Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—N.D. Miss.: Spinal device manufacturer puts the screws to products liability claims, (Dec 29, 2015)

By Mary Damitio, J.D.

An patient who brought a products liability suit against a spinal device manufacturer for injuries he suffered after two implanted screws fractured did not present sufficient evidence to establish that a question of fact existed as to whether the company negligently designed or manufactured the device, a district court found in granting partial summary judgment. However, the parties did not address whether federal law preempted the patient’s fraudulent concealment claims, which were based on the manufacturer allegedly selling the device prior to obtaining appropriate FDA approval. As a result, the parties were ordered to address the preemption issue in further briefing before the court (Estes v. Lanx, Inc., December 23, 2015, Aycock, S.).

Spinal fusion. In 2011, the patient underwent spinal fusion surgery and had the Lanx Telluride Spinal Fixation System (Telluride System) implanted. Within five months after the surgery, two screws fractured, and the patient required revision surgery in 2012 to remove the broken screws and to replace the Telluride System with new hardware. The patient brought suit against the device manufacturer, Lanx, Inc., and alleged claims for products liability based on design and manufacturing defects, breaches of warranties, and the company’s failure to obtain FDA approval for the Telluride System. Lanx moved for summary judgment on the patient’s claims.

Products liability. Lanx was entitled to summary judgment on the patient’s design and manufacturing defect claims. The patient did not put forth evidence of an alternative design or that his physician would not have used the product had he known that it was not FDA-approved. Additionally, the patient did not establish how the manufacturing of the allegedly defective screws deviated from the company’s manufacturing specifications.

Negligence. The patient also failed to put forth any evidence regarding Lanx’ manufacturing negligence. The broken screws were not available for examination because they were not retained after their removal, and the patient did not establish Lanx’ bad faith in failing to retain the screws. Additionally, the patient did not demonstrate that his injuries were caused by Lanx negligently releasing its product into commerce without obtaining FDA approval.

Warranties. Lanx was also entitled to summary judgment on the patient’s warranty claims. The patient did not present any evidence that Lanx made claims about the safety of its products or that he relied on the representations. Additionally, the patient could not maintain a breach of implied warranty claim because he never allowed Lanx to cure the alleged defect.

FDA claims. The parties failed to address whether the patient’s claims that centered on Lanx’ failure to obtain FDA approval for the Telluride System were preempted by federal law. As a result, the parties were ordered to show cause as to whether the claims were preempted.

The case is No. 1:14-cv-00052-SA-DAS.

Attorneys: Duncan L. Lott (Duncan Lott, P.A.) for Rocky Estes. Adria H. Jetton (Baker Donelson Bearman Caldwell & Berkowitz, PC) for Lanx, Inc.

Companies: Lanx, Inc.

Cases: CaseDecisions FDCActNews MDeviceNews PreemptionNews PLDeviceNews MississippiNews