Medtronic Infuse Bone Graft Lawsuits are being filed as a result of complications with the product as well as allegations that Medtronic illegally engaged in marketing practices intended to promote the Infuse Bone Graft product for uses for which it did not have FDA market approval.
Infuse Bone Graft Facts
The infuse bone graft first received FDA market approval in 2002. The Infuse Medical device was approved for use in use in lumbar spine procedures as well as some dental and other oral procedures. The Infuse Bone Graft product was not approved for use in any other areas of the spine.
Prior to the existence of engineered bone growth products such as Infuse, bone was often taken from the hip and used in spinal fusion surgeries which are most often intended to repair a collapsed spinal disk. The Infuse Bone Graft product was initially viewed by many surgeons as a major breath through in spinal fusion technology as it eliminated the need for the additional invasive surgery to remove bone from a patient’s hip.
In July of 2008, the FDA issues an Alert directed at surgeons and patients warning them of the risks associated with the off label (unapproved) use of the Infuse Bone Graft Product in cervical (neck) spine procedures. The FDAs warnings were prompted by Adverse Events reports in which the Infuse Bone Graft product have been used by surgeons in cervical spine procedures resulting in complications which could be fatal. By September of 2008 it was reported that the number of FDA adverse events reports related to the Infuse Bone Graft product had risen to 200.
Medtronic Infuse Bone Graft Lawsuit Claims
Lawyers representing clients injured by the Infuse Bone Graft make numerous allegations against the manufacturer. One of the most significant claims against Medtronic in Infuse Lawsuits is the claim that Medtronic Illegally promoted the off label use of the Infuse Bone Graft Product. It is further alleged that this off label use resulted in injuries to Infuse Lawsuit plaintiffs.
Allegations against Medtronic also include claims that the medical device maker misrepresented or failed to reveal certain Infuse Bone Graft Complications that they became aware of in clinical trails. A report in the “Spine Journal” published in 2011 made accusations that Medtronic failed to accurately report complications they became aware of during client trials. The Spine Journal article alse made allegations that researchers and other individuals who participated in the clinical trials of the Infuse Bone Graft product had significant financial ties to the manufacturer.
A Senate Investigation into allegations against Medtronic over the Infuse Bone Graft Medical Device was also begun in 2011. Demand for financial records was made to Medtronic and individuals who participated in Clinical Research and other matters involving the Infuse Bone Graft product.
The underlying implication behind the accusations and investigations into Medtronic and the Infuse Bone Graft product paints a picture of a company that put profits ahead of patient safety. The allegations that Medtronic illegally promoted the off label use of the Infuse Bone Graft Medical Device is significant by itself. The allegations that Medtronic engaged in deceptive practices to gain FDA market approval could be very significant problem for Medtronic in their attempt to defend Infuse Bone Graft Lawsuits.
Infuse Lawsuits Arising from Off Label Cervical Spine Use
Some of the most significant Infuse Bone Graft Lawsuits filed to date are the result of use of the Infuse Bone Graft Medical Device for cervical spine procedures. Infuse Lawsuit have been filed in several states due to injuries to patients who were implanted with Infuse during cervical spine procedures. If a surgeon had elected to use the Infuse Bone Graft product for off label unapproved procedures without any participation from Medtronic than the liability for such action might fall on the surgeon alone. However, the is ample and mounting evidence that Medtronic not only engaged in off label marketing encouraging surgeons to use Infuse for cervical spine procedures, but also provided training for those procedures.
Although Infuse spine surgery patients would rarely be aware of this fact, one of the individuals in the surgical suite, dressed in surgical scrubs during their surgery, was a sales representative from Medtronic. The fact that many if not most Infuse Bone Graft surgeries may have been attended by a Medtronic Sales Representative is not surprising.
It is common for surgical device sales representatives to “scrub in” on surgeries involving their products. These sales representatives are product experts and can provided valuable information to a surgeon during surgery. What is however noteworthy is that if Medtronic Sales Representatives were present during procedures in which Infuse was used for cervical spine surgery, there will be far to many witnesses for the company to attempt to deny this fact. It is common for there to be a large number of individuals other than the surgeon to be in attendance of a surgery. Technicians, Surgical Nurses, Anesthesiologists and other medical personnel may have witnessed a Medtronic Sales Representative in attendance while a surgeon engaged in the off label use of the Infuse Bone Graft Medical Device.
Complications Leading to Infuse Bone Graft Lawsuits
The primary grounds for Infuse Bone Graft Lawsuits will arise from complications which resulted in injury or death to a patient. Although the issues with off label marketing, possible research manipulation and other allegations being made against Medtronic may not be the primary cause of Infuse Lawsuits, these aggravating issues may well effect the financial impact felt by Medtronic as a result of Infuse Bone Graft Lawsuits.
Putting aside any punitive legal damages Infuse Lawsuit plaintiffs could be entitled to, there is another factor that could have a significant impact on jury awards for plaintiffs in Infuse Bone Graft Lawsuits. The factor that may impact Medtronic the most at trial is jury sentiment.
Juries are made up of human beings and human beings are subject to personal sentiments. If a jury or juror simply felt that Medtronic had produced a product with good intentions that had unintended complications, they may still find in favor of the plaintiff and award the plaintiff reasonable monetary damages for their injuries. On the other hand, if a jury or juries feel that Medtronic willfully and negligently engaged in actions or deceptions that caused or contributed to the plaintiff’s injuries, the jury may feel that Medtronic needs to be punished.
It is within a jury’s power to award Punitive damages for the purpose of discouraging a defendant from engaging in future bad acts. These punitive damages can far exceed any amount awarded for actual damages to a defendant.
Infuse Bone Graft Class Action Lawsuit
At this point in time, we are not aware of the existence of a Infuse Class Action Lawsuit. If a mass litigation does occur it is as probable that that litigation will be an Infuse Lawsuit Multidistrict Litigation as it is that it will be an Infuse Class Action Lawsuit.
Regardless of whether an Infuse Class Action Lawsuit ever exists or not, your ability to file an independent Infuse Bone Graft Lawsuit is not effected. All though a large number of potential plaintiffs may file Infuse Lawsuits, it is not necessary that an Infuse Class Action Lawsuit exist prior to filing your own Infuse Bone Graft Lawsuit.
How to file an Infuse Bone Graft Lawsuit
If you or a family member underwent a surgery in which the Medtronic Infuse Bone Graft was used and experienced severe complications, you may have grounds to file an Infuse Bone Graft Lawsuit.
If you believe that you have grounds to file an Infuse Bone Graft Lawsuit on your own behalf or due to the death of a loved one, please contact us on our toll free number to arrange a free legal consultation about your potential Infuse Lawsuit.