Generic Drugs: A Closely Watched Case

In 2005, Karen Bartlett visited her doctor complaining of shoulder pain. Her doctor prescribed Sulindac, a nonsteroidal anti-inflammatory drug used to relieve pain and address symptoms of arthritis. Ms. Bartlett was dispensed the generic form of Sulindac, manufactured by Mutual Pharmaceutical Company. Her life was never the same.

Ms. Bartlett suffered a rare but life threatening drug reaction related to Stevens-Johnson Syndrome called toxic epidermal necrolysis (TENS). TENS is diagnosed when 10 percent of the outer layer of human skin is catastrophically damaged or destroyed. Ms. Bartlett suffered burns and skin loss affecting 60 to 65 percent of her total skin area.

Spending months in a medically-induced coma, Ms. Bartlett suffered two septic shock episodes, was treated in five different hospitals, and was left with external and internal burns and disfigurement that rendered her legally blind, unable to eat normally, have sexual relations or exercise. Once active, independent and gainfully employed, Ms. Bartlett, only 53, is almost blind and unable to read or drive.

A trial court awarded Ms. Bartlett $21 million dollars in her action against Mutual Pharmaceutical and the decision was upheld by an appeals court. Mutual has requested the Supreme Court to determine if a generic drug manufacturer should be held liable for injuries caused by an exact replica of a drug as it was created by the originating company.

About 80 percent of prescriptions in the United States are filled using economical generic drugs. In a case that could have far-reaching legal consequences, the Supreme Court recently agreed to hear the case and decide whether a generic drug manufacturer can be held liable for injuries caused by a defective drug.

In the past, the Court held generic drug manufacturers cannot be held liable for labeling deficiencies over which the generic manufacturer has no control — this case questions the inherent safety of the drug itself, not the labeling. The findings in this case may decide if injured patients can legally challenge generic manufacturers of dangerous, defective drugs. Time and the Supreme Court will tell.

If you have been injured by a reaction to a drug, you may be eligible to file a lawsuit to receive compensation for your injuries. Contact a product liability lawyer at our office to find out more.