Johnson and Johnson 2014 Annual Report Download - page 73

The Companies have also received Civil Investigative Demands from multiple State Attorneys General Offices broadly
relating to the McNeil recall issues. The Companies continue to cooperate with these inquiries, which are being
coordinated through a multi-state coalition. If a resolution cannot be reached with this multi-state coalition, it is possible
that individual State Attorneys General Offices may file civil monetary claims against the Companies. In January 2011, the
Oregon Attorney General filed a civil complaint against Johnson & Johnson, McNEIL-PPC and McNeil Healthcare LLC in
state court alleging civil violations of the Oregon Unlawful Trade Practices Act relating to an earlier recall of a McNeil OTC
product. In November 2012, the state court granted a motion by the Companies to dismiss Oregon’s complaint in its
entirety, with prejudice. In December 2012, Oregon filed a Notice of Appeal in the Court of Appeals of the State of
Oregon. Oral argument took place in July 2014 and the parties are awaiting a decision.
Opioids Litigation
Along with other pharmaceutical companies, Janssen Pharmaceuticals, Inc. (JPI) has been named in a number of lawsuits
alleging claims related to opioid marketing practices. In May 2014, Santa Clara and Orange Counties in California (the
Counties) filed a complaint in state court in Orange County, California against numerous pharmaceutical manufacturers,
including JPI, alleging claims related to opioid marketing practices, including false advertising, unfair competition, and
public nuisance. In June 2014, the City of Chicago filed a complaint in Cook County Circuit Court against several
pharmaceutical manufacturers, including JPI, alleging a number of claims related to opioid marketing practices, including
consumer fraud violations and false claims. The case was later removed to the United States District Court for the
Northern District of Illinois, and in December 2014, defendants filed a motion to dismiss the City of Chicago’s First
Amended Complaint for failure to state a claim. In September 2014, the Tennessee Attorney General Division of
Consumer Affairs issued a Request for Information to JPI related to opioids marketing practices.
Other
In September 2011, Synthes, Inc. (Synthes) received a Civil Investigative Demand issued pursuant to the False Claims Act
from the United States Attorney’s Office for the Eastern District of Pennsylvania. The Demand sought information
regarding allegations that fellowships had been offered to hospitals in exchange for agreements to purchase products.
Synthes has produced documents and information in response to the Demand and is cooperating with the inquiry.
In May 2012, Acclarent, Inc. (Acclarent) received a subpoena from the United States Attorney’s Office for the District of
Massachusetts requesting documents broadly relating to the sales, marketing and alleged off-label promotion by Acclarent
of RELIEVA STRATUS®MicroFlow Spacer products. The investigation is continuing and Acclarent is cooperating with the
United States Attorney’s Office in responding to the subpoena.
In August 2012, DePuy Orthopaedics, Inc., DePuy, Inc. (now DePuy Synthes, Inc.), and Johnson & Johnson Services, Inc.
(the Companies) received an informal request from the United States Attorney’s Office for the District of Massachusetts
and the Civil Division of the United States Department of Justice (the United States) for the production of materials relating
to the ASR™ XL Hip device. In July 2014, the United States notified the United States District Court for the District of
Massachusetts that it had declined to intervene in a qui tam case filed pursuant to the False Claims Act against the
Companies. The District Court issued an order in August 2014 that publicly unsealed the United States’ declination
notice; however, the complaint in the matter remains under seal. In addition, in October 2013, a group of state Attorneys
General issued Civil Investigative Demands relating to the development, sales and marketing of several of DePuy
Orthopaedics, Inc.’s hip products. In July 2014, the Oregon Department of Justice, which was investigating these matters
independently of the other states, announced a settlement of its ASR™ XL Hip device investigation for a total payment of
$4 million to the State of Oregon.
In October 2012, Johnson & Johnson was contacted by the California Attorney General’s office regarding a multi-state
Attorney General investigation of the marketing of surgical mesh products for hernia and urogynecological purposes by
Johnson & Johnson’s subsidiary, Ethicon, Inc. (Ethicon). Johnson & Johnson and Ethicon have since entered into a series
of tolling agreements with the 45 states and the District of Columbia participating in the multi-state investigation and have
responded to Civil Investigative Demands served by certain of the participating states.
In December 2012, Therakos, Inc. (Therakos), formerly a subsidiary of Johnson & Johnson and part of the Ortho-Clinical
Diagnostics, Inc. (OCD) franchise, received a letter from the civil division of the United States Attorney’s Office for the
Eastern District of Pennsylvania informing Therakos that the United States Attorney’s Office was investigating the sales
and marketing of Uvadex®(methoxsalen) and the Uvar Xts®System during the period 2000 to the present. The United
States Attorney’s Office requested that OCD and Johnson & Johnson preserve documents that could relate to the
investigation. Therakos was subsequently acquired by an affiliate of Gores Capital Partners III, L.P. in January 2013. OCD
and Johnson & Johnson retain certain liabilities that may result from the investigation for activity that occurred prior to the
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