Yesterday the U.S. Supreme Court ruled in a medical malpractice case, Riegel v. Medtronic, holding that the federal law, Medical Device Amendments, preempts any state laws regarding medical devices where the device manufacturer complied with federal requirements. By now, everyone is aware of how little protection is frequently offered by “federal requirements” when oversight is provided by agencies such as the Food and Drug Administration or the Consumer Product Safety Commission. Now state law can offer no protection against the negligently designed or manufactured medical device so long as federal requirements are satisfied – feel safer?
The Supreme Court found that Food and Drug Administration approval of medical devices preempts personal injury claims filed under state laws. Justices voted 8 to 1 in favor of preempting devices such as internal defibrillators that meet FDA specifications and were approved by the agency prior to being marketed to the public. Wednesday’s decision in Riegel v. Medtronic concerned only devices that were approved for market under the Medical Device Amendments of 1976.
In this case, Charles Riegel received a balloon catheter made by Medtronic which subsequently ruptured due to overinflation. Riegel developed a heart block and underwent emergency surgery. The Riegels later brought claims against Medtronic in the United States District Court for the Northern District of New York. The court found that the Riegels claims were preempted under the Medical Device Act, and the Second Circuit Court affirmed the decision. In this opinion, the Supreme Court affirms.
The Supreme Court held that state law claims regarding medical devices are preempted under the Medical Device Amendments (MDA) where the device manufacturer complied with federal requirements. In the opinion, the Court notes that review of the MDA turns on the definition of “requirements” in the statute. The decision states: “Absent other indication, reference to a State’s ‘requirements’ includes its common-law duties.” Thus, the holding expands beyond conflicting State regulations and statutes, which Congress was addressing in the MDA.
It appears that the Court tried to limit the decision in several ways.
• The opinion applies to medical devices only (not approved drugs) based on the preemption language included in the Medical Device Amendments.
• The Court draws a distinction between state law claims made regarding devices approved under substantial equivalent review requirements and §510(k) pre-market approval requirements.
• The Court discusses the extensive FDA review process for Class III medical devices only, rendering the application of the opinion to Class I and II devices uncertain.
• The Court expressly states that the decision does not apply to cases where the manufacturer did not comply with federal requirements.
Justice Scalia, writing for the Court, asserts that the “Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices.” The opinion claims that lay juries do not appreciate the benefits of medical devices. “A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”
In her dissent, Justice Ginsburg’s first footnote states that the “Court’s holding does not reach an important issue outside the bounds of this case: the preemptive effect of §360k(a) where evidence of a medical device’s defect comes to light only after the device receives pre-market approval.”
For the complete opinion click here.