Dow Jones Newswires | A U.S. judge has ordered Abbott Laboratories (ABT) to hand over to federal prosecutors some its chief executive’s email messages, as part of a federal probe into whether Abbott improperly marketed the anti-seizure drug Depakote for unauthorized uses.
The U.S. Attorney’s Office for the Western District of Virginia is investigating Abbott for “potential federal violations arising out of Abbott’s impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health care fraud arising out of that allegedly improper use,” U.S. District Judge Samuel Wilson wrote in an opinion dated March 10.
Depakote is approved by the U.S. Food and Drug Administration to treat
seizure disorders and acute manic episodes associated with bipolar
disorder, and to prevent migraine headaches, but not for treatment of
agitation and aggression in the elderly.
Drug makers are barred from actively promoting FDA-approved drugs for
unapproved–also known as off-label–uses, though doctors have the
discretion to prescribe off-label. Federal and state authorities have
targeted off-label marketing in recent years because they allege such
activities unduly inflate drug-reimbursement costs for government health
programs such as Medicaid.
Depakote was once one of Abbott’s best-selling drugs, generating nearly
$1.4 billion in sales for 2008, but sales have declined substantially
since generic competition began that year.
The Abbott Park, Ill., company previously disclosed in November that
prosecutors were looking into its marketing of Depakote, but new details
about the nature of the probe recently surfaced due to a dispute
between Abbott and prosecutors over the scope of federal subpoenas.
Prosecutors issued a number of subpoenas for Abbott documents, but
Abbott refused to comply with some because the company deemed them
overly burdensome, according to court documents. The disputed subpoenas
sought all emails sent or received by 13 people from 1996 through 2008,
including CEO Miles White.
The government offered to limit the scope of the subpoenas to the emails
of three people including White, relating to Depakote and potential
off-label marketing of other Abbott drugs.
Abbott, however, argued that complying with the subpoenas would be
prohibitively expensive because it would entail restoring 53 backup
tapes containing emails that were preserved for other litigation,
according to court documents. Abbott also challenged the relevance of
emails related to the off-label marketing of drugs other than Depakote.
In response, the U.S. Attorney’s Office in Abingdon, Va., in January
asked Judge Wilson to order Abbott to comply with the subpoenas.
Judge Wilson on March 10 largely sided with prosecutors, ordering Abbott
to turn over the emails of White and two former Abbott executives:
William Dempsey, who retired as executive vice president of Abbott’s
pharmaceutical products group in 2007, and Jeffrey Leiden, who stepped
down as president and chief operating officer of the pharmaceutical
products group in 2006.
Judge Wilson wrote that the subpoenas, as limited by the government,
weren’t unreasonably burdensome. Also, he concluded that emails related
to alleged off-label marketing of additional Abbott drugs were relevant
to the probe centering on Depakote.
“The government has indicated that it has evidence that the off-label
marketing of other FDA approved drugs may have followed a similar
pattern to the off-label marketing of Depakote,” Wilson wrote. “If this
is so, the off-label marketing of these other drugs may raise the same
related health care fraud issues that the marketing of Depakote raises.”
A spokesman for the U.S. Attorney’s Office in Virginia declined comment.
Abbott spokesman Scott Stoffel said the company continues to cooperate
with the investigation. The former executives, Dempsey and Leiden,
couldn’t be reached for comment.
Abbott shares fell 6 cents to $52.67 Monday.