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1st Bellwether Trial In Kugel Patch MDL Ends In Defense Verdict

PROVIDENCE, R.I. — (Mealey's) The first bellwether trial involving the Kugel surgical mesh patch ended in a defense verdict on April 14 when a Rhode Island federal jury found that the plaintiff had not proven that his injuries were directly caused by or contributed to by negligent design of the device (In Re:  Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842; John Whitfield v. Davol, Inc., et al., No. 07-1918, D. R.I.).

A nine-member jury in the U.S. District Court for the District of Rhode Island, where the Kugel mesh hernia patch multidistrict litigation is centralized, found that plaintiff John Whitfield did not prove that the CK (Composix Kugel) patch was defectively designed or inadequately labeled or that defendants C.R. Bard Inc. and subsidiary Davol Inc. were negligent in labeling the device.

The jury did find that Whitfield had proved that the defendants’ design of the patch was negligent.

Having answered “yes” to one of the first four questions on the verdict form, the jury then found that Whitfield had not proved damages caused by or contributed to by the patch.

Whitfield’s claims for actual damages and punitive damages were bifurcated.  After the jury returned its verdict on actual damages, Chief Judge Mary M. Lisi ruled that there was insufficient evidence to support a claim for punitive damages.

Judge Lisi also denied the defendants’ oral and written motions for judgment as a matter of law.

The trial began March 29.  The jury began deliberating April 12.

The patch is a piece of surgical mesh attached to a ring of polyethylene terephthalate plastic.  The ring can be folded for insertion through incisions, then its “memory” causes the ring to spring open, deploying the mesh over the hernia for surgical attachment. 

In 2004, Whitfield underwent hernia repair surgery in which a Kugel surgical mesh patch was implanted, according to his complaint.  Whitfield alleged that the ring broke inside his abdomen, causing a bowel obstruction, severe abdominal pain, swelling and disfigurement.  He noted that certain Kugel mesh products were later recalled because of ring breaks.

Whitfield claims that the Kugel patch was defective and unreasonably dangerous and caused his injury and that Davol and Bard failed to warn doctors and patients of the risk of ring breakage.

[Editor's Note:  Full coverage will be in the May 6 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the verdict form and jury instructions are available at or by calling the Customer Support Department at 1-800-833-9844.  Verdict form.  Document #28-100506-001V.  Jury instructions.  Document #28-100506-002J.  For all of your legal news needs, please visit]
Download the verdict form now: - Document #28-100506-001V

Download the jury instructions now: - Document #28-100506-002J

For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at