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Polypropylene is not a safe biomaterial, plaintiff alleged

Amount:

$3,270,000

Type:

Verdict-Plaintiff

State:

West Virginia

Venue:

Federal

Court:

U.S. District Court, Southern District of West Virginia

Injury Type(s):

other-infection; pelvis; urological-dyspareunia; urological-incontinence

Case Type:

Products Liability – Design Defect, Failure to Warn, Medical Devices, Strict Liability, Manufacturing Defect

Case Name:

Jo Huskey and Allen Huskey v. Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson,
No. 2:12-cv-05201

Date:

September 5, 2014

Parties

Plaintiff(s):

Jo Huskey (Female, 52 Years), 

Allen Huskey (Male, 50 Years)

Plaintiff Attorney(s):

Jeffrey M. Kuntz;
Wagstaff & Cartmell;
Kansas City,
MO,
for
Jo Huskey, Allen Huskey ■ Fidelma L. Fitzpatrick;
Motley Rice;
New York,
NY,
for
Jo Huskey, Allen Huskey ■ Edward A. Wallace;
Wexler Wallace;
Chicago,
IL,
for
Jo Huskey, Allen Huskey

Plaintiff Expert(s):

Bruce Rosenzweig;
M.D.;
Urogynecology;
Chicago,
IL called by
Jeffrey M. Kuntz, Fidelma L. Fitzpatrick, Edward A. Wallace ■ Jerry Blaivas;
M.D.;
Urology;
New York,
NY called by
Jeffrey M. Kuntz, Fidelma L. Fitzpatrick, Edward A. Wallace ■ Scott Guelcher;
Ph.D.;
Chemical Engineering;
Nashville,
TN called by
Jeffrey M. Kuntz, Fidelma L. Fitzpatrick, Edward A. Wallace

Defendant(s):

Ethicon, LLC, 

Ethicon, Inc., 

Johnson & Johnson

Defense Attorney(s):

David B. Thomas;
Thomas Combs & Spann;
Charleston,
WV,
for
Ethicon, LLC, Ethicon, Inc., Johnson & Johnson ■ Cristy D. Jones;
Butler Snow LLP;
Ridgeland,
MS,
for
Ethicon, LLC, Ethicon, Inc., Johnson & Johnson

Defendant Expert(s):

Shelby Thames;
Chemical Engineering;
Hattiesburg,
MS called by
David B. Thomas, Cristy D. Jones ■ Christina Pramudji;
Urology;
Houston,
TX called by
David B. Thomas, Cristy D. Jones

Facts:

On Feb. 23, 2011, plaintiff Jo Huskey, 52, was implanted with a Gynecare TVT Obturator, or TVT-O, transvaginal mesh device to treat stress urinary incontinence. The device was manufactured by Ethicon, Inc. and Johnson & Johnson, Inc. (collectively, "Ethicon"). The TVT-O is a medical device that includes a mechanism used to place a mesh tape, or sling, under the urethra to provide support to the urethra to treat stress urinary incontinence. After the surgery, Huskey experienced several complications, including erosion of the mesh and dyspareunia. Her symptoms included constant pelvic pain. Huskey sued Ethicon and Johnson & Johnson for products liability that included negligence, strict liability for design defect, strict liability for failure to warn, strict liability for manufacturing defect, fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express and implied warranty, gross negligence, unjust enrichment, and violation of the Illinois Consumer Fraud Act, 815 Ill. Comp. Stat. 505/1 et seq. The surgery occurred in Illinois where Huskey resides. This case is one of more than 60,000 in seven multi-district litigations that have been assigned to the U.S. District Court for the Southern District of West Virginia in Charleston by the Judicial Panel on Multidistrict Litigation. It was Huskey’s core contention that the TVT-O was constructed from polypropylene, which plaintiff’s counsel sought to prove was inappropriate for implantable medical devices and alleged that the device was unreasonably dangerous and the defendant negligently failed to warn her doctor and Huskey of the risk of the mesh shrinking and injuring internal organs. The pivotal issue in the case was whether polypropylene is a safe biomaterial for internal use in the human body and specifically for pelvic floor repair. Ethicon argued that expert opinions relating to polypropylene do not apply to the Prolene mesh used in the TVT-O. Ethicon advanced the reports of experts as to how polypropylene fails "to account for the important chemical differences between generic polypropylene and Prolene, which is an isotactic form of polypropylene that has been treated with two proprietary antioxidants." These arguments were barred by the court in pretrial Daubert hearings.

Injury:

Before being implanted with the TVT-O, Huskey suffered from stress urinary incontinence which caused her to leak urine when she laughed, coughed, sneezed, exercised, or experienced abdominal pressure. Huskey initially utilized pelvic floor strengthening exercises to alleviate her symptoms. When those exercises failed to fully remedy her stress urinary incontinence, she sought surgical treatment. Huskey’s physician implanted the TVT-O device on Feb. 23, 2011. After the surgery, Huskey experienced several complications, including erosion of the mesh and dyspareunia. Huskey underwent a revision surgery with on Nov. 18, 2011, which excised a portion of the TVT-O’s mesh. After her revision, Huskey’s stress urinary incontinence symptoms returned, and she experienced constant pelvic and vaginal pain.

Result:

The jury found that the TVT-O was defective in its design and Ethicon failed to give adequate warnings to Huskey or her physiccian of the products potential risks. The jury returned a damage award of $3.27 million.

Trial Information:

Judge:

Joseph R. Goodwin

Trial Length:

9
 days

Trial Deliberations:

3
 hours

Post Trial:

Defendants have filed motions for a new trial and anticipate filing an appeal.

Editor’s Comment:

This report is based on information that was provided by plaintiff’s and defense counsel.