FDA Policy/General

9th Circuit Returns LapBand Case to District Court

The 9^th Circuit Court of Appeals says that a California federal court erred in granting the federal government’s motion to compel production of many attorney-client documents as part of an obstruction of FDA case involving 1-800-Get-Thin, a weight loss call center that marketed the LapBand medical device to medical and surgical facilities. After receiving a complaint that the call center’s advertising did not contain sufficient risk information, the decision says, FDA opened an investigation and sent Warning Letters to the center and several healthcare facilities.

Responses to the agency from attorneys for the parties were found by the government to contain false statements intended to obstruct the FDA investigation. Under the crime-fraud exception to attorney-client privilege, grand jury subpoenas were issued to the lawyers to produce (1) all communications relating to their correspondence to FDA, including documents and notes showing the information received and identifying the sources of information for the statements and representations made; and (2) retainer agreements and billing records identifying the client(s) who retained and paid for their services in communicating with FDA. The appeals court says the attorneys provided some information but did not fully comply with the subpoenas.

In response to a government motion to compel compliance with the subpoena, the district court, without reviewing any documents in camera, determined from independent, non-privileged evidence that the government had established a prima facie case that the lawyers’ services were obtained “in furtherance of and sufficiently related to ongoing” crimes, that is, false statements to and obstruction of FDA. The court then granted the government’s motion to compel production of all items identified in the subpoenas.

The appeals court ruled that while in camera review of documents is not needed to establish a prima facie case, it is needed to determine which specific documents should be produced.

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