By Robert B. Barnett Jr., J.D.
A products liability class action against Medtronic involving the medical device Infuse® was dismissed by a federal district court in Ohio primarily because the Medical Device Amendments to the federal Food, Drug and Cosmetic Act (FDC Act) preempted state law claims for failure to warn, design defect, misrepresentation, negligence, and breach of express and implied warranties. The one set of claims not preempted—involving Medtronic’s alleged misrepresentation of Infuse’s safety or effectiveness—was nevertheless dismissed because the claims failed to satisfy the heightened pleading standards for fraud claims (Aaron v. Medtronic, Inc., September 22, 2016, Black, T.).
Background. Several hundred patients of a Cincinnati-area orthopedic surgeon filed a class action suit against Medtronic and Medtronic Sofamor Danek, USA, Inc., in Ohio federal court alleging fraud, strict products liability, negligence, and breach of express and implied warranties. All of the patients had undergone surgery using Infuse, a medical device manufactured and sold by Medtronic that stimulates bone growth in spinal fusion surgeries. Medtronic filed a motion to dismiss all claims.
Premarket approval. Under the Medical Device Amendments (MDA) to the FDC Act, different types of medical devices are subject to different levels of FDA scrutiny, depending on their risk of injury. Infuse was classified as a Class III medical device, which meant that it received the FDA’s strictest regulation and that Medtronic was required to obtain the FDA’s Premarket Approval (PMA) before it could be sold. Medtronic received the FDA’s PMA in 2002.
State law claims. Recognizing the rigor of the application process, the MDA expressly preempts state laws that impose requirements "different from, or in addition to" those the FDA already imposes (21 U.S.C. §360k(a)). Thus, all such state laws are preempted except those that impose common law duties that parallel the federal requirements. The patient class argued that the preemption did not apply to Infuse because it was a component part of an approved medical device and preemption did not apply to component parts. The court, however, rejected the argument, finding that the FDA had established specific federal requirements for Infuse and that, in any event, the FDC Act defines "device" to include any component part.
In examining the various state law claims, the court found that those based on strict products liability (failure to warn, design defect, and misrepresentation), products liability (negligence), and breach of express and implied warranties all sought to impose requirements that were different from, or in addition to, those that the FDA already imposed. As a result, they were all preempted by §360k(a). For example, the state duty to provide warnings to patients or their physicians was not identical to the federal duty to report information to the FDA. Thus, the two warnings were not parallel claims, which justified preemption.
Enforcement. Even if the patient class could somehow successfully argue that the state claims were parallel, it faced a second preemption roadblock. When Congress enacted the FDC Act, it created no private right of action. Thus, only the federal government is permitted to enforce the rules established under the FDC Act (21 U.S.C. §337(a)). Private rights of action that would not exist but for the existence of the FDC Act are barred.
OPLA. The patient class’s products liability claims faced yet a third preemption roadblock. The Ohio Product Liability Act (Ohio Rev. Code Ann. §§2307.71 et seq.) is the sole means through which a products liability claim may be pursued in Ohio. As a result, all products liability claims not brought under the OPLA—including this one—are subject to dismissal.
Fraud. The patient class’s fraud claims, however, were not preempted because they alleged Medtronic’s misrepresentations about Infuse’s safety or effectiveness, which were separate from claims based on Infuse’s manufacture or labeling. These fraud claims, though, were subject to the heightened pleading standard dictated by Federal Rule of Civil Procedure 9. The complaint, the court said, failed to meet those heightened standards in several ways, most notably by alleging two contradictory sets of facts. The class alleged both that the surgeon was a knowing accomplice to the fraud and that he was an innocent dupe. Alternative claims may be made but not alternative factual statements. If a plaintiff lacks sufficient knowledge of facts to plead his case, he will not be allowed to survive the motion to dismiss so that he can use discovery to fish for the missing information.
The court, therefore, granted Medtronic’s motion to dismiss all claims.
Attorneys: Robert Albert Winter, Jr. (Law Office of Robert A. Winter, Jr.) for Frieda Aaron. James Eugene Burke (Keating Muething & Klekamp PLL), Andrew E. Tauber (Mayer Brown LLP) and Nicholas M. Kouletsis (Pepper Hamilton LLP) for Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.
Companies: Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc.
MainStory: TopStory PreemptionNews DesignManufacturingNews WarningsNews MedicalDevicesNews OhioNews
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