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Former FDA Commissioner Might Testify Against J&J in Risperdal Case

Company Accused of Inappropriate Sales Tactics Related to Antipsychotic Drug That Allegedly Has Harmful Effects
David Kessler
David Aaron Kessler Justin Hoch

PHILADELPHIA, PA–In a lawsuit against Hub City drugmaker Johnson & Johnson (J&J), former Food and Drug Administration (FDA) Commissioner David Kessler may testify against the company, Philly.com’s David Sell reports.

Kessler served as FDA Commissioner from 1990 through 1997, under Presidents George H.W. Bush and Bill Clinton.

The ongoing trial, related to the antipsychotic drug Risperdal, made by J&J's Janssen Pharmaceuticals division, is being heard in Philadelphia Court of Common Pleas.

It is not the first case involving the drug, which has proven to be a headache for the embattled company.

“Prosecutors have accused J&J and Janssen of hiding the risks associated with Risperdal... Side effects can include weight gain, an increased risk of diabetes and, in older patients, and increased risk of stroke,” reads a 2012 New York Times report.

As we reported, J&J has been accused of promoting the drug for unapproved uses. The company eventually agreed to pay a $2.2 billion penalty in a federal case.

Thomas Melsheimer, a lawyer who represented a whistleblower in a Texas case regarding Risperdal, told the Times that J&J was trumpeting Risperdal as a miracle breakthrough drug.

But, he said that it was no better than cheaper generic alternatives.

“[Risperdal] is grossly overpriced in relation to its qualities,” he said.

Many teenage boys developed large breasts, a condition known as gynecomastia, after being prescribed Risperdal for various reasons.

In 2012, Sell was in a Common Pleas court room, in a previous gynecomastia case.

However, in that case, J&J settled before Kessler took the stand, but his 92-page expert report, which is critical of the drugmaker, came to light as part of J&J's motion to preclude him from testifying, according to Philly.com.

"In my opinion," Kessler wrote in the report, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug and Cosmetic Act.”

The report adds: "The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning."

"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling,’"

“I think it’s part of a bigger picture of a growing intolerance of pharmaceutical companies ignoring the rules of the road,” attorney Erika A. Kelton told the Times.  

J&J settled four so-called "bellweather" Risperdal cases on October 4, 2012.

At that time, Philly.com asked the plaintiffs' attorney, Stephen Sheller, "if the prospect of Kessler testyifying against [J&J] prompted it to offer enough to settle," and Sheller said, "Yes," according to their coverage.