Janssen Pharmaceuticals, a subsidiary of healthcare giant Johnson & Johnson, has been accused of illegally marketing and omitting safety data on its blockbuster antipsychotic drug Risperdal, according to an authoritative new exposé published in the Huffington Post.
Free Risperdal Lawsuit Evaluation: If you or a loved one developed male breast growth (gynecomastia) after taking Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Huffington Post Introduces 58,000 Word ‘DocuSerial’
September 15, 2015 – Journalist and media entrepreneur Steve Brill today unveiled the first chapter of a 15-part “DocuSerial” titled “America’s Most Admired Law Breaker” on HuffingtonPost.com. The sweeping analysis details how pharmaceutical giant Johnson & Johnson violated FDA restrictions in its marketing and sale of its massively successful antipsychotic medication Risperdal (generic: risperidone).
“My goal in doing this was to demonstrate that digital media can propel long-form substantive journalism rather than threaten it. And the best way to think of it is a different way to publish a nonfiction book, not just as a long magazine article that’s not printed,” Brill said.
Risperdal Background Information
Risperdal is one of only two drugs on the U.S. market approved to treat autism. It was originally developed as an antipsychotic medication for adults with schizophrenia in 1993.
At the time of its approval, Risperdal was determined to be unsafe for prepubescent children because it can increase levels of the hormone prolactin, which can cause a number of serious side effects including the abnormal breast growth in males, a condition called gynecomastia.
Janssen Backed Study Finds No Link Between Risperdal and Gynecomastia
A 2003 study published in the Journal of Clinical Psychiatry failed to identify a link between Risperdal and gynecomastia or other side effects that could have been caused by elevated levels of prolactin. As a result, the U.S. Food & Drug Administration (FDA) in October 2006 approved Risperdal for easing irritability in autistic children, which may manifest in the form of aggressive outbursts; however, the agency acknowledged that the drug could potentially cause serious side effects, including severe weight gain.
J&J Pays $2.2 Billion to Settle Illegal Marketing Allegations
In 2013, Janssen settled a lawsuit brought by the FDA for $2.2 billion, one of the largest penalties ever levied against a corporation for healthcare fraud. The complaint alleged that in 2002 and 2003, the company aggressively marketed Risperdal for use in autistic children and other “off-label” or unapproved uses. Janssen agreed to pay criminal fines totaling $485 million, as well as another $1.72 billion to settle civil lawsuits with the federal government and 45 states.
Autistic Man Awarded $2.5 Million After Developing Gynecomastia from Risperdal
A large number of individual lawsuits followed the 2013 settlement, including one filed on behalf of Austin Pledger, a 20-year-old autistic man who grew size 46DD breasts after taking Risperdal as a child, according to the Wall Street Journal. In February 2015, a Philadelphia jury awarded Pledger $2.5 million. The case was the first to go to trial alleging that J&J hid the risks of gynecomastia associated with Risperdal after other such complaints were settled out of court.
The Boy with 46-DD Breasts: HuffPost Highline Video
Trial Evidence Indicates J&J Hid Risperdal Study Results
Documents used as evidence against Janssen in the Pledger case included an early manuscript of the 2003 study that includes 2 data tables missing from the published version. The study was designed to ferret out potential adverse effects of long-term risperdal use, according to MedPage Today.
A research team led by Janssen analyzed data on 700 children who were prescribed risperidone. They reported that prolactin levels were elevated in the children over the first 2 months of treatment, but returned to normal after 5 months.
The researchers reported some incidences of what they referred to as “side effects hypothetically attributable to prolactin,” or SHAP, which included gynecomastia; nevertheless, the study concluded that “there was no direct correlation between elevated prolactin and SHAP.”
However, data in the tables introduced in the Pledger lawsuit contradicts this assertion, indicating a statistical correlation between elevated prolactin levels and the side effects. According to an article published New Brunswick Today, a Janssen biochemist testified that these tables were never submitted to the FDA.
Do I Have a Risperdal Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal lawsuits. We are handling individual litigation nationwide and currently accepting new gynecomastia cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one suffered an injury you feel may have been caused by Risperdal side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a Risperdal Suit and our lawyers can help.