Drugs

Plaintiffs Need to Prove ‘Newly Acquired Evidence’: Attorney

Attorney Steven Boranian (Reed Smith) says plaintiffs alleging that innovator companies failed to issue a warning after receiving “newly acquired evidence” of a risk must be able to tell what the company knew and when it knew it. Writing in a Drug and Device Law blog post, Boranian reviews a number of court cases that recognize that implied preemption depends on whether the plaintiff can present newly acquired evidence of a relevant risk.

He quotes an Alabama federal court decision that “if a plaintiff can allege the existence of newly-acquired information that supports a labeling change under the changes being effected regulation, and if the manufacturer subsequently fails to show by ‘clear evidence’ that FDA would not have approved a change to the label, then a failure-to-warn claim will survive the manufacturer’s preemption defense.”

The Alabama case involved a complaint that Boehringer Ingelheim failed to warn adequately about the risk of diabetic ketoacidosis in one of its drugs. But, the post says, the complaint was ambiguous on what the manufacturer knew about that condition and when the manufacturer knew it. Boranian says the court particularly objected to what it terms allegations that were “nothing but a useless set of legal conclusions.” The court allowed the plaintiff to submit an amended complaint, but said it must “eliminate the unnecessary and unhelpful shotgun assertions and claims.”

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