Some women who have had a pelvic mesh product inserted have filed product liability lawsuits against manufacturers Johnson & Johnson and its subsidiary Ethicon Inc., alleging that the medical device is defective.

So many of these claims have been made that the lawsuits have been consolidated into an Ethicon MDL, or multidistrict litigation, to streamline the legal process.

Plaintiff Kathleen J. is one such woman who has filed a pelvic mesh lawsuit following an alleged pelvic mesh injury. Kathleen states she was implanted with the TVT-Obturator in July 2014 and June 2016.

Kathleen has raised claims of negligence, strict product liability for manufacturing defect, design defect, defective product and failure to warn, common law fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, breaches of express and implied warranties, violation of consumer protection laws, gross negligence, unjust enrichment, punitive damages, and discovery rule and tolling.

The plantiff is seeking a trial by jury for unspecified damages.

The Ethicon Lawsuit is Case No. 2:17-cv-03211, and is part of the Ethicon MDL, In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327, in the U.S. District Court for the Southern District of West Virginia.

Ethicon MDL Claims

The Ethicon pelvic mesh product is typically inserted to treat medical conditions such as stress urinary incontinence and pelvic organ prolapse.

It allegedly contains polypropylene mesh. Claims stated in the Ethicon MDL allege that although Ethicon claims the material is inert, evidence has shown that the mesh material is biologically incompatible with human tissue.

According to the Ethicon MDL claims, “the mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving defendants’ Pelvic Mesh Products.”

The pelvic mesh lawsuits allege that the polypropylene mesh degrades as the body’s immune response becomes heightened. As a result, the pelvic tissue also degrades and it can contribute to severe adverse side effects to the polypropylene mesh.

According to the Ethicon MDL, the plaintiffs allege that the defendants had a legal duty to ensure the “safety and effectiveness” of the pelvic mesh product. And by doing so, they had a legal duty to conduct “adequate and well controlled studies on their products prior to marketing.”

The plaintiffs also allege that the defendants “deliberately chose to manipulate the only studies that were conducted on their products and by so doing provided doctors and patients with false and misleading information about the safety and effectiveness of their pelvic mesh products.”

Claims in the Ethicon MDL state that the defendants deliberately relinquished performing thorough studies and “creating registries” that would have provided both consumers and doctors accurate information regarding, “the lack of proof of the safety and effectiveness of their pelvic mesh products.”

Contrary to the alleged marketing scheme conducted by the defendants, the plaintiffs allege that the pelvic mesh products have a high malfunction and failure rate, do not perform as indicated, require additional operations that are incapacitating and frequent, and cause serious and irreversible injuries.

FDA Concerns Over Ethicon MDL Pelvic Mesh Product

According to the Ethicon MDL lawsuit claims, the U.S. Food and Drug Administration issued a Public Health Notification that “described over 1,000 complaints (otherwise known as “adverse events”) that had been reported over a three-year period relating to pelvic mesh products.”

In July 2011, moreover, the FDA issued a Safety Communication titled: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” The safety communication had advised that while the agency conducted additional research and analysis, it still concluded that using a surgical mesh in transvaginal repair of pelvic organ prolapse was still an area of “continuing serious concern.”

New Jersey-based Johnson & Johnson is the parent company of Ethicon Inc. According to the Ethicon MDL lawsuit, Johnson & Johnson is the “world’s largest and most diverse medical device and diagnostics company.”