The INFUSE Bone Graft, which was once believed to
be a game changer in bone surgery, has come under fire, as has the product’s
manufacturer, Medtronic. Originally approved by the Food and Drug
Administration (FDA) in 2002 for use in certain spinal procedures, was used for
promoting bone growth. Following the approval for use during single-level
anterior lumbar fusion surgery, it was approved in 2004 for tibia repairs and
in 2007 for dental procedures.
It was developed as an alternative to traditional
bone graft procedures, which involve either the use of bone harvested from the
hip or another part of the body, or bone extracted from dead bodies. Complications
from these traditional procedures involved the risk of the cadaver bone being
rejected by the body. In essence, the graft is used to fill in spaces where
bone is needed.
Recently, a
number of lawsuits have been filed against Medtronic concerning INFUSE Bone
Graft. Plaintiffs accuse the manufacturer of intentionally concealing dangerous
side effects and encouraging off-label uses of the bone graft. The product has
been promoted for off-label uses in certain spinal surgeries. These actions drew
two whistle-blower lawsuits and a $40 million settlement with the Department of
Justice in 2006.
In a recent
securities filing by Medtronic, they state there are approximately 700 pending
lawsuits over INFUSE. Although many cases have been filed across the country,
most have been moved to Arizona, the home of Medtronic. To date, the Judicial
Panel on Multidistrict Litigation has not centralized these cases in
multidistrict litigation or “MDL”. Of course, with more and more lawsuits being
filed, the JPML may consolidate these actions in the future.
The off-label uses in
other spinal surgeries include cervical fusion, thoracic fusion, posterior
lumbar fusion, as well as multi-level fusions. It is estimated that 1 Million
people were implanted with INFUSE Bone Graft, with 85% of those uses off-label.
When used during these unapproved
procedures, Medtronic
Infuse side effects may cause bone growth in areas where it is not wanted, which may cause severe
inflammatory reaction, airway compression or breathing problems, nerve
impingement resulting in severe back or neck pain, hospitalization with treatment
in ICU, need for a feeding tube or tracheotomy, additional surgery to remove
excessive bone from the spinal canal, or death. There are even claims that
INFUSE use can lead to cancer.
In
May of this year, Medtronic announced that they will settle about 950 lawsuits
for $22 million, and an additional $120-140 million will be set aside to
resolve over 3,000 additional claims.
Pittman, Dutton & Hellums, P.C. is
currently investigating INFUSE Bone Graft injury claims. If you or a loved one
were injured as a result of Medtronic’s INFUSE Bone Graft, please contact Booth
Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.
