Drugs

Appeals Court Backs Greer Labs Win in Whistleblower Case

The 4^th Circuit Court of Appeals has affirmed a federal district court’s summary judgment in favor of Greer Laboratories in a case in which whistleblowers said the company had sold custom mixes of allergenic extracts to doctors under an FDA general license rather than a required separate license for custom mixes. Jones Day attorneys write in an online analysis that the appeals court said the whistleblowers, who were former Greer employees, could not establish scienter (knowledge of wrongdoing) under the False Claims Act (FCA) and also had not engaged in a protected activity under that act.

“The conventional wisdom that the scienter requirement is not ripe for summary judgment because intent is traditionally an issue to be decided by the trier of fact is appropriately turned on its head in this case,” the attorneys write. “Scienter, like materiality, remains subject to a rigorous inquiry and should be considered as the focus of any summary judgment motion in an FCA case.”

After reviewing the history of the case and the courts’ holdings, the attorneys offer three takeaways:

the FCA’s scienter requirement remains rigorous and should not be overlooked as a basis for summary judgment, particularly with ambiguous statutes or regulations;
industry practice can be a useful avenue for compelling evidence on whether a defendant acted with requisite scienter and might be an appropriate area for expert testimony; and
FDA inspections or audits that do not result in any adverse findings can negate any claim that a defendant knowingly misled the government about the conduct at issue.

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