AUGUST 2, 2016 – By Jim Spencer Star Tribune
Two patients who were injured by Medtronic’s controversial Infuse bone graft product will receive a combined $8.45 million in settlements with the University of California Los Angeles, where a doctor with financial ties to the company used the product on them.
Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed. They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.
Claims of injuries from such “off-label” use have plagued Infuse almost from the time of its introduction into the market in 2002, and the company’s possible role in promoting those treatments has sparked government investigations and lawsuits. Studies have shown that the bone growth product is used 85 percent of the time in ways the FDA did not specifically approve.
Medtronic denied any wrongdoing in the Weiss or Lew cases. The company settled with Lew for an additional amount of money that it declined to reveal.
“Medtronic’s company policies and extensive training expressly provide that we promote our products only for those uses that are consistent with the labeling approved by the FDA,” a spokesman said in a statement.
Both Weiss and Lew ended up with unwanted bone growth in their spines that caused nerve damage. Weiss got $4.25 million from UCLA, while Lew got $4.2 million.