GlaxoSmithKline Whistleblower Lawsuit Leads to $750M Settlement

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GlaxoSmithKline has agreed to pay $750 million to resolve civil and criminal charges that the drug maker sold Medicaid and other government health plans adulterated products, including Avandamet and Paxil.

The settlement came as a result of a GlaxoSmithKline whistleblower lawsuit originally filed in 2004 over violations of government manufacturing standards at a facility in Cidra, Puerto Rico run by its subsidiary SB Pharmco.

GlaxoSmithKline will pay a $150 million criminal fee, $600 million in civil penalities and admit guilt. The whistleblower who brought the case to the government’s attention, Cheryl Eckard, will receive an estimated $96 million of that settlement.

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Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Eckard is a former global quality assurance manager for GlaxoSmithKline. She alleged in her lawsuit against the company that she saw problems with the facility and brought it to the attention of the company, at which point she was fired and the problems went unaddressed. 

FDA investigators began citing the plant for quality control problems in 2002, and in 2005, the factory was raided by U.S. Marshalls. Federal investigators said Glaxo was ignoring public health standards with the deplorable conditions at the factory, which was shut down last year. The factory is no longer owned by GlaxoSmithKline.

Some of the problems at the plant included defective Paxil CR tablets that could incorrectly deliver drug dosage, knowingly selling a topical antibiotic, Bactroban, that may have been contaminated, and failing to take action on Avandamet pills whose ingredients were not uniformly blended properly.

“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 the Senior Vice-President PD Villarreal, head of global litigation, in a statement addressing the settlement.

Tags: Antibiotic, Avandamet, GlaxoSmithKline, Paxil, Qui Tam, Whistleblower

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10 Comments

  1. Daniel Haszard

    Glaxo whistle-blower gets millions

    The deal with Zyprexa is that Eli Lilly pleaded guilty to criminal wrongs (“viva Zyprexa” campaign) the Zyprexa saga was rotten through and through.
    Eight Lilly EMPLOYEES got millions each as supposed informant ‘whistle blowers’.Lawyers on BOTH sides got millions and millions……most patient claimants who got sick are ‘mentally challenged’ and less able to advocate for themselves.
    The Class action Lawsuits in the US had payouts of $85,000 BUT the lawyers got 45 percent and then the govt got most of the rest for having to take care of the victim/patients medical expenses.Soooo,$85K turned into about $9,000 for Zyprexa claimants many had their food stamps and other state benefits taken away because of their *windfall profit* making them worse off in the end.
    *
    Daniel Haszard Zyprexa victim activist and patient who got diabetes from it.

  2. Kimberly

    I think that is crazy that Cheryl Eckard will receive 96 million dollars from the government when she KNEW what they were doing and for how long and decided to repoprt that after she is terminated. THAT IS SICK!

  3. Howard

    It is reassuring to know that Glaxo and other “big pharma” companies have the public’s interest and safety at heart, just like British Petroleum, Exxon and “big oil”.
    The pharmaceutical industry’s dishonesty and price gouging policies should result in public outrage. Instead most patients have little concern about the obscene cost of medications in the US as long as their insurance companies charge a low co-pay and pass the cost on to everyone else. This collusion between the insurers and pharmaceutical companies is against the public’s interest and bankrupting our government and businesses/individuals who pay the premiums.

  4. tammy

    All the recalls and fake drugs by major companies is just the tip of the iceberg. I think the list of recalled and bad drugs will only increase. Nobody wants cures for diseases when Drug lords can make so many millions, results be damned.

  5. Lori

    I have been prescribed Avandamet for over two years, I think? Since started using the medicine I have several side affects which include extremely low blood sugars, extremely painful leg cramps and have since developed a heart murmur, but I also have an increase of night sweats. Just recently, has my Dr. office has taken me off this medicine.

  6. Bobby

    I have been prescribed Avandamet for the last 5-6 years. I have had heart concerns for the last several years. It appears from my heart doctors testing, that I have an enlarge heart, and a leaky heart valve.

  7. Sandy

    when you sign up with the lawyer they answer your question right away. now the case is almost over you can’t hear anything from your lawyer they know how much money and don’t want you to know?
    THE BIG QUESTION NOW IS WHY///

  8. Scott

    My Daughter had this put on her pick lines and central lines at riley Hospital she Died 11-7-10

  9. Ira

    i was and still a victim of glaxosmithkline under the product of proventil at the percentage of 5%, how ever iam discourage due to the settlement that i feel is a defraud to scheme, only for the reason of my settlemnt at 5% of 4.5 million dollars as a third party from $750. million dollars – i got paid $190.00 dollars in two paymentsi feel this is an enbarasment to not only the food and drug administration but to the federal government who order this lawsuit to commence.

  10. Janet

    My husband took Avandia for a few years. He developed severe heart problems and had a bovine valve by surgery Oct. 2006. I contacted the atty. for the class action suit. He was supposed to receive settlement of $46,000.00. The atty. did not award the total amt., only $ 30,000.00. To date, 7-16-13 the atty. is holding back $6,900.00 for more than a yr. Hopefully an atty. will answer this to let me understand why, and who is able to hold this money…Thanks

    o date the atty has been paid 40% of the $30,000.00 and it has been more that a yr. since the so called hold back of $6,900.00 has not been paid. This is July of 2013 and the case was settled in 2012. Does anyone know how to handle this and get the atty. to pay the money due to my ailing husband? Bovine vales must be replace 6-10 yrs. Seems as though he has gotten a big screw job!!! I do hope we are not all undergoing the same thing. If an atty can answer me I would be more than greatful!!!

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