Failure to Warn Claim Against Drug Manufacturer Rejected

A claim that a drug manufacturer failed to properly warn under Tennessee law based on its failure to include a medication guide required by FDA regulations is impliedly preempted by federal law.

In McDaniel v. Upsher-Smith Laboratories, Inc., No. 2:16-cv-02604 (6th Cir. June 29, 2018), plaintiff brought suit after her husband died after taking medication manufactured by defendant. Plaintiff claimed that defendant’s “failure to ensure that a Medication Guide accompanied the prescription led to her husband ingesting—and dying because of—a drug that wasn’t meant for him.” Plaintiff’s husband had been prescribed a generic form of a medication intended as a “last resort for patients suffering from ventricular fibrillation and ventricular tachycardia.” The husband, however, was suffering from non-life threatening atrial fibrillation. Plaintiff asserted that because defendant did not include the required medication guide, her husband “was unaware that only adults with life-threatening heartbeat problems who had unsuccessfully sought alternative treatments should take the drug.” He thus suffered from a serious lung side effect and died.

The trial court dismissed the case, finding that plaintiff’s “Tennessee failure-to-warn claims premised solely on [defendant’s] failure to provide the Medication Guide as required by FDA regulations” was impliedly preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”). The Court of Appeals affirmed.

FDA regulations include certain labeling requirements for drugs. “One of those labeling requirements is to make “Medication Guides” available for distribution to each patient with each prescription[.]” (citing 21 C.F.R. § 208.24(b)). Further, because defendant was manufacturing a generic drug, it was required to “ensure that it includes the same labeling approved for its brand-name counterpart.” (citing 21 U.S.C. § 355(j)(2)(A)(v)). The FDCA provides that, “[e]xcept in certain circumstances not relevant here, all such proceedings for the enforcement, or to restrain violations, of the FDCA shall be by and in the name of the United States.” (citing 21 U.S.C. § 337(a); internal quotation omitted).

The Court began its analysis with a brief review of federal preemption:

When state and federal laws clash, federal law reigns supreme and state law is preempted. …In the absence of an express preemption statute, as here, federal law may impliedly preempt state law to the extent the two laws conflict. This type of implied preemption, known as conflict preemption, comes in two forms—impossibility and obstacle preemption. Impossibility preemption exists when compliance with both federal and state law is impossible. Obstacle preemption exists when state law serves as an obstacle to the purposes and objectives embodied in a federal law.

(internal citations omitted).

Here, the Court found that plaintiff’s “failure-to-warn claims based on [defendant’s] alleged failure to provide a Medication Guide [were] impliedly preempted.” The Court stressed that plaintiff was not relying “on traditional state tort law,” but that she was instead “seek[ing] to enforce the federal regulation requiring drug manufacturers to ensure the availability of Medication Guides for distribution to patients.” The Court pointed out that her complaint stated several times that the Medication Guide was required by FDA regulations. Further, the Court emphasized that in her response to the motion to dismiss, plaintiff “insisted” her claim was based on the failure to provide a Medication Guide and “explicitly disclaimed the argument that her failure-to-warn claims stem from inadequate content,” as her response stated: “The allegation is not one of adequacy or ‘content’ failure to warn…but an actual and physical negligent failure…to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients…”

The Court of Appeals reasoned that “the federal duty of ensuring that Medication Guides are available for distribution to a patient is the only element of [plaintiff’s] failure-to-warn claims.” The Court found that plaintiff was “suing [defendant] because its alleged conduct violates the federal Medication Guide regulations,” and that because her claims “would exert an extraneous pull on the scheme established by Congress,” they were preempted by the FDCA. (internal citation omitted).

Interestingly, the Court specifically noted that it was not addressing “whether the FDCA impliedly preempts a claim under the doctrine of negligence per se,” as plaintiff failed to properly plead such a claim in her complaint.

Chief Judge Cole wrote a separate opinion in this case, dissenting from the holding that dismissal was appropriate at this stage. He wrote that the “crux” of plaintiff’s state law claim was that defendant “failed to provide a medication guide to her late husband, and that failure rendered inadequate the warnings of [the drug’s] potential risks and side effects it did provide and caused her late husband’s death.” According to his analysis, plaintiff referenced federal regulations to show why her claims should not be barred by impossibility preemption, not in an attempt to make a federal claim under state law. He wrote:

[Plaintiff] must discuss federal law to show why her claims are not barred by impossibility preemption. It does not mean that she ‘seeks to enforce…federal regulations.’ [Plaintiff’s] claims are premised on a violation of an independent Tennessee duty to warn, not federal law. The alleged breach arises from the same act—namely, the failure to provide a medication guide. But the legal basis is different. [Plaintiff’s] claims depend on whether the warnings provided were adequate and proximately caused her late husband’s death. Because the fact of a federal-law violation is not a necessary element of those claims, they are not subject to obstacle preemption…

(internal citations and quotations omitted).

While plaintiff’s claim here ultimately failed, the opinion did seem to leave the door open for some state law failure to warn claims based on drug medication guides. Anyone considering such a claim should read this opinion carefully.