J&J Sold Pelvic Mesh While Concealing Risks: Washington State Attorney General

• AG FILES MAJOR LAWSUIT AGAINST JOHNSON & JOHNSON OVER CONCEALED RISKS OF PELVIC MESH

• FOR IMMEDIATE RELEASE: 

May 24 2016  FiDA highlight

Complications left women permanently disabled, in chronic pain

SEATTLE — Attorney General Bob Ferguson filed a consumer protection lawsuit today against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.

These complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.

“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”

The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.

The state alleges tens of thousands of violations of the CPA, potentially placing penalties well into the millions of dollars.

Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.

The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.

The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs.

The mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.

One patient shared this about her ordeal:

“I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, & I couldn’t lie on my left side due to severe pain and numbness at my left groin area.  Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times. … I had no quality of life.  My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’  … I still suffer left side groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre-op.” 

A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician.  She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”  

The company never told consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.

The company never told consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.

The company never told consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication.

One patient said, “[I] had all kinds of problems with chronic pain, bleeding, dyspareunia (even my husband complained of scraping and poking)…The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent and miserable sex, and marital problems was almost more than I could bear.”

And the company never told consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.

Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.

This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.

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The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.

- See more at: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh#sthash.V0tz1X8g.Myhh7sWx.dpuf

http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh

Peter Lavallee, Communications Director, (360) 586-0725; PeterL@atg.wa.gov

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

REQUEST FOR INVESTIGATION DELIVEREDTO TEXAS ATTORNEY GENERAL GREG ABBOTT  

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).

[2] http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm

[3] http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html

[4] http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071512.pdf

[5] http://www.bloomberg.com/news/2013-12-04/j-j-lost-or-destroyed-vaginal-mesh-files-lawyers-contend.html

[6]http://www.investor.jnj.com/governance/managementdetail.cfm?bioid=38097

[7] Wal-Mart Stores, Inc. v. Johnson, 106 S.W.3d 718, 722 (Tex. 2003) and Sec. 32.47 of the Texas Penal Code

[8] http://www.bloomberg.com/news/2013-12-04/j-j-lost-or-destroyed-vaginal-mesh-files-lawyers-contend.html

http://www.wfaa.com/news/health/Texas-Attorney-General-Investigating-Pelvic-Mesh-266293941.html

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