Company dismisses ECT dangers and, instead, blames ECT critics and lawsuits for its financial demise; CCHR accuses MECTA of ignoring damaging adverse effects of shock treatment.

MECTA Corp., one of the USA’s two manufacturers of electroshock machines, filed for bankruptcy following lawsuits related to the company’s SpECTrum device. MECTA (Monitored Electro-Convulsive Therapy Apparatus) cited lawsuits, filed by patients seeking redress over electroshock-caused brain damage and serious memory loss, as the reason for its bankruptcy. The company was thus unable to obtain product liability insurance to cover the device.[1] Jan Eastgate, president of the international mental health industry watchdog, Citizens Commission on Human Rights International (CCHR), responded, saying, “Electroshock victims can finally draw solace from the fact that at least one ‘shock box’ has come to an end; however, this should be a precedent for all such damaging devices to be removed from the market.”

Because of the loss of liability insurance, MECTA was forced to discontinue manufacturing and servicing its SpECTrum device as of September 1, 2021. On September 30th, 2021, MECTA filed for bankruptcy in the Bankruptcy Court for the District of Delaware. It also claimed that it resorted to this action because it has been facing a concerted campaign against the company, electroshock, and psychiatry for years.

CCHR is one of the most prolific opponents of electroshock treatment (ECT). Its online petition has more than 126,000 signatures supporting a ban on ECT. Since 1976, CCHR has testified before Congress, the Food and Drug Administration (FDA) and state legislators about the need to prohibit the practice. It helped secure a ban on the use of ECT on minors in California in 1976, with three other states following. As a clearinghouse and voice for patients’ rights, CCHR International documents allegations of abuse every year, including accusations that ECT causes severe memory loss, cognitive dysfunction and brain damage; it encourages patients to seek compensation for any damage incurred.

Both MECTA and the other U.S. shock device manufacturer, Somatics Inc., have been deluged by more than 20 lawsuits. MECTA cited “…numerous nearly identical lawsuits have been filed across the country” and is currently a defendant in five active lawsuits—all filed by two Los Angeles law firms.

MECTA conceded that “Litigants have named MECTA in lawsuits relating to alleged ECT damages for years.” Recently, however, the company believed that “an organized and concerted litigation effort surfaced where it was clear that the actual goal was to put the Debtors out of business.”

In viewing the documents filed with the court, litigation is often based on patients aggrieved by the damage they experienced from ECT or the failure to be properly informed of the ECT device risk—a fact which is evidently lost on the company.

The two law firms that have been litigating electroshock cases are DK Law Firm and Baum Hedlund Aristei & Goldman (BHA&G), both based in Los Angeles. DK attorney David Karen fired the first salvo against Somatics’ ECT machine, the Thymatron, and later recruited nationally acclaimed BHA&G to try the case. Karen reported: “In October of 2018, in Riera v. Somatics, LLC, the United States District Court for the Central District of California ruled that there was sufficient evidence for a reasonable jury to find that the prominent manufacturer of ECT devices, Somatics, LLC, caused brain injury in the plaintiffs by failing to warn their treating physicians of the risk of brain injury associated with ECT, and also through a failure to investigate and report to the FDA complaints of brain damage and death resulting from ECT.”[2]

Somatics settled the case on the eve of trial and then posted on its website that ECT may cause permanent brain damage.[3] This is a fact that psychiatrists and the FDA continue to ignore, thereby jeopardizing patient lives.

BHA&G has developed a reputation for breaking new legal ground, and for its success in personal injury and wrongful death cases, including litigating over 3,000 antidepressant cases in the past 20 years.[4]

Electroshock is often marketed for use in so-called “treatment-resistant” patients after antidepressants have failed. A January 2022 UK study published in Psychological Medicine criticizes both treatments as ineffective and risky. The authors reviewed ECT studies, of which numerous ones found ECT recipients are more likely than other patients to kill themselves. One study, which was a review of the findings of 82 prior studies, found that patients experience “major adverse cardiac events,” the leading cause of ECT-related deaths.[5]

Dr. John Read, a professor of clinical psychology in the UK, Laura McGrath, Ph.D., and Prof. Irving Kirsch, an expert on placebo effects based at Harvard Medical School, authored a peer-reviewed research article published in the journal Ethical Human Psychology and Psychiatry in 2020, finding “the failure to find any meaningful benefits in long-term benefits compared to placebo groups are particularly distressing. On the basis of the clinical trial data, ECT should not be used for depressed individuals.” The authors reviewed five meta-analyses of ECT versus simulated ECT (SECT) and concluded, “The quality of most SECT–ECT studies is so poor that the meta-analyses were wrong to conclude anything about efficacy, either during or beyond the treatment period.” Indeed, “There is no evidence that ECT is effective for its target demographic—older women, or its target diagnostic group—severely depressed people, or for suicidal people, people who have unsuccessfully tried other treatments first, involuntary patients, or children and adolescents.”[6]

BHA&G took up the plight of electroshock victims, including one woman who alleges ECT caused permanent neurological damage that impaired her ability to learn and retain information.[7] The plaintiff asserts that Somatics (a) failed to provide adequate warnings to the medical community and the public about the risks of ECT; (b) failed to adequately research, test, and analyze the safety of the ECT device; (c) failed to adequately investigate the reports of serious adverse events, including but not limited to permanent memory loss, neurocognitive decline, death, burns, and brain injury.[8]

Lie 1: ECT is Safe and Effective

Neither MECTA nor Somatics have conducted clinical trials to prove the safety and efficacy of their devices. In a 2005 lawsuit against MECTA, the company could not provide clinical evidence to the court of how ECT works other than the shock device is designed to cause a grand mal seizure. Beyond that, ECT’s “therapeutic” mechanism is entirely theoretical.[9]

• The president of MECTA, Robin Nicol, made an astounding admission that the company “does not do research.” She said she would be “compassionate,” but not curious to know why victims complained about injuries from her devices, as “We are not responsible for individual patients…. That is not our responsibility from the FDA perspective or from our perspective as medical-device manufacturers.”[10] Furthermore, no effort is made to acquire adverse information caused by MECTA devices, she said.[11]

• As recorded in a Citizens Petition filed with the FDA Commissioner in 2016 on behalf of five shock treatment survivors, Nicol admitted that if she “had information that [its] devices weren’t safe, it would not be considered unless the information came from double-blind studies.” And “Thus, MECTA’s President’s view was that if patients claim to have brain damage or to have lost large chapters of the memories of their lives, they must be lying,” according to the Petition.[12]

• Asked by a lawyer for the plaintiff whether severe loss of memory would be a “serious enough complaint to deal with,” MECTA’s co-owner, Gorham Nicol, replied, “We don’t deal with it unless it’s from a doctor or hospital.” Nicol was also asked if his firm employed anyone capable of conducting ECT clinical studies. His reply? “Absolutely not.”[13]

Lie 2: Critics and Detractors are Misleading About ECT

MECTA told the bankruptcy court that it is “not without critics and detractors” and there have been “disturbing newspaper and online campaigns targeting the Debtors.” Further, “By virtue of the Debtors’ business, certain social and religious groups who disapprove of psychiatric medicine and ECT actively protest the Debtors’ operations.”

MECTA implies some nefarious “conspiracy” against it. It is not. Rather than look at the harm the shock device has caused, MECTA blames its failed business, in part, on its critics that “have made it their goal to effect a ban on the use of ECT in this country.”

In doing so, MECTA failed to tell the court about the huge and diverse public outcry over the use of ECT as a mental health treatment. Groups include not only CCHR but also independent of CCHR, shock survivor and patient rights groups such as Mind Freedom, Coalition for the Abolition of Electroshock, The Committee for Truth in Psychiatry, and Network Against Psychiatric Assault (NAPA), most of which existed before MECTA was formed in 1984. It also begs the question whether MECTA considers dozens of healthcare professionals, including psychiatrists, questioning the merits of ECT, are part of this imagined conspiracy against it, along with international agencies such as the United Nations Committee Against Torture and the World Health Organization (WHO).

There is much information missing from its pleadings to the court, for example:

• 2009: More than 3,000 comments were made to the FDA in response to its Public Docket on ECT, most of which (79%) opposed reclassifying the ECT device from Class III to Class II. The comments related hundreds of stories of permanent memory loss, deaths of loved ones, and the debilitating effects of ECT. In addition, there were 92 group submissions representing 6,462 individuals against reclassification and only 462 in favor.[14]

• 2013: United Nations committees and special rapporteurs have condemned forced use of ECT. In 2013, Juan E. Méndez, the Special Rapporteur on Torture, called for “an absolute ban on all forced and non-consensual medical interventions” such as “electroshock and mind-altering drugs….”[15]

• 2014: Manfred Nowak, professor of International Law and Human Rights, Vienna University, also voiced his opinion that in the absence of informed consent, ECT is torture. Every state that has ratified the United Nations Convention against Torture, “has an obligation to prohibit torture, to make it a crime under domestic law and to bring the perpetrators to justice.”[16]

• August 2017: The National Association for the Advancement of Colored People (NAACP) unanimously passed a resolution supporting a ban on electroshock use on anyone younger than 21. Dozens of African American community groups also signed letters supporting a full ban.

• August 2017: Australian psychiatrist Dr. Niall McClaren’s article “Electroconvulsive Therapy: A Critical Perspective,” published in Ethical Human Psychology and Psychiatry, states: “Ideally, all patients advised to have ECT should be told that while their psychiatrist advises it, other psychiatrists in the same town would not; while, in some countries, it is so severely restricted that the question would not arise… whether patients receive ECT or not is not a matter of science, it is a matter of the psychiatrist’s personal predilection, meaning chance.”[17]

• December 2017: After being criticized over its failure to adequately make Manufacturer and User Facility Device Experience (MAUDE) reports to the FDA, MECTA filed 16 reports about adverse incidents involving its ECT device. Apart from several 2016 events, the adverse events dated back to 1999—MECTA had never filed any of the reports at the time of the event, including two deaths. In 2016, attorneys filed a Citizens Petition to the FDA on behalf of five shock survivors which noted that no “MDRs [medical device reporting] from MECTA appear on the FDA’s MAUDE data base,” yet the ECT machines “utilized at each of the facilities where patients died after receiving ECT, were manufactured by MECTA and Somatics, and apparently not reported to MAUDE.”[18]

• July 2018: The UN Human Rights Council report on “Mental health and human rights” described forced ECT as a practice “constituting torture or other cruel, inhuman or degrading treatment or punishment….” It, too, called for a prohibition of forced ECT.[19]

• July 2020: Forty experts (including researchers, psychiatrists and other mental health professionals, and ECT recipients and family members) wrote to the UK Minister of Health about their serious concerns about ECT, calling for an independent inquiry into how ECT is administered and monitored in the UK.[20] An inquiry was endorsed by several key UK organizations, including the National Counselling Society, the Association of Clinical Psychologists UK, the Council for Evidence-Based Psychiatry, the mental health charity and NGO, Mind, and Headway, a brain injury association.[21] 

• July 2020: UK peer-reviewed research published in Ethical Human Psychology and Psychiatry reported ECT has “no place” in evidence-based medicine due to risks of brain damage. The researchers, which included Prof. Irving Kirsch, an expert on placebo effects based at Harvard Medical School, concluded that, “the high risk of permanent memory loss and the small mortality risk… means that its use should be immediately suspended.”[22]

• 2021: Preparation of a class action lawsuit began in the UK, focusing on the failure of psychiatrists to inform patients of the risk of brain damage from ECT.[23]

• June 2021: The WHO issued a “Guidance on Community Mental Health Services: Promoting Person-Centered and Rights-Based Approaches” supporting prohibition of coercive practices such as forced ECT. WHO reinforced the UN Convention on the Rights of Persons with Disabilities (CRPD) which states that patients must not be put at risk of “torture or cruel, inhuman or degrading treatment or punishment” and recommended prohibiting “coercive practices such as forced admission and treatment, seclusion and restraint, as well as the administering of antipsychotic medication, electroconvulsive therapy (ECT) and psychosurgery without informed consent.”[24]

It further stated that people who are subjected to forced treatment, such as electroshock report “feelings of dehumanization, disempowerment and being disrespected.”

Lie 3: FDA Says ECT Devices are Safe and Effective

MECTA vice president Adrian Kettering told the bankruptcy court: “Despite the support of the U.S. Food & Drug Administration and the breadth of tremendously successful scientific research regarding ECT, unfortunately MECTA is not without critics and detractors.”[25]

He would know that even the FDA’s Final Rule on ECT from December 2018, includes the determination that ECT devices must carry this warning: “Long-term safety and effectiveness of ECT treatment has not been demonstrated.”[26]

There has been a massive rejection of the FDA’s handling of the ECT device classification (2009-2018) process and its failure to obtain pre-marketing applications (PMAs) from MECTA and Somatics with clinical trials proving safety and efficacy. Both companies have failed to conduct such studies for the safety of patients subjected to their devices.

There also remains contention about the FDA’s capricious and arbitrary determination on ECT device classification, which relied upon studies biased in favor of its pre-conceived findings.

• In 2017, in a review of ECT studies since 2009, John Read, a professor of clinical psychology at the University of East London, et al., determined that of 91 studies reviewed, only two aimed to evaluate the efficacy of ECT. Both were severely flawed. None of the other 89 studies produced robust evidence that ECT is effective for depression, primarily because at least 60% maintained ECT participants on medication and 89% produced no meaningful follow-up data beyond the end of treatment. Between 2010 and the end of 2016, there were zero placebo-controlled studies comparing ECT and simulated electroconvulsive therapy [SECT].[27]

• A sample of 64 studies that the FDA relied upon for its 2010 Executive Summary on ECT and the 2011 meeting of its Neurological Devices Panel, which examined the reclassification of ECT devices, showed no definitive scientific evidence of ECT being “safe and effective.” Fifteen studies stated that they were too small in size to be conclusive. For example, statements included: “too small to yield definitive statistical conclusions,” “The numbers are too small to permit significance tests for any relationship between response and depression subtype,” and “the small sample size in the comparisons of the treatment subgroups at long-term follow-up was another limitation.”[28]

• FDA claimed involuntary ECT is “uncommon” and only done with a judiciary approval. This was patently misleading. Including the District of Columbia and Puerto Rico, there are 33 geographical jurisdictions where the state laws and administrative codes do not even comment on the use of ECT, let alone provide judiciary determinations.[29] Nor does the FDA keep statistics on ECT’s use in the country and how many patients are forced to undergo it. In fact, CCHR has needed to use state Freedom of Information Act requests to obtain statistics on ECT usage alone.

Lie 4: “Movie” Against ECT is “Misleading”

MECTA asserted it was dogged by protests and a “misleading” “movie” produced about ECT.[30] On the contrary, past movies have poignantly shown the inherent dangers of firing up to 460 volts of electricity through the brain (ECT) causing a grand mal seizure, among them One Flew Over the Cuckoo’s Nest (1975) and Frances (1982)—the latter about actress Frances Farmer, who was mercilessly electroshocked.

In 2019, CCHR also released its documentary, Therapy or Torture: The Truth About Electroshock, which includes interviews with more than a dozen experts, including a psychiatrist, psychologists, physicians, nurses, and attorneys, as well as shock treatment survivors.[31] The documentary was necessary to provide facts that the shock device manufacturers and psychiatrists fail to fully inform consumers or their families of. Jan Eastgate, president of CCHR International, is interviewed about her own experience being electroshocked as a young woman in the 1970s when a thyroid condition was misdiagnosed as “depression.”

However, as earlier mentioned, MECTA simply dismisses patient allegations. MECTA’s president admitted under oath that the company made no “effort to solicit information from persons who have received ECT to see whether or not they have been harmed,” because that would not be part of her company’s responsibilities.[32]

Let that sink in for a moment.

CCHR International’s website TruthAboutECT.org also provides expert statements and quotes, including successful ECT lawsuits and death findings that consumers, in the interest of informed consent and compensation for damage, should be aware of. So too should the bankruptcy court have been informed. Instead, it was led to believe that MECTA’s business failed because bad things have been erroneously said about a good “treatment.” Not so:

• 2005: A South Carolina jury determined 60-year-old Peggy Salters’ memory loss of 30 years was due to ECT. Mrs. Salters held a Master of Science in nursing but lost her knowledge of nursing skills and was unable to return to work after ECT. She was awarded over $635,177.[33]

• 2007: Richard Green from the UK was awarded £500,000 ($975,000) in an out-of-court settlement over brain damage that left him paralyzed from the chest down, and with speech difficulties from ECT, during which his airways became blocked.[34]

• 2014: CCHR International assisted CCHR Australia in obtaining reforms to the Western Australian Mental Health Act that bans the use of ECT on those younger than 14, with criminal penalties, including jail and a $15,000 fine.[35]

• 2018: The South Carolina appellate court revived a malpractice case that alleges 86 ECT treatments left Clair Craver Johnson with substantial memory loss. The repeated use caused her “excruciating, intractable pain and suffering, loss of memory….”[36]

• 2018: A coroner in Victoria, Australia, ruled that Gerard Helliar (62) died a preventable death after being forcibly given hundreds of ECT treatments. The coroner found no evidence that the involuntary ECT could have given the grandfather any relief.[37]

• A pathologist in another inquest said that that the seizure from ECT caused irreparable brain damage.[38]

Since 2017, CCHR has kept state legislators in every U.S. state apprised of the studies, expert statements, and statistics of ECT usage in states from which it was able to obtain (with difficulty).

Lie 5:  Electroshock is “Life-Saving”

Yet another MECTA public relations spin was telling the bankruptcy court that it planned to pursue a reorganization “so that the Debtors can emerge and continue to provide the life-saving devices.”[39]

Nowhere in the FDA’s Final Rule on ECT in December 2018 or in the subsequent Code of Federal Regulations, Title 21, does it say that electroshock is lifesaving.[40] Rather:

• A January 2022 study reinforced the risk of death from ECT and that it can also induce suicidal actions. The study by two UK experts, John Read, Ph.D., and Joanna Moncrieff, M.D., a psychiatrist, published in Psychological Medicine, reveals how meta-analyses have failed to identify any evidence that ECT prevents suicide, as often claimed. Numerous studies have found ECT recipients are more likely than other patients to kill themselves. In a 2020 study, 14,810 ECT patients were 16 times more likely to try to kill themselves than a matched control group of 58,369.[41]

• A 2021 U.S. study found that 1,524 homeless U.S. veterans who received ECT had made significantly more suicide attempts at 30 days follow up than 3,025 matched homeless veterans who hadn’t had ECT. The difference remained significant at 90 days and 1 year.

• A review of 82 studies found that one in 39 ECT patients (25.8 per 1000) experience “major adverse cardiac events,” the leading cause of ECT-related deaths.

• Even on its consent form for ECT, Johns Hopkins Hospital in Baltimore, Maryland, says, no guarantees can be “made concerning the outcome [of ECT], as the practice of medicine and psychiatry is not an exact science.”[42]

MECTA told the court that its remaining “innovative ∑igma™ [ECT] device is different from SpECTrum, and is insured and cleared by the FDA as a Class II medical device,” but that global supply shortages due to the Covid-19 pandemic has caused uncertainty regarding manufacturing, impacting projected receivables.[43] How the FDA cleared the ∑igma (pronounced Sigma) is highly questionable.

MECTA Corporation and its wholly owned subsidiary Balance Point, which was formed to hold, maintain, develop and license intellectual property supporting the medical devices used in the treatment of mental illness, are both parties in the bankruptcy.

Ideally, both the SpECTrum and ∑igma shock devices will both be taken off the market and thereafter, Somatics’ Thymatron series. All shock delivery hospitals currently using a SpECTrum should be on notice that they are putting patients at risk by using it and any other ECT device.

CCHR will steadfastly continue to work to achieve a ban on ECT for the protection of patients. Sign the petition here to support total ban on all ECT.

References:/……continue reading on:

Psychiatry loses weapon of mental destruction in major win against the enemies of humanity