Drug Reaction

By Thomas Brom

The first week of November promises to deliver profound change, and not just at the polls. On November 3, the Monday before Election Day, the U.S. Supreme Court will hear oral arguments in Wyeth v. Levine (No. 06-1249), a failure-to-warn case that may determine the extent of implied-conflicts preemption in the U.S. pharmaceutical industry. "Last year, the Court heard four cases dealing with preemption and found it in all four," says Erwin Chemerinsky, dean of the UC Irvine School of Law. "Wyeth is the most important of all the cases."

To the plaintiffs bar, the stakes couldn't be higher. "This case is vital not just for us, but for all Americans," says Gerie Voss, regulatory affairs director for the American Association for Justice in Washington, D.C. "In a worst-case scenario the Court could give drug manufacturers complete immunity, leaving consumers no recourse if harmed."

Wyeth was brought by Diana Levine, a Vermont musician whose arm was amputated after she developed gangrene from an injection of Wyeth's antinausea drug Phenergan. Levine sued for damages, arguing that Wyeth should have prohibited the intravenous-push method of administering the drug and not just advise doctors--as the company did--of its significantly increased risks. Wyeth claims that the FDA's approval of its warning preempted claims under state law, even though Congress did not include an express preemption provision in the federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301). A jury awarded Levine $6.8 million, upheld by the Vermont Supreme Court, and Wyeth petitioned for cert.

By the end of August more than two dozen amicus briefs had been submitted in the case. The most intriguing one, filed on behalf of the National Conference of State Legislatures, was written by Elizabeth J. Cabraser, name partner at plaintiffs firm Lieff Cabraser Heimann & Bernstein in San Francisco. She provides Wyeth with a backstory, describing how a Bush administration political appointee allegedly played a central role in the FDA's insertion of key language in the preamble to a revised drug-labeling rule.

Cabraser calls out by name Daniel E. Troy, a defense attorney for drug companies who was appointed FDA chief counsel by the Bush administration in August 2001. "Once appointed, Mr. Troy publicly called for industry representatives to suggest cases in which the FDA could advocate for preemption," Cabraser writes. "No such position had ever been advocated in the over 90-year history of the FDA."

Troy resigned his post in November 2004 to join Sidley Austin; he later coauthored an amicus brief in Wyeth for the defense bar, and in September he became senior vice president and general counsel for GlaxoSmithKline. He did not respond to interview requests.

Cabraser implies that Troy's influence at the FDA was apparent in December 2005, when the agency notified the National Conference of State Legislatures that it "would be including a statement preempting state laws" in a long-dormant labeling rule--the first such revision in more than 25 years. (Brief of Nat'l Conf. of State Legislatures as Amicus Curiae at 8-14, Wyeth v. Levine (No. 06-1249).)

With no further rule-making or public notice, Cabraser states, the FDA in January 2006 simply attached a "preamble" to the final rule that "had not, prior to its publication, seen the light of day."

According to the preamble's text, the revised FDA labeling rule included "revisions made by the agency on its own initiative."

Among other things, the agency stated its belief that "under existing preemption principles, FDA approval of labeling under the act ... preempts conflicting or contrary state law." In addition, the agency claimed that "[s]tate law actions can ... frustrate the agency's implementation of its statutory mandate." (71 Fed. Reg. at 3934 (2006).) The FDA sees itself as setting both a "floor" and a "ceiling" on labeling and takes the position that "additional requirements for the disclosure of risk information are not necessarily more protective of patients." (71 Fed. Reg. at 3935.) The agency's preamble specifically points to--and condemns--state tort claims that "encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risk of a specific drug to the general public." (71 Fed. Reg. at 3935.)

It's a remarkable document, challenging a century-old system of joint regulation through both federal agencies and state laws. Even more audacious, the FDA simply asserted the revisions on its own authority in the text of the preamble.

"A regulatory rule is promulgated by a notice-and-comment process," says David C. Vladeck, a professor at Georgetown University Law Center in Washington, D.C., and counsel for former FDA commissioners Kennedy and Kessler as respondent's amici in Wyeth. "If the preamble language were in a final rule, it would have been amenable to judicial review. But you can't sue over a preamble."

The FDA's revised rule eventually generated congressional hearings--in September 2007 and again last May--but very little action. It also set off a lively debate in academia. "At the extreme," wrote Professor Catherine M. Sharkey of Columbia Law School, "a disquieting scenario emerges, whereby aggressive regulatory preemption, combined with renewed vigor toward evisceration of federal private causes of action, could lead to a nearly complete substitution of public for private enforcement." ("Preemption by Preamble: Federal Agencies and the Federalization of Tort Law," 56 DEPAUL L. REV., 227, 229 (2007).)

The more immediate question, however, was whether trial courts would give judicial deference to the FDA's claim of implied-conflicts preemption, and if so, how much. According to Mark Herr-mann, a partner in the Chicago office of Jones Day and coauthor of the Drug and Device Law blog, state courts have been "inconsistent" on that issue. The only appellate case to date was a defense victory (Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008)). "The principles of federalism are now colliding," Herrmann says. "The expertise of the FDA is more nuanced than it was 50 years ago, and binding state tort law is more intrusive."

Predictions of what the Supreme Court will do in Wyeth are all over the lot. "Preemption is a funny question--it's hard to find a constituency for it," Herr-mann says. "Liberals are split: they are for big government, but are also pro-consumer. Conservatives are split: they are for states rights, but are also pro-business. The justices do a funny dance when their knees are jerking in different directions."

Georgetown's Vladeck predicts that Levine will win for two reasons. "First, there is no preemption provision in the FDCA, so a decision favoring Wyeth would create a broad immunity for drug companies when Congress did not intend it," he says. "And second, a decision for Wyeth relies on the Court making assumptions about the FDA's having perfect knowledge--which it doesn't have. The tort system actually helps the FDA do its job."

Cabraser, too, is optimistic, but for other reasons. "Most of the justices on the Court are of an age to be taking prescription drugs," she says. "However [they] might be characterized politically, we all share a concern with drug safety. Risk-benefit analysis is most searchingly conducted when it affects you personally."

Just ask Diana Levine.

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