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Legal & Regulatory Features & News

Data Mining / Source: Wikimedia Commons and Marksenizer
Data Mining / Source: Wikimedia Commons and Marksenizer

The Social Media Advantage for Post Market Device Performance Data – Part II

The current adverse event reporting system clearly has its flaws. Can social media make a difference? This week, in Part II, our guest authors take a deeper dive into the pros and cons of the MAUDE, MedWatch and social media data bases as a source of information. And have specific recommendations.

More Cases Emerge From FBI’s California “Spinal Cap” Investigation

Image created by RRY Publications, LLC / Source: Wikimedia Commons
Image created by RRY Publications, LLC / Source: Wikimedia Commons

More cases are emerging from the FBI’s “Spinal Cap” investigation. Now the allegations are around unapproved spine devices, bribed docs and elected officials, and tragically, a dead baby. It all started with the flawed California workers’ comp law and the ways in which administrators, surgeons and companies tried to game the system.

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Social Media Trumps Peer-Review Journals?-Part I

Diagram of a Social Network / Source: Wikimedia Commons and Katherine Willis
Diagram of a Social Network / Source: Wikimedia Commons and Katherine Willis

Social media is proving to be a better and faster source of medical device and drug post market approval performance than either the FDA or, depressingly, the community of peer-review journals. How does this new tool work? Is it a force for good or ill? The McAfees have an answer.

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Humana Accuses Medtronic of Infuse Racketeering

Image created by RRY Publications: / Sources: RICO Act and logos courtesy of Humana and Medtronic
Image created by RRY Publications: / Sources: RICO Act and logos courtesy of Humana and Medtronic

In a puzzling legal move Humana Inc. filed suit against Medtronic, Inc. and is trying to invoke the organized crime inspired RICO statute. Humana accuses Medtronic of conspiring with secretly paid surgeon agents to cook peer-review literature and then promote the off-label use of Infuse. Their evidence? The Spine Journal, the U.S. Senate and Yale’s YODA study.

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“Spinal Cap” Caper in California

Wikimedia Commons and FBI
Wikimedia Commons and FBI

A small hospital in California performing half a billion dollars in spine surgeries over six years became the target of an FBI investigation called, “Spinal Cap.” This story has it all. Tens of millions in illegal kick-backs, public corruption, device sales schemes and one businessman who pled guilty to it all. Read it here.

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