On September 11, 2017, DK Law Group, LLP filed a Class Action Complaint against Mecta Corporation and Somatics, LLC, the manufacturers of ECT shock devices. It alleges that the manufacturers caused injury to patients by withholding from the FDA data relating to serious iatrogenic brain injuries resulting from ECT, in violation of federal medical device regulations, resulting in a lack of public disclosure of the risk of iatrogenic brain injury and a grossly inadequate warning to patients.
The following developments have taken place since then:
On December 10, 2017, the named Plaintiffs filed their Motion for Class Certification. This is a document that Plaintiffs must file in every class action. It is the Plaintiffs’ chance to assert to the Court that the case can move forward as a class action, rather than as a series of individual actions. The argument over class certification between parties is often the most contentious and hard-fought battle in class action cases, due to the significant stakes for each side. If class certification is denied, plaintiffs must shoulder the immense burden of filing suit on behalf of everyone individually if they wish to proceed.
In our motion, we argue that that this case presents the rare situation involving personal injuries that are properly certified as a class action, in which there are significant questions common among every single class member. When appropriate, a federal court can resolve the common questions first, and leave the remaining individual issues to prove up in separate mini-trials for groups of victims. The common questions here include Defendants’ regulatory compliance or lack thereof, whether the FDA’s regulatory regime should prevent these Plaintiffs from suing, and whether ECT can cause electrical injury to the brain when used as intended.
Plaintiffs assert that these common questions are of such significance, both in terms of relative magnitude within the case and in terms of the public’s interest in their common resolution, that the proper way to proceed is as a bifurcated class action.
Plaintiffs’ trial plan in the Joint Report proposes that the United States District Court for the Central District of California should first resolve the common issues of generic causation, federal preemption, regulatory noncompliance, and the propriety of punitive damages, as well as any other common issues. Then, if a class trial is completed and the action proceeds, the Plaintiffs propose conducting mini-trials for groups of plaintiffs to resolve the extent of individual injury and the defense of voluntary assumption of risk. Plaintiffs contend this would materially advance the disposition of the litigation and render it manageable. The Joint Report also contains each side’s view of the case. I thought it would be in the community’s interest to review and discuss, if anyone feels so inclined. An excerpt:
Defendants fraudulently concealed the fact that ECT causes concussive brain injury, concealed all of the complaints they received from ECT victims by failing to submit adverse event reports, concealed the seriousness of the injuries inflicted upon members of the putative class, and concealed their regulatory noncompliance, tolling the statute of limitations for all Plaintiffs. Moreover, many putative class members did not know, nor should they reasonably have known, about the conduct giving rise to this suit — namely Defendants’ comprehensive failure to comply with the Medical Device Reporting obligation of the Food, Drug and Cosmetic Act, failure to comply with the adulteration and misbranding obligations of the Food, Drug and Cosmetic Act, and failure to submit all safety and effectiveness data to the FDA in response to its three orders. Finally, Defendants are equitably estopped from asserting the statute of limitations.
The Scheduling Conference will take place Monday, February 5. There, the Court and parties will discuss procedural issues and make a good-faith attempt to resolve them, as well as work out a discovery and motion schedule.
The hearing on class certification is scheduled for March 12. The parties will hold argument on the propriety of class certification. Both sides will fight tooth and nail here.