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| Sen. Al Franken (D-MN) |
Medtronic ($MDT) never intended to hide a study showing serious side effects linked to its Infuse bone graft, the company said in letters to two inquiring lawmakers. The company's response comes a month after reports showed that Medtronic pulled the plug on a study of its Infuse bone graft and allegedly buried the evidence.
Medtronic Spine President Douglas King in letters to Sens. Al Franken (D-MN) and Amy Klobuchar (D-MN) said the reporting issue stemmed from problems with the way the business handled its retrospective chart reviews. The spine business did not have clear policies for reporting patient injuries in related studies or a master list of its clinical activities, King said.
The review, which looked at 3,647 Infuse patient records, turned up 1,045 serious side effects linked to the product. Medtronic shut down the study in 2008 and did not report the adverse events to the FDA until 2013.
"While we regret that events from the retrospective chart review were not reported earlier, we have no information to suggest the failure to report was intentional," King said in his letter to Franken.
Medtronic has taken some responsibility for mishandling study data after The Minneapolis Star Tribune published an article about the review in April. The company said that employees running the study misfiled data in its internal archives.
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| Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device |
But the company's responses have not satisfied Franken. The senator still has some questions about Medtronic's behavior, Franken told the Star Tribune.
"Ultimately, the fact that this could occur at one of the world's leading medical device companies demonstrates that we need to improve the way we monitor the safety and efficacy of medical devices in the United States," Franken said after getting Medtronic's recent letter.
Franken and Klobuchar also are coming down on the FDA for its role in the Infuse study. The FDA had issued two warning letters to Medtronic asking for adverse event reports from the review, but never penalized the company for its tardy response.
"Medtronic and the FDA have both admitted to making mistakes in this case," Klobuchar said in a statement to the Star Tribune. "It is critical that we all work together to examine current practices and identify needed improvements to guarantee adverse events are reported as quickly and efficiently as possible."
- here's King's letter to Franken (PDF)
- get King's letter to Klobuchar (PDF)
- read the Star Tribune story