As a patient suffering from persistent pain, you look anywhere for relief. So, when your doctor informs you about a new medical device that can reduce your pain, you’re going to listen. Unfortunately, thousands of patients looking for an escape from their daily pain had their doctors implant Stimwave devices in their bodies. But, as it turns out, these Stimwave devices were nothing more than a piece of plastic that served no purpose and provided no relief. Yet, these patients were deceived into undergoing a potentially dangerous surgery---just so the manufacturer of the device could continue to sell the product.
If you had a Stimwave device implanted in your body, both you and your doctor were tricked by the company. Thus, you went through the time, stress, pain and risk of unnecessary surgery. However, as we’ve discussed in prior posts, manufacturers have a legal duty not to mislead consumers into buying their products, especially when a company’s product means that you’ll be subjected to a medical procedure that carries significant risks. The manufacturer of Stimwave recently agreed to settle a healthcare fraud case brought against the company; however, this settlement will not put money in the pockets of aggrieved patients. Instead, patients can pursue their own product liability claim against the company in hopes of recovering fair compensation for what they’ve been through. To learn more, reach out to a Stimwave lawyer to schedule a consultation to discuss your options.
What Is Stimwave?
Stimwave, LLC was a Florida-based medical device company that designed, manufactured and sold medical devices that were implanted into patients suffering from chronic pain. The company was founded by Laura Perryman in 2010.
Why Is Stimwave Facing Fraud Charges?
Stimwave sold neurostimulation devices to help patients suffering from chronic intractable pain avoid opioid use. One of the company’s products, and the subject of the recent fraud lawsuit, the StimQ PNS System, contained three primary components:
1. An implantable electrode array (the “Lead”) that stimulated the nerve;
2. An externally worn battery worn on the body that wirelessly provided power to the Lead through the patient’s skin (the “Battery”); and
3. A separate implantable receiver measuring approximately 23 centimeters in length with a distinctive pink handle (“Pink Stylet.”).
Stimwave sold this device to doctors and other healthcare professionals for $16,000. In turn, doctors would implant these devices in patients and then bill the patient’s insurance or, as was often the case, Medicare. However, shortly after the StimQ PNS System was released, doctors began informing Stimwave that the device was too long to fit into most patients’ bodies.
In turn, Stimwave created an alternate product. However, because the original device could not be cut down in length without affecting its efficacy, Stimwave simply replaced the Pink Stylet with a White Stylet that could be trimmed to size, seemingly solving doctors’ concerns. However, as it turns out, the White Stylet was nothing more than a piece of plastic that served no purpose whatsoever. Despite this fact, Stimwave continued to sell the device for $16,000.
The federal government opened an investigation, leading to healthcare fraud charges being filed against Stimwave as well as the company’s founder.
Do Stimwave’s Products Reduce Pain?
No, the Stimwave StimQ PNS System is a fake medical device. While Stimwave manufactured several different types of medical devices, the company’s StimQ PNS System is a useless medical device that serves no purpose and will not do anything to reduce a patient’s pain. The company modified a previous version of the product after doctors complained that it was too large. However, in doing so, the company knowingly sold a device that served absolutely no purpose.
What Are the Risks of Getting a Stimwave Device Implanted?
Every single person who had a Stimwave StimQ PNS System implanted in their body unnecessarily went through a medical procedure. While many patients suffered no adverse consequences of the implantation procedure, it still subjected them to unnecessary risk and expense. That said, so far, there have not been any reports that anyone who had a Stimwave device implanted in their body suffered harm related to the product itself. The risk comes from the unnecessary surgery needed to place the Stimwave StimQ PNS System device in a patient’s body.
Is Stimwave Liable to Patients for Tricking Them into Undergoing an Unnecessary Medical Procedure?
Under several legal theories, including product liability, patients who asked their doctor to implant a Stimwave StimQ PNS System may be able to bring a claim against Stimwave. Unlike many other personal injury cases involving defective or dangerous medical devices, Stimwave claims are based on the fact that the company intentionally misled patients to believe they were implanting a medically useful device in their bodies. This subjected thousands of patients to unnecessary medical procedures, which could lead to infection, paralysis, stroke, long-term disability, and even death.
Is There a Stimwave Class Action Case?
The United States Attorney for the Southern District of New York only recently announced the outcome of the Stimwave fraud case. Thus, at this point, there is not yet a Stimwave class action lawsuit. However, as the thousands of patients who were tricked into asking their doctors to implant this fake medical device into their bodies learn about the company’s unethical and illegal conduct, a Stimwave class action lawsuit is possible.
