○May 31st Thelen v. Somatics LLC, and Electrika, Inc.. He went to a jury trial in Tampa, Florida. It is the latest in dozens of lawsuits filed in the United States against manufacturers and distributors of electroconvulsive therapy (ECT) devices alleging negligence in manufacturing the devices. be. duty to warn patient about known risks The most prominent are neurocognitive decline and permanent brain damage.
how selenium allegation of lawsuit
Plaintiff, Nebraska resident Jeffrey Sellen, underwent approximately 95 ECT treatments for depression between May 2014 and July 2016.
The machine used by Selene was Cymatron System IVis manufactured and sold by Somatics, Inc., a company founded in the 1980s by Richard Abrams, M.D., and Conrad Swartz, M.D.; is a major supplier.
ECT did not improve Selene’s depression, according to the report. Complaint. Instead, he had “severe and permanent short-term and long-term memory loss and cognitive impairment, inability to concentrate and concentrate, to remember and learn new things, leading to constant panic and depression.” suffered from symptoms. Additionally, he reported that he was “severely impaired in his daily life, often confused, unable to finish sentences, and having difficulty caring for himself on a daily basis.”
Prior to ECT, Thelen worked in the tree logging and removal industry. After treatment, he lost all memory of the skills and abilities necessary for his trade. He is now permanently disabled and unable to work. In this lawsuit, he seeks damages for lost wages, pain and suffering, and medical expenses.
As with previous ECT exams, there are questions such as: informed consent It was central.of Complaint “Had Thalen been warned about the risk of brain damage and permanent neurocognitive decline, he would not have consented to ECT treatment.”
dangerous loophole
If you neglect to warn in the case of selenium Plaintiffs’ attorneys require that manufacturers be able to demonstrate that they are aware of the risks and dangers of their medical devices and willfully withhold that information from the public.in the ComplaintSomatics was accused of “deliberately and intentionally withholding” adverse event information that was “important to providers and patients.”
In addition to concealing the risks of ECT, Somatics exaggerated the safety and efficacy of its device, stating, “To the medical community, including the public, patients, and plaintiffs’ healthcare professionals, our Cymatron ECT Intentionally positively misrepresented that the device was ‘the safest’.” and the most effective treatment for severe depression. ”
There is no evidence to support Somatics’ above claims, but device makers continue to be protected by dangerous regulations. loophole.
None of the ECT devices, including the Cymatron device used by Sellen, received FDA approval. Instead, they “grandfathered” the provision that happened to allow Class III devices previously on the market. Revision of medical devices Enacted in 1976, it will remain in force until the FDA requests final rulemaking. Premarket approval applicationor PMA, provided by the device manufacturer.
FDA approval of PMA is based on clinical trials demonstrating the safety and efficacy of Class III devices with risks of illness and injury. His two existing ECT device makers, Somatics and MECTA, are not yet obligated to do so. Dr. Abrams, co-founder of Somatics, said: Said In a 2018 court deposition, he said, “We are not in the business of doing traumatic brain injury research. We sell Cymatron.”
of selenium The lawsuit alleges that Somatics’ misrepresentation extended to claims that the device “does not cause brain damage or permanent memory loss.” or long-term or persistent effects on intellectual performance or memory contrary to established evidence. ”
In 2018, two years after Selene’s ECT treatment ended, Somatics settled a similar “failed to warn” lawsuit. Riera vs. Somatics LLC. At this point the company website First acknowledged potential risks: “ECT can cause anterograde or retrograde amnesia. Amnesia after such treatment usually disappears over time. However, recovery is It can be incomplete.In rare cases, patients may experience permanent memory loss or permanent brain damage.”
“Such a warning, and a more conclusive warning about permanent memory loss and brain damage, should have been given by the defendants to medical professionals and the public.” decades ago When such risks were first reported and made known to defendants.” selenium The complaint writes:
verdict and next step
On June 8, a jury found that Somatics put its device on the market “without giving proper instructions and warnings to the physician who prescribed the ECT treatment” to Mr. Sellen. However, the jury disagreed that the lack of warning was “immediate cause of injury” to him. No damages were awarded.
This paradoxical ruling may be attributed to the court’s failure to recognize significant evidence about the laws of electromagnetism and how the human brain is affected by electricity at the cellular level.
ECT survivor and activist Sarah Price Hancock, who has been following the case closely, told Mad in America: It’s like denying the existence of the law of gravity in the case of a bridge collapsing. ”
She noted that one of the experts who testified, Dr. Bennett Omalu, was interrupted each time he mentioned that seizures cause brain damage. He was not allowed to talk about the effects of the electrical injury he saw under the microscope.
In a statement released shortly after the ruling, lead trial attorney Bijan Esfandiari said, “Disappointing with the outcome, Jeffrey is committed to the ECT to prevent others from experiencing similar injuries. I am grateful to have had a day in court to expose the dangers.” by ECT. We will appeal many of the evidence issues and will continue to fight on behalf of Jeffrey and others harmed by Somatics’ failure to warn. ”
Selene’s attorneys filed a motion for retrial on July 7, according to documents accessed through DocketBird. The basis for the reconsideration motion appears to be the court’s refusal to admit significant scientific evidence regarding the effects of ECT on brain cells.
Further development is coming soon, but Price Hancock believes: selenium Verdict as a partial victory. “The jury agreed that the manufacturer ‘failed to warn.’ That sounds great. It’s a step in the right direction.”
