Abbott vs. Boston Scientific Spinal Cord Stimulators

Abbott and Boston Scientific together control the majority of the U.S. spinal cord stimulators market, implanting approximately 50,000 devices per year between them. Despite building on different technologies — Abbott's BurstDR waveform and Boston Scientific's FAST sub-perception therapy — both companies are named as defendants in the same MDL for a common reason: the lawsuits allege both evolved their spinal cord stimulator product lines through serial PMA supplements that avoided clinical testing, and both produced devices with overlapping failure patterns.

The Two Product Lines

Both Abbott and Boston Scientific build their current SCS product lines on original devices that received FDA Premarket Approval more than two decades ago. Since those initial approvals, each company has introduced multiple generations of successors through PMA supplements — the regulatory mechanism at the center of the litigation.

Side-by-Side Comparison

The following comparison highlights the key differences and similarities between the two product lines. While the technologies differ, the regulatory pathway, the patterns of complications, and the legal allegations are strikingly similar.

Common Failure Patterns

Despite building on different underlying technologies, the FDA's adverse event data and the pending lawsuits describe a remarkably similar set of complications for both manufacturers' devices. The FDA's September 2020 safety communication covered all SCS manufacturers and identified consistent problem categories across the industry.

Both the Tuttle v. Abbott and Martini v. Boston Scientific lawsuits — among the earliest filed in this litigation — describe patients whose devices failed within a relatively short period after implantation, leading to revision or explant surgeries. In the Tuttle case, the plaintiff alleges lead migration was identified approximately two months after implantation of an Abbott Eterna. In the Martini case, the plaintiff describes years of battery and programming failures with a Boston Scientific Precision Montage before ultimately undergoing explant surgery in 2022.

The Same Regulatory Shortcut

The core legal theory against both companies is identical: both allegedly used the PMA supplement process to introduce devices so substantially different from their originals that they should have been submitted as entirely new PMA applications — with full clinical testing.

A PMA supplement is intended for modifications that do not significantly alter the device's safety or effectiveness profile. It requires less evidence than a full PMA, costs less, and is processed faster. The lawsuits allege that both Abbott and Boston Scientific used serial supplements to introduce changes that fundamentally transformed their devices: new waveform technologies (BurstDR and FAST), redesigned lead architectures, expanded electrode configurations, Bluetooth wireless programming, updated battery chemistry and charging systems, and MRI compatibility — changes so extensive that the current products bear little resemblance to the devices originally approved in 2001 and 2004.

The lawsuits further allege that neither company submitted its own clinical studies as part of the original PMA applications. Both Abbott and Boston Scientific allegedly relied on published literature about other manufacturers' devices to support their initial approvals — and then continued to modify their products through supplements without conducting independent clinical trials on the new designs.

Why Both Belong in One MDL

The February 2026 motion to the JPML argues that despite being different manufacturers with different devices, the cases should be consolidated because they share common questions of fact that would be inefficient to litigate separately.

Common Legal Questions

The litigation against both companies raises overlapping legal issues. The federal preemption defense is the most significant: both Abbott and Boston Scientific argue that PMA approval immunizes their devices from state law product liability claims under Riegel v. Medtronic. The plaintiffs' response — that "parallel claims" based on violations of federal requirements can proceed, and that the APA provides an additional avenue to challenge the FDA's approval decisions — applies equally to both manufacturers. A single MDL judge can resolve these threshold legal questions once, rather than having multiple courts reach potentially conflicting conclusions.

Common Regulatory Framework

Both product lines went through the same FDA regulatory pathway: original PMA followed by serial supplements. The question of whether the FDA properly approved these supplements — and whether the manufacturers properly characterized their design changes — involves the same regulatory standards and the same FDA institutional practices. Much of the discovery regarding FDA procedures, internal review practices, and the standard for what constitutes a "significant" device change will apply to both companies' products.

Efficiency for Plaintiffs

Many plaintiffs may not know whether they have an Abbott or Boston Scientific device without checking their medical records. Others may have had devices from both manufacturers over the course of multiple revision surgeries. Consolidating the cases ensures that all SCS plaintiffs have access to the same coordinated legal resources regardless of which manufacturer's device caused their injuries.

Recalls and Safety Advisories

Both manufacturers have been subject to FDA recall actions or safety advisories for their SCS products, reinforcing the argument that device-level problems extend across both product lines.

Abbott: Class I Recall (September 2023)

Abbott issued a Class I recall — the most serious recall classification — for 155,028 Proclaim and Infinity implantable pulse generators. The recall was triggered by a Bluetooth communication failure that could prevent the devices from properly entering or exiting MRI mode. Patients undergoing MRI scans with a device stuck in the wrong mode faced risks of overheating, unintended stimulation, or tissue damage. At the time of the recall, Abbott had received 186 complaints and 73 reports of patient injury associated with the defect.

Boston Scientific: Safety Advisory (July 2024)

Boston Scientific issued a safety advisory covering 77,674 WaveWriter Alpha implantable pulse generators after identifying a software defect that could cause unexpected device resets during charging. When a reset occurred, the device would return to default settings, potentially interrupting the patient's programmed therapy and requiring a physician visit to reprogram the device. The advisory recommended that patients and physicians be aware of the potential for resets and monitor device behavior during and after charging sessions.

Earlier Abbott Recall: Eon Mini (2011)

Abbott's predecessor product, the Eon Mini SCS system, was subject to a recall due to battery weld failures that caused IPG overheating. This earlier recall is cited in the pending lawsuits as evidence that battery-related design problems have persisted across multiple generations of Abbott's SCS product line.

Frequently Asked Questions