An Arizona federal judge last month rejected Medtronic Inc.’s arguments that federal law preempted a personal injury lawsuit involving claims that the company promoted off-label use of its bone graft substitute. U.S. District Judge G. Murray Snow granted in part and denied in part Medtronic’s motion to dismiss Cristina Ramirez’s lawsuit. It was contended in the lawsuit that she has suffered from back pain since undergoing a lumbar fusion procedure involving the company’s Infuse bone graft substitute. Ms. Ramirez sued Medtronic in March for fraud, failure to warn, defective design, misrepresentation, negligence and breach of express warranty. In 2009, Ms. Ramirez underwent a lumbar fusion operation to alleviate her back pain, and her surgeon used Infuse in the surgery despite the fact the device was not approved for use in such a procedure. It was alleged that the procedure caused uncontrolled bone growth near the site of the Infuse implant.
Medtronic sought to have the complaint dismissed on the grounds all of Ms. Ramirez’s claims are preempted by the Medical Device Amendments to the Food Drug and Cosmetic Act (FDCA), which give the FDA extensive control over how an FDA-approved medical device is manufactured and marketed. The judge found that the majority of the Plaintiff’s claims are not preempted by federal law. Manufacturers who violate federal safety laws should not be allowed to evade state tort liability to injured patients.
Judge Snow ruled that while physicians can legally use medical devices for purposes other than their FDA-approved use — known as “off-label” uses — a medical device’s manufacturer can’t actively promote those off-label uses. In her complaint, Ms. Ramirez accuses Medtronic of inducing physicians to employ Infuse for off-label uses by promoting them in journal articles and advertisements, despite being aware of potentially severe side effects. Medtronic argued that the MDA and FDCA preempted all of Ms. Ramirez’s state common law claims. But Judge Snow concluded that Ms. Ramirez’s claims that trace her doctor’s use of Infuse to the company’s promotion of off-label uses for the product are not preempted by federal law because the FDA explicitly prohibits off-label promotion. The judge’s order stated that those claims can be pursued under state law. The order said:
When Medtronic allegedly violated federal law by engaging in off-label promotion that damaged the plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies.
But Judge Snow ruled that Ms. Ramirez’s theory of negligence that relies on Medtronic’s alleged failure to comply with MDA and FDCA standards is preempted because the responsibility for enforcing those laws lies exclusively with the federal government. The judge also dismissed all the portions of Ramirez’s claims that contain allegations of harm solely based on her doctor’s off-label use of Infuse, absent any off-label promotion by Medtronic. The order said:
Without the core allegation of off-label promotion, Ramirez’s claims that the labeling and information provided with Infuse were incomplete and should have contained additional health or safety information amount to attacks on the FDA approval process.
Judge Snow dismissed Ms. Ramirez’s breach of express warranty claim without prejudice, saying she did not adequately plead that Medtronic targeted her directly with its off-label promotions for Infuse.
Ms. Ramirez is represented by Kent. L. Klaudt, Cecilia Han, Lisa J. Cisneros, Michael P. Stark and Wendy R. Fleishman, lawyers with the Lieff Cabraser Heimann & Bernstein law firm. The case is Ramirez v. Medtronic Inc. et al., which is in the U.S. District Court for the District of Arizona.
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