Another cloud is on the horizon for lumbar artificial discs. This time, injury lawyers Bagolie Friedman announced in the wee hours of this morning that it has formed the International Charite Artificial Disc Practice Group based on their belief there will numerous people in the US and abroad who "suffer Charite artificial disc failure".
Putting aside the recent academic studies showing an absence of catastrophic failures, Bagolie Friedman is asserting that "Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market."
The firm has already begun to review and accept injury cases from surviving family members and individuals who have suffered "serious" complications after receiving the Charite artificial disc. "We will be reviewing potential cases from the United States, Australia and Europe," said Bagolie.
A year ago there was a fervor about this device when it was approved by the FDA. Today the fervor is all about criticisms of the FDA clinical trial, reimbursement issues and now this new attack on the artificial disc have caused Charite to lose its allure. We are hopeful that cool minds will prevail, however. That should mean a dispassionate review of clinical data as it becomes available. Our own view is that lumbar artificial discs have a possible place in the future: a place as a highly specialized device that address a small subsegment of the degenerative disc diease area for the highly skilled spine surgeon.
