Johnson & Johnson and Ethicon face a new transvaginal mesh lawsuit from a Texas woman alleging that their mesh products are defective and dangerous, leading to harmful complications.

Plaintiff Joan C. recently filed a transvaginal mesh lawsuit against Ethicon and Johnson & Johnson, alleging that the Prolift and TVT-Obturator mesh products used in her 2007 repair surgery were defective.

Since 2002, Ethicon and Johnson & Johnson have produced a series of mesh products used to treat pelvic organ prolapse and stress urinary incontinence. Products developed and sold by the defendants include Prolene Mesh, Gynemesh, Prolift, Prosima, Prolift+M, and TVT. These mesh products allegedly come in a kit including the surgical mesh, tissue fixation anchors, and insertion tools.

Transvaginal Mesh Lawsuit Alleges Materials Incompatible

The Ethicon mesh products contain polypropylene mesh — a material that according to the transvaginal mesh lawsuit is scientifically shown to be incompatible with human tissue. Polypropylene mesh can cause an immune response and adverse reactions, as has allegedly been reported with Ethicon pelvic mesh products.

In 2008, after receiving over 1,000 complaints from consumers regarding pelvic mesh products in a three year period, the U.S. Food and Drug Administration (FDA) reported that complications associated with vaginal mesh may be a widespread issue, according to the transvaginal mesh lawsuit. Although the notice from the agency did not specifically name Ethicon and Johnson & Johnson, the lawsuit alleges that “a review of the FDA’s MAUDE database indicates that the defendants are one of the manufacturers of the pelvic mesh products that are the subject of the notification.”

In 2011, the FDA updated the public on the issue of pelvic mesh products, stating that complications with the products were “not rare” and an area of “continuing serious concern”. In the same year, the American College of Obstetricians & Gynecologists and the American Urogynecologic Society released a joint opinion.

“There are increasing reports of vaginal pain associated with changes that can occur with mesh (contraction, retraction, or shrinkage) that result in taut sections of mesh […] Some of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.”

Joan claims that Ethicon and Johnson & Johnson failed to acknowledge scientific evidence which showed that their products were defective, and “concealed the defects, suppress[ed] reports, fail[ed] to follow through on FDA notification requirements, and fail[ed] to disclose known defects to physicians.” Joan also alleges that the defendants had a duty to consumers and physicians to disclose any defects associated with their products for the sake of public safety, a duty they allegedly failed to complete.

Joan accuses the defendants of negligence, manufacturing defect, failure to warn, defective design, fraud, fraudulent concealment, negligence misrepresentation, breach of warranties, violation of consumer protection laws, and unjust enrichment. The transvaginal mesh lawsuit seeks compensatory damages, punitive damages, economic damages, restitution, disgorgement, court costs, and attorneys’ fees.

The Transvaginal Mesh Lawsuit is Case No. 2:18-cv-01191 and is part of the Transvaginal Mesh MDL, In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327, in the United States District Court for the Southern District of West Virginia.