James E. Miller of Shepherd, Finkelman, Miller & Shah, LLP , Lead Litigation Counsel for plaintiffs-relators, Charles Arnstein and Hossam Senousy , announced today that Teva Pharmaceuticals has agreed to settle alleged violations of the False Claims Act based on a complaint filed by the Whistleblowers in 2013 asserting that Teva used "speaker programs" to pay physician speakers unlawful compensation in violation of the False Claims Act, 31 U.S.C. §§ 3729-3733, and the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b.
The Whistleblowers were represented by Shepherd, Finkelman, Miller & Shah, LLP ("SFMS"), and its co-counsel, Eric L. Young of McEldrew Young (https://www.mceldrewyoung.com), David J. Caputo and Joseph Trautwein of Youman & Caputo, LLC (https://youmancaputo.com), and Heidi A. Wendel (https://heidiwendellaw.com).
"I would like to take this opportunity to express my sincere appreciation for the courageous actions of Mr. Arnstein and Mr. Senousy in stepping forward to challenge Teva's alleged use of 'speaker programs' to influence the prescription writing of neurologists with respect to Azilect (a Parkinson's Disease drug) and Copaxone (a Multiple Sclerosis drug)," said James E. Miller.
Mr. Miller also stated: "In addition to thanking the entire SFMS team that worked on this case, including Natalie Finkelman Bennett, Jillian M. Boyce, Jonathan Dilger, Betsy Ferling Hitriz, Nicolas Lussier, Bruce Parke, Laurie Rubinow, James C. Shah and Nathan Zipperian, as well as our highly skilled co-counsel, Eric L. Young, and David J. Caputo, Joseph Trautwein and Heidi A. Wendel, I would like to take this opportunity to state that it was a pleasure and honor to work closely with the Office of Geoffrey S. Berman, the United States Attorney for the Southern District of New York, in resolving this important matter. I would like to specifically thank Pierre G. Armand, the Co-Chief of Civil Frauds Unit for the U.S. Attorney's Office for the Southern District of New York, and Assistant U.S. Attorneys, Li Yu and Jessica Hu, for their diligence, hard work and guidance on behalf of the United States of America. I also would like to thank Carrie L. Bashaw, Senior Counsel of the State of Washington Medicaid Fraud Control Unit and Kathryn M. Heim Harris, Special Assistant Attorney General of the New York Medicaid Fraud Control Unit, for their persistence and hard work on behalf of the various states participating in the settlement."
According to the complaint, physicians who participated in alleged sham speaker programs wrote prescriptions for the two drugs – Copaxone and Azilect - that were filled at pharmacies across the country. After filling and dispensing the prescriptions, the pharmacies then submitted claims for reimbursement to various government-funded health care programs. The pharmacies' claims resulted in payments by the government for prescriptions that were allegedly induced through fraud, i.e., Teva's alleged illegal payments to physicians who wrote the prescriptions. Since Teva's actions allegedly caused the submission of false claims to the government via the dispensing pharmacies, those actions were alleged to constitute violations of the False Claims Act and the Anti-Kickback Statute ("AKS" ), 42 U.S.C. § 1320a-7b, which criminalizes, among other things, "knowingly or willingly" offering or paying a person "remuneration," in the form of kickbacks, bribes, or rebates, to "induce" that person to "recommend" the purchase of a drug covered by a "Federal health care program." 42 U.S.C. § 1320a-7b(b)(2).
SFMS and McEldrew Young filed the original qui tam complaint on behalf of Mr. Arnstein and Mr. Senousy in May 2013. The complaint alleged that Teva provided bogus honoraria or speaking fees to physicians for participation in numerous sham speaker programs in connection with the drugs Azilect and Copaxone. On March 12, 2015, the Court issued an Order unsealing the complaint and permitting Mr. Arnstein and Mr. Senousy to prosecute claims on behalf of the United States and various states. Teva's attempt to dismiss the Whistleblowers' case was unsuccessful and counsel for the Whistleblowers engaged in substantial discovery, including the review of millions of pages of documents, scores of depositions of Teva employees and former employees and expert discovery, including the production by the Relators of expert reports by several world renowned experts that they retained to support their claims.
Summary Judgment Motion
On February 27, 2019, the Honorable Colleen McMahon, the Chief Judge for the United States District Court for the Southern District of New York, issued a thoughtful and comprehensive Memorandum Decision and Order denying Teva's motion for summary judgment. In a detailed, seventy-page opinion, Judge McMahon rejected numerous arguments asserted by Teva and ruled that the case would proceed to trial.
In denying summary judgment, Chief Judge McMahon rejected Teva's argument that Relators were required to produce evidence of a quid pro quo arrangement: "The statute also does not require evidence of negotiations with the party receiving the kickback. Rather, the payor must offer or pay 'with the intent to gain influence over the reason or judgment of a person making referral decisions.'" United States v. Teva Pharm. USA, Inc., No. 13 CIV. 3702 (CM), 2019 WL 1245656, at *10 (S.D.N.Y. Feb. 27, 2019)("Teva II"). Chief Judge McMahon also rejected the argument that Teva's written compliance policies could be used to shield it from liability: "The question is whether these policies are worth the paper they are written on." Teva II at * 12 (emphasis added). Importantly, Chief Judge McMahon found that "Relators … have introduced substantial evidence that Teva did, in fact, track speakers' prescription writing," and that "[s]ales representatives linked prescriber habits with their retention as paid speakers for Teva." Teva II at * 13. Chief Judge McMahon noted that "Teva has no real answer to this evidence," and that the evidence included "dozens of examples of sales representatives using speaker prescriptions to see whether the programs were producing tangible results and to suggest working more closely with high volume prescribing speakers." Teva II at * 14. In denying summary judgment, Chief Judge McMahon also cited to the substantial evidence developed by counsel for Relators in discovery:
"Relators have also submitted evidence showing that the same programs were repeatedly presented to the same attendees. For example, they have introduced evidence showing 1,500 examples of health care providers' attending three or more events related to the same drug within six months, (Rels. 56.1 ¶ 75 (citing PX177) ); paid speakers who attended speaker programs on the same topic for which they also serve as a speaker, (Rels. 56.1 ¶ 74 (citing PX166; PX172; PX185; and PX193) ); and health care providers' "rotating" by attending sequential Teva programs as the speaker at one and audience member at the other, (id. (citing PX169)).
Teva II at * 16. Chief Judge McMahon likewise rejected Teva's argument that Relators' evidence of sham speaker programs was insufficient, noting that "Relators submit that Teva routinely carried out speaker program events in a sham manner, as evidenced by the location at which many programs were held, the amount of alcohol served, and the fact that the audience was frequently made up of either Teva representatives, speakers themselves, repeat attendees, or physicians' family members," that "Relators … offer considerable data showing that events not qualifying as useful … occurred regularly," that, "[f]or that data, Teva has no answers" and, as a result, "Relators have raised a genuine issue of material fact that Teva structured its speaker programs in a sham manner." Teva II at * 20–21 (emphasis added).
"We believe that this settlement will help to ensure that when a physician chooses a prescription drug for his or her patient, that choice will be motivated solely by the best interests of the patient and not tainted by any improper financial considerations," said James E. Miller. Mr. Miller echoed the comments of co-counsel, Eric L. Young, who added, "We were inspired by the level of our clients' commitment to ensuring that Teva was held to account for its alleged misconduct. Today's result is also a victory for the American taxpayers who are the ultimate victims when unscrupulous individuals and companies defraud the government, oftentimes with impunity."
As SFMS's Managing Partner, James E. Miller has a distinguished track record of success. Mr. Miller has tried over thirty cases to successful verdict as lead counsel and has recovered more than $3 billion dollars for his clients. SFMS represents whistleblowers throughout the United States and on a global basis. Many whistleblower cases are brought under the False Claims Act, which allows a private individual, known as a relator, to file a lawsuit on behalf of the United States government against a company that has perpetrated a fraud against the government. If a relator successfully recovers funds on behalf of the government, he or she may receive a reward of up to thirty percent (30%) depending on the circumstances of the case. SFMS has taken the lead in prosecuting some of the most important and significant cases in the United States regarding "speaker programs" and efforts by pharmaceutical companies and medical device manufacturers to influence the behavior of physicians, prescribers and other providers through allegedly unlawful payments.
Case citation: United States ex rel. Arnstein and Senousy v. Teva Pharmaceuticals USA, Inc., No. 1:13-cv-03702-CM-OTW (S.D.N.Y.)
Shepherd, Finkelman, Miller & Shah, LLP (www.sfmslaw.com) has obtained billions of dollars in recoveries for its clients since its founding in 2002. Our attorneys have attended some of the best law schools in the country and have extensive experience in litigating cases against large and powerful companies. We maintain eight offices in the United States and two offices in Europe to serve our worldwide clients. SFMS has handled some of the most significant whistleblower cases in the United States and is increasingly recognized as one of the "go to" law firms when a whistleblower case needs to be litigated to trial.
ContactJames E, MillerShepherd, Finkelman, Miller & Shah, LLP65 Main StreetChester, CTTel: (866) 540-5505Email: email@example.com or firstname.lastname@example.org
SOURCE Shepherd, Finkelman, Miller & Shah, LLP
Shepherd , Finkelman , Miller & Shah , LLP , Charles Arnstein 和 Hossam Senousy 首席诉讼顾问 James E . Miller ,今天宣布， Teva Pharmaceuticals 已同意根据 Whistler 在2013年提交的一份申诉解决据称违反《虚假声明法案》的行为，该申诉声称梯瓦（Teva）使用“发言人程序”向医生发言人支付非法赔偿，违反了《虚假声明法案》31 U.S.C .§3729-3733和《反 Kickback 规约》，42 U.S.C .§1320a-7b 。
惠斯勒鼓吹者由 Shepherd 、 Finkelman 、 Miller & Shah 、 LLP (" SFMS ")及其联合律师 Eric L . Young of McEldra Young ( https://www.mceldrewoung.com )、 David J . Caputo 和 Joseph Trautwein of Youman & Caputo , LLC ( https://youmancaputo.com )和 Heidi A . Wendel ( https://heidiwendelaw.com )代表。
"我谨借此机会对阿恩斯坦先生和森努西先生勇敢地采取行动，挑战梯瓦（Teva）据称利用"演讲者方案"影响神经学家关于 Azilect (一种帕金森病药物)和 Copaxone (一种多发性硬化症药物)的处方编写工作的说法，表示衷心感谢，詹姆斯·米勒说。
米勒先生还说："除了感谢处理此案的整个 SFMS 小组，包括 Natalie Finkelman Bennett 、 Jillian M . Boyce 、 Jonathan Dinger 、 Betsy Ferling Hitriz 、 Nicolas Lussier 、 Bruce Parke 、 Laurie Rubinow 、 James C . Shah 和 Nathan Zipperian ，以及我们的高技能联合律师 Eric L . Young 和 David J . Caputo ，Joseph Trautwein 和 Heidi A . Wendel ，我想借此机会指出，与纽约南区美国检察官 Geoffrey S . Berman 办公室密切合作解决这一重要问题是令人高兴和荣幸的。我要特别感谢美国纽约南区联邦检察官办公室民事欺诈股联合股长 Pierre G . Armand 和美国助理检察官 Li Yu 和 Jessica Hu 代表美利坚合众国所作的努力、辛勤工作和指导。我还要感谢华盛顿州 Medicaid 欺诈控制股高级顾问 Carrie L . Bashaw 和纽约 Medicaid 欺诈控制股特别助理总检察长 Kathryn M . Heim Harris 代表参与和解的各个州坚持不懈地努力工作。这是一个很好的例子
据起诉书称，参与所谓假手术组发言人项目的医生为两种药物—— Copaxone 和 Azilect ——撰写处方，这两种药物在全国各地的药店都有售。在填写和分发处方后，药房随后向各政府资助的医疗保健方案提交报销申请。药房的报销要求导致政府支付了据称是由欺诈引起的处方费用，即梯瓦（Teva）涉嫌非法支付医生谁写处方。由于梯瓦（Teva）的行动据称通过药房向政府提交了虚假索赔，这些行动被指控构成违反《虚假索赔法》和《反 Kickback 规约》（《 AKS 》），42 U.S.C .§1320a-7b ，除其他外，这些行为构成犯罪，有意或自愿地以回扣、贿赂或回扣的形式提供或支付一个人的报酬，以“诱使”该人“建议”购买“联邦医疗保健计划”所涵盖的药物。42 U.S.C .§1320a-7b ( b )(2)。
2013年5月， SFMS 和 McEldraYoung 代表 Arnstein 先生和 Senousy 先生提交了原始的 quitam 投诉。控罪指梯瓦（Teva）向医生提供虚假的酬金或演讲费，让他们参与与 Azilect 和 Copaxone 药物有关的许多假手术组发言人项目。2015年3月12日，法院发布命令，驳回该申诉，并允许 Arnstein 先生和 Senousy 先生代表美国和各州提起诉讼。Teva 试图驳回 Whistler 的案件的努力未获成功， Whistler 的律师参与了重大发现，包括审查了数百万页的文件、梯瓦（Teva）雇员和前雇员的成绩单以及专家发现。包括由 Relator 制作的专家报告，这些报告由一些世界知名专家保留以支持他们的索赔。
2019年2月27日，美国纽约南区联邦地方法院首席法官、尊敬的 Colleen McMahon 发布了一份深思熟虑和全面的备忘录决定和命令，否认梯瓦（Teva）关于简易判决的动议。麦克马洪法官在一份长达70页的详细意见中驳回了梯瓦（Teva）声称的许多论点，并裁定该案将进行审判。
在否认即决判决时，首席法官麦克马洪驳回了梯瓦（Teva）的论点，即 Relators 被要求出示一项和解协议的证据：“法令也不要求提供与接受回扣的一方进行谈判的证据。”相反，付款人必须提供或支付“意图获得影响的理由或判断的人作出转介决定。"美国诉梯瓦（Teva） Pharm 案。美国，13号 CIV 。3702( CM )，2019年 WL 1245656， at *10( S.D.N.Y . No.27，2019)("梯瓦（Teva） II ")。首席法官麦克马洪还驳斥了梯瓦（Teva）书面合规政策可以用来保护其免于承担责任的说法：“问题在于，这些政策是否值得他们撰写的论文。”梯瓦（Teva） II at *12（强调添加）。重要的是，首席法官麦克马洪发现，“ Relators …引入了大量证据，证明 Teva 确实追踪了说话者的处方书写”，并且“[ s ] ales 代表将处方者的习惯与他们作为梯瓦（Teva）付费发言人的保留联系起来。”梯瓦（Teva） II at *13。首席法官麦克马洪指出，“梯瓦（Teva）对这一证据没有真正的答案”，证据包括“数十个销售代表使用发言人处方，看看节目是否产生了切实的效果，并建议与大量开处方的演讲者更密切合作。”梯瓦（Teva） II at *14。在否认即决判决时，首席法官 McMahon 还援引了 Relators 律师在发现时提出的实质性证据：
“ Relator 还提交了证据，证明同一程序多次被提交给同一与会者。例如，他们提供的证据显示，在六个月内有1500个保健提供者参加了三个或更多与同一药物有关的活动( Rels.56.1′75(援引 PX177))；有报酬的发言者参加了他们也担任发言者的同一主题的发言者方案，（ rels.56.1′74（引用 PX166； PX172； PX185；和 PX193））；以及卫生保健提供者“轮流”参加顺序的梯瓦（Teva）节目作为演讲者在一个和观众在另一个（ id ）（引用 PX169）。
梯瓦（Teva） II at *16。首席法官麦克马洪同样驳回了 Teva 的论点，即 Relator 提供的虚假发言人节目证据不足，指出" Relators 认为梯瓦（Teva）经常以假手术组的方式进行发言人节目活动，许多节目的举办地点、提供的酒量都证明了这一点，事实上，听众常常由 Teva 的代表、演讲者自己、重复的与会者或医生的家庭成员组成，“ Relator …提供了大量数据，表明没有资格被认为有用的事件……经常发生，即，“[ f ]或数据，梯瓦（Teva）没有答案”，因此，“ Relators 提出了一个真实的实质性问题，即梯瓦（Teva）以一种假手术组的方式构建了自己的发言人程序。”梯瓦（Teva） II at *20-21（强调添加）。
“我们相信，这种解决方案将有助于确保当医生为他或她的病人选择处方药时，这种选择将完全出于病人的最大利益，不会受到任何不正当的经济考虑的影响，” James E . Miller 说。米勒先生赞同联合律师 Eric L . Young 的评论，他补充说，"我们受到客户承诺确保梯瓦（Teva）被追究其不当行为责任的程度的鼓舞。今天的结果也是美国纳税人的胜利，他们是无耻的个人和公司欺骗政府时的最终受害者，常常逍遥法外。
作为 SFMS 的执行合伙人， James E.Miller 拥有卓越的成功记录。米勒以首席律师的身份对30多个案件进行了审判，并为客户追回了30多亿美元。SFMS 在美国和全球范围内代表举报人。许多告密者的案件都是根据《虚假索赔法》提起的，该法允许一名私人人士，即一名关系人，代表美国政府对一家欺诈政府的公司提起诉讼。如果继任人代表政府成功收回资金，他或她可以根据案件的情况获得高达百分之三十（30%）的报酬。SFMS 率先起诉了美国一些最重要和最重要的案件，涉及“发言人计划”，以及制药公司和医疗设备制造商通过涉嫌非法付款影响医生、处方者和其他提供者的行为。
案例引用：美国的.Arnstein 和 Senousy 诉梯瓦（Teva） Pharmaceuticals USA , Inc .， No .1:13-cv-03702-CM-OTW ( S.D.N.Y .)
Shepherd , Finkelman , Miller & Shah , LLP ( www.sfmslaw.com )自2002年成立以来，已为客户追回了数十亿美元。我们的律师曾就读于国内一些最好的法学院，在针对大公司和有实力的公司提起诉讼方面拥有丰富的经验。我们在美国设有八个办事处，在欧洲设有两个办事处，为全球客户提供服务。在美国， SFMS 已经处理了一些最重要的告密者案件，当需要对告密者案件进行诉讼审理时，它越来越被认为是“去”律师事务所之一。
联系人 James E , MillerShepherd , Finkelman , Miller & Shah , LLP65 Main StreetChester , CTTel :(866)540-5555电子邮件: jmiller @ sfmslaw.com 或 lrubinow @ sfmslaw.com
SoURCE Shepherd , Finkelman , Miller & Shah , LLP