Judgment Against Acutane Manufacturer Relating To Label Reversed For Entry Of Directed Verdict

In Hoffman-La Roche Inc. and Roche Laboratories Inc. (1D08-2032), the First District reversed the trial court's denial of a motion for directed verdict after a judgment was entered faulting the manufacturer for putting "Accutane on the market with an inadequate warning to Appellee’s physicians about the risk of developing inflammatory bowel disease."

The court stated:

As a general rule, drug companies have the duty to warn of a drug’s dangerous side effects; however, the duty to warn is directed to physicians rather than patients under the “learned intermediary” doctrine...Thus, the duty of a drug manufacturer to warn of the dangers involved in the use of a drug is satisfied if it gives an adequate warning to the physician who prescribes the drug.

***

While Appellee presented testimony that the warning label was inadequate to warn physicians that Accutane use could lead to IBD, Dr. Fisher, the prescribing physician, testified that he understood the warning label to mean that there was at least a possibility of a causal relationship between Accutane and IBD. He testified that he would still be willing to prescribe Accutane to his patients even if there was evidence showing that it could cause IBD in rare cases. He also testified that even if the warning label contained all of the information suggested by Appellee’s expert, he would still have prescribed the medication for Appellee. Thus, any inadequacies in Accutane’s warning label could not have been the proximate cause of Appellee’s injury because Dr. Fisher understood that there was a possibility that use of the drug could lead to Appellee developing IBD and he made an informed decision to prescribe the drug for Appellee despite this risk. Because Appellee presented no evidence to establish proximate cause, the trial court erred in denying Appellants’ motion for a directed verdict.

The emphasis is mine.