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From Products Liability Law Daily, September 9, 2014

Treating/prescribing physician duality raises causation issue in Phen-Fen action

By Pamela C. Maloney, J.D.

Because a patient had both a prescribing physician, who had not read any of the warnings provided by the maker of a weight loss drug, and a treating physician, who was aware of those warnings, it could not be determined, as a matter of law, that the prescribing physician’s failure to read negated the patient’s failure to warn claims, a federal district court held. The court also denied the manufacturer’s motion for summary judgment on the patient’s request for punitive damages (Heineman v. American Home Products Corp., September 9, 2014, Krieger, M.).

Background. The patient, Jennifer Heineman, convinced her parents, both of whom were physicians, to issue her a prescription for Pondimim, a brand-name variant of the weight-loss drug fenfluramine, manufactured by Wyeth. The patient’s father, who never heard of the drug or read any of the warnings, signed one or more blank prescription drug forms for his wife, who filled in the relevant information. The patient alleged that as a result of taking the drug, she developed pulmonary arterial hypertension (PAH), a progressive and potentially fatal lung disease. She brought negligence and strict product liability claims against the manufacturer. The manufacturer moved for summary judgment, arguing that the patient’s claim failed as a matter of law because her prescribing physician had not read the warnings and, therefore, the patient could not prove that the allegedly defective warning was the proximate cause of her injury.

Learned intermediary doctrine. Under the learned intermediary doctrine, a drug manufacturer’s duty to warn runs only to the prescribing physician, not to the patient or any other person. Thus, under the doctrine, the prescribing physician assumes the responsibility of ascertaining the drug’s dangers and evaluating whether its risks outweigh its benefits. The patient argued that in this case, the manufacturer’s duty ran not only to her father—the physician who technically prescribed the drug—but to her mother as the physician who ostensibly was treating her and consulting with the prescribing physician on the suitability of the drug.

Prescribing v. treating physician. The court found that the manufacturer’s interpretation of the learned intermediary doctrine as extending the manufacturer’s duty to warn only to the prescribing physician failed to address how to apply the phrase “prescribing physician” in the unusual factual scenario presented. The record showed that the father did nothing more than sign a blank prescription form, which he turned over to someone else, apparently abdicating any and all professional responsibilities that accompany the act of prescribing medicine. Instead, those responsibilities were performed by the patient’s mother, who allegedly considered the suitability of the drug for the patient’s use. According to the court, neither party cited any authority that would define which physician (be it either or both) should be considered the prescribing physician for purposes of the learned intermediary doctrine. Because the parties failed to adequately address the means by which the court could identify the prescribing physician in this case, the court could not determine, as a matter of law, the causation question presented, i.e., whether the physician father’s failure to read the warnings accompanying the drug before prescribing the drug negated the failure-to-warn claims because any inadequacies in the warning could not have caused the patient’s injuries.

Punitive damages. Likewise, the court refused to grant the manufacturer’s motion for summary judgment on the patient’s claim for punitive damages. The manufacturer had argued that the patient could not establish beyond a reasonable doubt that the drug maker had engaged in “willful and wanton conduct.” In support of its position, the manufacturer argued that the patient’s evidence purporting to show that company officials tried to neutralize efforts by physicians and researchers to highlight a link between the drug and PAH had no connection to the case. However, the court noted that the evidence was relevant to the question of whether a stronger warning was needed and pointed to evidence suggesting that the physician mother had given due weight to existing warnings about the drug before prescribing it. The court also rejected the manufacturer’s argument that based on U.S. Supreme Court precedent, the patient was precluded from asserting that fraud on the FDA was evidence of a drug manufacturer’s malicious or wanton state of mind. The court stated that the high court’s holding only precluded state law claims sounding in fraud on the FDA.

The case number is 13-cv-02070-MSL-CBS.

Attorneys: James DeNice Sill, Jr. (Sill Law Group) for Jennifer Heineman. Eric Keith Blumenfeld (Hughes Hubbard & Reed, LLP) for American Home Products Corp., Wyeth-Ayerst Pharmaceuticals, Inc., Wyeth-Ayerst International, Inc., and Wyeth-Ayerst Laboratories Division of American Home Products Corp.

Companies: American Home Products Corp.; Wyeth-Ayerst Pharmaceuticals, Inc.; Wyeth-Ayerst International, Inc.; Wyeth-Ayerst Laboratories Division of American Home Products Corp.

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