By David Karen, Esq.
April 21, 2018
As I reported in a previous blog, on September 11, 2017, DK Law Group, LLP filed a case against Mecta Corporation and Somatics, LLC, the two manufacturers of shock devices. The Complaint alleges that both Defendants, as the only two manufacturers that make and deliver shock devices, wholly failed to comply with the FDA’s requirements applicable to medical device manufacturers.
Namely, the FDA and its governing law, the Food, Drug and Cosmetic Act (FDCA) require that all medical device manufacturers, whenever they encounter “information reasonably suggesting death or serious injury” that their devices “may have caused” or to which they “may have contributed,” must investigate the information, evaluate the cause of the event, and submit all “reasonably known information” to the FDA. “Reasonably known” information is information that can possibly be gathered through testing and evaluation of the device or by contacting anyone, including user facilities and manufacturers, that are subject to the FDA’s reporting requirements.
If a manufacturer falls short of these requirements, or does not have a system in place for the timely investigation and/or reporting of adverse events (deaths or serious injuries), they cannot manufacture or deliver their devices for use in the United States under 21 U.S.C. section 331. Defendants have encountered thousands of allegations of serious brain injury resulting from ECT, and know of the existence of entire support groups of ECT victims. Despite that, Defendants have never properly investigated, evaluated, or reported a single adverse event allegation.
As a separate violation of the FDCA, ECT devices access the market under the “substantial equivalence” market access provision of the FDCA — meaning the devices have to be substantially the same, in terms of safety and effectiveness-related technological characteristics, as pre-1976 ECT devices, in order to evade the typical “premarket approval” (proof of safety and effectiveness) requirement for Class III medical devices. Defendants stated in their argumentation over “class certification” (discussed below) that their devices are new and technologically improved, such that they are more safe and effective than 1980’s devices. This obliterates any claim to “substantial equivalence” that Defendants may have had, and Plaintiffs’ position is that this renders invalid their devices’ market access, proving that their devices are, and have been, “adulterated” and/or “misbranded” — meaning “illegally marketed” in legalese.
Somatics, LLC also utilizes an unregistered contract manufacturer to manufacture all of their devices. This also renders their devices illegally marketed, on separate grounds.
Had Defendants complied with FDA regulations, they would have prevented injury to shock victims two separate ways:
1) If Defendants had complied with the “Medical Device Reporting” (MDR) requirements of the FDCA (21 U.S.C. 360i, 21 C.F.R. 803.50) they would have reported, tested, and evaluated the cause of thousands of allegations of serious brain injury resulting from ECT. Honest, good-faith reporting would have required that Defendants inform the FDA that ECT was causing tens of thousands of concussive brain injuries. The FDA would then have published the reports in its MAUDE database, which is the database intended to inform the relevant professional communities of the risks inherent in FDA-regulated products. Psychiatrists, then, bearing a legal duty to convey the information in the MAUDE database to patients, would have complied with the law by consulting the MAUDE database and relaying a warning of concussive brain injury to patients prior to administering shock.
2) If Defendants had complied with the “adulteration” and/or “misbranding” provisions of the FDCA (21 U.S.C. 331), prohibiting the manufacture and delivery of adulterated and/or misbranded devices entirely, Defendants never would have manufactured or delivered the devices that caused injury to Plaintiffs in the first instance.
Therefore, Defendants are liable for all unwarned brain injury caused by their devices.
Between September of 2017 and early March of 2018, both sides were making their arguments for “class certification,” or why the case should (or should not) proceed as a class action, rather than as a series of individual cases (see “Shock Class Action – Case Update“). The District Court set a hearing date for March 12, 2018, where the parties were prepared to argue their positions in open court regarding why the case should, or should not, proceed as a class action.
Just before March 12, 2018 the date scheduled for the class certification hearing, the Central District Court took the Class Certification hearing off its calendar and declared that it would be basing its ruling solely on the papers the parties submitted. Shortly thereafter, the Court issued an Order denying class certification. The primary rationales for denying class certification were: (1) mini-trials for each individual would be required after all the common issues were resolved, rendering a class action unmanageable, and (2) based on the severity of the alleged injuries, claimants would want to exercise control over their individual damages determinations.
Plaintiffs also put forth an argument for “partial certification,” in which certain questions common to everyone can be resolved all at once, such as (1) Defendants’ violation of FDA regulations, (2) whether ECT causes gross structural brain pathology, and (3) whether this lawsuit would intrude upon the FDA’s regulatory scheme. The Court thought these questions were “very discrete” such that the time saved through resolving these questions on a common basis would be “insignificant.” In concluding its ruling, the court stated that an individual verdict followed by settlements would be equally efficacious.
The attorneys for the ECT victims strongly disagree with the Court’s assessment, for the following reasons:
- The Ninth Circuit and other federal Courts of Appeals expressly approve of separate mini-trials after a class trial as a method of managing a class action, so mini-trials alone cannot be the basis for a finding of a lack of class manageability.
- The severity of some claimants’ injuries is far from the only relevant factor in determining whether shock victims would prefer to proceed individually or as a class. Plus, as the District Court stated, there would be mini-trials after the class trial anyway, which would allow claimants to exercise control over their individual damages determinations.
- The common issues here are not “very discrete” — they determine the outcome of the whole case — and the time saved through class resolution would be colossal.
- The last four decades of regulatory noncompliance by Defendants, and the availability of individual lawsuits for that entire period, shows that individual litigation is an insufficient means of resolving this problem.
As a result, Plaintiffs’ counsel have now petitioned the Ninth Circuit Court of Appeals for permission to appeal the District Court’s ruling denying class certification. The Ninth Circuit will overturn the ruling only if they find that the District Court “abused its discretion.” While counsel for Plaintiffs hope the Ninth Circuit sees the manifest error in the District Court’s ruling, they are now proceeding individually on behalf of the five named Plaintiffs as a test-run to see how these cases will play out. If successful, all other similarly situated ECT victims can follow with identical actions.
The Road Ahead
While, clearly, evidence of traumatic brain injury caused by ECT is well-known, for purposes of the litigation each of the named Plaintiffs will now need to undergo specialized neuropsychological testing to ascertain, measure and establish the extent of brain damage caused by ECT for the upcoming trial, where the all-too-familiar disinformation from ECT device manufacturers will appear in full force. As is typically the case with many ECT patients, careers have been ruined and financial pressures only add to the long road of recovery. Accordingly, well-needed donations for their expenses of litigation, including the necessary neuropsychological testing for each Plaintiff, are now being sought to help the victims of ECT in challenging the shock manufacturers in this litigation.
If you would like to help fund this cause, please follow this link and/or click the Donate button below. Know that every dollar and cent contributed counts immeasurably. It will be used to further this litigation to help offset the tremendous challenge of taking on this ethically necessary, legally cutting-edge and timely shock litigation against an industry that will spare no effort or expense in attempting to defeat these claims.