The United States Court of Appeals for the Eleventh Circuit has affirmed a lower court’s grant of summary judgment in favor of the makers and marketers of the biologic drug Enbrel, finding that the plaintiffs' injury claims were barred by the learned intermediary doctrine and that the direct “patient labeling requirement” in the U.S. Food and Drug Administration (FDA) medication guidelines did not preempt application of the doctrine. Shook Partner Dan Rogers, with co-counsel Hogan Lovells, represented pharmaceutical companies Amgen, Pfizer and Wyeth on appeal; Partner Bill Geraghty and Associate Iain Kennedy, with co-counsel Hogan Lovells, represented defendants in the district court.
In 2002, the plaintiff, Rebecca Small, was prescribed Enbrel for treatment of rheumatoid arthritis. After experiencing a gastrointestinal infection and undergoing surgery in 2008, she and her husband filed suit against the companies that manufactured and marketed the drug. In 2014, the U.S. District Court for the Middle District of Florida granted summary judgment to the defendants on two failure-to-warn claims, finding the claims were precluded by the state’s learned intermediary law. In 2017, the defendants learned that Mrs. Small had not retained an expert to testify on causation, and filed for summary judgment on the remaining claims. The court granted the motion, concluding that without expert testimony on either specific or general causation each of the plaintiffs’ claims failed as a matter of law. The plaintiffs then appealed the 2014 grant of summary judgment.
The appeals court affirmed the ruling on the learned intermediary doctrine, noting that Florida law provides that a drug manufacturer’s duty to warn is directed at the prescribing physician, not the patient—if the warning to the physician is adequate, the manufacturer has fulfilled its duty. Moreover, the court said, Mrs. Small’s physician had 22 years of experience in rheumatology and was involved in clinical trials of Enbrel. Not only did she qualify as a learned intermediary, the court said, but because the doctor was in a position to have “independent knowledge of the risk” of the drug, and actually had such knowledge, any alleged failure to warn on the part of the drug manufacturers “could not have been the proximate cause of the patient’s injury.”
In addition, the appeals court considered the purpose of FDA’s medication guide regulations and cited FDA’s own statement that the regulations did “not alter the duty, or set the standard of care for manufacturers, physicians, pharmacists and other dispensers” of drugs. FDA also concluded that its rules had no evidence that its regulations had a “noticeable change” in tort rules affecting civil liability; the appeals court affirmed the district court’s conclusion that the regulations did not preempt Florida’s learned intermediary doctrine.
Because the plaintiffs appealed only the 2014 grant of summary judgment, the court also held that they waived any challenge to the 2017 grant of summary judgment and its finding that the plaintiffs could not prove causation for any of their claims, affirming both judgments.
Small v. Amgen, No. 17-11440 (11th Cir. 2018).