Senator grills Medtronic, FDA over alleged mishandling of Infuse bone graft study data

Sen. Al Franken (D-MN)

Medtronic ($MDT) has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers.

Sen. Al Franken (D-MN) in letters to Medtronic CEO Omar Ishrak and FDA Commissioner Robert Califf said that he was "writing out of concern" after the Star Tribune published a story recently saying that Medtronic waited 5 years before reporting serious adverse events to the FDA.

"This lack of information potentially skewed the risk profile of the device, which may have affected the treatment of thousands of patients," Franken said in both letters. And the Star Tribune story "raises troubling questions about the FDA's insufficient vigilance in its industry watchdog role."

In 2008, Medtronic shut down a study of Infuse that looked at the medical records of 3,647 patients at 26 sites who got the graft. Some of the records showed more than 1,000 complications, and a portion of those were linked to Infuse.

Employees running the study filed the data in the company's internal archives and did not report the data until 2013, after reports of complications with Infuse surfaced. Now, the company and the FDA are coming under fire for their roles in the buried data.

The FDA let the company file a summary instead a of a detailed report for the remaining adverse events because the information "was dated" and "didn't reflect new public health concerns," an FDA spokesman told the Star Tribune in an email.

And Medtronic said that the reporting delay didn't hurt anyone, because adverse events in the chart review didn't reveal new problems with Infuse. The company has admitted that it mishandled data at the time, though.

Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device

Still, Franken is not satisfied with those answers. The lawmaker asked Ishrak why Medtronic's staff did not know that adverse events in the study should be reported. And Franken wants to know what the company is doing to prevent a similar situation from reoccurring. "What assurances can you provide to rule out any intentional lack of reporting adverse event data from Medtronic?" Franken said in his letter to Ishrak.

Franken also had some questions for the FDA. Medtronic did not submit adverse event reports to the agency until 5 years after they were due, "despite the fact that the (FDA) had previously issued two warning letters" to the company for tardy submission of other data, Franken said. "Did the agency consider taking additional steps to penalize the company for noncompliance?" Franken said in his letter to Califf. "If not, why?"

Medtronic said that it got Franken's letter. The company also called out the Star Tribune for making "insinuations that are false" and that do not "include important information regarding the [retrospective chart review] and Medtronic's actions," a spokesman told the newspaper. "We look forward to further discussing these issues with Sen. Franken and his staff in our response."

The FDA also said that it got Franken's letter, and that it would "respond directly to the senator," an agency spokesman told the Star Tribune.

- read Franken's letter to Omar Ishrak (PDF)
- here's Franken's letter to the FDA (PDF)
- get the Star Tribune story

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