Malpractice Lawsuit Filed Over Medtronic Infuse BMP Surgery
An Arizona couple has filed a lawsuit against two spine surgeons, a Texas hospital and the medical device manufacturer Medtronic, alleging that a bone-grafting product, marketed as Medtronic Infuse BMP, was misused during a spinal fusion surgery.
The complaint (PDF) was filed on October 25 by Alan W. Jones and his wife, Kathryn Marie Jones, in U.S. District Court for the District of Arizona.
Defendants named in the lawsuit include Medtronic, Texas Health Presbyterian Hospital of Dallas and Drs. Jeremy Denning and Richard Jackson of Dallas Neurosurgical and Spine Associates.
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The lawsuit was filed propria persona, meaning it was written by Alan Jones, without representation of an attorney. Such filings are also often known as pro-se pleadings.
Lawsuit Alleges Malpractice for Use of Medtronic Infuse BMP
According to Jones, his wife underwent spinal fusion surgery on October 26 and 27 of 2010. During the surgery, Drs. Denning and Jackson allegedly experimented on Marie Jones without prior consent, by implanting a Medtronic Infuse bone morphogenetic protein (BMP) at 12 different locations, which is not an approved procedure for the bone graft product.
Medtronic Infuse was introduced in 2002 as an alternative to traditional bone-grafting procedures, where bone is harvested from another part of the body or from cadavers to encourage bone growth and fuse the gaps between vertebrae.
The medical malpractice lawsuit alleges that the doctors planned to use Infuse BMP beforehand, but lied to the couple, saying they would be using Kathryn Jones’ own bone for the procedure. The complaint maintains that use of Medtronic Infuse BMP was never mentioned before the operation.
As a result of complications from Medtronic Infuse BMP, Jones allegedly suffered severe pain. However, the lawsuit claims that Dr. Dennings refused to tell the couple it was because the spine surgery failed and the vertebrae did not fuse as they were supposed to do. The lawsuit also claims that Denning actively dissuaded the couple from getting a second opinion and undergoing diagnostic tests.
The couple indicates that they only learned that Medtronic Infuse was used in September, after Dr. Denning sent them a letter saying he used it in all his procedures.
The lawsuit also claims that present during the surgery was James Sherman, a Medtronic Representative and a woman named Nora or Lora Jean Enty, a “Business Growth Strategy Observer” for the medical device manufacturer. Both allegedly observed the procedure, despite the surgeons’ performance of an being off-label operation that Medtronic warned against on paper. The couple claims they did not give consent for the two to be there and did not know who they were or why they were present.
Medtronic Infuse BMP Off-Label Complications
Although the FDA only approved the Medtronic Infuse for limited spinal procedures in adults, involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery.
Off-label use of Medtronic Infuse BMP has been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth around the spine. This can result in nerve damage, inflammatory reactions and other problems
In 2008, the FDA issued an alert about the risks associated with such unapproved uses of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.
Medtronic has been accused of illegally promoting off-label use of Infuse by providing false and misleading statements and paying “opinion leaders” to encourage uses beyond what was approved by the FDA. As a result, some estimates suggest that as much as 85% of all sales for Medtronic Infuse were for such off-label uses.
The Jones’ complaint joins a growing number of similar Medtronic Infuse BMP lawsuits filed in courts throughout the United States by individuals who have experienced similar problems following off-label use of the bone graft device.
Complaints allege that the manufacturer intentionally marketed use of Infuse BMP during surgical procedures for which it was never established as safe or effective. In addition, Medtronic has been accused of withholding information about the risk of complications from consumers and the medical community.
JacquelynJuly 16, 2021 at 10:38 am
After getting an MRI, Dr. Jeremy Denning told me to wait a few months to decide if my current pain was worth the pain of surgery. A few days later he called to say we should do the surgery in two months. About a week later he called to say we should do it in a week. The next day he called to tell me to check in the next morning as my spinal cord was exposed. Dr. Denning did a cervical fusion with [Show More]After getting an MRI, Dr. Jeremy Denning told me to wait a few months to decide if my current pain was worth the pain of surgery. A few days later he called to say we should do the surgery in two months. About a week later he called to say we should do it in a week. The next day he called to tell me to check in the next morning as my spinal cord was exposed. Dr. Denning did a cervical fusion with a hinge to me in 2007. He also told me that he used my bone spurs to "make a paste" to rebuild the vertebrae and had gone all the way to C1 to gather the material. Promising me a two hour procedure and a two incision, it took about seven hours and I had a seven inch cut, ear to ear. Three years later I saw another neurosurgeon as the pain in my cervical region and neck was worse and he did MRIs as he injected anesthesia and cortisone to alleviate the pain. He told me the material used for the rebuild was notorious for growing bone spikes and I had long thin spikes throughout the area and my only relief was to have Dr. Denning remove the spikes although there was no guarantee they wouldn't grow back. So Denning had lied about not using any other material. I called, emailed and faxed my concerns but never heard from him. After a few years I gave up. Other surgeons would not touch me and told me Dr. Denning should fix it. I have relied on pain medication since then and am currently under medicated after CDC guidelines which are now being reconsidered. I am on many medications and losing my teeth because of degenerative arthritis. I have developed polymyalgia rheumatica. Between my multiple medical medication and dental work I spend many of my days just crying in bed.
leamonAugust 23, 2014 at 1:57 am
I had the same surgery by Jeremy denning twice but he did not disclose what part he was putting in parts broke in both instances and now the screws has dislodged I am total disabled. Anybody know an attorney that can take this case.
Keith AApril 26, 2013 at 8:48 pm
Sherri, I had anterior cervical surgery 3-4,-,5-6 in Aug 09, Neurosurgeon used BMP In Oct I had a pulmonary embolism, 10 days ICU, dysphagia, severe hoarsness,Diagnosed with T4, squamous cell throat cancer in may of 2012 finished chemo and radiation in Aug of 2012 Feeding tube for Cancer treatment was removed in Oct ----BMP was not an approved appliance for neck surgery !!!!!!I'm in the Atlanta A[Show More]Sherri, I had anterior cervical surgery 3-4,-,5-6 in Aug 09, Neurosurgeon used BMP In Oct I had a pulmonary embolism, 10 days ICU, dysphagia, severe hoarsness,Diagnosed with T4, squamous cell throat cancer in may of 2012 finished chemo and radiation in Aug of 2012 Feeding tube for Cancer treatment was removed in Oct ----BMP was not an approved appliance for neck surgery !!!!!!I'm in the Atlanta Area
SherriApril 6, 2013 at 4:54 am
I also has an anterior cervical surgery two levels in 2007 c5/6 6/7. I had trouble swallowing, speaking, felt i could not breath, had bone spurs which needed to be operated on 5/2010 due to C8 nerve root compression. I now have C5 compression on the L side. The last MRI has shown significant bone spurs(osteohytes). I have a feeding tube in due to the damage to my nerve in my throat, have trouble s[Show More]I also has an anterior cervical surgery two levels in 2007 c5/6 6/7. I had trouble swallowing, speaking, felt i could not breath, had bone spurs which needed to be operated on 5/2010 due to C8 nerve root compression. I now have C5 compression on the L side. The last MRI has shown significant bone spurs(osteohytes). I have a feeding tube in due to the damage to my nerve in my throat, have trouble speaking, and typically can not be understood, I had my surgery in Northern NJ just wanted to know if anyone else has had this surgery in NJ with complications?
BEYNovember 18, 2012 at 7:42 pm
same thing happened to me. i was never told they would be using medtronic infused bone graft. surgery was 2008 in nj doctors there told me they couldnt explain why i didnt fused , pain worsen. their sollution was their was no more that could be done for me.
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