[Updated May 2019] 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. An Emcure whistleblower with information about cover ups and serious GMP violations leading to adulterated products could receive a multimillion dollar whistleblower reward.
Two Emcure Manufactured Drugs Fail Sterility Testing
For four long years we have worried about bad drugs being imported into the United States by Emcure. Those fears became real in May 2019.
According to an FDA safety alert released on May 28th, Heritage Pharmaceuticals Inc. announced a voluntary nationwide recall of two drugs, Amikacin Sulfate Injection and Prochlorperazine Edisylate Injection. The FDA says the recall is the result of a sterility failure. Both drugs were manufactured by Emcure.
Heritage Pharmaceuticals in located in East Hanover, New Jersey but it is simply the U.S. distributor of these drugs. The actual manufacture is contracted to Emcure Pharmaceuticals Ltd.
The voluntary recall is because of microbial growth having been detected in one unreleased sublot of each of the drugs. It is not uncommon that other lots are affected by the same sterility problems.
This is a critical issues as one of these two drugs are given to very sick people suffering from Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species. That means patients taking these drugs are already quite sick and have compromised immune systems.
According to the FDA alert, patients taking adulterated Amikacin Sulfate Injection and Prochlorperazine Edisylate Injection may require hospitalization, suffer organ damage or even die. The FDA says no one has reported any adverse events this far.
The lack of reported organ damage or death is not surprising. Because these patients are already so ill, most doctors would think that any death or complication was the result of the underlying disease and not the drugs used to treat those diseases.
One month earlier in April 2019, the State of Connecticut brought action against 18 generic drug companies including Heritage and Emcure. Prosecutors say the companies are conspiring to fix prices. The state says this may be the “largest cartel case in the history of the United States”.
Seeking Emcure Whistleblower
The United States Congress passed an anti-fraud measure called the False Claims Act. Under the 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, Heritage, Sanofi, Novartis and Pfizer) and have knowledge of contaminated products being introduced into the marketplace, give us a call.
We are especially interested in Heritage in that it is an affiliate of Emcure. Earlier this year, Heritage hd acquired 23 new drug applications. We worry that since the FDA banned certain drugs being imported from Emcure, the company is now hiding behind its American front company.
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.
Interested in learning more? Visit our FDA whistleblower and cGMP fraud pages 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) (direct).
MahanyLaw – America’s Whistleblower Lawyers