Tag: gynecomastia

Fierce Pharma reports: "Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and...

On Monday, the US Supreme Court declined to hear Johnson and Johnson’s final appeal, forcing the company to pay $124 million for the deceptive marketing of the antipsychotic Risperdal. In 2011, South Carolina ordered the company to pay $327 million for pursuing “profits-at-all-costs” in its efforts to persuade doctors to prescribe their drug, but the fine was lowered to $136 million last year. The company had hoped to argue that the remaining penalties constituted an “excessive fine” and was supported by PhRMA, the Washington Legal Foundation, the Cato Institute and the Chamber of Commerce.

In the third major verdict of its kind, drug giant Johnson & Johnson was ordered to pay a Maryland man who grew female breasts while taking the antipsychotic Risperdal. The company failed to warn doctors, patients, and regulators of the risk of abnormal breast development in young males and now faces about 5,400 lawsuits involving the drug.

Johnson & Johnson is exposed to personal injury and product liability lawsuits over the failure to warn about Risperdal gynecomastia side effects in boys.

Huffington Post and journalist Steve Brill have combined to launch a 15 part series about how Johnson & Johnson illegally violated FDA restrictions by pushing the antipsychotic drug, Risperdal, for use with adolescents and the elderly. The series, entitled “America’s Most Admired Lawbreaker,” launched yesterday and will include mixed media, videos, podcasts, source documents, as well as 15 written chapters. Click more for a synopsis of part 1.

MedPageToday reports that Janssen Pharmaceuticals omitted data from a 2003 study that connected Risperdal with serious side effects. Janssen was previously sued by the FDA for marketing Risperdal for off-label uses and settled for $2.2 billion in 2013. Earlier this year, a man with autism was awarded $2.5 million after growing breasts while on Risperdal. According to MedPage, documents from this latest case reveal missing data tables from a 2003 study “designed to ferret out potential adverse effects of long-term risperidone use.” The missing tables were related to elevated prolactin levels and side effects, including gynecomastia in men.

As I wrote in Let’s All Support Stephen Sheller’s FDA Petition to Revoke the Pediatric Approval of Risperdal, Stephen Sheller's law firm, which represents hundreds of boys who were prescribed Risperdal and then grew breasts (gynecomastia) as a result, filed a petition with the Food and Drug Administration (FDA) to change the label and revoke its approval for use on children. During the course of discovery for litigation in its Risperdal cases, Sheller became privy to documents not provided to the FDA that showed Johnson & Johnson hid the problem. This is a very important case. If it is successful, it will give hope of forcing the FDA to follow its mandate to protect the public from harmful drugs.