Whistleblower Law Blog : Whistleblower Lawyer & Attorney : LaBovick Law Firm, Florida : Federal False Claims Act, Qui Tam

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.

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The United States filed a qui tam or False Claims Act complaint against Johnson & Johnson (J&J) and its subsidiary companies Johnson & Johnson Health Care Systems Inc. and Ortho-McNeil-Janssen Pharmaceuticals Inc. According to the complaint, Omnicare Inc., the U.S.’s largest dispenser of pharmaceuticals to patients in nursing homes, was receiving millions of dollars in kickbacks from the companies. This complaint comes after Omnicare entered into a $98 million settlement with the federal government and multiple states in November of last year, an action that supposedly resolved Omnicare’s liability for taking previous kickbacks from Johnson & Johnson.

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." 

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Pfizer Inc has agreed to pay a record settlement of $2.3 billion to resolve a qui tam case and to settle federal and criminal probes. According to the DOJ and several published reports, this involves the alleged Medicare/Medicaid fraud, and the illegal use off-label marketing of multiple drugs.

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.
 

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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.

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The captivating Pharma Fraud blog brings us an interesting perspective into the world of drug diversion by leading Pharmaceutical companies.  In a recent post, Pharma Fraud, includes an interview with a Relator in The USA et al Relator v McKesson et al case. This is the case that alleges three Big Wholesalers and Henry Schein,  encouraged and engaged in the diversion into the gray market of drugs manufactured by Merck & Co., Inc. (“Merck”). It names the giant distributer, Henry Schein as a major player in purchasing diverted Merck drugs and selling them to wholesalers.

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.

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Readers,

Does it smell bad? It smells very bad to me. What smells bad? The administration of our country is what smells bad. 

I just read the August 1, 2007 Washington Post Article by Amy Goldstein and Carrie Johnson. The article, "U.S. Attorney Became Target After Rebuffing Justice Dept" talks about how an Assistant U.S. Attorney, John L. Brownlee, while prosecuting the OxyContin case was called by Michael J. Elston, the chief of staff to the Deputy Attorney General Paul J. McNulty (read Alberto Gonzales underling) the night before the plea deal and was instructed to "slow down" the prosecution. Mr. Brownlee, boldly, did not listen to those instructions and went forward with the prosecution.

Interesting. A few weeks ago, I blogged on Presidential hopeful, Rudy Giuliani, being the dealmaker for Purdue Pharma, the multi-billion dollar company who manufactured Oxy. Recently company executives were sentenced for defrauding the government but avoided the real punishment of significant jail time. We all know that rich people get to avoid criminal prosecution whenever possible. I am sure having a presidential hopeful as your lawyer and a president as you buddy didn't hurt.

According to the article, someone had enough influence and power to actually get to an Assistant U.S. Attorney's superior office, have them call the poor US Attorney the night before he concludes the biggest case of his life and try and stall or kill the prosecution. I know that is no longer shocking. But it should be!

We applaud the work of the bold and good Mr. Brownlee, but what was his reward? Somehow his name was on a November 1 list of Assistant US Attorneys who were recommended for dismissal. That seems logical. Let's dismiss the guy who just prosecuted a huge pharma company and worked his tail off and helped recover $635 million for the government. Why would Mr. Gonzales want to dismiss Mr. Brownlee? Maybe because he was pushing to prosecute the President of United State's buddies? I criticized the deal as too lenient. I think the public needed to see real justice and retribution by having the evildoing executives go to jail. I am betting the Administration felt it came far too fast and was far too costly.

I guess, as a lawyer, I am imprinted with the feeling that our justice system (one of the best and most fair systems in the world) is the third leg of American Government. The American way of life depends on the judicial system running as an independent entity free of political manipulation. Certainly there have always been attempts to manipulate the Judiciary. But this administration has made a full out frontal attack on the entire Judicial System. They attack the civil system by trying to stop civil lawsuits. They propagandize the American public that they need to stop the "greedy trial lawyers" at the small guys expense. Big corporations, big drug companies and big insurance companies can continue to hurt the little guy and this Administration could not be happier. Now they are fully attacking the criminal justice system. They are directly and intentionally interfering with criminal prosecutions. I do not trust any of their motives. Purdue Pharma plead guilty to hurting and killing and defrauding the public and the government. They got away with a $635 million dollar slap on the wrist. I know that sounds like a lot of money, but when your liberty is at steak, it is just money. I promise they will make more. It should be criminal for the Administration to interfere and attempt to stop even that from happening. It makes me imagine how much money and fraud is not being prosecuted in the multi-BILLION dollar contracts to the Iraq multi-national companies.

This is just another bad smell reeking from the bowels of an administration mired in the muck of just being bad to the core. Bad at administrating. Bad at being transparent with the public. Bad at caring for the country. Bad at making international policy. Bad at dealing with prisoners of war. Bad for the environment. Just bad for America. It is just so very bad.

Sick and signing off.
Brian

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Merck's former billion dollar baby, Vioxx, popular arthritis Medicine, is still making headlines, despite having been pulled off the market for several years.  A recent  2,434-patient study, published on Wednesday in the New England Journal of Medicine, finds that increased heart risk begins much earlier than after 18 months of use, as previously indicated by the drug maker. Of course, Merck is denying the relevancy of this study. According to Merck, the study is not conclusive.

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

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Jazz Pharmaceuticals, Inc. and it subsidiary Orphan pharmaceuticals, has agreed to pay $20 million in penalties and victim compensation to resolve criminal and civil investigations surrounding illegal promotion of narcolepsy drug, Xyrem.  With this settlement, Jazz Pharmaceuticals settles a $3.75 million Federal False Claims Act case with the government and agrees to pay interest. The active ingredient,  GHB is a powerful, fast acting depressant that has been abused as a recreational drug and classified as a "date rape" drug.  The company admitted to falsely promoting the Xyrem drug to doctors for unapproved uses such as fatigue, insomnia, chronic pain, weight loss, depression and bipolar disorder, according to the Justice Department.

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

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It is finished... Purdue Pharma Executives were sentenced by Federal Judge James P. Jones, yesterday in Virginia. Judge Jones sentenced the three top executives of Purdue Pharma to three years’ probation and 400 hours each of community service in drug treatment programs. The New York Times reported that Judge Jones was "troubled by his inability to send the executives to prison. The  federal prosecutors had not produced evidence as part of recent plea deals to show that the officials were aware of wrongdoing at the drug’s maker".

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

 

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Peter Rost is amazing. He manages to break the best stories and do the best interviews on Pharmaceutical fraud.  This time around, is about a fired Novartis Whistleblower, with over 20 years in the pharma industry.

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.

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It troubles me that Rudy Giuliani is defending the bad guys at Purdue Pharma. I am almost ready to start preaching on a soapbox about the topic of Presidential election politics and the candidates. Until now I have remained silent on this issue because I feel like the entire group continues to spout off about "non" issue positions. They are giving us dialogue that means nothing. (Lets put aside the voting stances related to the Immigration Bill and the recent vote to fund the troops, since I think the actual voting position will mean much more than their political rhetoric.)

I enjoy listening to Rudy Giuliani, the most, out of all the candidates. He is direct, plain spoken and seems accessible. I think that this is what made him a great prosecutor. Not long ago Rudy helped put away the bad guys. Mr. Giuliani’s reputation was that of a hard-core prosecutor. A punisher of criminal behavior. As a candidate for the Presidency, his employment history encourages me about what Mr. Giuliani will do for America. I venture to say, it makes me feel like I understand him because I understand his passion.

Since he is now running for President, I expected him to continue on this path. But that does not seem like it will happen. Presidential campaigns cost enormous amounts of money and requires candidates to have several friends with money, to run for President. Keeping those "monied" friends out of jail would help gather the funds necessary to run for the President's Office.

There is no doubt that the drug OxyContin has ruined many lives. There is no question that the owner and executives at Purdue Pharma, the manufacturer of OxyContin, was guilty of fraud in how they marketed the drug. Their flagrant behavior caused the government to prosecute both the individuals and the company itself. The Judge fined the company $634.5 million dollars after the company's chief executives (Michael Friedman, the company’s president; Howard R. Udell, its top lawyer; and Dr. Paul D. Goldenheim, its former medical director) plead GUILTY to criminal charges of misleading doctors and patients about the drug.

Continue Reading...

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Dear Readers:

Get ready for the propaganda storm blitz of the century. If you think cigarettes are healthy and that steroids in cow milk is hunky dory, then you will be happy to know that a bunch of Corporatist Party Think Tanks are ready to do whatever it takes to counter the assertions made by the new Movie SiCKO. Earlier this month, I blogged on pharmaceutical fraud and SiCKO,  the new startling news is that Think Tanks such as The Cato Institute are hosting symposiums to mobilize a force to rebut the movie. This is another example of dark forces of the Corporatist Party wanting us to sit back and believe their propaganda and accept that fraud is a "normal" way of doing business, and the sale of untested poison to the American public is A-Okay.

Who knows what they will think up next. It is going to be interesting.

Brian

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.

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Well, well, well! Poor Dr. Palazzo. She was caught with her hand in the fraud cookie jar. Yesterday we found out that the US Attorney’s office in New Orleans is filing a 55 count indictment on Dr. Maria Carmen Palazzo, a local psychiatrist. Dr. Palazzo was falsifying her data on Paxil (manufactured by GlaxoSmithKline) clinical trials on CHILDREN. She made a grand total of just over $653,000 and failed to maintain and prepare the proper records required by the FDA for evaluation of the drug’s safety. Now this error is going to cost her something big! The total indictment could run approximately $10 million in fines and 445 years in prison!

Wow, and who said crime and fraud pays!

Click Here to read more on this topic from an Associated Press article.

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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?

Continue Reading...

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Medicis Pharmaceutical Corporation of Scottsdale, Ariz., agreed to pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid, according to a Department of Justice announcement earlier this week. The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA).

The United States and the whistleblowers – four former Medicis employees – alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the doctors to use Loprox as a treatment for diaper rash.

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.

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Is there a correlation between a doctor's prescriptions to patients and the relationship with the prospective pharmaceutical company? There could be. According to a survey, The New England Journal of Medicine recently reported physician relationships with the pharmaceutical industry. Most physicians (94%) reported some type of relationship with the pharmaceutical industry, and most of these relationships involved receiving food in the workplace (83%) or receiving drug samples (78%). More than one third of the respondents (35%) received reimbursement for costs associated with professional meetings or continuing medical education, and more than one quarter (28%) received payments for consulting, giving lectures, or enrolling patients in trials.

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.

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Long line of pending cases involves milking government health-care program

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

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