Wyeth v. Levine

555 U.S. _

Case Year: 2009

Case Ruling: 6-3, Affirmed

Opinion Justice: Stevens

FACTS

A professional musician specializing in children’s music, Diana Levine played the guitar, bass, and piano. On April 7, 2000, the Vermont resident went to her local health care facility for treatment of a severe migraine headache, as she had done on several previous occasions. She was treated with Demerol for her pain and Phenergan, a powerful antihistamine, to combat nausea. The next day, she was still suffering and returned to the clinic for an additional Demerol/Phenergan treatment.

Phenergan is manufactured by Wyeth. The drug can be administered three ways, by intermuscular injection, by an IV drip method where the drug is combined with a saline solution, and by an IV push method where the drug is forced directly into the vein. Phenergan is a dangerous drug when administered improperly. If the drug enters the arteries, the result can be severe and irreversible gangrene. Package labeling informs the clinician that the intermuscular approach is preferred because it poses almost no danger of artery involvement. If this approach is ineffective, administration by IV infusion is also considered safe when done correctly. The IV push method carries the highest risk of artery involvement. These facts were included at several points in the package instructions with one statement in bold, uppercase lettering that read: “Inter-arterial injection can result in gangrene of the affected extremity.” The warnings met Federal Drug Administration requirements.

Levine’s first treatment was done by intermuscular injection, but her second dose of Phenergan was administered by IV push. Because either the needle entered the artery or the drug escaped the vein into the surrounding tissue, Levine’s arteries became involved. She developed gangrene in her right arm. Physicians unsuccessfully attempted to stop the damage. They initially were forced to amputate Levine’s hand and eventually to amputate her right forearm as well.

Levine initiated a state common-law negligence suit for malpractice against the clinic, the supervising physician, and the physician’s assistant who administered the drug. She eventually settled the case successfully. She also sued Wyeth, claiming that the company had failed to provide adequate and effective warnings that would have prevented her injuries. A jury agreed with her and awarded Levine $7.4 million for pain, medical bills, loss of her arm, and loss of her ability to practice her profession. The amount of damages was later reduced to take into account the settlement awards from the earlier lawsuit. The state supreme court upheld the award. Wyeth appealed to the U.S. Supreme Court arguing that the federal drug labeling laws and the FDA’s approval of Wyeth’s Phenergan warnings preempted any action under state law.

 

JUSTICE STEVENS DELIVERED THE OPINION OF THE COURT.

The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not. . . .

Wyeth makes two separate pre-emption arguments: first, that it would have been impossible for it to comply with the state-law duty to modify Phenergan’s labeling without violating federal law, and second, that recognition of Levine’s state tort action creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz (1941), because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA. As a preface to our evaluation of these arguments, we identify two factual propositions decided during the trial court proceedings, emphasize two legal principles that guide our analysis, and review the history of the controlling federal statute.

The trial court proceedings established that Levine’s injury would not have occurred if Phenergan’s label had included an adequate warning about the risks of the IV-push method of administering the drug. . . .

The trial court proceedings further established that the critical defect in Phenergan’s label was the lack of an adequate warning about the risks of IV-push administration. . . . The . . . question presented is whether federal law pre-empts Levine’s claim that Phenergan’s label did not contain an adequate warning about using the IV-push method of administration.

Our 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.” 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.’ ” [ Medtronic v. ] Lohr, [1996].

In order to identify the “purpose of Congress,” it is appropriate to briefly review the history of federal regulation of drugs and drug labeling. In 1906, Congress enacted its first significant public health law, the Federal Food and Drugs Act. The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress became increasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA). The Act’s most substantial innovation was its provision for premarket approval of new drugs. . . .

In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Before 1962, the agency had to prove harm to keep a drug out of the market, but the amendments required the manufacturer to demonstrate that its drug was “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before it could distribute the drug. In addition, the amendments required the manufacturer to prove the drug’s effectiveness by introducing “substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling.”

As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliability of drugs,” Congress took care to preserve state law. The 1962 amendments added a saving clause, indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with the FDCA. Consistent with that provision, state common-law suits “continued unabated despite . . . FDA regulation.” And when Congress enacted an express pre-emption provision for medical devices in 1976, it declined to enact such a provision for prescription drugs.

In 2007, after Levine’s injury and lawsuit, Congress again amended the FDCA. For the first time, it granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. In doing so, however, Congress did not enact a provision in the Senate bill that would have required the FDA to pre-approve all changes to drug labels. Instead, it adopted a rule of construction to make it clear that manufacturers remain responsible for updating their labels.

Wyeth first argues that Levine’s state-law claims are pre-empted because it is impossible for it to comply with both the state-law duties underlying those claims and its federal labeling duties. The FDA’s premarket approval of a new drug application includes the approval of the exact text in the proposed label. Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among other things, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “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,” it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval.

Wyeth argues that the CBE regulation is not implicated in this case because a 2008 amendment provides that a manufacturer may only change its label “to reflect newly acquired information.” Resting on this language (which Wyeth argues simply reaffirmed the interpretation of the regulation in effect when this case was tried), Wyeth contends that it could have changed Phenergan’s label only in response to new information that the FDA had not considered. And it maintains that Levine has not pointed to any such information concerning the risks of IV-push administration. Thus, Wyeth insists, it was impossible for it to discharge its state-law obligation to provide a stronger warning about IV-push administration without violating federal law. Wyeth’s argument misapprehends both the federal drug regulatory scheme and its burden in establishing a pre-emption defense.

We need not decide whether the 2008 CBE regulation is consistent with the FDCA and the previous version of the regulation, because Wyeth could have revised Phenergan’s label even in accordance with the amended regulation. As the FDA explained in its notice of the final rule, “ ‘newly acquired information’ ” is not limited to new data, but also encompasses “new analyses of previously submitted data.” The rule accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments: “[I]f the sponsor submits adverse event information to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severity or frequency than did reports previously submitted to FDA, the sponsor meets the requirement for ‘newly acquired information.’ ”

The record is limited concerning what newly acquired information Wyeth had or should have had about the risks of IV-push administration of Phenergan because Wyeth did not argue before the trial court that such information was required for a CBE labeling change. Levine did, however, present evidence of at least 20 incidents prior to her injury in which a Phenergan injection resulted in gangrene and an amputation. After the first such incident came to Wyeth’s attention in 1967, it notified the FDA and worked with the agency to change Phenergan’s label. In later years, as amputations continued to occur, Wyeth could have analyzed the accumulating data and added a stronger warning about IV-push administration of the drug. . . .

. . . Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.

Indeed, prior to 2007, the FDA lacked the authority to order manufacturers to revise their labels. When Congress granted the FDA this authority, it reaffirmed the manufacturer’s obligations and referred specifically to the CBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior to FDA approval. Thus, when the risk of gangrene from IV-push injection of Phenergan became apparent, Wyeth had a duty to provide a warning that adequately described that risk, and the CBE regulation permitted it to provide such a warning before receiving the FDA’s approval.

Of course, the FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application, just as it retains such authority in reviewing all supplemental applications. But absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements. . . .

Impossibility pre-emption is a demanding defense. On the record before us, Wyeth has failed to demonstrate that it was impossible for it to comply with both federal and state requirements. The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan’s label does not establish that it would have prohibited such a change.

Wyeth also argues that requiring it to comply with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation. Levine’s tort claims, it maintains, are pre-empted because they interfere with “Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.” We find no merit in this argument, which relies on an untenable interpretation of congressional intent and an overbroad view of an agency’s power to pre-empt state law.

Wyeth contends that the FDCA establishes both a floor and a ceiling for drug regulation: Once the FDA has approved a drug’s label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue. The most glaring problem with this argument is that all evidence of Congress’ purposes is to the contrary. . . . Congress did not provide a federal remedy for consumers harmed by unsafe or ineffective drugs in the 1938 statute or in any subsequent amendment. Evidently, it determined that widely available state rights of action provided appropriate relief for injured consumers. It may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.

If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history. . . .

In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation. . . .

In short, Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.

We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed.

It is so ordered.

JUSTICE THOMAS, CONCURRING IN THE JUDGMENT.

I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyeth’s drug Phenergan does not pre-empt the state-law judgment before the Court. . . .

I write separately, however, because I cannot join the majority’s implicit endorsement of far-reaching implied pre-emption doctrines. In particular, I have become increasingly skeptical of this Court’s “purposes and objectives” pre-emption jurisprudence. Under this approach, the Court routinely invalidates state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law. Because implied pre-emption doctrines that wander far from the statutory text are inconsistent with the Constitution, I concur only in the judgment. . . .

. . . [T]his Court’s “purposes and objectives” pre-emption jurisprudence . . . and its broad application . . . illustrate that this brand of the Court’s pre-emption jurisprudence facilitates freewheeling, extratextual, and broad evaluations of the “purposes and objectives” embodied within federal law. This, in turn, leads to decisions giving improperly broad pre-emptive effect to judicially manufactured policies, rather than to the statutory text enacted by Congress pursuant to the Constitution and the agency actions authorized thereby. Because such a sweeping approach to pre-emption leads to the illegitimate—and thus, unconstitutional—invalidation of state laws, I can no longer assent to a doctrine that pre-empts state laws merely because they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives” of federal law as perceived by this Court. I therefore respectfully concur only in the judgment.

JUSTICE ALITO, WITH WHOM THE CHIEF JUSTICE AND JUSTICE SCALIA JOIN, DISSENTING.

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with . . . general principles of conflict pre-emption. I respectfully dissent.

The Court frames the question presented as a “narro[w]” one—namely, whether Wyeth has a duty to provide “an adequate warning about using the IV-push method” to administer Phenergan. But that ignores the antecedent question of who—the FDA or a jury in Vermont—has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings. Moreover, it is unclear how a “stronger” warning could have helped respondent; after all, the physician’s assistant who treated her disregarded at least six separate warnings that are already on Phenergan’s labeling, so respondent would be hard pressed to prove that a seventh would have made a difference.

More to the point, the question presented by this case is not a “narrow” one, and it does not concern whether Phenergan’s label should bear a “stronger” warning. Rather, the real issue is whether a state tort jury can countermand the FDA’s considered judgment that Phenergan’s FDA-mandated warning label renders its intravenous (IV) use “safe.” Indeed, respondent’s amended complaint alleged that Phenergan is “not reasonably safe for intravenous administration;” respondent’s attorney told the jury that Phenergan’s label should say, “ ‘Do not use this drug intravenously’ ”; respondent’s expert told the jury, “I think the drug should be labeled ‘Not for IV use’ ”; and during his closing argument, respondent’s attorney told the jury, “Thank God we don’t rely on the FDA to . . . make the safe[ty] decision. You will make the decision. . . . The FDA doesn’t make the decision, you do.”

Federal law, however, does rely on the FDA to make safety determinations like the one it made here. The FDA has long known about the risks associated with IV push in general and its use to administer Phenergan in particular. Whether wisely or not, the FDA has concluded—over the course of extensive, 54-year-long regulatory proceedings—that the drug is “safe” and “effective” when used in accordance with its FDA-mandated labeling. The unfortunate fact that respondent’s healthcare providers ignored Phenergan’s labeling may make this an ideal medical-malpractice case. But turning a common-law tort suit into a “frontal assault” on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict pre-emption jurisprudence. . . .

To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence. The FDA told Wyeth that Phenergan’s label renders its use “safe.” But the State of Vermont, through its tort law, said: “Not so.”

The state-law rule at issue here is squarely pre-empted. Therefore, I would reverse the judgment of the Supreme Court of Vermont.