Pharmaceutical Company, Allergan, to Pay $600 Million & Enter Guilty Plea to Settle Charges of Off-Label Marketing of Botox®

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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. The investigation was aided by Albert Hallivis, company employee turned whistleblower, who was represented by Jay Holland ("jholland@jgllaw.com) and Brian Markovitz ("bmarkovitz@jgllaw.com") of Joseph, Greenwald & Laake, P.A. (http://www.jgllaw.com).

Jay Holland

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

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 million as part of the settlement of three False Claims Act whistleblower lawsuits. At the same time, Allergan has agreed to plead guilty to a criminal charge involving off-label marketing of the drugs.

Today's settlement covers all three whistleblower lawsuits. Holland and Markovitz praised the work of Assistant U.S. Attorney Sally Molloy and Randy Chartash, Chief of the Economic Crime Section of the Northern District of Georgia, and their office, as well as officials and attorneys in the Department of Justice, including Edward Crooke, in reaching this result.

Joseph, Greenwald and Laake, P.A. is a 34-lawyer firm, with offices in Greenbelt and Rockville, Maryland. The firm, one of the largest and oldest in suburban Maryland, emphasizes effective legal representation and outstanding service to clients, including whistleblower claims. For more information about Joseph, Greenwald and Laake, P.A. and whistleblower cases, see http://www.whistleblowers.net, and http://www.jgllaw.com/CM/Labor/False-Claims-Act-Qui-Tam.asp.

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