Investigation Shows High Failure Rate of Spinal Cord Stimulators
A yearlong joint investigation of the global medical devices industry was recently concluded in November 2018. That investigation was spearheaded by the Associated Press and the International Consortium of Investigative Journalists, which is comprised of more than 250 journalists in 36 countries representing more than 50 media organizations around the world. As a part of that investigation, journalists interviewed doctors, patients, researchers, and company whistleblowers, in addition to collecting and analyzing millions of medical records, recall notices, and other medical device product safety warnings for the ten-year period from 2008 through 2017.
The joint investigation revealed that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the Food and Drug Administration (FDA) during the decade from 2008-2017. Although the FDA’s data comprises more than 4,000 different types of medical devices, spinal cord stimulators were noted to have the third highest rate of injury reports among all devices. Spinal cord stimulators placed third behind only hip prostheses and insulin pumps, both of which are in far higher use.
Of the approximately 600,000 spinal cord stimulators that were implanted in patients from 2008-2017, the FDA’s data revealed that more than 78,000 injuries were reported in relation to those devices. This amounts to a 13% failure rate for spinal cord stimulators over a ten-year period, which is disproportionately high when compared to other commonly implanted medical devices. This high rate of failure – coupled with the significant expense of implantation and the potentially serious consequences of any device failure involving the spinal cord – should cause pain management physicians to consider spinal cord stimulators only as a last resort for treatment of chronic pain.
Based on the findings of this joint investigation, we will use this data to defeat treatment recommendations in litigated cases and as part of settlement negotiations and Medicare Set-Aside discussions. We also caution our clients against the approval of spinal cord stimulators in voluntary pay cases, without first obtaining an independent medical evaluation as to the efficacy, risk versus benefit, and medical necessity of such treatment.
For further discussion regarding this joint investigation, please feel free to contact Keller Thoma attorneys Brian Richards (313-965-0850), Lauri Read (313-965-8935), or Tom Fleury (313-965-0857).