Please login to the form below

Not currently logged in
Email:
Password:

J&J hit by $8bn judgment for man claiming breast growth due to Risperdal

Company will appeal the verdict, but there are other lawsuits pending

Johnson and Johnson logo

Johnson & Johnson has been ordered to pay $8bn in damages to a US man who claims he was not warned that taking the company’s antipsychotic Risperdal could lead to breast growth.

A jury in Philadelphia agreed with the allegation that J&J’s Janssen unit had downplayed the risk that use of Risperdal (risperidone) in male children can cause enlarged breasts, a condition known as gynaecomastia.

J&J has said it will appeal the verdict, which comes from just one of thousands of lawsuits claiming damages for gynaecomastia caused by Risperdal, saying the size of the payout is “grossly disproportionate”.

It also said it had been prevented from presenting “key evidence” to the jury that would have shown how Risperdal’s label outlined the risks of the drug. Other lawsuits are pending in Pennsylvania, California and Missouri.

26-year-old Nicholas Murray started taking Risperdal as a child in 2003 after being diagnosed with autism spectrum disorder. Risperdal isn’t approved for that use, but was prescribed off-label – something that is legal based on physician judgment.

Murray was originally awarded $1.75m in damages in 2015, but that was reduced to $680,000 after an appeal last year that upheld the original verdict.

J&J says the award for a single plaintiff “is a clear violation of due process [and] US Supreme Court precedent dictates that punitive damages awards that are a double-digit multiplier of the compensatory award should be set aside”.

Risperdal’s link to gynaecomastia is well established, and the lawsuits against J&J pivot on whether the company failed to warn of the risks and inappropriately marketed the drug for off-label use in children.

Risperdal-associated breast growth generally goes away after a person discontinues use of the drug, although some cases do not resolve despite stopping treatment.

J&J has been hit with serial lawsuits claiming damages in the last few years, with cases involving asbestos in talc, hip replacement and vaginal mesh products, and opioid drugs all working their way through the courts.

In August the company was ordered to pay $572m following a legal verdict which found it responsible for fuelling the opioid crisis in the US state of Oklahoma, and last month J&J agreed a $20m settlement of similar allegations in Ohio.

Article by
Phil Taylor

9th October 2019

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Novasecta

We are a specialist strategy consulting firm for pharmaceutical and biotech companies. We help our clients to achieve significant performance...

Latest intelligence

Tapping the potential of rare diseases: A journey into uncharted territory
...
The 2019 WHO essential medicine list: Narrowing the access gap to innovative cancer treatments
The essential medicine list (EML) contains treatments considered to be the most effective and safe in targeting global health concerns. On 9 July 2019, the World Health Organization (WHO) published...
NICE
Evolution or revolution: the latest review of NICE methods
By Leela Barham...

Infographics