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First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated.  Case law now appears to be more settled in the wake of Caronia.

First amendment contests are usually brought as either defenses to off-label prosecutions (as in Caronia) or by advocacy groups and drug companies seeking injunctive relief (Washington Legal Foundation). Continue reading ›

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Jeffrey Friedlander, physician at the Neurology & Pain Center in Tampa, was recently convicted of Medicare fraud and drug conspiracy through his participation in a “pill mill.” Friedlander facilitated a drug-trafficking scheme by signing blank prescriptions, used to obtain powerful pain killers that were then sold on the street. Centers such as Friedlander’s are being dubbed the new face of health care fraud.

Clinic employees filed bogus Medicare claims for tests and procedures never performed, and billed Medicare for painkillers with fake patient profiles. Continue reading ›

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The First Amendment of the United States Constitution protects the freedom of speech.  Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury.  So-called “commercial speech” is a category of speech afforded partial, but not total, protection by the country’s courts.  Regarding the First Amendment debate, the FDA faces a conflict: to balance the need for neutral and candid research within the medical community concerning off-label uses against the self interest of drug makers, who stand to profit if their drugs may be sold for more medical conditions. Continue reading ›

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In the wake of a large settlement (for more, see here), GlaxoSmithKline attorney Lauren Stevens was indicted for obstruction and making false statements to the FDA. Allegedly, the attorney withheld incriminating documents and made misrepresentations in letters sent to the FDA. In addition to actions related to poor manufacturing, charges also relate to GSK programs to promote off-label uses of Wellbutrin. At the time, the antidepressant was promoted off-label for weight loss. Continue reading ›

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According to Dodd-Frank legislation, the SEC is required to adopt regulations regarding its whistleblower program no later than April 21 2011 (nine months from enactment). According to a recent report released by the SEC, the agency has set aside about $450 million for future payments to whistleblowers whose information results in successful cases and penalties.

The SEC is currently soliciting comments on how the proposed whistleblower program may best co-exist with current corporate compliance programs. Comments may be submitted via the SEC’s online form here. Continue reading ›

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The Louis Berger Group settled a False Claims Act case for $69.3 million, after receiving contracts for reconstruction projects in both Iraq and Afghanistan with both the United States Agency for International Development (USAID) and the Department of Defense. The suit alleged that LBG intentionally overbilled the government through an elaborate accounting fraud scheme. Specifically, LBG executives conspired to charge falsely inflated overhead rates to the government by: Continue reading ›

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Mission Essential Personnel, a government contractor providing language translators in Afghanistan, has recently lost a motion to dismiss a False Claims Act case filed by whistleblower Paul Funk. Funk, a former manager in 2007 and 2008, alleges that MEP committed fraud on the government by providing substandard translators overseas. Continue reading ›

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Rocky Mountain Instrument Company (RMI) recently entered into a settlement agreement with the DOJ to resolve False Claims Act allegations. RMI, a manufacturer of optical components used in laser and imaging applications, allegedly violated both the Arms Export Control Act and International Traffic in Arms Regulations by manufacturing some components overseas, using foreign workers. Because Department of Defense would not purchased components made in violation of law, RMI violated the False Claims Act as a subcontractor by causing contractors to submit claims for payment to the government. Continue reading ›

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Cheryl Eckard, the whistleblower responsible for the recent GlaxoSmithKline settlement, recently received a reward of $96 million — the largest award in history to a single whistleblower. As a result of her whistleblowing activities, many sources have labeled Eckard as a “role model for whistleblowers.” In a statement given Tuesday, October October 26th, Eckard said, “This is not something I ever wanted to do, but I felt I had no choice because of the safety concerns.”

Eckard worked for GlaxoSmithKline from 1992 to 2003 and was a manager of global quality assurance at the company’s research center in North Carolina. Continue reading ›

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