A California state appeals court rejected Johnson & Johnson's motion to dismiss a claim alleging the firm was negligent for not providing specific warnings about Stevens-Johnson Syndrome on Motrin labels.

The California Second Appellate District Court's Jan. 20 ruling illustrates the level of judicial scrutiny firms can face when using FDA's approval of labels as a shield against damages claims.

Appellate Judge William Willett upheld a state trial court judge's denial of J&J's motion for a summary adjudication to dismiss the 2008 complaint filed in Los Angeles County against the firm and its McNeil Consumer Healthcare business.

The plaintiff, Christopher Trejo, alleges he developed SJS after he used Motrin in 2005, when he was 15 years old.

Leaning On FDA’s Responsibility

While attorneys for J&J and McNeil argue FDA policies precluded adding an SJS warning on Motrin labels, Willett said "relevant federal regulations place the burden on manufacturers to ensure their drug labeling is adequate at all times."

Willett pointed out that in the 2009 Wyeth v. Levine decision, the Supreme Court noted manufacturers' responsibility for label content "has remained a central premise" of FDA regulations throughout "many" amendments to the Food, Drug & Cosmetic Act (Also see "High Court’s Wyeth v. Levine Ruling Returns Pre-Emption Status Quo" - Pink Sheet, 9 March, 2009.).

According to Willett's ruling, J&J/McNeil's argument focused on how "FDA-approved labeling" for Motrin protects the firms from charges of "despicable conduct or conscious disregard for safety" related to the product's label.

But J&J's arguments, the judge wrote, "are not entirely accurate in characterizing the relationship between and respective duties of the FDA and drug manufacturers."

Willett wrote, although lawyers for Trejo showed McNeil "has known since the 1980s" of an ibuprofen-SJS link, the firm "never asked the FDA to include that fact in the OTC label warning, despite the fact it could have done so."

Syndromes Versus Symptoms

Labeling FDA approved in 2000 was on Motrin containers at the time Trejo used the product, October 2005. The labeling included a warning that ibuprofen may cause a severe allergic reaction, which may include hives, facial swelling, asthma or shock.

"Relevant federal regulations place the burden on manufacturers to ensure their drug labeling is adequate at all times."

– California Judge Willett

FDA required McNeil and other NSAIDs manufacturers in December 2005 to use labels with additional language, including warnings about increased risk of cardiovascular complications and ulcers, along with warnings that consumers allergic to aspirin may react to NSAIDs.

However, the California ruling points out that in response to a February 2005 citizen petition about possible SJS risks linked to ibuprofen, FDA said the agency did "not believe that it is useful" to refer specifically to SJS or the more severe form of the condition, toxic epidermal necrolysis, in ibuprofen label warnings.

According to the ruling, FDA in 2005 said "a description of symptoms is more appropriate" for warnings on drug labels. The agency pointed out it had already required label changes with additional warning language to go into effect later that year.

J&J/McNeil cited FDA's policy in their argument. The firms said if they had asked FDA to add "a more explicit warning" about SJS or TEN, the agency would have held that "most consumers are unfamiliar with the terms" and would have rejected the change.

But the judge found that unconvincing, stating that Trejo's position is that the firms should have acted earlier to add SJS symptoms to Motrin labels, not that they should have identified the condition.

Willett said "there is arguably a significant difference between" a general warning about allergic reactions on NSAID product labels, as required by FDA, and a "description of the specific symptoms associated with the rare but potentially fatal conditions" of SJS.

Further, the judge said J&J/McNeil made an "irrelevant" argument by stating in their motion to dismiss "that they have been in discussions" and have had "frequent contact with the FDA about labeling of the OTC ibuprofen products on a continuous basis."

Willett explained the firms alluded to discussions about dosing that had "nothing to do with" SJS or TEN.

Notably, the ruling pointed out the firm's motion to dismiss the claim does not address causation – whether the failure to warn was substantial in bringing about the plaintiff's injury. Instead, the motion discussed "solely whether the failure to warn is sufficient to show malice so as to support punitive damages."

Opposite Motrin Rulings Cite Wyeth Case

The California ruling differs from a 2010 ruling in the U.S. Court of Appeals for the Seventh Circuit that deferred to FDA on labeling concerns (Also see "Decision For McNeil In Children's Motrin Suit Notes Limits Of OTC Labeling" - Pink Sheet, 30 August, 2010.).

Both decisions pointed out the Supreme Court ruled in Wyeth that FDA-approved labeling does not block individuals from pursuing personal injury claims under state law.

However, while the California judge ruled a trial court can decide whether J&J/McNeil was negligent in labeling for Motrin, the U.S. Seventh Circuit ruling said that despite the Wyeth decision, warnings requested by consumers, though not required by FDA or a state, are not reasons for judicial intervention.

A plaintiff's attorney in the Seventh Circuit case made an argument similar to a point stated in the California court ruling: although FDA sets minimum label warning requirements, drug manufacturers are free to add additional warnings if they have evidence to justify a need for the information.

Among others claims consumers have made alleging a Motrin-SJS link, a lawsuit the family of an 11-year-old girl filed against J&J, McNeil and other companies connected to the product was among the most publicized. A jury ruled in favor of McNeil in July 2008 ("J&J no liability," "The Tan Sheet" July 28, 2008, In Brief).

By Malcolm Spicer

Judge Returns Motrin Suit To Trial Court, Reject's J&J's Motion To Dismiss

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