Glaxo to pay $750 million in defective drug settlement

GlaxoSmithKline Plc, one of the world’s largest pharmaceutical companies, has agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs. The lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company came to a settlement finally. Eckard, 51, said, “This is not something I wanted to do, but because of patient safety it was necessary.” Being the one to bring this to notice she would receive $96 million from the settlement money. She had warned the company earlier but was fired because of her efforts.

Among the charges faced by Glaxo the medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet. The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement. Carmen M. Ortiz, the U.S. Attorney in Boston said, “We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers.”

SB Pharmco Puerto Rico Inc., a Glaxo unit finally pleaded guilty to charges relating to the manufacture and distribution of adulterated drugs made at the plant. PD Villarreal, a Glaxo senior vice president wrote, “We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality.”

The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department revealed.

There were other drugs manufactured at the unit. This includes Kytril, an anti- nausea medication, Bactroban, an ointment used to treat skin infections, Coreg a drug for heart disease and Tagamet an acid reflux drug.. Altogether, GlaxoSmithKline sold 20 drugs with questionable safety. The court papers read, “The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use.” The U.S. Food and Drug Administration in 2005 laid their hands on some Paxil CR lots after it was discovered that the pills sometimes split inappropriately. Some of the pills lacked an active ingredient. Ortiz said, “We did not uncover any evidence that patients were harmed from these adulterated batches…It is critical we keep pressure on companies to follow FDA standards and play by the rules.”

Eckard’s complaint was joined by the states of California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New Mexico, New York, Tennessee, Texas and Virginia, as well as the District of Columbia, Chicago and New York City.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.


Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Mandal, Ananya. (2018, August 23). Glaxo to pay $750 million in defective drug settlement. News-Medical. Retrieved on May 29, 2023 from

  • MLA

    Mandal, Ananya. "Glaxo to pay $750 million in defective drug settlement". News-Medical. 29 May 2023. <>.

  • Chicago

    Mandal, Ananya. "Glaxo to pay $750 million in defective drug settlement". News-Medical. (accessed May 29, 2023).

  • Harvard

    Mandal, Ananya. 2018. Glaxo to pay $750 million in defective drug settlement. News-Medical, viewed 29 May 2023,


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
You might also like...
Novel combination of AI and production techniques could revolutionize nanomedicine