Attorney General Jennings Announces Multistate Settlement with Boston Scientific Corporation
Department of Justice | Department of Justice Press Releases | News | Date Posted: Monday, March 29, 2021
Department of Justice | Department of Justice Press Releases | News | Date Posted: Monday, March 29, 2021
Attorney General Jennings announced Monday a settlement with Boston Scientific Corporation (Boston), a medical device manufacturer, to resolve allegations of deceptive marketing of its transvaginal surgical mesh devices for patients. The multistate settlement follows a 2019 settlement with Johnson & Johnson, Ethicon, Inc. and a 2020 settlement with C.R. Bard, Inc. for similar conduct.
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in patients such as stress, urinary incontinence, and pelvic organ prolapse. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors. Although the use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of patients were implanted with the devices and thousands are alleged to have suffered serious complications resulting from these devices.
The complaint alleges that Boston misrepresented the safety of these products by failing to disclose the full range of potentially serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.
“Today’s settlement holds Boston Scientific accountable for their failures,” said Attorney General Jennings. “My office will continue to work to ensure that Delawareans can rely on manufacturers’ assurances as to the safety and effectiveness of medical devices.”
The settlement provides comprehensive injunctive relief. Under the terms of the settlement, Boston is required to implement several reforms:
Marketing Reforms:
Training Reforms:
Clinical Trial Reforms:
Boston has agreed to pay a total of $188.6 million to the 48 states and the District of Columbia. Delaware will receive $1,386,237 of this amount, which will be placed in the Consumer Protection Fund. The matter was handled for Delaware by Deputy Director of Consumer Protection Regina S. Schoenberg.
A copy of the Cease and Desist Order by Agreement is here.
Keep up to date by receiving a daily digest email, around noon, of current news release posts from state agencies on news.delaware.gov.
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Department of Justice | Department of Justice Press Releases | News | Date Posted: Monday, March 29, 2021
Attorney General Jennings announced Monday a settlement with Boston Scientific Corporation (Boston), a medical device manufacturer, to resolve allegations of deceptive marketing of its transvaginal surgical mesh devices for patients. The multistate settlement follows a 2019 settlement with Johnson & Johnson, Ethicon, Inc. and a 2020 settlement with C.R. Bard, Inc. for similar conduct.
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in patients such as stress, urinary incontinence, and pelvic organ prolapse. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors. Although the use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of patients were implanted with the devices and thousands are alleged to have suffered serious complications resulting from these devices.
The complaint alleges that Boston misrepresented the safety of these products by failing to disclose the full range of potentially serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.
“Today’s settlement holds Boston Scientific accountable for their failures,” said Attorney General Jennings. “My office will continue to work to ensure that Delawareans can rely on manufacturers’ assurances as to the safety and effectiveness of medical devices.”
The settlement provides comprehensive injunctive relief. Under the terms of the settlement, Boston is required to implement several reforms:
Marketing Reforms:
Training Reforms:
Clinical Trial Reforms:
Boston has agreed to pay a total of $188.6 million to the 48 states and the District of Columbia. Delaware will receive $1,386,237 of this amount, which will be placed in the Consumer Protection Fund. The matter was handled for Delaware by Deputy Director of Consumer Protection Regina S. Schoenberg.
A copy of the Cease and Desist Order by Agreement is here.
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.