After delivering some punishing blows this term to class action plaintiffs suing securities issuers and underwriters, the U.S. Supreme Court's conservative majority appears to be swiveling its turret to take aim at plaintiffs suing medical device manufacturers. Are plaintiffs suing the pharmaceutical industry next?
Yesterday, the Court agreed to hear Riegel v. Medtronic, a case which presents the issue of whether plaintiffs who claim injury from a defective medical device -- in this case the Medtronic (MDT) Evergreen balloon catheter -- are generally barred from bringing state court tort suits by the fact that the Federal Drug Administration has already approved the safety and efficacy of the device and the necessary warnings that must accompany its sale. (Stephen Labaton of the New York Times has a good item about the case here.)
The claim that FDA approval of a device should "preempt" later attempts by injured plaintiffs to challenge before state court juries the safety of those devices or the adequacy of their warnings is, obviously, closely analogous to the claim -- aggressively advanced by the George W. Bush administration's first FDA chief counsel Daniel Troy -- that FDA approval of pharmaceuticals should likewise preempt most tort lawsuits against drug-makers, too. Nevertheless, there are important legal distinctions between the medical devices and pharmaceuticals, since the FDA's jurisdiction over the former was set up by a different statute -- the Medical Devices Amendments of 1976. Importantly, that law has an express preemption provision that, while still crammed with ambiguities, provides a firmer toehold for preemption advocates than exists in the pharmaceuticals realm. Indeed, all but one of the federal appeals courts that have addressed the medical device preemption question so far have found that most medical device suits are, in fact, preempted by the FDA approval process. Nevertheless, the federal appeals court that sits in Atlanta and the Illinois Supreme Court have each come out the other way.
The Court's reasoning when it decides the Riegel case, which it will not actually hear until next Fall, cannot help but provide enticing clues about how receptive the justices might be to the more controversial question: the degree to which most tort suits against drug makers -- like the tens of thousands of Vioxx-related suits now pending against Merck (MRK) -- might also be preempted. This bigger issue is slowly making its way up the court system, with lower courts split.) So while Riegel will be of greatest interest, of course, to device makers like Medtronic, Johnson & Johnson (JNJ) and Boston Scientific (BSX) -- the recent acquiror of Guidant and all its potential heart defibrillator liability -- it should also get very close readings from attorneys at Pfizer (PFE), Merck, and all the rest.
Although most courts -- "the great majority," according to the U.S. Solicitor General's brief -- have found that most medical device suits are preempted, the FDA itself has flip-flopped on the issue. Under the Clinton Administration it opposed preemption (or at least argued for a very narrow application of the doctrine), while under the current Bush administration, it has supported broad preemption. The Supreme Court took the case yesterday even though the Solicitor General had recommended against hearing it. (The Solicitor General had argued, in essence, that a clear consensus in favor of preemption was building without the Court's intervention.)
The Riegel case has been brought on behalf of Charles Riegel and his wife. While Riegel was undergoing an angioplasty in 1996 to dilate his coronary artery, a Medtronic balloon catheter burst, causing serious injuries and necessitating emergency bypass surgery. The district court threw out much of the case against him on preemption grounds, and the federal appeals court that sits in New York affirmed the preemption, with one judge dissenting.