Devices

Appeals Court Affirms Medical Device Sentence

The 11^th Circuit Court of Appeals has affirmed the sentence approved by a Florida federal court jury for a former Ethicon employee accused of stealing and reselling prescription medical devices on the grey market. The jury had sentenced Kerri Kaley, who formerly supervised sales representatives for Ethicon, to 36 months in jail and ordered her to pay restitution of $821,420.

The appeals court opinion says Kaley claimed (1) the government violated her due process rights by arguing a theory of prosecution that differed from the theory it presented in a separate trial against an alleged co-conspirator; (2) there was insufficient evidence to support a conviction for witness tampering in her initial trial; (3) the district court erred in Kaley’s second trial when it limited cross-examination of a government witness and allowed the government to use a demonstrative chart in closing arguments; and (4) the district court erred in calculating the restitution amount,

The appeals court affirmed the conviction and sentencing in all respects, rejecting all of Kaley’s arguments.

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