Health Law Daily Motrin® manufacturer unable to change active ingredient, avoids liability
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Friday, March 11, 2016

Motrin® manufacturer unable to change active ingredient, avoids liability

By Harold Bishop, J.D.

A district court granted summary judgment to the manufacturers of the over-the-counter (OTC) drug Motrin® on failure to warn and design defect claims. The mother of a child who ingested only one dose of the drug brought suit after her child immediately developed rare and extremely painful skin conditions which eventually lead to his suicide. The court concluded that the failure to warn claim could not be sustained because there was no admissible evidence that the child would not have taken Motrin had the label contained more explicit warnings. The court further found that because federal regulations barred the manufacturers from changing the active ingredient in Motrin without prior approval by the FDA, federal law prevented them from complying with the alleged state law duties to alter the chemical composition of Motrin. Therefore, federal law preempted the design defect claim, as well (Batoh v. McNeill-PPC, Inc., March 10, 2016, Shea, M.).

FDA approval of Motrin. McNeil-PPC, Inc. (McNeil) and Johnson & Johnson (J&J) (together, manufacturers) are New Jersey Corporations. J&J owns all of the stock of Janssen Pharmaceuticals, Inc., which in turn owns all of McNeil’s stock. McNeil manufactures and sells Motrin, an FDA-approved OTC medication for the relief of pain and inflammation and the reduction of fever. The nonsteroidal anti-inflammatory drug ibuprofen is the active ingredient in Motrin. The FDA approved ibuprofen as a prescription medication for adults in 1974, and approved Motrin as an OTC medication in 1984. The FDA reviewed drug applications for ibuprofen and concluded that the drug is safe and effective for use as recommended in the submitted labeling.

Injuries and suicide. In October 2010, the child developed the rare and extremely painful skin conditions known as Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) after taking one dose of OTC Motrin. SJS and TEN are severe cutaneous adverse reactions characterized by inflammation of the mucous membranes of the mouth, throat, eyelids, and anogenital region and painful and debilitating tissue injury and loss, epidermal blistering, necrosis, and sloughing. Over a year later, overcome by continued pain and suffering from these conditions and the damage they had done to his life, the child killed himself.

The lawsuit. The child’s mother brought a products liability suit against the manufacturers alleging that the Motrin he took contained inadequate warnings and was defective as designed.

On summary judgment, the district court was asked to decide two questions: (1) whether there was admissible evidence in the record from which a reasonable juror could find that the child would not have taken the Motrin had the label borne more explicit warnings; and (2) whether the manufacturers established their defense of “impossibility preemption” with respect to the claim that Motrin harbored a design defect in its chemical composition.

Failure to warn claim. With regard to the failure to warn claim, the mother submitted the following as evidence of causation: (1) testimony from the family that her child was a cautious person who was careful with medications and had a habit of checking their warnings; (2) her child’s statements to his brother and her that he would not have taken Motrin if it had borne a different warning; and (3) the manufacturers’ failure to warn her child’s physicians of Motrin’s risks through adequate labeling.

To support these allegations, the mother testified that, after her child’s hospitalization in October 2010, he told her that he “was upset the warnings were not more specific and if he would have known, he would not have taken Motrin.” The child’s brother testified that he told him that “if it would have warned him on the bottle that this could have happened to him, he never would have taken it.” The mother could not testify whether her child ever saw a Motrin advertisement, but knew that he used Motrin prior to the incident that caused his hospitalization in October 2010.

The court found that the mother offered no examples of which she had personal knowledge of her child’s reading the label or warnings for a medication to establish a pattern of cautious conduct. The court also found that the mother failed to establish that the statements by her child to her and his brother were especially trustworthy, which was her burden. As such, the court concluded that there was no admissible evidence that the child would not have taken the Motrin had the label been more explicit and, as a result, the mother could not sustain the causation element of this claim.

Design defect claim. Regarding the design defect claim, the court found that the case involved conflict preemption. Conflict preemption occurs when compliance with both state and federal law is impossible. The court decided that because federal regulations barred the manufacturers from changing the active ingredient in Motrin without prior approval by the FDA, federal law prevented them from complying with the alleged state law duties to alter the chemical composition of Motrin. Therefore, federal law preempted the state design defect claim and the court granted summary judgment to the manufacturers.

The case is No. 3:14-cv-01462 (MPS).

Attorneys: Christopher L. Schnieders (Wagstaff & Cartmell, LLP) for Amy Batoh. David F. Abernethy (Drinker Biddle & Reath, LLP) and Christopher R. Drury (Shipman & Goodwin LLP) for McNeil-PPC, Inc. and Johnson & Johnson.

Companies: McNeil-PPC, Inc.; Johnson & Johnson; Janssen Pharmaceuticals, Inc.

MainStory: TopStory CaseDecisions PLDrugNews FDCActNews DrugBiologicNews LabelingNews OTCNews PreemptionNews SafetyNews ConnecticutNews

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