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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Tuesday, June 10, 2014

Surgical Mesh Harmed Patients call on Attorney General: Dangerous Product




Posted: Monday, June 9, 2014 12:33 pm
Injured Women Call on Washington Attorney General to Investigate
Johnson & Johnson:

Washington Women Cite Injuries and Public Health Care Costs in Letter to AG Ferguson
Olympia, WA – Washington women who have been seriously injured by pelvic mesh implants asked Washington Attorney General Bob Ferguson to investigate Johnson & Johnson for its dangerous pelvic mesh implants, citing their personal health problems and costs incurred by Washington taxpayers.
“We ask that Attorney General Ferguson investigate Johnson & Johnson and its CEO Alex Gorsky for selling dangerous products to women throughout the state of Washington. The damage this product has caused already has cost taxpayers too much money through Medicaid and other state public health systems,” stated Jane Akre, who has been organizing survivors of pelvic mesh implants for more than five years.
“Across Washington, women are being hurt by Johnson & Johnson’s dangerous products, and the company’s top executive, CEO Alex Gorsky, needs to be held accountable for the women he has hurt,” added Akre. “Pelvic mesh implants are perhaps the most dangerous product to women’s health on the market today. Gorsky should immediately take this dangerous pelvic mesh product off the market.”
More than 70,000 separate lawsuits have been filed against manufacturers of pelvic mesh implants. Local survivors in Washington signed onto today’s request for an investigation.
"Johnson & Johnson should be investigated because too many have suffered too long, and they need to bring a stop to it,” stated survivor Danyelle Robinson of Washington. “Something has to be done to assure there are substantial penalties."
See the letter to Attorney General Ferguson directly below.
# # #
June 9, 2014
By Facsimile: 206-587-5636
The Honorable Bob Ferguson
Attorney General
Washington State Office of the Attorney General
1125 Washington Street SE
PO Box 40100
Olympia, WA 98504-0100
Dear Attorney General Ferguson,
As survivors of pelvic mesh implants and Washington taxpayers, we request that your office immediately begin investigating whether Johnson and Johnson should be held liable for 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 Washington, 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 section 19.86.20 of the Revised Code of Washington for deceptive and fraudulent business for their knowledge of the danger of the mesh implants and the public health systems’ costs to the taxpayers of Washington.
This request follows the recent revelation by a West Virginia court that Johnson and 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 Washington State 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 the ability of Washington 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 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, 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 section 19.86.20 of the Revised Code of Washington for unfair or deceptive business practices concerning both his corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction.
The Washington State 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 Washington consumer protection laws by misrepresenting the safety of pelvic mesh implants.
The fact that Johnson & Johnson has offices and conducts business throughout Washington only adds to the importance of your office pursuing this matter.
Johnson & Johnson also may have violated Washington Case Law pertaining to destroying physical evidence in an official proceeding.[7] In Pier 67, Inc. v. King County, the Court held “where relevant evidence which would properly be a part of a case is within the control of a party whose interests it would naturally be to produce it and he fails to do so, without satisfactory explanation, the only inference which the finder of fact may draw is that such evidence would be unfavorable to him.”[8] Culpability turns on whether the party acted in bad faith or whether there is an innocent explanation for the destruction.[9]
After initial denials by top executives, it is now clear that Johnson & Johnson destroyed thousands of documents related to Ethicon’s development and marketing of pelvic mesh implants.[10]
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 Washington 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,
Patricia Buchanan – Seattle, WA
Danyelle Robinson – Spokane, WA
Mary Wakefield – Colbert, WA

Elizabeth Weber – Spokane, WA

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