Joseph P. Thomas Esq.
Answer: In Pliva, Inc. v. Mensing1, the U.S. Supreme Court provided
its latest pronouncement on federal preemption in the context of product liability. At issue was whether state-law product liability claims against generic drug manufacturers for failure to provide adequate warnings are preempted. In a 5-4 decision, the Court held that such state law claims are preempted because federal law requires generic drug manufacturers to provide warnings that are the “same as” the warnings provided by the branded manufacturer.
In Mensing, the Court consolidated two cases filed against manufacturers of generic metoclopramide. In each case, the plaintiff was prescribed metoclopramide for a gastrointestinal disorder and later claimed to develop tardive dyskinesia, a movement disorder that sometimes has been reported to be irreversible. Each plaintiff sued the manufacturers of the metoclopramide she had taken, alleging state-law failure-to-warn claims.
In Mensing, Pliva prevailed in the trial court, and plaintiff’s claims were dismissed on the basis of federal preemption. However, the Eighth Circuit reversed, and Pliva then petitioned the Supreme Court for a writ of certiorari. In the companion case, Actavis lost in the trial court and the Fifth Circuit and also petitioned for a writ of certiorari.
Preemption can be express or implied. The Hatch-Waxman amendments to the Food Drug and Cosmetic Act2 require the labeling of generic drugs to be the “same as” the labeling for the branded counterpart. However, the Hatch-Waxman amendments do not include an express preemption provision. Therefore, an implied preemption analysis is appropriate. That analysis turns on the conflict between state and federal law.3 There are many expressions of the concept of implied preemption in federal case law. A recent, simple expression of the concept is that, when state and federal law directly conflict, state law must give way.4
Generally, the premise of generic-drug product liability litigation is that the warning provided by the generic drug manufacturer is inadequate and should be strengthened, irrespective of any action taken by the branded company. However, as a result of the requirement that generic manufacturers accompany their products with labeling that is the “same as” the branded drug, generic drug manufacturers may not provide stronger warnings about the risks associated with the generic drugs they sell. It is this “ongoing federal duty of ‘sameness’” that conflicts with state law claims that the labeling on generic drugs should be changed.5
Reglan® (branded metoclopramide) labeling contained a comprehensive warning about the risk of tardive dyskinesia. However, as often is the case in product liability litigation, plaintiffs argued the warning was inaccurate and should have been stronger. The Supreme Court concluded that, because it would be impossible for the generic manufacturers to satisfy both state and federal law simultaneously, state law claims for failure to warn are preempted.
By the time Mensing was argued before the Supreme Court, the United States had filed briefs agreeing, in large part, with Pliva’s interpretation of FDA regulations promulgated pursuant to the Hatch-Waxman amendments. For that reason, plaintiffs pursued alternative arguments that generic manufacturers could provide additional risk information to prescribing physicians via “Dear Doctor” letters or provide that information to FDA so that it could consider label revisions. Relying on the FDA’s amicus brief stating that it considers “Dear Doctor” letters as “labeling,” the Court held that generic manufacturers are no freer to supplement warnings via “Dear Doctor” letters than they are to do so by altering the drug’s other labeling. The Court also found no merit in the notion that there might be a state-law claim for failing to provide additional risk information to FDA and asking it to review the branded label.
The majority of courts to consider state-law based failure-to-warn claims against generic manufacturers after the decision in Mensing have relied on its holding to dismiss such claims, including claims against makers of metoclopramide, promethazine, methotrexate, isotretinoin, and propofol. The Supreme Court also recently vacated a Ninth Circuit decision involving a generic over-the-counter medication and remanded the case for further consideration in light of Mensing.6
Despite the Supreme Court’s rulings, a couple of courts have not dismissed state-law based warning claims against generic manufacturers. Motion practice in those matters is ongoing, and it is not yet clear whether those cases also will be dismissed.
Generic manufacturers should remain vigilant in their efforts to pursue Mensing dismissals of the claims against them and should resist efforts by plaintiffs’ attorneys to circumvent or limit the Mensing holding.
1 131 S. Ct. 2567 (U.S. 2011).
2 The Hatch-Waxman amendments were enacted to remove barriers to market entry, with the goal of increasing competition and reducing the costs of prescription drugs. Generic drug manufacturers could enter the market after demonstrating that a generic drug was the same as its branded counterpart in active ingredient, route of administration, dosage form, strength, and conditions of use recommended in the labeling. See 21 U.S.C.A. § 355(j) (1999).
3 The Supremacy Clause of the Constitution, Article VI, Clause 2 provides: “This Constitution, and the Laws of the United States which shall be made in pursuance thereof…shall be the supreme law of the land…anything in the constitution or laws of any state to the contrary notwithstanding.”
4 Wyeth v. Levine, 555 U.S. 555, 583 (2010).
5 See Mensing, 131 S. Ct. at 2575.
6 See L. Perrigo Co. v. Gaeta, 2011 WL 2326476 (Oct. 31 2011).
Joseph P. Thomas, Esq., is a Partner at Ulmer & Berne LLP and the Chair of the Life Sciences Group. Joe has extensive experience in scientifically complex litigation.
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