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.
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
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.
By Reuben Guttman
For fraudsters, government expenditures are a license to steal. One thing fraudsters know is that with trillions of dollars in expenditures from federal and state governments in healthcare dollars and bucks for battle tanks and fighter jets, there are not enough eyes watching the till to keep cheaters in line.
Now, in response to a pandemic, the government has pushed over $2 trillion out the door in stimulus money. Government dollars will be earmarked for grants, loans, and for the procurement necessary to battle the COVID-19 pandemic and mitigate the economic consequences of the consequent quarantine.
With government investigators already stretched too thin in enforcing compliance, there will be a need for whistleblowers to pick up the slack. Whistleblowers are no more than everyday honest citizens with an inherent litmus test fabricated from common sense and integrity which causes them to raise questions when they see impropriety. Though the current President has through his words and conducted attempted to cast a pall over the conduct of whistleblowers — particularly as they have lent transparency to his conduct — the truth is that we are a nation whose rule of law was tempered for the better by the work of whistleblowers. Those challenging the statute quo eradicated the evil of slavery, brought voting rights to women, worked to eradicate discrimination in our educational systems, and have challenged workplace harassment and discrimination based on race, gender, religion and sexual orientation. Whistleblowers have exposed unlawful pharmaceutical marketing practices and scams by fraudsters selling college and graduate degrees.
Whistleblowers now have a new challenge. In the provision of healthcare supplies and healthcare itself, they will have an opportunity to be the watchful eyes who can protect government expenditures and the quality of healthcare. In businesses — large and small — across the country they can monitor applications for government grants and loans and make their voices heard when they see impropriety.
For those who step forward and seek to bring transparency to wrongdoing, there is in existence a law dating back to 1864 that provides individuals the right to step into the shoes of the government, report fraud, and bring litigation in the name of the government to seek economic redress on behalf of the government. That statute is called the False Claims Act allowing redress against those who cheat the Federal Government. More than 20 states — including California, New York, Illinois and Florida — have their own False Claims Acts allowing whistleblowers to bring litigation when the fraud involves sate dollars.
There has been over the past several weeks clamor about the importance of this statute and perhaps a need to amend it to make it more effective in batting the fraud that will arise out of the misuse of stimulus dollars. Those who litigate under the False Claims Act know that the law was thoughtfully drafted and is effective. It needs no amendment. What is needed is an administration that fully respects the importance of whistleblowers. Americans need an administration that will fully staff — at the agency level — the ability to investigate and analyze the information and complaints brought forward by whistleblowers. We need an administration committed to imposing the full panoply of damages — treble actual damages and civil penalties — on wrongdoers. And we need an administration that goes after individuals and not merely the corporate shells that provide cover for their misconduct.
Whistleblowers are our heritage; they are an American tradition. Honoring them and protecting our stimulus dollars means aggressive enforcement compliance under a law that is on the books and works.
Description: Each year private citizen suits under the False Claims Act have returned billions of dollars to Federal and State treasuries. These suits leverage the government’s compliance enforcement resources and provide bounties to those individuals or entities – known as relators – who initiate them.
Who has standing to bring these suits? How are they investigated and put together? What are the pleading requirements and what role does the government play in overseeing this litigation. These issues along with relevant ethical concerns will be discussed from both the Relator and the Defendant perspective.
It is a program of particular interest to plaintiff counsel’s seeking to explore new litigation opportunities, and defense counsel, in-house and insurance counsel who work with clients who do direct or indirect business with the government and are subject to liability under the False Claims Act. It is a program of particular interest to those in the healthcare, education, and defense arenas or for those involved with any client operating in whole or in part with government monies.
The False Claims Act, involving cases filed under seal on behalf of the government, presents unique challenges under the ethical rules. The program will explore these challenges with an eye toward the applicable ethical rules and considerations.
Reuben Guttman is a founding member of Guttman, Buschner & Brooks PLLC (GBB). His practice involves complex litigation and class actions. He has tried and/or litigated claims involving fraud, breach of fiduciary duty, environmental derelictions, antitrust, business interference and other common law torts or statutory violations.
The International Business Times called Mr. Guttman “one of the world’s most prominent whistleblower attorneys,” and he has been recognized as a Washingtonian Top Lawyer by Washingtonian Magazine. A February 19, 2015 profile of Mr Guttman by the Boston Globe’s STAT NEWS referred to him as the “Lawyer Pharma Loves to Hate.” Citing a $98 million recovery from Community Health Systems, Inc., Law 360 named Mr. Guttman a “Health Care MVP” and profiled him in a December 1, 2014 article. Author David Dayen, writing in his Book, Chain of Title (The New Press, 2016) cited Mr. Guttman’s work on behalf of robo-signing whistleblower, Lynn Szymoniak, noting “he had won some of the largest awards in the history of the False Claims Act; there was really nobody better for the case.” Writing in their book, The Corporate Whistleblower’s Survival Guide, (Berrett-Koehler Publishers, Inc., 2011), authors Tom Devine and Tarek F. Massarani wrote that “in settling qui tam litigation, [Mr. Guttman] has aggressively and successfully negotiated for corrective action against public health and safety consequences from prescription drug fraud.” In the book, When Good Companies Go Bad, (ABC CLIO, 2014), authors Donald Beachler and Thomas Shevory profiled Mr. Guttman’s off label marketing case against Abbott labs, involving the drug Depakote, which resulted in a $1.6 billion recovery in 2012 for state and federal governments. The Spring, 2013 Cover Story for the Emory Lawyer, profiled Mr. Guttman as one of Emory Law School’s leading players in the area of complex litigation noting that “even before filing a case, Guttman’s team engages in intensive investigation, retains experts and prepares as if a trial is imminent.”
Adam S. Hoffinger is co-chair of the firm’s White Collar Defense & Government Investigations Group. Adam focuses his practice on complex civil and white collar criminal matters, including securities, health care, False Claims Act (“qui tam”), the Foreign Corrupt Practices Act (FCPA), export sanctions, criminal tax, money laundering, antitrust and bankruptcy. He conducts internal investigations on behalf of corporate boards of directors, bankruptcy trustees and public authorities. He counsels corporations and individuals in compliance matters, government investigations, and Congressional and regulatory matters. He also represents corporations and individuals in high-stakes civil litigation. Adam has defended numerous high-ranking executives and general counsel from some of the world’s largest companies, as well as high-profile staff and members of the Senate, Congress, White House and various government agencies, faced with federal and state criminal investigations and indictments. Adam is a fellow of the American College of Trial Lawyers and has successfully tried cases throughout the country.
Adam has been recognized in Chambers USA as “an absolutely fearless criminal defense lawyer” as well as for his “immense talent as a trial lawyer” and “strong advocacy skills,” in The Legal 500 US as “an aggressive trial advocate,” and in Benchmark Litigation: The Definitive Guide to America’s Leading Litigation Firms and Attorneys as a “celebrated government investigations practitioner.” He has also been recognized in The Best Lawyers in America, Expert Guide to the World’s Leading White Collar Crime Lawyers, Who’s Who Legal: Business Crime Defence, Global Investigations Review, Washingtonian Magazine and Washington DC Super Lawyers. Adam was named “Government Investigations Attorney of the Year” for 2015 and “Life Sciences Star” from 2013 to 2019 in LMG Life Sciences. In addition, he was recognized in the National Law Journal’s “Hot Defense List” for his jury trial victory on behalf of a former pharmaceutical executive in a criminal case charging conspiracy and violations of the federal Anti-Kickback statute. From 1985 to 1990, Adam served as an Assistant U.S. Attorney for the Southern District of New York. He received the Director’s Award for Superior Performance from the U.S. Department of Justice (DOJ) in 1990. He is an adjunct professor at The George Washington University Law School and has been an instructor at Georgetown University Law Center’s National Institute of Trial Advocacy (NITA) since 1992. He also serves on the alumni board of the Fordham University School of Law.