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.

Weiss had lumbar spine surgery. Lew’s spine surgery involved placement of Infuse in his neck, where the FDA had warned it could cause nerve and breathing problems.

In addition to allegations of improper use of Infuse, Lew’s suit said Medtronic illegally misbranded the cage device that Wang implanted in Lew’s neck to hold the synthetic bone growth product. Lew’s suit alleged that Medtronic got the U.S. Food and Drug Administration (FDA) to approve the device without testing by saying it would be used in the chest and lower spine, but that Medtronic designed the device so that it was too small and the wrong shape to fit anywhere but the neck.

Records in the Lew case show that one of the device’s designers testified that he intended it to be used in the neck. Lew’s lawyers also found an e-mail from a Medtronic employee to UCLA officials noting that “because of its small size many surgeons prefer to use it in the cervical spine.”

Lew’s principal attorney, Robert Vaage, told Los Angeles Superior Court Judge Terry Green that he could find no examples of the cage being used anywhere except the neck.

Medtronic said decisions on which devices to use rested with the physician and the patient. “The upper vertebrae in the thoracic spine can be quite small so the system comes in a variety of sizes to accommodate the unique anatomies of different sized patients,” the company said in its statement.

The company said that Wang was not paid for using the Medtronic products used in Lew’s surgery, and that as of the time of the surgery involving Lew he was not a consultant for Medtronic.

UCLA did not respond to the specific allegations of the suits but said it settled so the school and its medical system “could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”

Wang’s lawyer did not respond to a request for comment. Records show that Medtronic paid Wang nearly $300,000 in grants, royalties and consulting fees from 2000-2009. Wang’s image and quotes remain on Medtronic’s neck pain website. He is now chief of the orthopedic spine service at the University of Southern California medical school.

Medtronic has already written off $140 million to pay for “probable and reasonably estimated damages” in Infuse cases, as well as $90 million to settle a shareholder Infuse suit. In October, the company faces a leadoff trial among hundreds of lawsuits filed by Infuse recipients who say the product injured them.

Weiss’ and Lew’s individual awards are large in comparison to other announced Infuse settlements, which have averaged less than $30,000 per patient.

Weiss’ case was strictly about an unapproved use of Infuse in Weiss’ lower spine, said Vaage, who represented both Weiss and Lew. Medtronic was dropped from the suit as a defendant because Wang admitted he knew the risks of Infuse, Vaage said.

Doctors are allowed to use medical devices in non-FDA-approved ways if they think it will help their patients. But federal law says device makers are not supposed to promote those uses.

Lew’s suit is among the first — if not the first — to successfully raise the issue of misbranded spinal cages for off-label uses of Infuse. Vaage said the case settled for a “confidential amount” after he interviewed current and former Medtronic employees, including Dr. Zafar Khan, one of the designers of the cage that went into Lew’s neck.

Khan testified under oath that the cage was designed and intended for use in the cervical spine, Vaage said. Vaage also unearthed correspondence that he says showed that Medtronic marketed the device for use in the neck despite the fact that the company told the FDA it was not supposed to be used there. Medtronic produced a “surgical technique guide” that showed the cage being used in the neck, Vaage said.

“We took the position that but for this cage being made available, Infuse would never have been used in Jeremy Lew’s neck,” and he never would have been injured, Vaage said.

The law does not require doctors to disclose to patients if they are receiving off-label treatments. But patient advocates say cases like Weiss’ and Lew’s show why public policy should pay more attention to informed consent.

Patients “assume that if the doctor says do it, that it’s been approved and tested and all of those things,” said Lisa McGiffert of Consumers Union’s Safe Patient Project. “There’s a lot of off-label use and patients don’t really understand that.”

 

Staff writer Joe Carlson contributed to this report.