Whistleblowers in Action

Whistleblowers-in-Action-qui-tam

Dr. Helen Ge

Baum Hedlund is proud to represent the former Takeda medical doctor, Helen Ge, in her whistleblower lawsuit against the Actos maker for failing to properly report all Actos related bladder cancer and congestive heart failure adverse events to the FDA. Takeda hired Dr. Ge to work in the company’s pharmacovigilance department in the U.S. to review adverse events and to identify and evaluate potential safety signals for the diabetes drug Actos (amongst other drugs).

When she tried to report bladder cancer and congestive heart failures as serious adverse events related to patients’ Actos use, she encountered resistance from her superiors. She claims in her qui tam lawsuit that she was ordered to falsely report adverse events that occurred between 2007 and 2010 so that Takeda could avoid its responsibility of accurately analyzing and reporting hundreds of serious adverse events to the FDA. When Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and that adverse events were being under-reported to the FDA, her contract with Takeda was terminated. Her whistleblower lawsuit was unsealed in February 2012.

Cheryl Eckard

Concerns for public safety motivated Cheryl Eckard to file a whistleblower lawsuit against GlaxoSmithKline (GSK) shortly after she was fired from her job as global quality assurance manager for the company. Ms Eckard alleged that GSK’s Cidra, Puerto Rico, plant was manufacturing adulterated medication, including the popular antidepressant Paxil and diabetes drug Avandamet. For about eight months in 2002, Ms. Eckard reported her concerns to her supervisors and GSK executives but her warnings fell on deaf ears. She was later fired.

Cheryl Eckard then voiced her concerns to the Food and Drug Administration, which prompted an investigation and subsequent raid of the Puerto Rico plant. Federal investigators confirmed Ms. Eckard’s allegations when they found flagrant manufacturing violations at the Cidra plant, which was promptly shut down.  On October 26, 2010, seven years after becoming a whistleblower, GSK agreed to settle the lawsuit for $750 million. Ms. Eckard will be awarded a record $96 million for her involvement in the qui tam case, the highest amount an individual whistleblower has received in history under the federal False Claims Act.

David Graham

FDA Safety Officer, Dr. David Graham, became an outspoken whistleblower in 2004 when he publicly exposed regulatory failures on the part of his employer, the United States Food and Drug Administration (FDA). During a U.S. Senate Committee on Finance hearing, Dr. Graham gave eye-opening testimony on the anti-inflammatory drug Vioxx, specifically stating that the FDA had failed to recognize just how dangerous the drug was to the American public. Over four million Americans took Vioxx when the drug was on the market, and estimates are that the drug caused 140,000 heart attacks and 60,000 deaths.

In his testimony, Dr. Graham accused the FDA of ignoring warnings that the prescription drug, manufactured by Merck Pharmaceuticals, was causing heart attacks and strokes. In speaking about the FDA’s regulatory policies, Dr. Graham said the agency “is incapable of protecting America against another Vioxx.”

Dr. Graham also warned that the “FDA is inherently biased in favor of the pharmaceutical industry” and “views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.”

Dr. Graham’s 2004 testimony garnered a great deal of media attention and reverberated throughout the agency, so much so that he was publicly criticized by the FDA. This prompted Dr. Graham to seek whistleblower protection advice from the Government Accountability Project. Despite agency attempts to silence him, Dr. Graham refused to give in and pushed forward in exposing Vioxx’s risks. Dr. Graham’s efforts exposed weaknesses in an agency many believed  was nearly infallible.  His exposure of drug safety risks and the problems with our drug regulatory system did not begin with Vioxx.  In fact, Dr. Graham featured prominently in exposing the liver failure risks of the diabetes drug Rezulin, which was subsequently removed from the market. He was also instrumental in the removal of Omniflox (an antibiotic), Fen-Phen (weight loss drug) and phenylpropanolamine (nasal decongestant) from the U.S. market.

Read:

FDA Incapable of Protecting U.S., Scientist Alleges:
An Interview with Dr. David J. Graham, Associate Director of the FDA’s Office of Drug Safety

Published by Fraud Magazine, September/October 2005 Issue

Face Of The Year: David Graham
Published by Forbes, December 13, 2004

John Kopchinski:

Gulf War veteran and former sales representative for Pfizer Inc., John Kopchinski, began a whistleblower lawsuit against the world’s largest drug maker in 2003. Kopchinski was appalled by the tactics Pfizer used to sell the pain medication Bextra and filed a qui tam lawsuit against Pfizer for Medicare fraud. The suit resulted in Pfizer being ordered to pay $2.3 billion in September 2009, which included $1.8 billion in criminal and civil penalties. Pfizer also pled guilty to a felony charge for promoting Bextra and 12 other drugs for unapproved uses and doses.

Kopchinski was dismissed from Pfizer for raising his concerns with the company and went from earning around $125,000 yearly to living off of his retirement and finally finding employment with an insurance company for around $40,000. Kopchinski knew he was taking a risk by filing this qui tam suit. In 2009, the risk paid off. Because he blew the whistle on Pfizer’s illegal activity and fraud, Kopchinski will be getting more than $50 million of the record penalty that Pfizer was ordered to pay.

Cynthia Fitzgerald:

Cynthia Fitzgerald is responsible for filing what could become one of the largest whistleblower lawsuits to date. Her case, filed in 2003, names more than one dozen companies including Johnson and Johnson, Merck, and Becton Dickinson for improper sales practices and erroneous accounting, draining millions of dollars out of public programs such as Medicare.

When Cynthia Fitzgerald became a health care purchaser for Novation in 1998 she did things by the book and she expected her employer and colleagues to do the same. After uncovering what she called “systemic” medical-supply fraud, Fitzgerald decided to do something about it. For years, she continued to work at Novation but she was constantly at odds with what she believed were unethical and illegal practices. She was ultimately fired by Novation.

For now, Ms. Fitzgerald’ qui tam litigation remains unresolved.