FDA and DOJ tag team Spectranetics Corporation

The following is a textbook example of why you don’t want to cross the FDA. Not only are they the most underrated heavyweights around, they’re also best buddies with The Justice Department. And together, they can bring the pain. Big time.

Spectranetics Corporation, a Colorado Springs medical device manufacturer, allegedly “…illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.”

It apparently wasn’t small level stuff like gauze or bandages that were illegally brought over, either.

“The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.”

Whoops!

So now after a quick tag-team match with the DOJ and FDA, Spectranetics now “…has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company.”

There were no criminal charges filed against Spectranetics, even though they “caused false claims to be submitted to the Medicare Program during portions of the time period from 2003 to 2008.”

And as part of the no criminal charges deal, “Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation.”

Here’s the link to the DOJ article.

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