Gilead Inc. Agrees to $97m FCA Settlement

The Justice Department has announced that California based pharmaceutical company Gilead Sciences, Inc. has agreed to pay $97 million to settle allegations of fraud. Whistleblowers accused the company of using a foundation to illegally pay the prescription copays for a hypertension drug, Letairis, for millions of Medicare patients. Drug companies are prohibited, under the Anti-kickback Statute, from directly or indirectly incentivizing patients to purchase their drug; by covering the copay for Letairis patients, Gilead was able to increase the drug’s price to what would have otherwise resulted in prohibitively expensive copays. The Justice Department stated that price manipulation and unscrupulous subsidization of a company’s own drugs are exactly the types of behavior the Medicare copay structure was designed to prohibit, and that this settlement demonstrates the government’s emphasis on combatting healthcare fraud.

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DOJ Announces FCA Lawsuit Against Teva Neuroscience, Inc.

The DOJ announced that the U.S. has filed a False Claims Act lawsuit against Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc., accusing the companies of illegally paying the Medicare co-pays for patients taking Copaxone, a drug for multiple sclerosis. The complaint alleges that Teva violated the Anti-Kickback Statute, which prohibits drug companies from “offering or paying, directly or indirectly, any remuneration… to induce Medicare patients to purchase the companies’ drugs.” Teva skirted this regulation by paying seemingly independent charitable organizations with the understanding that the funds would cover Medicare co-pays for patients taking Copaxone. At the same time, the company increased the annual price of the drug from $17,000 to over $70,000. The DOJ states that the government’s pursuit of this lawsuit illustrates the U.S. commitment to preventing pharmaceutical companies from defrauding government programs at the expense of American taxpayers and customers.

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DUSA Inc. Settles FCA Lawsuit for $20m

DUSA Pharmaceuticals, Inc. has agreed to pay the U.S. $20.75 million to settle a lawsuit filed under the whistleblower provision of the False Claims Act. DUSA, a subsidiary of Sun Pharmaceutical Industries, Inc., was accused of knowingly promoting a topical drug administration schedule program that resulted in fraudulent billings to Medicare and the Federal Employee Health Benefit Program. DUSA encouraged the drug administration program, which was neither approved within the FDA product instructions nor verified by sufficient clinical data, by offering prescribers paid speaker positions and programs, providing false or misleading information, and promotion by the company sales team. The U.S. alleged that senior officials of DUSA and Sun Pharma were aware that the new administration schedule resulted in significantly lower clearance rates for the indicated health condition, and that pushing the schedule “undermine[d] the health of patients and the financial integrity of federal health care programs.” The whistleblower and relator, a former sales representative of DUSA, will receive $3.5 million as part of the case’s resolution.

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NITA Podcast: Best Practices for Remote Hearings

with Judge Amy Hanley and D.C. civil litigator Reuben Guttman to talk about how to get it right in video and telephonic hearings.

In Episode 8 of the podcast, we are joined by Kansas District Court Judge Amy Hanley and D.C. civil litigator Reuben Guttman to talk about how to get it right in video and telephonic hearings. The disruptions caused by the covid pandemic have suddenly moved the courtroom into your dining room, and our guests are sharing their best do’s and don’ts from their respective positions on and before the bench. The Honorable Amy Hanley is based in Lawrence, Kansas, and presides over a civil, domestic, and criminal docket for the Seventh Judicial District of Douglas County. In his class action and complex civil litigation practice, Reuben Guttman has become one of the most prominent whistleblower lawyers in the world. Topics6:04    Constitutional and statutory constraints9:12    Preparing your client 11:20  Judges’ expectations13:40  Putting clients at ease15:08  Courtroom transition to online 16:51  Views from the bench18:33  Creating formality23:17  Equal time 29:25  Exhibits and judge preferences31:43  Presenting exhibits33:45  Making a court record35:25  Recording the hearing36:44  Communicating with client40:25  Witness sequestration41:42  Confidentiality issues43:26  Public Zoom hearings46:00  Closing advice48:20  Technology’s impact on the law49:07  Signature “softball”Quotes“If your judge doesn’t have the protocol [for remote hearings], don’t be afraid to ask for it. A little secret that I’ll let you in on is that judges love it when counsel does that work for us. You might be better suited to draft and propose a protocol due to your familiarity with the technology or because you know the witnesses and exhibits that need to be used. And we love it when you do that work for us ahead of time and send in a draft that we can use as a starting point.” Judge Amy Hanley“It’s important to get [clients] to appreciate what it’s going to look like, what they’re going to look like, in the courtroom and to have them to appreciate that maybe the judge might actually pose a question to them directly, to rehearse some of that so they’re not surprised. If you’re sitting next to somebody, it’s a lot easier to tap them and say, ‘It’s ok, don’t worry about it. Answer the question,’ but remotely, I mean, there’s an intuitive sense of fear: ‘Oh, my God, I’m not prepared for this.’ So, the idea is that you want to make sure whether you’re putting your client on from prison or jail, or whether you’re putting your client on from a hospital room, you want to make sure that at least they understand what the possibilities are, in preparing them. I call it inoculation, inoculation against the possibilities that may give them anxiety.” Reuben Guttman

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False Claims Act Litigation: CLE

Program Date: June 22, 2020 |

Over the last several years Americans have had a crash course in the role that whistleblowers play in compliance enforcement. No statute gives whistleblowers a greater role than federal and state false claims acts. These statutes not only allow the government to bring suit to address fraud on the government, but they allow private citizens to step into the shoes of the government to bring suit. Now, particularly in a Covid19 era – with trillions of taxpayer dollars poured into the economy – the false claims acts are taking on even greater importance. This seminar will cover:

• what you need to know about these laws
• who can bring suit?
• what bounty provisions exist?
• what are the cases that will arise in the Covid19 era?
• what are the pleading and evidentiary issues you need to know?

Reuben Guttman of Guttman, Buschner & Brooks, PLLC is a leading whistleblower lawyer and coauthor of a soon to be published text on pre-trial litigation; Adam Hoffinger is co-chair of the white collar defense and government litigation group at Schulte, Roth & Zabel, PLLC and is one of the nation’s leading defense lawyers.

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