Throughout the past few years, Medtronic has been the target of negative publicity with its grafting product, Bone Infuse. Articles in medical journals have been published, disclosing Medtronic as a company that has been less than forthcoming regarding their private studies and the findings those private studies have produced. The side effects that were demonstrated in those studies showed severe complications with their synthetically created protein when used in bone grafting procedures. Additionally, it was shown that Medtronic’s researchers were paid in royalties and consulting fees annually, in some cases exceeding twenty million dollars ($20,000,000.00).
There have been multiple articles published by The Spine Journal exclusively with regards to Medtronic and its Bone Infuse product used in grafting procedures. Also, The United States Senate conducted an investigation in 2011, based on medical journal entries which were alleged to have been written by physicians paid by Medtronic. The journal entries stated no mention of possible side effects in using Medtronic’s Bone Infuse product in grafting procedures. The reality is there were issues with the product, including problems which had potential of causing death. As a result of the investigation by the United States Senate, considerations were made to require all drug companies to publicly reveal payments they made to physicians in the Physician Payment Sunshine Act.
The United States Department of Justice had already begun their own investigation on Medtronic prior to the light being shined on their testing. In fact, the United States Department of Justice filed a lawsuit against Medtronic and claimed that the company was paying physicians for their recommendations to their patients in the use of Bone Infuse. It was claimed that Medtronic was conducting this type of business for over five (5) years. Medtronic was also accused of financing get-away trips as indicated in the lawsuit. The civil case was settled in 2006 for forty million dollars ($40,000,000.00).
Eventually, Medtronic made arrangements to have independent studies conducted by Yale University on its product, Bone Infuse. The studies were made to review the clinical trials which Medtronic conducted since 2002 on its product as well as the reports made by the FDA.
There have been multiple lawsuits filed against the company Medtronic throughout the course of the past few years. A few of those lawsuits include:
December 2008: A wrongful death lawsuit was filed on behalf of a woman in California. The woman received Medtronic Infuse as a part of her surgical procedure. Following the surgery, the women fell into a coma and eventually died. The allegations in the suit provided that there was a failure to warn of possible risks when using the product for off-label purposes, and because Medtronic promoted this type of off-label use, which had never been approved by the FDA, it was asserted that they were liable for her death.
July 2011: April Cabana, another California woman, filed a suit against Medtronic, additionally naming Stryker Biotech as a defendant, for fraudulent promotion of their products. Her assertion was that both companies were encouraging physicians to use the product for off-label uses. The claim made by Ms. Cabana was subsequent to severe injuries she sustained in a second surgery performed on her with the product Medtronic Infuse. The second procedure was performed to fuse her bone, but the product had not yet been approved for that type of procedure.
September 2011: Jennifer English, a plaintiff from Florida, filed a claim against the company after a surgical procedure was done on her using Medtronic Infuse. The personal injury lawsuit came after Ms. English experienced excessive bone growth in her spine which ultimately created unbearable pain in her body. Again, the claim included the fact the Medtronic did not properly market its product, and in fact encouraged it to be used for unapproved procedures.
If you or a loved one has suffered from the fraudulent conduct of Medtronic, it is important that you seek the proper legal assistance needed to help you recover for your injury. Contact the injury attorneys at Madalon Law today for your free consultation. We are based in Fort Lauderdale and fight for the rights of Medtronic Bone Infuse victims throughout the state of Florida.