Johnson & Johnson And Subsidiary To Pay $117 Million Settlement After Endangering Women's Health

Johnson & Johnson and Subsidiary to Pay $117 Million
危害女性健康后结算

消费者误导的安全性,有效性, 和阴道网格设备的潜在风险

NEW YORK – New York Attorney General Letitia James today announced a multistate settlement, along with 41 additional attorneys general, requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for the deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation. 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.

“健康和安全必须拿出利润之前,” 总检察长詹姆斯 said. “While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers.”

经阴道手术网是通过外科手术通过阴道植入支持妇女的盆腔脏器谁从压力性尿失禁或盆腔器官脱垂遭受合成材料。 

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 that Johnson & Johnson and its subsidiary were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.

Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and the District of Columbia. New York State will receive $5,203,122.50 under the settlement.

结算也提供禁令救济,因此需要充分公开的设备的风险和宣传材料的准确信息,除了产品的“使用信息”包装插页。

具体要求中,企业必须:

  • 从参考模型作为“美国FDA批准,”不要当事实并非如此。
  • 从代表,在促销,与网格相关的风险,可以单独用手术经验或技术来消除避免。
  • 确保提供医疗专业人士认为,产品培训涵盖了与网格相关的风险。
  • 停止声称:该手术网状延伸或保持植入后手感柔软,即异物反应是暂时的,异物反应“可能”会出现,当研究表明,他们这样做,事实上,发生。
  • 披露目风险包括:瘘管形成和炎症,以及网格挤压,曝光和侵蚀插入阴道等器官。
  • 披露的风险:经阴道植入和阴道的疤痕组织收缩,性交疼痛,性功能丧失,急迫性尿失禁,从头失禁,感染。
  • 披露的风险包括翻修手术:可能需要治疗的并发症,可能无法解决并发症,也与不良反应的风险。

在此多态结算加盟总检察长詹姆斯是一般阿拉巴马,阿拉斯加,亚利桑那,阿肯色,科罗拉多,康涅狄格,特拉华,佛罗里达,佐治亚,夏威夷,爱达荷,伊利诺伊州,印第安纳州,爱荷华州,堪萨斯州,路易斯安那州,缅因州,马里兰州,马萨诸塞州的律师,密歇根州,密苏里州,蒙大拿州,内布拉斯加州,内华达州,新泽西州,新墨西哥州,北卡罗来纳州,北达科他州,俄亥俄州,俄克拉荷马州,宾夕法尼亚州,罗得岛州,南卡罗来纳州,南达科他州,田纳西州,得克萨斯州,犹他州,佛蒙特州,弗吉尼亚州,威斯康星州,和哥伦比亚特区。

代表纽约,该案由消费者欺诈和保护局的特别顾问玛丽alestra处理,副局劳拉j的监督之下。 Levine和局长简汇亚大厦。消费者欺诈和保护局是经济公正的划分,这是由副总检察长克里斯托弗·德安杰洛领导的一部分。