Drugs

Supreme Court Won’t Hear Park Doctrine Appeal

The Supreme Court has declined to hear an appeal filed by Jack and Peter DeCoster over their three-month prison sentences under the Park doctrine’s responsible corporate officer provisions. The jail term had been upheld by a 2-1 8^th Circuit Court of Appeals decision, attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in an online FDA Law Blog post. The DeCosters’ legal problems began with a 2010 salmonella outbreak.

Thomas says that a supervisory liability conviction may justify a penalty of imprisonment without violating due process only where “blameworthiness” exists, either inherent in the offense or based on case-specific findings of fact. “Even if the Park doctrine itself does not implicate blameworthiness,” she writes, “the facts of the DeCosters’ case demonstrate that pleading guilty to a Park offense without admitting knowledge or negligence does not preclude the sentencing judge from going on to find facts that support scienter” (knowledge that an act is wrong before committing the act).

She says that attorney general Jeff Sessions continues to favor aggressive prosecution and sentencing of strict liability offenses. Given the importance of individual responsibility to the Justice Department, she says, and the unsettled nature of the 8^th Circuit’s ruling, it would not be surprising to see another case testing Park limits.

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