Stryker to pay $1.35M penalties for deceptive marketing of OP-1 in Massachusetts
Stryker Settles State OP-1 Complaint (OrthopedicsThisWeek) AG Coakley Announces $1.35 Million Settlement with Stryker Biotech (Mass Attorney General)
FDA to examine user fees
FDA to examine user fees: User fees keep going up for medical device companies. Is FDA holding up its end of the bargain? (MassDevice)
Feds are now investigating JNJ, Medtronic and Zimmer for sales outside the US
Device makers under scrutiny in international bribery beef (MassDevice) The SEC is expanding an investigation begun in 2007 into “potential violations of the U.S.Foreign Corrupt Practices Act in connection with the sale of medical devices in an unspecified number of foreign countries,” adding Turkey, Italy and Malaysia to a list that already included Greece, Poland [...]
Orthopedic Surgeon whistleblower at Rush University Medical Center exposes Medicare fraud
Whistleblowers Return for a Second Bite at False Claims Case Against Rush University Medical Center (AIS Health) Orthopedic surgeon, Robert Goldberg MD, and another whistleblower has filed a new complaint against Rush University Medical Center in Chicago, alleging the facility and an affiliated group of orthopedic surgeons overbooked operating rooms, left residents in charge of [...]
Senator Grassley demands to see Zimmer’s product complaint files
Grassley’s letter to Zimmer Zimmer Gets Grassley Request for Reports on Product Complaints (Bloomberg) Now Zimmer has received a request from U.S. Senator Chuck Grassley asking for complaint files reported by consultants or contractors since 2008, along with Zimmer’s responses. Grassley is following up on a NYTimes article that highlighted the public divorce of Zimmer [...]
Kaiser Permanente’s study shows that a national joint registry can enhance patient safety, quality of care, and cost-effectiveness
National joint replacement registry can influence optimal techniques, evaluate revision risk (OrthoSuperSite)
Zimmer, Biomet and others are fighting the new industry tax
Indiana medical device makers say fight isn’t over (IndyStar)
FDA’s Jeff Shuren talks about the upcoming changes to the 510(k) process
CDRH’s Shuren: FDA’s 510(k) findings due soon (MassDevice)
Fasten your seat belts for the FDA’s “Comparative Effectiveness”
Comparative Effectiveness Expected to Have Significant Impact on Orthopaedic Industry (John Engelhardt quote) Comparative Effectiveness Hits Medical Devices (Medical Devices Today)
Medtronic uses royalties to compensate surgeon inventors – Dr. Larry Lenke’s small royalty adds up to over $1M/year
Medtronic backs top doc with royalties (St Louis Business Journal)
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