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Plaintiff claimed transvaginal mesh device was unsafe

Amount:

$73,400,000

Type:

Verdict-Plaintiff

State:

Texas

Venue:

Dallas County

Court:

Dallas County District Court, 95th

Injury Type(s):

leg; other-groin; other-urethral erosion; pelvis; urological-dyspareunia; urological-urinary tract infection; neurological-nerve damage/neuropathy; gynecological-vagina

Case Type:

Products Liability – Design Defect, Failure to Warn, Medical Devices, Marketing Defect, Breach of Warranty

Case Name:

Martha Salazar and Felix Salazar v. Jorge Lopez, M.D., and Boston Scientific Corp.,
No. DC-12-14349

Date:

September 8, 2014

Parties

Plaintiff(s):

Felix Salazar (Male), 

Martha Salazar (Female, 38 Years)

Plaintiff Attorney(s):

David P. Matthews;
Matthews & Associates;
Houston,
TX,
for
Felix Salazar, Martha Salazar ■ Kevin L. Edwards;
Edwards & de la Cerda;
Dallas,
TX,
for
Felix Salazar, Martha Salazar ■ Richard A. Capshaw;
Capshaw & Associates;
Dallas,
TX,
for
Felix Salazar, Martha Salazar ■ Tim K. Goss;
Freese & Goss, PLLC;
Dallas,
TX,
for
Felix Salazar, Martha Salazar ■ Sheila M. Bossier;

Jackson,
MS,
for
Felix Salazar, Martha Salazar ■ John P. Harloe III;
Freese & Goss, PLLC;
Dallas,
TX,
for
Felix Salazar, Martha Salazar ■ Calle Mendenhall;
Freese & Goss, PLLC;
Birmingham,
AL,
for
Felix Salazar, Martha Salazar

Plaintiff Expert(s):

M. Margolis;
M.D.;
Urogynecology;
San Francisco,
CA called by
David P. Matthews, Kevin L. Edwards, Richard A. Capshaw, Tim K. Goss, Sheila M. Bossier, John P. Harloe III ■ T. Harrell;
Ph.D.;
Life Care Planning;
Austin,
TX called by
David P. Matthews, Kevin L. Edwards, Richard A. Capshaw, Tim K. Goss, Sheila M. Bossier, John P. Harloe III ■ Peggy Pence;
Ph.D., RAC;
Medical Devices;
Tustin,
CA called by
David P. Matthews, Kevin L. Edwards, Richard A. Capshaw, Tim K. Goss, Sheila M. Bossier, John P. Harloe III ■ Thomas Mayor;
Ph.D.;
Economics;
Houston,
TX called by
David P. Matthews, Kevin L. Edwards, Richard A. Capshaw, Tim K. Goss, Sheila M. Bossier, John P. Harloe III

Defendant(s):

Jorge Lopez, M.D., 

Boston Scientific Corp.

Defense Attorney(s):

Rob Adams;
Shook, Hardy & Bacon;
Kansas City,
MO,
for
Boston Scientific Corp. ■ Edward P. Quillin;
Quillin Law Firm;
Dallas,
TX,
for
Jorge Lopez, M.D. ■ Maria K. Karos;
Sedgwick, Detert, Moran & Arnold LLP;
Dallas,
TX,
for
Boston Scientific Corp. ■ Jon A. Strongman;
Shook Hardy & Bacon;
Kansas City,
MO,
for
Boston Scientific Corp.

Defendant Expert(s):

A. Staub;
OB-GYN;
Dallas,
TX called by
Rob Adams, Maria K. Karos, Jon A. Strongman ■ Chris Cuddy;
Medical Devices;
Boston,
MA called by
Rob Adams, Maria K. Karos, Jon A. Strongman ■ Janice Connor;
Medical Devices;
Boston,
MA called by
Rob Adams, Maria K. Karos, Jon A. Strongman ■ Steven Maislos;
Urology;
Houston,
TX called by
Rob Adams, Maria K. Karos, Jon A. Strongman

Facts:

On Jan. 17, 2011, plaintiff Martha Salazar, 38, a residential property manager, underwent implantation of the Obtryx Transobturator Mid-Urethral Sling System, a medical device designed and marketed by Boston Scientific Corp. as a safe and minimally invasive treatment for stress urinary incontinence in women. Salazar claimed injuries and complications from the device. Boston Scientific had begun marketing the Obtryx device in 2004. The device includes a narrow polypropylene mesh strip that is implanted transversely into the anterior vaginal wall, under the mid-portion of the urethra. The strip forms a sling designed to keep the urethra in place so that it does not press on the bladder when the patient coughs, sneezes, exercises, or otherwise strains. Implantation of the mesh is transvaginal, rather than transabdominal; that is, it is implanted through a vaginal incision, not an abdominal incision. The surgeon who recommended and performed the procedure on Salazar was Dr. Jorge Francisco Lopez and the surgery took place at Medical City Dallas Hospital. Salazar and her husband sued Boston Scientific for negligence and gross negligence in the manufacture, design, and marketing of the device; strict products liability design and manufacturing defects; strict liability failure to warn of the device’s dangers; and breach of express and implied warranties. Only the negligence and gross negligence claims went to trial. Salazar also sued Lopez and Columbia Hospital at Medical City Dallas Subsidiary L.P., operating as Medical City Dallas Hospital, for medical malpractice, but those defendants were dismissed. The hospital was dismissed in March 2014, and Lopez was dismissed during trial. The plaintiffs claimed that Boston Scientific put the device on the market without testing it and that the company lied to patients and doctors about how unsafe the device was. The plaintiffs claimed that Boston Scientific did not perform any clinical trials before launching the product. They further claimed that the company funded a single peer-reviewed, published study, and that this study showed the Obtryx to be less safe than existing treatments. The plaintiffs claimed that the company then emailed its sales force not to share this study with physicians. The plaintiffs argued that the Obtryx’s design was defective because the device was to be inserted into an area with high levels of pathogens that could adhere to the mesh; because "biomechanical issues" led to strong friction between the mesh and urethral tissue, which, along with degradation of the mesh over time, caused tissue degradation; because the device’s trochars (with which the device is inserted into the vagina) potentially passed through and injured major nerve routes in the pelvic region and frequently destroyed nerve endings; and because the device could not be easily or completely removed. The plaintiffs claimed that the company marketed the device and procedure to a broad range of specialists as safe, quick, easy and profitable. The plaintiffs claimed that, although the company created a complaint registry, the registry was inadequate, resulting in a backlog of more than 1,000 unreported complaints. Boston Scientific denied the allegations and maintained that the device was safe, effective, and well-studied, and that polypropylene had been used for more than 50 years in sutures and hernia mesh. The defense also contended that the plaintiff’s menstrual cramping and heavy menstruation flow were the causes of her conditions and that her doctor warned her of the device’s risks . The company further contended that numerous "poster sessions" with data indicating the device’s safety had been presented at medical conferences. At the time of trial, Boston Scientific was continuing to design, market, and sell transvaginal mesh products.

Injury:

After the implantation, Salazar claimed constant, severe groin, leg, and pelvic pain; dyspareunia, or pain during sexual intercourse; and constant urinary tract infections. Doctors found that the mesh had eroded into the surrounding tissue. In November 2011, she underwent surgery to remove the mesh, but doctors were unable to remove it all. They tried again a year later, but without success. In April 2014, she underwent surgery to repair her urethra, in which the mesh had caused a kink to form. She also claimed frequent urinary tract infections, and in August 2014, she underwent fulguration (similar to cauterization) of resulting lesions in her bladder lining. She claimed that, although she had had urinary tract infections before, they were much more frequent after the implantation. The plaintiff claimed that she may eventually need to have her entire bladder removed because of her persistent urinary tract infections, and that her future medical bills would be around $2 million. She also claimed that it was painful to sit for long periods. Salazar’s employer testified that he had been grooming her to take over as chief executive officer of the company, which had properties all over the state. Three weeks before trial, Salazar was fired, in a company reorganization. She claimed that the reason she was fired was that she could no longer travel or walk the properties. Her salary was $67,500 a year. Salazar’s husband claimed that he had to quit his job as a long-haul truck driver and take a job closer to home to take care of his wife. Plaintiffs’ attorneys argued that the device destroyed Salazar’s health and quality of life. Besides future medical bills and future lost earning capacity, Salazar sought unspecified amounts for past and future physical pain and mental anguish and past and future physical impairment. Her husband sought unspecified amounts for past and future loss of household services and past and future loss of consortium. The plaintiffs also sought unspecified punitive damages.

Result:

The jury found that Boston Scientific was negligent in designing and marketing the Obtryx at the time it left Boston Scientific, and that this negligence was a proximate cause of injury to Salazar. The jury also found, by clear and convincing evidence, that the harm to Salazar resulted from gross negligence by Boston Scientific. The jury awarded the plaintiffs $73,465,000 in actual and punitive damages. Of the punitive damages, which were $50 million, the jury apportioned 95 percent to Salazar and 5 percent to her husband.

Felix Salazar: $250,000 Personal Injury: Past Loss Of Consortium; $750,000 Personal Injury: Future Loss Of Consortium; $2,500,000 Personal Injury: Punitive Exemplary Damages; $15,000 Personal Injury: past loss of household services; $500,000 Personal Injury: future loss of household services; Martha Salazar: $3,000,000 Personal Injury: Future Medical Cost; $750,000 Personal Injury: Past Physical Impairment; $5,000,000 Personal Injury: Future Physical Impairment; $47,500,000 Personal Injury: Punitive Exemplary Damages; $1,500,000 Personal Injury: past physical pain and mental anguish; $10,000,000 Personal Injury: future physical pain and mental anguish; $1,700,000 Personal Injury: future lost earning capacity

Actual Award:

$34,645,000

Trial Information:

Judge:

Ken Molberg

Trial Length:

2
 weeks

Trial Deliberations:

3.75
 hours

Jury Vote:

10-2

Post Trial:

The punitive damages were capped by statute at $11,180,000, and the actual damages were $23,465,000. Thus, the final judgment was for $34,645,000.

Editor’s Comment:

This report is based on information that was provided by plaintiffs’ counsel. Defense counsel did not respond to the reporter’s phone calls.