In 2008, Medtronic employees mysteriously shut down a study documenting what happened to roughly 3,600 patients who had received the biotech giant’s latest bone-fusion product called Infuse. Now, lawmakers and those involved in a Medtronic Infuse lawsuit want to know why.
Over a two-year span, Medtronic employees analyzed patient medical records sent in by doctors and hospitals from all over the country that had administered Infuse. At the time, Medtronic had only received approval from the U.S. Food and Drug Administration (FDA) for the use of Infuse in one specific spine surgery, though the company had high hopes that these medical records could help build a case for the approval of other Infuse surgeries.
Medtronic asked doctors and hospitals to submit any adverse events experienced by patients who received Infuse. They did – more than 1,000 adverse events were reported to the company during this time, ranging from minor to serious complications. Four patients also died due to Infuse complications, according to the Star Tribune.
Under federal law, medical device manufacturers are required to submit any product-related adverse events to the FDA within 30 days of hearing about them. Medtronic didn’t do this, instead opting to effectively stop the study without telling FDA about these reported adverse events.
Medtronic finally got around to reporting the many reported adverse events more than five years after they were supposed to be submitted. This, of course, is troubling news. Perhaps just as troubling is the FDA’s role in this mess.
The FDA, which is charged with protecting the American public from dangerous drugs and medical devices, raised no issues with regard to Medtronic’s exceedingly late adverse events reporting. The agency also blacked out the total number of adverse events reported in a three-sentence summary that only recently became public. According to an FDA spokesperson, the FDA let Medtronic file a short summary, rather than a detailed report, for the adverse events because the information “was dated” and “didn’t reflect new public health concerns.”
The actual number of adverse events was made public only after the Star Tribune challenged the agency on its decision to keep the number private. To this day, Medtronic has not publicly disclosed what Infuse adverse events were reported in the study.
Senators Want to Know Why Medtronic Failed to Report Adverse Events to FDA
Fast forward to the present day and the landscape looks much different for Medtronic, at least with regard to its Infuse bone graft device. Infuse has been the subject of heavy scrutiny from the medical community and the government. The Justice Department, Congressional committees and state governments have all asked Medtronic to turn over information about Infuse. Thousands of people have made the decision to file a Medtronic Infuse lawsuit over injuries they claim to have suffered as a result of receiving the device.
In the wake of the Star Tribune’s reporting on Infuse, Senator Al Franken (D-MN) sent letters to Medtronic CEO Omar Ishrak and FDA Commissioner Robert Califf. Writing “out of concern,” Franken said in both letters that the “lack of information potentially skewed the risk profile of the device [Infuse], which may have affected the treatment of thousands of patients.” Franken added in both letters that the Star Tribune’s story raised “troubling questions about the FDA’s insufficient vigilance in its industry watchdog role.”
In response, Senator Franken recently received a letter from the president of Medtronic’s spine business, Douglas King, which stated that no one at the company ever intended to hide the unreported study. According to King, the reporting problem was attributed to a number of issues, not the least of which was an unclear internal company policy within the spine division for the reporting of adverse events.
One particularly interesting facet of King’s letter to Senator Franken was an admission that the “overwhelming majority” of Infuse procedures cited in the unreported study were off-label procedures.
When dealing with a Medtronic Infuse lawsuit, the company has consistently argued that it never promoted Infuse for off-label uses.
Nonetheless, Senator Franken still has questions, for both Medtronic and the FDA.
“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,” said Franken.
Medtronic Infuse Lawsuit
Patients who have been harmed by the Medtronic medical device Infuse may be entitled to compensation by filing a Medtronic Infuse lawsuit. Thousands of patients across the country have already made the decision to retain an Infuse lawyer after experiencing painful side effects related to their surgery. To learn more about your rights, contact an Infuse lawyer today to discuss your potential Medtronic Infuse lawsuit.