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Motrin May Have to Warn About Skin Loss

CHICAGO (CN) - Johnson & Johnson must face allegations that it did not properly warn consumers that Children's Motrin may cause permanent disabilities like blindness and massive skin loss, a federal judge ruled.

It has been known for decades that generic ibuprofen can cause Stevens-Johnson Syndrome (SJS) and its deadlier form known as Toxic Epidermal Necrolysis (TEN). These extremely rare life-threatening conditions can cause the top layer of skin to detach, resulting in massive skin loss. They especially affect mucous membranes such as the mouth, eyes and female genitalia.

McNeil Consumer Healthcare, a Johnson & Johnson company, has listed the possible SJS link on its prescription Motrin labels since 1983. Mention of SJS and TEN became a Food and Drug Administration labeling requirement for prescription Motrin in 2006.

But neither disease is mentioned on FDA-approved labels for the over-the-counter and children's versions of Motrin.

In 2006, the FDA specifically declined a consumer petition to require manufacturers to mention SJS and TEN on over-the-counter ibuprofen labels.

But the allegations caught up to McNeil in 2009, when two children were diagnosed with SJS and TEN after taking the over-the-counter and children's versions of Motrin to treat a fever.

The children, Blane Newman and Mariam Khawam, sued McNeil and Johnson & Johnson in 2010 along with Newman's parents, Gary and Debra.

The complaint alleged that Motrin labels failed to adequately warn consumers that consumption of the drugs could cause injuries related to SJS and TEN. Khawam and the Newmans also claimed that the label should describe possible SJS and TEN symptoms, including blindness, massive skin loss, extensive burns, massive scarring and organ damage.

U.S. Magistrate Judge Maria Valdez denied McNeil's motion for summary judgment last week, finding that federal law does not pre-empt the labeling claims.

"Plaintiffs have not alleged that the OTC Motrin warning label should use the terms 'SJS' or 'TEN'," Valdez wrote. "As opposed to terms like SJS and TEN, consumers are familiar with injuries like blindness and scarring; and including such information does not seem as if it would keep consumers from quickly and easily understanding the potential severity of an adverse reaction to ibuprofen."

Though the FDA denied a citizen's petition about Motrin warnings in 2006, that "is not clear evidence that the FDA would have prohibited in 2009 the warning plaintiffs allege is required," according to the 31-page opinion (italics in original).

McNeil claimed that it had no duty to warn consumers about SJS and TEN because they are "exceedingly rare diseases with unknown causes, and recent studies show that there is no statistically significant correlation between the disease and the use of ibuprofen," the decision states.

But Valdez disagreed. "Obviously, McNeil knew that users of its product might be injured; therefore even if there is 'unusual susceptibility' in this case, it is not a complete defense to plaintiffs' failure to warn claim," she wrote.

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