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Learned Intermediary Doctrine Applied to Patient’s Failure-to-Warn Claim Despite Assertion That Product Rep Had Influenced Treating Physician

August/September 2019

A Connecticut appellate court held that the learned intermediary doctrine, under which a manufacturer has no duty to warn a patient directly of a product’s dangers where adequate warnings were provided to the patient’s prescribing physician, applies to a spinal surgery patient’s failure-to-warn claim arising out of a fractured stabilizing titanium rod.

Here, Raymond Ferrari underwent surgery in which surgeon Paul Schwartz implanted components of the Synthes Matrix spinal system, including stabilizing titanium rods used to fuse Ferrari’s spine. The rod fractured after the surgery, however, necessitating another procedure. Ferrari sued Johnson & Johnson, Inc., and Synthes, Inc., alleging failure to warn, design defect, and breach of express and implied warranties. The defendants moved for summary judgment, arguing, in part, that the learned intermediary doctrine barred the plaintiff’s claims. The trial court granted the motion.

Affirming, the appellate court considered the plaintiff’s argument that the learned intermediary doctrine did not bar his claim because the warnings in the titanium rod’s product insert, while sufficient in and of themselves, were inadequate when combined with the feedback and influence of the product’s representative, who consulted with Schwartz before the first surgery. The court found that under Comment k to the Restatement (Second) of Torts §402A, a manufacturer of an unavoidably unsafe product is not strictly liable for adverse consequences resulting from the product’s use where the product is accompanied by adequate directions and warnings and is not defective or unreasonably dangerous.

Citing case law, the court added that under Connecticut law, the learned intermediary doctrine applies to cases involving implantable medical devices. Here, the court found, the plaintiff failed to demonstrate that the titanium rod representative made statements to Schwartz contradicting the product’s manual or acted in a way that was inconsistent with the manual. Thus, the plaintiff failed to provide an adequate evidentiary foundation showing the existence of a material issue of fact regarding application of the learned intermediary doctrine to his failure-to-warn claim.

Accordingly, summary judgment for the defense was proper.

Citation: Ferrari v. Johnson & Johnson, Inc., 2019 WL 2167849 (Conn. App. Ct. May 21, 2019).