Parker Waichman LLP

Florida Woman Claims Medtronic’s Infuse Bone Graft Left Her in Severe Pain

A Florida woman has filed suit against Medtronic, claiming off-label use of its Infuse Bone Graft product caused her to suffer serious injuries. The plaintiff in the lawsuit, Jennifer English of Lake Worth, alleges Infuse resulted in the development of ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and […]

A Florida woman has filed suit against Medtronic, claiming off-label use of its <"https://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">Infuse Bone Graft product caused her to suffer serious injuries. The plaintiff in the lawsuit, Jennifer English of Lake Worth, alleges Infuse resulted in the development of ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain.

Infuse, a spine product made from recombinant human Bone Morphogenetic Protein or rhBMP-2, was approved by the U.S. Food & Drug Administration (FDA) in 2002 as a treatment for anterior approach lumbar fusion. In July 2008, the FDA warned that Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

According to her lawsuit, English received Infuse during a posterior-approach lumbar spine surgery, a type of surgery for which the FDA has not approved Infuse. Since then, English has been forced to undergo two revision surgeries – including an emergency procedure – to remove the excessive bone growth. Her complaint alleges that due to Infuse, English suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.

Off-label use of FDA-approved medical products is not illegal, but manufacturers like Medtronic are legally barred from promoting such uses. Doctors must also inform their patient when a device is being used off-label, and all risks must be fully disclosed to the patient.

Infuse has long been a subject of controversy. Over the summer, we reported that several Medtronic-funded Infuse clinical trials were called into question by a review in The Spine Journal. The Spine Journal, which took the unprecedented step of devoting a whole issue to rhBMP-2, charged that the Infuse clinical trials downplayed its association with serious side effects, including male sterility, infection, bone loss and unwanted bone growth. At the same time, the journal’s editors criticized Medtronic for failing to disclose that it had paid many of the researchers involved in the trials millions of dollars in consulting fees.

The U.S. Senate Finance Committee has been investigating Infuse for several years, and recently demanded Medtronic turn over records detailing payments made to Infuse researchers. Meanwhile, the U.S. Justice Department is investigating off-label use of Infuse.

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
Diane Volpe
3 years ago
5 Star Reviews 150
Christina Morace was not only an an amazing expert in helping us navigate thru the required paperwork for the VCF 9/11 Fund claim, she was also so wonderful in helping us get through the emotional toll of this process. She gave us clarity and encouragement for 3 years now. She was truly helpful and very very kind. We ( including my sister who has passed) feel so fortunate to have Tina "on the case", as expert and friend. We are grateful to Tina and the services of Parker Waichman. Thank you so so much. With much gratitude Sharon Carr (deceased) Karen Carr (sister of deceased) Yvette Christofilis (sister-in-law of deceased)
Yvette Christofilis
a year ago
5 Star Reviews 150
I wanted to give huuuuugeee props to my Medical Coordinator, Joanne. She is professional, sweet, dedicated and committed to listening, comforting, and guiding me through this journey.
SooSweet NY
6 months 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