A subsidiary of India’s largest pharmaceutical company, Ranbaxy USA Inc, has agreed to pay the United States federal government a record $500 million in criminal and civil fines for selling adulterated drugs, including the generic version of Lipitor, and lying to regulators during the year-long investigation.
On Monday, May 13th, Ranbaxy entered a guilty plea and agreed to pay the largest fine against a pharmaceutical company in US history, for serious violations of the Federal Food, Drug, and Cosmetics Act, which prohibits the sale of impure drugs.
Ranbaxy admitted that the company sold impure and adulterated batches of drugs, produced at two manufacturing sites in India. Among the impure drugs were generic versions of Lipitor, an antibiotic, and medications for acne, epilepsy, and nerve pain.
So far, it is unknown of the generic drugs directly caused any health complications in patients. Last November, the FDA recalled generic Lipitor because tiny glass particles had been found in the drug, but the administration said they had received no reports of patients being injured by the generic drug.
However, the problems at Ranbaxy’s plants were disclosed in a whistleblower lawsuit, filed in Maryland in 2007. Personal injury claims were not part of the litigation against the pharmaceutical manufacturer.
Ranbaxy admitted to multiple deficiencies, including improperly storing drug samples waiting for testing, selling medications in the US that failed purity tests, and delaying a voluntary recall of medication despite the knowledge that the drug would not maintain its shelf life.
The pharmaceutical manufacturer also admitted to making false statements to the FDA between 2006 and 2007. They claimed to have falsified annual reports about test dates, which are designed to detect drug impurities and appropriate storage conditions. In some cases, according to Ranbaxy, tests were conducted weeks or even months after the company said they had been performed. In other cases, the company had ignored the prescribed testing interval.
In 2008, the FDA took the unusual step of barring the import of 30 drugs from two of Ranbaxy’s Indian plants. They then slapped the company with an “Application Integrity Policy” which halted the review process for any new drugs that from one of the two Indian facilities until Ranbaxy could prove their drugs’ quality and the truthfulness of their reports.
Despite concerns over their other drugs, in November 2011, the FDA granted exclusive first rights to Ranbaxy for the manufacture and sale of generic Lipitor. Just one year later, the pharmaceutical company recalled 41 batches of generic Lipitor after discovering it had been tainted with glass particles.
In January 2012, the Department of Justice added more restrictions to Ranbaxy by placing them under a sweeping consent decree. Several of the pharmaceutical manufacturer’s plants were barred from importing drugs, including generic Lipitor, into the US. The DOJ required that the company undergo independent auditing.
“While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance,” Ranbaxy CEO and managing director Arun Sawhney said in a statement.
The case concluded in the midst of federal scrutiny of drugs produced overseas, and the regulatory agencies responsible for their approval and distribution. “Over the last few years, the FDA and others have been increasingly focused on the risks associated with global drug manufacturing. The agency now has new authority and new resources which should result in an increased scrutiny on the highest-risk facilities,” said Alan Coukell, an expert on drug safety at The Pew Charitable Trusts.
The Strom Law Firm Can Help with Dangerous Drug Cases, Including Against Generic Lipitor
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, like generic Lipitor, transvaginal mesh, Actos, or an all-metal hip replacement. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800