Medtronic attorneys at Pintas & Mullins Law Firm report on the recent litigation in Minnesota concerning Medtronic’s Infuse bone graft device. These cases were previously stalled due to concerns about federal preemption. After a more in-depth analysis, however, the judge agreed to let the cases proceed.
The plaintiff in this case is suing Medtronic based on three charges: 1) that the company manipulated its research findings to downplay the Infuse’s dangers; 2) Medtronic misrepresented the product to physicians so they would use the Infuse off-label, and; 3)Medtronic committed fraud in paying physicians to submit research in its favor and urged employees to spin the research to sound more positive.
There are currently 32 cases pending in Minnesota concerning the Medtronic Infuse bone graft, and many more are expected to be filed if this case is allowed to go through. The judge previously refused to hear the plaintiff’s cases due to a previous U.S. Supreme Court (SCOTUS) ruling that banned patients from suing device manufacturers after an injury occurs. This SCOTUS decision was based on the principal that, if the medical device was approved by a federal agency – the FDA – and was thus deemed safe and effective, it should not be subject to injury-related litigation.
At issue now is not that an injury occurred, but that Medtronic fraudulently misrepresented the Infuse to downplay its risks and promote it for off-label uses. The Infuse bone graft was only approved by the FDA to treat lower-spine issues, and is only supposed to be inserted through the stomach.
Due to Medtronic’s aggressive and misleading marketing tactics, thousands of patients had the Infuse implanted into their upper- or middle-spine, with dire consequences. Not only were the Infuse products implanted in unapproved locations, but the mode through which the surgery was performed was improper as well. Many physicians, following Medtronic’s recommendations, inserted the device through incisions in the stomach, which is an untested and not sanctioned by the FDA.
Medtronic Pays Doctors $200 Million to “Study” the Infuse
After a slew of reports of serious injury from the Infuse, the Senate Finance Committee issued an investigative report on Medtronic’s suspicious activity. The feds revealed that Medtronic paid over $210 million to doctors to “study” the Infuse over 15 years.
In its report the Senate Committee also found several instances where Medtronic employees suggested that academic journal writers downplay problems and side effects from Infuse trials. Upon re-reading the journal articles on the device, it is clear the safety and effectiveness of the device is indeed significantly overstated.
The off-label use of Infuse bone graft is not insignificant, and Medtronic knew this. In fact, about 90% of all revenue Medtronic enjoyed from the Infuse was from off-label procedures, banking in around $800 million in 2011 alone.
In this Minnesota case, the plaintiff’s physician is willing to testify that another doctor associated with Medtronic approached him about the device. He notes that the physician blatantly misrepresented the device, and touted its use in procedures not sanctioned by the FDA. The testifying doctor would have to prove the exact time, date and place that these statements were made, however, to have a valid argument.
Our team of Medtronic lawyers is currently investigating cases of severe injury and death from the Infuse bone graft or other recalled devices. If you or a loved one was seriously injured in a procedure using a Medtronic device, contact our firm immediately. Our legal professionals can evaluate your potential case, free of charge and with the utmost sensitivity. We provide free legal consultations to injured patients nationwide.