J&J appeal of $140 million judgment denied by the U.S. Supreme Court
On January 19th, the U.S. Supreme Court denied to hear Johnson & Johnson’s (J&J) appeal of a $140 million judgment in a lawsuit alleging it failed to warn that Children’s Motrin pain and fever medication could cause a devastating skin condition. Johnson & Johnson v. Reckis, No. 15-449, 2016 U.S. LEXIS 801.
In 2003, seven year old Samantha T. Reckis developed toxic epidermal necrolysis (TEN) or the Stevens-Johnson Syndrome (SJS), a rare but life-threatening skin disorder, after receiving multiple doses of Children's Motrin. Children's Motrin is an over-the-counter (OTC) medication with ibuprofen as its active ingredient, manufactured and sold by the defendants McNeil-PPC, Inc., and its parent company, Johnson & Johnson. Reckis v. Johnson & Johnson, 471 Mass. 272 (2015).
The U.S. Supreme Court was urged by J&J to weigh on its verdict that the Pharmaceutical Company must pay because of the Children’s Motrin. J&J also argued that the court should look to a third party i.e. the U.S. Food and Drug Administration (FDA) for rejecting the warning labels proposed by the pharma giant.
The lawsuit filed indicated that the medication should have come with warnings that specifically mentioned toxic epidermal necrolysis, the related skin condition SJS, and a general warning that rashes or blisters that develop after taking the drug could lead to a “life-threatening” condition. SJS is a form of toxic epidermal necrolysis, wherein the cell death causes the epidermis to separate from the dermis. The syndrome is considered to be a hypersensitivity complex that affects the skin and the mucous membranes. The most well-known causes are certain medications, but it can also be due to infections, or more rarely, cancers. Toxic epidermal necrolysis and SJS essentially cause one’s skin to melt off the body.
Subsequently, J&J filed a brief before the High Court on December 30, 2015, to review the Massachusetts Supreme Judicial Court’s decision affirming the multi-million dollar February 2013 verdict stating that the FDA did not think it important to add warnings to the label, and so it was not them but the regulators who be held liable.
After a lengthy jury trial, the Superior Court held that FDA's rejection could not be regarded as the base for J&J’s appeal and that it was J&J’s failure to request FDA to attach a warning to be added. The jury awarded general damages to Samantha, and loss of consortium to her parents. The judgment totaled to $140 million with interest.