Reuters<\/font><\/strong>
By Margaret Cronin Fisk
Apr 13, 2012<\/div>\n
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Gorsky was named in February to take over April 26 as J&J’s CEO, succeeding Bill Weldon. Gorsky, who had been vice president of sales and later president of J&J’s Janssen unit, has “relevant knowledge” concerning the division’s marketing to Omnicare, attorneys for the U.S. said in court papers April 11. This includes “knowledge about various allegedly illegal payments that J&J made to induce Omnicare to purchase and recommend Risperdal,” the U.S. said. The company said it wouldn’t make Gorsky available for a deposition, calling the request “nothing more than a fishing expedition,” according to a March 26 letter sent to the Justice Department. J&J has argued that payments to Omnicare were allowable rebates and not illegal kickbacks. <\/p>\n
“Mr. Gorsky has no reasonable connection to the subject matter of the government’s complaint and was not involved with the facts underlying this case,” attorney Robert D. Keeling, of Sidley & Austin, said in the letter. The request for Gorsky’s testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive.” While with Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare [or members of Janssen’s own sales staff] that, in January 1999, the Food and Drug Administration had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the U.S. said in the April 11 filing. The company declined to comment because it is pending litigation, Bill Price, a J&J spokesman, said in an e-mail today…<\/sup><\/div>\n<\/blockquote>\n
\nFeds To J&J: Cough Up Alex Gorsky… Now!<\/font><\/strong><\/u><\/a>
Pharmalot<\/font><\/strong>
By Ed Silverman
April 13th, 2012<\/div>\n<\/p>\n
Once again, Johnson & Johnson and the federal government are locking horns. The latest instance is an attempt by the feds to compel Alex Gorsky, who is about to succeed the embattled Bill Weldon as ceo of the health care giant, to provide a deposition in a widely publicized kickback case involving the Omnicare nursing home pharmacy. For those who may not recall, J&J is denying claims in a whistleblower lawsuit<\/font><\/a><\/strong><\/u>, which was joined by the US government, that charges Omnicare received kickbacks – in the form of rebates, educational grants and payments for marketing data – so the Risperdal antipsychotic would be prescribed more often. The lawsuit also alleged J&J’s Janssen unit hid the payments from Medicaid to avoid reporting a ‘best price’ that would have triggered rebates to the agency…<\/p>\nSo the feds want to quiz Gorsky about his dealings with Omnicare and his knowledge of how J&J marketed Risperdal to the nursing home pharmacy, starting in the late 1990′s. And the feds contend that, unlike the lawyers who had difficulty recalling certain key details and interactions, Gorksy should know a thing or two. J&J argues that Gorsky “has no reasonable connection to the subject matter of the government’s complaint and was not involved in the facts underlying this case.” But the feds point out that he was the go-to guy when it came to Omnicare and Risperdal, and no one else possesses the same level of knowledge. <\/p>\n
From October 1998 to October 2001, Gorsky was Janssen’s vp of marketing, and from October 2001 to early 2003 he was the Janssen president, the feds note in court papers. During that time, he was responsible for selling Risperdal, and Omnicare was the biggest Risperdal customer. Moreover, according to his resume, Gorsky instituted a Janssen compliance program for regulatory and legal issues. He also regularly received monthly reports on J&J’s Long Term Care Group, including reports which had details about Omnicare efforts to promote Risperdal prescribing of Risperdal. And Gorsky met repeatedly with senior Omnicare execs to discuss those efforts.<\/p>\n
And this is the crucial part: “As vice president of marketing, and having previously worked closely with J&J’s Medical Development group [which was responsible for developing clinical trial data for Risperdal], he was in a position to know why J&J chose not to inform Omnicare [or members of Janssen’s own sales staff] that, in January 1999, the Food & Drug Administration had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading because the drug had not been adequately studied in that population,” the feds write. “Likewise, he was in a position to know why J&J did not disclose to Omnicare executives that, in 1999, the FDA had rejected J&J’s attempt to get approval to market Risperdal for treatment of psychotic and behavioral disturbances in dementia [by far, the most prevalent use of Risperdal in Omnicare-served nursing facilities] because of inadequate safety data” [here is the motion<\/font><\/a><\/strong><\/u> filed by the feds to depose Gorsky]…<\/sup><\/div>\n<\/blockquote>\n
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