Devices

False Claims Liability for Medical Device Off-Label Use

Attorney Keeley McCarty (Sheppard Mullin) says Department of Justice (DoJ) prosecution of Prometheus Group is a reminder that the government will use the False Claims Act (FCA) to target medical device manufacturers for off-label use of medical devices, even when healthcare providers have decided the devices are safe and effective. The department says Prometheus, which manufactures pelvic muscle therapeutic systems and related rectal probes, and its president violated the False Claims Act by causing healthcare providers to bill Medicare for services in which the providers improperly reused single-use rectal sensors and catheters on multiple patients.

McCarty says the DoJ complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems. “The message to medical device manufacturers is clear: even without submitting claims to the government themselves, manufacturers can face FCA liability for suggesting providers use their devices in any way FDA has not approved (and in this case warned against),” McCarty writes.

The attorney says the government will have to show that Prometheus’ alleged off-label use instructions caused providers to submit false claims, that the company knew this (or recklessly disregarded the falsity), and that the contraindicated use was material to Medicare’s decision to pay the providers’ claims.

“Prometheus declined to file a motion to dismiss and instead proceeded to file its answer on 7/18,” McCarty writes. “Thus, if not settled, the case will be decided on either a motion for summary judgment or at trial. But even where the government’s and relators’ (whistleblowers’) complaints do not survive a motion to dismiss, it can be costly to battle the allegations. Device manufacturers should keep this in mind when marketing their devices for off-label uses.”

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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