Prosecutions of Pharmaceutical Companies
for Off-Label Marketing:
Fueled By Government’s Desire to Modify
Corporate Conduct or Pursuit of a Lucrative
Lise T. Spacapan* & Jill M. Hutchison**
It has been estimated that health care fraud and abuse costs the federal
government tens of billions of dollars every year.1 Admirably, government
officials actively root out fraud and aggressively seek penalties to recoup
some of the dollars lost on fraudulent expenditures. Hundreds of civil and
criminal investigations are currently ongoing against the health care
industry brought by the federal government, along with associated
investigations by state attorneys general.2 Recently, Attorney General Eric
Holder stated during the National Summit on Health Care Fraud that:
In 2009, the Justice Department reached an all-time high in the number of
health care fraud defendants charged, more than 800. We also obtained
more than 580 convictions. And on the civil enforcement front, our health
care fraud recoveries last year under the false Claims Act exceeded a
stunning $2.2 billion dollars.3
In this environment, it is becoming almost commonplace for large
pharmaceutical companies to settle single fraud and abuse cases brought by
Lise Spacapan is a partner in the Chicago office of Husch Blackwell LLP.
** Jill Hutchison is a partner in the Chicago office of Jenner & Block LLP.
1. Donald M. Berwick & Andrew D. Hackbarth, Eliminating Waste in US Health Care,
307 JAMA 1513, 1514 (2012). In this April 2012 study, former CMS Administrator Donald
M. Berwick and RAND Corporation analyst Andrew D. Hackbarth estimated that fraud and
abuse added as much as $98 billion to Medicare and Medicaid spending in 2011.
3. Eric Holder, U.S. Attorney General, Speech at the National Summit on Health Care
Fraud (Jan. 28, 2010), available at http://www.justice.gov/ag/speeches/2010/ag-speech-
100128.html (emphasis added).