Drug Company Granted Appeal in SJS Lawsuit

December 11, 2012, 2:30PM. By Heidi Turner

Washington, DCA drug company that makes a drug linked to a Stevens Johnson syndrome reaction has been given the okay to appeal a $21 million jury award. The award was granted in a lawsuit filed by a woman who developed SJS after using a prescribed medication. Following her development of Stevens Johnson syndrome symptoms, the woman spent months in the hospital and suffered permanent injuries.

According to Courthouse News Service (12/3/12), Karen Bartlett was prescribed Clinoril in 2005 for shoulder pain. Although she was prescribed a brand name medication, her pharmacist gave her a generic version of the drug, sulindac, made by Mutual Pharmaceutical. After taking the medication, Bartlett developed Stevens Johnson syndrome, which progressed into its more extreme form, toxic epidermal necrolysis (TEN). During her ordeal, she lost approximately 60 percent of her skin and spent 70 days in the hospital.

Bartlett's lawsuit, filed in 2008, alleged the risks associated with sulindac outweighed the benefits and made the drug unreasonably dangerous. A jury sided with Bartlett and awarded her $21 million. According to Thomson Reuters (9/28/10), $16.5 million of that was for pain, suffering and loss of the enjoyment of life, $2.4 million was for future expenses and another $1 million was given for past medical expenses.

Mutual appealed, alleging generic drug makers cannot be sued for design defects and further claiming the award was excessive.

The federal appeals court in New Hampshire denied Mutual's claim. In writing for the three-judge panel—whose ruling was unanimous—Judge Michael Boudin wrote that while Mutual could not legally make sulindac in a different formulation, it could choose not to make the drug at all. The Supreme Court, however, has agreed to hear Mutual's appeal.

Although large, the $21 million award is not the highest given out linked to Stevens Johnson syndrome. According to The New York Times (5/25/12), earlier in 2012, a New York jury awarded a woman $120 million in her medical malpractice lawsuit against three hospitals after a woman suffered brain damage due to Stevens Johnson syndrome. According to the lawsuit, the plaintiff went to hospital for treatment for a seizure but developed SJS while in the hospital. The lawsuit alleged three hospitals mismanaged her condition, resulting in her suffering brain damage.

Stevens Johnson syndrome is a rare but serious allergic reaction to medication. It can occur at any time, even with medication that has previously been tolerated, and has been linked to common medications including ibuprofen. Patients are often treated in a hospital burn unit because their symptoms resemble those of burn victims, including skin sloughing off and severe blistering. Stevens Johnson syndrome and toxic epidermal necrolysis can be fatal. There is no known cure for either condition.

Sulindac is a non-steroidal anti-inflammatory drug. The brand name version, Clinoril, is sold by Merck & Co. The lawsuit is case No. 10-2277.