Health Law Daily Wal-Mart litigation continues over warning label for acetaminophen-containing products
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Friday, June 28, 2019

Wal-Mart litigation continues over warning label for acetaminophen-containing products

By Victoria Moran, J.D., M.H.A.

Court denies summary judgment on preemption question because of the absence of a federal prohibition on the challenged labeling changes.

Federal law does not prohibit manufacturers or retailers from adding warnings to over the counter (OTC) acetaminophen products. Accordingly, an Indiana district court allowed the purchaser and consumer of two different over-the-counter, acetaminophen-containing products to continue with product liability claims against the retailer—Wal-Mart. The court denied the defendants’ motions for summary judgment on preemption grounds because the federal regulatory scheme did not prevent the manufacturers from adding a warning of the risk of skin reactions to the labels (Emley v. Wal-Mart Stores, Inc., June 27, 2019, Lawrence, W.).

The plaintiffs in this case are consumers of two over-the-counter Equate brand products containing acetaminophen that were purchased at two separate Wal-Mart stores (one in Indiana and one in Tennessee). The acetaminophen was purchased at an Indiana Wal-Mart in November 2013 and was ingested on June 11 and 12, 2015. The acetaminophen was manufactured by L. Perrigo Company (the acetaminophen manufacturer). On June 13, 2015, the consumers traveled to Kentucky for a vacation and the female consumer developed a rash. The male consumer purchased an over-the-counter sinus and allergy medication from a Wal-Mart in Tennessee which contained acetaminophen. The allergy medication was manufactured by L.N.K. International (the allergy drug manufacturer). The woman was eventually hospitalized and diagnosed with Toxic Epidermal Necrolysis (TEN).

The consumers allege that the acetaminophen in the two products caused the woman to develop TEN and that the products were defective because their label did not contain a specific warning regarding the risk that acetaminophen could cause severe skin reactions.

Summary judgment on preemption denied. All defendants moved for summary judgment on the grounds that the consumers’ claims are preempted by federal law.

In reviewing Supreme Court precedent, the court concluded that the federal regulatory scheme did not prevent the defendants from adding the warning to the drugs’ labels. The defendants would not have violated the law by adding the additional warning. While the FDA could have taken regulatory action if it considered the content of the warning improper, that possibility is insufficient to create preemption unless the manufacturer can show by clear evidence that the FDA would not have approved the change. With regard to the retailer, while it may not have the ability to change the labels from a practical standpoint, the retailer could point to no federal law it would have violated if it had somehow been able to change the label. The court denied summary judgment on preemption grounds.

State law Acetaminophen claims. The court granted the acetaminophen manufacturer’s motion for summary judgment as to the claims for common law negligence, gross negligence, breach of express warranty, and breach of implied warranty. Under Indiana law, a specific statute—not common law—governs actions brought by a consumer against a manufacturer or seller for harm caused by a product. Similarly, the consumer’s claim for negligent misrepresentation and fraud is also governed by the statute and the court granted the manufacturer’s motion for summary judgment on these common law-based claims.

The court also concluded that the consumer did not assert a design defect claim and only reasserted the failure to warn claim as a design defect claim. Thus, the court granted the manufacturer’s request for summary judgment on the design defect claim.

However, the court denied summary judgment on the state-based failure to warn claim because the manufacturer was permitted to strengthen the warning label under federal law and a jury could conclude that a more effective warning could have been used.

State law allergy Drug claims. The court agreed with the allergy drug manufacturer that Tennessee law should apply to the claims against it because the product was purchased in Tennessee, not Indiana.

The court was not persuaded by the manufacturer’s argument that the person who consumed the drug did not look at the label before taking two doses of the medication. The person who purchased and administered the medication gave deposition testimony that he would not have given her the drug if the warning had been on the product and a jury could conclude that but for the lack of the warning, the woman would not have taken the drug. In its motion for summary judgment, the allergy drug manufacturer also attempted to "incorporate by reference" some of the arguments made by the acetaminophen manufacturer in its motion. However, since the court concluded that Tennessee law applies to the allergy drug manufacturer, any arguments made by the acetaminophen manufacturer are irrelevant. Thus, the court denied the manufacturer’s motion for summary judgment on these points.

The case is No. 1:17-cv-02350-WTL-TAB.

Attorneys: Charles Andrew Childers (Childers Schlueter & Smith, LLC) for Donna Emley. Haley Johnston (Frost Brown Todd LLC) for Wal-Mart Stores, Inc. Katherine M. Haire (Reminger Co. LPA) for L.N.K. International Inc.

Companies: Wal-Mart Stores, Inc.; L.N.K. International Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews LabelingNews OTCNews SafetyNews IndianaNews

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