On appeal, the defendants argued that the trial court had erroneously failed to apply the Learned Intermediary Doctrine to the fraudulent misrepresentation or deceit claim; misapplied that doctrine to the failure-to-warn claim; should have recognized the causation evidence was insufficient to prove a failure to warn; made erroneous evidence rulings; and, mistakenly allowed the jury to consider punitive damages.
The Learned Intermediary Doctrine
The learned Intermediary Doctrine imposes a duty on a manufacturer to warn physicians of the risks involved with its product, thereby placing the physician in the role of intermediary between manufacturer and patient. Thus, the law considers a manufacturer’s warning to a physician to be a warning to the patient, and a manufacturer need not communicate directly with all ultimate users of its product.
The learned intermediary doctrine, however, does not allow or presuppose that physicians substitute their judgment for that of their patients, and the learned intermediary doctrine does not eliminate a factfinder’s need to consider whether the patient’s decision would have been different if the warning had been sufficiently thorough. Instead, the learned intermediary doctrine’s purpose is to enable patients to make informed and intelligent decisions whether to undergo a recommended therapy by balancing the probable risks against the probable benefits of the course of treatment proposed by their physicians.
The Appellate Court held that the learned intermediary doctrine could not bar the plaintiffs’ deceit claim because when there is a failure to adequately warn the physician, as the jury had found, the learned intermediary doctrine as a defense simply drops away (the intermediary cannot be said to be adequately learned because he or she was not adequately informed).
The Appellate Court further held that there was sufficient evidence by which the jury could reasonably conclude that the lack of adequate warnings was a proximate cause of plaintiff’s injuries; that the evidence was sufficient to allow the jury to find an adequate warning would have prevented the plaintiff’s injuries; that there was sufficient evidence for the jury to find that if Ethicon had placed adequate warnings in the IFU (Ethicon’s “instructions for use” for the Prolift transvaginal surgical mesh), the warnings would have altered the surgeon’s conduct and prevented the plaintiff’s injuries; and, that the evidence more than adequately supported the jury’s award of punitive damages (the jury was entitled to find from the evidence that the defendants provided warnings so deliberately misleading as to warrant the imposition of punitive damages, and when considering the nature of defendants’ misconduct and the serious harm to plaintiff, the award of punitive damages was justified). Lastly, the Appellate Court noted that the defendants did not argue that the amount of the punitive damages awarded was excessive.
Source Gross, et al. v. Gynecare, et al., Docket No. A-0011-14T2.
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