Did Johnson & Johnson Conceal Risperdal Test Results From The Public?
Written by Stephen Fields on December 24, 2014
Pharmaceutical giant Johnson & Johnson is no stranger to lawsuits claiming that it employs aggressive marketing practices to the point of violating consumer fraud laws. Nor is it a stranger to allegations that some of its drugs, such as Risperdal, expose users to inadequately-disclosed side effects. To that end, recent Risperdal litigation has seen J&J paying billions of dollars in settlements to victims, their families, and the U.S. Department of Justice (DOJ).
According to Johnson & Johnson’s 2013 annual report,1 the company is still facing approximately 500 Risperdal lawsuit claims. Plaintiffs have accused the drugmaker of failing to adequately warn them about the antipsychotic’s risks. For example, numerous Risperdal lawsuit claims allege that use of the drug caused the claimants to experience male breast growth, a condition known as gynecomastia.
In late 2013, J&J reached a $2.2 billion settlement with the Department of Justice. A press release from the agency noted that the amount constituted “one of the largest health care fraud settlements in U.S. history.” In addition, the investigation that preceded it uncovered evidence that the drugmaker may have hid clinical test results from the public nearly a decade ago.
$2.2 Billion Risperdal Settlement Reveals Hidden Test Results
The aforementioned DOJ complaint that resulted in a multi-billion dollar settlement was filed against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals.2 One of the many accusations made in the complaint was that Janssen had concealed clinical trial data involving the use of Risperdal to treat elderly patients with dementia. To wit, a 2003 study, referred to in the complaint as RIS-USA-232, had demonstrated an increased risk of cerebrovascular adverse events (CVAEs).
The company filed a non-public safety report with the Food and Drug Administration (FDA) in June 2003 that included results from RIS-USA-232. In March of the following year, Janssen also began to include the results in information packets requested by doctors. However, throughout 2004, it continued to send information to doctors and sales representatives that made no mention of RIS-USA-232 or its findings.
In March 2004, a physician who had been involved in the 2003 clinical trial sent a memo3 to Janssen executives noting that the company had not yet released the study’s results. He stated, “At this point, we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings from RIS 232.”
Families Are Unaware Of The Risperdal And Gynecomastia Risk
RIS 232 focused on the adverse effects of Risperdal observed in elderly patients with dementia. More recent concerns have focused on allegations that use of J&J’s antipsychotic Risperdal causes gynecomastia in men and young boys.
Research dating back to the late 1990s has shown that Risperdal therapy may be linked to an increased risk of male breast growth. A study published in the journal Pharmacopsychiatry in 1999 noted that gynecomastia may be a side effect of the drug.4 According to the study’s author, the effect stemmed from increased prolactin levels caused by the drug’s blockage of D2 dopamine receptors.
In 2006, a study in the Journal of Clinical Psychopharmacology found that use of Risperdal led to elevated prolactin levels in adolescents.5 The researchers posited that the effect could cause gynecomastia and galactorrhea (spontaneous lactation).
Unfortunately, the families of many young boys who are taking Risperdal remain unaware that the drug may be linked to an increased risk of gynecomastia. According to a growing number of lawsuits, neither Johnson & Johnson nor Janssen Pharmaceuticals have made the risk sufficiently clear.
Should You File A Risperdal Gynecomastia Lawsuit?
As more research surfaces demonstrating the possible link between Risperdal and male breast growth, the number of lawsuits targeting the manufacturers is expected to rise.
If you or your child developed gynecomastia after using Risperdal, you can hold the manufacturers accountable. Call 1-888-210-9968 for a free, no-obligation consultation. Find out today whether you are eligible to pursue a Risperdal lawsuit settlement that can help compensate you for your pain and suffering.
1. Johnson & Johnson Annual Report 2013
2. United States’ Complaint in Intervention
3. Exhibit 9, Redacted
4. Gynecomastia with risperidone-fluoxetine combination
5. Risperidone-induced symptomatic hyperprolactinaemia in adolescents