May 7, 2012 -- Oregon Attorney General John Kroger today announced a $100 million multistate agreement with global health care and medical
research company Abbott Laboratories over off-label promotional claims
related to its drug Depakote®. This agreement marks the largest ever
consumer protection-based pharmaceutical settlement.
“Protecting consumers from drug companies that use unscrupulous sales tactics is a top priority of the Department of Justice,” said Attorney General Kroger.
Oregon organized and co-led the multistate investigation into Abbott’s
promotion of Depakote®, a prescription drug approved by the U.S.
Food and Drug Administration (FDA) to treat seizure disorders, mania
associated with bipolar disorder and migraines. The investigation yielded evidence that Abbott representatives engaged in unfair and deceptive practices when it marketed the drug for uses not approved by the FDA; specifically, schizophrenia, and agitation associated with dementia.
The Complaint alleges that although Abbott could not substantiate its claim that Depakote is effective for the treatment of agitation associated with dementia, or as adjunct therapy with antipsychotics to treat schizophrenia, the company bypassed the regulatory process and actively promoted the drug off-label to treat these indications.
To bolster Depakote schizophrenia sales, Abbott promoted a clinical
trial that was not sufficient for FDA approval but showed Depakote to be
marginally effective for this indication. Subsequently, Abbott conducted a second clinical trial that showed Depakote was ineffective for the treatment of schizophrenia. Nevertheless, Abbott sales representatives allegedly continued to distribute and detail the positive study without disclosing the details of the negative study.
Abbott also allegedly distributed and promoted studies that were weak
evidence that Depakote was effective for treatment of agitation associated with dementia despite the fact that Abbot knew of a stronger study that found Depakote to be ineffective for this indication.
Under the stipulated judgment filed today in Multnomah County Circuit
Court, Abbott Laboratories will pay $100 million to the settling states
and make significant reforms to its marketing practices and cease. As
one of two lead states, Oregon will recover a total of $3, 569,179 under
the settlement. The Department of Justice was also able to negotiate
an additional payment of $283,000 to reimburse the Public Employees
Benefit Board (PEBB), State Accident Insurance Corporation Fund (SAIF), Oregon State Hospital, Oregon Youth Authority and the state Department of Corrections to recover that portion of Depakote purchases by these agencies that were associated with off-label uses.
“We are pleased to participate in efforts to recover these costs. We
know inmate health care is expensive and every dollar we can recover
matters. This settlement is about fiscal responsibility and accountability to taxpayers,” said Department of Corrections Director Colette S. Peters.
In conjunction with the monetary terms of the agreement, the multistate
settlement prohibits Abbott from making false or misleading claims about Depakote and promoting the drug for off-label uses. The company is required to ensure that any financial incentives on sales do not promote off-label uses of Depakote.
For a five-year period, Abbott must also:
- Limit the creation and use of responses to requests by physicians for non-promotional information about off-label uses of Depakote;
- Limit dissemination of reprints of clinical studies relating to off-label uses of Depakote;
- Limit use of grants and continuing medical education and disclose payments to physicians; and
- Register and disclose clinical trials.
Assistant Attorney-in-Charge of the Financial Fraud/Consumer Protection Section David Hart and Senior Assistant Attorney General Lucille Salmony handled this case for the Oregon Department of Justice.
Attorneys General of the District of Columbia and the following states
participated in today’s settlement: Alabama, Alaska, Arizona, Arkansas,
California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.
Attorney General John Kroger leads the Oregon Department of Justice.
The Department's mission is to fight crime and fraud, protect the
environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.
