How do you make $800 million in one year with a product known to cause uncontrolled bone growth, ectopic bone growth, paralysis, cancer, male sterility, trouble breathing and difficulty speaking? You leave that part out.
In 2002, the FDA approved a liquid bioengineered Bone Morphogenic Protein, commonly referred to as the Medtronic inFUSE Bone Graft, as an alternative to the typical bone graft surgical process which requires two surgeries (one to remove graft from some part of the body and another to place it in the necessary spot). The Medtronic company got the Medtronic inFUSE Bone Graft approved for anterior approach to lumbar or spine fusion only, but in an attempt to broaden their market base beyond such restrictions, they began proposing their product for use on other parts of the spine.
There are many products utilized by doctors outside of FDA approval which do not amount to any illegal or fraudulent practices. In fact, it is common for doctors to do so in what is known as “off-label” use with some reports stating as many as one in five prescriptions in the US being “off-label” prescribed. The unlawful actions, thus, begin when companies, in this case Medtronic, promote their product for alternative use and ignore any laws that might forbid them to do so. What makes this case even more scandalous is the extent to which Medtronic disregarded these laws and the lengths they went to in promoting their Medtronic inFUSE Bone Graft for other uses.
Recently, the Senate has begun an investigation that, in its short amount of time, has already uncovered records indicating that Medtronic spent $210 million in trying to cover up these harmful side effects. Part of this amount can be accredited to four apparent doctors who received between $22 million and $34 million to testify to the bone graft’s effectiveness and to falsify reports, with the assistance of Medtronic, which failed to mention the fatal side effects from irregular use. In some cases, the Senate found doctors who would take it even a step further and urge other doctors to join the deceit by advising them not to publish their findings. The more and more documents the Senate investigates out of the thousands they subpoenaed, the more evident it becomes of just how much effort Medtronic put in to swaying public opinion in favor of a fatal device.
These findings from the Senate’s investigations could be just the smoke and gun victims need to attain compensation in their allegations. If you or someone you know has suffered from the malpractices of Medtronic, you are potentially in a position to fight back and write the wrongs that have been done to you. Get in touch with the attorneys at Estey Bomberger who are specialists in lawsuits against Medtronic Bone Grafts. They will relentlessly fight against the Medtronic organization to make sure that you receive the maximum compensation for this fatal injustice that took place.