Florida’s share of deceptive marketing settlement is $11.5M | News
FLORIDA – A lawsuit filed by 47 states and the District of Columbia has resulted in a settlement agreement requiring Boston Scientific (BSC) to pay more than $ 188 million to resolve allegations that the company misleadingly marketed transvaginal surgical power supplies.
Florida’s stake in the settlement is $ 11.5 million.
In the lawsuit, BSC was accused of misrepresenting the safety of its products by failing to disclose all potential serious complications such as chronic pain, dysfunction and recurrence of incontinence.
“This company’s misleading marketing practices have created even more pain and stress for patients in Florida and across the country,” Attorney General Ashley Moody said in a press release. She added that she hopes “the strong injunctive relief our coalition has received will prevent this from happening again in the future.”
The surgical mesh is a synthetic tissue that is implanted in the pelvic floor to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse.
These are common conditions women face due to weakness in their pelvic floor muscles due to birth, age, or other factors. A significant percentage of women who received surgical mesh had serious complications including erosion of the mesh in organs and pain.
Under the terms of the agreement, BSC is required to carry out the following actions:
– Describe in an understandable way complications for marketing materials intended for consumers.
– Identify significant complications for specific marketing materials, including the risks associated with mesh.
– Refrain from showing that inherent mesh risks are risks typical of a pelvic floor or other non-mesh surgery.
– They must not show that inherent mesh complications can be eliminated through surgical experience or technique alone.
– Do not show that the surgical mesh will not cause a foreign body reaction.
– Do not depict the surgical mesh remaining soft, pliable, or pliable after the mesh is implanted in the body.
– Refrain from showing that the surgical mesh does not potentiate the infection or increase the likelihood of infection. and
– Refrain from demonstrating that surgical mesh repair is superior to conventional repair unless such representations are supported by valid scientific evidence.
Inform health care providers of significant complications in training related to placement and implantation procedures. and
Adhere to guidelines that independent contractors, agents, and employees who sell, market, or promote Mesh are properly trained to report patient complaints and adverse events to the company.
Clinical Trial Reforms
– When submitting a clinical study or clinical data on Mesh for publication, you are disclosing the company’s role as a sponsor and an author’s potential conflict of interest
– Do not cite clinical studies, clinical data, preclinical data, research results, or articles on meshes for which the company has failed to comply with the disclosure requirements of the injunction
– Include a disclosure requirement that requires consultants to contractually agree to disclose in a public presentation or submission for publication any assistance from BSC related to the contracted activity
-Register all BSC sponsored clinical trials on Mesh with ClinicalTrials.gov.
This is the third major case in multiple states against a network manufacturer involving the Florida Attorney General. The first two cases involved Johnson & Johnson and its wholly-owned subsidiary Ethicon, Inc. and CR Bard, Inc. This resulted in a similarly strong injunction of more than $ 176 million, which was split among the states filing the lawsuit.
Click here to view the Judgment Filed for Judicial Approval – https://bit.ly/2NQRsOT.