Medtronic
(NYSE: MDT)
and Boston Scientific
(NYSE: BSX)
both face patient lawsuits related to spinal cord stimulation (SCS) technologies.
The Minnesota Star Tribune reported last week that, in a lawsuit filed in Minnesota, patients alleged that Medtronic circumvented necessary regulatory approvals as it continued to update its SCS systems over several decades. Similar complaints target Boston Scientific and its own SCS systems.
According to the report, the complaints say the FDA approved changes to SCS devices through expedited channels. However, these approvals didn’t require either of the medtech giants to provide new safety data supporting the changes. The lawsuits include the FDA as a defendant with Medtronic and Boston Scientific.
Plaintiffs say they experienced worsening pain and electric shock following the alterations made to the implantable devices.
Within the Medtronic lawsuits, the plaintiffs allege that changes made to SCS implants “materially altered the safety and functionality profile.” Despite the alleged changes, the patients claim they weren’t made aware of updates — and neither were physicians, they claim.
Similarly, the Boston Scientific complaint, filed in U.S. District Court in Central California, alleged that alterations affected safety and effectiveness compared to the originally approved systems.
The Star Tribune report says that both companies believe the suits lack legal merit, while Medtronic reportedly said the company hasn’t been served in any of three cases filed against it. Additionally, the report cited industry lawyers who say preemption, a legal doctrine that blocks injury lawsuits against well-studied medical devices, means the complaints “can’t succeed.”
More about the complaints filed against Medtronic
In one of the three complaints filed against Medtronic — submitted by Cathryn Keys of Memphis, Tennessee — it’s outlined that Medtronic initially won FDA approval in 1984 for its Itrel II SCS system. Since that initial approval, the company has more than 400 premarket approval (PMA) supplements to expand the system. Changes include updates to pulse generator hardware, leads, software, firmware, stimulation waveforms, battery chemistry, surgical implantation tools and labeling.
Keys herself received the Medtronic Intellis system implant in 2019. The suit says Medtronic supplemented the system through a series of streamlined FDA processes. These processes didn’t require new clinical testing, including 30-day notices and real-time review pathways, according to the legal document.
The FDA’s Medical Device Reporting (MDR) system and Manufacturer and User Facility Device Experience (MAUDE) database, however, showed a significant rate of incidents with the implant Keys received, the lawsuit says. That included early hardware failure, lead migration, battery depletion and patient-reported worsening of pain.
MAUDE reports associated with the model received by Keys included more than 2,700 unique adverse events between 2017 and 2022. Reports highlighted recurring patterns of high-frequency charging failure, unintentional shocks and stimulator migration. The suit says Medtronic failed to adequately disclose the risks in labeling, training materials or risk mitigation strategies.
According to the lawsuit, the plaintiffs claim changes to the system “materially altered the safety and functionality profile of the system but were not disclosed to physicians or patients.”
More about the complaints filed against Boston Scientific
The complaint in California targets Boston Scientific’s SCS product line that originated with the Precision system. Precision initially received FDA approval in 2004.
Since that approval, Boston Scientific introduced a number of new models, including Precision Plus, Precision Spectra and Spectra WaveWriter. Newer generations of SCS systems include multiwaveform stimulation, posture-adaptive programming, expanded electrode arrays, Bluetooth-enabled programming and revisions to battery architecture and lead designs.
The complaint alleges that Boston Scientific “aggressively marketed” Spectra WaveWriter and other upgraded models as capable of offering superior pain relief through innovative stimulation patterns. However, plaintiffs say the system lacked independent premarket clinical testing validating long-term safety and effectiveness with the modifications.
According to the legal document, Boston Scientific submitted successive PMA supplements for its modifications. The supplements treated changes as discrete “minor” updates to “avoid the heightened scrutiny, public transparency, and rigorous independent clinical evaluation required for new PMA applications.
“This regulatory strategy deprived physicians, patients and the FDA of complete information necessary to evaluate the true risks associated with the modified devices, particularly in the areas of neurological safety, device longevity, stimulation safety and autonomic complications,” the complaint reads. “As a direct consequence of these omissions and regulatory manipulations, the Spectra WaveWriter and other successor systems entered the market and were widely implanted without sufficient scientific validations of their safety and effectiveness.
