Supreme Court Hears Stevens Johnson Syndrome Lawsuit

April 1, 2013, 8:00AM. By Heidi Turner

Washington, DCThe US Supreme Court has heard arguments in a Stevens Johnson Syndrome lawsuit over whether generic drugs can be held liable for injuries sustained by patients. The lawsuit, originally filed by a patient who developed SJS after using a generic version of sulindac, questions whether generic drugmakers are responsible for selling an unreasonably dangerous product, especially when that product is linked to a condition as serious as Stevens Johnson Syndrome.

The lawsuit was filed by Karen Bartlett who took sulindac, a pain medication, in 2004 for soreness in her shoulder. She then developed Stevens Johnson Syndrome and spent two months in a medically induced coma. During her ordeal, Bartlett suffered burns to her throat so severe that she cannot eat normally. The Washington Post (3/19/13) notes Bartlett lost 60 percent of the skin on her body and is now legally blind.

According to the Los Angeles Times (3/20/13), Bartlett was awarded $21 million in her lawsuit against Mutual Pharmaceutical, but the Supreme Court has agreed to hear arguments in favor of throwing that verdict out. A lawyer for Mutual said the company cannot take precautionary measures because sulindac is a generic version of a brand-name drug and therefore required to carry the same formulation and warnings as the brand-name version.

Bartlett’s lawyer argued that the severity of adverse reactions such as Stevens Johnson Syndrome far outweigh the potential benefits of minor pain relief, especially when there are safer alternatives on the market.

A decision is not expected for at least a few months. But the court’s decision could change how generic drugmakers are held accountable for their medications.

Meanwhile, a different SJS lawsuit is also pending appeal. In 2011, a jury awarded Alicia E. Maya $10 million in compensatory damages in her lawsuit regarding her daughter’s SJS ordeal. Maya reportedly developed SJS after being given Children’s Motrin and Children’s Tylenol. According to The Pennsylvania Record (2/27/13), McNeil PPC, defendant in the lawsuit, filed a notice of appeal with the Pennsylvania Superior Court, arguing the judge in the case made evidentiary errors that affected the verdict.

Stevens Johnson Syndrome is a rare but serious allergic reaction to certain medications. It can arise in pain medications, even when such drugs have been previously tolerated by the patient. Patients who develop SJS experience burn-like blistering over their body and often suffer damage to internal organs. Some patients who develop SJS and its more extreme form, Toxic Epidermal Necrolysis, die from their injuries.

Various drugmakers have faced lawsuits alleging their medications are unreasonably dangerous or alleging the drugmaker failed to adequately warn about the risks associated with a medication. Some drug warning labels in the past have only mentioned a risk of serious allergic reaction, but not how severe that reaction can be.