In the first transvaginal mesh
lawsuit to go to trial, a jury
in California ruled that transvaginal mesh implants manufacturer C.R. Bard was
responsible for a patient’s injuries (Scott v. Kannappan, S-1500-CV-266034-WDE,
Superior Court for Kern County, California, Bakersfield). In the jury trial,
the Plaintiff, Christine Scott, was awarded $5 million for her injuries and
$500,000 was awarded to her husband for loss of consortium. CR Bard was found 60% liable, while Scott’s doctor,
Tillakarasi Kannappan, was found 40% liable. In Alabama, the percentage of
fault would not have made a difference because of joint and several liability.
Scott had two Avaulta
Plus transvaginal mesh devices implanted in her to treat urinary incontinence.
She contended that the Bard Avaulta Plus
vaginal mesh implant was defective and the manufacturer failed to warn about
its safety risks. The Defendants included
the manufacturer of the device CR Bard and her physician.
The transvaginal mesh caused complications that left her
entirely incontinent, with chronic pain and the inability to have sex. She underwent nine revision surgeries and eight other
procedures to try to get both devices removed that doctors said the devices
could not be safely taken out of her body. Court documents report that the
device has cut Scott’s colon and tissue, which continues to grow through the
mesh holes. She will likely experience chronic pain for life and her runner lifestyle
has been affected.
Although Scott is the first transvaginal mesh victim to
get her day in court, hundreds of other women have filed their defective
medical device lawsuits because of injuries and health complications they have
suffered after getting a transvaginal mesh implant. Mesh product manufacturers
named as defendants have included Boston Scientific Corp. (BSX), Murray Hill,
Johnson & Johnson (JNJ), Endo Pharmaceutical Holdings Inc., and other
companies.
This verdict comes more than a month after Johnson& Johnson
Ethicon discontinued four lines of vaginal mesh devices. Many filed cases have been streamlined into multiple MDL’s
and include C.R. Bard (MDL 2187),
American Medical Systems (MDL 2325), Johnson & Johnson’s Ethicon (MDL 2327
) and Boston Scientific (MDL 2326).
The vaginal mesh implant devices have been popular for treating
Stress Urinary Incontinence and Pelvic Organ Prolapse. However, in the last few
years, there have been reports of women suffering serious complications,
including severe bleeding, pain during intercourse, infection, and erosion of
the device. Between just 2005 and 2007 alone, the US Food and Drug
Administration said it received over 1000 report of adverse events. Also, Scott
is not the only woman to have undergone multiple procedures to try removing the
device.
Last July, the FDA updated its Public Health Notification on
transvaginal mesh products. While the original one from 2008 said that using
transvaginal mesh in medical procedures could potentially cause a patient harm,
the 2011 updated said that it is not unusual for someone undergoing a procedure
involving this surgical device to suffer “serious complications.” The FDA also said
that getting a transvaginal mesh does not give a patient a higher likelihood of
a successful outcome than if she had undergone traditional surgery to treat the
same condition.
C.R. Bard continued to keep its Avaulta products-- including the
Avaulta Biosynthetic, Avaulta Plus and Avaulta Solo devices—on the market until
they pulled it from the shelves in the US at the beginning of July 2012. The
products were pulled only when the FDA asked for more clinical trials to
determine their safety. Incredibly, Bard is still selling its Avaulta line in
other countries.
