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Today’s case is Thelen v. Somatics, LLC, 2023 WL 3338221 (M.D. Fla. May 5, 2023).  It is a straightforward products liability case involving a medical device used in electro-convulsive therapy.  Plaintiff alleges the device caused a permanent neurological injury, memory loss, and brain damage and that the manufacturer is liable for failure to warn, design defect, manufacturing defect, and breach of express warranty under Nebraska law.  Defendant moved for summary judgement, and while certain of defendant’s arguments were not adopted by the court, in the end plaintiff was left with only a portion of his failure to warn claim.

The court found there were genuine factual disputes as to the statute of limitations, id. at *2, and whether the learned intermediaries had independent medical knowledge of the alleged risks.  Id. at *3. The court also determined that plaintiff had admissible expert evidence on both general and specific medical causation.  Id. at *3-4.  But, on the individual claims, plaintiff’s path to trial was full of hurdles he could not overcome.

On his negligent failure to warn claim, plaintiff alleged that defendant failed to adequately investigate reports of serious adverse events, failed to report adverse events to the FDA, and violated FDA’s reporting and record keeping requirements.  The court found the latter two preempted.  The duty to report to the FDA is a duty that runs to the FDA.  It is not a duty owed to plaintiff under state law.  Id. at *5.  On that basis, the court distinguished an alleged failure to investigate as a duty grounded in state tort law, not dependent on any federal requirement. 

Plaintiff’s remaining three claims were all dismissed in their entirety.  Plaintiff alleged a manufacturing defect claim but adduced no evidence that the device used to treat him deviated from the device’s intended design or specifications.   On breach of express warranty, plaintiff pointed to statements made on defendant’s website, but neglected to provide any evidence that anyone relied on those statements or even looked at the website.  Absent reliance, that claim also failed.  Finally, Nebraska applies the “consumer expectations” test to claims for design defect – is the product more dangerous than the ordinary consumer would anticipate.  Plaintiff argued that the relevant consumers are patients, not physicians and the court agreed.  However, plaintiff offered no evidence to establish the expectations of the ordinary consumer.  Plaintiff offered only his own expectations, “which may or may not reflect the ordinary knowledge common to the community.”  Id. at *6. 

Overall, defendant won more than it lost and plaintiff is left with only a part of his warning claim to take to trial.