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CHARLESTON, W.Va. — (Mealey’s) A West Virginia federal jury on Sept. 5 returned a $3.27 million verdict in the second Ethicon Inc. multidistrict litigation pelvic mesh bellwether trial (Jo Huskey, et al. v. Ethicon, Inc., et al., No. 2:12-5201, S.D. W.Va.).
After deliberating for less than half a day, the jury in the U.S. District Court for the Southern District of West Virginia found that Jo Huskey proved her claims of strict liability defective design, strict liability failure to warn, negligent design and negligent failure to warn. The panel awarded Huskey $100,000 for past medical expenses, $470,000 for past pain suffering, mental anguish, disability or loss of enjoyment of life and $2.5 million for future pain, suffering, mental anguish, disability or loss of enjoyment of life.
The jury awarded Huskey’s husband, Allan Huskey, $200,000 for loss of consortium.
Judge Joseph R. Goodwin, who presided over the eight-day trial, previously denied Huskey’s claim for punitive damages.
Ethicon Will Appeal
“The verdict is disappointing and we believe we have strong grounds for appeal,” said Ethicon spokesman Matthew Johnson in a Sept. 8 statement. “Ethicon’s TVT-O midurethral sling was properly designed, and Ethicon acted appropriately and responsibly in the research, development and marketing of the product. We have always made patient safety a top priority and will continue to do so.
“TVT-O has been deemed safe and effective by regulators and practitioners alike, and it continues to be an important option for treating physicians to offer to women suffering from SUI [stress urinary incontinence],” Johnson said.
The trial began Aug. 25 and the jury was charged late Sept. 4. The verdict was returned late morning Sept. 5.
In February 2011, Huskey, now 55, was implanted with a TVT-O pelvic mesh device made by the Ethicon Inc., a division of Johnson & Johnson, to treat stress urinary incontinence. Huskey awoke from surgery with bilateral hip pain.
In March 2011, Huskey experienced vaginal bleeding and said intercourse was painful. Her implanting surgeon found mesh exposed in her vaginal cavity and performed a procedure in which she oversewed the exposed mesh.
By July 2011, the mesh was still exposed and Huskey was referred to another doctor. In November 2011, the second doctor excised the mesh and repaired the vagina.
By April 2012, Huskey was again experiencing pain and was treated with steroid and local anesthetic injections and underwent physical therapy. She also was treated with seven drugs and experienced side effects with those. Her stress urinary incontinence has reoccurred.
Huskey complains of constant pelvic and vaginal pain and says she is prevented from working, exercising or having intercourse.
At the close of evidence, Ethicon renewed its motion for judgment as a matter of law. It argues that Huskey’s implanting surgeon was warned of the complications Huskey experienced and that Huskey did not show that different warnings would have changed the doctor’s decision to use the TVT-O device.
Benefit Outweighs Risk
Ethicon also argues that Huskey failed to show that the risk of the TVT-O outweighs its utility. It argues that a design defect was not the proximate cause of Huskey’s alleged injury.
Finally, Ethicon argues that Huskey’s claims are preempted by federal law because the device used Prolene polypropylene filaments that were approved as sutures by the U.S. Food and Drug Administration.
The trial was the second involving an Ethicon pelvic mesh device. In February, Judge Goodwin granted judgment as a matter of law in the first trial involving a Gynecare TVT device.
In February, an MDL magistrate judge found that Ethicon failed to preserve documents that it could reasonably anticipate would be subject to litigation.
In April, a Texas state court jury awarded a plaintiff $1.2 million. In 2013, a New Jersey state court jury awarded a plaintiff $11.11 million in compensatory and punitive damages.
As of Aug. 15, there are 19,380 Ethicon pelvic mesh cases pending in the multidistrict litigation involving several types of devices. In 2012, the company stopped selling some types of devices.
As of Aug. 15, there are more than 61,000 pelvic mesh cases pending in seven separate multidistrict litigations in the Southern District of West Virginia. Ethicon has the most cases.
Pelvic mesh are medical devices consisting of surgical mesh. They are implanted in the pelvises of women to treat stress urinary incontinence and pelvic organ prolapse.
Plaintiffs alleged that the mesh can harden and cut into the urethra and vagina, causing pain, bleeding and infection and requiring surgical removal and surgical repair.
Huskey is represented by Edward A. Wallace and Mark Miller of Wexler Wallace in Chicago, Fidelma L. Fitzpatrick of Motley Rice in Providence, R.I., and Thomas P. Cartmell and Jeffrey M. Kuntz of Wagstaff & Cartmell in Kansas City, Mo.
Ethicon and Johnson & Johnson are represented by Christy D. Jones of Butler Snow in Ridgeland, Miss., and David B. Thomas of Thomas, Combs & Spann in Charleston.
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