Hatfield v. Wal-Mart Stores, Inc.

Background

Robin Hatfield and Lisa Roberts, individually and on behalf of their minor children, brought separate actions against Wal-Mart Stores, Inc. The complaints alleged that Hatfield and Roberts took Equate, Walmart’s over-the-counter acetaminophen product, while pregnant and that their children later developed autism spectrum disorder. Roberts’s child was also diagnosed with attention-deficit/hyperactivity disorder. The plaintiffs alleged that Walmart violated state law by failing to warn about the risks of prenatal exposure to acetaminophen.

Hatfield allegedly took Equate two to three times per week during her third trimester in or around October 2011 to treat back pain. Roberts allegedly took Equate two to four times during her pregnancy in early 2008 to treat headaches. Both alleged that they believed Equate was safe during pregnancy and would not have taken it if they had received a warning about the alleged risks. At the relevant times, the product label included the warning, “If pregnant or breast-feeding, ask a health professional before use,” but did not specifically warn about autism spectrum disorder or attention-deficit/hyperactivity disorder.

The cases were filed in the U.S. District Court for the Western District of Arkansas and later transferred to the Southern District of New York as part of multidistrict litigation. Walmart moved to dismiss both complaints, arguing that federal law preempted the state-law claims. The opinion addresses the duty-to-warn theory because the parties’ motion papers treated the other claims as depending on the alleged breach of that state-law duty.

Choice of Law

The court explained that a multidistrict-litigation transferee court applies the substantive law, including choice-of-law rules, of the jurisdiction where the action was originally filed. Under Arkansas choice-of-law rules, the court ordinarily considers the place where the wrong occurred along with five additional factors. For Hatfield’s claims, the potentially relevant laws were those of Tennessee and Arkansas; for Roberts’s claims, they were those of Nevada and Arkansas.

The court did not resolve the choice-of-law issue because the relevant state-law duties were nearly identical. Tennessee, Nevada, and Arkansas each recognize an inadequate warning as a basis for product-liability responsibility in the circumstances discussed in the opinion. No party argued that resolving the choice of law would change the preemption analysis.

Federal Preemption Standard

Walmart relied on conflict preemption, which applies when federal and state requirements cannot both be followed. The court described impossibility preemption as a demanding defense requiring Walmart to show that the federal and state duties were so directly conflicting that they could not be reconciled.

The court reviewed Supreme Court decisions involving prescription drugs. Under those decisions, a state failure-to-warn claim generally is not preempted when a manufacturer could have strengthened its warning without prior federal approval. By contrast, preemption can apply when federal law prevents a manufacturer from changing its label.

FDA Regulation of Acetaminophen

The court explained that acetaminophen is regulated under the Food and Drug Administration’s over-the-counter monograph system rather than through an individualized application for approval of a particular drug and label. The applicable monograph required acetaminophen products to satisfy specified conditions but did not include a pregnancy-specific warning for acetaminophen.

Separate federal labeling regulations required over-the-counter products intended for systemic absorption to include the general pregnancy warning: “If pregnant or breast-feeding, ask a health professional before use.” The regulation did not state that this general warning was the only pregnancy-related warning a manufacturer could provide. The court also noted that the federal statute preserving state product-liability actions supported its conclusion that the labeling rules did not preempt these claims.

Court’s Analysis and Ruling

The court held that the plaintiffs’ failure-to-warn claims were not preempted. The decisive question was whether the manufacturer could have added a warning about the risks of prenatal exposure to acetaminophen and autism spectrum disorder or attention-deficit/hyperactivity disorder without violating the applicable federal regulations. The court answered yes.

The court rejected Walmart’s arguments that the word “shall” in the pregnancy-warning regulation made the required warning exclusive; that the regulation’s use of the word “general” barred a more specific warning; that a separate provision addressing specific pregnancy warnings prevented manufacturers from creating their own warnings; and that the regulation’s express authorization of a warning symbol showed that no other optional warnings were allowed. The court concluded that a manufacturer could include an additional specific warning while retaining the required general pregnancy warning.

The court also rejected Walmart’s argument that the absence of a federal procedure for obtaining approval of an added warning showed that label changes were prohibited. Because over-the-counter drugs sold under the monograph system did not require FDA approval of their labels, the court reasoned that a manufacturer could change its label as long as the revised label complied with the monograph and other applicable regulations.

The court stated that concerns about different warnings appearing on different products did not control the conflict-preemption analysis. It also explained that the FDA’s 2015 statement describing the evidence concerning acetaminophen and attention-deficit/hyperactivity disorder as inconclusive did not change the preemption analysis.

Finally, Walmart argued that it was not responsible for changing the Equate label. The court did not accept that argument as a basis for dismissal because the complaints alleged that Walmart manufactured and labeled Equate, and the factual allegations had to be accepted as true at the motion-to-dismiss stage. The court denied Walmart’s September 6 motions to dismiss.