Boston Scientific Faces Spinal-Cord Stimulator Lawsuit Over Seminar Robocalls

Published on December 5, 2018 by Sandy Liebhard

A consumer recently filed a spinal-cord stimulator lawsuit against Boston Scientific Corp., after he allegedly received unauthorized robocalls for the Spectra WaveWriter system.

The complaint seeks class action status on behalf of others who received similar telemarking calls.

Plaintiff Was Registered with Do Not Call List

According to the filing in Massachusetts federal court, the plaintiff had previoulsly registered with the National Do Not Call Registry . However, he received two robocalls in July for seminars promoting Boston Scientific’s Spectra WaveWriter spinal-cord stimulator implant system. (Case No. 1:18-cv-11826)

Both calls were identical and mentioned the plaintiff’s pain-management doctor by name. What’s more, neither of the robocalls provided an option that would have allowed him to opt out of future calls.

Among other things, the lawsuit asserts that the plaintiff had no prior relationship with Boston Scientific. He also denies ever granting the company prior express written consent to call him via a prerecorded message.

“Seeking redress for these injuries, (the lead plaintiff), on behalf of himself and Classes of similarly situated individuals, brings suit under the Telephone Consumer Protection Act, 47 U.S.C. § 227, et seq., which prohibits unsolicited prerecorded voice calls to landline and cellular phone and numbers, and unsolicited marketing calls to phone numbers registered on the DNC,” the lawsuit states.

Spinal-Cord Stimulator Implants for Chronic Pain

The U.S. Food & Drug Administration (FDA) has approved the Spectra WaveWriter and similar spinal-cord stimulator implants to treat a wide range of chronic pain disorders, including:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Intractable low back and leg pain

Generally, these systems include a pulse generator implanted into the back or abdomen and a lead placed into the spine’s epidural space. Once implanted, the devices emit low-voltage electronic pulses that block pain signals from traveling from the spine cord to the brain.

Boston Scientific is one of four medical device makers that currently dominate the spinal-cord stimulator implant market. The others include Abbott/St. Jude, Medtronic, Inc., and Nevro.

The market for the pain implants has grown from just $300 million in 2001 to nearly $2 billion in 2017. Among other things, device makers have promoted the systems as a solution to the opioid crises.

Spinal-Cord Stimulator Implant Injuries and Complications

Unfortunately, an investigation conducted by the Associated Press and other global media outlets suggested that  spinal-cord stimulator implants have actually harmed many patients.

Investigators found, for example, that the FDA received over 80,000 spinal-cord stimulator injury reports since 2008, including burns, shocks, worsening pain, and infections.

The FDA reports also indicated that 500 had died after receiving spinal-cord pain systems. However, its not clear if the devices or the implants caused those deaths.

Spinal-Cord Stimulator Lawsuit Filings

Unfortunately, the spinal-cord stimulator lawsuit pending in Massachusetts isn’t the first to raise questions about marketing practices.

In fact,  a 2011 whistleblower lawsuit claimed Boston Scientific had paid kickbacks to doctors and engaged in other illegal schemes to drive sales of its Precision Plus SCS spinal cord stimulation system.

What’s more, Medtronic actually settled a similar case in 2015.

In recent years, plaintiffs have also sued manufacturers and doctors over injuries that allegedly resulted from negligent spinal-cord simulator surgeries and defective devices.