News
September 26, 2019 After Hours: 513-235-6655 alugbill@murphypllc.com mhanna@murphypllc.com
U.S. District Court in Akron Ohio Settlement of Over $ 108 Million for Murphy Anderson Whistleblower in Case Against Avanir For Medicare Pharmaceutical Fraud
False Claims Act Whistleblower Settlement Alleges Japanese-Owned Avanir Paid Doctors to Write Unnecessary Prescriptions for Neudexta, Doctors Indicted
Avanir Pharmaceuticals is accused of defrauding 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 Justice Department indicted four individuals for conduct related to Avanir's alleged scheme, including a physician who is mentioned in Mr. Manieri's lawsuit, Dr. Deepak Raheja of Cleveland, Ohio.
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, who was personally named in Mr. Manieri's complaint, received more than $56,000 in Avanir fees and wrote double the number of Neudexta prescriptions as any other doctor, far more prescriptions than is consistent with the number of patients who truly need such medication and actually have PBA.
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, allegedly without actually suffering from PBA.
Manieri’s whistleblower lawyers Ann Lugbill and Mark Hanna pointed out: “This Avanir Complaint 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. Avanir agreed to a Deferred Prosecution Agreement under federal criminal laws earlier this week in Georgia.
Mr. Manieri and two other whistleblowers who filed a second related FCA lawsuit against Avanir will each receive a share of any 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 pending before Judge Sara Lioi of the U.S. District Court for the Northern District of Ohio in Akron.
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), Neeli Ben-David (ND Georgia), 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 about the indictment.
Read Mr. Manieri's Complaint.
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September 26, 2019 202-223-2620/513-784-1280 After Hours: 513-235-6655 alugbill@murphypllc.com
U.S. District Court in Akron Ohio Unseals Case Against Avanir For Medicare Pharmaceutical Fraud
False Claims Act Whistleblower Settlement Alleges Japanese-Owned Avanir Paid Doctors to Write Unnecessary Prescriptions for Neudexta, Doctors Indicted
Avanir Pharmaceuticals is accused of defrauding 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 Justice Department indicted four individuals for conduct related to Avanir's alleged scheme, including a physician who is mentioned in Mr. Manieri's lawsuit, Dr. Deepak Raheja of Cleveland, Ohio.
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, who was personally named in Mr. Manieri's complaint, received more than $56,000 in Avanir fees and wrote double the number of Neudexta prescriptions as any other doctor, far more prescriptions than is consistent with the number of patients who truly need such medication and actually have PBA.
Other Nuedexta sales to nursing homes, long-term care facilities, and other institutional providers of care to the elderly and disabled occurred, where many individuals were prescribed the drug, allegedly to sedate them but without actually suffering from PBA.
Manieri’s whistleblower lawyers Ann Lugbill and Mark Hanna pointed out: “This Avanir Complaint 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. Avanir agreed to a Deferred Prosecution Agreement under federal criminal laws earlier this week in Georgia.
Mr. Manieri and two other whistleblowers who filed a second related FCA lawsuit against Avanir will each receive a share of any 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 pending before Judge Sara Lioi of the U.S. District Court for the Northern District of Ohio in Akron.
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.
. 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 about the indictment.
Read Mr. Manieri's Complaint.
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Ann Lugbill and Mark Hanna Join United States Department of Justice and United States Attorneys Office of the District of Columbia in Announcing $ 56 million False Claims Act and FDA Settlement involving Novo Nordisk's diabetes drug, Victoza
September 5, 2017
The Department of Justice Press Release states:
Novo Nordisk Agrees to Pay $58 Million for Failure to Comply with FDA-Mandated Risk Program
Payments Resolve Allegations Highlighted in DOJ Civil Complaint and Recently Unsealed Whistleblower Actions
Pharmaceutical Manufacturer Novo Nordisk Inc. will pay $58.65 million to resolve allegations that the company failed to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza, the Justice Department announced today. The resolution includes disgorgement of $12.15 million for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) from 2010 to 2012 and a payment of $46.5 million for alleged violations of the False Claims Act (FCA) from 2010 to 2014. Novo Nordisk is a subsidiary of Novo Nordisk U.S. Holdings Inc., which is a subsidiary of Novo Nordisk A/S of Denmark. Novo Nordisk’s U.S. headquarters is in Plainsboro, New Jersey.
“Today’s resolution demonstrates the Department of Justice’s continued commitment to ensuring that drug manufacturers comply with the law,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making.”
In a civil complaint filed today in the U.S. District Court for the District of Columbia asserting claims under the FDCA, the government alleged that, at the time of Victoza’s approval in 2010, the Food and Drug Administration (FDA) required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. The REMS required Novo Nordisk to provide information regarding Victoza’s potential risk of MTC to physicians. A manufacturer that fails to comply with the requirements of the REMS, including requirements to communicate accurate risk information, renders the drug misbranded under the law.
As alleged in the complaint, some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint further alleges that Novo Nordisk failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza.
As alleged in the government’s complaint, after a survey in 2011 showed that half of primary care doctors polled were unaware of the potential risk of MTC associated with the drug, the FDA required a modification to the REMS to increase awareness of the potential risk. Rather than appropriately implementing the modification, the complaint alleges that Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification. Novo Nordisk has agreed to disgorge $12.15 million in profits derived from its unlawful conduct in violation of the FDCA.
“Novo Nordisk’s actions unnecessarily put vulnerable patients at risk,” said U.S. Attorney Channing D. Phillips for the District of Columbia. “We are committed to holding companies accountable for violating the integrity of the FDA’s efforts to ensure that doctors and patients have accurate information that allows them to make appropriate decisions about which drugs to use in their care. Working with the FDA and other law enforcement partners, we have sent a strong signal to the drug industry today.”
“Novo Nordisk Inc. sales representatives misled physicians by failing to accurately disclose a potential life threatening side effect of a prescription drug, and needlessly increased risks to patients being treated with this drug,” said Assistant Director in Charge Andrew W. Vale of the FBI’s Washington Field Office. “The FBI is committed to ensuring that the private industry provides honest and accurate risk information to the public and will continue to work closely with our law enforcement partners to investigate companies who do not comply with FDA-mandated policies.”
“We need to trust that pharmaceutical companies truthfully represent their products’ potential risks,” said Special Agent in Charge Nick DiGiulio for the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG). “We will continue to work with our partners to ensure federal health care dollars are spent only on drugs that are marketed honestly.”
Novo Nordisk will pay an additional $46.5 million to the federal government and the states to resolve claims under the FCA and state false claims acts. This portion of the settlement resolves allegations that Novo Nordisk caused the submission of false claims from 2010 to 2014 to federal health care programs for Victoza by arming its sales force with messages that could create a false or misleading impression with physicians that the Victoza REMS-required message about the potential risk of MTC associated with Victoza was erroneous, irrelevant, or unimportant and by encouraging the sale to and use of Victoza by adult patients who did not have Type II diabetes. The Food and Drug Administration (FDA) has not approved Victoza as safe and effective for use by adult patients who do not have Type II diabetes.
As a result of today’s FCA settlement, the federal government will receive $43,129,026 and state Medicaid programs will receive $3,320,963. The Medicaid program is funded jointly by the state and federal governments.
The FCA settlement resolves seven lawsuits filed under the whistleblower provision of the federal FCA, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuits are captioned as follows: United States, et al. ex rel. Kennedy, v. Novo A/S, et al., No. 13-cv-01529 (D.D.C.), United States, et al. ex rel. Dastous, et al. v. Novo Nordisk, No. 11-cv-01662 (D.D.C), United States, et al., ex rel. Ferrara and Kelling v Novo Nordisk, Inc., et al., No. 1:11-cv-00074 (D.D.C.), United States, et al., ex rel. Myers v. Novo Nordisk, Inc., No. 11-cv-1596 (D.D.C.), United States, et al. ex rel Stepe v. Novo Nordisk, Inc., No. 13-cv-221 (D.D.C.), United States et al. ex rel Doe, et al. v. Novo Nordisk, Inc., et al., No. 1:17-00791 (D.D.C.), and United States ex rel. Smith, et al. v. Novo Nordisk, Inc., Civ. Action No. 16-1605 (D.D.C.). The amount to be recovered by the private parties has not been determined.
The settlements were the result of a coordinated effort among the U.S. Attorney’s Office for the District of Columbia and the Civil Division’s Consumer Protection Branch and Commercial Litigation Branch, with assistance from the FDA’s Office of Chief Counsel. The investigation was conducted by the FDA’s Office of Criminal Investigations, the FBI, HHS-OIG, the Defense Criminal Investigative Service and the Office of Personnel Management, Office of the Inspector General.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information on the Commercial Litigation Branch’s Fraud Section, visit https://www.justice.gov/civil/fraud-section. For more information about the U.S. Attorney’s Office for the District of Columbia, visit https://www.justice.gov/usao-dc.
Ann Lugbill Speaks on Government Procurement Fraud at Taxpayers Against Fraud Conference in Washington, D.C. Mayflower Hotel September 15, 2016
Ann Lugbill of Murphy Anderson PLLC focused her presentation on challenging legal issues facing lawyers who venture beyond healthcare and pharmaceutical drug marketing and safety False Claims Act qui tam cases. Ann led discussions on her experiences with False Claims Act procurement of specialized services, such as computer hardware and machine tools, jet engine, helicopter, and other military hardware; state and federal procurement of construction projects and products, including security systems and roofing, as well as procedures around classified information, new theories of liability, and common types of procurement fraud.
The record $2.3 billion criminal and civil settlement paid by Pfizer Inc. for illegally marketing perscription drugs, and concerns about drug company influence on the practice of evidence-based medicine, with former Pfizer employee and whistleblower Glenn DeMott, his attorney Ann Lugbill, and PharmedOut.org Principal Investigator Dr. Adriane Fugh-Berman.
--WOSU Radio Interview Listen Now
If Greg Rudolph had not courageously reported to the Government, it 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, represented Greg Rudolph. Government attorneys include Beverly Russell, DC Assistant US Attorney and Arnold Auerhan, US Department of Justice.
--- Providence Journal, Rhode Island, "$61 Million False Claims Act Roofing Settlement--RPM International, Inc. and Tremco, Inc. Government Services Administration (GSA) False Claims Act Case," September 3, 2013 (edited).
December 20, 2013
Justice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
Second Largest Annual Recovery in History Whistleblower Lawsuits Soar to 752
The Justice Department secured $3. 8 billion in settlements and judgments from civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2013, Assistant Attorney General for the Civil Division Stuart F. Delery announced today. This dollar amount, which is the second largest annual recovery of its type in history, brings total recoveries under the False Claims Act since January 2009 to $ 17 billion – nearly half the total recoveries since the Act was amended 27 years ago in 1986. ****
The department also settled allegations of false claims with two companies in connection with their contracts with the General Services Administration (GSA) to market their products through the Multiple Award Schedule (MAS) program. To be awarded a MAS contract, and thereby gain access to the broad government marketplace, contractors must provide GSA with complete, accurate and current information about their commercial sales practices, including discounts afforded to their commercial customers. The government alleged that ... Ohio-based RPM International Inc. and its subsidiary, Tremco Inc., a roofing supplies and services firm, failed to disclose discounts given to their commercial customers, which resulted in government customers paying higher prices. The department recovered ... in a settlement ...$61 million from RPM International Inc. and Tremco. (emphasis supplied).
Glenn DeMott of Upper Arlington outside Columbus is hardly a household name, though in the annals of whistleblowing, perhaps he should be. Pfizer paid $2.3 billion in 2009 to the government to settle civil and criminal allegations that it had improperly marketed drugs, including the painkiller Bextra, now withdrawn, after Demott and a handful of other employees challenged such practices.
****"He is highly principled," his attorney Ann Lugbill said of Demott. "He has a very strong sense of right and wrong."
Demott said he would speak up about corporate wrongdoing again. But he wouldn't complain internally. He said he would get a lawyer on his side like Lugbill, experienced in whistleblowing laws, before opening his mouth.
--The Plain Dealer (Cleveland, Ohio), by Alison Grant, September 07, 2012, Whistleblowers at Pfizer, Eaton rival face personal and professional fallout
"The government contracts are designed for honest contractors," Lugbill said, noting that companies sign agreements that they will conduct business according to law. "We do not want the government to spend time policing contracting, so they can use taxpayer resources to move troops and families. ... You can't fault the government for people committing criminal acts," she said.
--Military Times, May 2008.
[F]ew whistleblowers have any education about the process. Even when whistleblowers have knowledge, they may not avoid retaliation. ****Obtaining early legal counsel can help whistleblowers avoid some problems with administrations and can acquaint them with federal and state statutes for the protection of whistleblowers, says Ann Lugbill, an Ohio attorney who specializes in such cases.****"One of the reasons ... to get a lawyer early on is because there are some things that you could do that would preclude [you] from bringing a law suit later," Lugbill says.
--The Scientist, "When You Must Report Misconduct," by July 22, 2002.
“One of the reasons … to get a lawyer early on is because there are some things that you could do that would preclude [you] from bringing a law suit later,” Lugbill says. “There are some things … that might seem to be legal but aren’t, such as violating trade secret rules.”
--The Whistle: Newsletter of Whistleblowers Australia
Pfizer must pay $2.3 billion
A Franklin County man who worked for Pfizer Inc. and was a whistle-blower in a case against the company will get a piece of the drugmaker's record $2.3 billion criminal and civil settlement with the federal government. ****
Officials said this is the largest criminal fine in U.S. history -- $1.2 billion. The agreement also includes $1 billion in civil penalties and a criminal forfeiture of $105 million.
They called Pfizer a repeat offender, noting that this is the fourth time it's settled government charges in the past decade. The government will monitor the company's conduct for the next five years to rein in the abuses.
Federal officials said Pfizer marketed drugs by inviting doctors to consultant meetings at resort locations, paying their expenses and providing perks.
"They were entertained with golf, massages and other activities," said Mike Loucks, the U.S. attorney in Massachusetts. ****
Six corporate whistle-blowers, including Glenn Demott of Upper Arlington...brought the misconduct to light...
--Columbus Dispatch, by Suzanne Hoholik, "Pfizer must pay $2.3 billion, Upper Arlington man helped blow whistle on drugmaker's marketing," September 3, 2009