A man suffered from chronic back pain and leg pain. To manage that pain, a neurostimulator was surgically implanted into the man’s back. The neurostimulator delivered mild electrical signals to the epidural space near the spine through one or more thin wires that provided electrical impulses to thin plastic leads. These electrical impulses blocked pain signals before they reach the brain.
As a device regulated by the FDA, the neurostimulator underwent a rigorous premarket approval process that resulted in a finding that there was a reasonable assurance of the neurostimulator’s safety and effectiveness. This process also included a review of the neurostimulator’s labeling to ensure it was not false or misleading. The FDA approved a statement that the neurostimulator’s battery life was nine years
Approximately a year and a half after it was implanted, the device malfunctioned. The man started to experience additional pain. The man consulted with two doctors about removing the neurostimulator.
The first doctor determined that the neurostimulator had stopped working and that the additional pain did not seem to be the result of any physiological change in the man’s condition. The first doctor’s notes suggested that representatives of the manufacturer of the neurostimulator were present at the man’s medical appointments and the manufacturer was notified of problems with the man’s neurostimulator. The first doctor referred the man to another doctor to replace the neurostimulator’s battery.
The second doctor concluded that the left side of the neurostimulator had stopped working. The second doctor’s notes indicated that the manufacturer had tried to get the neurostimulator to work, but had concluded that the neurostimulator needed to be removed. The manufacturer’s representatives present at the second doctor’s appointment determined that the entire device was not functioning.
Approximately one month after the man’s appointment with the second doctor, the man had surgery to remove the neurostimulator. The incision was closed with surgical staples. The area with surgical staples became infected. The wound site drained liquid and caused significant pain.
Approximately one month after the neurostimulator was removed, the man saw a third doctor. The third doctor discovered that an abscess had formed at the surgical site. An additional surgery was required to treat the abscess.
The man was unable to work for five months due to the multiple surgeries required to remove the neurostimulator and address the resulting surgical site infection.
The man brought a claim in state court against the medical device manufacturer for breach of express warranty under Texas law. The complaint alleged that the neurostimulator functioned properly for approximately 18 months. However, in written marketing materials the manufacturer claimed that the neurostimulator had a device life of nine years. The complaint claimed that the man relied on the following statement from the manufacturer’s website about the neurostimulator:
While other manufacturers may state that their batteries have a longevity greater than 9 years, it’s important to understand that many other factors and components are involved in determining the overall longevity of an implanted medical device. The result of extensive design and testing involved in manufacturing rechargeable neurostimulators give [the manufacturer] the confidence that our device is reliable for 9 years.
To achieve this distinction, [the manufacturer] rigorously verified and validated the many components that impact device longevity, not just the battery. The result is a rechargeable neurostimulator that delivers reliable performance over the entire period of predicted service. [The manufacturer] is the only company to offer a Neuromodulation Product Performance Report.
The complaint further alleged that this warranty language was never reviewed by or submitted to the FDA for approval.
After the action was removed to federal court, the manufacturer moved for judgment on the pleadings. The motion argued that the man’s claim was preempted by the federal Food, Drug, and Cosmetic Act (FDCA), the man failed to adequately plead reliance on the warranty, and that the manufacturer’s limited warranty was the exclusive remedy available to the man.
The United States District Court for the Western District of Texas granted the manufacturer’s motion for judgment on the pleadings. The district court concluded that the man’s claim was preempted by the FDCA.
The Fifth Circuit United States Court of Appeals reversed and remanded. The court held that implied preemption under the FDCA did not apply to the man’s claim and the man’s claim was not expressly preempted by the FDCA.
Implied preemption under the FDCA did not apply to the man’s claim. The claim against a medical device manufacturer under Texas law for breach of an express warranty did not exist solely because of the FDA’s medical device requirements. Such a claim could be brought against manufacturers of products in all types of industries.
The man’s claim was not expressly preempted by the FDCA. The manufacturer’s statements on its website with respect to expected longevity of its neurostimulator went beyond what the FDA evaluated in its premarket approval process for the neurostimulator. The FDA only approved the manufacturer’s statement that the neurostimulator’s battery life was nine years. However, the manufacturer’s statements offered an express warranty on the longevity of the entire device by repeatedly making distinctions between the device’s battery and its other components and guaranteeing reliability of its other components. A manufacturer may make such representations, but it faces state law liability if they are proven false. The manufacturer had a duty under federal law not to make misleading representations about its device. A verdict finding that the manufacturer misled consumers like the man in making this representation would enforce a duty that existed under both state and federal law: to not make misleading representations about the neurostimulator. Accordingly, the narrow breach of express warranty claim the man asserted was not preempted by the FDCA.
The Fifth Circuit United States Court of Appeals reversed the district court’s grant of the manufacturer’s motion for judgment on the pleadings and remanded.
See: Wildman, v. Medtronic, Inc., 2017 WL 4926804 (C.A.5 (Tex.), October 31, 2017) (not designated for publication).
See also Medical Law Perspectives Report: Spinal Cord Injury Malpractice: Back to Back Problems
See also Medical Law Perspectives Report: Backaches and Court Battles: When Chronic Back Pain Leads to Litigation
See the Medical Law Perspectives Blog: New Back Pain Treatment Options Offer Hope, Require Caution
See the Medical Law Perspectives Blog: Jury Instruction in Product Liability Case That Violation of the FDCA is Negligence Per Se; Preemption Considerations