Abbott, Boston Scientific Oppose Spinal Cord Stimulator Lawsuit MDL

Manufacturers indicate there are too few cases filed, which involve too many different types of spinal cord stimulators and problems experienced by patients to justify consolidating the litigation before one federal judge.

Although a rapidly growing number of spinal cord stimulator lawsuits have been brought throughout the federal court system over the past few months, manufacturers of the controversial devices are opposing a recent request to centralize the claims before one U.S. District Judge, arguing the number of claims is still too limited, and many cases are already well advanced in the litigation process.

Abbott Laboratories and Boston Scientific are two of the leading manufacturers of spinal cord stimulators, which are surgical implants meant to help relieve severe, chronic back pain. Consisting of a battery-powered pulse generator, electrical leads, an external controller and the battery, the systems deliver small electrical pulses to the spinal cord to prevent pain signals from reaching the brain.

While the devices are marketed as a permanent solution to individuals suffering from failed back surgery, nerve damage or persistent lower back pain, both companies have faced a growing number of spinal cord stimulator lawsuits filed in recent months. 

Each claim alleges the devices, originally approved in the early 2000s, were repeatedly modified without undergoing full safety reviews or rigorous testing. Rather, these updated versions were cleared through the FDA’s 510(k) process, which allows manufacturers to bring altered products to market without new clinical data by claiming they are substantially equivalent to existing devices.

Due to the alleged failures to adequately test device revisions, plaintiffs claim they have suffered lead fractures, lead migration, electrical overstimulation, failed pain relief, worsening pain, sudden jolts of electricity, burning sensations and other neurological symptoms when the devices failed or were not properly programmed. This often leads to the need for additional surgeries or revision surgery to remove the failed implant.

In February, a group of plaintiffs filed a motion to establish a spinal cord stimulator MDL, or multidistrict litigation, indicating that cases brought against Abbott Laboratories and Boston Scientific throughout the federal court system should be consolidated before one judge in the Northern District of Illinois, for coordinated discovery and pretrial proceedings.

The plaintiffs noted that at least 15 lawsuits are currently pending across five federal jurisdictions, with five of those claims in the Northern District of California where plaintiffs seek to have the MDL formed. That number is expected to climb in the coming weeks and months as spinal cord stimulator attorneys indicate hundreds of additional injured patients have already retained legal representation.

According to the motion to transfer filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), consolidating the litigation would prevent duplicative discovery, contradictory rulings, and would serve the convenience of parties, the court and witnesses.

Abbott, Boston Scientific Oppose MDL

However, both Abbott and Boston Scientific filed briefs on March 13 asking the JPML to reject the request to form a spinal cord stimulator MDL. According to Abbott’s brief (PDF), the devices in question have not been linked to a “common signature defect” that would justify consolidation involving different manufacturers who make different products.

“Cases against different manufacturers necessarily involve different products that present individual factual questions. Consolidation of different-product cases presents little opportunity for judicial efficiency.”

– Abbott Laboratories Inc.

Boston Scientific’s opposition brief (PDF) argued that there are too few claims, particularly against Boston Scientific itself. The brief indicates that many of the cases already filed are well-developed and deep into discovery and pretrial proceedings, and questions the efficiency of consolidation.

The manufacturer also says that it intends to swiftly show that the cases are without merit because they are preempted by federal laws that limit the risk warnings Boston Scientific could have placed on its spinal cord stimulator warning labels.

If the JPML consolidates the litigation, each case will remain an individual lawsuit that requires plaintiffs to prove their injuries to a jury. However, if an MDL is formed, a federal judge would likely arrange for a series of early, bellwether trials designed to see how juries respond to evidence and arguments that the parties would likely make in almost every spinal cord stimulator lawsuit that goes to trial.

After these early trial dates, if the parties have still been unable to reach a settlement or other agreement, all of the lawsuits would be remanded back to their originating districts for individual trial dates.

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