Confirming recent statements by Department of Justice
("DOJ") and Food & Drug Administration
("FDA") officials that the government will increasingly
target individual executives for criminal prosecution, DOJ has
indicted a former Associate General Counsel for pharmaceutical
giant GlaxoSmithKline ("GSK") on two counts of
obstruction of justice and four counts of making false statements
during an FDA investigation.
The indictment – filed on November 9, 2010 in the
District of Maryland, where the FDA's main offices are located,
but brought by the United States Attorney's Office for the
District of Massachusetts – alleges that the in-house
lawyer obstructed an FDA investigation into whether GSK promoted
its anti-depressant Wellbutrin for off-label purposes. While the
indictment does not specifically name GSK or the drug, a GSK
spokesperson confirmed that the in-house lawyer, Laura Stevens, was
a former employee. According to the indictment, Stevens authored
several letters during the investigation denying that GSK promoted
Wellbutrin for off-label purposes, despite allegedly knowing that
the company had sponsored events at which Wellbutrin was improperly
marketed. The indictment further alleges that Stevens failed to
provide the FDA with slides used by physicians to promote
Wellbutrin, despite committing to produce them. Instead, Stevens
allegedly concluded that the slides were "incriminating"
and informed the FDA that GSK's production was
"final" and "complete."
Stevens has denied liability. The obstruction charges each carry a
maximum penalty of 20 years imprisonment and the false statement
charges each carry a maximum penalty of 5 years imprisonment. The
indictment is unrelated to the $750 million settlement that GSK
announced on October 26, 2010.
This case is an example of the FDA's and DOJ's recent
coordinated interest in prosecuting individual executives for
corporate misconduct. At the Annual Food and Drug Law Institute
Enforcement Conference last month in Washington, DC, many speakers
discussed the focus on prosecutions of individuals, including
strict-liability prosecutions of responsible corporate officials
under the so-called Park doctrine (United States v. Park,
421 U.S. 658 (1975)), even if there is no proof that the employee
directly participated in or knew of the violations.
Commenting on the Stevens indictment, Tony West, Assistant Attorney
General for the Civil Division of the DOJ, forewarned that,
"Where the facts and law allow, the Justice Department will
pursue individuals responsible for illegal conduct just as
vigorously as we pursue corporations." The indictment is
undeniable proof that DOJ believes individual prosecutions are
necessary to deter corporate wrongdoing, and is no longer content
to obtain convictions solely against entities. It is also further
warning that, like the Martha Stewart and Scooter Libby cases, the
government will prosecute individuals for obstructing
investigations with the same zeal that it pursues the underlying
violations.
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