Law Street Media

Iowa Judge Rules For Medical Manufacturers’ Immunity From Duty to Warn

A medical professional with a stethoscope.

Cropped shot of an unrecognizable doctor holding s stethoscope

On October 16, Susan Kelly sued Ethicon Inc. and Johnson & Johnson, creators of a mesh implant, in the Northern District of Iowa on grounds that the defendants were negligent in giving warnings about the dangers of the mesh surgically placed inside Kelly, resulting in the implant extensively harming the plaintiff. The court granted summary judgment in favor of the defendants. 

Kelly received the mesh implant to stabilize a bladder injury. The plaintiff asserted that she received information about the risks of the implant surgery, but not about the risks of the implant itself. Kelly averred that the implant corroded, leaving the plaintiff with “depression, pelvic pain, dyspareunia…” and other injuries.

Kelly then sued the defendants for damages, arguing that the manufacturers’ failure to thoroughly warn the plaintiff of the mesh’s risks before the implant surgery operated as a negligent failure to warn that served as the proximate cause of the plaintiff’s injuries, in violation of Iowa state law. The court disagreed, explaining that Iowa uses the learned intermediary doctrine for claims of negligent duty to warn, which requires adequate warnings to the implanting physician and not the patient. 

The court further elucidated on the intermediary rule, explicating that when asserting a claim against a manufacturer for a negligent failure to warn, in order to establish proximate causation, “the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would not have used or prescribed the product.” However, the court continued, even if the manufacturer’s warnings were subpar, “(u)nder the learned intermediary doctrine, the manufacturer’s failure to provide the physician with adequate warnings of the risks associated with a particular … product is not the proximate cause of a patient’s injury if the … physician had independent knowledge of the risk that the adequate warning should have communicated … Thus, the causal link between a patient’s injury and the alleged failure to warn is broken when the … physician had ‘substantially the same’ knowledge as an adequate warning from the manufacturer should have communicated to him.”

The court concluded by ruling that given the aforementioned legal standard, the plaintiff’s claim failed as a matter of law due to Kelly failing to provide evidence that the doctor did or did not possess adequate knowledge of the risks of the vaginal mesh at the time of implantation. The court did acknowledge that the plaintiff requested leave to depose the doctor; however, the court ruled against the plaintiff, holding that no such deposition could take place given that the discovery period had passed. 

The plaintiffs were represented by Flint Law Firm. The defendants were represented by Shuttleworth & Ingersoll, Butler Snow, and Thomas Combs & Spann.

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