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GlaxoSmithKline Big Pharma Fraud
Whistleblower Case Study

Getnick Law filed a qui tam suit under the False Claims Act that resulted in GlaxoSmithKline paying the government $600 million to settle the case along with a $150 million criminal fine. The Justice Department awarded our client $96 million of the federal portion of the recovery, the then-largest reward for a single whistleblower.

Filing the Qui Tam Suit Against GSK

The groundbreaking case represented the first time the False Claims Act was successfully used to hold a pharmaceutical company accountable for violations of FDA manufacturing regulations, known as current Good Manufacturing Practices or cGMPs. The settlement was the result of a qui tam suit filed by Getnick Law on behalf of Cheryl Eckard, a former Quality Assurance Manager with GSK.

Ms. Eckard learned of serious and systemic violations of manufacturing standards at GSK’s factory in Cidra, Puerto Rico. Cidra was then one of GSK’s largest factories in the world, making over 20 products worth $5.5 billion annually, including blockbuster drugs Avandia, Paxil, and Coreg. Ms. Eckard repeatedly urged GSK executives to fix the Cidra plant. She was terminated for “redundancy.” She made a full report to the GSK Compliance Department, to no avail. She then reported to the FDA in San Juan, leading to the execution of search warrants. Her qui tam suit filed by a Getnick Law team led by Neil Getnick and Lesley Ann Skillen included details about mixed-up products, super and subpotent diabetes drugs, injectable drugs that were not sterile, air handling systems that misdirected the flow of product powders, a water system that was contaminated, and a host of other manufacturing and quality testing problems.

The FDA’s actions ultimately included the seizure of all stocks of two Cidra drugs, Avandamet and Paxil CR, the largest seizure in FDA history. The FDA also placed the Cidra plant under a Consent Decree, requiring third-party oversight. The Cidra plant was subsequently closed.

$600 Million Civil Settlement

The civil settlement of $600 million resolved charges that GSK released adulterated drugs from its plant in Cidra, Puerto Rico, including Bactroban, a topical antibiotic used to treat skin infections in babies, that was contaminated; Kytril injection, an anti-nausea drug used by cancer patients, that was not sterile; Paxil CR tablets, for depression, that lacked the active ingredient; and Avandamet tablets, for diabetes, that were superpotent and subpotent. GSK pled guilty to a felony and paid a criminal fine of $150 million.

The Justice Department awarded our client $96 million of the federal portion of the recovery, the then-largest reward for a single whistleblower.

The case was featured in a segment on 60 Minutes that included interviews with Ms. Eckard and Neil Getnick.

Relevant documents include: