PHILADELPHIA (CN) - After a middle school boy in Wisconsin grew breasts because of the medication he took for Tourette’s syndrome, Janssen Pharmaceuticals was hit with a $535,106 jury verdict. The Pennsylvania Superior Court has now cleared the way for punitive damages.
Timothy Stange was 12 years old in 2006 when a pediatric neurologist prescribed him Risperdal to treat his Tourette’s syndrome.
Manufactured by Janssen, a subsidiary of Johnson & Johnson, the drug belongs to a class of antipsychotics, but the Food and Drug Administration approved it in 2006 to treat symptoms of autism in pediatric and adolescent populations.
Stange experienced a stabbing pain in his nipple the following year but stayed on Risperdal until 2009. Two years later, Stange’s pediatrician diagnosed him with gynecomastia, a condition where an imbalance of the hormones estrogen and testosterone causes male breast tissue to swell.
The boy suffered years of teasing from his classmates before undergoing a double mastectomy at age 18 to have his breasts removed.
Stange later joined a group of 5,500 former Risperdal users from around the country who have accused Janssen in Philadelphia of failing to warn them about the risk of gynecomastia.
His case went before a jury in 2015, and both parties appealed when a jury awarded Stange more than half a million dollars.
On Monday, a three-judge panel of the Pennsylvania Superior Court determined that Stange could also be eligible for punitive damages.
The problem, according to the ruling, is that the trial court left Wisconsin law out when it determined which state law governing punitive damages should apply.
Janssen failed to sway the Superior Court panel that New Jersey law was correctly chosen “because the defendants’ principal places of business were in New Jersey, the Risperdal labeling was developed and distributed from New Jersey, Janssen’s overall Risperdal marketing and sales strategy was developed in New Jersey, and communications with the FDA and the medical community occurred in New Jersey.”
Though the trial court did not fully address the issue, the Superior Court found Monday that Stange did not waived the choice-of-law argument.
Janssen Pharmaceuticals spokeswoman Kelsey Buckholtz said the company is evaluating its next steps after reviewing the court’s disappointing reversal.
“Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Resperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” Buckholtz said in an email.
Stange’s attorneys at Sheller PC did not return phone or email requests for comment.
The Superior Court says a new record on choice of law must be developed on remand, with attention in particular to the unique circumstances of Stange’s case.
“Stange argues that Wisconsin law should apply because he was prescribed Risperdal in Wisconsin and developed gynecomastia in Wisconsin; Janssen’s inadequate warnings reached [Stange's pediatric neurologist] in Wisconsin; Janssen’s salespeople visited [Stange's pediatric neurologist] in Wisconsin on multiple occasions over many years and failed to disclose Risperdal’s actual risks; and his medical and legal injuries all occurred in Wisconsin,” President Judge Emeritus Kate Ford Elliott wrote for the Superior Court panel. “Stange also argues that Wisconsin has the greater governmental interests where he is a Wisconsin resident and Wisconsin has a strong interest in regulating the activities of pharmaceutical companies that choose to do business within its borders. Stange contends that Wisconsin’s overriding interest in regulating corporate entities conducting business there and punishing outrageous behavior is greater than New Jersey’s interest in maintaining the profitability of its pharmaceutical industry.”
Judge Jack Panella concurred, and the third member of the Superior Court panel, Judge Alice Beck Dubow, did not participate in the consideration or decision of the case.