Pharmaceutical Law Update -- October 2012: Learned Intermediary Doctrine Applies to Failure-to-Warn Pharmaceutical Cases in Florida

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[author: Mimi Dennis]

An August 7, 2012 decision by the New Jersey Appellate Division overturned three judgments totaling almost $12 million in damages previously awarded against New Jersey drug manufacturer Hoffman–La Roche, Inc. for injuries associated with the use of its acne drug Accutane.  The three suits, all brought under Florida law, involved teenage Accutane users who alleged that they developed permanent inflammatory bowel disease after using the drug.  Central to the Appellate Division’s decision was the application of Florida’s precedent requiring a careful evaluation of the behavior of a prescribing physician when applying the “learned intermediary doctrine.” 

 

In the three suits, Sager v. Hoffman-La Roche, Inc. et al., Docket No. A-3427-09T4 (N.J. Sup. Ct. App. Div. Aug. 7, 2012), Speisman v. Hoffman-La Roche, Inc., et al, Docket No. A-3428-09T4 (N.J. Sup. Ct. App. Div. Aug. 7, 2012) and Mace v. Hoffman-La Roche, Inc. et al., Docket No. A-3702-09T4 (N.J. Sup. Ct. App. Div. Aug. 7, 2012), each plaintiff took Accutane as a teenager in order to treat severe acne, and each claimed to have developed chronic and permanent bowel disease shortly thereafter.  At the time each plaintiff was prescribed the drug, Accutane came with a physician insert warning that Accutane “has been temporally associated with inflammatory bowel disease,” and also a patient brochure warning of possible gastrointestinal side effects with the drug. 

 

Florida, like many states, follows the learned intermediary doctrine when evaluating product liability claims involving prescription drugs, and requires that the behavior of the prescribing physician be analyzed in determining the proximate cause of a patient’s injury.  Under controlling Florida law, a physician’s independent knowledge of a drug’s potential risk has the ability to break the chain of causation between an inadequate warning and an injury.  A plaintiff must, therefore, show that the alleged inadequate warning would have altered his or her physician’s conduct.  This premise was confirmed in Hoffmann-La Roche v. Mason, 37 So. 848 (Fla. 2010), where Florida’s intermediate appellate court found that an important consideration bearing upon this causation question is whether the doctor would have still prescribed the drug to the plaintiff, even if the manufacturer supplied a more pointed warning.   

 

Notably, the Appellate Division focused on the fact that each plaintiff’s prescribing physician testified at trial that he or she would have prescribed the drug to that plaintiff even if the physician warnings had been more strongly worded because it was the best, most effective treatment for this type of acne.  Each physician admitted that a stronger warning would not have affected his or her recommendation or prescription of the product; therefore, the New Jersey Appellate Division reversed the lower judgments, stating that “it is not our place to second guess the appellate courts of Florida and the wisdom of their decisions,” and holding that Hoffman–La Roche, Inc. would not be held liable for the plaintiffs’ injuries. 

 

The Appellate Division’s decision provides important support for pharmaceutical manufacturers defending failure-to-warn claims under Florida law in New Jersey, and elsewhere.  Pharmaceutical manufacturers facing failure-to-warn product litigation should evaluate whether the learned intermediary doctrine is a viable defense to causation, and the necessary requirements to assert such a defense.  To the extent a product liability plaintiff is a Florida resident, and Florida law applies, then time should be spent determining whether a prescribing physician would have prescribed the product at issue even if a stronger warning was given by the manufacturer.

Published In: Civil Remedies Updates, Health Updates, Products Liability Updates, Professional Malpractice Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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