September 24, 2020
Carson City, NV – Today, Nevada Attorney
General Aaron D. Ford announced a $60 million bipartisan, multistate settlement
with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company. In
addition to providing financial relief to impacted states, C.R. Bard and Becton,
Dickinson and Company are required to abide by certain terms if they reenter
the transvaginal mesh market. Nevada’s share of the
settlement is $803,620.
Today’s settlement results from allegations that C.R. Bard
misrepresented or failed to adequately disclose to women the serious and
life-altering risks of surgical mesh devices, such as chronic pain, scarring
and shrinking of bodily tissue, painful sexual relations, and recurring
infections, among other complications.
“When
making important decisions about their healthcare, patients must be fully
informed of all of the risks,” saidAG Ford. “My office helps
protect Nevadans by holding companies accountable for failing to disclose risks
and complications of products.”
Surgical
mesh is a synthetic knitted or woven fabric that is permanently implanted in
the pelvic floor through the vagina to treat pelvic organ prolapse and stress
urinary incontinence. These are common conditions faced by women because of a
weakening in their pelvic floor muscles caused by childbirth, age and other
factors.
This
settlement follows an October 2019 multistate settlement with Johnson &
Johnson and its subsidiary Ethicon Inc. to pay nearly $117 million for their
deceptive marketing of transvaginal surgical mesh devices.
Today’s
multistate effort was prompted after women throughout the nation who were implanted
with surgical mesh made claims that they suffered serious complications
resulting from these devices, including erosion of mesh through organs, pain
during sexual intercourse and voiding dysfunction.
Under the terms of the
settlement, the companies are required to:
Provide
patients with understandable descriptions of complications in marketing
materials;
Include
a list of certain complications in all marketing materials that address
complications;
Disclose
complications related to the use of mesh in any training provided that includes
risk information;
Disclose
sponsorship in clinical studies, clinical data or preclinical data for
publication;
Refrain
from citing to any clinical study, clinical data, or preclinical data regarding
mesh, for which the company has not complied with the disclosure requirements;
Require
consultants to agree to disclose in any public presentation or submission for
publication Bard’s sponsorship of the contracted for activity;
Register
all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov;
Train
independent contractors, agents, and employees who sell, market, or promote
mesh, regarding their obligations to report all patient complaints and adverse
events to the company; and
Ensure
that its practices regarding the reporting of patient complaints are consistent
with FDA requirements.
Joining
Nevada in this multistate settlement are: Alabama, Alaska, Arizona, Arkansas,
California, Colorado, Connecticut, Delaware, District of Columbia, Florida,
Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,
Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri,
Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North
Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island,
South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington
and Wisconsin.
The
settlement agreement is attached.
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