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Weekly News, Analysis, and Commentary

Legal & Regulatory Features & News

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Spinal Cap III: The Taming of the Pedicle Screw – Part I

Photo creation by RRY Publications LLC / Sources: Wikimedia Commons and Kaudris
Photo creation by RRY Publications LLC / Sources: Wikimedia Commons and Kaudris

The whistleblower lawsuit that started the FBI Spinal Cap investigation in California has been made public. Michael Drobot is still at the center of this drama. Act III of the drama now unfolds as patients sue Drobot and his accomplices for causing counterfeit screws and rods to be implanted in their spines. Read Part 1 this week.

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DePuy Scores Big Pinnacle Court Victory

Image created by RRY Publications, LLC / Sources: Wikimedia Commons and Morguefile
Image created by RRY Publications, LLC / Sources: Wikimedia Commons and Morguefile

A federal jury gives DePuy Orthopaedics a big court victory in the second big metal-on-metal hip implant set of lawsuits. After settling the ASR hip case for $2.5 billion, the company is digging in its heels over 6,000+ Pinnacle implant lawsuits. But the Vioxx slayer representing the plaintiff won’t give up easy.

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FDA Abused Power, ReGen Biologics Exonerated

Image created by RRY Publications, LLC / Source: cctpp.com
Image created by RRY Publications, LLC / Source: cctpp.com

A U.S. Court of Appeals called the actions of the FDA unlawful and exonerated ReGen Biologics of accusations of misconduct. Short of misconduct, the FDA has no power to rescind the 510(k) clearance of the company’s Menaflex collagen scaffold, said the Court. What does this all mean for your next encounter with the FDA? Read it here.

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POD Defender Puts DOJ on Ropes

Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons
Source: U.S. Navy photo by Mass Communication Specialist Seaman Apprentice Matthew Bookwalter and Wikimedia Commons

The government’s healthcare cop, the DOJ, says Reliance Medical violated the Anti-Kickback Statue of the False Claims Act. Rubbish, says Reliance’s lawyer, Pat Hooper who beat the DOJ the last time they went after physician owned entities. He says the government’s just coming back for a second bite of the apple. Read how he is defending his clients and PODs.

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First PODS Prosecuted

Image created by RRY Publications, LLC
Image created by RRY Publications, LLC

The government has fired the first legal shot against physician-owned distributors (PODs) by filing a False Claim lawsuit against Reliance Medical, two PODs and Aria Sabit, M.D., an investor in the PODs. The suit says the group sailed outside Safe-Harbor waters and therefore filed false Medicare claims. The government wants its money back.

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

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

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.

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