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Supreme Court to Hear Generic Drugmaker Liability Case

The Supreme Court is scheduled to begin hearing arguments on Tuesday in a case involving the question of whether generic drugmakers can be held liable for design flaws in their medications despite the fact that they are required by federal law to copy the design of brand-name drugs.

The outcome of the case will determine whether individuals injured by dangerous "copycat" drugs can file suit against generic drug manufacturers.

The case was filed against Mutual Pharmaceutical Co, the maker of the generic anti-inflammatory drug sulindac, by Karen Bartlett, a New Hampshire resident who was prescribed the drug for shoulder pain. 

Bartlett began taking the drug in 2004, and soon after suffered a rare hypersensitivity reaction to the drug, which caused her skin to begin peeling and forming burn-like lesions that covered two-thirds of her body. She was hospitalized for nearly two months and placed into a medically induced coma. She has also undergone 13 eye surgeries as a result of the reaction.

She filed a lawsuit against Mutual in 2008.

A jury awarded $21 million to Bartlett at the trial-court level, and the judge in that case upheld the jury's award. A federal court of appeals affirmed the trial judge's ruling.

Doctors say Bartlett now has a severe form of Stevens-Johnson Syndrome, is almost completely blind and suffers from extensive lung scarring and a constricted esophagus which makes it difficult for her to breathe or swallow.

Mutual has appealed the case to the Supreme Court, arguing that federal law prohibits claims against generic drug manufacturers because it requires them to copy the same design as the manufacturer of the brand-name drug.