The Infuse Bone Graft is a device often used in spinal fusion operations. The device consists of a metal cylinder that is filled with a genetically engineered protein to stimulate bone growth. The protein acts to stimulate bone growth in a specific area of the spine, by mimicking a protein which is naturally released by the body. The Infuse Bone Graft system was approved in 2002 by the FDA to be used in only one specific type of spinal surgery: an anterior approach lumbar spinal fusion between the L5 and S1 vertebrae, for patients with degenerative disk disease.
Between the years of 2002-2009, various physician authors wrote 11 different papers for medical journals, claiming that Medtronic Inc.’s Infuse Bone Graft (IBG), was a major breakthrough in back surgery. However, ABC News recently published an article concerning the Senate Committee on Finance’s investigation into the alleged corrupt behavior by Medtronic. It appears Medtronic has been downplaying concerns about some very serious complications of IBG, while overstating its benefits in peer-reviewed medical journals. The article also reveals that many of the physician authors of the referenced medical papers were covertly paid great sums of money in the years prior to the peer-reviewed publications.
The Senate Committee’s investigation into Medtronic Inc. explores the alleged corruption of the peer-review process. The investigation was inspired in part by the Journal Sentinel/MedPage Today’s statement that the “practice of medicine has been corrupted by conflicts of interest involving doctors, drug and device companies and medical journals.” The Senate report reveals the collaborative involvement of Medtronic Inc.’s employees with physician authors, which created the incentive for the physician authors to provide biased medical opinions to the public. This type of collaboration confirms the necessity of the Physician Payments Sunshine Act, which will go into effect next year. The PPSA will require drug and device companies to disclose these types of payments to authors of peer-review medical journals.
Throughout the Medtronic investigation, the Senate Committee discovered emails and reports indicating Medtronic Inc. encouraged doctors to use the device in more dangerous unapproved “off-label” surgeries. Using IBG in unapproved surgeries has been known to cause serious complications. In 2008, the FDA issued a warning to doctors concerning the harmful use of Infuse in unapproved cervical spine fusions. The FDA cited 38 cases of swelling in the neck and throat, leading to compression of the airway that sometimes required emergency tracheotomies. The
ABC News article also highlights other adverse findings in case studies that should have been reported by Medtronic years ago.
Finally, the article provides us with the personal story of Patricia Caplinger, an ER Nurse as well as a spinal surgery patient. In 2010, Caplinger underwent spinal surgery involving IBG, which led to the serious complication of excess bone growth. Due to this bone growth, Caplinger lives in daily pain in her back and legs. She has also developed a condition known as foot drop, which will require her to undergo multiple required revision surgeries due to the continuation of bone growth. As a result, she filed suit against Medtronic Inc. earlier this year. Caplinger alleges that her doctor, and other surgeons, may have been persuaded by Medtronic Inc to use Infuse bone graft in the unapproved and dangerous “off-label” surgeries. According to the article, Caplinger’s lawsuit alleges “a Medtronic representative actually was present during her surgery and was “actively involved,” providing information about the use of Infuse in Caplinger’s procedure.”
Unfortunately, the above is a reminder that there are times when the latest medical breakthrough may not be the best answer. Furthermore, one cannot simply assume that a medical device or product is safe just because it has been approved by the FDA. If you have been harmed by a medical device or product, we encourage you to contact the law offices of Padilla Law Group, LLP to determine your legal rights.