In Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (June 24, 2013), plaintiff suffered a severe dermatologic reaction after taking sulindac, a generic version of the non-steroidal anti-inflammatory drug Clinoril®. Plaintiff sued the drug’s manufacturer in New Hampshire state court alleging, among other things, that the drug was defectively designed. After defendant removed the case to the United States District Court for the District of New Hampshire, the jury returned a $21 million verdict for plaintiff.
The United States Court of Appeals for the First Circuit affirmed, holding that the Federal Food Drug & Cosmetic Act (“FDCA”) did not preempt design defect claims against generic pharmaceutical manufacturers (see July 2012 Foley Hoag Product Liability Update). The circuit court acknowledged that under the FDCA the generic manufacturer could not change the drug’s design to vary from that of the branded manufacturer, but reasoned that because the manufacturer could lawfully decide not to sell the drug at all, there was no actual conflict between defendant’s state and federal law obligations.
After granting certiorari, the United States Supreme Court first noted that under the Hatch- Waxman Amendments to the FDCA, a generic manufacturer’s drug was required to have the same active ingredients, route of administration, dosage form, strength and labeling as the brand-name drug on which it was based. Under New Hampshire design defect law, however, the manufacturer had a duty to ensure that its product’s design was not unreasonably dangerous, and the warnings accompanying the product were a factor to be weighed in assessing the adequacy of the design. Accordingly, defendant could only have satisfied its state law duties either by changing the drug’s design or its labeling (or both), either of which would have been a violation of defendant’s duties under the FDCA (the Court also noted that a design change would not be possible as a matter of basic chemistry, as sulindac is a single-molecule drug). Because it was impossible for defendant to comply with both its state- and federal-law duties, plaintiff’s design defect claim was preempted.
The Court then explicitly rejected the First Circuit’s rationale that defendant could escape the impossibility of complying with both federal and state law by stopping the sale of sulindac in New Hampshire. The Court noted that this rationale was incompatible with all or virtually all of the Court’s previous conflict preemption decisions, which presumed that a defendant seeking to satisfy both its federal and state law obligations was not required to cease acting altogether in order to avoid liability. Indeed, “if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be ‘all but meaningless.’”