Press Releases
For More information, contact Murphy Anderson at 202-223-2620 or 513-784-1280*
Big Pharma Otsuka-owned Avanir Sued in False Claims Act Qui Tam Actions in Ohio and Georgia
Thanks to persevering False Claims Act qui tam whistleblower Kevin Manieri and his lawyers at TELG and Murphy Anderson PLLC in Washington and Ohio
*Alleged Physician Kickback Scheme to Prescribe Nuedexa is Revealed
* Criminal Indictments in Northern District of Ohio Federal Court
Avanir Pharmaceuticals, Inc. Accused of Medicare Pharmaceutical Fraud in False Claims Act Whistleblower Case Unsealed Today in Akron, Ohio
lleges Japanese-Owned Avanir Paid Doctors to Write Unnecessary Prescriptions for Neudexta
Avanir Pharmaceuticals is accused of claims that it defrauded Medicare and other government insurance programs by paying kickbacks to doctors in the form of speaker fees, in exchange for writing unnecessary Nuedexta prescriptions. The claims were originally raised by whistleblower Kevin Manieri in a False Claims Act (FCA) qui tam complaint filed in Akron, Ohio. Whistleblower Manieri is a former Avanir sales director and is represented by The Employment Law Group and Murphy Anderson PLLC attorneys.
The FDA approved Nuedexta for treating patients with a rare, non‑life threatening disorder, pseudobulbar affect (PBA), which causes spontaneous laughing or crying unrelated to the patient's emotional state. California‑based Avanir, a subsidiary of Japanese Otsuka Pharmaceutical Co., Ltd., manufactured the drug and publicized the rare disorder.
Mr. Manieri, an experienced sales director in the pharmaceutical industry, joined Avanir in 2014 to manage Neudexta sales in the northern United States. His Complaint alleges that he quickly learned that Avanir management was instructing sales representatives to promote Neudexta to a relatively few prescribers willing to prescribe Neudexta for patients with only a "bare minimum of symptoms," in exchange for thousands of dollars in speaking fees. One neurologist in the Cleveland/Akron area received more than $56,000 in Avanir fees and wrote double the number of Neudexta prescriptions as any other doctor, including a number who wrote far more prescriptions than is consistent with the number of patients who truly need such medication and actually have PBA. The indictment of this physician , Dr. Deepak Raheja, was announced today in Cleveland.
Another Avanir sales manager oversaw Nuedexta sales to nursing homes, long‑term care facilities, and other institutional providers of care to the elderly and disabled, where many individuals were prescribed the drug for what is a rare condition and difficult to diagnose, allegedly without actually suffering from PBA.
Manieri’s Murphy Anderson whistleblower lawyers Ann Lugbill and Mark Hanna pointed out: "This Avanir whistleblower lawsuit demonstrates how important a brave whistleblower is to our country's health and the Medicare budget. We should all thank whistleblowers like Kevin Manieri and his fellow Georgia whistleblowers who exposed the alleged kickback scheme to sell Nuedexta by getting unscrupulous doctors to prescribe an expensive drug for patients who did not need it‑‑many of these patients were elderly, disabled, or suffering from dementia."
After opposing the scam speaker fees, Mr. Manieri was terminated and filed a whistleblower complaint in 2015. The suit remained sealed while the U.S. Justice Department investigated the allegations, but is now public today. the Government seeks payment under the FCA and several similar anti‑fraud state laws. Avanir recently agreed to a Deferred Prosecution Agreement under federal criminal laws in Georgia.
Mr. Manieri and two other whistleblowers who filed a second related FCA lawsuit against Avanir will each receive a share of any proceeds from the case, such as in a settlement. Both the federal and state false claims acts empower whistleblowers to file "qui tam" lawsuits on the government's behalf, with the whistleblower receiving a portion of any recovery.
While the FCA prohibits employers from retaliating against whistleblowers who seek to prevent fraud, Mr. Manieri's whistleblower retaliation lawsuit against Avanir is still pending before Judge Sara Lioi of the U.S. District Court for the Northern District of Ohio in Akron.
Avanir is believed to have entered into a Corporate Integrity Agreement with the Department of Health & Human Services, intended to prevent its alleged misconduct from reoccurring. The company does not admit to wrongdoing in any of the settlements.
Mr. Manieri's attorneys include Ann Lugbill and Mark Hanna of Murphy Anderson in Cincinnati and Washington, D.C., and R. Scott Oswald and Janel Quinn of The Employment Law Group. The case was investigated and resolved on behalf of the United States by Assistant U.S. Attorneys Patricia M. Fitzgerald and Brendan F. Barker of the U.S. Attorneys Office for the Northern District of Ohio (Cleveland), and Natalie Waites, senior counsel for health care fraud at the U.S Justice Department in Washington, D.C. Counsel in the N.D. Georgia U.S. Attorneys Office also contributed to the result and investigated the companion Georgia qui tam action.
The settlement involves two cases against Avanir. Kevin Manieri, Murphy Anderson PLLC and The Employment Law Group, filed his qui tam action on March 30, 2015 in the U.S. District Court for the Northern District of Ohio: United States ex rel. Manieri v. Avanir Pharmaceuticals, Inc., et al., No. 5:15CV611. Duane R. Arnold and Mark A. Shipman, represented by Bondurant Mixson & Elmore LLP, filed their qui tam action on April 17, 2015, in the U.S. District Court for the Northern District of Georgia: United States ex rel. Arnold and Shipman, et al. v. Avanir Pharmaceuticals, Inc., No. 1:15-cv-01250.
Read DOJ's Press release here: www.justice.gov/civil/civil-division-press-room
Read Mr. Manieri's Complaint here: www.murphypllc.com/section/news
*********************************************************************************************************
Novo Nordisk Agrees to Pay $58 Million for Failure to Comply with FDA-Mandated Risk and Safety Program, "REMS"
Thanks to persevering False Claims Act qui tam whistleblowers and innovative Murphy Anderson PLLC lawyers in Washington and Cincinnati, the False Claims Act now prohibits unsafe drug marketing tactics.
In a first-of-its-kind settlement, Novo Nordisk, Inc., a Danish company, agreed to pay $ 46.5 million, according to the Department of Justice (DOJ) to resolve False Claims Act allegations and additional $ 12 million to the FDA. The settlement resolves whistleblower claims that Novo Nordisk did not comply with safety communications required by the federal Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) law. The FDA conditioned its approval of Victoza, a synthetic insulin for diabetes, upon Novo Nordisk's compliance with REMS.
The settlement was the result of whistleblowing former Novo Nordisk sales personnel, including those represented by Murphy Anderson lawyers Mark Hanna and Ann Lugbill, who alleged that Novo Nordisk defrauded federal Medicare, VA, and employee insurance programs and state Medicaid programs. The whistleblower suit alleges that doctors prescribed Victoza without adequate knowledge of safety issues. The Murphy Anderson whistleblowers alleged that Novo Nordisk, in order to maximize sales, failed to adequately inform prescribers of Victoza's medullary thyroid cancer risks.
The case demonstrates that the Civil War-era False Claims Act can be used to penalize pharmaceutical companies that use slick marketing tactics to avoid mandatory drug safety warnings and patient protections required by REMS. REMS was enacted by Congress in 2007, amidst an avalanche of media reports that pharmaceutical companies hid potential risks of harmful or fatal adverse drug effects. REMS requires manufacturers to conduct risk evaluation and mitigation efforts, individually tailored for each drug and its risks. REMS mandates that drug companies engage in ongoing action to study potential drug hazards and warn doctors and patients of risks. Consumers and prescribers alike can monitor current REMS warnings impacting prescription drug decisions.
Ann Lugbill explained that the REMS-False Claims legal theory utilized in this case is so significant that "had REMS' drug safety scheme been in place in the 1990's when opiate painkillers were marketed as safe and effective, our current heroin epidemic might not exist." With REMS in place and deployed with the False Claims Act, observed Mark Hanna, "countless overdoses might have been avoided and billions of dollars in law enforcement, drug treatment, and medical care saved."
The FDA currently lists, as of July 2017, some 70 FDA-approved prescription medicines subject to REMS safety obligations. The restrictions may limit where and by whom drugs are administered or require communications strategies so that prescribers or patients are more aware of the conflicting risks and benefits of medicines. The list of REMS-regulated drugs includes applications of Adasuve, Addyi, Afrezza, Alosetron, Aveed, Blincyto, Caprelsa, Clozapine, Emtricitabine/tenofovir disoproxil fumarate, Entereg, Farydak, Gattex, Iclusig, Juxtapid, Kynamro, Lemtrada, Lotronex, Mifeprex, Myalept, Mycophenolate, Nplate, Omontys, Pomalyst, Revlimid, Saxenda (liraglutide), Siliq, Thalomid (thalidomide), Trulicity (dulaglutide), Victoza (liraglutide),Vigabatrin, Xiaflex, Xultophy (insulin degludec and liraglutide), Zinbryta, Zydelig, Adempas, Bupropion, Extraneal, Isotretinoin iPLEDGE, Letairis, Opsumit, Prolia, Qsymia, Sodium Oxybate, Soliris, Tracleer, Tysabri, Vivitrol, Xyrem, and Zyprexa Relprevv (olanzapine). FDA's REMS list also includes various opiods, anti-opiate dependence drugs, and testosterone and androgen hormonal drugs.
$ 61 Million False Claims Act Roofing Settlement RPM International, Inc. and Tremco, Inc. Government Services Administration (GSA) False Claims Act Case
August 28, 2013 - Murphy Anderson PLLC announces unsealing of a $60,058,963 Department of Justice settlement with RPM International, Inc., and Tremco, Inc. Medina, Ohio-based RPM and Tremco, its subsidiary, paid $61 million to settle claims that Tremco submitted false claims to the United States.
Gregory Rudolph, Rocky River, Ohio, filed his whistleblower suit in 2010 alleging that Tremco illegally overcharged government agencies for roofing products and services, via the federal Government Services Administration (GSA) purchasing system. The United States investigated and intervened in his False Claims Act qui tam complaint. The United States will share 17.9% of the $ 61 million settlement with Rudolph.
Greg Rudolph voluntarily resigned as a Tremco vice president to report the alleged nationwide scheme. During the investigation, Rudolph educated federal attorneys and investigators about roofing. His new business, Raw Solutions, Inc., struggled in a down economy—aiming to provide quality, fairly-priced roofing and reputable roofing consultants.
If Greg Rudolph had not courageously reported the scheme, the Government would never have known—and never recovered the $ 61 million. His brave efforts saved taxpayers millions of dollars. Rudolph’s actions demonstrate that contractors must play by the rules when selling to the Government.
Attorneys Ann Lugbill of Cincinnati and Mark Hanna, with Murphy Anderson PLLC’s D.C. office, represented Greg Rudolph, with Ann-Marie Ahern of Cleveland, Ohio. Ms. Lugbill co-authored False Claims Act: Whistleblower Litigation and Representing the Terminated Employee in Ohio. Government attorneys include Beverly Russell, DC Assistant US Attorney and Arnold Auerhan, US Department of Justice.
Murphy Anderson proudly participates in NELA-National Employment Lawyers Association (NELA) and watchdog group Taxpayers Against Fraud. The public interest firm’s clients include whistleblowers in healthcare, construction, GSA pricing fraud, and procurement cases. The whistleblower practice includes international fraud schemes, owing to firm foreign language expertise. Murphy Anderson represented the late Glenn DeMott, Columbus, Ohio, who participated in the 2009 record-breaking $ 2.3 billion Pfizer whistleblower settlement. Murphy Anderson attorneys have counseled dozens of successful False Claims Act, SEC, and IRS whistleblowers.
The False Claims Act pays bounties to confidential whistleblowers working with the US Government to recover funds fraudulently obtained--over $25 billion since 1986.
Pfizer’s False Claims Act $ 2.3 Billion Settlement
The “Abe Lincoln Law” is –A Tool for Taxpayers, Whistleblowers and the Government to Fight Fraud
Today, September 2, 2009, Pfizer General Counsel Amy Schulman, the United States Department of Justice and the Attorneys General of many of the States announced a proposed settlement of $ 2.3 billion, including resolution of multiple False Claims Act qui tam actions alleging violations of the False Claims Act related to Pfizer’s provision of prescription pharmaceuticals to various government programs, including Medicare and Medicaid.
The settlement is part of an overall public-private partnership between False Claims Act qui tam whistleblower plaintiffs, like Murphy Anderson client, Glenn DeMott of Columbus, Ohio, one of the whistleblowers whose case is part of the overall settlement—and federal and state civil and criminal prosecutors. “With this settlement, the False Claims Act shows that it is a cost- effective way to attack and prosecute False Claims Act violations,” said Ann Lugbill, a Cincinnati attorney who is counsel to the law firm of Murphy Anderson, an active member of the watchdog group, Taxpayers Against Fraud, and co-author of the book, False Claims Act: Whistleblower Litigation. Murphy Anderson attorneys Mark Hanna, of Washington, D.C., and Michael Anderson of Boston, Massachusetts, and Ann Lugbill all represented Glenn DeMott in his qui tam whistleblower litigation.
“This record-breaking settlement is appropriately announced in the 200th anniversary year of the birth of Abraham Lincoln, the father of the False Claims Act,” remarked Lugbill.
As stated by Cincinnati, Ohio native and Secretary of Department of Health and Human Services Secretary Kathleen Sebelius: "This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,"said Kathleen Sebelius. "The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."
The False Claims Act makes clear that subcontractors cheating the government are liable under the False Claims Act and gives the U.S. Department of Justice additional abilities to fight fraud.
The False Claims Act works by paying a bounty to those whistleblowers who come forward and file a lawsuit, in partnership with the U.S. Government to recover funds that fraudulent contractors have received from the Government. The False Claims Act has been responsible for over $ 20 billion in recoveries from fraudulent contractors, since the 1986 Amendments. In virtually every year since 1986, recoveries have increased over the prior year. Over 1,000 False Claims Act cases are believed to be pending under seal, awaiting increased Government resources, agents, and lawyers to prosecute the fraudulent contractors.
This settlement shows the importance of the False Claims Act and the recent amendments in the Fraud Enforcement and Recovery Act (FERA) May 2009 and how they strengthen the Department of Justice’s ability to pursue fraud claims against those who cheat the Federal Government. While over 20 states, including New York, Michigan, Illinois, Indiana and Florida, now have their own False Claims Act, the States of Maryland, Ohio, and Kentucky still lack this important fraud-fighting law.
President Obama Signs Landmark False Claims Act Anti-Fraud Bill
The “Abe Lincoln Law” is Amended for the 21st Century—A Better Tool for Taxpayers, Whistleblowers and the Government to Fight Fraud
May 20, 2009 - Today, President Barack Obama signed into law the Fraud Enforcement and Recovery Act (FERA), strengthening the Department of Justice’s ability to pursue fraud claims against those who cheat the Federal Government.
The Amendments come at a welcome time, when whistleblowers seeking to report fraud against the Government want to help the Department of Justice recover billions of dollars in defense contracting, Medicare and Medicaid, and other fraud scheme. “With these amendments, the False Claims Act will provide the way to more effectively attack and prosecute unscrupulous contractors who bilk the Government,” said Ann Lugbill, a Cincinnati attorney who is counsel to the law firm of Murphy Anderson, an active member of Taxpayers Against Fraud and co-author of the book, False Claims Act: Whistleblower Litigation.
“This Lincoln Law amendment is appropriately passed in the 200th anniversary year of the birth of Abraham Lincoln, the father of the False Claims Act,” remarked Lugbill.
FERA was passed by strong and bipartisan majorities in the Congress, representing the first significant amendment to the False Claims Act since 1986, when President Reagan signed modernizing legislation to the venerable law.
The new False Claims Act as amended makes clear that subcontractors cheating the government are liable under the False Claims Act and gives the U.S. Department of Justice additional abilities to fight fraud.
The False Claims Act works by paying a bounty to those whistleblowers who come forward and file a lawsuit, in partnership with the U.S. Government to recover funds that fraudulent contractors have received from the Government. The False Claims Act has been responsible for over $ 20 billion in recoveries from fraudulent contractors, since the 1986 Amendments. In virtually every year since 1986, recoveries have increased over the prior year. Over 1,000 False Claims Act cases are believed to be pending under seal, awaiting increased Government resources, agents, and lawyers to prosecute the fraudulent contractors.