Johnson and Johnson 2012 Annual Report Download - page 72

from the facilities, and certifies that any deviations reviewed do not adversely affect the quality of the selected batches.
McNEIL-PPC submitted a workplan to the FDA for remediation of the Lancaster and Las Piedras facilities, and that plan
was approved by the FDA in October 2012. Third-party batch record review may cease if the FDA has stated that the
facilities appear to be in compliance with applicable law. Each facility is subject to a five-year audit period by a third party
after the facility has been deemed by the FDA to be in apparent compliance with applicable law.
OTHER
In July 2005, Scios Inc. (Scios) received a subpoena from the United States Attorney’s Office for the District of
Massachusetts, seeking documents related to the sales and marketing of NATRECOR®. In August 2005, Scios was
advised that the investigation would be handled by the United States Attorney’s Office for the Northern District of
California in San Francisco. In February 2009, two qui tam complaints were unsealed in the United States District Court
for the Northern District of California, alleging, among other things, improper activities in the promotion of NATRECOR®.In
June 2009, the United States government intervened in one of the qui tam actions, and filed a complaint against Scios and
Johnson & Johnson seeking relief under the Federal False Claims Act and asserting a claim of unjust enrichment. In
October 2011, the criminal matter was resolved. The civil case has been stayed pending resolution of the potential
settlement discussed in the RISPERDAL®section above.
In June 2008, Johnson & Johnson received a subpoena from the United States Attorney’s Office for the District of
Massachusetts relating to the marketing of biliary stents by Cordis Corporation (Cordis). In February 2012, the
government informed Cordis that it was closing its investigation. In addition, in January 2010, a complaint was unsealed in
the United States District Court for the Northern District of Texas, filed by Kevin Colquitt, seeking damages against Cordis
and other parties for alleged violations of the Federal False Claims Act and several similar state laws in connection with the
marketing of biliary stents. The United States Department of Justice and several states declined to intervene. In January
2013, the Court granted Cordis’s motion to dismiss the claims against Cordis, with prejudice. Plaintiff has appealed.
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 October 2011, the European Commission (EC) announced that it opened an investigation concerning an agreement
between Janssen-Cilag B.V. (Janssen-Cilag) and Sandoz B.V. relating to the supply of fentanyl patches in The Netherlands
and whether the agreement infringes European competition law. In January 2013, the EC issued a Statement of
Objections setting out facts regarding a potential violation of EU antitrust laws. Janssen-Cilag is preparing a response to
the Statement of Objections.
In April 2012, Janssen Pharmaceuticals, Inc. (JPI) received a letter requesting certain documents from the United States
Department of Justice relating to the marketing and promotion of DORIBAX®. JPI has provided documents and continues
to cooperate with this government 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 promotion by Acclarent of RELIEVA
STRATUS™MicroFlow Spacer products. 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. (DePuy Synthes)), and Johnson &
Johnson Services, Inc. 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 for the production of materials relating to
the ASR™XL Hip device. The government has since made additional informal requests for the production of documents as
to the device. The government is investigating whether any person or entity submitted or caused to be submitted false
claims or false statements affecting federal health care programs in connection with the marketing and use of the ASR™XL
Hip device. DePuy Orthopaedics, Inc., DePuy Synthes, and Johnson & Johnson Services, Inc. have voluntarily produced
documents in response to the government’s informal requests and are fully cooperating with the government’s civil
investigation.
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 subsidiaries. Johnson & Johnson and its subsidiaries have since entered into a tolling agreement with
the 42 states participating in the multi-state investigation.
64 •Johnson & Johnson 2012 Annual Report