and effectiveness of the device.  Once a medical device has been approved, the manufacturer may not make changes that would affect the safety or effectiveness of the device until they have obtained permission for the change from the FDA.

Charles Riegel was injured when a Medtronic catheter ruptured during a 1996 coronary angioplasty in response to a myocardial infarction caused, in part, by a right coronary artery that was diffusely diseased and heavily calcified.  During the surgery, Riegel’s doctor inserted the Medtronic balloon catheter into Riegel’s diseased coronary artery and attempted to dilate the artery, despite device labeling warning that such use was contraindicated for patients, like Riegel, having diffuse or calcified stenoses.  Although the label further warned that the catheter should not be inflated beyond its rated burst pressure of 8 atmospheres (just over 117 psi), Riegel’s doctor inflated the catheter five times, to a pressure of 10 atmospheres (147 psi).  During the fifth inflation, the catheter ruptured, resulting in a blockage that necessitated emergency coronary bypass surgery.

Although the catheter was a Class III device that had passed FDA’s most rigorous premarket approval and was used in a manner inconsistent with the device labeling, Riegel filed suit in New York alleged that Medtronic’s device was designed, labeled, and manufactured in violation of New York common law and that he was entitled to recover damages on claims of strict liability, breach of implied warranty and negligence in the design of the catheter.  In disposing of the lawsuit, the U.S. District Court noted that Riegel’s claim was not based on any allegation that Medtronic had violated federal law and dismissed Riegel’s state law claims as being preempted by the MDA.  On appeal, the U.S. Circuit Court for the Second Circuit affirmed the lower court’s decision.

Justice Scalia, writing for an 8-1 majority, held that the MDA preempts the imposition of liability under state laws for Class III devices that have passed the FDA’s approval process, the most rigorous of the FDA’s testing procedures.  Scalia reasoned that allowing juries to award damages when something goes wrong would be unfair because patients “would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations.”

Justice Ginsburg dissented, arguing that Congress had not intended the preemption clause “to effect a radical curtailment of state common law suits seeking compensation for injuries caused by defectively designed or labeled medical devices” and that she doubted Congress meant leave no remedy to consumers injured by FDA-approved devices that “nevertheless prove unsafe.”  She further noted MDA’s “failure to create any federal compensatory remedy for such consumers” as evidence that Congress did not intend the MDA to preempt all state common-law suits alleging deficiencies in FDA-approved medical devices.

gregbrummett.jpgGregory P. Brummett of the Capitol Patent & Trademark Law Firm is a patent attorney with 15 years experience in the drafting and prosecution of patent applications before the USPTO in a wide range of technologies including, in particular, chemical and semiconductor processes. 

He may be reached at (703) 266-3330 or

Scroll to Top
Share via
Copy link