In the wake of Riegel, if you are a consumer advocate or a products liability lawyer you certainly wait with bated breath for the outcome in Wyeth v. Levine, No. 06-1249, the case currently pending on appeal to the High Court for review of whether or not a prescription drug failure-to-warn case is preempted by federal law. [NOTE: I use the term “federal law” as loosely as Pharma Counsel uses it the prescription drug context. You can pick your meaning – statute, regulation, notice-and-comment rule – because it is equally difficult to find preemptive force in any category you might search.]
The plaintiff, Diana Levine, developed gangrene and lost her arm to amputation following intravenous injection of Wyeth’s drug, Phenergen, which was administered to treat her nausea. She sued Wyeth alleging, inter alia, that the company failed to adequately warn her physician that Phenergen should not be administered intravenously. Following trial, she won a verdict of approximately $6.7 million, and the trial court denied Wyeth’s motions for summary judgment and judgment as a matter of law based upon preemption. The Vermont Supreme Court affirmed, and Wyeth petitioned the United States Supreme Court for certiorari.
While the Court was still reviewing the certiorari petition, it invited the United States to file an amicus curiae brief to express its views on preemption. The FDA’s brief requested that the Court hold its decision on the petition until the outcome in Riegel and another preemption case – Warner-Lambert, LLC v. Kent (since affirmed per curiam, without opinion) – but the thrust of its amicus brief predictably argued for preemption consistent with Wyeth’s position. Essentially, the FDA argues that its mere approval of the Phenergen labeling insulates Wyeth from tort liability because the approval was based upon the agency’s expert weighing of the risks and benefits of the drug and because FDA regulations do not permit a company’s unilateral adjustment of labeling without some “new” information to which the FDA has never been privy.
In its appellate briefing, filed recently in May 2008, Wyeth has framed the issue to invite the same broad preemption:
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.
In Wyeth’s and the FDA’s view, Wyeth is responsible only to the executive branch, not to consumers. And the FDA continues to insist, as it has for the last eight years, that it is entitled to announce and interpret the preemptive effect of its own regulations notwithstanding a lack of Congressional intent and in bold disregard of the plain text of at least several of those regulations. That should, of course, come as no surprise under the current administration. Indeed, President Bush once commented in a speech: “The legislature’s job is to write law. It’s the executive branch’s job to interpret law.” Certainly, a victory for Pharma in Wyeth v. Levine will mean that our President’s tortured understanding of the separation of powers is more accurate than your high school civics teacher would ever have imagined.