Drugs

7th Circuit Backs Dismissal of AbbVie False Claims Suit

The 7th Circuit Court of Appeals has affirmed a lower court’s dismissal of a False Claims Act (FCA) retaliation suit against AbbVie (formerly Allergan) that was brought by a former company sales representative. The sales rep, Jeffrey Lewis, said he was denied a promotion and given onerous assignments after complaining that AbbVie aggressively promoted its antipsychotic drug Vraylar (cariprazine) for off-label use to treat major depressive disorder and substance abuse.

Attorneys at ArentFox Schiff wrote in a blog post that the lower court had agreed with AbbVie that Lewis’ theory of recovery was “implausible.” While the appeals court rejected the lower court’s rationale, the attorneys write, it ultimately affirmed causation, noting that FCA suits against drug manufacturers for deceptive off-label marketing campaigns were not novel and it was foreseeable that a false prescription would result in a false claim. The panel affirmed, the attorneys say, because Lewis failed to put AbbVie on sufficient notice of a potential FCA violation.

Lewis’ internal emails discussed regulatory non-compliance and corporate policy, the blog says, without indicating a concern about government fraud. “Thus,” the 7th Circuit concluded, “AbbVie could not have known he was engaging in protected activity aimed at preventing FCA violations.”

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