Since our last comprehensive preemption update in March 2007, drug and medical device preemption has taken on an even higher profile, with a lot of activity in the Supreme Court—including some breaking developments from earlier today. Below, we review this latest news and the cases pending before the Supreme Court, as well as the other state and federal drug and medical device preemption cases decided since March. At the end of this article, we also discuss recent federal legislative activity that has received little notice, but which may have a significant—and unwelcome—impact on preemption, particularly in cases involving prescription drugs.

Drug and Device Preemption Matters Before the U.S. Supreme Court

Riegel v. Medtronic, Inc. For the past six years, the United States Supreme Court has been silent on the express and implied preemption doctrines in medical device and pharmaceutical cases, routinely denying petitions for review presenting those questions. This term is shaping up to be quite different.

As we noted in our March update, the Supreme Court invited the Solicitor General to weigh in on whether certiorari should be granted in a case in which the Second Circuit had joined the majority view and upheld preemption for a medical device approved through the rigorous premarket approval (PMA) process, Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006). Reed Smith’s Michael K. Brown and Lisa M. Baird briefed Riegel in the Second Circuit, and Michael argued the case.

The Solicitor General’s amicus brief was supportive of the majority view; explained the rigors of the premarket approval process; and counseled against granting review. Brief for the United States as Amicus Curiae in Riegel v. Medtronic, Inc., 2007 WL 1511526 (S. Ct. May 23, 2007) (No. 06-179).

The Supreme Court nevertheless granted cert at the end of last term. Riegel v. Medtronic, Inc., 127 S. Ct. 3000 (June 25, 2007) (granting cert.). The plaintiffs’ merits brief was filed August 27, 2007 [2007 WL 2456946], along with briefs from supporting amici Senator Edward M. Kennedy and Congressman Henry A. Waxman [2007 WL 2456945], AARP and other organizations [2007 WL 2456947], Consumers Union [2007 WL 2456948], the State of New York, et al. [2007 WL 2456949], Public Health Advocacy Institute and other organizations [2007 WL 2456950], and American Association for Justice and Public Justice [2007 WL 2576842]. Medtronic’s brief is due October 19, 2007.

As merits briefing was underway, an unusual wrinkle developed when plaintiffs’ counsel filed a motion on August 1, 2007 seeking to substitute an estate in place of plaintiff Charles Riegel, who had died several years earlier. Medtronic opposed. Earlier today, October 1, the Supreme Court granted the substitution, allowing Riegel to proceed. Two versions of the Supreme Court’s order were available on its website—an odd occurrence—one indicating Chief Justice Roberts and Justice Scalia would have denied the motion, and another indicating Justice Kennedy also dissented.

Baker v. St. Jude Medical. Also earlier today, the Supreme Court left pending a petition for review filed in Baker v. St. Jude Medical, S.C., Inc. et al., 178 S.W.3d 127 (Tex. App. 2005), rev. den. (Tex. Dec. 15, 2006) (No. 06-0223). Reed Smith’s James C. Martin and Lisa M. Baird briefed Baker and In re Heart Valve Litigation, 2005 WL 1541059 (Tex. App. June 30, 2005), a companion case involving the claims of an additional 69 Texas plaintiffs in a coordinated proceeding from Harris County. They also represent St. Jude Medical before the Supreme Court.

Baker also involves questions regarding whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.

Warner-Lambert Co. v. Kent. Last week, in the implied preemption context, the Supreme Court granted the petition for review in Warner-Lambert Co. v. Kent, : -- S. Ct. --, 2007 WL 1420397 (U.S. Sept. 25, 2007) (No. 06-1498) . Warner-Lambert involves an appeal from the Second Circuit’s Desiano v. Warner-Lambert Co., 467 F.3d 85 (2d. Cir. 2006). At issue is the effect of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), on a Michigan statute that exempts pharmaceutical manufacturers from liability unless the plaintiff establishes that the manufacturer intentionally withheld from, or misrepresented information to, the FDA. Since Buckman barred “fraud on the FDA” claims under the doctrine of implied preemption, manufacturers contend the statutory exception is foreclosed, meaning there can be no liability for manufacturers who fit within the statute. The Second Circuit’s decision was in conflict with the Sixth and Ninth Circuits on the issue.

It is possible that Warner-Lambert will provide further guidance on the reach of the Buckman holding, which could assist courts grappling with similar questions about how broadly it should apply. Ledbetter v. Merck & Co., Inc., Nos. 2005-59499, 2005-58543, 2007 WL 1181991 (Tex. Dist. April 19, 2007), for example, examined Texas

Wyeth v. Levine. Over the past year-and-a-half, questions about preemption in prescription drug cases have garnered a lot of attention, following the FDA’s release of its Final Rule, “Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products,” 71 Fed. Reg. 3922-01, 2006 WL 160271 (Jan. 24, 2006). One cert petition now pending may give the Supreme Court an opportunity to weigh in on these issues soon.

In Levine v. Wyeth, the Vermont Supreme Court majority rejected an implied preemption defense in a prescription drug case, concluding that the manufacturer could have implemented label changes without FDA approval, and warned against a method of drug administration when the FDA-approved label did not. In reaching its decision, the majority refused to give any weight to FDA’s Final Rule, stating that the FDA’s analysis was “neither an authoritative interpretation of an ambiguous statutory provision entitled to deference, nor a persuasive policy statement entitled to respect.”

Wyeth then petitioned for certiorari, seeking review of the following question: “Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (“FDA”) pursuant to FDA’s comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.” Wyeth v. Levine, No. 06-1249, 2007 WL 776723 (S. Ct. March 12, 2007) (cert petition).

In May, the Supreme Court invited the Solicitor General to file an amicus brief on whether certiorari should be granted. While there is no deadline for this filing, the Solicitor General’s amicus brief should be filed sometime this fall, perhaps soon. Once it does, the Court will decide whether to grant review a short time later. PhRMA and PLAC already have filed amicus briefs supporting certiorari as well.