FDA premarket approval prevents patients from suing medical device companies over claims of a defective product in most circumstances, the Supreme Court decided Feb. 20 in the case of Riegel v. Medtronic.

In an 8-1 decision, the court held that the Medical Device Amendments to the Food, Drug and Cosmetic Act bar state liability suits against manufacturers of a "medical device marketed in a form that received premarket approval from the FDA."

The decision is a major victory for the device industry, which feared that a limitation on PMA pre-emption - an industry defense that had been supported by most but not all federal appeals courts - would lead to a substantial uptick in patient lawsuits.

"The FDA - and not a patchwork of state regulations or multiple jury verdicts - should determine the safety and effectiveness of medical technology," said Steve Ubl, president and CEO of the Advanced Medical Technology Association. "We are pleased today's ruling will allow the FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles."

Critics of the ruling, including some patient advocate groups and trial lawyers, said the decision subverts the legal system and is bad for consumers. "We believe this ruling seriously misconstrues congressional intent," said Jon Haber, CEO of the American Association of Justice, which represents trial lawyers.

Haber stressed that the decision only impacts PMA-approved devices and not the majority of products, which are cleared via the more lenient 510(k) premarket notification process.

Congress intended to limit lawsuits- Court

Medtronic was sued in New York in 1999 by Charles and Donna Riegel, three years after the firm's Evergreen balloon catheter burst during a coronary angioplasty procedure performed on Mr. Riegel. The Riegels claimed that the device's design, manufacturing and labeling were negligent.

The Supreme Court accepted the plaintiffs' request for a final ruling after a federal appeals court decided in favor of Medtronic on the grounds of federal pre-emption in 2006.

The overwhelming majority of the high court justices affirmed the appeals court decision.

The 1976 Medical Device Amendments suggest "that the solicitude for those injured by FDA-approved devices ... was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations," writes Justice Antonin Scalia in the majority opinion for him and six of his colleagues on the bench.

The only time the PMA pre-emption defense would not apply, according to the majority opinion, would be in the case of claims by a plaintiff that a device violated FDA's PMA requirements.

Justice John Paul Stevens concurred with the court's judgment, but in a separate opinion disputed some elements of Scalia's argument. Justice Ruth Bader Ginsburg was the sole dissenting voice.

With some allowance for states to apply for exemptions, Section 360(k)(a) of the Medical Device Amendments precludes states from establishing a requirement "which is different from, or in addition to, any requirement" established by the federal law and "which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."

The majority ruling rests on the findings that PMAs do in fact represent federal requirements and that common-law state tort claims are requirements that are "different from or, in addition to" PMA mandates.

Scalia cites the court's 1996 Medtronic v. Lohr ruling to support much of his opinion. In that case, a 5-4 majority decided that 510(k) clearance does not pre-empt state lawsuits. But he points in this case to the more stringent and specific PMA requirements, noting that "attributes that Lohr found lacking in 510(k) review are present here."

He also points to the majority Lohr finding that common law actions, as a general rule, do impose requirements as defined by the Medical Device Amendments.

Decision curtails consumer protections - Ginsburg

Justice Ginsburg, in her dissenting opinion, calls the majority's opinion "a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Ginsburg disputes the majority's claim that it was Congress' intent to pre-empt state lawsuits. Instead, she asserts, section 360(k)(a) of the Medical Device Amendments was expressly designed to assert federal dominance over medical device regulations that had been put into place by states including California prior to the federal regulations established in 1976.

Ginsburg says that judicial precedent should instruct the court to make a "presumption against pre-emption" when the statutory language is not absolutely clear.

"The constriction of state authority ordered today was not mandated by Congress and is at odds with MDA's central purpose: to protect consumer safety," she writes.

Stevens, who sides with the majority, nevertheless largely agrees with Ginsburg's account of congressional intent. "There is nothing in the preenactment history of the MDA suggesting that Congress thought state tort remedies had impeded the development of medical devices," he writes in his separate opinion.

Stevens, however, is ultimately persuaded that, despite intent, the text of the provision objectively provides for PMA pre-emption over state suits.

"It is an example of a statute whose text and general objective cover territory not actually envisioned by its authors," he writes.

-David Filmore (d.filmore@elsevier.com)

Supreme Court: FDA Approval Of Medical Devices Pre-empts Lawsuits

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