Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—D.N.M.: Product defect and failure-to-warn claims allowed to proceed against mesh device manufacturer, (Mar 24, 2017)

By Kathleen Bianco, J.D.

Certain claims by an individual allegedly injured by a defective surgical mesh product used to treat an abdominal hernia properly stated a claim upon which relief could be granted, a federal district court in New Mexico held in a decision granting-in-part and denying-in-part a motion to dismiss filed by the manufacturers. The manufacturers sought dismissal of the claims, which included negligence, strict product liability design defect, strict liability manufacturing defect, strict liability failure to warn, breach of warranty, and fraud, alleging that the injured party failed to state a claim upon which relief was available (Mims v. Davol, Inc., March 22, 2017, Armijo, M.).

The injured patient underwent a surgical procedure in 2005 in Colorado Springs, Colorado to repair an abdominal hernia, during which the Bard® Composix® Kugel® Medium Oval surgical mesh was implanted into her abdomen. The patient alleged that in 2011 she began feeling nauseated, and experienced severe abdominal pain and discomfort and fever. Her symptoms eventually led her to the emergency room at a hospital in New Mexico where she learned that she had intestinal perforations caused by the migration of the mesh product through her abdominal wall. Additionally, the mesh product created an inflammatory response in the patient’s body, entrapping nerves, eroding and sticking to nearby structures, and causing extreme pain, necessitating multiple surgeries. The patient alleged that as a result of the mesh product, she incurred the pain and inconvenience of these surgeries.

The patient asserted claims for negligence, strict liability product defect, strict liability manufacturing defect, strict liability failure to warn, breach of express warranty, breach of implied warranty, and fraud. The manufacturer moved to dismiss the complaint, alleging initially that they were untimely under Colorado’s statute of liability, and alternatively, if Colorado law did not apply, that they failed to state a claim upon which relief could be granted under New Mexico law.

Choice of law. A federal court hearing state law claims applies the choice-of-law rules of the forum state. Under New Mexico’s choice of law rules—based on the where the wrong occurred—the court determined that the claims by the plaintiff were governed by New Mexico law because that was where the adverse effects manifested.

New Mexico Products Liability Act. The New Mexico Products Liability Act recognizes product liability claims sounding in negligence and in strict liability. There are three categories of defects recognized in New Mexico: manufacture, design, and failure to warn. To prevail on a negligence claim, the plaintiff must establish a duty owed to plaintiff, a breach of that duty, a causal link between the breach and the injury, and damages. For the strict liability claims, the plaintiff must show that the product was defective when it left the manufacturer’s control, it was unreasonably dangerous because of the defect, a user was injured, and the defective product was the proximate cause of the injury. Based on this analysis, the manufacturer argued that the complaint must be dismissed because the patient failed to allege facts showing that the product defects had caused her injuries.

Upon review of the evidence, the court concluded that the allegations made by the patient have plausibly demonstrated causation for both the design defect and the failure-to-warn claims because the complaint asserted that but for the product defect, the patient would not have endured intestinal symptoms or had to undergo multiple surgical interventions. Furthermore, the complaint asserted that had the patient been warned of the actual risks associated with the product, she would have declined to have it implanted in her body. Thus, the manufacturer’s motions to dismiss the negligence and strict liability claims based on design defect and failure to warn and the breach of implied warranty were denied. However, the claims based on a manufacturing defect were dismissed because the patient failed to allege that the product had deviated from its intended design.

Remaining claims. The patient fraud claim was dismissed because it failed to satisfy the heightened pleading requirements applicable to fraud claims. The breach of express warranty claim failed because the patient failed to state an adequate claim. The remaining claims, which dealt with discovery rules, tolling, and punitive damages, were dismissed because they did not constitute independent claims.

The case is No. 2:16-cv-00136-MCA-GBW.

Attorneys: Jason S. Montclare (Law Office of Jason S. Montclare) for Rosemarie B. Mims. Alex Cameron Walker (Modrall, Sperling, Roehl, Harris & Sisk, PA) for Davol, Inc. and C.R. Bard, Inc.

Companies: Davol, Inc.; C.R. Bard, Inc.

Cases: CaseDecisions FDCActNews MDeviceNews PLDeviceNews SafetyNews NewMexicoNews