5 Things to Know About the Sanford Health Spinal Device Settlement Agreement

This past December, Sioux Falls, S.D.-based Sanford Health settled a lawsuit alleging Anti-Kickback Statute violations by some of the health system's neurosurgeons.

Here are five key things to know about the case.

1. Whistleblower David Dubay originally filed a qui tam action in a South Dakota district court in January 2011. The lawsuit named Wilson Asfora, MD, and Bryan Wellman, MD, both neurosurgeons employed at Sanford Clinic, a subsidiary of Sanford Health. The suit also named Sanford Health, Sanford Clinic and Sanford Medical Center, along with Sanford Clinic Neurosurgery and Spine.

2. Dr. Asfora is the founder and part owners of the medical device company Medical Designs, which manufactured the Asfora Bullet Cage, a device used in spinal inter-body fusion procedures. Medical Designs was also named a defendant in Mr. Dubay's qui tam suit.

3. The lawsuit alleged that, from May 2010 to April 2011, Medical Designs made payments to Dr. Wellman and two other Sanford employees to allegedly encourage their promotion and use of the Asfora Bullet Cage, violating the Federal Anti-Kickback Statute.

4. Under the settlement agreement, the defendants agreed to pay the U.S. and South Dakota governments $625,000. As the relator, Mr. Dubay will receive $156,250 from this settlement amount under the False Claims Act.

5.  The defendants have expressly denied the allegations and maintain that they did not engage in wrongful conduct.

More Articles on Anti-Kickback Lawsuits:
Is ASC Litigation on the Rise?  
Physician Compensation: 10 Core Legal and Regulatory Concepts
Emerging Trends in Stark, False Claims and Anti-Kickback Cases for Health Systems 

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