- A bipartisan group of 48 AGs, led by former California AG Xavier Becerra and Washington AG Bob Ferguson, reached a settlement with Boston Scientific Corporation to resolve allegations that it falsely and deceptively marketed its surgical mesh products for women in violation of the settling jurisdictions’ consumer protection laws.
- The states’ complaints alleged that Boston Scientific deceptively marketed transvaginal surgical mesh devices to patients and healthcare providers by touting the devices’ unproven efficacy while misrepresenting the safety of these devices and the risk of serious and permanent complications such as urinary dysfunction, chronic inflammation and pain, and risk of infection.
- Under the terms of the settlement agreement, Boston Scientific will pay $188.6 million to the states. Boston Scientific will also undertake reforms of its marketing, training, and clinical-trial practices, including disclosing to consumers in understandable terms the inherent significant risks of complications, maintaining policies for the adequate reporting of patient complaints and adverse events to the company, and registering all Boston Scientific-sponsored mesh clinical studies in the Food and Drug Administration’s clinical trials portal, ClinicalTrials.gov.
- As previously reported, AG Becerraobtained a $344 million judgment in civil penalties against Johnson & Johnson, Ethicon, Inc., and related defendants over similar allegations.