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Case 7.2 Stange v. Janssen Pharmaceuticals, Inc. Superior Court of Pennsylvania, 2018 PA Super 4, 179 A.3d 45 (2018). Background and Facts Timothy Stange was twelve years old when his doctor prescribed Risperdal, an antipsychotic drug, to treat his Tourette's syndrome. Stange subsequently developed female breasts, a condition known as gynecomastia Surgery successfully removed Stange's breasts, but left him with permanent scars and pain. Risperdal is made by Janssen Pharmaceuticals, Inc. Janssen knew that gynecomastia was a frequent adverse event in children and adolescents who took Risperdal. But its label significantly downplayed the risk, stating, for example, that the disorder's occurrence was "rare." K Stange filed a suit in a Pennsylvania state court against Janssen, alleging that the maker had negligently failed to adequately wam of the risk of gynecomastia associated with Risperdal use. The court entered a judgment in favor of the plaintiff for more than $500,000. Janssen appealed to a state intermediate appellate court In the Language of the Court Opinion by FORD ELLIOTT, P.J.E. [Presiding Judge Emeritus) * Janssen argues that Stange failed to prove proximate cause, le, that an inadequate warning was the cause of Stange's injuries. * * * Janssen argues that it was entitled to a judgment notwithstanding the verdict (INOV) because] Stange failed to prove that additional risk information would have changed Dr. Kovnar's prescribing decision To support his claim of negligence, Stange must establish that Janssen breached its duty to warn, and that the breach caused his injuries. . A plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury. *** Absent proof thata. more complete or explicit warning would have prevented Stange's use of Risperdal, he cannot establish more complete or explicit warning would have prevented Stange's use of Risperdal, he cannot establish that Janssen's alleged failure to warn was the proximate cause of his injuries. [Emphasis added.] In cases involving the failure to warn of risks associated with prescription drugs, a manufacturer will be held liable only where it fails to exercise reasonable care to inform a physician of the facts which make the drug likely to be dangerous. The manufacturer has the duty to disclose risks to the physician, as opposed to the patient, because it is the duty of the prescribing physician to be fully aware of 1. the characteristics of the drug he is prescribing 2. the amount of the drug which can be safely administered, and 3. the different medications the patient is taking It is also the duty of the prescribing physician to advise the patient of any dangers or side effects associated with the use of the drug as well as how and when to take the drug *** There was substantial evidence that Janssen intentionally downplayed the risk of gynecomastia for *** There was substantial evidence that Janssen intentionally downplayed the risk of gynecomastia for adolescent boys using Risperdal. * The *** label *** reported that gynecomastia occurred in less than 1% of adult patients and less than 5% of pediatric patients treated with Risperdal. Both of these warnings were inaccurate based on the scientific evidence that the Defendants possessed (which] indicated that gynecomastia was a frequent adverse event, not "rare."*** These warnings were not accurate, strong, or clear. Instead, the warnings, to the extent they warned at all, were inaccurate and misleading about the risks of gynecomastia Furthermore, Dr. Kovnar, Stange's pediatric neurologist, testified that *** he would not have prescribed Risperdal to Stange had he been aware of the increased risk. The trial court did not err in refusing to grant INOV