The recent lawsuit in the United States under the False Claims Act (“FCA”) in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for the off-label use of medical devices, even when healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained vendors to reuse disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, resulting in vendors submitting false Medicare claims for services that misuse catheters. The complaint alleges that Prometheus endangered vulnerable Medicare patients to gain a marketing advantage by reducing overhead costs associated with its systems. The message to medical device manufacturers is clear: even without filing government claims themselves, manufacturers can face FCA liability for suggesting that suppliers use their devices in ways that the FDA does not. ‘t endorsed (and in this case, warned against).
Prometheus manufactures a pelvic muscle rehabilitation system and associated rectal pressure probe used to treat pelvic floor disorders. The FDA has approved the probe for single-person use, but Prometheus has reportedly trained providers to reuse the device on multiple patients by covering the probe with a glove or condom. Prometheus also reportedly asked suppliers to reuse another company’s probe with a different pelvic rehabilitation system it manufactures, although the FDA approved the probe for single use only. The FDA even required warnings on the packaging of the probes, “restricted for use by one person only” and “[d]o do not reuse. »
To prove an FCA violation, the government will need to show that Prometheus’ allegedly non-compliant user instructions caused vendors to submit false statements, that Prometheus knew about it (or recklessly ignored the falsehood), and that the use contraindicated was important to Medicare’s decision. pay supplier debts. To establish the knowledge element, the government alleges that Prometheus knew that the probes were single-use or single-use, and also knew that its provider customers were submitting claims to Medicare for procedures using the devices because Prometheus told the providers how to bill for pelvic rehab. services. The government attempts to prove materiality using Medicare’s coverage requirement that procedures must be “reasonable and necessary.” The Centers for Medicare and Medicaid codified the definition of “reasonable and necessary” last year, including the requirement that procedures be “[f]urinated in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition…” The government alleges that the reuse of the rectal probes was not “reasonable and necessary”, even though the procedures and treatment under It appears that the government is also trying to demonstrate falsity based on failure to meet the “reasonable and necessary” requirement.
This is not the first time the government has used the FCA against medical device manufacturers for off-label uses of their products. In 2018, AngioDynamics has settled for $12.5 million following allegations that he misleadingly promoted his drug delivery product LC Bead as doing more than the FDA had approved. Some of the largest FCA settlements ever recorded involve pharmaceutical manufacturers encouraging off-label use of their drugs: Pfizer settled for $2.3 billion– of which $1 billion was an FCA settlement – for the off-label marketing of Bextra, and Warner-Lambert pleaded guilty in 2004 and paid a $430 million settlement as part of the promotion of its drug Neurontin for off-label uses.
But all hope is not lost for manufacturers of medical devices. 9e Circuit recently refused to sanction a medical device manufacturer for marketing its products for a use that the FDA specifically contraindicated on labels. In Dan Abrams Co. v. Medtronic Inc.Case No. 19-56377 (9th Cir. Apr. 2, 2021), 9e Circuit upheld the partial dismissal of the parent’s FCA claim and found that Medicare does not distinguish between in- and out-of-compliance uses in determining whether to pay claims, and that even contraindicated uses are eligible for the payment if medically necessary and reasonable. The court went on to note that simply showing that harm may result from off-label or contraindicated use is not sufficient to satisfy materiality, as every surgical procedure carries risks. The Southern District of Florida followed suit with its recent decision in United States ex rel. Watt vs. VirtuOx, Inc.dismissing the parent’s claim that the defendant’s use of a medical device was not medically necessary or reasonable simply because it was non-compliant.
Prometheus declined to file a motion to dismiss and instead filed its response on July 18, 2022. So if not settled, the case will be decided either on a motion for summary judgment or at trial. But even when government and rapporteur complaints do not survive a motion to dismiss, it can be costly to fight the allegations. Device manufacturers should keep this in mind when marketing their devices for off-label use.