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False Claims Act Lawyer Discusses Par Pharmaceutical Settlement

As attorneys that represent individuals and entities that blow the whistle on fraud in the medical and healthcare industries including for pharmaceutical drug and medical device companies, it was refreshing to see that Par Pharmaceuticals has agreed to pay $45  million dollars to resolve civil and criminal allegations related to off label marketing.

New Jersey based Par Pharmaceuticals Companies, Inc. pleaded guilty in federal court on March 5, 2013 and agreed to pay $45 million dollars to resolve the company’s promotion of its prescription drug Megace es for uses not approved as safe and effective by the Food and Drug Administration.  Chief Executive Officer Paul B. Capanelly pleaded guilty on behalf of Par.  Federal courts have fined for $18 million dollars and ordered $4.5 million in criminal forfeiture.  Par also agreed to pay $22.5 million to resolve its civil liability.

Par pleaded guilty to an information charging it with a criminal misdemeanor for mis-branding Megace es in violation of the Federal Food, Drug and Cosmetic Act.  The drug is one that was approved by the FDA to treat Anorexia or other significant weight loss suffered by patients with AIDS.  Megace, however, was distributed nationwide by Par as mis-branded because it lacked adequate directions for use in the treatment of non-Aids related geriatric wasting a use that was intended by Par but never approved by the FDA.  Once approved, a drug may not be distributed in interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.

The civil settlement resolves allegations that Par, by promoting the sale and use of Megace for uses that were not FDA approved, caused false claims to be submitted to Medicare programs.  The United States alleged in the lawsuit brought initially by a Relator that Par deliberately and improperly targeted sales to elderly nursing home residents with weight loss, whether or not such patients were suffering from Aids, and loss a long term care sales force to market to this population.  During this marketing campaign, Par was allegedly aware of adverse side effects associated with the use of magistral in elderly patients, including an increased risk of deep vein thrombosis, toxic reactions, impaired renal function, and mortality.  Par allegedly made unsubstantiated and misleading representations about the superiority of the drug over other products, and encouraged providers to switch patients from generic Magistral acetate to Megace es despite having conducted no well controlled study to support a claim for greater efficacy.

The settlement resolves three lawsuits filed under the whistle blower provisions of the False Claims Act, including three different cases filed in New Jersey.  As part of the settlement, Relators Makim and Combs (who filed the first lawsuit) will receive $4.4 million dollars.

There are two important things to take out of this lawsuit.  The first is that there were three different Relators that filed a claim under the False Claims Act, but only one will receive any monies.  The last two will receive nothing because the False Claims Act only allows recovery by the first in time in filing a case.  Second, it reminds us all that it takes individuals willing to blow the whistle on fraud in order to correct wrongdoing by companies including pharmaceutical company and medical device companies.

If you know of any potential fraud, call us today for a confidential evaluation so that we might of help.

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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