Johnson and Johnson 2015 Annual Report Download - page 87

In August 2015, the New Hampshire Attorney General, Consumer Protection and Antitrust Bureau issued a subpoena to
JPI and other pharmaceutical companies related to opioids marketing practices. JPI objected to private contingent fee
counsel’s participation in the investigation on the State’s behalf, and in October 2015, the State moved to enforce the
subpoena.
In December 2015, the State of Mississippi filed a complaint in the Chancery Court of the First Judicial District of Hinds
County against the same group of pharmaceutical manufacturers, including J&J and JPI, alleging a number of claims
related to opioid marketing practices. The State of Mississippi is seeking penalties and injunctive and monetary relief.
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 the RELIEVA STRATUS®MicroFlow Spacer product (the STRATUS®Spacer). In April 2015, an Indictment was filed in
the United States District Court for the District of Massachusetts charging the former President/CEO and Vice President
of Sales of Acclarent (the former Acclarent officers). The Indictment charges the former Acclarent officers with various
violations related to the off-label promotion of the STRATUS®Spacer. The allegations against the former Acclarent
officers relate to the development, sale and marketing of the STRATUS®Spacer, as well as actions allegedly taken by the
former Acclarent officers in connection with the acquisition of Acclarent by Ethicon, Inc. in 2010. There are no charges
against Acclarent, Ethicon, Inc. or Johnson & Johnson.
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 47 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. The states are seeking monetary
and injunctive relief.
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
sale of Therakos. In March 2014, the United States Attorney’s Office requested that Johnson & Johnson produce certain
documents, and Johnson & Johnson is cooperating with the request. Following the divestiture of OCD, Johnson & Johnson
retains OCD’s portion of any liability that may result from the investigation for activity that occurred prior to the sale of
Therakos.
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.
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