Feds, J&J Agree to $2.2 Bil. Settlement in Risperdal Suit

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The assistant U.S. attorneys who worked on the case in the Eastern District of Pennsylvania were Charlene Fullmer, Mary Catherine Frye, Albert Glenn and Scott Cullen.

Regarding the conduct of the drug companies, Stephen Sheller of Sheller P.C. said, "They targeted children and the elderly."

Sheller represents Starr and has separate cases related to Risperdal's effects on children, allegedly causing boys to develop breasts, currently pending. One of those children was giving a deposition in his office when the Risperdal settlement was announced Monday.

Thomas Sheridan of Sheridan & Murray, who represented Barry, said that the size of the settlement was possible largely because of the volume of sales for Risperdal, which, he said, was at one point the leading antipsychotic drug on the market.

Sales for the drug approached $2 billion in one year, he said, explaining that companies typically get limited approval for their drugs—like the FDA's approval for Risperdal in the relatively small schizophrenia market—so they try to capture pieces of other drug markets through promotion of off-label uses.

Barry had contributed evidence that the sales goals set by the company for the drugs went beyond what would be possible from the schizophrenia market share, according to Sheridan. What was striking about this case, Sheridan said, was that the pharmaceutical company marketed the off-label uses for its drug to the "most vulnerable members of society."

Johnson & Johnson has also agreed to go into a corporate integrity agreement, or CIA, with the U.S. Department of Health and Human Services.

"Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct," according to a release from the Department of Justice.

"The CIA also requires J&J's pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J's independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations," it says.

Janssen is expected to plead guilty to one count of introducing misbranded Risperdal into interstate commerce in front of U.S. District Judge Timothy J. Savage on Thursday morning.

Saranac Hale Spencer can be contacted at 215-557-2449 or sspencer@alm.com. Follow her on Twitter @SSpencerTLI.

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