Attorney General Jennings Announces Multistate Settlement with Johnson & Johnson, Ethicon, Inc.
Consumer Protection | Department of Justice | Department of Justice Press Releases | Date Posted: Thursday, October 17, 2019
Consumer Protection | Department of Justice | Department of Justice Press Releases | Date Posted: Thursday, October 17, 2019
Delaware Attorney General Kathleen Jennings announced Thursday a multistate settlement with Johnson & Johnson and its subsidiary, Ethicon, Inc., for their deceptive marketing of transvaginal surgical mesh devices.
A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.
“Manufacturers of medical devices must do better than the cavalier and dangerous attitude towards women exhibited here by Johnson and Johnson. Today’s settlement holds Johnson and Johnson accountable for their failures and my office will continue to ensure that Delawarean’s can rely on manufacturer’s assurances as to the safety and effectiveness of medical devices,” said Attorney General Jennings.
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.
The multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. 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 devices.
The settlement requires J&J and Ethicon to provide full disclosure of the device’s risks and accurate information on promotional material and package inserts.
Among the specific requirements, the companies must:
Additionally, Johnson & Johnson has agreed to pay a combined $116.86 million to the 41 participating states and District of Columbia. Delaware will receive $1.4 million under the settlement which will go to the state’s Consumer Protection Fund. The Fund pays the investigative costs, consumer outreach activities and operations of Delaware DOJ’s Consumer Protection Unit, with excess amounts returned to the state’s General Fund for allocation by the state legislature and Governor through the normal budgetary process.
Joining Delaware in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
The matter was handled by Assistant Director of Consumer Protection Regina S. Schoenberg.
Related Topics: Attorney General Kathy Jennings, Delaware Department of Justice, Division of Fraud and Consumer Protection, Johnson & Johnson
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Consumer Protection | Department of Justice | Department of Justice Press Releases | Date Posted: Thursday, October 17, 2019
Delaware Attorney General Kathleen Jennings announced Thursday a multistate settlement with Johnson & Johnson and its subsidiary, Ethicon, Inc., for their deceptive marketing of transvaginal surgical mesh devices.
A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.
“Manufacturers of medical devices must do better than the cavalier and dangerous attitude towards women exhibited here by Johnson and Johnson. Today’s settlement holds Johnson and Johnson accountable for their failures and my office will continue to ensure that Delawarean’s can rely on manufacturer’s assurances as to the safety and effectiveness of medical devices,” said Attorney General Jennings.
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.
The multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. 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 devices.
The settlement requires J&J and Ethicon to provide full disclosure of the device’s risks and accurate information on promotional material and package inserts.
Among the specific requirements, the companies must:
Additionally, Johnson & Johnson has agreed to pay a combined $116.86 million to the 41 participating states and District of Columbia. Delaware will receive $1.4 million under the settlement which will go to the state’s Consumer Protection Fund. The Fund pays the investigative costs, consumer outreach activities and operations of Delaware DOJ’s Consumer Protection Unit, with excess amounts returned to the state’s General Fund for allocation by the state legislature and Governor through the normal budgetary process.
Joining Delaware in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
The matter was handled by Assistant Director of Consumer Protection Regina S. Schoenberg.
Related Topics: Attorney General Kathy Jennings, Delaware Department of Justice, Division of Fraud and Consumer Protection, Johnson & Johnson
Keep up to date by receiving a daily digest email, around noon, of current news release posts from state agencies on news.delaware.gov.
Here you can subscribe to future news updates.