Illegal FDA Surveillance of Whistleblowers

On July 14, 2012, the New York Times issued an article that uncovered a U.S. government secret spying program that targeted a group of whistleblowers working for the Food and Drug Administration (FDA).

The government program that the story uncovered is illegal. It shows how high government officials used a spy program that intended to undermine federal employees’ rights to lawfully report significant health threats and concerns to Congress, law enforcement officials and the American people.

Stephen M. Kohn, the Executive Director of the National Whistleblower Center and the head attorney for the FDA whistleblowers stressed that these employees do not give up their First or Fourth Amendment rights while holding government positions. Kohn stated that it is in fact more important for government workers to make note of wrongdoing in order to expose crimes, misconduct, corruption and wasted taxpayer dollars. 

In reference to the news article, Stephen M. Kohn also stated: “We hope that the revelations in today's New York Times will mark a turning point in the battle to stop the retaliatory surveillance of whistleblowers who risk their careers to report misconduct.”

Mr. Kohn hopes that the individuals responsible for attempting to prevent FDA agents from uncovering serious health and safety violations will be punished.

Find the New York Times article that started it all here: http://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html?_r=1&pagewanted=all

Politics is the only thing that will save the drug companies from their own illegal schemes

Florida Qui Tam

Politics is the only thing that will save the drug companies from their own illegal schemes. Unless they can gather the forces of the pro-business political wing of America, and change the law, I believe the Federal False Claims Act is working literal magic on the US budget by actually prosecuting drug companies for their illegal marketing of drugs for off-label use.

Today, the Department of Justice Announced a staggering $1,600,000,000 settlement with Abbott Labs. According to the Chicago Tribune (http://www.chicagotribune.com/business/breaking/chi-abbott-to-pay-16b-to-settle-depakote-claims-20120507,0,7263674.story), of the total award, $800,000,000 will resolve the civil case and $700,000,000 will resolve the criminal penalties and $100,000,000 will resolve the state consumer protection actions, which sprung out of the investigation.

How much money did Abbott Lab make to be able to buy themselves out of criminal and civil penalties? What was the giant settlement about? It was about Abbott Labs being accused of illegal marketing practices for its blockbuster drug Depakote. Depakote is an anti-seizure medication, and this settlement has generated a lot of negative press for Abbott. Recently ABC World News reported that the drug was being illegally prescribed in nursing homes nationwide. Abbott was allegedly convincing the nursing homes to use the drugs to treat aggression in dementia patients. In fact, they admitted they trained a special marketing force to teach the nursing homes that the drug was not regulated by the federal laws designed to stop the use of medications for unnecessary purposes in nursing homes. They did this even though they had no credible evidence or testing to show Depakote helped the condition.

There is a definite increase in the Justice Department's desire to prosecute illegal marketing schemes in which drug companies engage. This is especially true when the drug company markets their drug for an "off-label" use. Due to the number of calls we are now receiving to investigate this type of practice, it is almost worth specializing in just off-label drug cases as a law firm. Even in the Abbott settlement the Wall Street Journal is saying Abbott will still plead guilty to some criminal charges as well as to stay on probation for five years, during which time it must self report any probable violations of the law to their probation officer. That is amazing! To pay a staggering fine and then plead guilty to a crime is a harsh penalty.

According to the Washington Post (http://www.washingtonpost.com/national/health-science/abbott-laboratories-agrees-to-16-billion-settlement-over-marketing-of-depakote/2012/05/07/gIQAh5098T_story.html) this settlement is the "second-largest" enforcement action that is the result of the increased enforcement efforts by the Justice Department criminal division concentrating on drug makers off-label or misbranding their drugs in the market.

If you have a question regarding the marketing practices of any drug company, please call the LaBovick Law Group. We have staff trained to understand this type of claim and answer your questions.