Parker Waichman LLP

Medtronic Halted Infuse Study and Hid Data Report Says

Medtronic Has had A Number Of Issues Regarding Infuse Medtronic has had a number of issues regarding Infuse, a bone graft product that has become controversial amidst allegations that it hid complications in industry-funded studies, among other things. Now, The Minneapolis Star Tribune has published a report indicating that the company shut down an Infuse study […]

Infuse Study

Medtronic Has had A Number Of Issues Regarding Infuse Medtronic has had a number of issues regarding Infuse, a bone graft product that has become controversial amidst allegations that it hid complications in industry-funded studies, among other things.

Now, The Minneapolis Star Tribune has published a report indicating that the company shut down an Infuse study in 2008 and hid the data after it showed unfavorable results.

According to the report, Medtronic was conducting a retrospective chart review (RCR) of Infuse in 2008. Researchers evaluated medical records of 3,647 patients who received Infuse at 26 sites. The Minneapolis Star Tribune reports that the study was intended to promote Infuse and gather data for new uses.

The data did show some good outcomes, but it also documented over 1,000 complications, many of which were linked to Infuse. The report indicates that four deaths were also unveiled due to cases such as heart problems and cancer.

Company’s Internal Archives Entered by Employees Without Notifying The FDA

Star Tribune reports that employees entered this data in the company’s internal archives without notifying the U.S. Food and Drug Administration (FDA). Medtronic’s chief scientific, regulatory and medical officer told the Star Tribune that the company recorded each adverse event years later in 2013.

It was not until 2013, when reports of serious complications arose, that Medtronic reported the adverse events to the FDA. That year, the company filed four death reports and an injury report. Medtronic also asked the FDA how to share information about the remaining adverse events.

The agency allowed to the company to file a summary, rather than a detailed report, “because this information was dated, and didn’t reflect new public health concerns,” an FDA spokesperson said, according to Fierce Medical Devices.

David Prince of Mitchell Hamline School of Law commented on the FDA’s response to the situation, telling Star Tribune “In some ways what’s curious about this particular case is the FDA’s behavior, even more than Medtronic’s behavior,” In noting that Infuse “is a widely, routinely used product,” Prince said

“When you get that kind of feedback from the marketplace telling you things are going wrong with some frequency, to just shrug and say, ‘Well, we won’t look at it any further’ is the ostrich approach. You’re just burying your head in the sand.”

Need Legal Help Regarding Infuse Study Lawsuit

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact 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
I originally met Joanne Stevens at an orthopedic office. After hearing my story she got in contact with me, and recommended I get in contact with Parker waichman where she works, and got me involved in a class action suit She has kept up communications and has answered all the questions I've had during this process.
Jim Langille
5 years ago
5 Star Reviews 150
Gina Viti..My Lawyer with PW LLP.., Gina is an extra special person with Neverending patience..I am OLD SCHOOL..She had to walk me through all necessary steps and did so with knowledge and kind consideration..Not easy to deal with an elder..Gina miraculously got my HEARING going over the phone..Gina is a thorough all encompassing Lawyer..I so much appreciate her and will never forget her
Dorothy Zaharatos
4 weeks ago
5 Star Reviews 150
Parker Waichman was there for me when I needed them. They came through 100% x 10.. I highly recommend Parker Waichman LLP.
Even Levee
a month 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