GSK Whistleblower Case Gets TV Airing

January 7, 2011

GlaxoSmithKline has responded to a recently aired 60 Minutes program about the whistleblower lawsuit that resulted in GSK paying $750 million to settle civil and criminal charges.

GlaxoSmithKline has responded to a recently aired 60 Minutes program about the whistleblower lawsuit that resulted in GSK paying $750 million to settle civil and criminal charges. GSK was accused of manufacturing and selling adulterated drug products to Medicaid and other government health plans. The products were manufactured at the company’s Cidra plant in Puerto Rico, which was closed in 2009 due to declining demand. The plant is no longer owned by GSK.

The 60 Minutes program interviewed Cheryl Eckard, a former GSK Quality Assurance Manager about the violations at the Cidra facility, which was GSK’s top facility in 2002, making more than 20 products worth $5.5 billion annually, including Avandia and Paxil.

According to documents from Getnick & Getnick law firm, Eckard learned of “serious and systemic violations of manufacturing standards” at the Cidra factory in 2002 and urged managers to take action. "All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career," said Eckhard on the 60 Minutes program.

Eckhard claimed that no action was taken and then in 2003 she was made redundant. She filed the whistleblower suit in February 2004 and the FDA subsequently seized all stocks of Avandamet and Paxil CR manufactured at Cidra — the largest seizure in FDA history. The FDA also placed the Cidra plant under a Consent Decree, requiring that all products released to the market be approved by an independent monitor.

The 60 Minutes program provides a rare, detailed look at a whistleblower case, but is also a harsh blow to GSK’s reputation, with claims being made that some medicines may have been contaminated with bacteria or mislabeled, while others may have been too strong or not strong enough. Additionally, claims were made that GSK tried to cover up the problems after a pharmacist called to report a mix up with an antidepressant medicine.

“They [GSK] filed a report with the FDA that said that the mix-up was not real. And did not happen at the factory,” said Eckhard. “We all knew, they all knew it was real."

In its response to the program, GSK says that it regrets the manufacturing issues at the Cidra facility and “strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result”. GSK also emphasized that the issues outlined in the 60 Minutes story occurred between 2001 and early 2005 and related to one manufacturing facility. “GSK had been working with the FDA to improve the plant’s performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address issues cited by the FDA,” said a GSK statement.

GSK also rejected claims made by Eckard in the 60 Minutes interview that she was terminated for bringing the manufacturing problems to light. “The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns that they may have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.”

The company added: “The FDA; the US Department of Justice; and Neil Getnick, Cheryl Eckard’s attorney, all stated that there was no indication that patients were harmed as a result of the production issues.”

Under the agreement reached in October 2010, GSK agreed to pay a criminal fine of $150 million and an additional $600 million to the federal government and states to resolve the claims. As part of the resolution, Eckard was to receive approximately $96 million from the federal share of the settlement amount, according to a statement from the US Department of Justice.

“This settlement resolves a significant and long-standing legal issue facing the company,” said PD Villarreal, GSK’s senior vice president and head of global litigation, in a statement issued by GSK in October. "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009, and we are committed to continuous improvement in our manufacturing processes. Our commitment to compliance with cGMP is demonstrated by the fact that we have not received an FDA warning letter at any plant since the Cidra facility was cited in July 2002.”