The FDA and Pharmaceutical Integrity Coalition report that counterfeit drugs have been detected in Europe. The drug, called BiCNU or carmustine, is used to treat several life threatening diseases including brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). While there is no known instances of fake BiCNU coming into the United States, such incidents are not rare.
The FDA approved BiCNU is manufactured by Emcure Pharmaceuticals and distributed by Heritage Pharmaceuticals in the United States. There is no suggestion or indication that the fake carmustine was made by Emcure.
Several years ago many people in the U.S. were killed by counterfeit heparin which was manufactured by Baxter Pharmaceuticals. Baxter did not deliberately manufacture fake (lethal) drugs yet it was still responsible since it relied on a Chinese provider of the active pharmaceutical ingredient of the drug. The FDA believed that the supplier used a chemically similar ingredient that would pass quality control testing but was medically worthless.
Why would someone swap ingredients? In most cases the answer is greed. In the heparin case, there was a huge difference in cost between the real heparin ingredient ($900 per pound) versus the chemical fake ($9 per pound).
Much like the heparin scandal, we worry that Emcure’s suppliers could be the same people behind the counterfeit drugs. There is also a growing problem of U.S. doctors and clinics purchasing unlicensed copies of drugs from illegal offshore suppliers.
Although there is no evidence that Emcure manufactured the counterfeit and adulterated at issue in this case, the company is no angel. For more about the company and its troubles, visit our Emcure whistleblower page.
Once again, the motive is greed. Early this month a Lodi, California physician settled federal False Claims Act charges with the government. The Justice Department said he purchased unapproved cancer drugs, some of which were counterfeit. In that case, prosecutors say that the physician purchased the unapproved drugs at a steep discount and billed Medicare for the regular cost. Worse, some of his patients received a counterfeit drug for their life threatening cancer.
Medicare fraud costs every U.S. taxpayer. When the fraud involves fake, adulterated or counterfeit drugs, public safety is a risk. Our friends and loved ones suffer and die.
Fake Pharma – Whistleblower Awards – False Claims Act
If you have knowledge of fake pharmaceutical drugs being marketed in the United States, call us immediately. The False Claims Act pays cash awards to whistleblowers with inside information about fraud involving government funds. Since almost all drugs are approved for reimbursement by Medicare, Medicaid or Tricare, the importation, sale or distribution of these drugs can be a False Claims Act violation.
Whether you report to save a life or collect a reward, stopping counterfeit drugs from entering our stream of commerce makes you a hero. To date, we have helped our hero clients collect over $100 million in awards. You could be next.
Not a citizen or resident of the United States? It doesn’t matter. Awards are available for anyone with inside information.
To qualify for an award, one must have inside (direct) information of the fraud, file a lawsuit under seal in federal court and generally be the first to file.
Worried about filing a lawsuit? Don’t be. We do all the work and only get paid if you collect an award. Calling a toll free hotline may earn you an award of up to $1000 but filing a False Claims Act lawsuit is the only way to earn the large awards. The amount of the award is generally between 15% and 30% of whatever damages and penalties collected by the government from the wrongdoer.
MahanyLaw – America’s Whistleblower Lawyers
Need more information? Give us a call. We have the experience and track record to pursue False Claims Act cases. From small cases to billion dollar recoveries, we are not afraid to tackle the world’s biggest companies and seek the highest possible whistleblower awards. (For more information, see our other Emcure post or visit our pharmaceutical whistleblower page.)