Archive for category: NEWS

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.

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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.

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.

Download the AMENDED COMPLAINT

Media Contact:

J.D. Cargill

713-659-5200

jdc@lanierlawfirm.com

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.