Sun, Jan 17, 2010 page11

• US files lawsuit against J&J over drug kickbacks

  • BLOOMBERG
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  Johnson & Johnson (J&J) paid kickbacks to Omnicare Inc to push prescriptions for its antipsychotic drug Risperdal for elderly patients, the US said on Friday in a lawsuit.

  The US said J&J and two subsidiaries paid millions of dollars to induce Omnicare, the largest US pharmacy for nursing home patients, to buy and recommend J&J drugs including Risperdal. The government alleges that J&J knew doctors accepted Omnicare pharmacists’ recommendations more than 80 percent of the time.

  “Kickbacks such as those alleged here distort the judgment of health care professionals and put profits ahead of sound medical treatment,” said Tony West, assistant attorney general for the Justice Department’s civil division.

  The drugmaker viewed Omnicare’s pharmacists as “an extension of [J&J’s] sales force,” the US said, quoting an internal document.

  From 1999 to 2004, J&J used various forms of kickbacks “including market share rebate payments conditioned on Omnicare engaging in ‘active intervention’ programs for J&J drugs,” the US said in its complaint filed on Friday in federal court in Boston. These payments “were ostensibly for the purchase of Omnicare data, and various ‘grants’ and other payments, all of which J&J intended to induce Omnicare to purchase and to recommend J&J drugs.”

  Last month the government joined two lawsuits filed previously by whistleblowers.

  “We are reviewing the complaint filed today [Friday] and will address the government’s lawsuit in court,” Jeff Leebaw, a J&J spokesman, said in an e-mailed statement. “We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.”

  As a result of kickbacks during these years, “Omnicare engaged in intensive efforts to convince physicians to prescribe J&J drugs and Omnicare’s annual purchases of J&J drugs increased from approximately US$100 million to over US$280 million, with annual purchases of Risperdal alone rising to over US$100 million,” the US said.

  Omnicare, based in Covington, Kentucky, agreed on Nov. 3 to pay US$98 million to settle civil allegations by the US government and various states that it took kickbacks from J&J. Omnicare, which didn’t admit liability, entered into a five-year corporate integrity agreement as part of the settlement.

  Meanwhile, J&J expanded on Friday a Tylenol recall after US federal authorities warned the company was being too slow in dealing with a public health threat.

  The expanded recall covers the pain reliever and other over-the-counter drugs sold in the Americas, the United Arab Emirates and Fiji.

  McNeil Consumer Healthcare, a unit of J&J, said it was voluntarily recalling about 500 lots of the products, which include pain relievers Tylenol, Motrin and St Joseph, a children’s aspirin.

  The company already had recalled last month all lots of a type of Tylenol product in response to consumer complaints of a foul odor that in some cases had prompted “non-serious” gastrointestinal disorders including vomiting and diarrhea.

  McNeil said an investigation had shown the “unusual moldy” odor is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).

  “This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials,” the company said. “The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature.”
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