TAMPA – A Florida man is suing Abbott Laboratories and the U.S. Food and Drug Administration, alleging he was implanted with a medical device that was “materially different” from what had been tested and originally approved by the FDA.
Winter Haven resident Joel Sampson filed his lawsuit in U.S. District Court for the Middle District of Florida.
Sampson alleges the spinal cord simulator, or SCS, system that the Illinois-based Abbott manufactured “failed to perform as promised and instead caused serious harm.”
He contends the SCS that was implanted in his body was not approved based on independent clinical trial data, but rather on a finding by the FDA – which is tasked with regulating medical devices under the Federal Food, Drug, and Cosmetic Act – that the device was “sufficiently similar” to other SCS systems.
“If spinal cord stimulator manufacturers wish to benefit from PMA preemption, they must also bear the burden of compliance,” the 52-page complaint states, referring to pre-market approval.
“Courts should not allow them to weaponize preemption as both sword and shield while quietly discarding the regulatory obligations that rationalize and support that protection.”
According to the lawsuit, Abbott assumed ownership of the SCS device portfolio at issue after acquiring St. Jude Medical in 2017.
“Plaintiff does not seek to second-guess FDA policy,” Sampson’s lawsuit states. “Rather, he seeks to enforce the letter of the law.
“Abbott cannot continue to market a materially altered device under the guise of a 2001 approval that was never supported by clinical trial data in the first place.”
Sampson was surgically implanted with an Abbott Proclaim XR5 SCS for the treatment of chronic pain in January 2021.
Prior to the implant, he was implanted with a temporary, external trial SCS system, but decided to move forward with a permanent implant based on representations made by Abbott sales representatives, he alleges.
In August 2024, Sampson claims he began having issues with his SCS. It was not relieving pain, especially when trying to pick up his granddaughter.
Eventually, Sampson reached out to a new Abbott sales rep, who guided Sampson through an “over-the-phone reprogramming.” However, in the process, the SCS device started to “violently shock” and electrocute Sampson.
“Plaintiff was in such excruciating pain due to his back spasms caused by the electrocution, all he could do was writhe on the floor for three minutes,” the filing states.
For the next two weeks, he alleges he suffered from a sore back, sore kidney and constant diarrhea.
Fast forward two months later, Sampson was still struggling with pain, so he met with another Abbott sales rep. According to his lawsuit, he asked the rep if there had been a recall on the device, already knowing the answer – yes, in 2023.
Sampson claims the rep brushed off his concerns and tried reprogramming his SCS twice. Both times, he alleges, he was electrocuted.
In April 2025 – after scheduling issues and fights with his insurance – Sampson had surgery to remove the SCS due to “mechanical and therapeutic failure” of the device.
According to Sampson’s complaint, the SCS device at issue received FDA approval in 2001 under PMA P010032, originally granted to Advanced Neuromodulation Systems, later acquired by St. Jude Medical.
“Advanced Neuromodulation Systems did not submit and the FDA did not consider clinical data or clinical evidence in support of P010032, or for any subsequent Abbott system that used P010032 as a predicate product for marketing purposes,” the filing states. “Abbott’s entire SCS product line, including the Proclaim system, are predicated on PMA P010032.”
But since its original approval, the device has been “fundamentally altered” through dozens of PMA supplements, Sampson argues.
This includes modifying its battery chemistry, firmware, waveform control, leads, and user interface, he claims.
“These cumulative changes, approved outside public view, transformed the device’s mechanism of action, performance characteristics, and risk profile,” the complaint states. “Abbott failed to disclose these material changes to patients, physicians, or Regulators.
“As a result, Plaintiff was implanted with a device that was materially different from what had been tested and originally approved. He suffered painful neurologic symptoms and worsening pain symptoms that required revision surgery and have left him permanently injured.”
Sampson’s filing hopes to “restore integrity” to the PMA process, he claims.
The FDCA requires that all Class III medical devices undergo pre-market approval, or PMA, by the FDA before they may be introduced into interstate commerce.
Once a PMA is approved, the law prohibits any change to the design, materials, energy source, software, manufacturing process, or labeling of the device that could significantly affect its safety or effectiveness without submission of a new PMA or a panel-track PMA supplement.
“Abbott’s cumulative modifications, comprising firmware upgrades, battery redesigns, Bluetooth-based interfaces, and waveform expansions, render the current device materially different from that approved in 2001,” Sampson’s lawsuit states. “None of these changes were subject to panel-track review or public advisory panel input.”
The filing continues, “The FDA’s passive endorsement of these changes, including its allowance of Abbott’s continued marketing under an outdated PMA, constitutes a final agency action subject to judicial review. It also constitutes unlawful withholding of action required by law.”
Sampson seeks compensatory damages, statutory damages, punitive or exemplary damages, pre- and post-judgment interest, attorney fees and court costs.
The Carlson Law Firm PC in Killeen, Texas, is representing Sampson. Judge Mary S. Scriven in the Tampa division has been assigned the case.
