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OIG Sues Novartis - Kickbacks

Anonymous

Guest
Manhattan U.S. Attorney Files Healthcare Fraud Lawsuit Against Novartis Pharmaceuticals Corp. For Orchestrating A Multi-Million Dollar Prescription Drug Kickback Scheme

FOR IMMEDIATE RELEASE
Tuesday, April 23, 2013

Suit Alleges Novartis Induced Pharmacies to Switch Thousands of Transplant Patients to One of Its Drugs with Kickbacks Disguised as Rebates and Discounts, Resulting in Medicare and Medicaid Paying Tens of Millions of Dollars in Kickback-Tainted Reimbursements

Preet Bharara, the United States Attorney for the Southern District of New York, and Ronald T. Hosko, the Assistant Director of the Federal Bureau of Investigation, Criminal Investigative Division (“FBI”), announced today that the United States has filed a civil healthcare fraud lawsuit against NOVARTIS PHARMACEUTICALS CORP. (“NOVARTIS”). The Government’s Complaint seeks treble damages and civil penalties under the False Claims Act against Novartis for giving kickbacks, in the form of rebates and discounts, to 20 or more pharmacies in exchange for their switching transplant patients from competitor drugs to NOVARTIS’s drug, Myfortic. The lawsuit alleges that, as a result of NOVARTIS’s kickback scheme, Medicare and Medicaid have issued tens of millions of dollars in reimbursements based on false, kickback-tainted claims.

Manhattan U.S. Attorney Preet Bharara said: “As alleged, using the lure of kickbacks disguised as rebates, Novartis co-opted the independence of certain pharmacists and turned them into salespeople for one of its drugs. And by allegedly hiding this illegal quid pro quo from physicians, patients, and federal healthcare programs, Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs that were dispensed by pharmacists who were in cahoots with the company. Novartis, as we allege, is a repeat offender, having settled healthcare fraud charges based on kickbacks less than three years ago.” (underline emphasis added)

FBI Assistant Director Ronald T. Hosko said: “The FBI takes these allegations very seriously because of the potential impact to the nation’s healthcare system and to the public. These cases are one of the highest priorities of the FBI’s health care fraud program. We have established a centralized unit called the Major Provider Response Team to provide nationwide investigative assistance given the complexity of such investigations.”

The following allegations are based on the Complaint filed today in Manhattan federal court:

NOVARTIS markets and manufactures Myfortic, an immunosuppressant drug approved for use by patients who have undergone kidney transplants. NOVARTIS markets Myfortic to hospital centers and pharmacies that serve these transplant patients. Since 2005, NOVARTIS has orchestrated a scheme whereby it offered kickbacks, disguised as “performance” rebates and discounts, to 20 or more pharmacies with influence over prescription decisions. In exchange, those pharmacies committed to use that influence to “convert” (i.e., switch) patients to Myfortic from competitor drugs and/or to oppose the use of a cheaper, generic immunosuppressant drug.

In one case, according to a NOVARTIS manager, NOVARTIS offered a pharmacist in Los Angeles a “bonus” rebate equal to 5% of that pharmacist’s annual Myfortic sales, amounting to several hundred thousand dollars, to induce the pharmacist to “shoulder the burden” of switching 700 to 1,000 transplant patients to Myfortic. NOVARTIS found that it was highly profitable to pay pharmacies even 10% or 20% in kickbacks in exchange for switching transplant patients to Myfortic because, in the words of a Novartis manager, the “short term cost” bought NOVARTIS “a long term annuity.”

In an effort to actively conceal the quid pro quo, NOVARTIS documented its relationships with the pharmacies in rebate and discount contracts that omitted the agreements between NOVARTIS and the pharmacies to switch patients to Myfortic or keep them from switching to competitor drugs. For example, in discussing a potential kickback relationship with a national pharmacy, NOVARTIS and the pharmacy recognized that, although a basic objective of that relationship was the “conversion” of patients to Myfortic, NOVARTIS “cannot put this in writing.” Further, the pharmacies hid the financial benefits they stood to gain from physicians, patients, and the federal healthcare programs, and instead, presented their efforts to switch patients to Myfortic as unbiased professional judgments.

NOVARTIS’s kickback scheme violated the federal anti-kickback statute, which prohibits the offer or payment of rebates and other types of remuneration to induce the purchase or recommendation of any drug or service covered by Medicare, Medicaid, or another federal healthcare program. By orchestrating this scheme, NOVARTIS further caused the pharmacies to submit tens of thousands of claims to Medicare and Medicaid, resulting in those programs paying out tens of millions of dollars in reimbursements based on false claims tainted by kickbacks.

* * *

The Complaint seeks treble damages and penalties under the False Claims Act, 31 U.S.C. §§ 3729 et seq., for the tens of millions of dollars in reimbursements that Medicare and Medicaid paid for Myfortic shipments that resulted from NOVARTIS’s kickback scheme. In addition, the United States seeks compensatory damages under the common law theory of unjust enrichment for the tens of millions of dollars in profits that NOVARTIS has obtained as result of Medicare and Medicaid reimbursements for Myfortic.

Mr. Bharara praised the investigative work of the FBI’s Major Provider Response Team. He also thanked the Office of Inspector General at the U.S. Department of Health and Human Services and the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division in Washington D.C., for their extraordinary assistance in this case.

The case is being handled by the Office’s Civil Frauds Unit. Mr. Bharara established the Civil Frauds Unit in March 2010 to bring renewed focus and additional resources to combating healthcare and other types of frauds. Assistant U.S. Attorneys Li Yu, Ellen M. London, and Rebecca C. Martin are in charge of the case.

13-145

http://www.justice.gov/usao/nys/pressreleases/April13/NovartisLawsuitPR.php

A copy of the actual complaint can be found at the bottom of the page:
http://www.justice.gov/usao/nys/pre...- Complaint in Intervention (11 Civ 8196).pdf

Hmmm. It appears as though it is just business as usual, and the cost to settle this lawsuit will be nothing more than the cost of doing business.
 




Seriously? One LA pharmacist made 'several hundred thousand dollars' at 5% back? How exactly did this guy convince patients to switch - since it's typically the doctor's decision what drug the patient goes on?
 




Seriously? One LA pharmacist made 'several hundred thousand dollars' at 5% back? How exactly did this guy convince patients to switch - since it's typically the doctor's decision what drug the patient goes on?

MDs don't give a shit - if a patient whines about side effects or cost...they'll change. Pharma spend a shit load of money to get patient switches. What's it to an MD if his patient and pharmacist want to use another drug as long as there is no clear and present danger to the patient? Unless there is some outstanding reason, it's just inertia that keeps a switch from happening. Money makes people do funny things.
 












This case will never see light of day. Even if the Gov can prove a portion of the charges to a jury, what jury won't tack on huge punitive damages? No one likes attorneys, insurance companies, and drug cos. Nov will most likely settle out of court.

I'm sure the Gov will bring up previous wrong doings, existing CIA (Corporate Integrity Agreement), Held gender discrimination case, and other stuff to paint a picture of management that behaves "well."

I for see another PITA iLear requirement about this crap, called CIA2.0.
 








Whistleblowers get 10% of ill gotten gains. Them mofos gonna be rich! And if they are still working for Novartanic, they essentially are untouchable. The ZS bah-stards could peg them for elimination, but they would likely prevail in a wrongful termination lawsuit for more $: retaliation.
 




not good, all pharma companies do speaker programs. Its funny when the reps worked here it was OK, now that they got displaced it not OK.

I do not know what they can prove, since every company does speaker programs, but Novartis once again will fold and pay off the Feds. They should not and make them prove that they did anything different than any other company.

Every company in every industry that sells does something similar, look at the baseball seats owned by every company, Coke, Pepsi so on. Why are products placed on supermarket shelves they pay of the store for placement.
 




not good, all pharma companies do speaker programs. Its funny when the reps worked here it was OK, now that they got displaced it not OK.

I do not know what they can prove, since every company does speaker programs, but Novartis once again will fold and pay off the Feds. They should not and make them prove that they did anything different than any other company.

Every company in every industry that sells does something similar, look at the baseball seats owned by every company, Coke, Pepsi so on. Why are products placed on supermarket shelves they pay of the store for placement.

What incredible insight. Thank you for that supermarket analogy. Perfectly makes sense now.
 




not good, all pharma companies do speaker programs. Its funny when the reps worked here it was OK, now that they got displaced it not OK.

I do not know what they can prove, since every company does speaker programs, but Novartis once again will fold and pay off the Feds. They should not and make them prove that they did anything different than any other company.

Every company in every industry that sells does something similar, look at the baseball seats owned by every company, Coke, Pepsi so on. Why are products placed on supermarket shelves they pay of the store for placement.

Not true-some reps called the hotline to report managements directive on this and were forced out by the company. I say, go get the management.
I know in one state that the FBI showed up at managements doors unannounced. I hope this is from that.
 




This case will never see light of day. Even if the Gov can prove a portion of the charges to a jury, what jury won't tack on huge punitive damages? No one likes attorneys, insurance companies, and drug cos. Nov will most likely settle out of court.

I'm sure the Gov will bring up previous wrong doings, existing CIA (Corporate Integrity Agreement), Held gender discrimination case, and other stuff to paint a picture of management that behaves "well."

I for see another PITA iLear requirement about this crap, called CIA2.0.

So Avenatti drops a bombshell the other day about questionable transactions NVS and other cos made to Trumps' pers. ATTY Cohen's shell company, consultancy, however you want to call it.

Business as usual? Pay to play for Presidential access and influence?

NVS goes into full damage control mode; it was the former CEO; we were under illusion of lobbying; it was a mistake...

Turning back time to 2017:
  1. January: Trump inaugurated POTUS; Jimenez elected Chairman of PhRMA; Jimenez/NVS and other cos meet with Trump for roundtable discussion
  2. February: Trump pers. ATTY Cohen/Essential Consultants approaches NVS/Jimenez or other way around
  3. March: NVS makes initial monthly installment of 1-year $1.2m contract to Cohen/Essential Consultants; NVS meets with Cohen/Essential Consultants, concludes he cannot deliver contracted services, but decides to keep the payment schedule to not upset anyone; FDA approves Kisqali breast cancer therapy
  4. April: FDA approves Rydapt AML treatment
  5. May: Gottlieb confirmed as FDA Commissioner; FDA approves NVS Zykadia lung cancer treatment
  6. June: FDA approves NVS Tafinlar/Mekinist combo for lung cancer
  7. August: FDA approves first CAR-T therapy NVS Kymriah for ALL
  8. September: Jimenez signals resignation; Narasimhan tipped to become next CEO in February 2018
  9. November: NVS cooperates with Mueller's special investigation re: payments made to Cohen/Essential Consultants
  10. January 2018: Narasimhan and other execs invited to private dinner with Trump at Davos/WEF
  11. February 2018: Cohen/Essential Consultants approaches Narasimhan/NVS to renew contract and offer rejected

At least Narasimhan/NVS did the right thing after learning from this mistake.

But, was it also a coincidence that Preet Bharara, former SDNY ATTY, was fired in March 2017?
 




So Avenatti drops a bombshell the other day about questionable transactions NVS and other cos made to Trumps' pers. ATTY Cohen's shell company, consultancy, however you want to call it.

Business as usual? Pay to play for Presidential access and influence?

NVS goes into full damage control mode; it was the former CEO; we were under illusion of lobbying; it was a mistake...

Turning back time to 2017:
  1. January: Trump inaugurated POTUS; Jimenez elected Chairman of PhRMA; Jimenez/NVS and other cos meet with Trump for roundtable discussion
  2. February: Trump pers. ATTY Cohen/Essential Consultants approaches NVS/Jimenez or other way around
  3. March: NVS makes initial monthly installment of 1-year $1.2m contract to Cohen/Essential Consultants; NVS meets with Cohen/Essential Consultants, concludes he cannot deliver contracted services, but decides to keep the payment schedule to not upset anyone; FDA approves Kisqali breast cancer therapy
  4. April: FDA approves Rydapt AML treatment
  5. May: Gottlieb confirmed as FDA Commissioner; FDA approves NVS Zykadia lung cancer treatment
  6. June: FDA approves NVS Tafinlar/Mekinist combo for lung cancer
  7. August: FDA approves first CAR-T therapy NVS Kymriah for ALL
  8. September: Jimenez signals resignation; Narasimhan tipped to become next CEO in February 2018
  9. November: NVS cooperates with Mueller's special investigation re: payments made to Cohen/Essential Consultants
  10. January 2018: Narasimhan and other execs invited to private dinner with Trump at Davos/WEF
  11. February 2018: Cohen/Essential Consultants approaches Narasimhan/NVS to renew contract and offer rejected

At least Narasimhan/NVS did the right thing after learning from this mistake.

But, was it also a coincidence that Preet Bharara, former SDNY ATTY, was fired in March 2017?

It looks like someone could be putting the pieces together. Preet is out soon after the meeting with Cohen. Preet was the one that oversaw current, pending and future whistleblower lawsuits against Novartis. The current case against Novartis was in the hands of the courts so that case could not be touched. The pending and potential future cases disappeared after Preet was fired. There were pending cases no one ever heard of and will only be found in the annual report. New SNDY atty aboard not pursing Novartis in pending and new cases. The new SDNY was hired by Trump.

Was this why the $1.2 million was paid? Did the $1.2 million payment was an investment to save hundreds of millions in additional whistleblower lawsuits? If so, it was a good investment.

We can only make these assumptions because we won't be able to see the inside information. But federal prosecutors can get the information. If you believe the above scenario could hold some merit and you are disgusted by Novartis' actions, send this information to the news networks and let them do the research. The media believes the money was for access to the administration. Maybe that is a smoke screen.
 




It looks like someone could be putting the pieces together. Preet is out soon after the meeting with Cohen. Preet was the one that oversaw current, pending and future whistleblower lawsuits against Novartis. The current case against Novartis was in the hands of the courts so that case could not be touched. The pending and potential future cases disappeared after Preet was fired. There were pending cases no one ever heard of and will only be found in the annual report. New SNDY atty aboard not pursing Novartis in pending and new cases. The new SDNY was hired by Trump.

Was this why the $1.2 million was paid? Did the $1.2 million payment was an investment to save hundreds of millions in additional whistleblower lawsuits? If so, it was a good investment.

We can only make these assumptions because we won't be able to see the inside information. But federal prosecutors can get the information. If you believe the above scenario could hold some merit and you are disgusted by Novartis' actions, send this information to the news networks and let them do the research. The media believes the money was for access to the administration. Maybe that is a smoke screen.
Please....no more smears on this industry! The public already hates us so let's clean up our own dirty linen.
 








It looks like someone could be putting the pieces together. Preet is out soon after the meeting with Cohen. Preet was the one that oversaw current, pending and future whistleblower lawsuits against Novartis. The current case against Novartis was in the hands of the courts so that case could not be touched. The pending and potential future cases disappeared after Preet was fired. There were pending cases no one ever heard of and will only be found in the annual report. New SNDY atty aboard not pursing Novartis in pending and new cases. The new SDNY was hired by Trump.

Was this why the $1.2 million was paid? Did the $1.2 million payment was an investment to save hundreds of millions in additional whistleblower lawsuits? If so, it was a good investment.

We can only make these assumptions because we won't be able to see the inside information. But federal prosecutors can get the information. If you believe the above scenario could hold some merit and you are disgusted by Novartis' actions, send this information to the news networks and let them do the research. The media believes the money was for access to the administration. Maybe that is a smoke screen.

Found the other whistle blower case. They really hid it in the annual report. The timing is suspicious.Why no press release if the case is not being pursued? Trying to keep everything quiet?
 




Found the other whistle blower case. They really hid it in the annual report. The timing is suspicious.Why no press release if the case is not being pursued? Trying to keep everything quiet?

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.
 




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.


COULD THE SMOKING GUN BE ON THIS LIST?