Johnson and Johnson 2013 Annual Report Download - page 75

NUCYNTA®IR and NUCYNTA®ER; and (2) any studies, reports and/or complaints regarding the safety and/or actual or
potential side effects of NUCYNTA®IR and NUCYNTA®ER. JPI is in the process of responding to the subpoena.
In recent years, Johnson & Johnson has received numerous requests from a variety of United States Congressional
Committees to produce information relevant to ongoing congressional inquiries. It is the policy of Johnson & Johnson to
cooperate with these inquiries by producing the requested information.
GENERAL LITIGATION
In June 2009, following the public announcement that Ortho-Clinical Diagnostics, Inc. (OCD) had received a grand jury
subpoena from the United States Department of Justice, Antitrust Division, in connection with an investigation that has
since been closed, multiple class action complaints were filed against OCD by direct purchasers seeking damages for
alleged price fixing. These cases were consolidated for pre-trial purposes in the United States District Court for the
Eastern District of Pennsylvania as In re Blood Reagent Antitrust Litigation. In August 2012, the District Court granted a
motion filed by Plaintiffs for class certification. In October 2012, the United States Court of Appeals for the Third Circuit
granted OCD’s petition for interlocutory review of the class certification ruling. Oral argument on the appeal was held in
February 2014 and the parties are awaiting a decision.
In September 2010, a shareholder, Ronald Monk, filed a lawsuit in the United States District Court for the District of
New Jersey seeking class certification and alleging that Johnson & Johnson and certain individuals, including executive
officers and employees of Johnson & Johnson, failed to disclose that a number of manufacturing facilities failed to maintain
current good manufacturing practices, and that as a result, the price of the Company’s stock declined significantly. Plaintiff
sought to pursue remedies under the Securities Exchange Act of 1934 to recover his alleged economic losses. In
December 2011, a motion by Johnson & Johnson to dismiss was granted in part and denied in part. Plaintiff moved the
Court to reconsider part of the December 2011 ruling. In May 2012, the Court denied Plaintiff’s motion for reconsideration.
In September 2012, Plaintiff filed a Second Amended Complaint and Johnson & Johnson and the individual defendants
moved to dismiss Plaintiff’s Second Amended Complaint in part. Following mediation, the parties reached an agreement in
principle to settle the case, and in July 2013, filed for preliminary approval of the proposed settlement. In November 2013,
the Court approved the settlement. Three parties that had objected to the settlement have appealed the Court’s approval
orders.
In April 2011, OMJ Pharmaceuticals, Inc. (OMJ PR) filed a lawsuit against the United States in United States District Court
for the District of Puerto Rico alleging overpayment of federal income taxes for the tax years ended November 30, 1999
and November 30, 2000. If OMJ PR loses this lawsuit, it may face liability for subsequent tax years. OMJ PR alleges that
the Internal Revenue Service erroneously calculated OMJ PR’s tax credits under Section 936 of the Tax Code. OMJ PR
filed a motion for summary judgment, and the United States filed a cross motion for summary judgment. In October 2012,
the Court granted a motion by the United States for summary judgment and denied a motion by OMJ PR for summary
judgment. OMJ PR has appealed this decision. Oral argument was held in November 2013.
In August 2011, an arbitration panel ruled that Mitsubishi Tanabe Pharma Corporation (Tanabe), Janssen Biotech, Inc.’s
(JBI’s) distributor of REMICADE®in Japan, could seek to modify the proportion of net sales revenue that Tanabe must
remit to JBI in exchange for distribution rights and commercial supply of REMICADE®(the Supply Price). Tanabe
commenced the arbitration against Centocor Ortho Biotech, Inc. (now JBI) in 2009 pursuant to the parties’ distribution
agreement, which grants Tanabe the right to distribute REMICADE®in Japan and certain other parts of Asia. JBI
counterclaimed for an increase in the Supply Price. A hearing was held in November 2011 to determine the appropriate
split of revenue. In February 2013, the arbitration panel determined that the Supply Price should be modified in favor of
Tanabe, and in July 2013 issued its Final Award. The Company previously accrued an amount to cover the impact of the
arbitration decision.
In September 2011, Johnson & Johnson, Johnson & Johnson Inc. and McNeil Consumer Healthcare Division of Johnson &
Johnson Inc. received a Notice of Civil Claim filed by Nick Field in the Supreme Court of British Columbia, Canada (the
BC Civil Claim). The BC Civil Claim is a putative class action brought on behalf of persons who reside in British Columbia
and who purchased during the period between September 20, 2001 and the present one or more various McNeil infants’
or children’s over-the-counter medicines that were manufactured at the Fort Washington facility. The BC Civil Claim
alleges that the defendants violated the BC Business Practices and Consumer Protection Act, and other Canadian
statutes and common laws, by selling medicines that were allegedly not safe and/or effective or did not comply with
Canadian Good Manufacturing Practices. The class certification hearing is scheduled for April 2014.
Johnson & Johnson or its subsidiaries are also parties to a number of proceedings brought under the Comprehensive
Environmental Response, Compensation, and Liability Act, commonly known as Superfund, and comparable state, local or
foreign laws in which the primary relief sought is the cost of past and/or future remediation.
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