Medtronic Challenges Infuse Media Report
Medtronic says that a Minneapolis Star Tribune investigative report that criticizes the company’s failure for many years to submit an adverse event database on its Infuse bone fusion product “makes insinuations that are false, and fails to include information” regarding the retrospective chart review and company actions. The newspaper account says that company executives have acknowledged that Medtronic should have promptly reported adverse events to FDA when it first learned of them. They told the newspaper that the adverse event database was misfiled internally and that it was reported to FDA after it was rediscovered more than five years later. The company insisted that no patients were hurt by the delay and that Medtronic has improved its reporting procedures.
“There was no analysis to suggest there was a problem … or there was an unusual set of complications and we better keep this quiet,” company chief scientific, regulatory, and medical officer Richard Kuntz told the Star Tribune.
The company statement offers these details that it says were provided to the newspaper but omitted from the article:
information from the retrospective chart review in question was not assessed for reportability during the 2006-2008 period and thus there is no basis for the implication that Medtronic intentionally failed to report information in 2008; When the retrospective chart review was discovered by the company in 2013 and properly assessed, staff concluded that the reported adverse events were consistent with those already known across a wide body of literature and clinical study; Medtronic submitted the adverse event data to FDA more than two years ago; the newspaper “mischaracterizes the use of adverse event data” by Yale University in a systematic review sought by the company, “despite our consistent explanations to them and statements provided to them by Yale to the contrary”; and the Star Tribune attributes statements to a former Medtronic employee but the company says that he had “extremely limited” involvement with the chart review process and the reporting of its findings to regulatory authorities during his brief tenure at the company.
"Patient safety is our primary concern with all of our products,” the company statement says, “and we continue to stand by the same and effective use of Infuse bone graft in its approved indications. Infuse is an important option for physicians treating patients requiring spinal surgery in FDA-approved indications for use…. We are committed to and have led the industry in transparency, transparency regarding our business, our interactions with physicians, and the disclosure of clinical evidence related to our therapies, in particular with Infuse.”
The newspaper quotes Mitchell Hamline School of Law professor David Prince, who has studied issues involving Infuse, as saying that “what’s curious about this particular case is FDA’s behavior, even more than Medtronic’s behavior. [Infuse] is a widely, routinely used product. When you get that kind of feedback from the marketplace telling you things are going wrong with some frequency, to just shrug and say, ‘Well, we won’t look at it any further’ is the ostrich approach. You’re just burying your head in the sand.”
And the Star Tribune reports that Sen. Al Franken (D-MN) said, “We need to get to the bottom of what happened, both with Medtronic and FDA. The public deserves answers.”