Lazaro Martinez suffered serious injury as the result of back surgery. During the surgery, our Miami medical malpractice lawyers allege that a neurosurgeon made several medical errors in the placement of pedicle screws which caused serious nerve damage. The Complaint also alleges that a radiologist reading an MRI shortly after surgery failed to recognize the misplacement of the pedicle screws, thus allowing the impingement upon Lazaro’s nerves to continue.
Furthermore, we allege that the negligent neurosurgeon used a dangerous product during surgery known as the Infuse bone graft, which is manufactured by Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. The surgeon used Infuse is a way that was not approved by the Food and Drug Administration and, as a result of this “off-label” use, the Infuse caused serious overgrowth of bone throughout Lazaro’s back, ultimately encasing his nerve roots and causing serious and irreversible nerve damage.
In our Complaint, , we allege that Medtronic was aware of the problems associated with Infuse but failed to make them known to both the FDA and the general public (including doctors that use their products). Instead of providing information to the FDA and the physicians, we allege that Medtronic concealed the information and actually paid physicians to write more favorable reports on the testing of Infuse. Further, we allege that Medtronic promoted Infuse for a use for which it was not approved. Lastly, we allege that when Medtronic became aware of problems associated with off label use of Infuse, Medtronic turned a blind eye and continued to promote a use which they knew was unreasonably dangerous.
This seems like a simple product liability case. But it’s not. Medtronic has been successful in many courts throughout the country in having claims against it dismissed under the protection of federal preemption. In short, Medtronic argues that the FDA forces it into a lengthy approval process for the product and once that approval has been granted, only the FDA can sanction or punish Medtronic for any wrongdoing. According to Medtronic, even if they are directly responsible for injuries to users of their products, they should not be held responsible for any damages suffered by people like Lazaro Martinez. The crux of Medtronic’s argument is threefold:
1. If there is not a state law claim that is identical to the federal regulations that govern Medtronic, than the claim is expressly preempted and should be dismissed;
2. Even if the claim is not expressly preempted, if the claim is borne from the regulations promulgated by the FDA, then only the FDA can enforce such a claim and, as such, the claims in state court are impliedly preempted and should be dismissed;
3. Even if the claims are not expressly or impliedly preempted, if the claim asserts that Medtronic’s actions likely would have resulted in the FDA doing something different (like punishing Medtronic or forcing Medtronic to strengthen its warnings to the public), than the claim is purely speculative and, thus, Plaintiff can never prove that any actions of Medtronic caused the Plaintiff’s damages.
Medtronic relies upon a litany of cases throughout the United States, each of which tends to have a different interpretation as to whether claims against Medtronic are preempted.
In our case, we argued many different points to address the deficiencies of Medtronic’s claims of preemption.
First, the United States Supreme Court was clear in its holding in Reigel v. U.S. that state law claims are not preempted if the state law claim parallels the federal law. The question becomes, what is a “parallel claim?” We assert, in our Complaint, that Medtronic violated several of the Codes of Federal Regulations which govern their marketing and promotion activities, and that these claims of violations of the Code of Federal Regulations directly parallel Florida’s common law duty of care. Medtronic countered this argument by asserting that a parallel claim must be identical to the federal regulation. In other words, to believe Medtronic’s assertion, one would have to believe that the only way to assert a state law cause of action against Medtronic would be an instance where the state has a law that says that you cannot violate the exact federal law that we allege Medtronic violated. This is an argument that has been expressly rejected by several federal courts, and, logically speaking, it is an argument which makes no sense.
Second, we argued that several of the federal laws did not require us to speculate as to how the FDA would act in order to effectuate change. Instead, some of the laws specifically state that Medtronic was required to submit additional information to the FDA before offering the Infuse for anything other than iits approved use. Since Medtronic was promoting the Infuse for use in a way other than the expressly approved FDA use, Medtronic was first required to submit a supplemental application to the FDA to approve this new use. Failing to do so was a violation of the federal regulations and also a breach of its duty of care under state law.
Third, we argued that the Infuse was not entitled to the protections of federal preemption because Infuse, alone, was not a medical device approved by the FDA. Instead, the FDA approved a device with two distinct component parts: Infuse and LT-Cage. LT-Cage is a cage that holds Infuse and the FDA only approved Infuse for use with the LT-Cage. Promotion of Infuse without LT-Cage amounts to an unapproved use and, thus, we argued, there was no entitlement to any federal preemption.
The issues were briefed and the Court heard argument on March 1, 2013. After hearing argument from both sides, the Court denied Medtronic’s Motion to Dismiss, allowing Lazaro Martinez’s case to proceed.
Considering the success that Medtronic has had throughout the United States in suppressing similar claims, this was a very big victory not only for Lazaro Martinez but for any other person that is injured by the unapproved and off label use of Infuse. The tides are shifting and there have been many more courts rejecting Medtronic’s arguments. For victims that suffer the way Lazaro does, and many other people do, this shift means they can seek compensation for their injuries.