A major study has concluded that use of Risperdal (risperidone) or Invega (paliperidone, which is an active metabolite of risperidone) can increase the risk for gynecomastia by a staggering 69 percent. Meanwhile, Johnson and Johnson (J&J) subsidiaries Janssen Ortho LLC and Janssen Pharmaceuticals Inc. just last month settled a lawsuit first brought in 2008 by the State of Montana for $5.9 million. In so doing, Janssen was not required to admit to any wrongdoing (State of Montana v. Janssen Ortho, LLC and Janssen Pharmaceuticals, Inc., Montana First Judicial District Court, CDV-2008-164).
The state accused Janssen of concealing dangers associated with Risperdal and illegally promoting the drug off-label. “This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects our citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to our healthcare providers,” said Montana’s Attorney General Tim Fox, in a statement. “[O]n the behalf of Montana’s consumers and taxpayers, a pharmaceutical giant has been held accountable for deceptive marketing practices, and a significant recovery of the State’s public resources has been realized.”
With regard to Risperdal side effects that suggest the possibility of gynecomastia, many a Risperdal lawsuit has alleged the phenomenon. However, studies proving a causal link have been fleeting. It’s for this reason that a major Canadian study, unveiled earlier this month at a conference in Orlando, has made such an impact in both the medical and legal communities.
A “strong association…”
Dr. Mahyar Etminan and his team of researchers at the University of British Columbia (UBC) plowed through a massive database and identified 8,285 men having recently been diagnosed with gynecomastia (mostly older men), against 82,850 men who served as controls in the study with no incidence of gynecomastia.
Etminan ultimately found that 69 was the magic number. To wit, following adjustment for confounding variables, men who used Risperdal or the risperidone metabolite were found to have a 69 percent higher risk for gynecomastia (male breasts) than controls who had not used risperidone. Similarly, risperidone patients had a higher risk for gynecomastia than patients using other anti-psychotics.
“If we put this study in context with everything else we know, we can definitely say there is a strong association between the use of Risperdal and gynecomastia,” says Dr. Etminan, who presented his study at the American Association for Geriatric Psychiatry (AAGP) conference on March 15, 2014 in Orlando.
Meanwhile, in an ongoing lawsuit, defendant Janssen Pharmaceuticals Inc. is trying to escape from paying punitive damages by invoking the laws of New Jersey, the state in which J&J maintains its headquarters. As such, the New Jersey Product Liability Act bars punitive damages for claims related to a drug that was subject to premarket approval or licensure by the US Food & Drug Administration. The Act, Janssen argues, would have jurisdiction over any potential punitive conduct with regard to the marketing of Risperdal given the expectation that such conduct would have occurred at J&J’s two facilities in New Jersey.
As such J&J is looking, according to a motion filed last month, to shield itself from punitive liability. But those plaintiffs in the Risperdal multidistrict litigation alleging gynecomastia aren’t buying it.
Did the deal go down in Pennsylvania?
Responding March 24, the plaintiffs reminded the defendant of those offices Janssen maintains in Pennsylvania, where the Risperdal lawsuit is based. Plaintiffs also claim that Janssen officials often met in their Pennsylvania offices in the late 1990s and early 2000s to undertake discussions over Risperdal marketing strategies.
“Here, Pennsylvania punitive damages law should apply because significant regulatory compliance, pre-approval submissions, labeling and testing for Risperdal were performed by defendants in Pennsylvania,” the plaintiffs responded, according to court records. “Further, plaintiffs have offered extensive evidence demonstrating that wrongful conduct occurred in Pennsylvania, the state of Janssen’s incorporation.”
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However, Janssen has a habit of settling before trials have the chance to start. In September 2012, the pharmaceutical giant settled the first case on the very morning the first trial was scheduled to commence. The second case was settled later that month, about a week into testimony before a jury. On that day, Janssen settled with the remaining four plaintiffs.
The Risperdal side effects cases all alleged gynecomastia (male breasts).