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Florida Couple Files Pelvic Mesh Lawsuit Against 10 Manufacturers

In a pelvic mesh lawsuit filed against ten manufacturers of transvaginal mesh, the plaintiffs argue that the defendants acted with oppression, fraud, malice and deliberate disregard for the foreseeable  harm caused by their products. The case was filed by a Florida husband and wife who are demanding compensatory and punitive damages, plus restitution of profits, costs of litigation and any other damages the court deems equitable.

The lawsuit lists C.R. Bard, American Medical Systems, Sofradim Production SAS, Tissue Science Laboratories Limited, Boston Scientific, Ethicon, Johnson & Johnson, Coloplast, and Mentor Worldwide as defendants. The case was filed in the U.S. District Court, Eastern District of Pennsylvania on July 12, 2013.

Details and allegations of pelvic mesh lawsuit

Court documents state that the wife suffered from stress urinary incontinence (SUI) and pelvic organ prolapse (POP) – two conditions that warranted her surgical treatment with vaginal mesh. On December 10, 2001, the claimant was implanted with several pelvic mesh products that were designed and manufactured by the defendants. Allegations state that though the woman used the mesh implants as prescribed, they were defective in nature, causing her to sustain foreseeable complications, including but not limited to:

  • Emotional and physical pain and suffering
  • Urinary incontinence problems
  • Recurrence of her pelvic organ prolapse
  • Diminished quality of life
  • Permanent injuries that require ongoing medical attention

Like the thousands of other women who’ve filed a pelvic mesh lawsuit, the Florida plaintiff claims that as a direct result of her mesh implants, she and her husband have suffered tremendously, both in their relationship with intimacy issues, as well as financial losses due to her continued obligation for medical care.

Defendants failed to conduct research confirming pelvic mesh safety

Considered a Class II medical device, the defendants’ bladder slings and pelvic mesh products have been linked to a slew of severe transvaginal mesh injuries and complications, according to the lawsuit. Emerging clinical evidence suggests that materials used in some vaginal mesh implants are incompatible with human tissue, contributing to serious adverse reactions. In addition, states the complaint, mesh has a propensity to migrate within the surrounding tissue, potentially causing irreparable nerve damage.

Other pelvic mesh complications reported to the FDA include adhesions, infection, inflammation, fistula, painful sexual intercourse, organ perforation and blood loss. Most of these are a consequence of extrusion or mesh erosion, where the implant erodes into the adjacent tissue.

In 2011, the FDA published a safety communication that highlighted the inherent risks posed to patients who received transvaginal mesh. After analyzing reported adverse events, the agency determined that serious complications with the use of surgical mesh were not rare, and that transvaginal POP repair with mesh offers no benefits when compared to traditional surgery.

Pelvic mesh deemed “unreasonably dangerous” by plaintiff

The claimants adopt several causes of action in their complaint, and the husband also seeks additional damages for loss of spousal consortium.

The defendants are charged with the following counts:

  • Strict Liability – failure to warn
  • Strict Liability – defective design
  • Strict Liability – defective manufacture
  • Negligence
  • Negligence per se
  • Fraud
  • Fraud by concealment
  • Negligent misrepresentation
  • Breach of express and implied warranties

Though the pelvic mesh lawsuit was filed in Pennsylvania district court, it may be eligible for transfer as a tag-along action to the ongoing consolidated vaginal mesh litigation proceeding in West Virginia federal court, where six MDLs have been formed to handle more than 20,000 lawsuits against mesh manufacturers.