A California appeals court has cleared the way for a punitive damages claim against Johnson & Johnson to move forward in a Motrin lawsuit that claims the company failed to warn U.S. consumers about the risks of serious and potentially fatal skin reactions known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
An appeal by Johnson & Johnson was rejected by the Court of Appeal of the State of California, Second Appellate District, in an order published last week. The Court affirmed a lower court’s ruling that the plaintiff in the Motrin Stevens-Johnson syndrome lawsuit can pursue punitive damages on the basis that the drug maker’s failure to provide adequate warnings on their ibuprofen product constituted malice.
Stevens-Johnson Syndrome, which is commonly referred to as SJS, is a painful and debilitating reaction that has been linked to the side effects of several medications. It can cause the skin to burn, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is typically referred to as toxic epidermal necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.
The case involves a lawsuit filed in 2008 by Christopher Trejo, who suffered Stevens-Johnson syndrome from Motrin in 2005, when he was 15 years old. According to the complaint, Johnson & Johnson and it’s subsidiary McNeil Consumer Healthcare, failed to adequately warn that the potential side effects of Motrin included a risk of SJS or the more severe TEN.
Trejo sought damages due to the company’s actions, but J&J claimed that it could not be subject to punitive damages or claims of gross negligence and malice since the labels were approved by the FDA. However, the appeals court pointed to the U.S. Supreme Court’s 2009 ruling in Wyeth v. Levine, which determined that the FDA’s labeling requirements are the minimum that companies must meet, and found that the companies are still responsible for warning of health risks even if they must go beyond the FDA minimum requirements to do so.
The complaint alleges that Johnson & Johnson misrepresented study results to the FDA and did not tell the agency the entire truth about the risk of SJS from Motrin when it asked to be able to sell the product over-the-counter. When the painkiller was prescription-only, it carried a warning about the risks of SJS.
Although warnings about Motrin SJS and TEN side effects is included in some other countries, Johnson & Johnson still does not warn about the severe skin reaction from Motrin on packaging in the United States.
The Appeals Court determined that the plaintiff may pursue the punitive damages claim, as triable issues of material fact remain that could allow a jury to conclude that the drug makers failed to warn about the risk of SJS and TEN with conscious disregard for the risk to safety from those conditions.