Clinoril Stevens-Johnson Syndrome Lawsuit Submitted to Jury

A federal jury is currently deliberating in a Stevens-Johnson syndrome lawsuit filed by a New Hampshire women who was blinded and suffered severe internal injuries from a drug reaction caused by a generic version of Clinoril, an anti-inflammatory medication. 

The case involves a claim filed by Karen Bartlett, 51, against Mutual Pharmaceutical Co. for allegedly failing to adequately warn about the side effects of Sulindac, a generic version of Clinoril. During a 14-day trial, Bartlett argued that the drug is useless and unnecessarily dangerous to consumers, and that the drug maker did not properly warn about the risk of severe skin reactions like Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).

Stevens-Johnson Syndrome (SJS) is highly debilitating reaction to certain medications that causes 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.

Bartlett took generic Sulindac in 2005 to treat shoulder pain. Two weeks later she began to show signs of a skin reaction on her face and around her eyes. Eventually she was admitted to the hospital and diagnosed as suffering SJS and TEN. The skin ailment eventually took her sight and caused permanent injuries to her throat, stomach and lungs. She was hospitalized for 112 days in the Massachusetts General Hospital Burn Unit, suffering damage to 65% of her skin.

On Friday, the jury began deliberations on her lawsuit against Mutual. The jury was instructed to find Mutual liable only if they determined that Mutual’s generic Sulindac was unreasonably dangerous and responsible for Barlett’s injuries.

While some estimates place the number of SJS deaths in the U.S. each year at 100,000, foundation officials say it is impossible to tell, since there are no mandatory reporting rules for adverse drug reactions.