Abbott Eterna Spinal Cord Stimulator Lawsuit Filed Over Lead Migration, Device Malfunction

Lawsuit claims that the device’s malfunction, failure and subsequent removal left a woman in worse pain than before she received the implant.

Two months after receiving an Abbott Eterna spinal cord stimulator, a Texas woman required additional surgery to have the device removed after it allegedly failed.

Zella Tuttle filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois, naming Abbott Laboratories as the defendant. The lawsuit argues that federal regulators never approved the system, and that Abbott sales representatives took actions that only trained physicians should do.

The Abbott Eterna spinal cord stimulator is an implantable medical device used to address chronic back pain. It sends programmable electrical pulses through leads implanted into the body, which are adjusted to block pain signals.

The Eterna and similar modern devices are based on older, previously approved versions of spinal cord stimulators. Many of the newer versions were then approved under the U.S. Food and Drug Administration’s 510(k) fast-track approval process, which only requires that the new device be “substantially equivalent” to an existing product.

However, manufacturers face a growing number of spinal cord stimulator lawsuits, like Tuttle’s, indicating that they made numerous changes to their devices and then told the FDA they were substantially equivalent to the predecessors. Plaintiffs say this allowed the devices to hit the market faster, increasing profit margins at the cost of patient safety.

The lawsuits indicate that the changes included updates to software, electrical output, batteries and internal components which altered how the devices function inside the human body, leading to symptoms including electric shocks, device migration, tissue burns and neurological problems. This often results in the need for revision surgery to have the failed implant removed.

According to Tuttle’s lawsuit, not only was the device put on the market without adequate FDA approval, but Abbott’s sales representatives made alterations and changes to the functions of the device without proper training or approval.

The complaint states that Tuttle received her Abbott Eterna spinal cord stimulator on October 6, 2023, for the treatment of chronic pain after meeting with Abbott sales representatives who said the implant would grant long-term pain relief, eliminating the need for other treatments. The filing notes that representatives indicated the device was backed by clinical validation, and that they reprogrammed the device to make therapeutic adjustments.

“Immediately after the permanent implant surgery, Abbott representatives programmed and made therapeutic adjustments to the Eterna SCS system without meaningful physician supervision. This occurred on numerous occasions after Plaintiff was implanted with the Eterna SCS system.”

– Zella Tuttle v. Abbot Laboratories Inc.

However, the lawsuit states that none of the sales representatives were a physician or had the appropriate medical training to make the kinds of changes they made.

In addition, Tuttle notes that what the agents did not tell her was that the version of the Eterna she received included various upgrades to its firmware, functions and features that were not present when the original Eterna was approved in 2001. These included “multiple unvalidated changes in waveform programming” without a public clinical review or updated safety data being made available.

On December 13, 2023, surgeons had to surgically remove the Eterna after discovering the stimulator leads had migrated out of position. As a result, Tuttle’s previous pain and symptoms have now been exacerbated by her experience with the spinal cord stimulator.

Tuttle presents claims of manufacturing defect, failure to warn, negligence per se, breach of express warranty, breach of implied warranty of merchantability and fitness for a particular purpose, negligence, negligent misrepresentation, fraud and fraudulent concealment, negligence per se: unauthorized practice of medicine, fraudulent misrepresentation, and negligent misrepresentation. She seeks both compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

Individuals who received a spinal cord stimulator from major manufacturers such as Abbott, Boston Scientific, Medtronic or others, and later suffered serious complications may have grounds to pursue a product liability claim for any of the following concerns:

• Revision surgery to reposition or replace device components
• Complete removal (explant) of a spinal cord stimulator
• Permanent nerve damage or neurological injury
• Worsening or uncontrolled pain after implantation
• Infections or other serious post-surgical complications
• Device failures involving leads, batteries, charging or power delivery
• Long-term disability or loss of quality of life
• Deaths potentially linked to complications from implanted spinal cord stimulators

Spinal cord stimulator lawsuits are typically handled on a contingency-fee basis, meaning there are no upfront costs and attorney fees are only paid if compensation is obtained through a settlement or trial verdict.

Sign up for more legal news that could affect you or your family.