Parker Waichman LLP

DOJ Investigates Medtronic’s Cardiac Ablation Therapy Marketing

Medtronic faces federal probe over cardiac ablation therapy. Medtronic Inc. is facing a federal investigation over its marketing of cardiac ablation therapy.  The revelation was made in a regulatory filing Wednesday. Cardiac ablation therapy involves threading devices through tubes in the circulatory system to burn, freeze or otherwise kill diseased  heart cells. The therapy is used to […]

Cardiac Ablation Therapy

Medtronic faces federal probe over cardiac ablation therapy. Medtronic Inc. is facing a federal investigation over its marketing of cardiac ablation therapy.  The revelation was made in a regulatory filing Wednesday.

Cardiac ablation therapy involves threading devices through tubes in the circulatory system to burn, freeze or otherwise kill diseased  heart cells. The therapy is used to treat irregular heart beats.

According to Bloomberg News, Medtronic and other medical device makers have said they plan to enter the ablation market. As part of that effort, last year Medtronic acquired CryoCath Technologies Inc., of Kirkland, Quebec. In February, the company also announced its intention to acquire Ablation Frontiers Inc. of Carlsbad.

Product is approved to treat a spinal condition

The Department of Justice (DOJ) informed Medtronic of the cardiac ablation therapy probe via a letter Feb. 9. According to Bloomberg News, Medtronic has said it would comply with the probe.

In November, Medtronic revealed  that the DOJ was investigating the marketing of one of its bone growth products, Infuse Bone Graft. The product is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.

Infuse Bone Graft is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Infuse Bone Graft and similar devices had caused serious problems

In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.

The Journal said that most of these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites.

The Wall Street Journal also reported that doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.

During a conference call with analysts last November, Medtronic chief executive Bill Hawkins said that the company was complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse. Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.”

Need Legal Help Regarding Cardiac Ablation Therapy?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
The team at Parker/Waichman was excellent in the handling of my claim, with Benita Rollis, my paralegal, being exceptional. I highly recommend this efficient, thorough, yet caring, legal establishment.
Rhonda Reid
3 years ago
5 Star Reviews 150
Working with Julia & Joanne at Parker & Waichman. Julia and Joanne were very helpful throughout the process and took good care of me. All of my questions were always answered and they always communicated with me, phone calls were always returned right away if they could not answer. I was recommended by my friend and would definitely recommend them. Thank you for all of your help Julia, Joanne and all of the Parker Waichman family.
Tusha Ramsaroop
5 years ago
5 Star Reviews 150
Positive: Professionalism , Quality I want to say thank you to Denny Tang for handling my case. He’s a great attorney, always responsive and pleasant to speak with. Thank you for everything.
Leyla Coello
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038