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Will Cook Medical Claims Soon Join Mesh Litigation in West Virginia?

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Depending on the U.S. Judicial Panel on Multidistrict Litigation (JPML), lawsuits alleging claims against Cook Medical, Inc. and their vaginal mesh products may soon join those consolidated in the Southern District of West Virginia. So far, the court is overseeing pre-trial proceedings in cases involving vaginal mesh products made by American Medical Systems, Boston Scientific, Coloplast, Ethicon (Johnson & Johnson), and C.R. Bard.

Some women have allegedly suffered injuries from Cook Medical products as well. The company is already defending more than 40 lawsuits involving its Surgisis and Stratasis vaginal mesh slings. On February 18, 2013, plaintiffs requested a motion for transfer of all federal cases to the vaginal mesh MDL. On March 13, 2013, Cook Medical submitted a response opposing any such consolidation.

Cook Medical Products Used to Treat Pelvic Organ Prolapse

According to its website, Cook Medical was founded in 1963, and focuses on medical research and developing products for endovascular therapy, general surgery, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, obstetrics and gynecology.

The Cook Medical Surgisis Biodesign mesh and Stratasis mesh products are designed for women suffering from pelvic organ prolapse (POP). The condition results when pelvic muscles and tissues become weakened and stretched due to age, surgery, and multiple childbirths, and can no longer completely support pelvic organs like the bladder, bowel, and uterus. These organs then drop or fall into the vaginal wall. Resulting symptoms can include pain, pressure, and stress urinary incontinence (SUI).

Cook Medical mesh is used during surgery to correct POP or SUI, providing support to the pelvic organs to help keep them in place and reduce symptoms. Some women, however, have suffered serious injuries including erosion of the mesh, infection, pelvic pain, urinary problems, pain during sexual intercourse, and mesh extrusion. Surgeries to repair these complications are sometimes numerous and may be only partially successful.

Cook Products May Increase Risk of Inflammation

When Cook initially launched the Surgisis Biodesign bladder sling, the company marketed it as being more effective than other implants because it was made from the small intestines of pigs rather than from synthetic materials. Post-marketing studies, however, suggest that mesh made of pig intestines may actually increase the risk of inflammatory side effects.

In 2011, the FDA warned about the serious nature of vaginal mesh complications, and stated that such side effects are not rare. Plaintiffs who petitioned the JPML for consolidation of Cook vaginal mesh lawsuits allege injuries from the following products:

  • Surgisis Biodesign Tension-Free Urethral Sling
  • Surgisis Biodesign Anterior Pelvic Floor Graft
  • Surgisis Biodesign Posterior Pelvic Floor Graft
  • Cook Urological Stratasis Urethral Sling
  • Stratasis Tension Free Urethral Sling

Lawsuits involving complaints against the manufacturer of these products have been filed in nine different U.S. District Courts. Mesh lawyers expect the number of complaints to continue to increase.

Cook Opposes Centralization

In their response to the motion to consolidate, Cook argues that 27 of the 42 cases cited by plaintiffs have already been dismissed, leaving only 15 pending—not enough to justify a new MDL. They add that their products are not "surgical mesh" as defined by the FDA, and thus they don’t belong in litigation with other manufacturers of pelvic mesh. The JPML is expected to hear arguments on the possible inclusion of Cook Medical claims on May 30, 2013.