Generic Stevens Johnson Syndrome Case Goes to Supreme Court

After developing Stevens Johnson Syndrome from the generic medication, Bartlett spent nearly two months in a burn unit. More than 60 percent of her skin peeled off. She remained in a medically induced coma for several months and required 13 eye surgeries. As a result, her eyes no longer produce tears and she must frequently moisten them with eye drops. Bartlett is now legally blind.

When Bartlett was prescribed sulindac, the label did mention that patients could develop Stevens Johnson Syndrome as a side effect. However, the risk was not listed in the label’s “Warning” section. In 2005, the U.S. Food & Drug Administration recommended that manufacturers of non-steroidal anti-inflammatory drugs should specifically warn consumers about the risk of developing SJS on the drug label.

Bartlett’s Stevens Johnson Syndrome attorney argued that the potentially fatal risks of SJS not only far outweigh the benefits of pain relief, but that there are also safer painkillers available. Rather than arguing that the drug was dangerous, Bartlett’s attorneys argued that Sulindac was a defective product that posed an unnecessary risk of injury.

Mutual Pharmaceutical countered that federal law regulating generic drugs preempts state design-defect law. Under federal law, the FDA’s designation that the brand name drug for Sulindac, Clinoril, was “safe and effective” permitted generic versions of the drug to be manufactured.

This case is not the first that has been heard by the U.S. Supreme Court regarding the responsibility of generic drug manufacturers. In 2011, the Court ruled that, because a generic drug manufacturer must follow the original brand label, the drug maker has no responsibility to include new or undisclosed risks on the generic label. The ruling claimed that generic drug makers did not have control over warning labels and could not be held legally responsible for failing to warn patients of the potential risks associated with using the medication. After this ruling, hundreds of cases from individuals injured by generic drugs have been dismissed.

If you have developed Stevens Johnson syndrome after taking medication, contact an SJS attorney immediately. You may be able to join a class action lawsuit and recover compensation for your SJS injuries. For more information, visit the Stevens Johnson (SJS) & Toxic Epidermal Necrolysis (TEN) Class Action Lawsuit Investigation page. If you submit information about your SJS injury on this page, an SJS attorney will review your situation and schedule a free consultation to determine whether you qualify to join the SJS class action lawsuit.