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.
READ MORE STEVENS JOHNSON SYNDROME (SJS) LEGAL NEWS
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.