Spinal cord stimulator claims: who can file and what to do

Who may qualify?

People with a Boston Scientific, Abbott or Nevro spinal cord stimulator who were hurt may be able to file a claim. The people who sued describe shocks, burns, leads that moved, nerve injuries and pain relief that failed. A problem alone does not prove the device was at fault.

What a spinal cord stimulator is

A spinal cord stimulator is an implant that sends electrical signals to the spinal cord to ease pain. Thin wires called leads carry the signals from a battery-powered unit. Doctors offer it for long-lasting pain in the back, arms or legs, such as pain that remains after back surgery. In 2020 the FDA estimated that about 50,000 are implanted each year.

Doctors usually test a temporary device first, often for 3 to 7 days. The FDA has told doctors to place a permanent device only after a trial shows enough pain relief. Some people later need more surgery to fix, move or remove parts. A lawyer will usually want to know the brand, the model and what went wrong.

Can federal law block these claims?

It can block some kinds of claims. The devices in these cases went through the FDA’s strictest review, called premarket approval. In 2008 the Supreme Court held that federal law bars many state claims that challenge the safety of a device sold as approved. It also said claims based on a company breaking FDA rules are not barred in the same way.

Lawyers call this preemption, which means federal law overrides state law. The companies are raising this defense, and the panel expects it to be argued in each group. The people who sued focus on claims that the companies broke FDA rules, such as rules for changing approved devices. Some also sued the FDA, saying it did not check the changes closely or act on safety reports.

The panel said it could not decide who is right on this question. That question is for the judges handling the cases. Ask a lawyer how those rulings may affect your claim.

What does it cost to get help?

A lawyer may charge a share of any money recovered, called a contingent fee. That agreement should be in writing and signed by you. It should give the percentage, the costs that come off the top and any costs you owe if you lose.

Copies of your own records may come with a reasonable charge for copying and mailing. A provider cannot charge you for searching for your records. It also cannot refuse copies because you have an unpaid bill.

What should I do today?

Talk to your doctor before you turn off, change or remove your device. Then gather records that show the device and what happened. Do not sign with two law firms for the same claim.

Records that help

Ask for the device maker, the model and the unique device identifier, or UDI. The FDA has asked doctors to give patients this information. Gather records from the trial period, the implant surgery and any later surgery to fix, move or remove parts.

Keep notes on each visit when someone changed your settings, including company staff. Save records of burns, shocks, emergency visits and scans. You have a right to copies of your medical and billing records from most providers and health plans.

You can report a problem with your device to the FDA through MedWatch. Tell your doctor too, so they can check the device.

What is the evidence that the product causes this?

Studies and FDA reports show these devices can have problems, but they cannot show what caused any one person’s injury. A 2023 review of trials found little proof of lasting benefit for low back pain. Other studies found that complications and repeat surgeries were common. The FDA has also said the devices give many patients a chance at real relief, so talk to your doctor about your own device.

From July 2016 to July 2020, the FDA received 107,728 reports about stimulators used for pain. Pain relief that was not good enough was the most common patient problem in those reports. Charging problems and leads that moved were among the most common device problems. The FDA said these reports cannot show how often problems happen or prove that a device caused them.

Researchers at the University of Sydney pooled 13 trials with 699 people with low back pain. They found the device probably does not improve pain more than a fake device at six months, but that finding came from one small trial. In one trial, 13 of 42 people needed repeat surgery within two years.

A 2023 study led by a University of California, San Francisco doctor used insurance records for 1,260 people with a stimulator. Within two years, about 18% had a device-related complication, and about 22% had the device revised or removed. Not every removal was for a complication, and the study cannot show why each problem happened.

A 2016 review of published research found that 30% to 40% of patients had at least one complication. Lead migration, when a lead moves out of place, was the most common hardware problem. Serious nerve damage was rare.

Sources

The sources below include the federal panel’s orders, FDA notices, a Supreme Court decision and published studies. Each one is linked so you can read it yourself.