Devices

Medtronic Attorney Defends Company Reps in ORs

Medtronic principal litigation counsel Max Heerman and Greenberg Traurig shareholder Daniel Smulian say that medical device company representatives should continue to be allowed in operating rooms because they “are a constructive presence, providing technical support to doctors and their staffs, and improving outcomes for patients.” Writing in a Washington Legal Foundation Legal Backgrounder, the two say that trade associations, hospital systems, and manufacturers have all put reasonable restrictions in place that should allay any concerns that reps will overstep their bounds.

The backgrounder discusses the technical support role that manufacturer reps play in the operating room and how it differs from the practice of medicine. It notes that reps are present only when invited by doctors and that the doctor remains in charge. The authors also discuss several court cases brought against reps arising from procedures they attended. They say that courts have too often misunderstood the role of reps in the operating room and should protect them from liability “in all but the rarest factual circumstances.”

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