Drugs

Jury Awards $8 Billion in Risperdal Case

A Philadelphia jury delivered an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the antispychotic drug Risperdal, according to a Law.com article. The three-week trial in Murray v. Janssen Pharmaceuticals resulted in the largest penalty to date in the Risperdal litigation, which involves nearly 7,000 cases pending in the Philadelphia Court of Common Pleas. Nicholas Murray had previously won $680,000 over his claims that the company failed to warn that young men using Risperdal could grow breasts.

“This jury resoundingly told Johnson & Johnson that its actions were deliberate and reckless,” plaintiff’s attorney Thomas R. Kline (Kline & Specter) was quoted as saying after the verdict was handed down. “And the conduct that the jury saw in this courtroom, clearly and convincingly, which is our legal standard, [was] a company that disregarded the safety of the most vulnerable of children. This is an important moment, not only for this litigation, but for J&J, which is a company that has lost its way.”

In a statement to the press, J&J spokesman Andrew Wheatley said the award was “grossly disproportionate” to the compensatory award and the company “is confident it will be overturned... The company was precluded from presenting a meaningful defense due to the court’s exclusion of key evidence. As a result, the jury did not hear evidence as to how the label for Risperdal clearly and appropriately outlined the risks associated with the medicine, or the benefits Risperdal 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.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome