On June 28, 2013, the New York Times published an editorial regarding the Supreme Court’s recent decision to reverse a $21 million jury verdict awarded to a woman who suffered serious and debilitating injuries as a result of taking the generic drug sulindac (name brand Clinoril). After taking sulindac for shoulder pain, Karen Bartlett developed toxic epidermal necrolysis causing her skin to slough off, damage to her lungs and esophagus and affecting her eye sight. A jury awarded Ms. Bartlett $21 million for her injuries and damages, which was upheld by the First Court of Appeals. However, the Supreme Court held that the generic pharmaceutical company that produced the generic version of the drug could not be held liable for the injuries sustained by Ms. Bartlett, as the company would have to violate federal law and US Food and Drug Administration (FDA) requirements in order to alter the chemical composition of the drug or change its warning label.
In a previous ruling, the Supreme Court held that a generic drug manufacturer could not be held liable for its failure to warn regarding the potential harm posed by the generic version of a drug. Wyeth v. Levine, 129 S. Ct. 1187 (2009). This is because generic drug manufacturers are required to use the same warning label utilized by the name brand manufacturer who produces or produced the original drug approved by the FDA. The ruling by the Supreme Court in Ms. Bartlett’s has gone a step further and stated that a consumer cannot bring a suit for design defects in the drug against a generic drug manufacturer as a result of injuries suffered from taking the generic drug since the manufacturer cannot alter the chemical composition of a generic drug without violating federal law or FDA regulations.
According to the editorial, the Supreme Court’s rulings concerning generic drugs do not leave many options for consumers who have been harmed by these types of medications. The article does note that the FDA is considering permitting generic drug manufacturers to change their labels in certain situations. This may allow the generic drug manufactures to be held liable for harm caused to a consumer.
See the New York Times editorial at: