New York City Pharmaceutical Fraud Qui Tam Lawyers
In 2003, a chemical engineer took a job with a pharmaceutical company. Nine years later, he received a $49 million award from the government for exposing the company’s fraudulent practices and helping the government recover more than $500 million for numerous abhorrent violations of the False Claims Act.
The company was Ranbaxy, one of the world’s largest generic pharmaceutical manufacturers. While working for Ranbaxy, the engineer, Mr. Thakur, discovered that the company was selling its drugs without the data necessary to prove that they were “bioequivalent” to their non-generic counterparts. This meant that no one knew if the drugs did what they were supposed to or not. It also meant that no one knew if they had dangerous side effects.
Thanks to Mr. Thakur’s willingness to come forward, the government was able to take action against this unscrupulous pharmaceutical giant – recovering hundreds of millions of dollars and shutting down several of the company’s U.S. operations.
Whistleblowers’ Role in Fighting Pharmaceutical Fraud
While the Ranbaxy case may sound extreme, sadly, it is not all that far out of the ordinary. Each year, pharmaceutical companies bill the government billions of dollars for untested, unapproved, and unused drugs.
These and other common fraudulent practices are violations of the federal False Claims Act. Under the False Claims Act, individuals who have information about illegal practices can sue pharmaceutical companies on behalf of the government. If their claims are successful, they can receive up to 30 percent of the amount recovered in exchange for their willingness to come forward.
How Pharmaceutical Companies Put Patients at Risk and Defraud the Government
Pharmaceutical companies have found numerous ways to help doctors charge Medicare, Medicaid, and other government healthcare programs for near-unimaginable sums that are not rightfully owed. Along with paying and receiving kickbacks, some of the most common forms of pharmaceutical fraud include the following:
Off-Label Drug Marketing
All drugs marketed in the United States are subject to approval by the Food and Drug Administration (FDA). The FDA’s approval process is designed to protect consumers by preventing the sale of drugs that have not been proven to meet the government’s standards.
When a drug receives FDA approval, the approval is for certain specific uses under prescribed conditions. However, pharmaceutical companies will often market their “FDA-approved” drugs for unapproved uses. This is known as “off-label” marketing.
While doctors can prescribe off-label medications if doing so meets the appropriate standard of care, they generally cannot bill government programs for off-label prescriptions. Pharmaceutical companies and healthcare providers regularly face False Claims Act violations for improperly billing for off-label drugs.
Submitting False Information to the FDA
The FDA simply does not have the resources necessary to thoroughly test every new drug that comes onto the market. In order to prevent a backlog of approvals that could leave patients waiting years to receive potentially life-saving drugs, the FDA has established a program known as “510(k) program” that allows pharmaceutical companies to bypass the normal approval process. With the 510(k) program, drug companies can market their drugs without standard FDA approval if they provide evidence that their drugs are “substantially equivalent’’ to other drugs that are already on the market.
If you think this sounds like it is ripe for abuse, you are correct. Numerous pharmaceutical companies have faced liability under the False Claims Act for knowingly submitting false or incomplete information on 510(k) applications.
Even outside of the 510(k) process, pharmaceutical companies can use false information to wrongfully obtain FDA approval. One of the most common ways this is done is through misrepresenting the results of clinical trials. Companies have been known to both submit false data to the FDA and withhold information about negative side effects in order to get potentially-dangerous drugs on the market.
Violating Current Good Manufacturing Practice
Drug manufacturers are held to a strict set of standards, known as Current Good Manufacturing Practice (CGMP). CGMP covers everything from maintaining accurate quality control records to properly equipping manufacturing facilities. Failure to comply with CGMP is considered a form of pharmaceutical fraud. In fact, it was largely CGMP violations that led to the $500 million whistleblower case against Ranbaxy discussed above.
Pharmacies Can Also Violate the False Claims Act
Another form of pharmaceutical fraud involves improper billing by pharmacies. While Medicare and other government healthcare programs establish maximum rates for drug reimbursements, pharmacies are prohibited from charging the government more than their “usual and customary” prices charged to the general public. Numerous pharmacies have been forced to pay significant sums in response to whistleblower claims relating to overcharging.
Contact a New York City Pharmaceutical Fraud Attorney Today
At Schwartzapfel Lawyers P.C., we are dedicated to helping whistleblowers expose fraudulent schemes and holding pharmaceutical companies and pharmacists responsible for defrauding government programs. If you have information about a possible pharmaceutical fraud, we can help you take action and protect your legal rights. To speak with one of our experienced attorneys in confidence, schedule a free consultation today.