Parker Waichman LLP

Lawsuit Filed Against Medtronic for Promoting Off-Label Use of Infuse

A lawsuit filed this week alleges that Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product. The complaint includes the names of 98 plaintiffs who allege that the off-label use of Medtronic caused them to incur serious and permanent damages. Off-label use refers to applying a product in ways not formally […]

medtronic_infuse_lawsuit_filedA lawsuit filed this week alleges that Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product.

The complaint includes the names of 98 plaintiffs who allege that the off-label use of Medtronic caused them to incur serious and permanent damages. Off-label use refers to applying a product in ways not formally approved by the U.S. Food and Drug Administration (FDA).

Medtronic introduced Infuse as a solution to the problem of pain and other complications associated with the treatment of degenerative disc disease. The company did so by positioning the product as a means of eliminating the need for additional surgery to harvest bone from a patient’s hip for transplantation to the spine.

The Infuse Bone Graft includes a bone-growth solution contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) soaked into an absorbable collagen sponge designed to dissipate. The solution-soaked sponge goes inside the LT-Cage, which is designed to stabilize the spine during fusion.

The U.S. Food and Drug Administration (FDA) approved Medtronic’s Infuse in 2002 for one use only: spinal surgery on the lower back in which the surgeon enters the patient through the front. Despite this, the agency was receiving alarming news about the use of Infuse on the upper, or cervical, spine; in response, the FDA sent out a July 1, 2008, notification to highlight that Infuse was not approved for use on the upper spine. The notification warned that, when used in cervical spinal fusions, the Infuse Bone Graft had been associated with serious complications – including:

  • Excessive swelling in the neck;
  • Compressed airways;
  • Difficulty breathing;
  • Problems swallowing; and
  • Nerve damage.

The Complaint further alleges that, in order to tap expand the potential of Infuse in the face of the FDA approval’s limitations, Medtronic “devised a well-financed and extensive scheme to promote and market Infuse for non-approved, off-label uses,” that would make use of “fraudulent pretenses, representations and concealments of material facts.”

The Medtronic lawsuit was filed by Parker Waichman LLP, Lanier Law Firm, based in Houston, Texas; Neblett, Beard & Arsenault, in Alexandria, La.; The Drakulich Firm, APLC, in San Diego, Cal.; and Holland, Groves, Schneller & Stolze LLO, in St. Louis, Mo.

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
Positive: Professionalism , Quality , Responsiveness , Value MY CONTACT PARALEGAL WAS TINA MORACE, SHE WAS WAY BEYOND FANTASTIC IN ALWAYS KEEPING ME UPDATED WITH THE STATUS OF MY 911 VICTIMS RELIEF FUND CASE STATUS.
TONY P
6 months ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value
Emma PyfromWard
2 years ago
5 Star Reviews 150
Took on my case when my original representative became dysfunctional. Accurate, knowledgeable, totally transparent. Excellent commincation, I couldn't have expected more. I highly recommend this firm!
Bob Ballard
4 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