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Stiff Amgen Fine Shows No Slowing Down in Government Prosecution of Off-Label Marketing

Posted  12/20/12
By Gordon Schnell It was only two weeks ago that the Second Circuit Court of Appeals came down with its groundbreaking decision in U.S. v. Caronia.  In a 2-to-1 ruling by a three-judge panel, the appeals court overturned the conviction of a drug company sales representative for promoting a prescription drug for uses not approved by the FDA.  The majority reasoned that banning such off-label marketing violated the...

Tagged in: Off-Label and Unapproved Use, Pharma Fraud,

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More Trouble for Orthofix

Posted  12/20/12
By Marlene Koury Medical device maker Orthofix, Inc. this week obtained court approval for its June 2012 settlement proposal to resolve civil and criminal allegations that it defrauded Medicare through kickback schemes and overbilling for its bone-growth stimulators.  Click here for the original government press release.  The company will pay approximately $43 million for its misdeeds.  This payment follows on...

Tagged in: Anti-Kickback and Stark, FCA Federal, Medicare,

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Big Pharma Does Good -- Providing Access to the Poor

Posted  12/6/12
By Gordon Schnell There has been a lot of negative press on the fraudulent misadventures of Big Pharma.  Particularly lately.  Whether it be for falsifying studies, selling bad or ineffective drugs, concealing risky side effects, or ignoring FDA restrictions, it seems like every major drugmaker has been sued recently for putting profits before public health and safety.  You name the industry player, chances are...

Tagged in: Healthcare Fraud,

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Blackstone Medical Caught “Entertaining” Physicians in Exchange for Business

Posted  11/13/12
By Marlene Koury Orthofix International NV has agreed to pay $30 million to settle allegations that its subsidiary, Blackstone Medical Inc., ran a seven year long kickback scheme ranging from sham consulting agreements to providing physicians with adult “entertainment” to induce them into ordering their products.  Click here to see Department of Justice press release and here for the complaint. Blackstone...

Tagged in: Healthcare Fraud, Other Government Health Programs,

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Fudging the Studies -- Senate Report Links Medtronic to Latest Case of Ghostwriting Medical Journal Articles

Posted  11/9/12
By Gordon Schnell  In a scathing report it recently released, the Senate Finance Committee charged medical device manufacturer Medtronic, Inc. with engaging in some fairly dastardly deeds to promote its once top-selling bone growth product called InFuse.  The alleged misconduct centers around the company paying off doctors to author medical journal pieces that downplayed or downright ignored serious risks and...

Tagged in: Healthcare Fraud, Medical Devices and DME,

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Fixing a Broken System -- The Institute of Medicine's Groundbreaking Report on Runaway Waste in American Healthcare

Posted  10/25/12
By Gordon Schnell There is a lot of chatter these days about trillion dollar deficits and multi-point plans to get the economy back in shape.  President Obama and Governor Romney stick to their respective talking points about their opponent's critical failings and how they will do things better.  The divisions that separate these candidates and their followers, and the country as a whole, have not been this...

Tagged in: Healthcare Fraud,

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CVS Sub Caught Duping Consumers in Prescription Drug Purchases

Posted  10/22/12
By Marlene Koury In one of the first False Claims Act settlements involving Medicare's "Part D" prescription drug program, CVS Caremark subsidiary, RxAmerica, agreed to pony up $5.25 million to resolve charges that it submitted false pricing information to the Centers for Medicare & Medicaid Services (CMS).  This is the government body that oversees the Medicare and Medicaid programs.  It also makes available the...

Tagged in: FCA Federal, Part D, Pharma Fraud,

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Deducting the Cost of Fraud -- The Widespread Treatment of Government Settlements as a Mere Business Expense

Posted  10/17/12
By Gordon Schnell With its $9 billion take, it has been a record year for the government in terms of its recoveries under the False Claims Act.  See Banner Year for Whistleblowers . . . .  There was the $3 billion settlement with GlaxoSmithKline over its marketing misdeeds with Paxil and Wellbutrin and its failure to report safety data for Avandia.  See Big Pharma Strikes Again . . . .   There was the $1.5...

Tagged in: Healthcare Fraud,

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The Fraud Behind the Fraud of Off-Label Drug Marketing

Posted  10/5/12
By Gordon Schnell It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label...

Tagged in: Healthcare Fraud, Off-Label and Unapproved Use, Pharma Fraud,

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What is Going On With Big Pharma?

Posted  09/13/12
By Gordon Schnell With GlaxoSmithKline’s recent blockbuster $3 billion settlement with the Department of Justice -- the largest health care fraud penalty on record -- you have to wonder what is going on in the world of Big Pharma these days.  This is an industry that constantly complains of being misunderstood, underappreciated and unfairly maligned.  And there is some legitimacy to their lament.  Afterall,...

Tagged in: Healthcare Fraud,

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