United States: No Expert, No Diluted Warning, No Case

Last Updated: June 10 2019
Article by Michelle Yeary

So said the Connecticut state appellate court last week. It's a pretty simple equation. Like No shoes, no shirt, no service. No pain, no gain. No risk, no reward. In other words, you can't get one without the other. In Ferrari v. Johnson & Johnson, Inc., — A.3d —, 2019 WL 2167849 (Ct. App. Ct. May 21, 2019) that meant summary judgement for defendant affirmed on design defect, warning defect, and breach of warranty claims.

Plaintiff underwent spinal fusion surgery in which components of defendant's spinal device system were implanted including titanium rods. Id. at *1. About eight months later, a second surgery revealed that one of the rods had fractured. Following fact discovery, plaintiff elected not to serve any expert reports. When defendant moved for summary judgment, plaintiff argued that his design defect and breach of warranty claims did not require expert testimony and that there was a material issue of fact on failure to warn. Both the trial and appellate courts disagreed.

On a strict liability design defect claim, Connecticut applies a consumer expectation test. But there are two. Under the ordinary consumer expectation test "[t]o be considered unreasonably dangerous, the article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics." Id. at *5 (citation omitted). Expert testimony is not required to satisfy the ordinary consumer expectation test. But, the Connecticut Supreme Court has also made clear that that test only applies in situations where the "incident causing injury is so bizarre or unusual that the jury would not need expert testimony." Id. Res ipsa type cases.

The primary test in Connecticut is the modified consumer expectation test. Id.

Under the modified consumer expectation test, the jury would weigh the product's risks and utility and then inquire, in light of those factors, whether a reasonable consumer would consider the product design unreasonably dangerous.

Id. This test requires both "expert testimony on [the product] design and manufacture, as well as the feasibility of an alternative design." Id. Because Ferrari involved a complex medical device, it was not one of the "limited" situations where the ordinary consumer expectation applied. To prove a defect, plaintiff needed expert testimony to evaluate the device's risks and benefits.

The court also concluded plaintiff could not rely on a malfunction theory to prove product defect. The malfunction theory allows a plaintiff to establish a design defect by "rely[ing] on circumstantial evidence to support an inference that an unspecified defect attributable to a product seller was the most likely cause of a product malfunction when other possible causes of the malfunction are absent…." Id. at *9n.6. But plaintiff had no facts to support that a rod fracture was something that would occur in the absence of a product defect and was not the result of other reasonably possible alternative causes. Id. Here, the risk of a broken device in the case of a spinal non-union was warned about in the device's labeling. Id. at *3.

Plaintiff also couldn't prove causation without expert testimony. Plaintiff argued that expert testimony was not required to prove causation because "[t]here is no dispute that the defendants' product failed." Id. at *6. There was no dispute that the rod fractured, which isn't the same as establishing causation. The complexity of the device required expert testimony on causation. Id.

Moving on to failure to warn, the decision makes clear that plaintiff did not challenge the adequacy of the warning that accompanied the device. It warned of the risk of fracture in the absence of a spinal union. Id. Plaintiff's sole argument was that the warnings were nullified "when combined with the input and influence of [the] defendants' product representative." Id.

The court begins its analysis by applying both Comment (k) to § 402A of the Restatement (Second) of Torts and the learned intermediary doctrine. Id. at *7-8. Against that backdrop, the court considered plaintiff's claim that defendant's representative undercut defendant's adequate warnings. However, the sum total of plaintiff's allegations concerning defendant's representative were that he had "discussions and consultations" with plaintiff's surgeon "in the nature of technical assistance, including the product to be used in the surgery and the properties thereof, including the size and type." Id. at *7. This was not evidence that the representative "said or did anything inconsistent with the product's warnings." Id. at *9. That, combined with testimony from the surgeon that the ultimate decision on what components to use was his, id. at *7, supported the conclusion the representative had no impact on the surgeon's decision and therefore there was no genuine issue of fact as whether the learned intermediary doctrine applied to bar plaintiff's claim.

Two Nos for plaintiff equal one Yes for defendant. Summary judgment across the board.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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