On June 23, 2011, the United States Supreme Court held in PLIVA, Inc. v. Mensing, No. 09-993, 564 U.S. __ (2011), that the Food, Drug, and Cosmetic Act (FDCA) and federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state tort-law failure-to-warn claims. According to the Court, because federal law requires the labeling for generic drugs to conform with the FDA-approved labeling of the corresponding brand-name drug (the package insert), it would be impossible for generic manufacturers to simultaneously comply with a state tort-law duty that would require them to use different, stronger warnings in their labeling. The Court held that the plaintiffs' state tort claims in this case were thus pre-empted. That ruling contrasts sharply with the Court's decision from a few years ago in Wyeth v. Levine, 129 S. Ct. 1187 (2009), in which it held that failure-to-warn claims against brand-name manufacturers are not pre-empted by the FDCA. The Court's decision in PLIVA is consistent, however, with the vast majority of lower courts that have addressed this issue previously and makes clear that consumers of generic drugs will largely be unable to bring state tort failure-to-warn claims with respect to generic drug labeling that mirrors approved labeling of their brand-name counterparts.
The Court's reasoning
The plaintiffs brought claims under Minnesota and Louisiana law, which they argued required generic manufacturers to warn of the risk of a particular neurological disorder that can result from extended use of metoclopramide, a drug used to treat digestive tract problems. The Court recognized that if the plaintiffs were correct in their theory that certain state laws required this warning, then those state laws would have required the manufacturers to use different labeling with additional safety information. That theory would run counter to the federal law mandate that generic drug labeling must be the same as the labeling of its brand-name counterpart at the time of FDA approval.1 In particular, the Court had to decide whether generic manufacturers could add additional or stronger warnings to their labeling after initial FDA approval without the brand-name manufacturer changing its labeling first. The Court concluded that they could not.
Notably, in reaching its decision, the Court deferred to the FDA's assertion of "an ongoing federal duty of 'sameness'" under which the labels on non-generic and generic drugs must be the same at all times. The Court repeatedly noted that under FDA's interpretation of its own regulations the generic manufacturers could not utilize the "changes-being-effected" (CBE) drug labeling process to add or strengthen the drugs' warnings, or use a "Dear Doctor" letter to send information about additional or stronger warnings to healthcare professionals, without violating the requirement of "sameness." The FDA acknowledged, however, that the generic manufacturers could have proposed to the agency, and may have even been required under federal law to propose, stronger or additional warnings for their labeling if the manufacturers thought such warnings were needed.
Turning to the issue of pre-emption, the Court concluded that it would have been impossible for the generic manufacturers to comply with both state and federal law—the former purportedly required the generic manufacturers to alter their labeling while the latter required the manufacturers to follow the approved labeling of the brand-name drug. Even if a requirement had existed to ask the FDA for assistance in strengthening the corresponding brand-name warnings, which in turn would be reflected in the generic drug labeling, it would not have changed the pre-emption analysis in the Court's view. The fundamental "question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it." As the Court explained, "when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes."2
Justice Sotomayor, along with three other justices, disagreed with the finding of impossibility in this case, explaining that "[u]ntil today, the mere possibility of impossibility had not been enough to establish pre-emption." According to the dissent, the manufacturers conceded that they could have asked the FDA to initiate a labeling change. Had they invoked this mechanism, they may have been able to comply with both federal and state law. At most, there was only "a hypothetical or potential conflict." The dissent thus would have required the manufacturers to demonstrate, as in Wyeth, that the FDA would not have approved the proposed labeling change in order to show impossibility.
The Court's decision is significant in two broad respects. First, the Court held that state law failure-to-warn claims relating to generic drug labeling that is the same as FDA-approved labeling found on the drug's brand-name counterpart are pre-empted. While the dissent criticized the majority for creating gaps in tort law remedies available to consumers injured by generic drugs, the Court disputed the significance of any gaps, noting the FDA's finding that genuinely new information requiring new warnings about drugs in long-term use "appears infrequently." Although the Court suggested that the need for new warnings may arise "infrequently," the reality is that safety issues can emerge or evolve over time. As a result, generic manufacturers would be well advised to keep these issues in mind when considering whether it would be appropriate to add to or strengthen the safety information in the approved labeling.
In essence, by virtue of this ruling, the Court has constructed a dual liability system. Among other possible consequences, the lack of any state law recourse may cause patients who are well insured to insist on getting the brand-name product and may convince doctors to write more "dispense as written" prescriptions in states that allow such instructions to override state laws that permit or require pharmacists automatically to substitute generics for brand-name drugs.
The second significance is the Court's clarification that the touchstone for determining "impossibility" is what can be done "independently," without "imagin[ing] that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it." In other words, the plaintiffs here could not overcome the pre-emption defense by dint of the fact that manufacturers could have asked the FDA for help and the FDA might have strengthened the warnings in the labeling or reinterpreted its regulations to open the CBE process to generic manufacturers. Thus, the Court opened the door to a further expansion of the conflict pre-emption defense.
A number of unresolved questions and concerns flow from the Court's Opinion. For example, the logic of the Opinion might lead lower courts to be more willing to find brand-name manufacturers liable for injuries caused by generics under a failure-to-warn theory, on the ground that the brand-name manufacturers' failure to update its warnings caused the generics' labeling to be deficient. Although a number of state courts faced with a similar question have declined to entertain claims against brand-name manufacturers based on injuries from other companies' generic drugs, at least two courts have concluded that such claims have enough legal merit at least to survive summary judgment. See, e.g., Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010); Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 110–11, 85 Cal. Rptr. 3d 299 (Ct. App. 2008). The Supreme Court's PLIVA opinion could prompt additional courts to take such claims seriously.
In addition, fact patterns not before the Court in PLIVA could pose challenges to applying the Court's reasoning to other sets of circumstances. One example is when the brand-name drug has been withdrawn from the market. Others include situations in which the generic label may differ from that of the brand-name label, such as when the generic has a different strength or other characteristic by virtue of a suitability petition or when a generic chooses to carve out of its label an indication contained in the brand-name manufacturer's label because that indication is protected by exclusivity.