Vol 22, 2013 Annals of Health Law 433
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
subsidiaries allegedly marketed the drug for the treatment of bipolar
disorder, mood and anxiety disorders, and bipolar disorder, as well as other
then-unapproved uses. In 2004, the DOJ began investigating the
company’s off-label promotion efforts.173 In 2011, the company reached an
agreement in principal with the United States Attorney’s Office for the
Eastern District of Pennsylvania to resolve criminal charges of a
misdemeanor violation of the FDCA.174 In 2012, the company then reached
an agreement in principle with the Department of Justice to settle three
pending False Claims Act matters, two of which implicated Risperdal
marketing practices.175 Although neither the company nor the government
has announced a dollar value for these agreements, the company has taken
after-tax charges of $1.7 billion to cover potential legal settlements, and
The Wall Street Journal estimates that the settlement with the federal
government could total as much as $2.2 billion.176
During the course of the DOJ’s investigation, forty states then brought
their own consumer protection or false claims suits against Johnson &
Johnson or its subsidiaries over the allegedly unlawful off-label marketing
of Risperdal. In 2010, claims brought by the Commonwealth of
Pennsylvania in a Pennsylvania state trial court were all dismissed,
including both statutory claims for submission of false and fraudulent
claims and common law claims, and the nonsuit was affirmed in July
2012.177 In August 2012, Johnson & Johnson reached an agreement with
thirty-six states and the District of Columbia to settle their claims for a
combined $181 million.178
In addition to these settlements, Johnson & Johnson has been hit with
sizeable verdicts in several states. In Caldwell ex rel. State of Louisiana v.
Janssen Pharmaceutica,179 Louisiana alleged that the company violated the
174. Id. at 27-28.
175. Johnson & Johnson Form 10-Q Quarterly Report, filed August 2, 2012.
176. Jonathan D. Rockoff and Joann S. Lublin, J&J Penalty May Total $2.2 Billion:
Settlement Over Risperdal Marketing Would Include $400 Million Criminal Fine, WALL ST.
J., July 19, 2012.
177. Commonwealth of Pennsylvania v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.,
No. 802 C.D. 2011, 2012 WL 3030512 (Commonwealth Ct. Pa. July 26, 2012).
178. Press Release, Johnson & Johnson, Janssen Pharmaceuticals, Inc. announced
RIPSERDAL consumer protection settlement with 36 states and the District of Columbia
(Aug. 30, 2012), available at http://www.investor.jnj.com/releasedetail.cfm?ReleaseID
=703611. In addition to the District of Columbia, the following thirty-six states are part of
the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho,
Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska,
Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont,
Washington, Wisconsin and Wyoming. Id.