Tag Archives: consequences

Medical Device Executives Found Guilty

Go Directly to Jail (23/366)

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Three of the four former Synthes executives who pled guilty to charges under the Park Doctrine were sentenced to jail time and large fines recently. The four men were charged for training and supplying doctors with bone cement to repair fractured vertebrae in spinal surgery, an indication that was off-label according to FDA. Continue reading

7 GPP Stories from Social Media, week of 11/25/2011

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We’re mining social media every week for the proverbial gold nuggets for pharmaceutical and medical device sales, marketing, legal, regulatory and compliance. This week has GPP stories about the consequences of getting marketing wrong (including jail time for execs at one company and just-shy-of-a-billion-dollar settlement for another), suggestions on how to get marketing right, and some insights on how to keep up with changing social media. Here are our top 7 GPP stories, posted this week on our Facebook page or tweeted on our Twitter handle @GPPnews.

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Build a Strong Ethical Sales Culture in 4 Steps

Originally published in PharmaPhorum
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Ethics is a broad field dominated by brilliant minds in academic institutions. We are all strapped for time and are constantly bombarded by information. How do you do the right thing? Continue reading

Attacks on FDA’s Aggressive Stance: Off vs. On-Label

Many manufacturers and industry watchers have recently renewed their challenges to the constitutionality of FDA’s expansive interpretation of off-label promotion on First Amendment grounds. Par Pharmaceutical Companies, Inc.’s recent lawsuit asked the courts to provide specific instruction and relief from prosecutorial threat for on-label communications to specific audiences who may also use their drug off-label. This is the latest in a series of attacks on the government’s aggressive stance on prosecution of pharmaceutical and medical device manufacturers and their executives for off-label promotion. Continue reading

Medical Devices: The New Low-Hanging Fruit for Healthcare Fraud?

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A highlight from the 7th Annual Medical Device and Diagnostic Compliance Congress in June was the talk by Jeremy Sternberg, deputy chief of the healthcare fraud unit, U.S. Attorney’s Office for the District of Massachusetts. His succinct and compelling story to medical device manufacturers, sales agents and distributors can be summarized as: We are smarter than ever (thanks pharma!), and we are coming after the new low-hanging fruit: medical devicesContinue reading