Lon Leavitt, a partner at Halunen Law and a former Assistant United States Attorney, recently shared his False Claims Act (FCA) expertise in an article published by Law360. Lon’s article addressed a significant decision by the United States Court of Appeals for the Ninth Circuit that strengthened tools traditionally used by the government and whistleblower counsel in enforcing the FCA. These tools—medical necessity, clinical judgments, sub-regulatory guidance, and statistics—are important when pleading and proving cases under the FCA. If you are aware of claims for medically unnecessary services, or other healthcare fraud against the government, and would like to know how these and other tools may be of use to you in pursuing a whistleblower action, contact Halunen Law’s False Claims Act Group for guidance and assistance.New FCA Ruling Revives Tools To Establish Falsity
Halunen Law is representing Tom Jefferson, a UK epidemiologist and researcher in a private False Claims Act whistleblower suit claiming the drug company Roche defrauded U.S. federal and state governments by falsely claiming that its antiviral drug oseltamivir (Tamiflu) could be a powerful tool in mitigating a flu pandemic. The suit, for $1.5 billion, is roughly the amount that US public health authorities spent building up their pandemic stockpile of oseltamivir. Read the full story below.
At an upcoming educational program, “Tips from the Trial Court on Winning Your Next Employment Trial,” a distinguished panel of trial court judges will discuss effective ways to persuasively conduct voir dire, motion practice, openings, objections, direct/cross exams, and closings in employment law cases. Moderated by Halunen Law employment attorney Emma Denny, the panel will provide valuable insight and examples, all in an effort to aid employment attorneys toward successful trial outcomes. Panelists include Hennepin County Judge Tanya Bransford, Hennepin County Judge Daniel Moreno, Hennepin County Judge Susan Robiner, Hennepin County Judge Mary Vasaly. This presentation is part of the Minnesota State Bar Association’s CLE programming. Learn more.
Emma Denny has successfully litigated cases in state and federal court and negotiated favorable resolutions for clients facing discrimination, whistleblower, harassment, FMLA, ERISA, disability and religious accommodation, wage, retaliation, contract agreements and a host of other disputes. Learn more about Emma Denny.
MINNEAPOLIS, MINN (February 4, 2020): Halunen Law is pleased to announce Gerald C. Robinson was recently made a Partner at the firm. Robinson joined Halunen Law in 2017 and is highly respected for his proven track record, intellectual curiosity, and out-of-the-box thinking. Robinson has nearly 30 years of success in complex litigation, with an intense focus on False Claims Act (FCA) cases since 2005. Having worked on FCA cases that collectively recovered several hundred million dollars, including making significant contributions to the development of a nationwide pharmaceutical case that settled for $360 million, Robinson brings a valued depth of experience to Halunen Law ‘s False Claims Act/Whistleblower team.
“Gerald’s keen ability to hone-in on details, develop and compile critical information, and create clear and successful legal paths forward is invaluable,” stated Clayton Halunen, founder and managing partner of Halunen Law. “His work on behalf of our whistleblower clients nationwide is exceptional, and we are pleased to recognize his work by making him a partner at the firm.”
Robinson earned his J.D. from the University of Minnesota, where he previously earned a B.A., cum laude, in International Relations, while garnering academic and leadership honors. He has authored and presented many legal articles. Robinson is licensed in three states, and holds admissions to the United States Supreme Court, three Federal Circuit Courts of Appeal, and several Federal District Courts. He has briefed, argued, and obtained reported decisions in cases on behalf of whistleblowers before the 4th, 8th, and 9th Circuits, and petitioned one case to the U.S. Supreme Court. He is an active member of Taxpayers Against Fraud, Minnesota Association for Justice, the Federal Bar Association, and numerous other professional organizations.
Amanda Crain and Colin Pasterski recently presented at the Minnesota Lavender Bar Association (MLBA) 19th Annual Conference on Saturday, February 1, 2020. The MLBA proudly supports the LGBTQ+ Community and promotes equality and diversity in hopes of creating a community supportive of all professionals. Amanda and Colin’s presentation took a deep dive into the three cases currently under advisement by the Supreme Court of the United States, which will determine whether Title VII of the 1964 Civil Rights Act prohibits discrimination on the basis of sexual orientation and transgender status.
Lawsuit: Roche Pharma misrepresented flu drug’s ability to contain influenza pandemic
BALTIMORE – Drug company Hoffmann-La Roche (OTCMKTS – RHHBY) bilked U.S. federal and state governments out of $1.5 billion by misrepresenting clinical studies and falsely claiming that its well-known influenza medicine Tamiflu was effective at containing potential pandemics, according to a recently unsealed whistleblower lawsuit.
The lawsuit claims the drugmaker’s scheme involved publishing misleading articles falsely stating that Tamiflu reduces complications, severity, hospitalizations, mortality and transmission of influenza. The company then used those articles to aggressively market the drug to the government for pandemic use. Relying on the supposed truthfulness of Roche’s claims, federal and state governments spent about $1.5 billion to stockpile Tamiflu to combat influenza pandemics, according to the complaint.
“As alleged in the complaint – Tamiflu does not do what Roche promised,” said attorney Mark Lanier of the Houston-based Lanier Law Firm. “Roche hid this fact for many years by selectively citing its studies and suppressing the data about Tamiflu. The company utilized lobbyists, key opinion leaders and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic.”
The lawsuit brings claims under the False Claims Act, which allows individuals to bring claims on behalf of the government. Unsealed on September 10, the lawsuit seeks reimbursement of taxpayer funds spent to purchase tens of millions of courses of Tamiflu for the Strategic National Stockpile. Roche is vulnerable to a judgment in excess of $4.5 billion because the False Claims Act mandates payment of triple damages, plus civil penalties.
Whistleblower Dr. Thomas Jefferson, a physician and public health researcher affiliated with the respected global Cochrane Collaboration research network, has researched neuraminidase inhibitors like Tamiflu for more than two decades. He began questioning Tamiflu’s efficacy in 2009 and spearheaded efforts to have the company release the underlying clinical study data. When he finally received the data in 2013, Dr. Jefferson analyzed it and concluded that the clinical data does not support Roche’s claims about Tamiflu’s effectiveness for use in an influenza pandemic, the lawsuit states.
According to the data as analyzed by the Food and Drug Administration, Tamiflu’s effectiveness is limited to a small benefit of reducing the duration of flu symptoms and preventing onset of symptoms but not transmission or infection. In addition, as early as 2000, the FDA had warned Roche that data did not support its broader efficacy claims and that such statements were misleading.
“The lawsuit alleges that Roche was well aware that Tamiflu is an ineffective product for fighting influenza pandemics,” said attorney Clayton Halunen of Minneapolis-based whistleblower law firm Halunen Law. “Yet Roche masterfully marketed this drug to fill Roche’s coffers at taxpayer expense. This is precisely the type of corporate behavior the False Claims Act is designed to stop.”
The case is United States of America, ex rel. Thomas Jefferson, et al. v Roche Holding AG, Hoffman-La Roche Inc., and Genentech Inc. in the U.S. District Court for the District of Maryland. Case No. 14-CV-03665.
About the Lanier Law Firm
For more than 30 years, the men and women at the Lanier Law Firm have worked tirelessly, throughout the United States, to find unique and effective solutions for their clients. More than 60 skilled attorneys practice law in a broad array of areas, including business litigation, pharmaceutical litigation, asbestos exposure, oil and gas litigation, personal injury, and defective and dangerous products, among others. Named an Elite Trial Law Firm by The National Law Journal, the Lanier Law Firm has offices in Houston, New York, Los Angeles and Oklahoma City. To learn more about Mark Lanier and the Lanier Law Firm, visit http://www.lanierlawfirm.com.
About Halunen Law
With offices in Minneapolis, Chicago and Phoenix, Halunen Law offers experienced legal representation to employees and whistleblowers across the country. Halunen Law has achieved a reputation as a fearless, tenacious and successful plaintiffs’ law firm, with a laser focus on achieving justice for its clients as well as meaningful social change. The firm’s qui tam / whistleblower practice group specializes in actions under the federal and state False Claims Acts and other whistleblower laws.
Heidi Weber talks in-depth with Clayton Halunen, founder of Halunen Law, in Season One, Episode Two of her podcast, the Whistleblower Revolution. They cover whistleblower laws, protections available to whistleblowers, steps to take when blowing the whistle, and what goes into bringing a case to trial. This podcast is a welcome reunion for Weber and Halunen. Halunen represented Weber in her 2013 landmark case against Globe University.
Get to Know Heidi Weber and Clayton Halunen
Halunen and Weber share the journey they experienced in their successful challenge of Globe University. Halunen offers insight into his long-standing professional motivation to hold companies and corporations responsible for illegal actions. He explores the impact his work has on creating societal change, and the obstacles whistleblowers face in bringing their concerns to light through a legal process. The podcast sheds light on the different types of whistleblowing claims, intricacies of the False Claims Act, the legal complexities of these cases, whistleblowers currently in the news, and much more.
We encourage you to listen and learn from these two engaging personalities as they offer personal perspective and professional expertise on those courageous enough to blow the whistle on wrongdoing.
About Heidi Weber: As Dean of the Globe Medical Assistant Program, Heidi Weber was fired in April 2011. She claimed the for-profit school engaged in consumer fraud by making misleading statements to students about its job placement rates and failing to meet its commitment to place all qualified medical assistant program students in externship programs, according to the court record. Rather than address her concerns constructively, Globe University officials chose to silence her by firing her. Represented by Clayton Halunen and Ross Stadheim of Halunen Law in Minneapolis, Weber won a $400,000 verdict in a civil court case in 2013.
About the Whistleblower Revolution: The launch of Weber’s Whistleblower Revolution podcast provides whistleblowers from around the country a unique space to share their stories. With her fierce spirit and empathetic approach, Weber highlights the daunting task of blowing the whistle and the personal toll the ordeal can take.
Halunen Law is proud to sponsor Season One of the Whistleblower Revolution podcast.
Episode 2: Whistle 101 with Clayton Halunen
This episode is 1 hour long
An experienced and respected former Assistant United States Attorney, Lon Leavitt has extensive experience handling successful investigations and cases under the False Claims Act. As a participant in two presentations at the upcoming HCCA Scottsdale Healthcare Compliance Conference on November 8, he will share his valuable expertise and professional perspective with members of the healthcare compliance community.
In the first presentation titled “Prosecution and Defense: Points of Collaboration and Contention,” Leavitt will be joined by Frank Sheeder, a partner at Alston & Bird, who represents defendants in FCA cases. Together they will review several FCA-related issues and discuss recurring divergent viewpoints, how to establish collaboration and cooperation, and practical approaches in government investigations.
The second presentation, “Communicating With Regulators & Enforcement: Avoiding Pitfalls,” will feature a panel discussion with federal and state law enforcement officials. As a former Assistant United States Attorney, and now in private practice with Halunen Law, Leavitt will bring unique insight to this panel, providing both the government’s and relator’s counsel’s perspective. The panel will cover topics including:
- The consequences of receiving regulatory inquiries and how a government investigation can impact a provider’s reputation, bottom line, and time.
- The importance of building a good working relationship with government representatives.
- The need for accurate, timely, and complete disclosure when reporting or self-disclosing to government representatives.
Leavitt joined Halunen Law after a successful 12-year tenure as an Assistant United States Attorney in the District of Arizona, one of the largest and busiest federal districts in the country. In that role, he managed FCA investigations and litigation on behalf of the federal government in a wide range of fields, including health care, defense, and education. Leavitt is especially knowledgeable in health care fraud enforcement, having pursued cases successfully against hospitals, hospices, physician groups, and other health care providers. Based in Halunen Law’s Phoenix office, Leavitt is a member of the Firm’s nationally-recognized Qui Tam/Whistleblower practice group.
About the HCCA: Established in 1996, Health Care Compliance Association (HCCA)® is a member-based association for healthcare compliance professionals. Serving more than 12,000 members across the country, HCCA is dedicated to enabling the lasting success and integrity of those working in, working with, or supporting healthcare organizations. Learn more.
The rise of the gig economy and increase in the use of arbitration agreements/class action waivers have yielded some interesting developments, particularly with respect to the question of how those agreements are applied (or not) to workers who drive for companies like Uber, Amazon, etc. Chris Moreland, Halunen Law partner and chair of the employment practice group, will examine current legal cases, developments, and insights on this timely topic at the 46th Annual Labor & Employment Law Institute.
As moderator of the session, “Current Trends and Topics in Arbitration Agreements and Class Action Waivers,” Chris will share what he has learned over the course of his 20 years representing workers in state and federal courts across the country. He will be joined by attorneys Reena I. Desai and Marko J. Mrkonich for the panel discussion.
The conference, which will be held on November 21 in Minneapolis, Minnesota, is presented by the Minnesota State Bar Association, Labor & Employment Law Section, the Minneapolis Office of the Equal Employment Opportunity Commission, and Minnesota Continuing Legal Education.
Chris Moreland is the Chair of Halunen Law’s Employment Litigation Practice Group. His national practice includes substantial verdicts for his clients in state and federal courts across the country, as well as a significant appellate practice, including arguments in the Supreme Courts of Minnesota, Nebraska, and Montana. Chris was selected several times to the Super Lawyers Rising Star list, and in 2018, he was selected to the Minnesota Super Lawyers list. Learn more about Chris and his work at Halunen Law.
Halunen Law, a nationally known plaintiffs’ law firm, is pleased to announce Lon R. Leavitt has joined the firm’s False Claims Act practice group as a partner. An experienced and respected former Assistant United States Attorney, Leavitt has deep expertise with the False Claims Act. He has handled dozens of investigations and cases that collectively returned tens of millions of dollars to the United States government. Leavitt will be based in Halunen Law’s new Phoenix office.
Leavitt joins Halunen Law after a successful 12-year tenure as an Assistant United States Attorney in the District of Arizona, one of the largest and busiest federal districts in the country. In that role, he managed False Claims Act investigations and litigation on behalf of the federal government in a wide range of fields, including health care, defense and education. Leavitt is especially knowledgeable in health care fraud enforcement, having pursued cases successfully against hospitals, hospices, physician groups, and other health care providers. For nearly 10 years, Leavitt also served as the Affirmative Civil Enforcement Coordinator and the Civil Health Care Fraud Coordinator for the District of Arizona. Before serving as a federal prosecutor in Arizona, Leavitt served as a Special Assistant United States Attorney in the District of Nevada, representing the federal government in civil fraud matters, criminal and civil asset forfeiture cases, and other civil litigation.
“Lon’s vast experience as a prosecutor for the federal government is invaluable,” said Clayton D. Halunen, managing partner. “We are delighted he is now part of our firm and our FCA practice group. We anticipate his experience and understanding of the government’s approach to FCA litigation will help advance the causes we believe in so strongly—eliminating fraud against the government and supporting whistleblowers.”
“The need for courageous whistleblowers to come forward—and their need for excellent representation and protection—has never been greater,” said Leavitt. “Halunen Law is an outstanding group of top-flight litigators and professionals with a great approach to the practice of law and a proven track record of success. I am excited about this unique opportunity to expand the reach and resources of the firm’s False Claims Act practice group and partner with them in the continued fight for justice on behalf of whistleblowers and the United States.”
Leavitt has received several awards, recognitions and commendations for his work, including the United States Department of Health and Human Services Inspector General’s Integrity Award. A frequent speaker at professional conferences, Leavitt has given numerous presentations and training sessions dealing with the False Claims Act, civil enforcement and health care fraud. Leavitt earned his law degree from the William S. Boyd School of Law at the University of Nevada Las Vegas and a bachelor’s degree, summa cum laude, in Political Science and Spanish from Southern Utah University.
About Halunen Law
With offices in Minneapolis, Chicago and Phoenix, Halunen Law offers experienced legal representation to employees and whistleblowers across the country. Halunen Law has achieved a reputation as a fearless, tenacious and successful plaintiffs’ law firm, with a laser focus on achieving justice for its clients as well as meaningful social change. The firm’s False Claims Act practice group specializes in actions under the federal and state False Claims Acts and other whistleblower laws. For more information contact us.
Phone: (312) 222-0660
Fax: (612) 605-4099
Phone: (602) 535-2203
Fax: (612) 605-4099