The Journey of the Childrens Motrin Label, And Where It Fell Through the Cracks

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Chicago, IllVarious Childrens Motrin and Motrin lawsuits carry a certain commonality: the manufacturers of Motrin failed to warn about the potential for a devastating adverse reaction to skin and mucus membranes that can be life-threatening.

Clouding the issue is the fact that prescription Motrin—which first appeared in 1974 after given approval by the US Food and Drug Administration (FDA)—has always contained a caution against the potential for Stevens Johnson Syndrome (SJS) and its more dire cousin, toxic epidermal necrolysis (TENS).

However, the non-prescription version contained no such reference until at least late 2009.

The manufacturer of Motrin (ibuprofen), McNeil Consumer Healthcare, a division of McNeil-PPC Inc. and a subsidiary of pharmaceutical giant Johnson & Johnson, has tried various legal maneuvers in an effort to defend its actions in the face of SJS lawsuits.

In Newman v. McNeil, No. 10-1541 ND Ill, the defendant petitioned the US District Court for the Northern District of Illinois for summary judgment over an accusation by the two plaintiffs that Motrin caused their SJS, and that the manufacturer failed to warn.

Plaintiffs Blane Newman and Mariam Khawam both used Motrin in the summer of 2009, and both claim to have suffered SJS and / or TENS as a result. McNeil moved for summary judgment, but the Court denied the motion. At issue was McNeil's position that it could not comply simultaneously with both federal and state requirements with regard to warning labels.

Health Law Week (2/3/12), in summarizing the issues at play with Newman v. McNeil, noted that the FDA received 49 reports of SJS/TEN related to ibuprofen (Motrin) in the 30 years between 1975 and 2005. The FDA's response was to require a label change on non-prescription Motrin articulating a warning for skin rash et al, without actually referencing Stevens Johnson Syndrome or TENS.

However, the Court noted that McNeil itself collected no fewer than 117 reports of SJS / TENS related to ibuprofen starting in June 2005, with 87 of those cases received prior to June 2009. At the time, there was no reference on the label of non-prescription Motrin related to Stevens Johnson Syndrome or TENS.

There would not have been, thus, any reference to SJS on the bottle of Childrens Motrin that the parents of 3-year-old Brianna Maya used to treat their daughter in 2000 after she developed a fever. The child would soon be in the fight of her life battling Stevens Johnson Syndrome.

At the time, according to ABC News (6/3/11), doctors concluded Brianna's SJS was triggered by the Childrens Motrin administered by her parents. In 2000, the only reference on the label was an allergy alert for hives, facial swelling, asthma and shock. Following reports of adverse reactions related to SJS / TENS, the FDA in December 2005 recommended the addition of references to skin reddening, rash and blisters—but required no mention of Stevens Johnson Syndrome (even though the prescription version has always referenced the potential for SJS since 1974).

Non-prescription Motrin and Childrens Motrin now contain references to Stevens Johnson Syndrome and SJS. But that came too late for Blane Newman and Mariam Khawam, or for Brianna Maya. In May of last year, a Philadelphia jury awarded Brianna's family $10 million for pain and suffering, and for the failure on the part of the manufacturer to adequately warn.

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