When Medtronic Incorporated, the manufacturer of Infuse lawsuit lubrication systems, finally paid a large sum of damages to an individual that sustained injuries from using their product, it was only after a large amount of public pressure that they agreed to pay the settlement out-of-court. The reasons given for the delay in reaching a settlement were not because of any negligence on the part of Medtronic or any other aspect of the case. Rather, it is simply a matter of timing. It would have been too difficult for Medtronic to have fully cooperated with an agreement to settle a case without having to face the likelihood of additional consumer damages charges levied against them by the United States Justice Department.
The reason the company settled the lawsuit filed allegations against three doctors involved in a case of patient misusing the product was because it did not want to risk the potential loss of further litigation and potential fines and penalties that could have been levied. At first, the company had intended to cooperate with the physicians and their attorneys in the effort to settle the case out of court. However, once the company realized how serious off-label use of its products might be for patients, they decided that it was in their best interest to avoid additional legal trouble by negotiating a settlement out of court. This would leave the doctors free to continue to provide this treatment to their patients while avoiding the expense of a lengthy and expensive trial. It also keeps Medtronic’s product off the shelves of pharmacies around the country and avoids the possibility of being sanctioned and banned by the FDA.
As previously stated, the reasons given by the company for settling the infuse lawsuit is primarily to avoid additional legal liability.
But the potential disfigurement and permanent damage that these potential cases of spinal misalignment may cause to a person’s quality of life has also been a factor in the company’s decision to negotiate a settlement out of court. The use of infusions has become more common in recent years, as people seek out a more natural approach to healing their neck and back pain problems. An injection of any foreign substance into the body can cause severe and life altering side effects. These consequences are far greater than even the most severe complications that could have been resulted from more traditional procedures like surgery. While surgery is undoubtedly an effective option for some spinal misalignment related issues, doctors at Medtronic prefer to keep patients safe by using infusions as an additional method of pain management in cases where traditional procedures have failed.
Because of the potential for serious adverse health effects when patients use off-label use surgery to treat spinal misalignment, the company has vigorously opposed efforts by off-label practitioners to introduce infusions as a cure for spinal pain and other disorders.
In particular, the concern has been expressed is the concern that injections of synthetic collagen and hyaluronic acid will lead to the development of cyst formation. Cysts form when fluid filled sacs develop in the body. The presence of these sacs is what leads to cyst formation in a number of bodily tissues, including the skin, bladder and prostate, and many other organs.
Both the plaintiff’s attorney and defendants’ attorney are challenging the validity of this supposed off-label application for spinal fusion surgery.
Both sides have filed briefs to the appeals court questioning the validity of a plaintiff’s lawsuit regarding the development of cysts during the course of her off-label treatment with Mesotherapy. One of the main reasons cited by the defendants for not having a case worthy of an appeal is that the plaintiffs failed to provide sufficient evidence that they developed cysts during or after their mesotherapists treatment. They argue that the plaintiffs failed to establish that there was a causal relationship between Mesotherapy and cyst development.
The fact that this particular medical malpractice occurred more than five decades ago is irrelevant to the current issue.
Current issues arise from the failure of plaintiffs to properly establish a causal link between Mesotherapy and the development of non-cancerous growths such as fibrous tumors, polyps, and precancerous growths. This point is simply not relevant to whether or not Mesotherapy can be used to treat such complications. The real question is whether or not the dangers of its use were sufficiently severe to warrant a lawsuit.