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From Products Liability Law Daily, January 22, 2015

Medtronic must face bone graft patient’s state claims that it violated federal laws

By Pamela C. Maloney, J.D.

A patient’s state law tort claims arising from spinal surgery involving the off-label use of a bone graft/spinal fusion cage combination device were not expressly or impliedly preempted by the Medical Device Amendments of 1976, a federal district court in Wisconsin held, denying the manufacturer’s motion to dismiss on preemption grounds. The court also denied the manufacturer’s motion to dismiss based on several other theories, including the applicable statute of limitations, the learned intermediary and sophisticated user doctrines, and the patient’s failure to adequately plead her claims. The court did dismiss the patient’s breach of warranty claims (Garross v. Medtronic, Inc., January 21, 2015, Adelman, L.).

Background. The patient, Kathlene Penich Garross, underwent spinal surgery during which her surgeon implanted the infuse bone graft component of Medtronic Inc.’s Infuse bone graft/ltcage lumbar tapered fusion device (combination device), a Class III device designed to treat degenerative disc disease which affects the spine. The patient alleged that since her surgery, she has experienced “exuberant bone growth,” causing pain and requiring additional surgeries. The patient further alleged that the off-label use of the bone graft component of the combination device caused her injuries.

FDA approval. The Food and Drug Administration’s premarket approval of the device specified that the combination device could be used in the lumbar spine (L4-S1) via an anterior, or abdominal, approach. The FDA never approved use of the combination device in other parts of the body or in any other type of procedure. Further, the FDA never approved use of the bone graft component separate from the cage component.

Allegations against Medtronic. In her complaint against Medtronic, the patient alleged that the company (1) promoted the type of off-label use that the surgeon utilized in her surgery—specifically, use of the bone graft component via a posterior approach—in violation of federal law; (2) paid opinion leaders in the medical community to promote riskier off-label uses of the bone graft component and to hide and downplay the risks of these off-label uses; (3) discouraged publication of adverse events resulting from these off-label uses; and (4) failed to report adverse events related to off-label uses to the FDA. Her complaint included counts sounding in various state law torts including strict products liability failure to warn, strict products liability design defect, negligence, negligent misrepresentation, breach of express and implied warranties, fraudulent misrepresentation, fraud in the inducement, and constructive fraud. The manufacturer moved to dismiss the claims on several grounds but argued primarily that the claims were expressly and impliedly preempted by federal law.

Express preemption. The Food Drug and Cosmetic Act expressly preempts any state or local requirement relating to medical devices that are different from, or in addition to, federal requirements and that relate to the safety or effectiveness of the device. As an initial matter, the court clarified that FDA premarket approval of the combination device as a Class III device did impose requirements within the meaning of the FDCA and that these requirements were applicable to off-label uses of a pre-approved device.

The court went on to explain because the purpose of the FDCA is to protect a medical device manufacturer from liability to the extent that it has complied with federal law; its protection did not extend to claims based on a violation of federal law. According to the court, each of the patient’s claims was based on an underlying violation of federal law. As such, her state law claims did not seek to place different or added requirements on the manufacturer; instead her state law claims merely seek to impose state remedies on the manufacturer for federal violations. Thus, none of the state law claims were expressly preempted.

Implied preemption. Similarly, the patient’s state law claims were not impliedly preempted because none of them arose solely from a violation of federal law or federal requirements. Again, the court explained that each claim arose from an independent, well-recognized duty owed under state law and, therefore, the claims were not impliedly preempted.

Other grounds for dismissal. The court refused to dismiss the patient’s claims as barred by Wisconsin’s three-year statute of limitations because the issue of when the patient should have discovered her injuries was a fact question that could be determined only after discovery. Allegations that the manufacturer intentionally misrepresented and misled the medical community about the risks associated with the promoted off-label use of the infuse bone graft component of the device also raised a fact issue as to whether the sophisticated use doctrine applied. There was also a fact question as to whether the learned intermediary doctrine applied in Wisconsin that would mitigate against dismissal on that ground.

Finally, the court determined that under federal pleading standards, the patient’s strict liability, negligence, and failure to report adverse events claims were sufficient to survive the manufacturer’s motion to dismiss. Although the manufacturer complained of an absence of detail to support these claims, the court noted that much of the product-specific information needed to investigate these claims was kept confidential by federal law. Formal discovery was necessary before the patient could be expected to provide a detailed statement of the specific bases for her claims.

Because the patient failed to respond to the manufacturer’s motion to dismiss her breach of express and implied warranty claims, the court granted the motion.

The case is No. 14-cv-0134.

Attorneys: John T. Cichon (Polansky & Cichon Chtd.) for Kathlene A. Penich Garross. Andrew E. Tauber (Mayer Brown LLP), Joseph M. Fasi, II (Gonzalez Saggio & Harlan LLP), and Murray S. Levin (Pepper Hamilton LLP) for Medtronic Inc., and Medtronic Sofamor Danek U.S.A. Inc.

Companies: Medtronic Inc.; Medtronic Sofamor Danek U.S.A. Inc.

MainStory: TopStory PreemptionNews DesignManufacturingNews WarningsNews MedicalDevicesNews WisconsinNews

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