[See update at bottom of post; Supreme Court ruled 10-1-07.]

A much anticipated Supreme Court ruling potentially impacting every personal injury suit against a medical device maker has been imperiled by a weird procedural wrinkle. Unbeknownst to the lawyers handling the appeal, known as Riegel v. Medtronic, plaintiff Charles Riegel died in December 2004, almost three years ago, and about 20 months before they filed the Supreme Court petition on his behalf.

Riegel sued after a Medtronic balloon catheter burst during an angioplasty in 1996, causing serious injuries. The Supreme Court agreed to hear the Riegel case in November 2006, because it raised the question of whether state law tort suits against medical device makers are preempted — i.e., barred — by certain language contained in the federal regulatory laws governing such devices. (The case does not directly impact suits against pharmaceutical manufacturers, who are regulated under a different federal statute that lacks the specific language in dispute.)

Often when a plaintiff in a personal injury suit dies, his case can survive him so long as the plaintiffs lawyers act promptly to substitute his estate as the new plaintiff. Under the relevant Supreme Court rule, the lawyer is supposed to do so within 6 months of the plaintiff’s death. Medtronic (MDT) is now arguing that because the plaintiffs lawyers didn’t meet that deadline, Riegel’s suit long ago “abated” (i.e., ended) and the appeal must now be dismissed. Though much of the medical device industry — which includes companies like Boston Scientific (BSX) and Johnson & Johnson (JNJ) — is eager for the case to be heard, anticipating a pro-industry ruling, Medtronic won the Riegel case in the courts below, and therefore would like to see this particular appeal dismissed (preserving their victory).

On August 1 Riegel’s appellate counsel at the Public Citizen Litigation Group, Allison Zieve, filed what’s oddly known as a “suggestion of death” motion, in which she sought to substitute Charles Riegel’s wife, Donna — the administrator of Charles’s estate — for Charles as the plaintiff. In her motion papers Zieve wrote that she first learned of Charles’s death from Donna in June of this year, and only managed to have Donna officially appointed as his administrator in late July. Zieve writes that she continually kept the Riegels apprised of the status of the case by writing to Donna, and that Donna, as a lay person, had simply not realized the impact her husband’s death would have on his suit. She argues that the Court has discretion to waive the 6-month rule and that, in any event, Donna was already a co-plaintiff in the case, suing for loss of her husband’s consortium (companionship), so her claim should go forward in any event.
Medtronic argues, on the other hand, that the abatement rule is mandatory and claims that it’s unclear under New York law whether Donna’s consortium claims survive Charles’s death. (The Court likes to hear cases that are unclouded by such state law side-issues.)

The Riegel suggestion of death motion was first reported in the Legal Times of Washington, here, and has also been noted subsequently in the blogosphere, here and here, for instance.

While pro-business bloggers have had some fun with the situation — as allegedly reflecting how distantly plaintiffs lawyers are in touch with their clients — to my ears the developments have more of a “there-but-for-the-grace-of-God-go-I” ring to them. I can well imagine a lay person, upon her husband’s death, having other things on her mind than rushing to the surrogate’s court to be formally appointed administrator of his lawsuit.

What do others think?

UPDATE (October 1, 2007, at 3:38) : This morning the Supreme Court allowed the plaintiff to substitute Donna, as administrator for the estate, for Charles. Chief Justice John Roberts and Associate Justice Antonin Scalia dissented. See Drug and Device Log post here.)

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.