FIDA Highlight
Post Date
June 25, 2014
June 25, 2014
By Facsimile: 512-275-2994
The Honorable Greg Abbott
Office of the Attorney General
State of Texas
300 W. 15th Street
Austin, TX 78701
Dear Attorney General Abbott,
As
survivors of pelvic mesh implants and Texas taxpayers, we request that your
office immediately begin investigating whether Johnson & Johnson (JNJ)
should be held liable for expenses incurred by the state as a result of
dangerous and defective pelvic mesh implants. Johnson
& Johnson is the largest producer of pelvic mesh implants in the world.
This product is creating a health crisis among women across the state of Texas,
which in turn is resulting in significant costs to the state’s public health systems.
Specifically, we ask for you to investigate Johnson & Johnson and
its CEO Alex Gorsky for
criminal violation of the Texas Penal Code pursuant to Sec. 32.42 of the
Deceptive Business
Practices Act for the corporation’s knowledge of the inherent danger of the mesh
implants as well as the document
destruction.
The pelvic mesh industry also should be held accountable
to the Texas State treasury for those funds spent for pelvic mesh-attributable
costs to the Medicaid Program, the State Employee Retirement System, the State
Employee Group Insurance Program, and charity care.
The State of Texas also
operates a number of health care facilities that provide medical care to
qualifying persons who are not eligible for Medicaid, including state hospitals
and university health science centers. The State of Texas pays for all or part
of this care. The State of
Texas has expended and will continue to expend substantial sums of money due to
the increased cost of providing health care services for treatment of pelvic mesh-related
injuries.
This request follows the recent revelation by a West
Virginia court that Johnson & Johnson destroyed numerous documents relevant
to lawsuits filed against the company by thousands of women across the United
States who have been seriously injured by the company’s pelvic mesh implants
[1].
It is critical that the Texas Attorney General’s Office
pursue this matter to recoup
the state taxpayer dollars Medicaid and other public health systems have
been and will be forced to spend to treat women who have been injured.
Only the Texas Attorney General,
not consumers, can bring suit under the statute’s broad prohibition of
deceptive acts.
Action by the state attorney general will also demonstrate
that a major U.S. corporation should not destroy evidence in judicial
proceedings. The destruction of this evidence undermines our ability as
Texas women who have been hurt by Johnson & Johnson to receive justice.
Background
In the last few years, medical device manufacturers including
Johnson & Johnson have come under fire for marketing dangerous medical
devices, drugs and other consumer products, often without receiving proper
regulatory approval. Many of these companies, including Johnson &
Johnson, have paid billions of dollars in fines in litigation and settlement
costs and made repeated pledges of reform, yet continue to display an indifferent attitude toward the
harm they have caused as well as a willingness to evade the law.
Currently,
Johnson & Johnson faces thousands of product liability lawsuits
relating to the company’s pelvic mesh implants, marketed most commonly as
treatment for pelvic organ prolapse and stress urinary incontinence. There are estimated to be hundreds of
thousands of women that have been – and continue to be – implanted with these
dangerous products. Women have suffered severe pain and injuries due to
these ineffective and dangerous implants.
Investigations into the pelvic mesh
products produced by several companies, including Johnson & Johnson, date
back to before October 20, 2008, when the FDA first issued a Public Health
Notification [2].
Beginning in March 2005, Johnson & Johnson
sold one of its most popular devices, the Gynecare Prolift, without alerting
the Food and Drug Administration for three years. When the FDA was made aware
of the Prolift device, the agency informed Johnson & Johnson that the
device required government approval [3]. In May 2008, the Prolift was
cleared for sale under the 510(k) process under the claim of “substantial
equivalence” to devices already on the market. It had never been rigorously
tested nor demonstrated effective in clinical trials [4].
Further
indicating Johnson & Johnson knew how harmful pelvic mesh implants were but
nevertheless continued marketing the defective product to unsuspecting women,
the company destroyed thousands of documents regarding the implants.
Although top company executives initially denied it, a magistrate judge found
that Ethicon, the wholly owned subsidiary of Johnson & Johnson that
manufactured the implants, destroyed documents pertaining to their
effectiveness and safety as far back as 2007 [5]. Alex Gorsky, the
current Chairman and CEO of Johnson & Johnson, was named head of Ethicon in
2008, before most of the documents were destroyed, and has continued to oversee
it in his climb through the company’s ranks [6].
Apparent Violation of Law
The
pelvic mesh industry led by Johnson & Johnson and its CEO Alex Gorsky may
be in criminal violation of Texas Penal Code pursuant to Sec. 32.42 of the
Deceptive Business Practices for both his corporation’s knowledge of the inherent
danger of the mesh implants as well as the document destruction.
The Texas
Attorney General’s Office has the sole authority to conduct a comprehensive and
thorough investigation into whether Johnson & Johnson, in the course of
advertising, soliciting, selling, promoting and distributing pelvic mesh
implants, has engaged in a course of trade or commerce that constitutes
deceptive business practices and is therefore unlawful under the Texas consumer protection laws by
misrepresenting the safety of pelvic mesh implants.
Johnson &
Johnson also may have violated Texas Case Law pertaining to destroying physical
evidence in an official proceeding [7]. After initial denials by top
executives and their counsel, it is now clear that Johnson & Johnson destroyed
thousands of documents related to Ethicon’s development and marketing of pelvic
mesh implants [8].
The fact that Johnson & Johnson conducts business
throughout Texas only adds to the importance of your office pursuing this
matter.
Johnson & Johnson is one of the world’s largest corporations
whose products are used throughout Texas. This investigation is urgently
needed as the lives and
safety of so many women in Texas and elsewhere depend on it.
Please do
not hesitate to contact us if we can provide any further information.
Thank you for your consideration.
Sincerely,
Janet Holt – Floresville, TX
Kimberly Fox – Dallas, TX
Diana Coleman – Lavernia, TX
Debbie Mitchell – Red Oak, TX
Donna Hart — Pointblank, TX
Texas survivors of pelvic mesh
implants.
[1] Consolidated case is In Re
Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S.
District Court, Southern District of West Virginia (Charleston).
[7] Wal-Mart Stores, Inc. v.
Johnson, 106 S.W.3d 718, 722 (Tex. 2003) and Sec. 32.47 of the Texas Penal
Code
addendum:
The 9 other states include California, Colorado, Florida, Illinois, Maryland, Ohio, Pennsylvania, South Carolina,Washington State
 | JjrkCh Texas Attorney General http://t.co/opGrIxRIBu #ptsafety #MedX #TEDMED #fda #s4pm 7/8/14, 5:39 PM |
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