Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, July 10, 2014

PUBLIC COST of J&J surgical mesh: will TX Attorney General act?

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.


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.  


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

The 9 other states include California, Colorado, Florida, Illinois,  Maryland, Ohio, Pennsylvania, South Carolina,Washington State

Texas Attorney General #ptsafety #MedX #TEDMED #fda #s4pm
7/8/14, 5:39 PM

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