{"id":116723,"date":"2021-03-23T22:23:14","date_gmt":"2021-03-24T05:23:14","guid":{"rendered":"http:\/\/69.46.6.243\/?p=116723"},"modified":"2021-03-23T22:23:14","modified_gmt":"2021-03-24T05:23:14","slug":"california-department-of-justice-announces-188-6-million-multistate-settlement-with-medical-device-manufacturer-boston-scientific-corporation","status":"publish","type":"post","link":"https:\/\/new.thepinetree.net\/?p=116723","title":{"rendered":"California Department of Justice Announces $188.6 Million Multistate Settlement with Medical Device Manufacturer Boston Scientific Corporation"},"content":{"rendered":"<p>Sacramento, CA&#8230; The California Department of Justice and Washington Attorney General Bob Ferguson today announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations of deceptive marketing of its surgical mesh products for women. The settlement requires Boston to pay $188.6 million to 47 states and the District of Columbia to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients. California\u2019s share of the settlement is $19.3 million.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-82791\" src=\"https:\/\/new.thepinetree.net\/wp-content\/uploads\/2019\/07\/cadoj.jpg\" alt=\"\" width=\"225\" height=\"224\" srcset=\"https:\/\/new.thepinetree.net\/wp-content\/uploads\/2019\/07\/cadoj.jpg 225w, https:\/\/new.thepinetree.net\/wp-content\/uploads\/2019\/07\/cadoj-150x150.jpg 150w, https:\/\/new.thepinetree.net\/wp-content\/uploads\/2019\/07\/cadoj-30x30.jpg 30w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/><\/p>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td colspan=\"2\" align=\"left\" bgcolor=\"#ffffff\" width=\"560\">\n<div>\n<p>Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in women 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 use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions\u00a0of women were implanted with the device\u00a0and thousands of women are alleged to have suffered serious complications resulting from these devices.<\/p>\n<p>The complaint alleges that\u00a0Boston misrepresented the safety of these\u00a0products\u00a0by failing to disclose the full\u00a0range\u00a0of\u00a0potential serious and irreversible complications caused by mesh, including chronic pain,\u00a0voiding dysfunction, and new onset\u00a0of incontinence. The settlement with Boston follows a $344 million\u00a0<a href=\"https:\/\/oag.ca.gov\/news\/press-releases\/attorney-general-becerra-secures-nearly-344-million-judgment-against-johnson\" target=\"_blank\" rel=\"noopener noreferrer\">California\u00a0Superior Court judgment\u00a0in January 2020 against surgical mesh manufacturer Johnson &amp; Johnson<\/a>\u00a0and a\u00a0<a href=\"https:\/\/oag.ca.gov\/news\/press-releases\/attorney-general-becerra-announces-60-million-multistate-settlement-medical\" target=\"_blank\" rel=\"noopener noreferrer\">$60 million\u00a0multistate settlement with C.R. Bard Inc.\u00a0in September 2020<\/a>\u00a0to resolve an\u00a0investigation into Bard\u2019s marketing of its\u00a0pelvic\u00a0mesh products\u00a0for\u00a0women.<\/p>\n<p>The settlement provides comprehensive injunctive relief.\u00a0Boston has agreed to the settlement\u2019s injunctive terms which include but are not limited to the following reforms:<\/p>\n<p><b>Marketing Reforms:<\/b><\/p>\n<ul type=\"disc\">\n<li>Disseminate marketing materials\u00a0for\u00a0consumers describing complications in understandable terms;<\/li>\n<li>Disclose significant complications in certain marketing materials, including the inherent risks of mesh;<b>\u00a0<\/b><\/li>\n<\/ul>\n<p><b>Training Reforms:<\/b><\/p>\n<ul type=\"disc\">\n<li>Inform healthcare providers of significant complications during\u00a0Boston trainings regarding procedures\u00a0for\u00a0insertion and implantation;<\/li>\n<li>Maintain policies requiring independent contractors, agents, and employees who sell, market, or promote mesh\u00a0to\u00a0be adequately trained to report patient complaints and adverse events to the company;<\/li>\n<\/ul>\n<p><b>Clinical Trial Reforms:<\/b><\/p>\n<ul type=\"disc\">\n<li>Disclose its role as a sponsor and any author\u2019s potential conflict of interest when submitting a clinical study or clinical data regarding mesh\u00a0for\u00a0publication; and<\/li>\n<li>Register all Boston-sponsored clinical studies regarding mesh with\u00a0<a href=\"http:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">ClinicalTrials.gov<\/a>.<\/li>\n<\/ul>\n<p>The investigation that\u00a0resulted in\u00a0today\u2019s settlement was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas. Joining this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.<\/p>\n<p>A copy of the\u00a0complaint is\u00a0<a href=\"https:\/\/oag.ca.gov\/system\/files\/attachments\/press-docs\/BostonComplaint.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>\u00a0and the\u00a0stipulated judgment submitted\u00a0for\u00a0court\u00a0approval\u00a0is\u00a0<a href=\"https:\/\/oag.ca.gov\/system\/files\/attachments\/press-docs\/Boston%20final%20judgment.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/p>\n<\/div>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" align=\"center\" bgcolor=\"#ffffff\" width=\"560\"># # #<\/p>\n<p>You may view the full account of this posting, including possible attachments, in the News &amp; Alerts section of our website at:\u00a0<a href=\"https:\/\/oag.ca.gov\/news\/press-releases\/california-department-justice-announces-1886-million-multistate-settlement\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/oag.ca.gov\/news\/press-releases\/california-department-justice-announces-1886-million-multistate-settlement<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Sacramento, CA&#8230; The California Department of Justice and Washington Attorney General Bob Ferguson today announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations of deceptive marketing of its surgical mesh products for women. The settlement requires Boston to pay $188.6 million to 47 states and the District of Columbia to resolve allegations [&hellip;]<\/p>\n","protected":false},"author":1599,"featured_media":80592,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_cbd_carousel_blocks":"[]","jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[20,5,33,4,1],"tags":[],"class_list":["post-116723","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-government","category-health-fitness","category-life-style","category-news","last_archivepost"],"jetpack_featured_media_url":"https:\/\/new.thepinetree.net\/wp-content\/uploads\/2019\/05\/dojpng.png","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts\/116723","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/users\/1599"}],"replies":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=116723"}],"version-history":[{"count":0,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts\/116723\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/media\/80592"}],"wp:attachment":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=116723"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=116723"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=116723"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}