Ibuprofen ‘Regulatory History’ Pre-empts Failure-To-Warn Claims In State Court – CHPA

FDA regulations and decisions on ibuprofen labeling indicate the agency would not approve warnings plaintiffs seek for Motrin, preventing J&J/McNeil from making the changes without violating federal law, which pre-empts state laws, according to CHPA’s amicus brief in the firm’s appeal of a verdict in Massachusetts.

A damages claim against Motrin provides a platform to apply to non-monograph OTC products a Supreme Court ruling on whether FDA-approved labeling for Rx drugs pre-empts personal injury claims under state law, the Consumer Healthcare Products Association argues.

The trade group makes the argument in its amicus brief supporting Johnson & Johnson subsidiary McNeil-PPC Inc.’s appeal of a Massachusetts state court jury’s February 2013 verdict awarding $63 million to the family of a teenager who suffered toxic epidermal necrolysis after taking Children’s Motrin when she was 7 years old (Also see "In Brief" - Pink Sheet, 18 Feb, 2013.).

FDA’s “regulatory history” for ibuprofen labeling renders federal pre-emption of state laws “appropriate in this case” by meeting the “clear evidence” standard the Supreme Court noted in its 2009 ruling in Wyeth v. Levine, according to CHPA’s brief submitted by attorney Paul Schmidt from Covington & Burling LLC in Washington.

Additionally, J&J/McNeil is appealing state-court verdicts in California and Pennsylvania awarding damages to plaintiffs in lawsuits alleging onset of toxic epidermal necrolysis and Stephens-Johnson Syndrome linked to the use of Children’s Motrin (ibuprofen 100mg). The complaints allege the drug maker is negligent for failing to warn on product labels about the known risk of TEN or SJS in a manner that consumers could understand.

However, CHPA argues that Motrin products, marketed by McNeil’s McNeil Consumer Healthcaredivision, are compliant with all FDA labeling regulations and that adding the warnings sought by the plaintiff in the Massachusetts lawsuit would render the products noncompliant.

Further, the “clear evidence” standard from Wyeth v. Levine is applicable in failure-to-warn cases involving labeling of non-monograph OTC drugs, those approved through new drug applications, according to the amicus Schmidt prepared with other Covington & Burling attorneys and CHPA staff (Also see "High Court’s Wyeth v. Levine Ruling Returns Pre-Emption Status Quo" - Pink Sheet, 9 Mar, 2009.).

Although the decision held Wyeth liable for failing to provide adequate warning of the risks of IV-push administration of its anti-nausea drug Phenergan (promethazine), the clear evidence standard the Supreme Court cited would absolve J&J/McNeil of the failure-to-warn responsibility for Motrin labels, Schmidt argues.

As an Rx drug manufacturer, Wyeth, since acquired by Pfizer Inc., was allowed to use FDA’s “changes being effected” regulation to strengthen the warning in Phenergan labeling without prior FDA approval, though the agency has authority to later reject CBE labeling changes.

Wyeth did not implement a CBE label change and the Supreme Court said “absent clear evidence that the FDA would not have approved” a change, the failure-to-warn claims were not pre-empted, according to the amicus. Wyeth “offered no such evidence” and the High Court found no conflict pre-emption.

CHPA acknowledges that manufacturers of NDA-approved OTCs also can make CBE label changes without prior FDA approval.

However, FDA’s “regulatory history” on Motrin labeling indicates the agency would not approve the warnings the plaintiff seeks; and J&J/McNeil could not make those changes without violating FDA labeling law.

“The ‘clear evidence’ standard is satisfied when state law is trying to force a result that is at odds with the clear intent of FDA. Such a direct conflict renders compliance with both state law and FDA regulation impossible,” Schmidt wrote in the amicus filed Nov. 11 in Massachusetts Supreme Judicial Court.

FDA Response To Petition Supports McNeil

In addition to FDA regulations for OTC drug labeling, agency actions that address Motrin labeling include responding to a 2005 citizen petition requesting a “full risk assessment” of ibuprofen and the occurrence of SJS and TEN and that FDA withdraw approval of OTC pediatric ibuprofen products, or require manufacturers to include explicit warnings about the life-threatening reactions of SJS and TEN in the labeling, according to CHPA’s brief.

FDA’s 2006 response to the petition stated the agency conducted a “comprehensive analysis” of the risks of SJS and TEN associated with the use of ibuprofen and concluded that the risks “are significantly less than cited” by the petitioners, Schmidt notes in the amicus.

FDA granted the petition in part, noting it already had directed manufacturers of OTC ibuprofen products to include the terms skin reddening, rash, and blisters in the Allergy Alert section of labeling. However, FDA rejected the petition’s request to include additional language in the labeling about SJS and TEN.

The agency’s response stated it would not be useful to include the terms “SJS,” “TEN,” “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” in labeling “because most consumers are unfamiliar” with the terms.

FDA also noted that “effective OTC labeling communicates warning information in a manner that consumers can quickly and easily identify and understand,” according to CHPA’s amicus.

The brief points out that awarding damages in state-court complaints against Motrin could have a wide-reaching impact on the OTC industry.

“CHPA members have a vital interest in the labeling of OTC medicines, and in not being subject to labeling obligations under state law that create an impossible conflict with federal law,” Schmidt wrote.

“State-law failure-to-warn lawsuits asserting that manufacturers should label their OTC medicines in a manner that FDA has rejected would place CHPA’s members in an untenable position,” he added.