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As False Claims Act attorneys, and especially attorneys who represent clients that have the courage to blow the whistle on fraud against the federal government, we are pleased to see that a federal judge in New York has approved a settlement involving the improper false claims and use of Aransep.  The following will give a summary of this development which totals to $762 Million Dollars.

Bloomberg News (12/20, Smythe, 1M) reports, “A federal judge accepted Amgen Inc.’s plea agreement on a charge that it misbranded its anemia drug Aranesp, putting to rest a five-year probe of the company’s marketing practices.” US District Judge Sterling Johnson in Brooklyn, NY, signed off Wednesday “on the agreement with prosecutors, which will cost the company $150 million in criminal penalties. Amgen will also pay $612 million to settle civil claims by states and whistle-blowers alleging the company also illegally marketed other drugs. The company’s guilty plea and resolution of civil cases ‘demonstrate our vigilance in protecting American’s health-care consumers and pursuing any corporation that seeks to profit by violating U.S. Law,’ Marshall L. Miller, head of the criminal division for the Brooklyn U.S. Attorney’s office, said in a statement.”

MarketWatch (12/20, Spain) reports, “The plea is part of a settlement the company has made to avoid further criminal and civil liability and is the largest ever of its kind to involve a biotechnology firm. Amgen owned up to the charge of illegally pushing its Aranesp drug for ‘off-label’ uses in order to boost sales ‘and reap the resulting profits,’ the DOJ said. Under terms of the deal Amgen will pay a criminal fine of $136 million and forfeit another $14 million. It will also pay $587.2 million to the federal government and $24.8 million to individual states to resolve claims of Medicare, Medicaid and other government insurance fraud.”

The Danbury (CT) News Times (12/19, Varnon, 18K) reports, “New York Attorney General Eric T. Schneiderman said Wednesday, pharmaceutical maker Amgen has agreed to a $612 million national settlement of allegations it illegally marketed some drugs for use to treat kidney disease and cancer for a decade. The company also pleaded guilty to a misdemeanor in federal court that will require [it] to pay a $150 million fine.” The Times continues, “The agreement, reached with the 50 states and the District of Columbia, also settles allegations that Amgen fixed drug prices and paid kickbacks to health care professionals, which included the filing of false claims for Medicare reimbursement by doctors.”

The New York Times (12/20, Pollack, Subscription Publication, 1.68M) reports, “Jill Osiecki, a longtime sales representative at Amgen,” cooperated with the Department of Health and Human Services by wearing a recording device under her clothes and recording an Amgen manager who “boasted of how she had given a $10,000 unrestricted grant to a pet project of a doctor who was an adviser to the local Medicare contractor. In turn, she said, the doctor would help persuade the contractor to provide reimbursement for an unapproved use of Amgen’s anemia drug, Aranesp.” Ms. Osiecki, along with other whistle-blowers, provided the evidence that the government needed to secure the settlement.

MORE ON THE ARANSEP SETTLEMENT

Earlier today, at the federal courthouse in Brooklyn, New York, U.S. District Judge Sterling Johnson, Jr. accepted a guilty plea by American biotechnology giant Amgen Inc. (Amgen) for illegally introducing a misbranded drug into interstate commerce. The plea is part of a global settlement with the United States in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs. The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.

The announcement was made by Stuart F. Delery, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division; Marshall L. Miller, Acting U.S. Attorney for the Eastern District of New York; Jenny A. Durkan, U.S. Attorney, Western District of Washington; Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts; Thomas O’Donnell, Special Agent in Charge, U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), New York Regional Office; John Roth, Director, U.S. Food and Drug Administration (FDA), Office of Criminal Investigations; Eric Schneiderman, New York State Attorney General; and George Venizelos, Assistant Director in Charge of the FBI’s New York Field Office; along with numerous law enforcement and regulatory partners.

As part of the plea agreement and criminal settlement, Amgen entered a guilty plea yesterday before U.S. District Judge Sterling Johnson of the Eastern District of New York to a criminal information charging the company with illegally introducing a misbranded drug, Aranesp, into interstate commerce. Under the Food, Drug and Cosmetic Act, it is illegal for drug companies to introduce into the marketplace drugs that the company intends will be used “off-label,” i.e., for uses or at doses not approved by the FDA. Aranesp is an erythropoiesis-stimulating agent (ESA) that was approved by the FDA at calibrated doses for particular patient populations suffering from anemia. In order to increase sales of Aranesp and reap the resulting profits, Amgen illegally sold the drug with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved. Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.

As part of the civil settlement, Amgen has agreed to pay $612 million ($587.2 million to the United States and $24.8 million to the states) to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. The federal civil settlement agreement encompasses allegations that Amgen: (1) promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs; (2) offered illegal kickbacks to a wide range of entities in an effort to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary; and (3) engaged in false price reporting practices involving several of its drugs. As part of the global settlement, Amgen has also agreed to enter into a Corporate Integrity Agreement (CIA) with HHS-OIG that will govern its conduct, and ensure careful oversight of its branding and marketing practices.

“Today’s resolution reinforces the Department of Justice’s commitment to cracking down on unlawful conduct by pharmaceutical companies,” said Civil Division Principal Deputy Assistant Attorney General Delery. “When drug companies improperly misbrand their products, they not only could put individual patients at risk, but they also undermine the federal health care system that protects all of us.”

“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease. Americans expect – and the law requires – much more. Today’s settlement demonstrates our vigilance in protecting America’s healthcare consumers and pursuing any corporation that seeks to profit by violating U.S. law,” said Acting U.S. Attorney of the Eastern District of New York Miller. “To all who might consider introducing misbranded drugs into the marketplace, you are on notice: we remain steadfastly committed to prosecuting such violations of law.” Mr. Miller also expressed his appreciation to the Offices of Inspector General for the Department of Defense, the Office of Personnel Management and the Veterans Administration for their assistance.

“The public has been well served by this investigation and the FDA commends the efforts of the U.S. Attorney’s Office in the Eastern District of New York, the Department of Justice and the other law enforcement agencies that worked with us to vigorously pursue this matter,” said John Roth, Director of the FDA’s Office of Criminal Investigations in the FDA’s Office of Regulatory Affairs. “Today’s settlement demonstrates our continued scrutiny of any illegal practices used by pharmaceutical and biotechnology companies.”

“Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public,” said FBI Assistant Director Venizelos. “Preserving the integrity of the pharmaceutical industry is important work, and the FBI will continue working with our colleagues in law enforcement to investigate and charge those who inappropriately market drugs for scurrilous profits.”

“This sends a powerful message to pharma companies: you must not put profits ahead of patients’ health and doctors’ trust. Drugs should be prescribed because they make people better, not because they make companies money,” said Western District of Washington U.S. Attorney Durkan. “The coordination by our office, the U.S. Attorney’s Offices in the Eastern District of New York and Massachusetts and Main Justice also shows that there is no corner of the country where these actors can hide.”

“Today’s resolution is a testament to coordination and cooperation throughout the Department of Justice to ensure drug manufacturers are held to account and fraud is properly addressed,” said Massachusetts U.S. Attorney Ortiz. “The District of Massachusetts is proud to have played a role in the resolution of this matter, and in ensuring that drug manufacturers’ claims regarding their products are truthful and properly supported.”

“There are no excuses for illegally marketing off label drugs, offering kickbacks to health care professionals and ripping off the taxpayers by defrauding Medicaid and other programs,” said New York State Attorney General Schneiderman. “With this settlement the message we are sending is clear: biotechnology giants are not above the law, and my office will continue to ensure that prescriptions be written based on medical judgment – not profit motive.”

If you have information about any alleged fraud against the government, please contact us immediately.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

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