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

Qui Tam & Whistleblower Cases - Two billion dollar days for the US Attorney in a row!

Two billion dollar days for the US Attorney in a row! On January 6, Johnson & Johnson settled a U.S. probe into their anti-psychotic drug, Risperdal, for $1,000,000,000! According to the Bloomberg news, J&J is going to resolve their long running dispute over Risperdal for a whopping $1 billion. This settlement should cover all the damages each individual state has against J&J as well as the US government’s federal claims. Given GlaxoSmithKlein just settled a claim for $3.2 billion, this settlement shouldn’t hurt J&J too badly. Johnson & Johnson is the largest health product company in the world. If Glaxo can pay $3 billion and that doesn’t count the civil claims against them for Avandia, certainly J&J is better off settling for $1 billion now. The civil settlement may not have included a possible plea deal against Johnson for criminal penalties! Now that is HARSH! They are going to pay $1 billion and STILL pay a criminal price for their allegedly illegal sales practices. The investigation against Risperdal has been going on since 2004. The allegation is that the company was “off label” marketing the drug. That means the drug was being marketed for uses that were not approved by the FDA.

In this case, the Whistleblowing Qui Tam Plaintiff could earn $150,000,000!

Interestingly, the civil cases against J&J for Risperdal have been varied, with two states finding for against the company while two other states found for the company. We will see how this settlement effects the pending civil litigation in the future.

Botox maker Allergan pleads guilty and agrees to pay $600 Million fine for illegal off-label promotion

American pharmaceutical manufacturer Allergan Inc. has agreed to plead guilty and pay $600 million fine. This will resolve Allergan's criminal and civil liability arising from the unlawful promotion of Botox® Therapeutic, for uses not approved  by the Food and Drug Administration (FDA). The resolution includes a criminal fine and forfeiture totaling $375 million and a civil settlement with the federal government and the states of $225 million to resolve claims that its unlawful marketing practices caused false claims to be submitted to government health care programs.

The civil settlement resolves three lawsuits filed in federal court in the Northern District of Georgia under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. The following whistleblowers – Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O'Conner-Masse, and Edward Hallivis – will receive $37.8 million from the federal share of the settlement amount.

Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, and Sally Quillian Yates, U.S. Attorney for the Northern District of Georgia, filed charges against Allergan for promoting Botox® for headache, pain, spasticity and juvenile cerebral palsy – not approved by the FDA. According to the criminal charges, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses.

Allergan’s off-label marketing tactics included calling on doctors who typically treat patients with off-label conditions. In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops on billing for off-label uses, conducted detailed audits of doctors’ billing records, and provided a Botox® Reimbursement Hotline.

This settlement is part of the government’s emphasis on combating health care fraud.  Since January 2009, the False Claims Act has helped the Justice Department recover approximately $3.1 billion in cases involving fraud against federal health care programs.  The Justice Department’s total recoveries in False Claims Act cases since January 2009 have topped $4 billion.

Click on the following link to read more on the Allergan settlement:
Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox® - DOJ
 
Allergan Will Pay Fine, Plead Guilty to Misdemeanor - Bloomberg

Allergan To Pay $600 Million To Resolve Off-label Marketing Allegations, Agrees To Drop First Amendment Suit - Thompson

Eli Lilly agrees to pay $1.4 Billion in Qui tam fraud involving Zyprexa

Whistleblowers have a lot to celebrate in the wake of the recent $1.4 billion settlement from drug maker,  Eli Lilly. The drug giant, Eli Lilly, plead guilty to promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA). Included is a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind. Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states. Whistleblowers will share in about 20% of the government's share in the $800,000.

This settlement should help more whistleblowers come forward. AM Law Daily gives an insightful summary on how whistleblower cases have increased in the past year. I have to admit, at our firm, over the past year and even more recently, whistleblowers have been contacting us regarding qui tam claims. I think that this can be attributed to the large whistleblower rewards and media attention over the past year.  One word of caution, if you are a whistleblower with critical information, talk to an Attorney about your claim and rights before making statements public. This way you have a better way of protecting your claim.

Click here to read more on the $1.4 billion qui tam settlement from Eli Lilly from the Department of Justice.

Let's see how 2009 will treat qui tam and whistleblower claims under the new administration.

Pharmaceutical Fraud and Sicko

The level of fraud in America today is sickening. There is no comparison between the qui tam fraud in corporate America and the fraud of fake injury “victims”. I guarantee you the damage done to the American economy, the American ideal and the American tax system from qui tam fraud is 1000 times greater than all of the insurance scams put together. The fraud is so disturbing that it is actually hard to believe.

Coming this summer is a movie called Sicko. It is a documentary about the health and drug industry. I am almost certain it will document the conspiracy going on between doctors, drug manufacturers and the FDA.

As we speak (or rather, as you read) the drug lobby and their corporatist party lackeys are trying to make the FDA the final oversight of the drug industry and take away a injured victims right to sue if they are hurt by a drug. It is my prayer that this movie spurs politicians NOT to permit the drug lobby to have the FDA be there ONLY oversight. We must keep the drug companies honest and the only way they will be an honest broker is if they are held accountable through civil lawsuits. Is the system perfect? Certainly not. But it is far better than any other system out there. It is only through the power of the pocketbook that we can control the moral-less corporate beast.

So, you ask, why am I so “up in arms” about the FDA issue right now?

Here is the simple fact. Doctors are being paid to lie. The drug companies are so invested in their new drugs that they must turn a blind eye to bad data in their testing to make sure the drug gets FDA approval. Once the FDA, which is incompetent or under-funded/overworked or a combination of these problems gives the drug company the approval they are free to hurt or help as many people as the doctors can hook on the poison of their poorly tested pills.

As an example, I read a recent article in the St. Pete Times about a new drug called Ketek. Ketek is an antibiotic for persistent colds and coughs. Aventis Pharmaceuticals, Inc. (now Sano-Aventis) is the manufacturer of Ketek. The drug maker offered the doctors $400.00 PER PATIENT to test Ketek. Dr. Anne Kirkman Campbell, in Alabama was able to sign up over 400 patients. According to the article, she was able to sign up more patients than any other doctor in the entire nation by a huge margin.

In the past few years there has been a proliferation of lawsuits against pharmaceutical companies because of improper testing of their drugs. In this case Aventis hired an objective oversight company called PPD, Inc. PPD was hired to oversee the study and doctor testing of their new blockbuster drug. The oversight company would review the doctor’s charts and information and determine if the results were realistic and in line with every other doctors results.

Once PPD figured out the obvious and outrageous amount of fraud Dr. Campbell was committing, the question is “What did Aventis do?” The answer is the exact opposite of what it should have done. Instead of investigating the fraud and discounting the data and firing Dr. Campbell from the study, Aventis tried to ignore the fraud. No one at Aventis reported the crime to the FDA. Aventis did not even throw out her improper data. In fact, they did more than just ignore the fraud. Instead they flew a team of people in to Dr. Campbell’s office to review her files and to coach her though the FDA’s questions. Aventis actually included the fraudulent data in their submission to the FDA.

So, you again ask, what did the FDA do if the fraud was so clear? Even after Federal agents found Dr. Campbell's fraudulent data, as well as many other problems at many other doctor offices, the FDA APPROVED KETEK!

Our system is simply completely broken. The fox is watching the hen house and the farmer is being paid off by the fox as well.

Ketek was given to patients on false and fraudulent data. Eventually evidence arose linking 53 reported cases of liver failure including two transplants and five deaths to Ketek. Due to the rising tide of evidence Dr. Campbell was finally charged with 21 counts of fraud and sentenced to 57 months in prison.

That is not enough. Dr. Campbell is only one third of the problem. The system is the problem. Nine other doctors in this study alone had exceptionally high enrollment and they all had problems in their data. No one is looking into their data. If at all possible the FDA and the Drug Company and the Doctors will all turn their heads and ignore negative data. To make money on the fraud they are all willing to risk human life and tragedy for the benefit of a buck. The system is broken and the FDA simply CANNOT BE the final line of defense to protect the American public from harm.

Aventis made over $400,000,000 just during the initial launch months for Ketek. I pray the many lawsuits for the deaths of those poor individuals who were given this poison for the common cold and lost their lives far outweighs that amount. The only way corporations will learn that it is a good business decision to protect and care for the consumer is through this type of behavior modification – take away the profit motive to harm the public.

Click Here to read the St. Petersburg Times article. It will make you… Sicko.