J&J Will Appeal $8 Billion Verdict of Claims Risperdal Caused Breast Growth

因未能警示胸部发育风险被罚80亿美元,强生回应将上诉

2019-10-10 10:00:11 BioSpace

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One week after settling an opioid lawsuit in Ohio for $20 million, life science giant Johnson & Johnson was slammed with an $8 billion verdict in a lawsuit regarding its antipsychotic drug Risperdal. The jury found the company failed to warn patients of a side effect causing young men who used the drug to grow breasts (gynecomastia). The $8 billion in punitive damages was awarded Tuesday to a man who had won $680,000 in a previous lawsuit, Reuters said. This was the first of many lawsuits filed in Pennsylvania regarding Risperdal and the first in which a jury had been able to consider awarding punitive damages, the wire service added. That decision came after a 2018 Pennsylvania Superior Court ruling held that individual state’s laws should apply to punitive damages, rather than the laws of J&J’s home-state New Jersey, which barred punitive damages. Attorneys for the plaintiff Nicholas Murray said in a statement that the jury imposed punitive damages on J&J and its pharma subsidiary Janssen Pharmaceuticals because the company “valued profits over safety and profits over patients.” Murray, 26, had been prescribed the medication when he was a minor and alleged that the drug was the cause of the development of breasts. According to the Reuters report, Murray was prescribed the drug off-label by his doctor after he was diagnosed with autism spectrum disorder. In 2015, Murray initially won $1.75 million in court against J&J for the gynecomastia claims, but that was reduced to $680,000 in a 2018 state appeals court decision. In a statement issued last night, J&J said the verdict is “grossly disproportionate with the initial compensatory award” in the case and is confident that it will be overturned in the appeals process. The company added that the $8 billion verdict is inconsistent with other Risperdal lawsuits outside of Philadelphia. J&J said it will begin the process to set aside the verdict. “This award for a single plaintiff stands in stark contrast with the initial $680,000 compensatory award and is a clear violation of due process. United States Supreme Court precedent dictates that punitive damages awards that are a double-digit multiplier of the compensatory award should be set aside,” J&J said in its statement. Additionally, J&J claimed it had been prevented from presenting a “meaningful defense” due to the court’s exclusion of key evidence. J&J said if that information had been allowed, the jury would have heard evidence showing the label on Risperdal “clearly and appropriately outlined the risks associated with the medicine.” Additionally, the company said had it been allowed to present this evidence, the jury would have heard of the benefits the medication provides to patients “with serious mental illness.” “Further, the plaintiff’s attorneys failed to present any evidence that the plaintiff was actually harmed by the alleged conduct,” J&J added. J&J’s Risperdal is an antipsychotic drug first approved in 1993 by the U.S. Food and Drug Administration to treat adult and adolescent schizophrenia and bipolar disorder. It is also prescribed to autistic children for irritability. The Murray case isn’t the first Risperdal case to be heard regarding gynecomastia. In 2015, former FDA Commissioner David Kessler testified in a Philadelphia courtroom that the antipsychotic was “probably or very likely” to cause breast development in males. During his testimony, Kessler pointed to a 2001 clinical study that showed the adverse events of gynecomastia. This is not the first issue J&J has had with Risperdal. In 2013, the company pled guilty to promoting off-label use of the drug in elderly dementia patients. The company paid more than $2.2 billion to settle charges from the U.S. Department of Justice.
一周前,生命科学巨头强生公司在俄亥俄州以2000万美元的价格了结了一起阿片类药物诉讼,在一场有关其抗精神病药物 Rispedal 的诉讼中被判80亿美元的赔偿金。陪审团发现,该公司未能警告患者服用这种药物会导致年轻男性乳房发育不良。 路透社说,这80亿美元的惩罚性赔偿周二被判给了一名在前一次诉讼中胜诉的人。这是宾夕法尼亚州针对 Rispedal 提起的许多诉讼中的第一起,也是陪审团能够考虑判给惩罚性赔偿的第一起。这一决定是在2018年宾夕法尼亚州高等法院( Pennsylvania Superior Court )裁定,各州法律应适用于惩罚性赔偿,而不是禁止惩罚性赔偿的新泽西州的法律。 原告律师尼古拉斯•穆雷( Nicholas Murray )在一份声明中表示,陪审团对强生(J&J)及其医药子公司杨森制药(杨森(Janssen) Pharmaceuticals )实施惩罚性赔偿,因为该公司“对利润高于安全利润,对患者利润进行估值”。 26岁的默里在小时候就被开了处方药,并声称该药是导致乳房发育的原因。据路透社报道,穆雷被诊断患有自闭症谱系障碍后,医生给他开出了这种药物的标签。2015年, Murray 最初以女乳症索赔在法庭上赢得175万美元,但在2018年州上诉法院的判决中,这一数字降至68万美元。 在昨晚发布的一份声明中,强生(J&J)表示,判决“与本案最初的补偿性裁决严重不相称”,并有信心在上诉过程中推翻判决。该公司补充说,80亿美元的判决与费城以外的其他 Rispedal 诉讼不一致。强生(J&J)表示,将开始搁置判决的程序。 “这一针对单个原告的裁决与最初的68万美元补偿性裁决形成鲜明对比,明显违反了正当程序。美国最高法院的判例规定,惩罚性赔偿裁决是补偿性赔偿裁决的两位数乘数,应予以撤销,”强生(J&J)在声明中说。 此外,强生(J&J)还声称,由于法院排除了关键证据,该公司无法提出“有意义的抗辩”。强生(J&J)表示,如果这些信息被允许,陪审团将听取证据,表明 Rispedal 的标签“清楚、恰当地概述了与该药物相关的风险”。此外,该公司表示,如果它被允许提交这一证据,陪审团将听取药物对“严重精神疾病”患者的好处。 “此外,原告的律师没有提供任何证据证明原告实际上受到指控行为的伤害,” J & J 补充说。 J & J 的 Rispedal 是一种抗精神病药物,1993年首次被美国食品药品监督管理局(Food and Drug Administration)批准用于治疗成人和青少年精神分裂症和双相情感障碍。它也被规定为自闭症儿童的易怒。 Murray 病例不是第一例有关妇科乳腺炎的 Rispedal 病例。2015年, FDA 前专员戴维•凯斯勒( David Kessler )在费城一家法庭作证称,抗精神病药物“很可能或很可能”会导致男性的乳房发育。在他的证词中,凯斯勒指出,2001年的一项临床研究显示了妇科乳腺炎的不良事件。 这不是强生(J&J)与 Rispedal 的第一个问题。2013年,该公司承认在老年痴呆患者中推广该药物的非标签使用。该公司支付了超过22亿美元以了结美国司法部的指控。

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