Products Liability Law Daily FDA patient labeling requirement does not preempt learned intermediary doctrine
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Tuesday, January 23, 2018

FDA patient labeling requirement does not preempt learned intermediary doctrine

By Wendy Biddle, J.D.

Food and Drug Administration (FDA) drug labeling requirements did not preempt the learned intermediary doctrine in a patient’s action against the manufacturers of the arthritis drug Enbrel®, a panel for the Eleventh Circuit Court of Appeals ruled in an unpublished decision which upheld summary judgment for the manufacturers by a federal district court in Florida. Further, the court ruled that because the injured patient failed to challenge the district court’s grant of summary judgment for lack of expert testimony to prove causation, she waived the argument and could not prevail on appeal (Small v Amgen, Inc., January 22, 2018, per curiam, G).

Injury, surgeries and claims. In 2002, the patient was prescribed Enbrel for treatment of rheumatoid arthritis. In 2008, the patient had multiple surgeries for a perforated bowel and a diverticulitis infection. In 2012, she filed suit claiming strict liability for design defect and failure to warn, breach of express warranty, negligence, and loss of consortium. The district court granted summary judgment in 2014 for the patient’s strict liability and negligent failure to warn claims [see Products Liability Law Daily’s March 7, 2014 analysis]; and ruled that all failure to warn claims were precluded by Florida’s learned intermediary doctrine [see Products Liability Law Daily’s September 28, 2015 analysis].

In 2017, the pharmaceutical companies moved for summary judgment on the remaining claims after they learned that no experts would be testifying as to the cause of the injury. The district court granted the 2017 motion for summary judgment concluding that the remaining claims failed as a matter of law without expert testimony as to causation. The patient appealed, claiming that the 2014 summary judgment was improper because the district court found that her physician was a learned intermediary and that the FDA patient labeling requirement did not preempt the learned intermediary doctrine.

Learned intermediary and doctrine preemption. The patient’s physician had 22 years of experience and was involved in the clinical trials of Enbrel. The court record showed that the physician knew of the risk of infections, but determined those risks outweighed the benefits the patient would receive by using the drug. The district court record showed that the patient’s treating physician was qualified as a learned intermediary, and the appeals court agreed.

In considering preemption of the Florida’s learned intermediary doctrine, the Eleventh Circuit looked at the FDA’s own explanation of the purpose of the medication guide regulations, which was to provide information to patients for the safe and effective use of drugs. In the final version of the medication guide/labeling rule, the FDA stated it did not believe the rule would adversely affect civil tort liability, nor did it alter the duty of physicians or manufacturers. The agency also noted that courts have not recognized a patient labeling exception to the learned intermediary doctrine. After weighing the FDA’s explanation and intent of the patient labeling requirement, the court concluded that the district court did not err in holding that the FDA’s patient labeling requirement does not preempt Florida’s learned intermediary doctrine.

Causation issue. Lastly, the court addressed the patient’s reliance on the 2014 summary judgment ruling and the patient’s failure to challenge the 2017 summary judgement order. The court stated that since she did not challenge the 2017 order, she waived any appeal on lack of causation.

The case is No. 17-11440.

Attorneys: Keith L. Altman (Weininger Law, PLLC) for Rebecca A. Small. David Stephen Johnson (Shook Hardy & Bacon, LLP) and Catherine Emily Stetson (Hogan Lovells US, LLP) for Amgen, Inc., Pfizer, Inc. and Wyeth, Inc.

Companies: Amgen, Inc.; Pfizer, Inc.; Wyeth, Inc.

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