A class action lawsuit has been filed against Medtronic, Inc. on behalf of shareholders, alleging that the company made false and misleading statements that failed to disclose their Infuse Bone Graft problems and the extent to which sales of the bone stimulator were dependent on “off-label” uses the company was promoting, which have been associated with a number of serious and life-threatening complications.
The Medtronic Infuse bone graft is a liquid bone stimulator that includes a biologically engineered protein known as the bone morphogenetic protein or BMP. The product, which is soaked in a sponge-like material and implanted in a small cage between spinal vertebrae, encourages bone growth and helps replace spinal disks that are damaged.
Since receiving FDA approval in 2002, the Medtronic Infuse bone graft has been widely used in spinal fusions and some dental procedures, generating sales of over $3 billion. However, it has recently emerged that a large amount of the sales have come from off-label uses that have not been approved by the FDA as safe or effective, such as in the cervical spine or neck, which has been associated with possible swelling of the neck and compression of the airway or nerves.
Because the cervical spine and the airway are located in close proximity, the use in this region has led to a number of reported Infuse Bone Graft complications including individuals experiencing difficulty breathing, difficulty swallowing, trouble speaking, nerve damage, swelling of the neck, respiratory failure and death.
Medtronic has also recently disclosed that they face an investigation by the U.S. Department of Justice over alleged off-label promotion and marketing of the Infuse Bone Graft, which would violate federal laws and expose the company to substantial fines.
The Medtronic Infuse Bone Graft class action alleges that between November 19, 2007 and November 17, 2008, the company and its executives violated federal securities laws by providing repeated false and misleading information to investors about their flagship product.
The plaintiffs allege that the company concealed or failed to disclose the extent to which revenues were dependent on applications of the Infuse Bone Graft that were not approved by the FDA, and which Medtronic had not established as safe or effective. They also indicate that the company failed to disclose that a significant number of patients who received the Medtronic Infuse Bone Graft for an unapproved use, were suffering severe medical complications.
As result of the false statements, the investors indicate that the company’s stock was trading at inflated prices and as information about these Medtronic Infuse Bone Graft problems have emerged, the stock has declined drastically.
At least one Medtronic Infuse Bone Graft wrongful death lawsuit has already been filed against the company by the family of a California woman who died from respiratory arrest following the use of the bone stimulator in her neck. In addition, product liability lawyers are investigating and reviewing other potential Infuse bone stimulator lawsuits on behalf of individuals who have experienced complications.