In 2004, Karen Bartlett, of Plaistow, New Hampshire, begin taking the generic medication sulindac, an anti-inflammatory medication. Unfortunately, Bartlett soon began to suffer from one of the drug’s side effects, a condition known as toxic epidermal necrolysis, which left her with burns on 65% of her body and rendered her almost totally blind.
Bartlett sued the manufacturers of the medication, Mutual Pharmaceutical Company, and was awarded $21 million in damages. Mutual Pharmaceutical quickly appealed, claiming that it was an excessive award of damages, but the U.S. Court of Appeals for the First Circuit upheld the ruling.
Now, it appears likely that the case will be appealed to the U.S. Supreme Court for a final judgment. At issue is the degree of responsibility the manufacturers of generic drugs owe to their clients. Because Mutual Pharmaceutical Company had not originally created sulindac, they were legally prohibited from altering its chemical composition or changing its warning labeling. Therefore, Mutual Pharmaceutical argued that it should not be liable for Bartlett’s injuries. However, Mrs. Bartlett and her attorneys argue that the drug should not be on the market in the first place, as its risks outweigh its potential benefits.
This case represents an important new development in pharmaceutical liability law in the U.S., and could have a significant impact on how the manufacturers of generic drugs choose to make and market their products. For more information on this case, please visit this page.