By David Yucht, J.D.
An FDA Guidance indicated that the agency would not object to warnings on acetaminophen products concerning the possibility of severe skin reactions.
A federal district judge in Indiana refused to certify for an interlocutory appeal a preemption issue involving allegedly inadequate warnings on an over-the-counter medication. The court found that there was no "substantial ground for difference of opinion" that a deviation in warnings from the language of a tentative Food and Drug Administration (FDA) monograph (rather than a final monograph) was not grounds for an adverse regulatory action (Emley v. Wal-Mart Stores, Inc., January 8, 2020, Barker, S.).
A consumer ingested two Equate-brand acetaminophen pills which she had purchased from a Wal-Mart store. She developed a rash as well as itchy, watery eyes. Believing she was suffering from an allergic reaction, she took Equate-brand Severe Allergy and Sinus Headache medicine, also purchased from a Wal-Mart store. This product also contained acetaminophen. When her symptoms did not improve, she was admitted to a hospital and diagnosed with Toxic Epidermal Necrolysis, a severe skin disorder associated with acetaminophen. She sued Wal-Mart and the manufacturers of the drugs alleging that the Equate products were defective under Indiana law because their labels did not contain an adequate warning regarding acetaminophen’s risk of severe skin reactions. The district court denied the motion of the retailer and manufacturers seeking dismissal based upon federal preemption. The court held that the doctrine of impossibility preemption did not shield them from liability because there was no "clear evidence" that they would have faced adverse regulatory action by deviating from the exact language of a 30-year-old tentative final monograph by adding an allergy warning to the acetaminophen products. Wal-Mart and the manufacturers sought certification from the court allowing them to file an interlocutory appeal of this ruling.
Certification. The district court denied the motion for certification. District courts may certify otherwise unappealable non-final orders for immediate appellate review if the order "involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance the ultimate termination of the litigation." The district court agreed that the question of preemption, which involved the interpretation of federal regulations, presented a pure question of law. Moreover, the district court determined that the preemption question was controlling because a resolution of this issue would "likely affect the further course of the litigation." However, the district court could not find a "substantial ground for difference of opinion" as to the correct outcome here.
Preemption. Pursuant to federal regulations, acetaminophen is manufactured and sold pursuant to the Over-the-Counter (OTC) Drug Monograph Review Process, a regulatory system developed to allow marketing of OTC drugs generally considered safe and effective. Under this regulatory scheme, a final monograph is "final agency action." No final monograph for acetaminophen was enacted. Consequently, acetaminophen was regulated by a 30-year-old tentative final monograph which did not contain warnings relating to severe skin reactions. Rather, the FDA issued a Guidance indicating that it did not object to warnings on acetaminophen products concerning severe skin reactions. In ruling on the summary judgment motion, the district court concluded that there was no "clear evidence" that the Equate manufacturers would have faced adverse regulatory action by deviating from the exact language of the old tentative final monograph by adding an allergy warning to their acetaminophen products. The court held that an "applicable monograph," which would have resulted in possible preemption, meant "final monograph." Accordingly, the court held that the doctrine of impossibility preemption did not shield the manufacturers or Wal-Mart from liability. The district court noted that no other court had reached a contrary conclusion and, consequently, there was no "substantial ground for difference of opinion."
The case is No. 1:17-cv-02350-SEB-TAB.
Attorneys: Charles Andrew Childers (Childers, Schlueter & Smith, LLC) for Donna Emley, and Dennis Emley. Haley Johnston (Frost Brown Todd LLC) for Wal-Mart Stores, Inc. Brett T. Clayton (Reminger Co. LPA) for LNK International, Inc. Bonnie J. Beavan (Goodell, DeVries, Leech & Dann, LLP) for L. Perrigo Co.
Companies: Wal-Mart Stores, Inc.; LNK International, Inc.; L. Perrigo Co.
MainStory: TopStory PreemptionNews WarningsNews DefensesLiabilityNews DrugsNews IndianaNews
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