Medtronic Faces Litigation Over Infuse Bone Graft Substitute

Medtronic Infuse lawyers at Pintas & Mullins Law Firm report that a federal judge recently threw out Medtronic’s motion to dismiss an injury lawsuit concerning its popular bone graft substitute, the Infuse. The company attempted to argue that two federal laws preempted the injury lawsuit.

The plaintiff, Cristina Ramirez, has suffered from severe back pain ever since she underwent a lumbar fusion procedure, during which she was implanted with Medtronic’s Infuse. Ramirez was unaware that her surgeon was using the Infuse even though it was not approved for such a procedure. The chronic pain Ramirez now suffers is caused by an uncontrollable growth near the Infuse implant site.

Medtronic moved to have the lawsuit dismissed based on the Medical Device Amendments to the Food, Drug and Cosmetic Act (FDCA). These amendments give the FDA a substantial amount of control over how a medical device is manufactured and marketed. The Arizona federal judge, however, stated that most of Ramirez’s claims were not preempted by these laws.

The plaintiff sued Medtronic claiming failure to warn, defective design, fraud, negligence, breach of express warranty, and misrepresentation. The judge granted Ramirez’s suit based primarily on her claim that the company marketed the Infuse to physicians for uses not listed on its label, and therefore not approved by the FDA. The amendments would only apply if Medtronic recommended the device only for its intended purpose.

Ramirez accused the company of encouraging doctors to use the Infuse in off-label procedures, such as lumbar fusion surgery, through various marketing platforms, including medical journal articles. She claims Medtronic did this despite knowing the potentially severe side effects of such off-label use.

The judge agreed, noting that all of Ramirez’s claims stem from her surgeon’s use of the Infuse device based on Medtronic’s promotions and advertisements. The FDA blatantly forbids off-label marketing, and so Medtronic is not protected by the FDCA amendments. The judge’s order affirms that Medtronic’s off-label promotions misbranded the Infuse, which ultimately damaged the plaintiff.

In a ruling for the other side, in early August 2013 a judge in Minnesota ruled that federal law did preempt a claim against Medtronic. Plaintiffs in this case claimed that the Infuse caused severe nerve damage and chronic pain as a result of bone growth similar to that suffered by Ramirez.

The Minneapolis judge, however, citing a U.S. Supreme Court decision regarding the FDCA amendments, ruled that state courts will not hear the plaintiffs’ cases until they refile with more specific allegations. The plaintiffs will now be forced to change their injury claims to fit more closely to those filed by Ramirez, alleging fraud based on off-label promotion.

Lawmakers and spine experts have long claimed that Medtronic fraudulently sponsored studies so that they would overstate the benefits of the Infuse and understate the potential risks. In fact, Medtronic shelled out about $210 million over the past few years to physicians who examined the device and wrote scholarly articles about it.

About 35 plaintiffs were affected by the Minnesota ruling, however, all are planning to refile under charges of fraud. This will enable them to describe more specifically how they believe Medtronic was negligent. Specifically, they will attempt to argue that Medtronic gave them false and misleading information about the device, which led them and their doctors to believe it was safer than it is.

Similar claims in both California and Illinois were recently granted to go through. Both of these plaintiffs allege chronic pain from off-label Infuse bone graft implantation. Medtronic Infuse lawyers at Pintas & Mullins Law Firm have decades of experience with litigation involving dangerous medical devices, including the Infuse. If you or a loved one was seriously injured by off-label use of the Medtronic Infuse, contact one of our skilled attorneys as soon as possible for a free legal consultation.