Pharmaceutical

Risperdal makers attempt to discredit former FDA chief in gynecomastia lawsuit

risperdal Risperdal makers attempt to discredit former FDA chief in gynecomastia lawsuitJohnson & Johnson attorneys attempted to discredit former Food and Drug Administration (FDA) chief who testified against the company in a lawsuit claiming its antipsychotic drug Risperdal causes adolescent boys to grow breasts.

Former FDA Commissioner David Kessler testified in front of a Philadelphia jury last week in the gynocomastia lawsuit saying, “What (Johnson & Johnson and its subsidiary Janssen Pharmaceuticals) want to convey here, as you see in their own words, doesn’t match what the data show and, to me, that’s not telling the whole story, especially when you’re talking about adverse events that are significant.

“The one thing you have to do when you’re dealing with all medicines, including very powerful ones, is to tell the truth. You tell the whole truth, you tell the whole story, and you make sure the data support what you are saying,” he added.

Kessler was called as an expert witness by attorneys for the Pleger family, who claims their autistic son took the drug for several years and developed gynecommastia, a condition in which boys and young men develop breasts. The Pledgers claim that Johnson & Johnson and Janssen knew the drug could cause an imbalance of hormones that could result in gynecomastia but they failed to warn doctors or patients of this risk.

Gynecomastia is a devastating condition for adolescent boys. Treatment generally involves surgeries to remove the breast tissue such as liposuction or mastectomy.

In an attempt to squash the damning testimony Kessler provided, Johnson & Johnson attorneys claimed Kessler was a biased witness bent on discrediting drug makers.

Kessler has served as an expert witness for plaintiffs in several lawsuits involving drug side effects including ones against the now-withdrawn painkiller Vioxx, and the type 2 diabetes drug Actos.

Source: Fierce Pharma