A woman battled over her compensation rights for years, won the state court, but lost in the Supreme Court over legal proceedings against a generic maker.
Karen Bartlett took a generic drug named sulindac, a generic version of the non-steroidal anti-inflammatory drug Clinoril, manufactured by Mutual Pharmaceutical Co. back in 2004 to treat her shoulder pain. However, instead of it curing her shoulder pain, it made it worst with additional complications.
She was hospitalized at the Massachusetts General Hospital for three months in 2004. Her skin began to fall away, had lung complication and difficulty swallowing. The doctors diagnosed her with Stevens-Johnson syndrome, a life-threatening skin condition affecting the mucous membranes of the skin cells causing the upper layer and lower layer of the skin to separate. It is often triggered by medications, infections, or cancer.
Bartlett sued the generic maker and was favored by the New Hampshire Superior Court in 2010 requiring the opposition to pay her $21 million for the emotional and physical damages as well as the legal expenses.
The opposition appealed the case in the Supreme Court and last Monday, it ruled in favor of the generic maker. The court reasoned that Bartlett couldn’t sue the generic maker because it just copied the brand drug’s formula and warning label. According to the law, generic drugs are required to be chemically identical to the FDA-approved brand and must use the exact warning label.
'I was numb,' Bartlett told ABC News of the moment her lawyer delivered the news. 'I don't even have words to describe it because I can't believe that they would do that.'
Bartlett’s lawyer disputed that the generic maker missed to effectively warn users about the skin disease as a possible side effect of taking the drug. FDA discovered the side effect in 2005, a year after Bartlett’s case.
Jay P. Lefkowitz, lawyer of Mutual Pharmaceutical Co., believes that the decision was correct because if the Supreme Court favored Bartlett, it would invalidate FDA’s authority of assessing drug safety. However, he expressed his sympathy for the woman.
Ms. Bartlett was very upset of the decision and said in an interview with ABC News, 'I walk away with nothing except disability checks. They don't seem to care that this has affected me for rest of life.'
