Despite a myriad of decisions permitting state-law claims to proceed against generic drug manufacturers following the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (see our prior posts here), one plaintiff’s recent attempt to run around the federal preemption doctrine was swiftly rejected by the Seventh Circuit in Houston v. United States of America, et al., No. 15-2411 (7th Cir. Feb. 3, 2016).
The plaintiff, Michael Houston, developed Stevens-Johnson-Syndrome, a serious skin disorder, after taking allopurinol, a prescription drug used to treat gout. Houston brought tort claims in state court against the federally funded health clinic where he was treated, the physician’s assistant who prescribed allopurinol, and the generic manufacturer of the drug, Qualitest. The United States substituted itself as defendant in place of the federal healthcare providers, removed the case to federal court, and moved to dismiss for failure to exhaust administrative remedies. Qualitest also moved to dismiss on the grounds that Houston’s state tort claims were preempted by federal drug regulations that impose an “ongoing duty of sameness” on generic drug manufacturers to mirror the chemical design and labeling of their brand-name counterparts. See 21 U.S.C. § 355(j)(2)(A)(ii)-(v). The district court granted all defendants’ motions, dismissing the case with prejudice, and the Seventh Circuit affirmed.
To escape the duty of sameness, Houston offered three arguments, none of which the court found persuasive. First, he argued that his state-law claims did not necessarily require Qualitest to change allopurinol’s design or label. Order at 6. The court dismissed this argument as “self-defeating,” because the lawsuit in fact alleged that under state law, Qualitest should have labeled or designed the drug differently. By plaintiff’s logic, the only way Qualitest could avoid liability would be to exit the generic market altogether, which, according to the court, “is precisely the outcome that the duty of sameness and Mensing’s preemption principle are designed to prevent.” Id. Houston’s claims for defective design, negligence, consumer fraud, battery, and breach of express and implied warranties were held preempted under the same reasoning. Id.
Second, Houston relied on a line of Supreme Court cases that involved deceptive advertising claims against cigarette and pesticide makers to argue that his claims should survive preemption. See Order at 6 (citing Altria Gropu, Inc. v. Good, 555 U.S. 70 (2008); Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005); Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)). The court quickly rejected this argument as well based on the distinction that, in contrast to Houston’s claims, the claims in those cases did not require manufacturers to violate any federal duty. Order at 7.
Finally, Houston argued that Mensing and its successor Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct 2466 (2013) should not apply because his claims arose after the passage of the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (2007). Specifically, Houston urged that those amendments give the FDA authority to negotiate changes in drug labeling with generic-drug manufacturers. The court noted that although the Supreme Court reserved ruling on the effect of that legislation through a footnote in the Mensing decision, the amendments nonetheless “forbid a generic-drug maker from violating the duty of sameness without FDA permission.” Order at 7. On the issue of FDA “permission” to deviate from this duty, the court noted that “nothing in the amendments or other laws requires a manufacturer to seek that permission, the receipt of which would be speculative anyway.” Id.
The court also upheld the district court’s denial of Houston’s request to add claims against the manufacturer of the brand-name version of allopurionol on statute of limitations grounds. Citing examples of conflicting authority in the Northern District of Illinois, Sixth Circuit, and Fourth Circuit, the court nonetheless declined to “take sides” on the question of whether a consumer of a generic drug may sue the brand-name manufacturer. Id.
In the world of post-Mensing generic preemption cases, I would characterize this one as pretty clear cut. Safe to say Houston is not among those plaintiffs who have crafted theories original enough to convince a court to allow their state-law claims against generic drug manufacturers to proceed despite the preemption principle (for instance, on “failure-to-update” theories). Of the three theories Houston advanced to defeat preemption, his argument based on the FDA Amendments Act of 2007 might have gained the most traction, particularly in light of Mensing’s punting on the impact of that legislation, but the court still dismissed it with minimal discussion. A stronger approach likely would have been to try his luck asserting (timely) claims against the brand manufacturer, potentially forcing the Seventh Circuit to come down on one side of that contested question. For now, that question will sit unanswered for another day while the Mensing preemption principle enjoys this decided victory.