anonymous
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anonymous
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The infamous Note 19....they buried this:
https://www.sec.gov/Archives/edgar/data/1114448/000137036818000005/a180124-99_1.htm
SOUTHERN DISTRICT OF NEW YORK (S.D.N.Y.) MARKETING PRACTICES INVESTIGATION AND LITIGATION
In 2013, the US government filed a civil complaint in intervention to an individual qui tam action against Novartis Pharmaceuticals Corporation (NPC) in the United States District Court (USDC) for the S.D.N.Y. The complaint, as subsequently amended, asserts federal False Claims Act (FCA) and common law claims with respect to speaker programs and other promotional activities for certain NPC cardiovascular medications (Lotrel, Starlix andValturna) allegedly serving as mechanisms to provide kickbacks to healthcare professionals (HCPs). It seeks damages, which according to the complaint are “substantial”, including treble damages and maximum civil penalties per claim, as well as disgorgement of Novartis profits from the alleged unlawful conduct. Also in 2013, New York State filed a civil complaint in intervention asserting similar claims. Neither government complaint in intervention adopted the individual relator’s claims with respect to off-label promotion of Valturna, which were subsequently dismissed with prejudice by the court. The individual relator continues to litigate the kickback claims on behalf of other states and municipalities. NPC vigorously contests the S.D.N.Y., New York State and individual claims, both as to alleged liability and amount of damages and penalties.
S.D.N.Y. / WESTERN DISTRICT OF NEW YORK HEALTHCARE FRAUD INVESTIGATION
In 2011, Alcon Laboratories, Inc. (ALI) received a subpoena from the United States Department of Health & Human Services relating to an investigation into allegations of healthcare fraud. The subpoena requests the production of documents relating to marketing practices, including the remuneration of healthcare providers, in connection with certain ALI products (Vigamox, Nevanac, Omnipred, Econopred; surgical equipment). ALI is cooperating with this investigation.
S.D.N.Y. GILENYA MARKETING PRACTICES INVESTIGATION
In 2013, NPC received a civil investigative demand from the United States Attorney’s Office (USAO) for the S.D.N.Y. requesting the production of documents and information relating to marketing practices for Gilenya, including the remuneration of healthcare providers in connection therewith. In 2017, S.D.N.Y. and New York State declined to intervene in claims raised by an individual relator, which continue to be vigorously contested.
GOVERNMENT GENERIC PRICING ANTITRUST INVESTIGATIONS, ANTITRUST CLASS ACTIONS
In 2016 and 2017, Sandoz Inc. received subpoenas and interrogatories from the Antitrust Division of the US Department of Justice (DoJ) and from the Attorney General of the State of Connecticut requesting documents related to the marketing and pricing of generic pharmaceutical products sold by Sandoz Inc. and its subsidiaries, including Fougera Pharmaceuticals, Inc. (Fougera), and related communications with competitors. Sandoz Inc. is cooperating with these investigations, which it believes to be part of a broader inquiry into industry practice.
Since the third quarter of 2016, Sandoz Inc. and Fougera have been sued alongside other generic pharmaceutical companies in more than 20 consolidated complaints by proposed classes of direct and indirect purchasers, and Attorneys General for 45 states, the District of Columbia and Puerto Rico have sought leave to file a complaint, alleging that defendants, including Sandoz, engaged in anti-competitive conduct with regard to the sales of various generic drugs and asserting violations of federal and state antitrust laws as well as consumer protection laws. Lek Pharmaceuticals d.d., Novartis AG and Novartis International AG were dismissed from the proceedings. The cases have been consolidated for pretrial purposes in the USDC for the Eastern District of Pennsylvania (E.D. Pa.) and the claims are being vigorously contested.
DISTRICT OF MASSACHUSETTS (D. MASS.) CHARITABLE FOUNDATION INVESTIGATION
In 2016 and 2017, NPC received subpoenas from the USAO for the D. Mass. requesting documents related to NPC’s support of 501(c)(3) organizations that provide co-payment assistance to Medicare patients who are prescribed Novartis medicines, including the respective accounting and tax treatment, as well as related to pricing strategies for Gleevec, Tasigna, Zometa, and Gilenya. The requests are focused on potential violations of federal health care offenses, including the Anti-Kickback Statute, and FCA. NPC is cooperating with this investigation, which it believes to be part of a broader inquiry into industry practices.
ASIA/RUSSIA INVESTIGATION
In 2017, Novartis Group companies, as well as present and former senior executives of Alcon, received document requests and subpoenas from the DoJ and the US Securities and Exchange Commission (SEC) requesting information concerning Alcon’s business practices in Asia and Russia and related accounting treatment, both before and after Alcon became part of the Novartis Group. Novartis is cooperating with this investigation.
LUCENTIS/AVASTIN® MATTERS
In connection with an investigation into whether Novartis Farma S.p.A., Novartis AG, F. Hoffmann-La Roche AG, Genentech Inc. and Roche S.p.A. colluded to artificially preserve the market positions of Avastin® and Lucentis, in 2014 the Italian Competition Authority imposed a fine equivalent to USD 125 million on Novartis AG and Novartis Farma S.p.A. Novartis paid the fine, subject to the right to later claim recoupment, and is appealing before the Consiglio di Stato. In 2014 and 2015, the Italian Ministry of Health and the Lombardia region sent letters with payment requests for a total equivalent of approximately USD 1.5 billion in damages from Novartis and Roche entities based on the above allegations. In 2014, the French Competition Authority opened an investigation against Novartis Groupe France with respect to the French market for anti-vascular endothelial growth factor (VEGF) products indicated for the treatment of wet age-related macular degeneration (AMD). Novartis continues to vigorously contest all claims in Italy and France. Also, Novartis is challenging policies and regulations allowing off-label/unlicensed use and reimbursement for economic reasons in various countries, including in Italy and the UK.
JAPAN INVESTIGATION
In 2015, a trial started against a former Novartis Pharma K.K. (NPKK) employee, and also NPKK under the dual liability concept in Japanese law, over allegations brought by the Tokyo District Public Prosecutor Office in two counts for alleged manipulation of data in sub-analysis publications of the Kyoto Heart Study regarding valsartan. The charges against NPKK are subject to a maximum total fine of JPY 4 million. In 2017, the Tokyo District Court issued a not-guilty ruling for both the former NPKK employee and NPKK. An appeal by the Tokyo District Public Prosecutor Office remains pending.
SOUTH KOREA INVESTIGATION
In 2016, the Seoul Western District Prosecutor initiated a criminal investigation into, among other things, allegations that Novartis Korea utilized medical journals to provide inappropriate economic benefits to HCPs. A criminal trial is ongoing concerning allegations that Novartis Korea utilized medical journals to provide inappropriate economic benefits to HCPs. In addition, other authorities in South Korea, including the Korea Fair Trade Commission, the Ministry of Food and Drug Safety and the Ministry of Health and Welfare conducted investigations into Novartis Korea. Those investigations have led to total fines of approximately USD 53 million as well as sales and reimbursement suspensions on Novartis Korea products in 2017.
GREECE INVESTIGATION
Novartis is investigating allegations of potentially inappropriate economic benefits in Greece to HCPs and others. Novartis Group companies in Greece are providing information to the Greek authorities related to these allegations. Novartis is also responding to a subpoena and document requests from the SEC and DoJ that it received in 2016 and 2017 in connection with such allegations and is cooperating with their investigation.
Senator announced on CNN last night they are going to do a full investigation on Novartis and Cohen connection. Will they discover the real reason for the payment when they disregard the corporate press releases and they start to dig through this list?