In a ruling that is expected to shave the volume of lawsuits against device manufacturers, the Supreme Court held that FDA premarket approval should preclude patients from suing companies for personal injury in most cases.

The court handed down the 8-1 decision in the case of Riegel v. Medtronic Feb. 20, ruling 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, which has been supported by most but not all federal appeals courts, would trigger a surge in patient lawsuits. The ruling is also a victory for the Bush administration, which has made strengthening federal FDA pre-emption a priority.

The decision "definitively demolishes a lot of the arguments we've been seeing for years (if not decades) from plaintiffs opposing preemption," write Jim Beck, an attorney with Dechert LLP, and Mark Herrmann, a partner with Jones Day, in their ¹ Drug And Device Law blog (www.druganddevicelaw.blogspot.com). Beck and Herrmann represent device and drug firms in personal injury lawsuits.

Jaxon White, chairman of Medmarc, an insurance company that provides liability plans to device and life science companies, said that the decision will have an immediate practical impact. "There will still be challenges on the fringes, but I think there will be fewer cases brought," White said in an interview.

AdvaMed President and CEO Steve Ubl said that the industry is "pleased" with the ruling. "The FDA - and not a patchwork of state regulations or multiple jury verdicts - should determine the safety and effectiveness of medical technology," he said. (see chart: " ² Will The Ruling Impact Insurance Premiums? ")

Critics of the ruling, including Democratic members of Congress, trial lawyers and some consumer advocate groups, 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.

Democrats in the House and Senate, including Ted Kennedy, D-Mass., who sponsored the Medical Device Amendments in the Senate in 1976, agree and are vowing to craft legislative language to undo the effect of the decision (see ³ Also see "Democrats Seek To Overturn Supreme Court Device Liability Decision" - Medtech Insight, 25 February, 2008.).

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 (⁴ Also see "Supreme Court Majority Appears To Support PMA Pre-emption Defense" - Medtech Insight, 10 December, 2007., p. 3).

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

Court Says Congress Intended To Limit Lawsuits

The case does not impact devices cleared by the more lenient 510(k) premarket notification process, which account for the majority of products on the market. The Supreme Court has previously ruled that 510(k)s do not pre-empt state suits (⁵ Also see "Riegel v. Medtronic At Supreme Court: Common Law Against Federal Statute" - Medtech Insight, 12 November, 2007., p. 9).

The decision also leaves open the opportunity for plaintiffs to sue based on claims that a company explicitly violated its PMA requirements.

Otherwise, the majority's language was strong in favor of PMA pre-emption.

"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.

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 concludes that PMAs represent federal requirements and, therefore, 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 to the more stringent and specific PMA requirements, noting that "attributes that Lohr found lacking in 510(k) review are present here."

He also cites 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' intention 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 1976 when the federal regulations were established.

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.

Justice Stevens sides with the majority but nonetheless 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)

In Victory For Device Industry, Supreme Court Favors PMA Pre-emption

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