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ChatIn the recent Supreme Court of the United States decision in Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), generic drug manufacturers were given what Justice Sotomayor called “immunity” from state law based design-defect claims when the claims “turn on the adequacy of the drug’s warnings.”
In Bartlett, the plaintiff Karen Bartlett was suffering from shoulder pain. Her doctor prescribed her Clinoril, a non-steroidal anti-inflammatory drug for pain relief, and she received a generic version of the drug, sulindac, from her pharmacist. While taking the medication she developed a condition called toxic epidermal necrosis that Johns Hopkins describes as a “life threatening skin disorder.” The condition caused her skin to be burned off or otherwise severely damaged on over half her body. She was hospitalized and put into a medically induced coma for several months.
As the result of the condition she is now physically disabled and will need care for the rest of her life. She is severely disfigured and almost blind. Because of the personal injury she suffered, she brought a New Hampshire design-defect products liability suit against the manufacturer of the generic drug. She prevailed at the lower court levels, but the case eventually made its way to the Supreme Court of the United States.
Ms. Bartlett was never warned about the possibility of toxic epidermal necrosis. The lack of warning made the drug “unreasonably dangerous” under state law and subject to strict liability. To determine if a product is “unreasonably dangerous” a court weighs the product’s danger, including its attached warnings, and compares it to its overall utility.
Here, Ms. Bartlett was denied recovery for her damages despite the fact that she was never warned about toxic epidermal necrosis. In Part II, this RI products liability lawyer will discuss why she was denied.