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As attorneys who are providing free case evaluations to individuals injured by the off-label use of the Medtronic infuse product, we wanted to advise that state law claims accusing Medtronic of improperly promoting the off-label use of its bone graft device were not preempted according to Arizona Federal Judge G. Murray Snow of the United States District Court for the District of Arizona.
On March 2, 2009, Christina Ramirez underwent a lumbar fusion procedure to alleviate her back pain during which her surgeon used Medtronic’s infuse, a bioengineered liquid bone graft substance that is a class 3 medical device under the Food, Drug and Cosmetic Act. After surgery, Ms. Ramirez began experiencing severe pain and it was discovered that she had developed uncontrolled bone growth in the area where the surgeon had implanted the infuse device. Ramirez sued Medtronic in March 2013 asserting claims of fraudulent misrepresentation/fraud in the inducement, failure to warn, defective design, misrepresentation, negligence and breach of express warranty. All state law claims were based on the surgeon’s off-label use of the device, which allegedly resulted from Medtronic’s active promotion of that use.
Medtronic moved to dismiss the complaint in its entirety asserting that the complaints were federally pre-empted under Section 360(k) of the Medical Device Act which prohibits states from imposing any requirement which is different from or in addition to any requirement which relates to the safety or effectiveness of a Class 3 pre-market approved medical device intended for human use.
Judge Snow reviewed in detail infuse’s safety and effectiveness only for the uses Medtronic specified in its pre-market approval application, and held that the regulations were based on that review. However, because the requirements are not use-specific, a claim arising solely from the off-label use of the device could face pre-emption. “The MDA does not seek to control how physicians use regulated devices; indeed, off-label use is expressly permitted as an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Judge Snow followed stating that “when a plaintiff is injured because her doctor used a FDA-approved device for an unapproved use, and she brings state law claims against the manufacturer claiming that it should have provided additional warnings or designed the product differently in light of its unapproved use, the plaintiff is asking the manufacturer to do something ‘different from or in addition to’ federal law.”
The crux of Ramirez’s claim is that she was injured due to an off-label use of infuse that resulted in Medtronic’s practice of promoting such uses. Judge Snow concluded that Ms. Ramirez’s allegations regarding Medtronic’s off-label promotion allowed the majority of her claims to escape pre-emption. “When the device is not being used in the manner of the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to preempt the application of state law designed to provide that protection.” Judge Snow further explained that “it is true that federal requirements are still applicable to the device, including requirements that Medtronic not alter the design or label of the device without FDA consent. But when Medtronic allegedly violated federal law by engaging in off-label promotion that damaged that plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies.”
Judge Snow not only found that claims not preempted, Judge Snow found that under Fed. R. Civ. P. 9, Ms. Ramirez had sufficiently alleged why statements made by Medtronic representatives were false or misleading and how Medtronic assured the medical community that off-label use of Infuse was safe and effective despite Medtronic’s knowledge of the true effects of off-label use. Furthermore, Ms. Ramirez alleged that her surgeon was paid a consultant fee by Medtronic and therefore was a recipient of the alleged off-label promotion. The judge similarly ruled that failure to warn and misrepresentation claims survive any pre-emption challenge because those claims exist independent of any federal enactment. Likewise, the design defect claim was not pre-empted because Ms. Ramirez alleged that Medtronic actually promoted the use of Infuse outside of the prescribed federal approval process.
All this being said, Judge Snow did dismiss the negligence claims as impliedly pre-empted pursuant to Buckman because that claim was based wholly on violations of the FCA and MDA. The claims were not parallel to any such violation.
Finally, the judge dismissed the breach of express warranty claims in which Ms. Ramirez alleged Medtronic of using articles, advertisements, and the like to promote off-label usage of the Infuse device. Although the claims survives pre-emption, it fails under Arizona law because Ms. Ramirez failed to allege that Medtronic targeted her specifically with any guarantees.
If you have been injured by a Medtronic Infuse device, please contact us as soon as possible for a free case evaluation.
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