Devices

False Claims Act Used in Off-Label Cases: Attorney

Attorney Keeley McCarty (SheppardMullin) says medical device manufacturers should be aware that the federal government is using False Claims Act prosecution to target manufacturers for off-label use of their devices, even where healthcare providers have decided the use is safe and effective. Writing in an online post, McCarty cites the recent case of United States v. Prometheus Group, et al.

In that case, she says, the government alleges that the company trained providers to re-use disposable rectal probes against FDA recommendations, causing the providers to submit false claims to Medicare for the services misusing the probes.

“The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face False Claims Act liability for suggesting providers use their devices in any way FDA has not approved (and in this case, warned against),” McCarty writes.

The post also cites a 2018 case in which AngioDynamics settled for $12.5 million and says that some of the largest False Claims Act settlements have been with drug companies for promoting off-label use of their drugs.

Saying that all hope is not lost for manufacturers, McCarty also references a recent 9th Circuit Court of Appeals decision that declined to penalize Medtronic for marketing its products for a use that FDA expressly contraindicated on the labeling. The court found that Medicare does not distinguish between on-label and off-label uses in determining whether to pay claims and that even contraindicated uses are eligible for payment if they are medically necessary and reasonable.

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

Read more

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