Legal Cases Involve Injured Infuse Patients With Serious Side Effects Such As Ectopic, Excessive, Or Unwanted Bone Growth And Neurological Impairment
(Posted by Tom Lamb at DrugInjuryWatch.com)
As part of our series of articles about the Medtronic Infuse Bone Graft spinal product, this article focuses on lawsuits being filed on behalf of patients who have developed ectopic, excessive, or unwanted bone growth and neurological impairment.
By way of background, in August 2011 Medtronic gave a $2.5 million grant to Yale University for the purpose of conducting an independent review of all clinical study data that examined the effectiveness and safety of the Infuse Bone Graft product -- also known as Medtronic’s recombinant bone morphogenetic protein-2 (rhBMP-2) product -- as well as post-marketing and safety data.
The results of the much anticipated Yale Medtronic Infuse study were released in June 2013 and are summarized in these two news reports:
- "Medtronic bone graft has limited benefit, may cause harm: reviews" (6/17/13, Reuters)
- "Reviewers: Medtronic's controversial Infuse offers little to no benefit" (6/17/13, Minnesota Public Radio)
Even before these somewhat damning study results became public, Infuse Bone Graft lawsuits were being filed by patients allegedly injured by this Medtronic product, and more legal claims against Medtronic involving Infuse have been filed since then. But as noted below, these new Infuse Bone cases face some legal obstacles.
From a June 15, Reuters article "Plaintiff lawyers seek a new lifeline in medical device cases" (accessed 6/18/13; paid subscription required now):
Plaintiff lawyers are trying a new strategy to get around a 2008 Supreme Court ruling [Riegel v. Medtronic] that protects many types of medical device makers from personal injury lawsuits....
Now, in a new wave of litigation, hundreds of plaintiffs allegedly injured by Medtronic Inc's Infuse Bone Graft device are claiming that the company illegally promoted the device for uses not approved by the FDA. That alleged off-label promotion, they argue, constitutes a parallel claim, which means that their lawsuits are not barred by federal law....
Around 300 lawsuits have been served on Medtronic, alleging off-label promotion of its Infuse device, with 900 more cases in the investigation stage....
The litigation over off-label promotion as a parallel claim is still in its early stages and has already divided some courts, said Louis Bograd of the Center for Constitutional Litigation....
"It's a really undeveloped area of post-Riegel pre-emption jurisprudence," said Bograd....
Bograd said he knows of seven trial court rulings over Infuse so far, with four finding that the plaintiffs' claims were pre-empted, and three rejecting that defense.
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For an example of an Infuse lawsuit against Medtronic filed after the Yale study was released in mid-June 2013, we get this information from a June 21, 2013 news report, "Medtronic profited from improper bone graft sales, California suit claims":
In a jointly filed California state court suit, 37 plaintiffs say they were injured by undergoing spinal fusion procedures in which Medtronic’s Infuse bone graft product was used in a way unapproved by the federal government....
The plaintiffs say Medtronic paid false consulting fees and kickbacks to influential medical community members, leading to an 80 percent increase in “off-label” use of Infuse bone growth stimulant since its 2002 debut....
The suit says Medtronic encouraged sales representatives to promote Infuse for unapproved procedures, including posterior lumbar interfusions, posterolateral fusions and transforaminal lumbar interbody fusions, all involving surgery done from the back.
Medtronic is also accused in the complaint of suggesting the use of Infuse in the cervical spine, or neck, despite FDA warnings that such use risks life-threatening throat and neck swelling, according to the suit.
The plaintiffs allege the Infuse bone graft material caused them to develop “heterotopic,” or unwanted bone growth, resulting in pain and nerve damage.
We are monitoring legal developments in the Infuse Bone Graft litigation and investigating possible Infuse cases against Medtronic.______________________________________________________________________________