Wyeth v. Levine: The Intersection of FDA Drug Labeling Requirements, State Tort Laws, and Drug Manufacturer Responsibility According to the U.S. Supreme Court
Although it originated as a personal injury lawsuit in Vermont state court, the Wyeth v. Levine case quickly assumed the “mantel” of a constitutional law case because it involved constitutional law principles involving the doctrine of pre-emption. Under the pre-emption doctrine, federal law, including federal statutes, treaties, administrative rules, and common law “trumps” state law that is inconsistent with the specific terms of overall objectives of the federal law.
In Wyeth v. Levine, 555 U.S. (2009) (complete citation not available as of the date of this post; citations are for Slip Opinion), the Plaintiff, a professional musician, lost her hand to gangrene when she was administered Phenergan, an FDA-approved drug manufactured by Wyeth Pharmaceuticals for treating the nausea which often accompanies severe migraine headaches. During her first visit to the clinic, Phenergan was administered by an intra-muscular injection. The Plaintiff returned later in the day, but this time the drug was administered by an “IV-push” intravenous injection by the attending physician’s assistant. Unfortunately for the Plaintiff, the “second” injection procedure caused the drug to come into contact with arterial blood, resulting in the onset of gangrene and eventually the amputation of her hand and forearm.
The Plaintiff sued Wyeth in Vermont State Court on grounds of negligence for failure to provide an adequate warning concerning the potential danger of an “IV-push” procedure for administering the drug and product liability. A Vermont jury agreed and found Wyeth liable on grounds of negligence and product liability, and awarded Ms. Levine over $6,000,000.00 in damages.
Wyeth appealed the verdict to Vermont’s Supreme Court arguing that the drug’s label, which had been approved by the FDA, was in compliance with federal laws and regulations which govern drug safety and labeling requirements. Hence, the FDA’s regulatory requirements for prescription drug labels should pre-empt Vermont’s tort law which were in conflict with the FDA’s requirements. The Vermont Supreme Court affirmed the verdict and rejected Wyeth’s position. Wyeth appealed the decision to the U.S. Supreme Court.
The issue before the U.S. Supreme Court was whether Phenergan’s FDA- approved warning label "preempt state law product liability claims premised on the theory that different labeling judgments were neessary to make drugs reasonably safe for use." Slip Op. at 6. According to the U.S. Supreme Court, the answer is no. The Court, in a 6 to 3 decision, to the surprise of many observers, has affirmed the Vermont Supreme Court by holding that Vermont’s tort law was not pre-empted by the FDA’s labeling requirements for Phenergan.
Justice Stevens delivered the opinion of the Court, with Justice Kennedy and Justice Thomas concurring in separate opinions.
To better understand the US Supreme Court’s “pre-emption discussion,” some background on the pre-emption doctrine may be helpful. Generally pre-emption can be broken down into three distinct types: Conflict Pre-emption, Field Pre-emption, and Implied Pre-emption. The Wyeth decision focused on Conflict Pre-emption. Under case law developed for Conflict Preemption, federal law generally will trump state law under the following two circumstances:
1. A conflict between federal and state law makes it physically impossible to comply with both federal and state standards. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963).
2. A state law may conflict with federal law by creating an “obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
Wyeth argued that FDA labeling requirements preempted or “trumped” Vermont’s tort laws on the basis of both types of Conflict Preemption as follows:
1. It is impossible for Wyeth to comply with both the state-law duties and federal-labeling regulations, since the latter forbids it from changing its label without FDA approval. See Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, 458 U. S. 141, 153 (1982). Slip Op. at 6.
2. Permitting states to require stronger warnings creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U. S. 52, 67 (1941), because it substitutes a lay jury’s decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA. Slip Op. at 6-7.
The majority’s analysis of the pre-emption issue begins by stating that “[o]ur answer to that question must be guided by two cornerstones of our pre-emption jurisprudence. “ ‘First, the purpose of Congress is the ultimate touchstone in every pre-emption case.’ ” Slip Op. at 8. citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (internal quotation marks omitted).
" Second, “ ‘[i]n all pre-emption cases, and particularly in those in which Congress has "legislated. . .in a field which the States have traditionally occupied, . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ " Lohr, 518 U.S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218 230 (1947)" Slip Op. at 8.
In reaching its conclusion that Wyeth’s two-pronged preemption argument must fail, the High Court first reviewed the history behind Congress’ establishment of the Food and Drug Administration in 1906 to the gradual expansion of the FDA’s power to ensure the safety and efficacy of prescription drugs in 1962. Since 1962, any prescription drug sold in the US must be pre-approved by the FDA before it can actually be sold in this country. Pre-market approval involves the submission of considerable safety and efficacy data to the FDA for evaluation. Clinical trials, performed according to defined clinical trial protocols are required and the results become part of the FDA “new drug” evaluation package. Slip Op. at 9-10.
Regarding Wyeth’s first pre-emption argument, the majority emphasized that re-labeling the drug to conform to Vermont law would not necessarily have violated federal labeling regulations.
Although a manufacturer generally needs FDA approval before changing a drug label, the agency's “changes being effected” (CBE) regulation permits certain unilateral labeling changes that improve drug safety without waiting for FDA approval. Such changes may include warnings that “add or strength an instruction about dosage and administration that is intended to increase the safe use of the drug product.” Slip Op. at 11 quoting the CBE regulation §§ 314.70(c)(6)(iii)(A), (C). Any such “CBE” changes must be accompanied by a supplemental application to the FDA which retains its authority to review all supplemental applications. Slip Op. at 11.
