Marshall v. Smith & Nephew, Inc

Background

Wayne W. Marshall alleged that a Smith & Nephew Journey Knee System used during his July 2, 2012 right-knee replacement later loosened, causing severe pain and discomfort. He underwent revision surgery on August 3, 2017 to remove and replace the device and alleged that he continued to experience pain afterward.

Marshall asserted seven counts: negligence; strict products liability based on design defect; strict products liability based on failure to warn; breach of express warranty; breach of implied warranty; negligent misrepresentation; and unjust enrichment. He sought damages and other relief. Smith & Nephew removed the case to federal court based on diversity jurisdiction and moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint states a legally sufficient claim.

Smith & Nephew argued that Marshall’s allegations were conclusory and did not identify the defect, explain how the device caused his injuries, or provide sufficient details about warnings and alleged misrepresentations. It also argued that the warranty claims were time-barred. Marshall conceded that the express- and implied-warranty claims were untimely, but maintained that his other claims were adequately pleaded. He asked that the negligent-misrepresentation claim be dismissed without prejudice if the court disagreed.

Preemption and pleading deficiencies

Because the case was based on diversity jurisdiction, the court applied federal procedural rules and Minnesota substantive law. The court explained that the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act can preempt state-law claims involving medical devices. Preemption means that federal law displaces a state-law requirement when the state requirement is different from or additional to federal requirements. A state-law claim may sometimes proceed if it parallels a federal requirement, but a private plaintiff generally cannot bring a claim that simply alleges a violation of federal medical-device law.

The court found that Marshall had not identified the precise model or generation of the device, its federal classification, or the approval process it had undergone. Without that information, the court could not meaningfully determine whether the claims were preempted. The court nevertheless concluded that the complaint was inadequately pleaded under Minnesota law and the federal pleading rules, which require enough specific facts to make a claim plausible rather than merely reciting legal conclusions.

Individual claims

For negligence, the court found that Marshall did not provide facts showing how Smith & Nephew breached a duty or how the alleged breach proximately caused his injury. Count I was dismissed with prejudice to the extent it was preempted and without prejudice as to any remaining state-law claim.

For design defect, the court stated that Marshall needed facts showing that the device was defective and unreasonably dangerous, that the defect existed when it left Smith & Nephew’s control, and that the defect caused his injury. The court found the allegations too vague to establish those points or to allege a parallel federal and state-law claim. Count II was dismissed with prejudice to the extent preempted and without prejudice as to any remaining state-law claim that was not expressly or impliedly preempted.

For failure to warn, the court found that Marshall did not identify the danger, Smith & Nephew’s knowledge, what warning should have been given, to whom it should have been given, or how a warning would have changed the outcome. The court also discussed Minnesota’s learned-intermediary doctrine, under which a medical-device manufacturer generally has a duty to warn doctors rather than patients. Count III was dismissed with prejudice to the extent preempted and without prejudice to the extent Marshall could replead a viable claim.

Marshall conceded that the express- and implied-warranty claims were untimely. The court dismissed Counts IV and V with prejudice.

For negligent misrepresentation, the court applied the heightened pleading rule for fraud, which requires the complaint to identify details such as the content, time, place, and speaker of an allegedly false statement. The court found that Marshall did not identify the statements made by or for Smith & Nephew that were allegedly false or explain how he or his doctors relied on them. Count VI was dismissed with prejudice to the extent preempted and without prejudice to the extent Marshall could replead a plausible claim.

For unjust enrichment, the court found that Marshall had not shown how Smith & Nephew acted illegally or unlawfully. Count VII was dismissed without prejudice.

Order and effect

The court’s final order granted Smith & Nephew’s motion to dismiss as follows: Counts I through III and Counts VI and VII, to the extent they were not preempted by federal law, were dismissed without prejudice; Counts IV and V were dismissed with prejudice. Marshall was permitted to file an amended complaint asserting the claims dismissed without prejudice within 30 days of the order. If he did not file within that period, the order stated that a final judgment of dismissal on all counts would result.

The court also stated that it would consider a written sanctions motion concerning Marshall’s withdrawn motion to remand. Smith & Nephew could submit a supporting letter brief, and Marshall could respond under the deadlines specified in the order.