Regulatory Focus™ > News Articles > J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner

J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner

Posted 05 October 2012 | By

Even after stepping down from his position as head of the US Food and Drug Administration (FDA), former Commissioner David Kessler seems to be having a strong impact on the fortunes of some pharmaceutical companies.

Kessler had been called on to testify on behalf of litigants in a series of trials set to be heard in a Pennsylvania court room the week of 8 October regarding Johnson & Johnson's marketing of its antipsychotic drug Risperdal (risperidone). Litigants have charged the company with improperly marketing the drug for indications not approved by the FDA, and have alleged that taking these products for off-label uses subsequently caused the litigants-all male-to develop excessive breast tissue.

The deposition and testimony of Kessler, head of FDA from 1990 to 1997, was already the subject of wide media coverage after a 92-page report he authored was released to the press. For J&J, Kessler's report was anything but flattering.

Kessler said in his opinion the company had marketed Risperdal for, "Non-approved uses in violation of the Federal Food, Drug and Cosmetic Act," and said the company's actions undercut FDA's ability to safeguard consumers from unnecessary harm. This promotion "is concerning," said Kessler.

Added Kessler: "The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning. The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning. Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."

For J&J's lawyers, the presence of Kessler may have proved to be too risky a venture. On 4 October, the company announced it had settled all five cases for undisclosed sums, and continued to deny its involvement in off-label marketing activities.

"During the time that it was actively promoted, our company policy was to promote Risperdal for its FDA-approved indication," a spokeswoman for Janssen, the J&J subsidiary which marketed the drug, said in a statement. "Since the early 1990s, Risperdal has improved the lives of countless people throughout the world who suffer from the devastating effects of serious mental illness."

The company has previous settled similar suits, including a massive $181 million settlement announced in August 2012 between it and 37 states. Janssen said in that settlement that it did not admit wrongdoing, but "reaffirmed it would not promote any of its atypical antipsychotics for off-label uses or make any false or misleading claims related to those products."

J&J still faces approximately 400 lawsuits related to Risperdal.

Read more:

Philadelphia Inquirer - Johnson & Johnson settles five Risperdal suits

Bloomberg - Johnson & Johnson Agrees to Settle Five Rispersal Suits

Pharmalot - Former FDA Commish Slams J&J Over Risperdal

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