As one of the nation’s leading whistleblower firms, we are always on the look out for bad drugs entering the U.S. marketplace. Contaminated, adulterated or misbranded drugs are a danger to the unsuspecting public. We trust that when we open our medicine cabinets, the drugs inside will be of the proper strength and not contain contaminants. The faith is lost when big pharma decides to cut corners in the manufacturing and testing process.
A recent alert from the U.S. Food and Drug Administration (FDA) banning imports from an Indian manufacturing facility of Emcure Pharmaceuticals Ltd has us very concerned. Emcure is one of India’s largest drug manufacturers and frequently contracts with other drug companies such as Roche, Pfizer, Novartis and Sanofi.
We know that some of the drugs made by Emcure are used to treat cardiac patients as well as infectious diseases and gynecological problems.
A full ban such as that announced by the FDA means that problems in Emcure’s manufacturing facilities are likely severe.
The announcement from the FDA says that Emcure’s plant in Hinjewadi, India failed to meet current good manufacturing practices or cGMP. These are minimum standards the FDA imposes on manufacturers to insure drug quality, safety and purity.
An import ban or cGMP violation alone is probably not enough to bring a whistleblower action under the federal False Claims Act. Those cases generally require proof of an adulterated pharmaceutical actually being imported and sold in the United States.
Under the False Claims Act, whistleblowers can receive up to 30% of whatever the government collects from wrongdoers. Whistleblower cases involving pharmaceuticals often involve fines and penalties of the hundreds of millions of dollars or more. Dinesh Thakur, a former manager at Indian drug manufacturer Ranbaxy, was paid $48 million for his information about adulterated drugs. Our whistleblower clients have received a total of over $100,000,000.00 within the last year. The awards are very real.
To receive an award, one must have original source (inside) knowledge of a contaminated, misbranded or adulterated drug being sold in the United States. The drug must also be approved for Medicare or be sold to the government. (99% of all drugs are Medicare approved.)
We are currently investigating cases of adulterated drugs being sold in the U.S. If you work or worked for Emcure Pharmaceuticals Ltd or another drug company who contracted with Emcure (Roche, Sanofi, Novartis and Pfizer) and have knowledge of contaminated products being introduced into the marketplace, give us a call.
Everyone in the industry has an obligation to fight dirty pharma. And the U.S. government will pay large cash awards for those who come forward with the right information. You do not need to be a U.S. citizen to collect a whistleblower award.
Do you have knowledge of adulterated or impure products made by Emcure Pharmaceuticals? Please give us a call. All inquiries are completely confidential and protected by the attorney – client privilege. For more information contact attorney Brian Mahany at or by telephone at (US) 414-704-6731 (direct).
MahanyLaw – America’s Whistleblower Lawyers