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Warning! Excluding Known Hazards from FDA-Approved Labeling Contraindicated by State Common Law Tort Suits and the Supreme Court

Health Law Update David B. Bartel

The Supreme Court of the United States dealt a surprising blow to both the pharmaceutical manufacturing industry and the FDA when it issued its opinion earlier this month, in Wyeth v. Levine, 555 U.S. ___, No. 06-1249 (March 4, 2009).

A Vermont jury awarded Diana Levine more than $6 million in damages to compensate her for injuries sustained from the administration of Wyeth Pharmaceuticals' drug, Phenergan. The factual background of the case is as follows. Ms. Levine, a musician, sought treatment twice in one day for a severe headache. During her second doctor's visit, a Physician Assistant ("P.A.") administered the drug Phenergan via the "IV Push" method to help alleviate Ms. Levine's pain. The P.A. chose this method of administration in spite of the drug's explicit warning that IV Push was not recommended due to the known risk of severe chemical irritation and gangrene. The P.A. accidentally penetrated Ms. Levine's arterial vein, causing an immediate, painful chemical reaction, followed by gangrene, resulting in the amputation of Ms. Levine's forearm - all risks disclosed on the drug's FDA-approved label. After settling claims against the P.A. and the health center, Ms. Levine sued Wyeth, alleging that its warning was deficient and should have prohibited the IV Push method of administration. The jury found that (1) Wyeth was negligent, (2) the drug's inadequate warnings and instructions caused the product to be defective, and (3) the P.A.'s decision to administer the drug via IV Push was not an intervening cause of Ms. Levine's injuries.

In its Opinion, the divided Court voted 6-3 to uphold the jury's verdict and reject Wyeth's defense that the FDA's comprehensive regulatory scheme preempts state laws and claims relating to drug labeling. Disagreeing with Wyeth's defense, the Court held that, unless it is impossible to comply with both state and federal laws at the same time, manufacturers are subject to both state and federal laws.

This decision is significant to drug manufacturers, as well as other regulated businesses, in at least three ways. First, the Court has clearly established that drug manufacturers have a duty to keep drug warning labels current and to disclose all reasonably known risks. Second, the Court distinguished between the regulatory schemes for drugs and devices. Third, the Court confirmed that regulated businesses cannot rely on nonbinding regulations or commentaries that do not have the force of law to preempt state laws and lawsuits. A discussion of each area of significance follows.

Duty to Warn:

The effect of the Court's decision is that a drug manufacturer's duty to warn of all known hazards does not end when the FDA approves a drug's label. Rather, "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the label at all times." Slip Opinion at 14. The Court reached this conclusion based on the FDA's "changes being effected" (CBE) regulation, which permits manufacturers to increase or strengthen their labeled warnings without prior FDA approval. See 21 C.F.R. §§314.70(c)(60(iii)(A), (C). The Court further confirmed that a 2008 amendment to the CBE regulation does not impede a manufacturer's ability to voluntarily "'add or strengthen a contraindication, warning, precaution, or adverse reaction' or to 'add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.'" Slip Opinion at 11. While commentary to the 2008 amendment states that manufacturers can only change a drug's label to "reflect newly acquired information", 73 Fed. Reg. 49609, the Court's commentary concludes that new information "is not limited to new data, but also encompasses 'new analysis of previously submitted data.'" Slip Opinion at 12. In other words, manufacturers have an ongoing duty to assess and reassess all data on a drug relating to dosage and administration. If, in the manufacturer's opinion, the risks are greater than those reflected on the FDA-approved labeling, it must amend its label to properly warn of those risks. Unfortunately, there is no way for a manufacturer to predict when its warning is insufficient under the Court's ruling. Rather, manufacturers are now subject to the judgment of juries nationwide in assessing the sufficiency of a drug's warning.

Drugs v. Devices:

The Court also clearly recognizes different duties for companies that manufacture drugs and companies that manufacture devices. Just last year, the Court held that device manufacturers could not be sued for alleged violations of state laws relating to device labeling. Riegel v. Medtronic, 522 U.S. ___ (2008). With Wyeth v. Levine, however, the Court holds that drug manufacturers can be sued for violations of state drug labeling laws and standards. This distinction is drawn from the fact that Congress expressly included preemption language in medical device legislation in 1976 but has never included similar language in drug legislation. See 21 U.S.C. §360k(a).

Thus, the current protections afforded device manufacturers appear intact, notwithstanding the Court's decision in Wyeth v. Levine. However, these protections have already been challenged by litigants and legislators, alike. For example, proposed legislation introduced earlier this month - the Medical Device and Safety Act of 2009 - threatens to erode the protections afforded device manufacturers in Riegel v. Medtronic by removing the express preemption language. And, in response to the Wyeth decision, at least one court has already allowed plaintiffs in a multidistrict litigation to amend their pleadings to allege failure-to-warn claims against a device manufacturer. See In re Medtronic, Inc., No. 08-1905, D. Minn. (Order issued March 9, 2009). Ultimately, the ongoing viability of the preemption defense to failure-to-warn claims for device manufacturers is uncertain.

Agency Action Must Have Force of Law:

Finally, the Court concludes, only regulations that have the force of law can preempt state laws. The Majority's Opinion concedes that "an agency regulation with the force of law can pre-empt conflicting state requirements" but directs that courts must "rely[] on the substance of state and federal law and not on agency proclamations of pre-emption." Slip Opinion at 19. In other words, regulatory agencies cannot simply "deem" state laws to be preempted but must instead receive Congressional instruction to preempt. The Majority reached this conclusion in response to the FDA's 2006 comments that "FDA approval of labeling … preempts conflicting or contrary state law" and that state failure to warn claims "threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs." Slip Opinion at 19; citing 71 Fed. Reg. 3922, 3934-3935 (2006). The Court did not find any Congressional support or grant of authority to justify the FDA's comments. This decision potentially diminishes the force of regulations, and interpretations thereof, adopted by all federal regulatory agencies - not just the FDA. As a result, federal agencies that intend to provide uniform regulation and preempt state law claims must now revisit their regulations and stated policies to ensure that they are adopted (1) pursuant to a Congressional grant of authority and (2) consistent with valid notice and comment rulemaking. Unless and until federal agencies undertake this review, all regulated businesses which presumed, based on preemption-related pronouncements by regulatory agencies, that they were protected from state law failure-to-warn claims are now potentially at increased risk for such claims.

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For more information please contact David Bartel at 414-277-5369 /, or your Quarles & Brady attorney.