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Demand an Investigation

Plenty of corporations put profits over people, but few more egregiously than Johnson & Johnson, which continues to sell pelvic mesh – the most dangerous product on the market for women – despite the tens of thousands of injuries their product has caused.

With a document hold in place as close to 100,000 defective product lawsuits amassed across the U.S. and the globe, Johnson & Johnson lost and destroyed documents that may have been related to the safety and efficacy of their pelvic mesh products. Moreover, they were fraudulently marketing one particularly egregious mesh kit before even seeking any FDA approval.

We’re delivering letters to all fifty state Attorneys General requesting investigations into Johnson & Johnson’s document destruction and fraud. Sign on below to demand an investigation in your state.

Here’s our most recent letter, to Arkansas Attorney General Dustin McDaniel: 

The Honorable Dustin McDaniel
Attorney General for the State of Arkansas
323 Center St., Suite 200
Little Rock, AR  72201

Dear Attorney General McDaniel,

As survivors of pelvic mesh implants and Arkansas state taxpayers, we respectfully request that your office immediately begin investigating whether Johnson and Johnson should be held liable for the expenses incurred by the state as a result of dangerous and defective pelvic implants.

Johnson and 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 Arkansas, which in turn is resulting in significant costs to the states’ public health systems.   

Specifically, we ask for you to investigate Johnson and Johnson and its Chairman Alex Gorsky for possible violation of Arkansas Code Section 4-88-107(a)(1) and (a)(10) for deceptively marketing a product to women without revealing the significant health risks.

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 Arkansas Office of the Attorney General 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.  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 Arkansas 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 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, the agency informed Johnson & Johnson that the device required government approval [3].  In May 2008, the Prolift was finally cleared for sale, but only 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, a 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

Johnson and Johnson and its CEO Alex Gorsky may be in violation of Arkansas Code Section 4-88-107(a)(1) and (a)(10) for deceptive business practices by marketing an inherently dangerous product to women.  

The Arkansas Office of the Attorney General has the 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 unfair or deceptive acts or practices, and is therefore unlawful under the Arkansas consumer protection laws by misrepresenting the safety of pelvic mesh implants.

The fact that Johnson & Johnson has offices and conducts business throughout Arkansas adds to the importance of your office pursuing this matter.

Arkansas expends funds to areas which include significantly increased charges attributable pelvic mesh implants.  These include medical payments for medical care services provided to recipients of public assistance.  Also Arkansas purchases health care insurance for public employees and dependents.  The premiums paid for all employees and dependents are high than they would be otherwise due to payments and problems related to pelvic mesh.

A foreseeable consequence of Johnson and Johnson’s conduct has been to unjustly enrich their corporation at the expense of Arkansas’ health care system, the state health care authority, state workers’ compensation funds and ultimately, all Arkansas residents and taxpayers.

Johnson & Johnson is one of the world’s largest corporations whose products are used not only by women but also children and men.  This investigation is urgently needed as the lives and safety of so many women in Arkansas and across the United States depend on it.

Please do not hesitate to contact us if we can provide any further information.  Thank you for your consideration.  

Sincerely,

Rebecca Miller — Carlisle, AR
Cathy Rodriguez    – Fort Smith, AR            
Gail Howard – Rogers, AR                  
Beverly Story Butler — Stuttgart, AR             
Wilma Collins — Mammoth Springs, AR       
Rosemary Sandlin Mustain — Texarkana, AR
Arkansas survivors of pelvic mesh implants.

[1] The current consolidated case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of WestVirginia (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