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Whistleblower Law - Protecting Patients

Whistleblower at GSK Plant to Receive $96 Million for Protecting Patients

Patient safety advocates and fraud watchdogs are applauding the recent victory of a drug maker whistleblower who lost her job after putting patient safety first. Whistleblower attorneys see a rising trend of False Claims Act lawsuits against drug and health care manufacturers, but are unsure if this will keep the companies from continuing their practices.

A GlaxoSmithKline whistleblower who repeatedly tried to raise concerns with her company about medicine production facilities and was eventually fired has recorded a huge victory. As part of the $750 million settlement GSK will pay the federal government, she will receive approximately $96 million.

Cheryl Eckard worked as a quality assurance manager for GSK and was originally sent to Puerto Rico by the company in 2002 to address concerns at its Cidra plant raised in a warning letter by the FDA. The plant was GSKs largest production facility, manufacturing $5.5 billion worth of pharmaceuticals each year. Eckard shortly discovered several problems, however, including contaminated water and air systems, overcrowded and improper storage facilities, mixing of different medication dosages and a lack of sterility for important cancer drugs.

In the government’s case against the drug maker, it also cited problems such as the production of ineffective medicine in some cases where layers of active ingredients would split from the barrier layers of pills during manufacturing.

According to Eckard, as a team leader she raised concerns to the company about the production deficiencies numerous times over the next few years but was ignored. Eventually, she was terminated in 2003.

In 2004, Eckard alerted the FDA and filed a whistleblower lawsuit under the Qui Tam provision of the False Claims Act. The Act, originally enacted during the Civil War, was designed to allow everyday citizens monitor for fraud on the government. Anyone who has evidence of false charges can file a lawsuit and share in the proceeds.

GlaxoSmithKline has agreed to pay $750 million and pled guilty to charges of manufacturing and distributing adulterated drugs at its Puerto Rico plant between 2001 and 2005. The payment includes criminal fines of $150 million and a settlement of civil penalties of $600 million.

Eckard and her attorney commented that she never wanted the case to reach the point where she filed a lawsuit, but that hopefully this would change the way drug companies ran their factories.

False Claims Act attorney Riley Allen worries that even the record fines might not be enough to deter the fraudulent behavior. "Even though they face the risk of fines of hundreds of millions of dollars, (these companies) keep up the outrageous conduct to the point it just becomes a 'cost of doing business' to them."

"Until those running the companies that commit outright fraud are put in jail, they'll continue to steal from the consuming public and they'll continue put your health and well-being at risk," Allen says.

If you have questions about a whistleblower or False Claims Act lawsuit, contact Riley Allen at Riley Allen Law.

 

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