Off-Label Use of Medical Device Subject to False Claims Act Litigation

August 15, 2022

Companies who promote unapproved uses of medical products may be liable for damages and civil penalties under the False Claims Act (“FCA”) and thus whistleblowers may potentially be eligible for pharmaceutical False Claims Act whistleblower awards.

“Off-label” promotion of a medical device or pharmaceutical product occurs when a company advertises or otherwise encourages a product’s use in a manner that has not been explicitly approved by the U.S. Food and Drug Administration (“FDA”). On May 17, 2022, the Department of Justice (“DOJ”) announced an FCA lawsuit against The Prometheus Group for encouraging the off-label reuse on multiple patients of rectal probes and catheters that the FDA had approved as single-user and single-use respectively. The DOJ alleged that the reuse of these devices exposed vulnerable Medicare beneficiaries to unnecessary risks of serious bacterial, fungal, and viral infections.

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According to the DOJ’s complaint, Prometheus’s rectal pressure probe was approved by the FDA to be inserted into the rectum of a single patient to assist in pelvic muscle rehabilitation. The FDA-approved instruction label identified the sensor as “a potential bio-hazard” and “restricted for single person use only.” Similarly, the manometry catheter used in conjunction with the rectal probe was approved by the FDA for single-use only. The DOJ alleged that Prometheus knew of these restrictions, but instructed health care providers to use rectal probes and catheters on multiple patients, using a glove or condom to cover the probes, as a way to reduce costs. Prometheus allegedly did not investigate whether the probes worked under these circumstances.

The Prometheus litigation is just the latest in the DOJ’s use of the FCA to crack down on off-label promotion and use of medical products. In 2009, Pfizer paid $2.3 billion to settle pharmaceutical whistleblower claims that it illegally promoted the sale of pharmaceutical products for off label uses, including the recalled Bextra.

Not all federal circuits accept the DOJ’s theory of using the FCA to enforce medical product usage, but of course, one needs to dig deeper into each case to determine its meaning in the fabric of False Claims Act law. In Dan Abrams Co. v. Medtronic Inc., Case No. 19-56377 (9th Cir. Apr. 2, 2021), the 9th Circuit affirmed the partial dismissal of an FCA claim, finding that on-label and off-label uses were not material to Medicare’s decision to pay in that instance. The court also found that contraindicated uses may be eligible for reimbursement if they are medically necessary and reasonable. Similarly, the Southern District of Florida dismissed the complaint in United States ex rel. Watt v. VirtuOx, Inc., in which a whistleblower alleged that defendant’s use of a medical device was not medically necessary or reasonable because it was off-label, however the court was troubled by other aspect of that case in addition to the off-label promotion theory.            

Nevertheless, whistleblowers should be mindful of off-label uses of medical products, especially when there is potential harm to patients. Health care professionals and pharmaceutical drug reps who want to learn more about the FDA and their rights under the FCA can contact experienced qui tam law firms like Brown, LLC. Led by former FBI Special Agent Jason T. Brown, the whistleblower team at Brown, LLC will advise you on how to navigate the complex landscape of FCA litigation. Contact the firm at 877-561-0000 or for a free and confidential consultation.