Bloomberg News

Abbott in Settlement Talks on Depakote Marketing, U.S. Says

June 02, 2011

(Updates with company comment in fifth paragraph.)

June 2 (Bloomberg) -- Abbott Laboratories and the U.S. are “engaged in active settlement discussions” of the government’s lawsuit alleging the company improperly marketed its drug Depakote, Justice Department lawyers said in court papers.

The U.S. asked the judge overseeing the suit to halt proceedings until July 8, postponing a May 31 scheduled filing of an amended complaint by the government and allowing settlement discussions to continue. The U.S. also asked the court to consolidate four related false-claims cases.

“The short extension would allow the parties to determine if a negotiated resolution is possible, which could reduce the demand on judicial resources,” Timothy Heaphey and Daniel Bubar, Justice Department lawyers, wrote in a May 20 filing in federal court in Abingdon, Virginia. “Consolidating the actions would avoid having nearly identical filings made in four different actions.”

Whistleblowers claim in the suits that Abbott Park, Illinois-based Abbott marketed Depakote, an epilepsy drug, for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders. The government joined the False Claims Act suits in February, according to court dockets. More than 25 states also sued Abbott over the marketing of Depakote.

“We continue to cooperate with the investigation,” Scott Stoffel, a spokesman for Abbott, said today in a phone interview.

Approved Uses

Depakote is approved to prevent migraines, treat acute manic episodes in bipolar patients and treat seizure disorders in adults and children, he said in an e-mail.

The company promoted the medicine for “unapproved, off- label uses in long-term care facilities, assisted-living facilities, mental retardation/developmentally disabled facilities and other like facilities” throughout the U.S., according to the complaint.

Abbott “knowingly disregarded federal law” and Food and Drug Administration rules on off-label promotion and “‘knowingly misrepresented the evidence concerning the efficacy and safety of the off-label uses” of Depakote, the U.S. said in its complaint filed in February.

“These false claims cheated the federal and state governments out of hundreds of millions of dollars,” the U.S. said.

Under U.S. law, a doctor can prescribe a medicine for any condition as long as it’s licensed by the FDA and proven safe and effective against at least one ailment. Drug companies aren’t allowed to promote a drug for uses other than those approved.

The case is U.S. ex rel. Spetter v. Abbott Laboratories, 1:10-cv-00006, U.S. District Court, Western District of Virginia (Abingdon).

--Editors: Fred Strasser, Stephen Farr

To contact the reporter on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.


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