The Daily Blog

Ex-Worker Wins $96M for Blowing Whistle on Drug Giant.

(Oct. 27) — Whistle-blower Cheryl Eckard has won $96 million as part of a $750 million penalty against GlaxoSmithKline over faulty drug manufacturing in a case she says was driven by worries about consumer safety.

“This is not something I ever wanted to do, but because of patient safety issues, it was necessary,” she told reporters in Boston after the British drug giant’s settlement was announced Tuesday, according to The Associated Press.

Eckard, 51, was the company’s quality control manager. She discovered violations at the company’s plant in Puerto Rico in 2002 and reported them to her bosses, her lawyers said. She was fired in 2003 after repeatedly reporting problems to the company, and she later filed a lawsuit.

GlaxoSmithKline agreed to pay the millions in fines, penalties and settlements to resolve claims that it knowingly made and sold adulterated drugs, including Paxil, a popular antidepressant. Other problems include the failure to guarantee that Bactroban, an ointment, and an anti-nausea drug, Kytril, were not contaminated, according to reports. No patients seem to have been harmed by the problems at the plant, a prosecutor said.Eckard, who worked in North Carolina, is to receive $96 million as a whistle-blower under the federal False Claims Act. The law offers a cut of the money recovered as incentive for people with knowledge of false claims to come forward.

She said going ahead with the lawsuit wasn’t easy.

“I think it’s very, very difficult to survive this,” Eckard said, according to New England Cable News. “It’s difficult to survive this financially, emotionally, you lose all your friends, because all your friends are people you have at work.”

Still, she said, “You really do have to understand that it’s a very difficult process, but very well worth it.”

Her lawyers, Neil Getnick and Leslie Ann Skillen, believe her share is the single-biggest whistle-blower award in the U.S., NECN reported.

“This case will change the way drugmakers run their factories,” Getnick said, according to The New York Times.Eckard was sent to the plant in Cidra, Puerto Rico, to fix problems the Food and Drug Administration had cited in a warning letter, according to the Times. She found that the company’s premier manufacturing facility had a contaminated water system, an air system that allowed products to be cross-contaminated and pills of different strengths mixed in the same bottles, among other problems, the newspaper said.

She complained to top company officials, but nothing was done, even after she threatened to call the FDA, the Times said. She filed her lawsuit, and the FDA began a criminal investigation. The plant was closed in 2009 because the company was unable to fix it, according to the newspaper.

Eckard hopes she’ll inspire others who see something wrong to speak up.

“You have to believe in your heart [that] this is the right thing,” she said, according to NECN. “In my case, I was very, very concerned about patient safety.”

GlaxoSmithKline to Pay $750M Fine for Sale of Bad Drugs.

(Oct. 26) — Another day, another hard pill to swallow for GlaxoSmithKline.

On Tuesday, the pharmaceutical giant agreed to pay $750 million to settle a government lawsuit alleging that the company sold defective and potentially dangerous medication.

The U.S. Justice Department brought suit against GSK after finding that the company’s Cidra, Puerto Rico, factory produced drugs sold to consumers that were often mislabeled, of the wrong dosage and contaminated with micro-organisms.

“Today’s settlement reminds the pharmaceutical industry that they must observe those standards and reflects the commitment of Federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk,” Patrick E. McFarland, inspector general of the U.S. Office of Personnel Management, said in a statement.
It’s a sharp turn south for the company from earlier this year, when the Food and Drug Administration initially ruled to keep the drug Avandia on the U.S. market and stop studying it before later withdrawing it from store shelves. GSK, which closed the Cidra factory in 2009, issued its own statement to as much affect about today’s settlement:

“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,” said PD Villarreal, GSK’s senior vice president and head of global litigation. “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.”

According to the Justice Department, the drugs found to be adulterated included Bactroban, Kytril, Paxil CR and Avandamet.
The federal government will receive $436,440,000, and GSK will pay $163,560,000 to states participating in the agreement, the Justice Department said.

In September, the FDA announced it was implementing new restrictions on rosiglitazone, the main ingredient in Avandia, Avandamet and Avandaryl, which are used to help control type 2 diabetes, and which earn GlaxoSmithKline billions in profit annually. The European Medicines Agency, meanwhile, recommended that Avandia be taken off the market altogether after studies indicated a sharp increase in heart attack risk associated with the drug.