Whistleblower Lawsuits and Quality Control

Whistleblower Lawsuits and Quality Control

Whistleblower Lawsuits and Quality Control

As consumers, we rely on quality control to ensure that our drugs are safe and effective. Regulations are in place in an effort to prevent subpar drugs and medical devices from the market, and whistleblowers can play a key role in identifying and reporting parties who break these laws. These individuals can file qui tam lawsuits under the False Claims Act and may be entitled to a share of recovered funds.

Current Good Manufacturing Practice (cGMP) regulations set standards for manufacturing drugs; these rules are intended to make sure drugs are safe and contain the appropriate ingredients. The Food, Drug and Cosmetic Act (FDCA) does not allow manufacturers to sell drugs that are adulterated, or fail to meet cGMP. These regulations provide standards for packaging, manufacturing and processing of a drug; a pharmaceutical company is required to have adequately trained staff, proper equipment and strict quality control methods.

Failure to comply with cGMP constitutes fraud. Whistleblowers have helped uncover substantial cases of fraud against parties who violated these regulations. In May 2013, the Department of Justice announced that generic drug maker Ranbaxy USA Inc. agreed to pay $500 million to resolve false claims allegations, cGMP violations and allegations of false statements to the U.S. Food and Drug Administration (FDA). The manufacturer, who is a subsidiary of Indian pharmaceutical company Ranbaxy Laboratories Limited, pleaded guilty to charges related to manufacturing and distributing adulterated drugs produced at two facilities in India. The whistleblower received $48.6 million of the government’s share.

Ranbaxy pleaded guilty to distributing adulterated batches of Sotret, gabapentin, and ciprofloxacin manufactured at its facility in Paonta Sahib. The company acknowledged that in 2006, an FDA inspection showed that testing records were incomplete and no adequate program was in place to test the stability characteristics of drugs. “When companies sell adulterated drugs, they undermine the integrity of the FDA’s approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe,” said Acting Assistant Attorney General for the Civil Division of the Department of Justice Stuart F. Delery, according to the DOJ release. “We will continue to work with our law enforcement partners to ensure that all manufacturers of drugs approved by the FDA for sale in the United States, both domestic and foreign, follow the FDA guidelines that protect all of us.”

It is illegal for companies to retaliate against whistleblowers for reporting fraudulent activities. Individuals who faced retaliatory action, such as being fired or demoted, should inquire about filing a whistleblower retaliation lawsuit.

Parker Waichman LLP provides free legal consultations to individuals who want to file a whistleblower lawsuit. If you or someone you know has knowledge of fraud or are aware of quality control violations and want more information about your legal rights, contact our firm today.

In 2010, a whistleblower received about $96 million for their participation in a case against GlaxoSmithKline subsidiary SB Pharmco Puerto Rico Inc. In an October 2010 press release, the Department of Justice announced that the company pleaded guilty to manufacturing and distributing adulterated drugs at its facility in Cidra, Puerto Rico and agreed to pay $750 million to resolve allegations. The drugs included Kytril, Bactroban, Paxil CR and Avandamet. According to the release, the manufacturing operations implemented at the facility did not ensure that Kytril and Bactroban were free of contamination from microorganisms. Additionally, the government alleged that the company’s practices caused Paxil CR two-layer tablets to split, which could result in tablets that were ineffective.

“Adulterated drugs undermine the integrity of the FDA’s approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients’ health at risk,” Assistant Attorney General for the Civil Division of the Department of Justice Tony West, according to the release. “We will continue to work with our law enforcement partners to hold pharmaceutical companies accountable for this type of conduct and protect taxpayers from fraud, waste, and abuse.”

Whistleblowers have been valuable in detecting fraud and subsequently saving the government and taxpayers’ money. If you or someone you know wants to file a whistleblower lawsuit through the False Claims Act or simply want more information, contact Parker Waichman LLP today.

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