Health Law Daily Wrap Up, MEDICAL DEVICES—E.D. Mo.: Suit against electroconvulsive therapy machine maker proceeds only in part, (Jan 24, 2022)

By Gregory Kane, J.D., M.B.A.

The maker of an electroconvulsive therapy machine was successful in dismissing five of seven counts in a complaint against it.

Claims for breach of implied and express warranty as well as state law product liability and common law fraud claims against the manufacturer of electroconvulsive therapy (ECT) machines were dismissed for failure to state a claim. The court noted that there was no common law duty in Missouri to comply with federal requirements, and because various claims were based solely on a failure to comply with the requirements of the Food, Drug and Cosmetics Act, all such claims were impliedly preempted. Certain claims for negligence based on a failure to warn and strict liability for design and manufacturing defects, however, survived the motion to dismiss (Schnulle v. Somatics, LLC, January 21, 2022, Hamilton, J.).

Background. Somatics, LLC manufacturers, promotes and distributes ECT devices, one of which was used at Mercy Hospital in St. Louis, Missouri in 2015 and 2016 to treat a patient suffering from severe depression. The patient brought suit alleging that the treatments with the ECT device caused permanent neurological damage. The complaint alleges seven counts: negligence, strict liability, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, breach of express warranty, violations of the Missouri Merchandising Practices Act (MMPA) and fraud. Somatics moved to dismiss the complaint for failure to state a claim.

Negligence. Various negligence theories of liability were proposed including failure to provide adequate warnings, failure to adequately test and failure to comply with FDA rules and regulations. As there is no common law duty in Missouri to comply with federal requirements, and multiple of these claims are based solely on a failure to comply with the requirements of the Food, Drug and Cosmetics Act, all such claims are impliedly preempted. To the extent any negligence theory was reliant on preempted theories of negligence, those claims were dismissed.

The motion to dismiss those negligence claims that were based on a failure to warn was denied. The manufacturer argued that the learned intermediary doctrine meant that an inadequate warning to a physician could not be the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that an adequate warning would have communicated. The learned intermediary doctrine is typically asserted in Missouri caselaw as an affirmative defense to a failure to warn. The patient was not required to plead facts to negate such an affirmative defense to survive a motion to dismiss.

Strict liability. The motion to dismiss the patient’s claim under strict liability theory were also denied. To support her claim for manufacturing defect, the patient alleged that although she was prescribed ECT treatment for her depression, the ECT did not improve her symptoms. This was sufficient to allege claims for design and manufacturing defects.

Warranty. The patient failed to provide the required notice to the manufacturer of her injury and did not allege any particular purpose for which the goods were used that is different than their ordinary use. As such, with the patient’s agreement, the two counts of implied warranty were dismissed. The claim of breach of express warranty was dismissed for failure to state a claim because there was no allegation that any of the purported warranties were made to plaintiff or to her doctors.

MMPA and common law fraud. The MMPA and common law fraud claims failed to meet the Rule 9(b) heightened pleading standards and were dismissed. The complaint failed to identify what particular misrepresentations or concealments were made to the patient and her physician, who made those representations, and when those events occurred.

The case number is 4:21-CV-00109 JCH.

Attorneys: Bijan Esfandiari (Baum Hedlund, APC) for Janelle Schnulle. David F. Fanning (Johnson and Bell Ltd.) for Somatics, LLC.

Companies: Somatics, LLC

Cases: CaseDecisions FDCActNews MDeviceNews PLDeviceNews MissouriNews