A recently-unsealed whistleblower lawsuit claims that Medtronic engaged in a bribery scheme at the Robert J. Dole VA Medical Center.
The lawsuit alleges that doctors used Medtronic devices to perform an excessive number of unnecessary procedures called atherectomies, which are used to remove plaques that narrow arteries in the legs.
Atherectomy procedures are usually low-risk, but there is always a chance of complications — and the risk increases when a lot of devices are used on a single patient. The risks include internal bleeding, vein damage, blood clots, amputations, or even death.
The lawsuit was originally filed in 2017 by Tom Schroeder, a sales manager who worked for Becton Dickinson (BD) who turned into a whistleblower when he noticed a bribery scheme involving the competing medical-device company Medtronic.
According to his lawsuit, Medtronic “bribed hospital staff to purchase its devices over those of competitors and to purchase grossly excessive inventory.”
The allegations in the lawsuit led to the VA opening its own investigation in 2018.
The investigation was led by Rick Ament, a new medical director at the VA who grew concerned when he noticed about $5 million in excess costs in a single department of the hospital.
That department was where doctors were using Medtronic devices to perform artery-clearing atherectomy procedures and other vascular interventions.
Ament said in a deposition, “We were more expensive than, I believe it was, the top 10 hospitals in the VA combined.”
The investigation found that evidence-based medicine had not been followed in most of the patient cases that were reviewed.
Instead, doctors were using Medtronic devices to perform procedures on patients in the early stages of artery disease.
They also commonly used a large number of Medtronic devices on a single patient, including balloons, atherectomy devices, and stents — rather than one or two devices per procedure, which was the norm.
For example, documents show that 33 devices were used on a single patient in one procedure — 3 atherectomy devices, 9 stents, and 21 balloons, according to ProPublica.
In another example, doctors used 17 devices from Medtronic to clear arteries on a single patient.
As a result of the investigation and the lawsuit, leadership at the Robert J. Dole VA Medical Center notified notified the Office of Inspector General (OIG) and shut down interventional radiology procedures in April 2018.