Murphy Anderson Lawyers Fighting Big Pharma Kickbacks to Doctors
Avanir Pharmaceuticals, Inc. Agrees To Pay $103 Million For Medicare Pharmaceutical Fraud
False Claims Act Whistleblower Settlement Alleges Japanese-Owned Avanir Paid Doctors to Write Unnecessary Prescriptions for Neudexta
Avanir Pharmaceuticals will pay $103 million to settle 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. That doctor was indicted today in the U.S. District Court for the N.D. of Ohio 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 whistleblower lawyers Ann Lugbill and Mark Hanna pointed out: "This $103 million Avanir settlement 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 after today's settlement, in which Avanir paid $103 million payment under the FCA and several similar anti‑fraud state laws and agreed to a Deferred Prosecution Agreement under federal criminal laws.
Mr. Manieri and two other whistleblowers who filed a second related FCA lawsuit against Avanir will each receive a share of the Government's 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. Interestingly, Avanir's current president formerly lives in the area and obtained a business degree in Akron.
In addition to the settlement payment, Avanir 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.
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 After hours contact is (513) 235-6655.
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Victoza Settlement Impact on Policing Drug Safety Dangers: The False Claims Act's Enforcement of FDA REMS - Risk Evaluation and Mitigation Strategies
As shown by the Department of Justice's September 5, 2017 announcement of a $ 56 million False Claims Act qui tam whistleblower settlement involving the Novo Nordisk diabetes drug, Victoza, the Department of Justice (DOJ), and the federal Food and Drug Administration (FDA) can now use the False Claims Act to protect patients from unsafe drugs. The False Claims Act can be employed to prevent pharmaceutical companies from using slick marketing tactics to avoid Congressionally-mandated drug safety warnings and patient protections, the FDA's Risk Evaluation and Mitigation Strategies (REMS) law. The Murphy Anderson PLLC law firm and its lawyers, Ann Lugbill, Mark Hanna, and Michael Anderson worked closely with the Government lawyers to develop this new legal recovery theory, in the course of representing their successful whistleblower clients, former pharmaceutical company insiders.
Had the False Claims Act been earlier partnered with FDA drug safety communication and monitoring requirements back in the 1990's when opiate painkillers were heavily marketed as safe, even though they are now credited with spawning the heroin epidemic in the United States, countless deaths might have been avoided.
Under the FDA's innovative 2007 REMS statutory scheme, passed amidst a deluge of media reports of pharmaceutical companies failing to reveal potential risks of devastating adverse effects and death, drug companies must now comply with FDA requirements to conduct risk evaluation and mitigation efforts. These REMS efforts, individually tailored for each drug and the risks involved, require that drug companies engage in ongoing action to monitor potential hazards of newly-approved drugs and existing drugs and to warn doctors and patients of these risks. Victoza was subject to REMS safety obligations and the whistleblowers represented by Murphy Anderson alleged the company failed to abide by the REMS marketing restrictions.
With the Novo Nordisk settlement regarding Victoza, the False Claims Act provides an additional enforcement mechanism to REMS, as False Claims Act liability and damages can rest upon pharmaceutical marketing that violates FDA REMS safety obligations or endangers patients by downplaying and minimizing known risks. The False Claims Act applies when drugs are paid for with federal or state funds in programs like Medicare and Medicaid, federal health insurance programs, or in VA and military Hospitals.
The FDA currently lists, as of July 2017, some 70 FDA-approved prescription medicines subject to REMS obligations. The restrictions may limit where drugs are administered or may 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 as of July includes 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). The FDA REMS list also includes various opiods, anti-opiate dependence drugs, and testosterone and androgen hormonal drugs. To be safe, consumers and prescribers alike can monitor whether there is a current REMS warning impacting patient health decisions.