Drugs

2nd Circuit Enforces ‘Rigorous’ Materiality Standard

Three Jones Day attorneys say in an online blog post that the 2^nd Circuit Court of Appeals has joined several other circuits in enforcing the “rigorous” materiality standard for False Claims Act cases set forth by the Supreme Court in its 2016 Escobar decision. The 2^nd Circuit ruled in a case involving Amgen’s Epogen (epoetin alfa) in which a whistleblower claimed that the drug’s packaging was misleading and induced government healthcare programs to pay claims they otherwise would not have paid.

A federal district court dismissed the case on public-disclosure grounds and the whistleblower appealed to the 2^nd Circuit. “Instead of addressing the public-disclosure arguments,” the attorneys write, “the 2^nd Circuit affirmed on alternate grounds of materiality.” They say the court emphasized that a complaint must present concrete allegations from which it may draw the reasonable inference that the misrepresentations in Epogen’s packaging and marketing materials caused the government to make the reimbursement decision.

The court said the whistleblower’s suit “relies on a conclusory assertion that Amgen’s failure to disclose [a] study to the Centers for Medicare and Medicaid Services was material to, or in effect caused, payment.” The attorneys say the court found that the whistleblower’s assertion was not enough.

“Coyne is the latest evidence that courts are taking seriously the Supreme Court’s statements in Escobar that the False Claims Act’s materiality requirement is ‘rigorous,’ that it is not ‘sufficient for a finding of materiality that the government would have the option to decline to pay if it knew of the defendant’s noncompliance,’ and that the standard is not too fact-sensitive to be enforced on a motion to dismiss,” the attorneys conclude. “Applying Escobar’s ‘rigorous’ standard, Coyne shows that materiality must be alleged with some detail and bolsters the growing consensus that the government’s decision to continue paying claims with knowledge of the misrepresentation precludes a finding of materiality.”

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