Pioneering Whistleblower Claims in the Global Arena

Pioneering Whistleblower Claims in the Global Arena

The Federal False Claims Act of the United States of America, along with the various state False Claims Acts, are having a global or international positive impact on the fight against fraud and unsafe practices. This is because many pharmaceutical manufacturing companies operate overseas. Generic manufacturers dominate the overseas manufacturing market, but sell their drugs to the largest market in the world — the United States.

These drug sales are dominated by the world’s largest payers of drug benefits, the United States government and its various state governments. These government benefit programs — Medicare, Medicaid, Tri Care, Veterans Administration and Correctional Facilities, for example — require drug manufacturers to adhere to certain pricing and safety requirements. A violation of these requirements, in many cases, is a violation of the False Claims Act. A whistleblowing informant who files appropriately under the False Claims Act may be able to claim to awards and protections.

The whistleblower doesn’t have to be an American citizen or legal resident to qualify for and receive awards. These awards can amount to between 15 and 30 percent of what the federal and or state governments collect from drug manufacturers or any company receiving or retaining government funds by way of false statements, fraud, kickbacks, illegal inducements, pricing violations, mis-manufacturing, off label marketing, off branding, unsafe packaging in or other violations of American law or regulations. Material breaches of American law that could have resulted in a denial of payment are also violations of the False Claims Act. Individuals, whether domestic or foreign, qualify as relators — people who may be entitled to large awards and are protected by the anti-retaliation laws of the United States and its state governments.

It has recently been reported that the Food and Drug Administration is planning surprise raids in India — based on the level and seriousness of violations of American law by Indian generic drug manufacturers. Previously, the FDA warned these drug manufacturers of pending inspections but, due to the level of safety and manufacturing violations that have been reported, these inspections will now be unannounced and by surprise.

The potential for fraud in India is enormous. The FDA has only increased its Indian inspection staff to 19 members from 12 and only has three offices in the entire country of India. Two of those were opened recently in Hyderabad and Mumbai; the first office was in New Delhi. This staff of 19 currently conducts these inspections for the entire sub-continent of Asia. When you consider that there are over 135 FDA-approved manufacturing units in India, servicing a Rs.1.1 trillion drug industry largely comprised of generics manufacturing, the small FDA staff has seemingly-impossible tasks at hand.

The main purpose of the False Claims Act is to assist the United States government in protecting the American people and taxpayers from fraud. However, with the size of the problem and the understaffed office of overseers in India, the potential for fraud there is rampant.
However, so is the opportunity for whistleblowers to assist the United States government in its battle against fraud and, at the same time, receive large financial awards.

If you have evidence or knowledge of such violations anywhere in the world against these aforementioned laws, you should call an experienced Qui Tam lawyer at Begelman & Orlow immediately. Learn more about why waiting may hurt your case! Call us for a free initial consultation today.

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