Juliar v. Ethicon, Inc.

Background

Ethicon, Inc. and Johnson and Johnson developed, manufactured, marketed, and sold Proceed Mesh for hernia repair. Jason Juliar was implanted with the mesh on September 14, 2016. During a February 7, 2017 revision procedure, his physician observed that the mesh had ruptured, causing re-herniation and strangulation, with resulting necrosis of the small bowel. The physician performed an emergency bowel resection and other procedures.

Juliar alleged that the mesh was unreasonably dangerous because of defects in its design and that the defendants knew about those defects but concealed information from his physician, the hospital, and the federal Food and Drug Administration. His amended complaint asserted negligence; strict liability for manufacturing defect, failure to warn, and design defect; breach of express warranty; breach of implied warranties; and a claim under the New Jersey Consumer Fraud Act.

Legal standard and products-liability framework

The defendants moved to dismiss under Rule 12(b)(6), which permits dismissal when a complaint does not plead enough factual matter to state a plausible claim for relief. Applying Minnesota law, the court explained that negligence and strict-liability theories in this products-liability case are merged into a single products-liability theory. The court therefore analyzed the design-defect, manufacturing-defect, and failure-to-warn theories rather than treating negligence and strict liability as separate theories for those defects.

Manufacturing defect

The court held that Juliar did not plead enough facts to support a manufacturing-defect claim. He alleged generally that the mesh had a manufacturing defect and differed from the defendants’ intended result or other identical units, but he did not identify the specific manufacturing flaw, explain how the mesh differed from its intended result, or adequately connect his injuries to that flaw. The motion to dismiss was therefore granted as to this claim.

Failure to warn

Minnesota’s failure-to-warn claim requires allegations that the defendant knew or had reason to know of the product’s dangers, that the warnings were inadequate, and that the inadequate warning caused the injury. Minnesota also follows the learned-intermediary doctrine, under which a medical-device manufacturer generally must warn the physician rather than the patient.

The court found Juliar’s allegations sufficient at the pleading stage. He alleged that the mesh ruptured, that the defendants knew of an increased risk of rupture, that the instructions and other warnings did not disclose that complication, and that he and his physician would not have agreed to use the product if the risk had been disclosed. The court denied the motion to dismiss the failure-to-warn claim. It also stated that the defendants’ argument concerning the full contents of the instructions for use was better addressed at summary judgment because that document was not part of the record before the court.

Design defect

The court also held that Juliar adequately pleaded a design-defect claim. He alleged that gamma irradiation, which the defendants used to sterilize the mesh and convert part of it into a dissolvable compound, reduced the mesh’s tensile strength and made it embrittled and weak. He further alleged that this design existed when the mesh left the defendants’ control, created an unreasonably high risk of rupture, and caused the rupture and resulting injuries. The motion to dismiss was denied as to Count VI.

Negligence

The court ruled that testing, failure to test, data analysis, safety improvements, post-market surveillance, instructions, advertising, promotion, and continued distribution could support design-defect or failure-to-warn claims, but could not be asserted as independent negligence causes of action under the allegations presented. The motion to dismiss was denied as to Count I to the extent it asserted negligence based on design defect and failure to warn, and granted in all other respects as to that count.

Warranty claims

The defendants argued that the warranty claims were untimely under Minnesota’s four-year period for breach-of-warranty claims and also argued that Juliar had not provided the required notice of breach. Juliar conceded that he had not provided pre-suit notice. The court held that the warranty claims must be dismissed, and the motion was granted as to Counts IV and V.

New Jersey Consumer Fraud Act and choice of law

The court determined that Minnesota and New Jersey law conflicted because the states’ consumer-fraud laws differ regarding omissions and available damages. It concluded that Minnesota had significant contacts with the dispute: Juliar was a Minnesota resident, the mesh was implanted in Minnesota, and he received a substantial portion of his medical care there. The court therefore applied Minnesota law and dismissed the New Jersey Consumer Fraud Act claim. The motion was granted as to Count VII.

Punitive damages and disposition

The court stated that Juliar had not complied with Minnesota’s procedure for seeking punitive damages and that punitive damages were derivative of the other claims. It therefore dismissed the punitive-damages claim as well.

The court ordered that the defendants’ motion to dismiss was DENIED in part and GRANTED in part. It was denied as to Count I to the extent it asserted negligence based on design defect and failure to warn, and denied as to Counts III and VI. The motion was granted in all other respects.