By David Yucht, J.D.
A federal judge in New York found that a patient who purportedly suffered gynecomastia, hypertension, liver disease and weight gain from the use of Risperdal® and Wellbutrin® failed to state a claim against the drugs’ manufacturers or corporate officers of the manufacturers for design defect, failure to warn, and common law fraud. Moreover, many of his claims were filed after the three year statute of limitation and were therefore time barred. Accordingly the court dismissed the patient’s complaint (Trisvan v. Heyman, March 30, 2018, Brodie, M.).
Risperdal and Wellbutrin. Risperdal was FDA approved for the treatment of schizophrenia and bipolar disorder. Wellbutrin was FDA approved for major depressive disorder. The patient was diagnosed with depression and psychosis. In 2001, a psychiatrist prescribed him Risperdal and Wellbutrin. Within two years of taking these medications, he allegedly developed gynecomastia, hypertension, and gained almost 100 pounds. He received test results indicating he had an enlarged liver and was in the early stages of fatty liver disease. His medical physician allegedly advised him that Risperdal and Wellbutrin was known to cause liver damage. He alleged that he had never previously been informed of potential side-effects.
Pro se law suit. In 2015, the patient brought suit against corporate manufacturers and their officers, alleging that Risperdal and Wellbutrin caused him weight gain, gynecomastia, hypertension, and liver damage. The court interpreted the patient’s complaint to raise state law claims for failure to warn, design defect, and fraud. The drug manufacturers moved to dismiss the complaint for lack of personal jurisdiction and failure to state a claim.
Limitations. The court ruled that the patient’s failure to warn and design defect claims based on his weight gain, hypertension, and gynecomastia were time-barred. The court noted that under New York law, an action to recover damages for a personal injury is subject to a three-year statute of limitations. In this case, the statute of limitations began to accrue from the date of discovery of the injury or from the date it should have been discovered.
The court ruled that the statutory fraud claim was also time barred. The court noted that in New York, the limitations period for a fraud claim is the greater of six years from the date the cause of action accrued or two years from the time the fraud was discovered. However, the courts will not apply the longer fraud limitations period when a fraud claim is incidental to another asserted claim. Here, the court found that the patient’s fraud claims were incidental to his personal injury claims because the only difference between the fraud and other claims was the element of scienter.
Failure to warn. The failure to warn claims were dismissed for failing to state a claim. The court noted that in New York, a manufacturer’s duty to warn is fulfilled by adequate warning to the prescribing physician, not directly to the patient. Here, the patient failed to provide any non-conclusory allegations to suggest that his treating physicians were not informed of the potential side-effects of Risperdral and Wellbutrin. Instead, his chief complaint was that he was never informed about the risks by his treating physicians. The court also noted that at the time the patient was prescribed these drugs, FDA warnings had in fact been affixed to their labels.
Moreover, the court noted that under New York law, a manufacturer must warn of the danger of off-label uses of a product provided these uses were reasonably foreseeable. However, the patient failed to explain whether he was prescribed Risperdal for off-label use, and could not make such an allegation as to Wellbutrin. Even if his use of Risperdal was off-label, he failed to provide any non-conclusory allegations as to how the warnings provided to his physicians were inadequate.
Design defect. The court dismissed the design defect claims. The patient argued that the companies continued to manufacture and market Risperdal and Wellbutrin despite reports of both medications causing liver damage. He also alleged that the manufacturers never changed the makeup of the drugs failing to make any attempt to eliminate or reduce the danger. The court found that these allegations failed to state a claim for defective design. The assertions that the drugs posed too significant a risk to be continued to be manufactured were wholly conclusory. The court also noted that the patient’s complaint did not lie with the design of the medications but the harms flowing from a lack of knowledge of their side-effects.
Fraud. The court ruled that the patient failed to state a claim for common law fraud. He only alleged conclusory allegations of fraudulent conduct. The court noted that the patient assumed fraudulent conduct based on the prior misconduct as to other off-label uses. The court opined that their prior misconduct, did not eliminate the pleading requirements. Aside from articles relating to prior misconduct, the patient assumed that the manufacturers did not disclose the side-effects of the medication because he was never informed. These bare assertions were solely based on information and belief and could not sustain a claim for fraud without any accompanying details.
The case is No. 1:16-cv-00084-MKB-ST.
Attorneys: John Trisvan, pro se. Thomas Philip Kurland (Patterson Belknap Webb & Tyler LLP) for Tom Heyman.
Companies: Johnson and Johnson; GlaxoSmithKline, LLC
MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PrescriptionDrugNews PLDrugNews NewYorkNews
Interested in submitting an article?
Submit your information to us today!Learn More
Health Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.