In an effort to resolve a qui tam claim regarding submitting false claims to Medicaid for Nitroglycerin Sustained Release (SR) capsules, Novartis Unit, Eon Labs Inc. agreed to pay the U.S. $3.5 million. The U.S. Department of Justice (DOJ) indicated that the settlement “resolves allegations against Eon in a multi-defendant whistleblower action,” case titled United States ex rel. Conrad v. Eon Labs, Inc., et al.

The U.S. Food and Drug Administration concluded in April 1999 that Nitroglycerin SR was “no longer legally eligible for reimbursement” by Medicaid and other government-run health care programs. According to the DOJ, Eon Labs, Inc., allegedly submitted false quarterly reports that included Nitroglycerin SR to the government from April 1999 through September 2008.

U.S. Attorney for the District of Massachusetts, Carmen M. Ortiz, stated the following:

"This is the first False Claims Act agreement with a drug company that sought to charge the government for less than effective drugs, and it shows that the Department of Justice will pursue those who market such drugs and expect the government to pay for them."

Under the False Claims Act, private persons are able to file a whistleblower and qui tam lawsuit on behalf of the U.S. government. If the claim is resolved successfully, the whistleblower may be entitled to receive a share of the settlement. According to the DOJ, the whistleblower involved in this claim will receive approximately $525,000.

Click on the following link to read more on the Eon Labs False Claims Act Settlement, Department of Justice and The Wallstreet Journal.

Allegedly, Omnicare accepted financial kickbacks in return for the company’s purchase and recommendation of Johnson & Johnson and its subsidiaries’ pharmaceutical products to nursing home patients.  Doctors accepted the recommendations of Omnicare’s pharmacists more than 80 percent of the time, and allegedly Johnson & Johnson viewed Omnicare pharmacists as “an extension of its sales force.”

Kickbacks were delivered in several ways, including:

1)      Offering Omnicare rebates when programs to increase the sale of Johnson & Johnson’s prescription drugs to nursing home patients were implemented.

2)      Paying Omnicare millions of dollars for “data”; the complaint alleges that these payments were false and used only to coerce the recommendation of Johnson & Johnson drugs from Omnicare pharmacists.

3)      Johnson & Johnson also made multiple “educational funding” and “grant” payments to Omnicare, with intent only to receive a recommendation from its pharmacists.

Assistant Attorney General for the Civil Division of the Department of Justice had this to say about the situation,

"We will pursue those who break the law to take advantage of the elderly and the poor. He went on to say that, “Kickbacks such as those alleged here distort the judgments of health care professionals and put profits ahead of sound medical treatment." 

The fines in this case are $1.3 billion, which are the largest settlement ever paid for a health care fraud claim and a criminal case. In addition to Pfizer, Pharmacia & Upjohn Co, a Pfizer subsidiary was also involved with misbranding a pharmaceutical.

The settlement involves the marketing drugs not included in the label approved by the FDA. Two drugs included in this probe are antibiotic Zyvox and antipsychotic Geodon.

Pfizer has agreed to pay $400 million to settle whistleblower claims involving Zyvox and Geodon drugs. They will pay an additional $33 million for improper marketing with 42 states and the District of Columbia.

The whistleblowers involved in this case will receive over $100 million for their roles in bringing this fraud to light.
 

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.

What makes this a Qui Tam case? The manufacturers are supposed to pay a rebate to Medicaid according to Federal and State Medicaid law. If they are guilty of hiding the huge discounts to commercial customers in order to avoid paying rebates on the difference between AMP (Average Manufacturer's Price)and Best Price, which Federal and State Medicaid law requires they pay, this is a violation of the False Claims Act and is a Qui Tam case.

The amended complaint was filed in Camera under seal in May, 2007 with Plaintiff's, U.S., several states including Florida and Texas. The Defendant's named in The USA et al Relator v McKesson et al  include McKesson, Cardinal Health, Amerisourcebergen and Henry Schein, Inc.

There are over 27,000 lawsuits against Merck from people who claim to have been harmed by Vioxx.  I wonder if this new study will impact these lawsuits or not.   A few months ago, a jury awarded a man $47.5 million verdict against Merck for Vioxx, finding it responsible for his heart attack.

As though it could not get worse, The FDA rejected Merck's new wonder drug,  Arcoxia, a replacement for Vioxx. It is in the class of anti-inflammatory drugs called Cox-2 inhibitors, which are touted as less likely to cause stomach bleeding or have other dangers, but they have been linked to heart risks. On the bright side, Arcoxia is on sale in over 60 other countries, and made $265 million last year. And more importantly, the stock is doing great. Merck closed at $53.38 today an increase over previous days trading. That being the case, the company and shareholders must be happy with progress and must not find the new study to have merit. It could be the calm before the storm or it could cause those pending lawsuits against  Merck for Vioxx to mushroom. 

Time will tell. Stay tuned... Click here to read more on the new s study on Vioxx from Reuters

The Whistleblower Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. LaBovick & LaBovick is a Plaintiff's firm that represents whistleblowers in Florida and throughout the United States in qui tam (False Claims Act) litigation

The brave whistleblower in this case, was a former sales representative that filed a qui tam lawsuit on behalf of the government in 2005.  This is a perfect example of how long a whistleblower may have to wait to see results in their qui tam (whistleblower) law suit. This case remained under seal until earlier this month. Therefore, whistleblowers must be patient and follow appropriate steps to ensure their relator's portion of what the government recovers is protected. Having the necessary proof and documentation that is not public knowledge and consulting with a knowledgeable and experienced qui tam attorney are good first steps for a whistleblower. The reward for their patience and bravery can be up to 30% of what the government recovers, depending upon the government's level of involvement in prosecuting the qui tam claim. 

Click here to read more on this case from the Justice Department and the WSJ Health Blog

If you are a whistleblower with information on a corporation, defrauding the government and need to discuss your case with an experienced qui tam attorney, contact LaBovick & LaBovick. 

The Whistleblower Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. LaBovick & LaBovick is a Plaintiff's firm that represents whistleblowers in Florida and throughout the United States in qui tam (False Claims Act) litigation

One thing that this sentencing does not do, is bring back the loved ones of the families that have been hurt by OxyContin. One valiant crusader in the fight against OxyContin abuse is Ed Bisch. He is a father that lost an 18 year old son, due to a drug overdose of this drug in 2001. In a quest to shed light on the devastating affects of "Oxy" as the teens called it, the day after his died from it, he started the website www.Oxyabusekills.com. He dedicated the www.Oxyabusekills.com site in memory of his son 18 yearold son Eddie Bisch. His goal is to bring awareness on how easy it is to overdose on Oxycontin (Oxy) and the dangers of prescription drug abuse. He deserves a round of applause for his efforts to bring the awareness to this nationwide public-health crisis. He took on the giant Pharma company to wage a public campaign with the simple, yet powerful message "this stuff is killing our kids, we have to do something".  This brave dad, Ed Bisch, took a tragedy  (the loss of his 18 year old son ) and has made it his mission to help save the lives and to educate the public before it is too late.

At the Purdue Sentencing on Friday, there were several loved ones and family members who lost loved ones due to OxyContin.  I am sure that you could feel the emotions in the courtroom. According to the Rhode Island news, Victor DelRegno, a dad who last his son Andrew, age 20, to OxyContin drug overdose in 2002, was one of  the witnesses that made a statement the sentencing. Prior to the sentencing Victot DeRegno is quoted as asking “What should the true cost for justice be?”  This is a question that will remain in the minds of several people, for years to come.

Where do we go from here on the war against OxyContin abuse and other prescription drugs? What will it take for pharma companies, such as Purdue Pharma, to be honest about the dangers of their drugs? Creation of public awareness campaigns, with real people like Ed Bisch, Victor DeRegno and others sharing their stories to the community at large.  It would be great if all of the Pharma companies would fund a non-profit group that educated the public on the dangers of prescription drug abuse. One that encourages participation from family members that have lost loved ones. This would be a good start for the pharma companies to show they are serious about being a good corporate citizen. Not to say, their charitable donations already being give to communities are not enough. But rather, showing  commitment to the fight against prescription drug abuse and all the damage that it does by taking lives, loss to families and communities.

Click Here to read more of this story from the New York Times, NewsDay, Money Times, Rhode Island News

The Whistleblower Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. LaBovick & LaBovick is a Plaintiff's firm that represents whistleblowers in Florida and throughout the United States in qui tam (False Claims Act) litigation

Read Peter Rost's article on OPEDnews.com regarding the new  cancer drug, Tasigna by Novartis. It is revealing and has a very important message for pharmaceutical whistleblowers regarding when and how they should report a whistleblower claim. It sheds light on the fact that most people want to believe in the good about their company. They want to inform them when they see an inconsistency in something and expect them to make it right, They are not expecting any rewards, just an acknowledgment and confirmation on how the company will correct the problem.

An important message to people who may bring a potential qui tam or whistleblower claim against a company, is to know your rights . A relator or whistleblower must take the proper steps to protect their qui tam or whistleblower claim. They need to speak to an attorney that understands and handles qui tam claims.  This can make the difference between getting a thank you from the government or a check in the amount of up to 30% of what the government recovers. Unfortunately, the whistleblower has to protect their interest first, and that is not only gathering the documentation and proof. If you have a potential qui tam claim, contact the civil justice prosecutors at LaBovick & LaBovick. They are former Federal Prosecutors and understand how to bring a case on behalf of the government. Consultations are confidential and FREE.  Act quickly, protect your rights.

The Whistleblower Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors. LaBovick & LaBovick is a Plaintiff's firm that represents whistleblowers in Florida and throughout the nation in qui tam (False Claims Act) litigation.

Click Here to read more from an article in the New York Times

Preparing my mind for on slaught of Jedi Mind Tricks these people are ready to throw at us.

Click Here to read more ion the subject in a recent blog post by Ed Silverman on Pharmalot.

According to Assistant Attorney General Peter D. Keisler, "Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.” More pharmaceutical companies should be put on notice, they will pay for their illegal activities.

The four whistleblowers will collectively receive in excess of $1,078,000 as their statutory award. Under the qui tam provisions of the False Claims Act, whistleblowers can file an action on behalf of the United States and receive a portion of the settlement if the government reaches a monetary agreement with the defendants.

Click Here to read more on this Medicis Settlement from the Department of Justice.

Medicis announced this week, their first quarter 2007 profits were better than expected. I guess confession is good for the soul. They are trying to put their past misdeeds behind them and move forward. Hopefully, they will learn from the past.

The survey found that 83% of physicians reported they had received food or beverages paid for by a pharmaceutical or medical products company. Similarly, 78% of doctors received free drug samples, 35% were reimbursed for professional meetings, and 28% were paid for consulting, speaking, or enrolling patients in clinical trials.

This gives one food for thought: Are doctor's prescribing the best drugs to patients based on relationships or the best drug of choice? There is a fine line between marketing and buying an endorsement from a doctor.  Whose job is it to determine if anyone crossed the line?  Who looks out for the patients? These are just a few of the questions that need to be answered. Hopefully, brave men and women in the pharmaceutical industry will come forward and shed light on any unfair and deceptive practices that put the public at risk.

According to a recent report by federal officials, members of Congress and a Watchdog group, the nation's big drugmakers have been systematically overcharging the Medicaid health-care program for the poor. They have been reaping billions of dollars in illegal windfalls at the expense of the taxpayers.

Drugmakers are required by law to provide Medicaid with the same discounts they offer to big managed-care plans and hospital chains, but they have been disguising those prices, Ronald Tenpas, a U.S. associate deputy attorney general, told the House Committee on Oversight and Government Reform earlier this month.  Read More on the Article from Star Ledger