*Update* Cook Medical Transvaginal Mesh Bellwether Trial Will Not Begin in May

Jane Akre
March 16, 2015
cook website

**UPDATE - The cases of Ailey and Lingo are dismissed and will not be pursued. The next two cases scheduled, Hovey and Watkins were also dismissed with prejudice by the plaintiffs on April 16th.

See the So. District of WV Cook MDL page here.

There are no further Cook Medical product liability trials scheduled.

These would have been the first product liability cases naming mesh manufacturer - Cook Medical. The rest of story stands. The litigation alleges the Cook mesh product - a porcine mesh- has a high recurrence rate, i.e. it doesn't work in many women, the pig intestine leads to a latent inflammatory response in some women, infections, scarring which causes pain and dyspareunia in some women. Like its polypropylene cousin, the pig mesh is implanted transvaginally, meaning it is going through a clean-contaminated field.

So far in pelvic mesh litigation, the name of mesh manufacturer Cook Medical has not been heard. That is about to change.

The federal court in Charleston, West Virginia, home of more than 70,000 product liability cases, is about to start a series of trials claiming defendant, Cook Medical, produced a defective product that has injured women. Charleston was chosen by a panel of federal judges to attempt to move similar pelvic mesh cases through the courts under one judge. Cook is one of seven defendants facing bellwether trials in this jurisdiction to test legal theories.

Pamela Ailey v. Cook Group, Inc.; Cook Incorporated; Cook Biotech, Inc; Cook Urological Incorporated; Cook Medical Inc., of Bloomington, Indiana, (case number is 2:13-cv-18888) is set to begin April 20, 2015. Lingo v Cook Inc, et al. 2:13-cv-20359 is the backup case that will be tried only if Ailey is dismissed or otherwise not ready for trial.

Ms. Ailey is a resident of Pleasant, Iowa. Her mesh was implanted in Huntsville, Alabama.

Cook is one of the smaller mesh manufacturers. At this writing, there are 377 product liability cases filed against Cook Medical, Inc. that have been consolidated from around the country to this federal court in West Virginia before The Honorable Judge Joseph Goodwin.

Judge Joseph R. Goodwin, overseeing bellwether mesh

Judge Joseph R. Goodwin, overseeing bellwether mesh trials

The action claims negligence, negligent misrepresentation, negligent infliction of emotional distress, breach of express warranty (promising safety, withholding information), a failure to warn her physician about the risks associated with the product, gross negligence for the rights of others, violation of consumer protection laws (for Iowa and Alabama, her implanting state), unjust enrichment, and knowingly marketing a dangerous medical device (strict liability). Ailey also asks for punitive damages to send a message to the company.

Her complaint is written by Erin Copeland of Fibich, Hampton, Leebron, Briggs and Josephson, LLP, Houston, TX . See it here:

Ailey v Cook April 2015 Complaint


biodesign logo

Pamela Ailey was implanted with a Surgisis Posterior Graft July 29, 2009 to treat SUI (stress urinary incontinence) and POP (pelvic organ prolapse). As a result, she claims she's experienced mental and physical pain, permanent injury, physical deformity, corrective surgery, financial loss and lost wages.

This is not only the first bellwether trial for Cook Medical but is the first trial for a mesh that claims it is made from a material other than polypropylene, the polymer-based synthetic so common in hernia and pelvic meshes. Cook claims to be advancing the next generation of technology that include biologic/ device design. See more here.

Cook claims its product are biomaterials from natural tissue sources using a porcine small intestinal submucosa (SIS) and therefore are resistant to infection and result in complete remodeling. The inflammatory response is limited to the area where synthetic sutures are/were utilized during surgery, according to Cook promotional materials.

Surgisis Biodesign Urethral Sling (510(k) approval September 23, 1999), 510(k) approval here

Surgisis Biodesign Tension-Free Urethral Sling (approved 510(k) April 9, 2002)

Surgisis Biodesign Anterior Pelvic Floor Graft

Surgisis Biodesign Posterior Pelvic Floor Graft

Surgisis Biodesign Vaginal Erosion Repair Graft (all cleared 510(k) on September 23, 1999)

All were derived from hernia products. Cook began in 1999 to market and sell products for POP and SUI.



Defendants Claim

The Defendants called it “A breakthrough technology, it incorporates the best attributes of a biologic graft –resistant to infection and complete remodeling – with the added benefits of moderate price, ease of use and widespread availability.” Here

Cook claims here of its Biodesign products “And unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.”

The Ailey complaint notes studies that support the product. Studies also show Surgisis Gold was inferior in aiding in the growth of fibrinolytic activity of human mesothelial cells; integration was insufficient; foreign body reaction was pronounced and shrinkage was excessive.

This is one of four cases being prepared for trial. Others include:

Connie Jean Lingo 2:13-cv-20359

May 18, 2015 - Toni Watkins 2:13-cv-20370

June 8, 2015 - Mary Hovey 2:13-cv-18900

Last year, U.S. Magistrate Judge Cheryl Eifert ordered Cook, and two related defendants, may not “discuss any aspect of the care and treatment of a plaintiff with the plaintiff’s former or current treating physician, regardless of whether the physician is an expert or a consultant,” she said. A treating physician may not be retained as an expert in these cases to opine on their own patient unless, “those opinions were documented by the treating physician in the patient’s medical record before the physician was retained by Cook to act as an expert,” Eifert said.

Of the seven mesh manufacturers, Johnson & Johnson (Ethicon) has suffered a series of losses in recent cases and settling cases for an undisclosed amount in some instances. Boston Scientific was successful in a couple of cases in a Massachusetts courtroom before it lost a monumental $73 million case last year in Dallas. That amount was later cut in half due to tort reform but still sets a record for transvaginal mesh litigation. AMS (American Medical Systems) is in the process of settling its cases. #

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