Highridge Medical Claims Lawsuit Over Mobi-C Failure Rates Should Be Preempted

Manufacturer argues that it should be immune from liability in claims alleging it withheld information about failures and problems with its Mobi-C devices.

The makers of the Mobi-C cervical disc implant have asked a federal judge to dismiss a product liability lawsuit filed over the device’s alleged failure and defective design, arguing that such claims are preempted by federal law.

The case involves problems with Mobi-C, a motion-preserving cervical disc implant first approved by the U.S. Food and Drug Administration (FDA) in 2013, which has been used in tens of thousands of patients nationwide to treat degenerative disc disease in the neck.

In December, Texas resident Tyler Gleaves filed a Mobi-C failure lawsuit against Highridge Medical LLC, formerly Zimmer Biomet Spine Inc., alleging that the implant catastrophically failed and left him permanently paralyzed. 

According to the complaint, Gleaves underwent cervical disc replacement surgery in 2017 and initially recovered well, returning to an active lifestyle. However, the lawsuit states that on September 30, 2023, the device suddenly fractured and migrated into his spinal canal, compressing his spinal cord and requiring emergency surgery.

Surgeons reportedly confirmed that the implant’s plastic core had broken, resulting in a complete spinal cord injury at the C6 level. Gleaves claims he is now quadriplegic, with loss of motor function below his chest and limited use of his hands.

The complaint alleges that the Mobi-C failure occurred during normal use, without trauma or unusual activity, indicating the device was defective. According to the lawsuit, the Mobi-C design relies on a plastic core made of ultra-high-molecular-weight polyethylene positioned between two metal plates, which can degrade if manufacturing and sterilization processes are not properly controlled.

Gleaves alleges that his implant was compromised by deviations from FDA manufacturing standards, including improper radiation sterilization, inadequate control of oxidation, and defective packaging that allowed oxygen exposure. 

These conditions, the Mobi-C lawsuit claims, can cause the plastic component to become brittle over time, increasing the risk of cracking and catastrophic failure under normal spinal movement.

Mobi-C Failure Lawsuit Challenged 

In response to the lawsuit, Highridge Medical filed a motion to dismiss (PDF) on March 27, arguing that Gleaves’ claims are preempted by federal law governing FDA-approved medical devices.

According to the complaint, Gleaves alleges the manufacturer failed to report numerous adverse events involving device failures to the FDA, including his own 2023 injury. He claims these omissions prevented regulators and investigators from identifying patterns of device failure and patient harm.

Highridge Medical disputes those allegations, arguing that Texas law does not impose a duty on manufacturers to report adverse events to the FDA.

“Texas law is clear. There is no duty under Texas state law to report information to the FDA.”

– Highridge Medical Motion to Dismiss

Based on that position, the company contends that Gleaves’ “failure to warn” claims, along with related negligence allegations, cannot proceed because they are based on reporting obligations governed by federal law.

The motion further argues that without those claims, the remaining allegations, including manufacturing defect and negligent manufacturing, are not sufficiently supported. Highridge asserts that the complaint does not clearly identify a specific defect or manufacturing error that directly caused the device to fail.

The court has not yet ruled on the motion.

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