| June 2
June 2 Managed care company Humana Inc
has filed a lawsuit against Medtronic Inc accusing the
medical device maker of falsely representing its Infuse bone
growth-stimulation product as safe and effective in spinal
The suit, filed on Friday in federal court in Tennessee,
alleges that Medtronic paid for academic literature that
fraudulently portrayed the product as safe and effective for
uses not approved by the U.S. Food and Drug Administration.
Humana said it paid for the use of Infuse, a bioengineered
bone protein, when less expensive and more medically sound
alternative procedures were available.
It said Medtronic engaged in a "sophisticated and deeply
deceptive marketing strategy" to expand the market for Infuse,
paying and encouraging spine surgeons to use the product by
overstating its benefits while minimizing serious risks.
Medtronic, in a separate statement, said the product's label
has reflected its risks from the time of FDA approval in 2002.
"Medtronic strongly believes that the safety profile
reported to the FDA and detailed in product labeling support the
continued safe use of Infuse Bone Graft for approved
indications," the company said.
Medtronic also said it "vigorously disagrees with any
suggestion that the company improperly influenced peer-reviewed
Physicians are compensated for intellectual property rights
and for legitimate and documented consulting services provided
to the company, Medtronic said.
Independent reviews of the product initiated by Medtronic
last year determined that Infuse works as well as traditional
bone grafts taken from patients, but may not be as safe.
The reviews were prompted by questions raised by spine
experts and U.S. lawmakers about the safety of the product,
which contains a genetically engineered protein known
recombinant human bone morphogenetic protein 2 to promote bone
Infuse was once hailed as a major advance in spinal fusion
surgery, offering an alternative to painful bone harvesting from
other parts of the body to perform a bone graft.
But in 2011, Infuse became the subject of investigations by
the U.S. Senate and Department of Justice over off-label use of
the product and omissions of safety problems from its clinical
The product also drew intense public scrutiny after the
influential Spine Journal ran an entire issue criticizing it in
June 2011, charging that surgeons who were paid tens of millions
of dollars by Medtronic failed to report serious complications
such as male sterility, increased risk of cancer, infections,
pain and bone dissolution.
(Reporting by Susan Kelly in Chicago; Editing by Eric Walsh)