Wall Street Journal, November 10, 2010
by Peter Loftus of Dow Jones Newswires
Johnson & Johnson (JNJ) said it’s in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal.
“Discussions are ongoing in an effort to resolve potential criminal and civil litigation arising from these matters,” J&J disclosed in a regulatory filing Wednesday. “Whether a resolution can be reached and on what terms is uncertain.”
J&J spokesman Jeff Leebaw declined further comment.
Risperdal, which is approved to treat schizophrenia and bipolar disorder, was once J&J’s best-selling drug, with global sales of about $4.9 billion in 2007, according to IMS Health, before its oral formulation lost patent protection and cleared the way for generic competition.
J&J has previously disclosed government inquiries regarding Risperdal and later, a newer antipsychotic, Invega, but hadn’t previously said it was in talks for a settlement.
In 2004, the Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena seeking documents regarding sales and marketing of Risperdal, as well as payments to physicians and clinical trials for the drug, from 1997 to 2002.
The U.S. Attorney’s Office in Philadelphia sent an additional subpoena in 2005, seeking information about Risperdal marketing and adverse reactions associated with the drug. Grand jury subpoenas have been issued seeking testimony from various witnesses.
Earlier this year, J&J, of New Brunswick, N.J., disclosed the government had served civil investigative demands seeking additional information about the marketing of Risperdal and Invega.
Other makers of popular antipsychotics have settled government probes of marketing practices in recent years. In April, AstraZeneca PLC (AZN) agreed to pay about $520 million to resolve Justice Department allegations that it promoted Seroquel off label, or for uses not approved by the Food and Drug Administration.
Last year, Eli Lilly & Co. (LLY) agreed to pay more than $1.4 billion and pleaded guilty to a criminal charge, admitting it promoted the antipsychotic Zyprexa for off-label uses including treatment of dementia in the elderly.
The drugs also have been linked to safety risks, including increased risk of death if used by elderly patients with dementia-related psychosis, as well as weight gain.
Several U.S. states have filed lawsuits against J&J seeking reimbursement of Medicaid funds used to pay for off-label uses of Risperdal, as well as compensation for treating beneficiaries for alleged adverse reactions to the drug.
In October, a jury in Louisiana awarded the state $257.7 million after concluding that J&J minimized the drug’s risk of causing weight gain leading to diabetes. J&J said it would appeal the verdict because the jury wasn’t properly told of applicable legal standards, and certain evidence was excluded. J&J said it didn’t violate the law.
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