Device maker, Medtronic, is the focus of another shareholder lawsuit over its InFuse® bone growth product.
Shareholders filed the lawsuit against Medtronic and some of its shareholders accusing them of intentionally minimizing potential dangers associated with InFuse® so that stock prices would be artificially inflated. The lawsuit, according to MassDevice, was led by an unnamed “institutional investor,” and also claims that Medtronic and the device maker’s leadership made misleading statements concerning InFuse® and the product’s use in pain management and degenerative disc disease treatment.
The shareholders’ attorneys issued a release stating that Medtronic was involved in a scheme with some researchers to minimize InFuse® side effects; the scheme led to artificially inflated stock prices during the class period, according to MassDevice. The lawsuit also cites recently released data from a Yale University Study that found that InFuse® was as safe as the other so-called “gold standard” treatments; however, the studies that supported the product were biased, wrote MassDevice.
Medtronic paid $2.5 million to Yale and supplied it with its data on InFuse® for the studies, which were conducted by two teams, one at England’s York University; the other at the Oregon Health & Science University. The research was called for following a June 2011 issue of the Spine Journal that alleged risks of adverse InFuse® events could be upwards of 50 percent, according to MassDevice. One of the many responding editorials called for resignation of Dr. Eugene Carragee, editor of the Spine Journal. The journal devoted an entire issue to problems with growth proteins, such as InFuse®, and refuted some InFuse® research.
The Spine Journal’s probe concluded that 13 studies minimized or omitted evidence of InFuse® safety risks and that the true rate of “frequent and occasionally catastrophic complications” associated with InFuse® was between “10% to 50% depending on approach.” Doctors and researchers who authored the medical journal reports about InFuse® were paid about $210 million in royalties and consulting fees, according to Bloomberg Businessweek.
Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to InFuse® side effects, as well as to promote off-label use. The U.S. Senate Finance Committee also found problems with most of the initial Medtronic-supported InFuse® research used to promote the product.
The U.S. Food and Drug Administration (FDA) approved InFuse® in 2002 for use in fusing damaged vertebrae in the lower spine; InFuse® was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek. In fact, the FDA released a July 1, 2008 notification warning that the InFuse® bone graft had been associated with serious complications, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage, when used in cervical spinal fusions.
“The take-home message from this debacle … is that the public needs better safeguards against conflicted and tainted medical research,” said Dr. Eugene Carragee, at the time the Yale findings were released, according to The Star Tribune.