By: Ken David, Esq.
We all know from experience that there is not a high success rate for spinal
cord stimulators in a workers’ comp claim, especially ones where there is
litigation. At KDA, Jennifer Smith and Jarvis Lakemaker have been studying this
issue and below are their thoughts on a recent AP study along with a link to
the AP article. This study did not focus on workers’ comp which makes its
finding even more concerning as it shows potentially systemic issues in this
Spinal cord stimulators, long touted as a panacea for many patients suffering from pain related injuries may in fact be oversold by physicians with a financial incentive to minimize the risk of a device that has a disproportionately high risk of causing additional injury. Many medical device providers in the $400 million medical device industry have long held spinal cord stimulators as the cure for pain and the option to elevate opioid dependency. However, since 2017, these companies have spent $22 million to influence and lobby for the further use of these devices. The stimulators use electronic currents to block pain signals before they reach the brain, but the benefits come with high risk as they have also been known to cause burns, shocks, and even paraplegia. These devices have the third highest number of reported medical injuries to the U.S. Food & Drug Administration, with more than 85,000 incidents tagged since 2018.
As discussed in the report, the FDA is charged with carrying out laws passed to ensure medical devices are regulated and tested. High risk devices, like the spinal cord stimulator, are required to undergo heightened scrutiny, however, a loophole for devices deemed substantially equivalent allows many manufacturers to get their devices to market with minimal testing. Once approved through the FDA process, device makers can make substantial modifications to their products without further review. Since 2005, over 50 of the devices have been recalled, an average of four a year in the last five years. As it stands, medical professionals are not required to disclose to their patients whether they receive any compensation from device manufacturers or any other medical device producer.
Ultimately, spinal cord stimulators may be a helpful device in a doctor’s tool kit, especially when the concerns of opioid crisis are at the forefront of everyone’s mind. However, it seems clear from the FDA reporting that these devices do carry a risk, and that at times, they are overprescribed in part due to the financial incentives provided to the doctors. Patients should be better informed of these risks and the potential financial motivations of medical providers before deciding if these devices are appropriate for them.
Here is a link to the AP article.