Rutledge Announces $116.9 Million Multistate Settlement with Johnson & Johnson
. . . Arkansas to receive $1.86 million
Arkansas Attorney General Leslie Rutledge: A $116.9 Million Multistate Settlement with Johnson & Johnson and its subsidiary Ethicon, Inc. are required to pay nearly $117 million for their deceptive marketing of the transvaginal surgical mesh device. An investigation of the company found violations of state consumer protection laws by misrepresenting the safety and effectiveness of the device and failing to sufficiently disclose risks associated with its use. Arkansas will receive $1,855,302.53 under the settlement.
“Arkansas moms, sisters and daughters have been deceived by false claims of Johnson & Johnson, and now they must endure irrevocable damage to their bodies,” Arkansas Attorney General Rutledge said. “This settlement confirms these victims have been heard, and I will remain diligent to protect Arkansans from companies not following the law.”
The multistate investigation found the companies misrepresented or failed to adequately disclose the product’s possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and other complications related to the implantation of the device. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the device.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and District of Columbia. The settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Among the specific requirements, the companies must:
For Arkansans who have a consumer complaint or questions please contact the office at (800) 482-8982 or visit ArkansasAG.gov.
About Attorney General Leslie Rutledge
Leslie Carol Rutledge is the 56th Attorney General of Arkansas. Elected on November 4, 2014, and sworn in on January 13, 2015, she is the first woman and first Republican in Arkansas history to be elected as Attorney General. She was resoundingly re-elected on November 6, 2018. Since taking office, she has significantly increased the number of arrests and convictions against online predators who exploit children and con artists who steal taxpayer money through Social Security Disability and Medicaid fraud. Further, she has held Rutledge Roundtable meetings and Mobile Office hours in every county of the State each year, and launched a Military and Veterans Initiative. She has led efforts to roll back government regulations that hurt job creators, fight the opioid epidemic, teach internet safety, combat domestic violence and make the office the top law firm for Arkansans. Rutledge serves as Chairwoman of the National Association of Attorneys General Southern Region and re-established and co-chairs the National Association of Attorneys General Committee on Agriculture.
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Leslie Rutledge is Arkansas Attorney General. She was a former Chairwoman of the Republican Attorneys General Association and remains active on the Executive Board. Rutledge clerked for the Arkansas Court of Appeals, was Deputy Counsel for former Governor Mike Huckabee. She served as a Deputy Prosecuting Attorney in Lonoke County, an Attorney at the Department of Human Services, and served as Counsel at the Republican National Committee.
Tags: Leslie Rutledge, Arkansas Attorney General, Announces, $116.9 Million Multistate Settlement, Johnson & Johnson To share or post to your site, click on "Post Link". Please mention / link to the ARRA News Service and "Like" Facebook Page - Thanks!
Arkansas AG Leslie Rutledge |
“Arkansas moms, sisters and daughters have been deceived by false claims of Johnson & Johnson, and now they must endure irrevocable damage to their bodies,” Arkansas Attorney General Rutledge said. “This settlement confirms these victims have been heard, and I will remain diligent to protect Arkansans from companies not following the law.”
The multistate investigation found the companies misrepresented or failed to adequately disclose the product’s possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and other complications related to the implantation of the device. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the device.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and District of Columbia. The settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.
Among the specific requirements, the companies must:
- Refrain from referring to the mesh as “FDA approved” when that is not the case
- Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone
- Ensure that product training provided to medical professionals covers the risks associated with the mesh
- Omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur (when in fact they will occur)
- Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs
- Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring
For Arkansans who have a consumer complaint or questions please contact the office at (800) 482-8982 or visit ArkansasAG.gov.
About Attorney General Leslie Rutledge
Leslie Carol Rutledge is the 56th Attorney General of Arkansas. Elected on November 4, 2014, and sworn in on January 13, 2015, she is the first woman and first Republican in Arkansas history to be elected as Attorney General. She was resoundingly re-elected on November 6, 2018. Since taking office, she has significantly increased the number of arrests and convictions against online predators who exploit children and con artists who steal taxpayer money through Social Security Disability and Medicaid fraud. Further, she has held Rutledge Roundtable meetings and Mobile Office hours in every county of the State each year, and launched a Military and Veterans Initiative. She has led efforts to roll back government regulations that hurt job creators, fight the opioid epidemic, teach internet safety, combat domestic violence and make the office the top law firm for Arkansans. Rutledge serves as Chairwoman of the National Association of Attorneys General Southern Region and re-established and co-chairs the National Association of Attorneys General Committee on Agriculture.
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Leslie Rutledge is Arkansas Attorney General. She was a former Chairwoman of the Republican Attorneys General Association and remains active on the Executive Board. Rutledge clerked for the Arkansas Court of Appeals, was Deputy Counsel for former Governor Mike Huckabee. She served as a Deputy Prosecuting Attorney in Lonoke County, an Attorney at the Department of Human Services, and served as Counsel at the Republican National Committee.
Tags: Leslie Rutledge, Arkansas Attorney General, Announces, $116.9 Million Multistate Settlement, Johnson & Johnson To share or post to your site, click on "Post Link". Please mention / link to the ARRA News Service and "Like" Facebook Page - Thanks!
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