U.S. Supreme Court Won't Take Up Preemption Of Over-The-Counter Drugs

U.S. Supreme Court Won't Take Up Preemption Of Over-The-Counter Drugs

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on Oct. 9 denied a petition by a Johnson & Johnson subsidiary asking the high court to find that state law failure-to-warn claims involving over-the-counter (OTC), nonprescription drugs are preempted under the court's 2011 ruling in which it found that warning claims involving generic prescription drugs are preempted (McNeil-PPC, Inc. v. Christina Hoyt Hutto, No. 12-122, U.S. Sup.).

In 2003, a hospital nurse told Christina Hoyt Hutto and Eric Hutto to give their daughter, Brianna Hutto, 5 months old, a teaspoon of Tylenol-brand acetaminophen. The Huttos had been giving Brianna Infant's Tylenol Concentrated Drops. The nurse, however, was referring to Children's Tylenol but did not specify that product.

The Huttos gave teaspoon doses of their Infant's Tylenol to Brianna, and because it has a higher concentration of acetaminophen than Children's Tylenol, the child developed acute liver injury and died while awaiting a liver transplant.

The Huttos sued the hospital and McNeil-PPC Inc., a subsidiary of Johnson & Johnson and the maker of Infants' Tylenol, in the St. Landry Parish, La., District Court. After a trial, the jury found McNeil 23 percent liable, and the court entered a $1,157,774 judgment against the company.

Appeals Court Affirms

McNeil appealed, and the Third District Louisiana Court of Appeal in December affirmed the verdict against all defendants and the apportionment. The appeals court found that the Huttos' claims were not preempted by federal law because McNeil admitted that it did not attempt to have all the warnings the Huttos sought included on the Infant's Tylenol label.

On July 26, McNeil filed a petition for a writ of certiorari. The defendant said the Supreme Court's generic drug preemption ruling in PLIVA, Inc. v. Mensing (131 S. Ct. 2567 [2011]) should apply to state law failure-to-warn claims challenging an OTC drug label.

McNeil argued that the Infant's Tylenol label was consistent with the applicable OTC monograph for acetaminophen and that the label could not be changed by McNeil without prior approval from the Food and Drug Administration.

McNeil said the Supreme Court should summarily reverse the Louisiana appeals court ruling or grant review, vacate the lower court ruling and remand the case (GVR) on the grounds that the Huttos' failure-to-warn claims are "plainly preempted" by Mensing. Alternatively, McNeil asked the high court to grant review and hold that federal law preempts state law failure-to-warn claims for drugs marketed pursuant to an OTC monograph.

No Preemption, Changes OK

In their Aug. 27 opposition, the Huttos said Congress has expressly preserved state court product liability claims involving OTC drugs from preemption. They said manufacturers of OTC drugs may add warnings to their labels without prior FDA approval "unless such warnings are prohibited by an applicable final monograph."

The Huttos said that at the time of Brianna's overdose, there was no final monograph for acetaminophen. In addition, they said, there is no evidence that the FDA would have prohibited the warnings that they argue should have been provided.

McNeil did not preserve its Mensing preemption argument for Supreme Court review, the Huttos said. Additionally, the lower court decision does not conflict with any Supreme Court decision, they said.

The case, the Huttos continued, does not squarely present the issue of the preemptive effect of a final OTC monograph.

Alito Sits Out

The court considered the case at its Oct. 5 conference and denied certiorari in its Oct. 9 orders. Justice Samuel Alito did not take part in the discussion or decision, according to the case docket.

McNeil was represented by Charles C. Lifland of O'Melveny & Myers in Los Angeles; Kathleen A. Manning of McGlinchey Stafford in New Orleans; Jonathan D. Hacker, Loren L. Alikhan and Laura L. Conn of O'Melveny & Myers in Washington; and Debra D. O'Gorman and Michael E. Planell of Dechert in New York.

The Huttos were represented by Louis M. Bograd of the Center for Constitutional Litigation in Washington and Cle Simon and Barry L. Domingue of the Simon Law Offices in Lafayette, La.

Amicus curiae Consumer Healthcare Products Association and Personal Care Products Council were represented by Robert A. Long Jr., Gerald F. Masoudi, Christopher H. Pruitt and Emily S. Ullman of Covington & Burling in Washington. Amicus Product Liability Advisory Council Inc. was represented by Nancy J. Marshall and Joseph L. McReynolds of Deutsch, Kerrigan & Stiles in New Orleans.

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