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injunction, and awarded $45 million in restitution and $6.5 million in civil penalties. The Court found in the J&J AWP
Defendants’ favor on the Commonwealth’s claims of unjust enrichment, misrepresentation/fraud, civil conspiracy, and on
certain of the Commonwealth’s claims under the UTPL. The J&J AWP Defendants appealed the Commonwealth Court’s
UTPL ruling, and in June 2014, the Pennsylvania Supreme Court vacated the judgment entered by the Commonwealth
Court and remanded the case for further proceedings. On remand, in January 2015, the Commonwealth Court dismissed
the monetary awards against the J&J AWP Defendants. In March 2015, the ruling was appealed back to the Pennsylvania
Supreme Court. In December 2015, the Pennsylvania Supreme Court affirmed the Order of the Commonwealth Court
dismissing the monetary awards against the J&J AWP Defendants.
RISPERDAL®
In November 2013, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc. (JPI), finalized previously
disclosed settlement agreements with the United States Department of Justice and forty-five states resolving federal
investigations and state Medicaid claims related to past promotional practices of RISPERDAL®from 1999 through 2005,
and other matters. JPI had also settled alleged consumer fraud claims in connection with the sale and marketing of
RISPERDAL®with thirty-six states and the District of Columbia in September 2012. In addition to these actions, the
Attorneys General of several states brought actions against JPI, related to the sale and marketing of RISPERDAL®,
seeking one or more of the following remedies: reimbursement of Medicaid or other public funds for RISPERDAL®
prescriptions written for off-label use, compensation for treating their citizens for alleged adverse reactions to
RISPERDAL®, civil fines or penalties for violations of state false claims acts or consumer fraud statutes, punitive damages,
or other relief relating to alleged unfair business practices. Certain of these actions also sought injunctive relief relating to
the promotion of RISPERDAL®. Many of the actions and claims brought by the state Attorneys General have been settled,
either individually or as part of the settlements described above. The cases brought by the Attorneys General of
Mississippi and Kentucky were settled in December 2015, without any admission of wrongdoing on the part of JPI. State
cases that went to judgment after trial are discussed below.
In 2004, the Attorney General of West Virginia commenced a lawsuit against Janssen Pharmaceutica, Inc. (now JPI) based
on claims of alleged consumer fraud as to DURAGESIC®, as well as RISPERDAL®. JPI was found liable and damages
were assessed at $4.5 million. JPI filed an appeal, and in November 2010, the West Virginia Supreme Court of Appeals
reversed the trial court’s decision. In December 2010, the Attorney General of West Virginia dismissed the case as it
related to RISPERDAL®without any payment. Thereafter, JPI settled the case insofar as it related to DURAGESIC®.
In 2004, the Attorney General of Louisiana filed a multi-count Complaint against Janssen Pharmaceutica, Inc. (now JPI).
Johnson & Johnson was later added as a defendant. The case was tried in October 2010. The issue tried to the jury was
whether Johnson & Johnson or JPI had violated the State’s Medical Assistance Program Integrity Law (the Act) through
misrepresentations allegedly made in the mailing of a November 2003 Dear Health Care Professional letter regarding
RISPERDAL®. The jury returned a verdict that JPI and Johnson & Johnson had violated the Act and awarded $257.7
million in damages. The trial judge subsequently awarded the Attorney General counsel fees and expenses in the amount
of $73 million. In January 2014, the Louisiana Supreme Court reversed the District Court’s judgment in favor of the
Attorney General, and rendered judgment in favor of Johnson & Johnson and JPI. In April 2014, the Louisiana Supreme
Court denied the Attorney General’s petition seeking a rehearing of the appellate arguments, resulting in final dismissal of
the case.
In 2007, the Office of General Counsel of the Commonwealth of Pennsylvania filed a lawsuit against Janssen
Pharmaceutica, Inc. (now JPI) on a multi-Count Complaint related to Janssen Pharmaceutica’s sale of RISPERDAL®to the
Commonwealth’s Medicaid program. The trial occurred in June 2010. The trial judge dismissed the case after the close of
the plaintiff’s evidence. The Commonwealth filed an appeal and in July 2012, the Pennsylvania Appeals Court upheld the
dismissal of the Commonwealth’s case.
In 2007, the Attorney General of South Carolina filed a lawsuit against Johnson & Johnson and Janssen Pharmaceutica,
Inc. (now JPI) on several counts. In March 2011, the matter was tried to a jury on liability only, at which time the lawsuit
was limited to claims of violation of the South Carolina Unfair Trade Practices Act, including, among others, questions of
whether Johnson & Johnson or JPI engaged in unfair or deceptive acts or practices in the conduct of any trade or
commerce by distributing the November 2003 Dear Health Care Professional letter regarding RISPERDAL®or in their use
of the product’s FDA-approved label. The jury found in favor of Johnson & Johnson and against JPI. In June 2011, the
Court awarded civil penalties of approximately $327.1 million against JPI. JPI appealed this judgment and in February
2015, the South Carolina Supreme Court affirmed the trial court’s decision in part, reversed it in part and remanded the
case back to the trial court. The net effect of the decision was to reduce the judgment to approximately $136 million, plus
Johnson & Johnson 2015 Annual Report 73