A Medical Device Daily

The U.S. Department of Justice (DOJ) reported that American Medical Response (AMR; Greenwood Colorado), one of the nation’s largest ambulance providers, reported that it has paid the U.S. more than $9 million to resolve allegations that the company allegedly violated the False Claims Act.

The settlement relates to allegations that the company provided or offered inducements to Texas hospitals in the form of contracts known as “swapping arrangements.” Such contracts gave the medical facilities discounts on transports in exchange for the referral of all or some of the ambulance transports of patients being discharged from the hospitals, which were billed to Medicare, officials claimed.

“Illegal inducements corrupt the integrity of the Medicare program by freezing out competitors, masking the true costs of services, and misdirecting program funds, among other things,” said Peter Keisler, assistant attorney general of the DOJ’s Civil Division. “This settlement shows our ongoing commitment to pursue allegations of fraud and abuse in the Medicare system vigorously.”

The settlement arose out of whistleblower lawsuits filed in 2000 and 2001 by two former AMR employees, Daniel Block and Adam Wightman. As a result of the settlement, the men will receive $1.62 million.

In other legalities: The FDA reported the entry of a Consent Decree of Permanent Injunction barring C.R. Canfield (Fairfield, New Jesey) and owner/president Garry Parsons from manufacturing and distributing unapproved drugs and drugs that do not satisfy current good manufacturing practice requirements.

Canfield and Parsons are further barred from manufacturing and distributing drugs until they correct Canfield’s manufacturing problems and obtain approvals.

The products are used in dentistry, and the FDA said it is advising dental professionals and consumers to stop using and discard any product from C.R. Canfield who have used this firm’s products and have concerns or questions should contact their dental practitioner.

The FDA obtained evidence that Canfield manufactured and distributed adulterated and unapproved drugs, including D.S. Dressing (20% Eugenol), D.S. Mini-Dressing (20% Eugenol), D.S. Syringe (20% Eugenol), and D.S. Ointment (20% Eugenol). Canfield promoted these products for the treatment of dry socket, a condition in which the socket does not heal properly following the extraction of a tooth. The products were available nationwide through dental practices for use by dentists and consumers.

Canfield has not corrected its cGMP violations — which include releasing products for distribution without proper testing and failing to conduct studies to determine appropriate product expiration dates — despite repeated FDA inspections, efforts, and warnings by the agency advising the firm of significant compliance deviations that require prompt corrective action.

No Comments