Medtronic SubQ Stimulation Settlement Results False Claims Allegations for $2.8M

Medtronic has reached a settlement, that will result in payments of $2.8 million to resolve claims that the company illegally promoted the SubQ spinal cord stimulation devices for unapproved uses. 

The U.S. Department of Justice announced the Medtronic SubQ stimulation settlement on February 6, resolving claims that the medical device manufacturer violated the False Claims Act from 2007 through 2011.

According to the allegations, Medtronic used “on-site training programs” for doctors and other methods to promote the use of its spinal cord stimulation devices for SubQ stimulation procedures, which involve placing the devices under the skin near an area of pain to provide electrical impulses meant to alleviate that pain. However, this procedure has never been approved by the FDA and has not been established as safe or effective.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The Justice Department claims that this means “Medtronic knowingly caused dozens of physicians located throughout more than 20 states to submit claims to Medicare and TRICARE for investigational medical procedures known as SubQ stimulation that were not reimbursable.”

The allegations came as the result of a whistleblower lawsuit brought by Jason Nickell, a former Medtronic sales representative. Under the Qui Tam provisions of the false claims act, Nickell will be rewarded $602,000 of the $2.8 million settlement for bringing the situation to the government’s attention.

“Patients should be able to trust that their health care providers only use — and bill Medicare for — medical procedures that have been shown to be safe and effective,” Special Agent in Charge Scott J. Lampert, of the Department of Health and Human Services’ Office of Inspector General, said in the press release. “Our agency will continue to pursue medical device makers that ignore requirements designed to protect patient health and federal health care programs.”

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

AT&T Data Breach Class Action Claims Telecom Giant
AT&T Data Breach Class Action Claims Telecom Giant "Disregarded" Customer Financial Safety (Posted today)

A Missouri woman is one of the latest person to file an class action claim over the AT&T data breach, after the telecom company admitted that hackers stole millions of customers' personal information and sold it on the internet.

Plaintiffs Oppose Phased Discovery Over Suboxone Tooth Decay Risks in MDL
Plaintiffs Oppose Phased Discovery Over Suboxone Tooth Decay Risks in MDL (Posted yesterday)

Plaintiffs say a federal judge should not waste time on a phased discovery plan requiring them to first prove Suboxone strips can cause tooth decay, saying the science is obvious and such a plan could delay resolution of hundreds of product liability lawsuits.