Cook Opposes Centralization of Surgisis Biodesign Mesh in MDL

Cook Medical, the makers of Surgisis Biodesign vaginal mesh and bladder slings, is opposing efforts to consolidate all product liability lawsuits filed in the federal courts system. 

Oral arguments on whether to create a Cook Surgisis Biodesign mesh MDL are scheduled to be heard on May 30, by the U.S. Judicial Panel on Multidistrict Litigation (JPML).

The panel of federal judges will decide whether the Cook Surgisis mesh litigation should be centralized for coordinated pretrial proceedings before the same judge who is presiding over thousands of vaginal mesh lawsuits filed by women throughout the country.

In a response (PDF) filed late Last month, Cook Biotech and other subsidiaries of Cook Medical indicated that it opposes the formation of a multidistrict litigation (MDF) for all Surgisis Biodesign mesh lawsuits. The manufacturer indicates that most of the complaints identified by plaintiffs in their original motion have already been dismissed, and argues that the remaining cases do not justify the formation of consolidated proceedings. In addition, Cook argues that their vaginal mesh products are different from synthetic surgical mesh involved in the other litigation.

Dispute Over Size of Cook Surgisis Biodesign Litigation

In the federal court system, there are already five different vaginal mesh MDLs pending before U.S. District Judge Joseph R. Goodwin in West Virginia, involving products manufactured by C.R. Bard, American Medical Systems (AMS), Boston Scientific, Ethicon and Coloplast Corp., respectively.

In a Motion to Transfer (PDF) filed in February, a group of plaintiffs requested that a sixth MDL be created before Judge Goodwin for Cook bladder sling cases, including injuries associated with the use of the Surgisis Biodesign Tension-Free Urethral Sling, Surgisis Biodesign Anterior Pelvic Floor Graft, Surgisis Biodesign Posterior Pelvic Floor Graft, Cook Urological Stratasis Urethral Sling or Stratasis Tension Free Urethral Sling.

That filing identified at least 42 surgical mesh lawsuits filed against Cook in 9 different U.S. District Courts throughout the country. All of the lawsuits involved similar allegations that plaintiffs suffered severe complications from the Surgisis mesh or Stratasis slings.

In their response, Cook Medical indicates that 27 of the 42 cases cited by plaintiffs have either been dismissed entirely, or the company has been removed as a defendant, leaving only 15 cases that would qualify for inclusion in any Cook Medical mesh MDL. The company claims there is no reason to create an MDL for just 15 cases, when judges dealing with other vaginal mesh litigation already are overseeing MDLs that involve a total of 13,557 claims; a number that is still growing.

Transferring federal lawsuits filed throughout the country to one U.S. District Court is designed to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

According to the latest updated (PDF) provided by the U.S. JPML on March 5, Judge Goodwin’s West Virginia court is currently presiding over 1,956 Bard Avaulta lawsuits; 3,974 AMS vaginal mesh lawsuits; 2,317 Boston Scientific pelvic mesh lawsuits; 3,798 Ethicon Gynecare mesh lawsuits and 188 Coloplast bladder sling lawsuits.

Warnings, Complaints Led to Lawsuits

The litigation has increased dramatically over the past two years, following an FDA warning issued in July 2011 about problems with vaginal mesh products submitted to the agency’s adverse event reporting system.  After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.

Cook has indicated in their response that the Biodesign Surgisis products are not “surgical mesh,” as defined by the FDA. Unlike other transvaginal mesh products, Cook’s Biodesign products are biologic grafts made from pig small intestinal submucosa, not metallic or polymeric screens. Therefore, the company argues that the facts to be presented in the litigation are “dramatically and materially different” from other synthetic mesh products centralized before Judge Goodwin.

The MDL hearing comes as some of the first vaginal mesh lawsuits are starting to go to trial.  In July 2012, a California state court awarded $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh, and in February, a New Jersey state court jury awarded $11.1 million in compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.

In the federal court system, Judge Goodwin has scheduled a series “bellwether” trials that will begin in the coming months, with the first case beginning in June, involving problems with Bard Avaulta mesh.  That case will be followed by at least three trials expected to begin in December 2013, involving similar lawsuits over products manufactured by AMS, Ethicon and Boston Scientific.

These early test cases are designed to help the parties gauge how juries are likely to respond to similar evidence and testimony that will be offered throughout the litigation and may help facilitate vaginal mesh settlement agreements.