On June 23, 2011, the U.S. Supreme Court issued a 5-4 decision in PLIVA v. Mensing, 131 S.Ct. 2567, 564 U.S.— (2011), which effectively bars claims against generic pharmaceutical manufacturers for state failure-to-warn claims, as being preempted under federal law. Currently, brand-name manufacturers have a continuing responsibility “for the accuracy and adequacy” of labeling and are specifically permitted to “change their labels” to add additional warnings. Id. at 2574. Generic manufacturers, on the other hand, “have an ongoing federal duty of ‘sameness.’” Id. at 2575.

Deferring to the Food and Drug Administration’s interpretation of its own regulations, the high court concluded that federal law did not permit generic manufacturers to unilaterally strengthen its warning labels. Id. In particular, the court held that generic pharmaceutical manufacturers are prohibited from using the FDA’s “Changes Being Effected” (CBE) process to unilaterally strengthen their labels with new safety information, and are also prohibited from sending “Dear Doctor” letters to warn physicians of risks that are not contained in the FDA-approved labeling of the brand name drug. Id.

Following that analysis, the Supreme Court concluded that generic manufacturers would violate federal labeling requirements if they unilaterally changed their warning labels to satisfy the state-law tort duties that a failure-to-warn claim necessarily would impose.

Theories of Liability

In the wake of Mensing, with thousands of failure-to-warn cases filed in New York and throughout the country presumably barred by the recent decision, plaintiffs fostered new theories of liability, beyond the traditional failure-to-warn claims in pharmaceutical litigation against generic manufacturers. Many of the novel theories pled have been challenged and tested in multiple state and federal courts nationwide, including New York. To date, the judicial scales have been tipped in favor of the generic manufacturers. Plaintiffs have primarily advanced arguments that can be grouped into five categories in an attempt to circumvent the Supreme Court’s Mensing decision, which held failure-to-warn claims are preempted.

1. Failure to Communicate. Plaintiffs rely heavily on a newly created argument that generic defendants failed to send Dear Doctor letters or otherwise communicate warnings to health care professionals. Most courts have rejected the proposition that generic manufacturers are exposed to liability for failing to communicate their warnings following the Mensing decision. See, e.g., In re Pamindronate Prods. Liab. Litig., No. 10-CV-1860 (KAM) (SMG) (E.D.N.Y Jan. 30, 2012), (holding all state law claims challenging the adequacy of the generic drug labeling are preempted); see also Mensing v. Wyeth, 658 F.3d 867 (8th Cir. 2011) (affirming the district court’s finding that the regulatory scheme does not allow for ANDA (Abbreviated New Drug Application) manufacturers to send ‘Dear Doctor’ letters).

2. Failure to Adopt Label. Plaintiffs contend that before asserting a preemption defense, each generic defendant must show that it complied with the applicable regulations obligating it to update its label in accordance with the most current FDA-approved labeling, and, if a generic manufacturer did not incorporate the changes, plaintiff’s failure-to-warn claims are not preempted. However, the Supreme Court, and many other courts post-Mensing, disagreed, finding failure-to-warn claims against all of the generic manufacturers in Mensing preempted by federal law, even after considering evidence that one generic defendant did not adopt the updated FDA-approved label. See, e.g., Smith v. Wyeth, 657 F.3d 420 (6th Cir. 2011).

3. Failure to Suspend Sales. Plaintiffs allege generic manufacturers could simultaneously comply with state and federal law if they stopped selling their pharmaceutical product. The Mensing plaintiffs raised this precise issue in their petition for rehearing. See Respondents’ Petition for Rehearing, PLIVA v. Mensing, No. 09-993, 2011 WL 2874547, at * 1 (U.S. July 18, 2011). The Supreme Court promptly denied that petition, which should have put this argument to rest, though it is still being advocated. PLIVA v. Mensing, No. 09-993, 2011 WL 3557247 (U.S. Aug. 15, 2011).

4. Design Defect. Plaintiffs allege that defective design claims are not preempted. However, the Eastern District of New York, along with other jurisdictions have disagreed. See In re Pamindronate Prods. Liab. Litig., No. 10-CV-1860 (KAM) (SMG) (E.D.N.Y Jan 30, 2012). U.S. District Judge Kiyo A. Matsumoto dismissed design defect claims against generic manufacturers in In re Pamindronate and held that the Mensing court found that a generic drug is “designed to be a copy of a reference listed drug (typically a brand-name drug).” Id. at 8. Thus, the “federal duty of ‘sameness,’” applied in the context of generic drug design, and federal law preempted state laws imposing a duty to change a drug’s design on generic drug manufacturers. See id.

5. Post-2007 FDAAA Cases Do Not Apply. Plaintiffs also assert the argument that claims arising after the 2007 Food and Drug Administration Amendments Act (FDAAA) are not preempted. While true that the Mensing court considered federal statutes and regulations in place before the FDAAA took effect, see Mensing, 131 S. Ct. at 2574 n.1, the FDAAA did not change or eliminate any of those laws or regulations. The “sameness” requirement for generic drug labeling remains in full effect. See 21 U.S.C. §355(j)(2)(A). Plaintiffs’ claim that FDAAA alters the applicable preemption analysis and necessitates a finding against preemption has not been accepted by any court post-Mensing. See, e.g., In re Fosamax Litigation, No. 08-008, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (finding nothing in the 2007 FDAAA that changes the generic preemption analysis and granting judgment on the pleadings in favor of generic pharmaceutical manufacturers).

Analysis and Conclusion

Following the Mensing decision, plaintiffs have survived defendants’ motion to dismiss on the pleadings in a limited number of jurisdictions. See, e.g., In re Reglan/Metoclopramide Litigation, No. 11090904, 2011 WL 6259558 (Pa. C.P. Philadelphia Co. Nov. 18, 2011) (metoclopramide). The implications following Mensing for brand-name manufacturers are much less clear. Despite an overwhelming majority rule to the contrary, plaintiffs have already argued that Mensing changes innovator liability analysis and requires that someone (i.e., the branded manufacturers) must be held accountable for injuries to a consumer injured by ingestion of a generic product with inadequate warnings.

However, several post-Mensing courts have not followed the minority rule espoused in California’s Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. App. 2008), and already dismissed claims based on an innovator liability theory. See Smith v. Wyeth, 657 F.3d 420 (6th Cir. 2011). In a post-Mensing world, given the inconsistent decisions issued across the country, it is likely these new theories against generic and brand-name pharmaceutical manufacturers will continue to be challenged and appealed.

Frederick H. Fern is a member of Harris Beach and the leader of its medical and life sciences practice group; he is also a registered pharmacist. Kelly E. Jones is a senior associate at the firm.