Post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration. Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients.
Although St. Jude collected data and information from participating physicians, the company allegedly knowingly and intentionally used the studies and registry as a means of increasing its device sales by paying certain physicians to select St. Jude pacemakers and implantable defibrillators for their patients. In each case, St. Jude paid each participating physician a fee that ranged up to $2,000 per patient.
Read the news release about St. Jude Medical’s settlement.
Read other coverage about company settlements:
– Pharmaceutical Company Will Pay $280M to Settle False Claims Allegations
– Kos Pharmaceuticals Will Pay $41M to Settle Kickback, Off-Label Promotion Allegations
– Three Pharmaceutical Companies Will Pay Combined $421M to Settle Drug-Pricing Lawsuits
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