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By: Irvin Jackson | Published: November 8th, 2012
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.
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.