Products Liability Law Reporter

A federal district court held that a plaintiff may proceed with her negligent production, breach of implied warranty, and gross negligence claims against the manufacturer of an implant used to treat musculoskeletal conditions. The court also denied without prejudice the defendant’s motion to dismiss the plaintiff’s failure-to-warn claim.

Alyssa Osos was born with a birth defect that necessitated limb lengthening surgery. She was implanted with the stainless steel Precice Stryde limb lengthening device (the Stryde nail), manufactured by NuVasive, Inc. This led to complications, including heavy menstrual bleeding and reproductive organ pain. Osos later was told that the Stryde nail had failed. She required revision surgery but still suffered from retained fragments around the implantation site and surrounding tissues. Follow-up testing showed that Osos had toxic chemicals in her liver, tibial bone damage, and chromium toxicity in her blood.

The FDA later warned the public of potential problems with NuVasive Precice devices used to treat limb length discrepancy, including pain in the areas in contact with the Stryde nail.

Osos sued NuVasive, Inc., alleging negligent production, breach of implied warranty, gross negligence-actual knowledge, and failure to warn. The defendant moved to dismiss.

Denying the defendant’s motion, the district court explained that to survive a motion to dismiss, a complaint must contain factual matter sufficient to state a claim for relief that is plausible on its face. Citing case law, the court added that factual allegations must do more than create speculation or suspicion of a legally cognizable claim. They must show the plaintiff’s entitlement to relief, the court said.

In Michigan, the court found, negligence and breach of warranty claims are distinct causes of action. To prove negligence, a plaintiff must show the defendant’s conduct was unreasonable, while an implied warranty claim focuses on the fitness of a product, irrespective of a defendant’s alleged conduct. A negligent production claim requires a plaintiff to prove that the product was negligently manufactured and reached the plaintiff in the same condition that it was in when it left the manufacturer, and that the defect proximately caused the plaintiff’s injury. For an implied warranty claim, the court added, a plaintiff must show that the product was transferred from the manufacturer’s possession while in a defective state and that the defect resulted in personal injury or property damage.

The court rejected the defense argument that the plaintiff had failed to plead elements of her claim with supporting facts, finding that the complaint incorporated factual allegations into each count and that the plaintiff alleged facts to establish the defendant’s liability, including that there were flaws in the choice of metal for the nail. Citing case law, the court found that the plaintiff need not describe the alleged defect in detail.

The court declined to dismiss the plaintiff’s failure-to-warn claim based on the learned intermediary doctrine. The court, in a separate decision, certified to the Michigan Supreme Court the questions of (1) whether, under previous case law, the court held that the doctrine does not exist in the state and will not exist until the legislature creates it; and (2) under what circumstances the doctrine applies if it does exist in Michigan.

Citation: Osos v. NuVasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024).

Plaintiff counsel: Michael L. Jones, Detroit.