Parker Waichman LLP

Medtronic Infuse Woes Prompt Subpoena from California Attorney General

Medtronic, Inc. has disclosed that the California Attorney General issued a subpoena to the company in October as part of an investigation into its Infuse bone graft product. In its latest 10-Q filing, Medtronic said it was fully cooperating with the California probe, as well as various other investigations involving Infuse. Medtronic’s Infuse bone graft […]

Medtronic, Inc. has disclosed that the California Attorney General issued a subpoena to the company in October as part of an investigation into its Infuse bone graft product. In its latest 10-Q filing, Medtronic said it was fully cooperating with the California probe, as well as various other investigations involving Infuse.

Medtronic’s Infuse bone graft is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. Infuse was approved by the U.S. Food and Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion. Later, it was approved for use in two types of dental surgeries.

Since its approval, Infuse has been at the center of several controversies. Not only has the device maker been accused of downplaying the serious side effects associated with Infuse, but most recently, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer. In 2008, the FDA warned that Infuse and similar bone growth products had caused serious problems when used in off-label in spinal procedures.

According to Medtronic’s latest 10-Q filing, it has received several subpoenas or document requests in connection:

“On October 6, 2008, the Company received a subpoena from the United States Attorney’s Office for the District of Massachusetts pursuant to HIPAA requesting production of documents relating to Medtronic’s INFUSE Bone Graft product. The Company has since received supplemental subpoenas or document requests in connection with the INFUSE Bone Graft product, including a December 18, 2008 civil investigative demand from the Massachusetts Attorney General’s Office, an October 14, 2011 subpoena issued by the California Attorney General’s office, and several inquiries from the United States Senate Finance Committee. The Company is fully cooperating with these investigations.”

Medtronic also said in the filing that sales of Infuse declined 16 percent in the company’s second quarter. It attributed the sales drop to the June publication of two articles in The Spine Journal that raised questions about the safety and effectiveness of Infuse. As we’ve reported previously, those articles suggested that some clinical trials sponsored by Medtronic may have underreported complications and serious side effects associated with Infuse. One of the articles examined payment data from Medtronic to doctors who co-authored the Infuse studies, and found that, the median amount to the company paid to doctors was at least $12 million to $16 million per study (though it should be noted that none of the royalty payments related to Infuse.)

Because of the questions raised by the Spine Journal articles, Medtronic commissioned Yale University to oversee two independent, systematic reviews of all Infuse-related clinical data. According to the 10-Q statement, it expects results of the reviews to be concluded in the next fiscal year. Medtronic also said it will make all of the Infuse clinical data and results available to medical researchers.

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 best lawyer company I have ever met, very attentive, very concerned about my case, especially Jorge Peniche, who helped me with everything with my medication, my therapy, and followed up on my case from the beginning. It is a company that I recommend to all my friends. Friends Parker Waichman
Nestor Herrera
5 years ago
5 Star Reviews 150
I have been conversing via phone, text and email with Tina Morace and I am very happy with her service. Tina, is professional, courteous, attentive and respectful. Any time I have had a question or needed information, Tina has replied promptly and with all of the information I need.
Ray Nugent
a month ago
5 Star Reviews 150
I had the pleasure of meeting Ms. Josama, Parker Waichman’s Settlement Coordinator. Ms. Josama was was extremely competent and professional.
Asher Kennedy
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