Pliva, Inc. et al v. Mensing
June 23, 2011
131 S.Ct. 2567
THE DECISION
On June 23, 2011, the United States Supreme Court reversed the decisions of the lower courts when it found that generic drug manufacturers, in a failure to warn case, could not simultaneously comply with state and federal regulations because federal regulations prevent generic drug manufacturers from independently changing their labels.
In these consolidated cases, from the Fifth and Eighth United States Circuit Courts of Appeals, plaintiffs, Gladys Mensing and Julie Demahy, were prescribed metoclopramide to treat digestive tract problems. They ultimately developed tardic dyskensia, a known side effect of long-term use of metoclopramide, and sued Pliva Incorporated and Actavis Elizabeth LLC, pharmaceuticals manufacturers, for failure to warn and marketing defects.
Reglan is the brand name metoclopramide product. Since its initial release, Reglan's labeling has been modified to reflect the risks associated with its use. As Reglan's manufacturer, Wyeth, gained knowledge of the severity of the risk, it has increased the severity of labeling, the most recent revision occurring in 2009. Both plaintiffs received the generic version of the drug. The manufacturers of the generic form asserted an affirmative defense of pre-emption, that according to the FDA they only had a duty to meet the same safety and efficacy labeling as the brand name product manufacturers of Reglan.
The Court accepted the generic drug manufacturers' arguments, and found that federal law pre-empted state law in this case. Using the doctrine of impossibility to support the decision, the majority ruled that it was impossible for generic drug manufacturers to unilaterally change their warning label without violating the federal regulation requiring generic and brand name drug labels to be uniform. It also found that even if communication with the FDA had been initiated, it would not satisfy the state law requirement to provide a safer label.
BACKGROUND
The Court relied heavily on Wyeth v. Levine on the impossibility issue. Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009). In that case, the plaintiff, respondent Levine, was given Phenergan through an IV and contracted gangrene. As a result her arm was amputated. Ms. Levine brought state law action alleging that Wyeth failed to provide an adequate warning of the risks associated with the IV drug, Phenergan. The Supreme Court found federal law did not pre-empt the claim that Phenergan's label did not contain an adequate warning about the IV-push method of administration. The Court reasoned that because Wyeth had the ability, via the FDA's "changes being effected" (CBE) regulation, to change its label and that there was no guarantee that the FDA would have rejected the change, the claim could not be pre-empted. As a brand name manufacturer, Wyeth had the ability to unilaterally change its label to reflect the risks involved with IV administration of Phenergan.
The Court used the Wyeth case to argue that the true question of impossibility was "whether the private party could independently do under federal law what state law requires of it." Wyeth 555 U.S. 555 at 573. The Court, supported by the Supremacy Clause, deferred to the FDA's interpretation of its own regulations to say that the CBE process was not open to generic drug manufacturers and therefore to place a duty upon those manufacturers to petition the FDA to reinterpret its provisions was unreasonable.
SIGNIFICANCE OF THE DECISION
The Court in Pliva defined the duty of generic drug manufacturers as an obligation to propose stronger warning labels to the agency if they believed the warnings were needed. The next step, if the FDA agreed with the change, would be working with the brand-name manufacturer to create a new label for both products. The Court left the question open whether this duty to act is statutory, and, if so, what the consequences are for non-compliance.
The Court recognized the decision could have a potentially negative impact on state-sponsorship of the use of generic drug prescriptions. Data shows this type of sponsorship reduces the cost of healthcare significantly. With this ruling, patients could also be more hesitant to use generic drugs, unless other mechanisms are put in place to compensate for their inability to bring state tort claims against generic drug manufacturers.
Clearly, the Court has defined differing duties for brand-name drug manufacturers and generic drug manufacturers, and will likely be called upon to clarify its ruling in the future. At this point, generic drug manufacturers should be aware of the FDA's interpretations of its own regulations and be clear on the duties required by the agency.
