Allergan pays 600 million fine 4 off label.

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Heard it was 8 million after lawyer fees. Heard a eye doc is going to blow whistle on Zymar. I am getting in on this,there were 5 WB for Botox ,one was doctor. If you have evidence of kickbacks(speaker programs,grants,ect,ect.). I suggest you get on board with me and the doc. He said why not, what do have lose, you have something maybe to gain. Millions... The DOJ love when the docs turn over evidence. Jump on the wagon. There 5 WB in Botox suit. Get lawyer off the TAF web- site.
 






Anyone keep old Zymar off label stuff and all the kickbacks. They want that evidence destroyed because of how unethical they were when they launched Zymar and after that. Why conversion to Zymaxid.No more paper trail of 10 years of illegal behavior. DO NOT destroy,take your evidence and file whistle blower suit. The govt can go as far back as 10 year of wrong doing.
 






Elan Pays $204M For Off-Label Marketing
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By Ed Silverman // December 16th, 2010 // 8:08 am

In the latest instance in which a drugmaker has been tagged for off-label marketing, Elan and its US subsidiary agreed to pay $203.5 million to resolve criminal and civil charges in connection with illegally promoting its Zonegran epilepsy med. And in a separate settlement, Eisai, which purchased the med from Elan, has paid $11 million to resolve civil charges of off-label marketing (see this).

The settlement is not a huge surprise, given that Elan signaled a deal was in the works last summer. But the scope of the off-label marketing is impressive. Keep in mind that Zonegran was approved to treat partial seizures in epilepsy for adults over the age of 16 - and nothing else. But the feds say Elan promoted the med to treat mood stabilization for mania and bipolar disorder; migraine headaches; chronic daily headaches; eating disorders; obesity; Parkinson’s disease; and for a variety of seizures in children under the age of 16. Elan also paid illegal kickbacks to docs.

These shenanigans helped the bottom line. According to the whistleblower lawsuit filed by Lee Chartock, a Massachusetts psychiatrist who became a Zonegran prescriber, sales in 2001 were $37.8 million but reached $113 million in the 12-month period ended March 31, 2006, even though the drug lost its patent protection in December 2005 and was subject to competition from generics. The “increase was due in large part to the illegal incentives provided to physicians in order to induce prescriptions of Zonegran as well as ELAN’s unlawful marketing activities,” the suit states.

Among the episodes he recounted: he was paid by Elan to attend a Florida conference, as an adviser, where off-label use for mood stabilization and the treatment of mania was endorsed by a specialist from the University of Pennsylvania, who discussed a six-month older poster. The specialist conceded that “controlled trials are warranted to further investigate the use…in bipolar disorder,” but maintained the drug “may be ad effective and well-tolerated adjunctive treatment for refractory bipolar patients.” This was based on 12 patients, five of whom reported adverse events. There was also talk of using the med for binge eating and bulimia nervosa based on data for just a few patients.

Under the deal, Elan agreed to pay a $97 million criminal fine and nearly $103 million to resolve the civil charges that were filed by a whistleblower under the False Claims Act (here is the civil settlement,
 


















Elan Pays $204M For Off-Label Marketing
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By Ed Silverman // December 16th, 2010 // 8:08 am

In the latest instance in which a drugmaker has been tagged for off-label marketing, Elan and its US subsidiary agreed to pay $203.5 million to resolve criminal and civil charges in connection with illegally promoting its Zonegran epilepsy med. And in a separate settlement, Eisai, which purchased the med from Elan, has paid $11 million to resolve civil charges of off-label marketing (see this).

The settlement is not a huge surprise, given that Elan signaled a deal was in the works last summer. But the scope of the off-label marketing is impressive. Keep in mind that Zonegran was approved to treat partial seizures in epilepsy for adults over the age of 16 - and nothing else. But the feds say Elan promoted the med to treat mood stabilization for mania and bipolar disorder; migraine headaches; chronic daily headaches; eating disorders; obesity; Parkinson’s disease; and for a variety of seizures in children under the age of 16. Elan also paid illegal kickbacks to docs.

These shenanigans helped the bottom line. According to the whistleblower lawsuit filed by Lee Chartock, a Massachusetts psychiatrist who became a Zonegran prescriber, sales in 2001 were $37.8 million but reached $113 million in the 12-month period ended March 31, 2006, even though the drug lost its patent protection in December 2005 and was subject to competition from generics. The “increase was due in large part to the illegal incentives provided to physicians in order to induce prescriptions of Zonegran as well as ELAN’s unlawful marketing activities,” the suit states.

Among the episodes he recounted: he was paid by Elan to attend a Florida conference, as an adviser, where off-label use for mood stabilization and the treatment of mania was endorsed by a specialist from the University of Pennsylvania, who discussed a six-month older poster. The specialist conceded that “controlled trials are warranted to further investigate the use…in bipolar disorder,” but maintained the drug “may be ad effective and well-tolerated adjunctive treatment for refractory bipolar patients.” This was based on 12 patients, five of whom reported adverse events. There was also talk of using the med for binge eating and bulimia nervosa based on data for just a few patients.

Under the deal, Elan agreed to pay a $97 million criminal fine and nearly $103 million to resolve the civil charges that were filed by a whistleblower under the False Claims Act (here is the civil settlement, this is the plea agreement and this is the Elan statement). For his trouble, Chartock is getting $11 million
 












Pharmaceutical Company, Allergan, to Pay $600 Million & Enter Guilty Plea to Settle Charges of Off-Label Marketing of Botox®
The pharmaceutical company Allergan, Inc., entered into a $600,000,000 settlement and agreement to plead guilty after a Federal investigation into illegal marketing practices of Botox (United States ex. Rel. Albert Edward Hallivis, United States District Court for the Northern District of Georgia, case #1:09-CV-3434-WSD). The investigation was aided by Albert Hallivis, company employee turned whistleblower, who was represented by Jay Holland and Brian Markovitz of Joseph, Greenwald & Laake, P.A.. Hallivis, who remains employed by Allergen, revealed to federal investigators that the company was urging doctors to prescribe Botox to treat for uses not approved by the Food and Drug Administration (FDA). The practice, known as “off-label” marketing, is prohibited by federal law.

As part of his job as sales representative, Hallivis was expected to market “off-label” uses for Botox as a way to increase sales. Hallivis, troubled that he was asked to violate federal law, called FDA's Help Line. Thereafter, Hallivis filed a whistleblower lawsuit under the False Claims Act and assisted the Department of Justice as well as the FBI by providing key information about Allergan's illegal practices.

The FDA approves drugs for specific uses. But doctors, in their reasonable discretion, can prescribe drugs for uses that are not FDA approved. However, drug companies are prohibited from promoting drugs for uses not approved by the FDA as “safe and effective.” The federal government determined that Allergen’s marketing of “off-label” uses resulted in illegal Medicare and Medicaid reimbursements. “Whistleblowers are key to uncovering and prosecuting fraud and illegal activity against the government. Often, employees fear retaliation from employers but there are laws protecting whistleblowers from retribution,” said attorney Jay Holland, who represented Hallivis. Mr. Markovitz added, “The FDA’s approval process is completely undermined by off-label marketing. Not only are patients put at risk, but in this case, the government found that Allergen’s actions cost the government hundreds of millions in Medicare and Medicaid reimbursements.”
Allergan, Inc., based in Irvine, California, will pay the federal government and numerous states a total of $600

Read more about Pharmaceutical Company, Allergan, to Pay $600 Million & Enter Guilty Plea to Settle Charges of Off-Label Marketing of Botox® | International Whistleblowers by www.internationalwhistleblowers.com
 
























For off label and kickback documentation
CALL: Botox Whistleblower Case Settles for $600 Million
Press Release: For Immediate Release
Contact: Ken Nolan, Marcella Auerbach, Jeb White
Phone: 954.779.3943
 
























Anonymous said:
You wouldn't know if I was or wasn't, DOJ keeps it underseal. How would know if there was case or not stupid!!!!!!!!
Click to expand...

It's all you've been talking about on this board "stupid". Off label Zymar..sssssssooooo off label, evidence from 7 years back etc. It's not hard to know that it YOU because you are so "stupid" you don't know how to type.

1. You put a space in between each and every word.
2. Put said space between words and commas, exclamation points etc.

Possibly, if you do learn to do these things your moronic posts won't be spotted a mile away as "that crazy Zymar guy".

Oh, btw how is your BIG case going?
 






Anonymous said:
It's all you've been talking about on this board "stupid". Off label Zymar..sssssssooooo off label, evidence from 7 years back etc. It's not hard to know that it YOU because you are so "stupid" you don't know how to type.

1. You put a space in between each and every word.
2. Put said space between words and commas, exclamation points etc.

Possibly, if you do learn to do these things your moronic posts won't be spotted a mile away as "that crazy Zymar guy".

Oh, btw how is your BIG case going?
Click to expand...

No shit this guy is such a DB!
 






For off label and kickback documentation
CALL: Botox Whistleblower Case Settles for $600 Million
Press Release: For Immediate Release
Contact: Ken Nolan, Marcella Auerbach, Jeb White
Phone: 954.779.3943
 












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