Three months ago, pharmaceutical maker GlaxoSmithKline agreed to pay $750 million to resolve a U.S. government false-claims lawsuit over charges that the company knowingly manufactured and sold adulterated drugs.The affected medications involved in the suit included the popular antidepressant Paxil and the type II diabetes medication Avandia.
This week, the whistleblower responsible for bringing to light the disturbing problems at a Glaxo plant that resulted in the false-claims lawsuit, spoke out for the first time on 60 minutes.In her interview, Cheryl Eckard, former Glaxo global quality assurance manager, made public the shocking disregard shown by the company for the safety and quality of the products they manufacture.
Cheryl Eckard first learned of problems when she was sent to evaluate a Glaxo factory in Cidra, Puerto Rico and observed numerous production problems causing some drugs to become tainted, mislabeled, or incorrectly dosed.Eckard told 60 Minutes reporter Scott Pelley "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.”
Eckard alleges, that after eight months of reporting these issues with no company response, she produced a chart for Glaxo executives showing nine problem areas at the Cidra plant.The chart included allegations that production issues at the plant were causing powerful drugs to be mixed together in the same bottles.
According to Eckard, her claims continued to be dismissed; and after a pharmacist reported a mix-up involving incorrectly labeled Paxil prescribed to an 8-year-old boy, the drug company filed a report with the FDA saying it was extremely unlikely that the drug mix-up occurred at Cidra.Cheryl Eckard was let go shortly after her letter to company executives detailing problems at Cidra.After Eckard was fired, she brought her complaints to the FDA.
In 2005, Cidra was raided and Federal investigators said that the conditions found at the Glaxo factory were far from meeting public health standards.Cidra was shut down in 2009 and is no longer owned by GlaxoSmithKline.
Under the federal False Claims Act, whistleblowers like Eckard may be entitled to receive a portion of any money that the government recovers from the offenders.In order to receive a portion of the recovered money, 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.Cheryl Eckard received a record $96 million from the settlement.
Whistleblower Lawsuits on the Rise
According to consumer watchdog group Public Citizen, the pharmaceutical industry has surpassed the defense industry to become the leading defrauder of the federal government.There have been 165 pharmaceutical industry settlements with the federal government over fraud charges in the last 20 years and drug companies have paid a total of $19.8 billion in Settlements; 73% of those cases, and 75% of that money, have happened in just the last five years. This increase in payments for fraud is likely due to both an increase in wrongdoing on the part of drug companies and better enforcement by the state and federal government.More than half of the pharmaceutical industry’s penalties have been paid by just four companies: GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough.
A public citizen report showed that from 1991 to 2000, whistleblower lawsuits accounted for only 9% of federal fraud settlements, however, from 2001 through 2010, they accounted for 67%.Whistleblowers like Cheryl Eckerd are one of the only ways for the government, and the public, to find out about potentially disastrous problems like those at GlaxoSmithKline, that threaten the safety of widely prescribed drugs like Paxil and Avandia.Patient advocates hope that Cheryl Eckerd making her story public, as well as her generous reward, will encourage others to hold these pharmaceutical giants to the huge responsibilities they undertake when manufacturing medicines for the nation.
At Parilman and Associates, we believe that when a doctor prescribes a medication, the patient should be able to know that the drug they are receiving is safe, authentic, and in the correct dosage.When something goes wrong, the results can be devastating or even deadly.If you believe that you or a loved one has been affected by a contaminated, defective, or otherwise dangerous drug or product, please call our office.
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