Yesterday, we received some very exciting news on behalf of one of our Medtronic Infuse clients. Judge Laurie Miller clarified an earlier ruling by denying Medtronic’s motion to dismiss and allowing our client, Stephen Lawrence, to proceed with his fraud claim against Medtronic. Mr. Lawrence’s amended complaint alleges he sustained serious and lasting injuries as a result of Infuse Bone Graft being implanted off-label in a spinal fusion procedure he underwent in 2011. The denial of Medtronic’s motion to dismiss means that the case will be allowed to proceed with discovery.
Since Goldenberg Lauricella began taking in cases involving injuries caused by Medtronic’s Infuse Bone Graft, we knew that there were difficult and important obstacles we would need to overcome in order for us to be able to give our clients a chance at succeeding with their claims. Specifically, in Riegel v. Medtronic, the U.S. Supreme Court held that the doctrine of preemption precludes plaintiffs from suing medical device manufacturers when their claims require anything “different from or in addition to” federal requirements. Under Reigel, plaintiffs generally cannot sue the manufacturer of a Class III device if the device received pre-market approval from the FDA.
However, the disturbing facts surrounding these cases compelled us to accept the challenge and risk of pursuing justice for our clients. Since then, Medtronic has been vigorously defending our clients’ claims with motions to dismiss the cases, contending that the claims are barred by preemption. We have opposed Medtronic’s motions to dismiss, alleging that Medtronic forfeited its protection under Riegel as a result of its fraudulent off-label marketing practices that violate Federal laws and regulations.
Last summer, Judge Miller held that Mr. Lawrence’s fraud claim against Medtronic could survive preemption as long as the claim was pled with more particularity. This meant that we had to be more specific as to how Medtronic’s marketing practices impacted the decisions of our clients’ doctors. Consequently, we filed Mr. Lawrence’s amended complaint with more detail, in compliance with Judge Miller’s order.
We are very pleased with Judge Miller’s decision to allow Mr. Lawrence’s Medtronic Infuse case to proceed. Numerous Medtronic Infuse cases throughout the country have faced similar preemption challenges. Some decisions have been favorable to plaintiffs. Others, however, have granted the motions to dismiss, leaving those plaintiffs without a legal remedy. This decision makes Mr. Lawrence’s case the first in the state of Minnesota that will be allowed to proceed to discovery.
However, it is important to remember that each case has unique facts which will lead to a variety of results in court. Medtronic Infuse cases are exceptionally complex, and each will face individual challenges based upon preemption and/or pleading requirements. Facts specific to each case are important to consider before making the decision to file a case in Minnesota.
If you believe you have been injured by Infuse Bone Graft (also known as “rh-BMP-2” or “BMP”), or if you are an attorney interested in a co-counsel or referral relationship, please contact us using this contact form.