The United States Supreme Court’s decision in Pliva v. Mensing, 131 S.Ct.,¹ in which the Court held that state law failure-to-warn claims involving generic prescription drugs were preempted, had a dramatic effect on failure-to- warn claims against generic manufacturers. Hundreds of cases were voluntarily dismissed following Mensing, and even where plaintiffs attempted to avoid the preemptive effects of Mensing, courts have generally held that the broad scope of the Mensing decision precludes virtually all failure-to-warn claims against generic manufacturers. There have, however, been a few cases where courts declined to dismiss cases at the 12(b)(6) stage, and plaintiffs are pushing various theories to avoid the effects of Mensing. This article discusses recent decisions in which courts did not dismiss failure-to-warn claims against generic manufacturers and the theories that plaintiffs are using to support those efforts.

In Mensing, the Court rested its finding of preemption on the requirement that a generic drug manufacturer is required to ensure that its label is the “same as” the brand name’s drug. The Court specifically rejected arguments that a generic manufacturer could use the changes-being-effected (CBE) process to amend its label, or that a generic manufacturer could utilize Dear Doctor letters to disseminate “substantial new warning information.”² The FDA asserted that generic manufacturers could petition the FDA for changes to the label, but the Court rejected this argument, finding that the possibility that the FDA might have accepted the generic manufacturer’s proposal was not enough to satisfy the requirements under state law failure-to-warn claims, thus triggering preemption. Mensing thus left very little — if any — room for exceptions, and it is against this background that plaintiffs have mounted an effort to avoid Mensing preemption.

Brasley-Thrash v. Teva Pharms. involved a plaintiff’s effort to amend a complaint to avoid the effects of Mensing by adding a claim that the generic manufacturer of metoclopramide should have sent out a Dear Doctor letter notifying physicians of new changes to the brand label for Reglan.³ The defendant opposed the plaintiff’s motion under Mensing, but in a short decision, the court permitted the amendment and denied the defendant’s motion. The court held that the defendants had not shown that the claims were preempted because there was not a clear indication that FDA approval would have been required for the generic manufacturers to send out a Dear Doctor letter addressing the new changes to the branded label. The defendants argued that 21 U.S.C. § 355-1(i) prohibited an Abbreviated New Drug Application (ANDA) holder from undertaking any communication plan, including Dear Healthcare Provider (DHCP) letters that apply to the brand.⁴ Without deciding whether this provision applied as the defendants argued, the court noted that the statutory provisions did not go into effect until 2008, while the events in question in the case happened before then. As a result, this decision does not foreclose the possibility that 21 U.S.C. § 355-1(i) prohibits an ANDA holder from sending out a DHCP letter. This decision also failed to address the argument espoused by the FDA in Mensing that generic drug manufacturers could not send out a Dear Doctor letter in the absence of the branded label doing so, because such a letter could imply a therapeutic difference between the brand and the generic, thus becoming impermissibly misleading under 21 C.F.R. § 314.50(b)(3) — the FDA may withdraw approval of a generic drug if the “labeling of the drug […] is false or misleading in any particular.” Nonetheless, the decision to permit the amendment in Brasley-Thrash will likely trigger copycat claims in other jurisdictions.

Keck v. Endoscopy Center also addressed the use of Dear Doctor letters updating physicians of labeling changes, but here, the plaintiffs creatively used a hypothetical Dear Doctor letter during corporate representative depositions in an effort to avoid the effects of Mensing.⁵ This decision stemmed from a plaintiff’s motion that Mensing did not prevent the plaintiffs from arguing to a jury that certain generic manufacturers of propofol should have sent a Dear Doctor letter that was “consistent with and not contrary to” the existing labeling. To advance their argument, the plaintiffs created a draft Dear Doctor letter and presented it to a corporate representative during his deposition. Using the proposed Dear Doctor letter, the plaintiffs were able to get the witness to agree that the language in their proposed letter was “consistent with and not contrary” to the existing label.⁶ They then argued that, since their proposed letter was consistent with the label, Mensing did not prevent the company from sending such a letter.

After openly noting its disagreement with the majority decision in Mensing, the Keck court noted that the Supreme Court’s decision held only that federal law did not permit a generic manufacturer to issue “additional warnings through Dear Doctor letters.” Since the defendant witness had agreed that the warning in the plaintiff’s proposed Dear Doctor letter was “consistent with and not contrary to” the existing labeling, the court concluded it was not an “additional warning” and thus was not preempted by Mensing. Nonetheless, the court limited its holding by stating that it did not conclude whether the plaintiffs had any remaining failure-to-warn cause of action and that it was not determining whether the defendants had any duty to send a Dear Doctor letter that was “consistent with and not contrary to” the drug’s existing label. These qualifications underscore the tenuous grounds for this decision. It seems unlikely that the Supreme Court’s holding that federal law preempted the use of Dear Doctor letters to send “additional warnings” would not include a Dear Doctor letter reiterating warnings in an existing label. In other words, this decision appears to represent much more of a stretch than the opinion in Brasley-Thrasher, and on its face appears to be at odds with the Supreme Court’s decision in Mensing.

Fisher v. Pelstring addressed the timing of changes to a generic label after changes to the branded drug’s label.⁷ In Fisher, the court denied a Mensing-based motion to dismiss on the grounds that the generic manufacturer did not promptly amend the label on its generic metoclopramide after the branded manufacturer amended its label. The court reasoned that the “same as” requirement that provided the foundation for the Supreme Court’s decision in Mensing would not be satisfied if the generic manufacturer failed to promptly amend its label following changes to the brand’s label. Although very technical, Fisher may be a persevering exception to Mensing, in that a significant lag between changes to the brand label and the generic label will provide a window in which plaintiffs may claim that the generic label was not “the same as” the branded label, thus potentially defeating preemption. Defenses to such arguments should include efforts to confirm that the prescriber relied on and was aware of the changes to the branded label rather than the generic label, prescriber awareness of any accompanying changes to the PDR, and emphasizing the fact that prescribers generally keep up with the brand, rather than generic label.

In re: Reglan/Metoclopramide Litigation⁸ involved motions to dismiss approximately 2,000 claims against generic metoclopramide manufacturers pursuant to Mensing. Although the court noted that, since Mensing, many courts have summarily dismissed failure-to-warn claims against generic manufacturers, it pointed out that courts had recognized some exceptions to Mensing and cited the opinions discussed above. In denying the defendants’ motions to dismiss, the court did not reach the conclusion that there was no preemption under Mensing. Rather, it indicated that factual disputes needed to be resolved and that the court would consider preemption defenses at the summary judgment stage. This decision therefore suggests, at least in mass-tort cases, that Mensing may not be a complete shield that can be used to trigger the early dismissal of failure-to-warn cases. Plaintiffs may be able to “plead-around” Mensing (particularly in state courts), triggering discovery and delaying a court’s consideration of preemption defenses until the summary judgment stage.

Although there are not yet any reported decisions addressing this issue, one can also expect to see arguments about the effects of Mensing where the branded drug is no longer on the market and the FDA has deemed the market-leading generic to be the reference listed drug (RLD). This is a common situation with older drugs where, after the introduction of several generics, the brand is no longer sold. In a citizen’s petition to the FDA seeking regulatory changes that would limit the scope of Mensing, Public Citizen took the position that, upon the exit of the branded manufacturer from the market, the generic manufacturer deemed the RLD by the FDA would have responsibility for the label and would not benefit from the preemptive effect of Mensing.⁹ Opposition to this position included several arguments. First, in a recent draft guidance document addressing required safety labeling changes, the FDA distinguishes between NDA holders and an ANDA without a marketed NDA RLD. Second, in the process of determining whether an NDA holder has withdrawn a product for reasons of safety and efficacy, the FDA has repeatedly stated that “[a]pproved ANDAs that refer to the NDAs […] are unaffected by the discontinued marketing of the products subject to those NDAs […]. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.”¹⁰ Finally, if accepted, the unilateral denomination by the FDA of one generic manufacturer as the RLD would cause that manufacturer to be unable to avail itself of the preemptive effects of Mensing and would seemingly give any other generic manufacturers of the same drug an unfair marketplace advantage. The FDA has not yet ruled on this petition.

Overall, the Court’s decision in Mensing is both broad-sweeping and without any obvious exception. Despite the efforts by plaintiffs to avoid Mensing, it appears unlikely that any significant exceptions will gain traction.

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[1] Pliva v. Mensing, 131 S.Ct. 2567 (2011).

[2] Id. at 2575-76.

[3] Brasley-Thrash v. Teva Pharms. USA, Inc., 2011 WL 4025734 (S.D. Ala. Sept. 12, 2011).

[4] 21 U.S.C. § 355-1 addresses risk evaluation and mitigation strategies. Section 355-1(i) provides that, for an ANDA holder, only the FDA shall undertake any communication plan required under section 355-1(e)(3). Subsection (e)(3) provides that a communication plan may include sending letters to healthcare providers. This provision would seem to preclude the argument asserted in Brasley-Thrash.

[5] Keck v. Endoscopy Center, 2011 WL 3921690 (Nev. Dist. Aug. 19, 2011).

[6] The “consistent and not contrary to” language stems from the FDA’s position in Mensing, where it argued that Dear Doctor letters qualify as labeling and must be consistent with and not contrary to the drug’s approved labeling as required under 21 CFR § 201.100(d)(1).

[7] Fisher v. Pelstring, 2011 WL 4552464 (D.S.C. Sept. 30, 2011).

[8] In re: Reglan/Metoclopramide Litigation, No. 11090904 (Penn. Civil, First Jud. Dist., Nov. 18, 2011).

[9] See Docket No. FDA-2011-0675.

[10] See, e.g., FDA Determination that Decadron Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 74 F.R. 22,751, 22,752 (May 14, 2009).

Finis