A Colorado jury awarded a 57-year old woman and her husband $14.9 million in a case whereas she was paralyzed by an epidural steroid injection that was clearly labeled as not for that use.
The jury found The Surgery Center in Lone Tree, CO, liable.
The plaintiff, Robbin Smith of Castle Rock, CO, was 57 when she received the injection of Kenalog in 2013. She was immediately paralyzed from the waist down.
Two years before she got the injection, Bristol-Myers Squibb got FDA approval to change its label for Kenalog to state: "Not for Epidural Use."
“This verdict won’t restore Robbin’s ability to walk,” attorney Bruce Braley of Leventhal & Puga told the Denver Business Journal. “But it will give Robbin and Ed the chance to make the most of the life they now have.”
Smith's attorneys showed the jury examples of bottles, packages, and labels with the printed warning. The warning label included language describing the adverse reaction that paralyzed Smith: "Spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke (including brainstem), have been reported after epidural administration of corticosteroids."
Doctors never informed Smith of these label warnings.