A New Jersey state court judge recently found that plaintiffs could not establish proximate cause in 31 failure to warn claims where the prescribing physicians testified that their decision to prescribe the drug would not change even if the manufacturer had given a stronger warning regarding irritable bowel disease. See January 29, 2016 Order. Judge Nelson Johnson dismissed each of the inadequate warning cases relating to Defendant Hoffmann-La Roche Ltd.’s acne drug Accutane.
In conducting its analysis, the Court recognized the application of the Learned Intermediary Doctrine in New Jersey, which holds that: (1) a prescription drug manufacturer fulfills its duty to warn if it provides adequate warnings to the prescribing physician; and (2) a manufacturer has no duty to ensure that the warning reaches the patient. Accordingly, the adequacy of that warning must be assessed from the physician’s – not the patient’s – perspective. In providing testimony in failure to warn cases, the physician is afforded the opportunity to engage in “hindsight” and opine on what he would have done differently, if anything, given what is known at the time of his deposition. Here, in each of the 31 cases, the plaintiffs’ doctors testified that, even with a different warning, he would still have prescribed Accutane. Therefore, the manufacturer’s failure to give the warning urged by the plaintiffs was not the proximate cause of plaintiffs’ injuries.
The fact that a physician’s testimony on the effect of an allegedly stronger warning can be dispositive is of great potential help to manufacturers facing challenges to good drugs with strong labels. Manufacturers’ counsel will certainly want to prepare to elicit a favorable admission during their prescribing physician examinations.