Recently, several
patients were administered a procedure known as the Medtronic Infuse Bone Graft
which has been shown to bring about side effects that present serious health
risks to patients who received the treatment off label.
Dangerous Complications Associated with Treatment
The Medtronic
Infuse procedure, when administered wrongly to patients, has been linked with a
number of terrible complications. Many patients had their airways swell up
which led to severe difficulty when it comes to activities such as breathing or
swallowing. Speech was also impaired. Another awful result of the Medtronic
Infuse bone graft procedure was something known as retrograde ejaculation. This
occurs in males and can cause sterility. As a result of these side-effects, a
number of lawsuits have arisen with patients seeking compensation for the
complications they experience. A number of these bone graft lawsuits insist
that the company had been promoting the product illegally.
Current Status of Lawsuits Related to the
Medtronic Infuse Procedure
As of March of
2013, it is believed by lawyers representing the plaintiffs in the ongoing
litigation surrounding the Medtronic Infuse Bone Graft that patients who may
have experienced injuries may still be able to file a claim, even if their
injuries date as far back as 2003. Of course, it is noted that these claims
will more than likely be subjected to a relatively rigorous statute of
limitations defense. This is often the case when litigation of this type is
concerned and lawyers will be working with any clients to make sure that their
claims are properly protected. Anybody believing they have been a victim of
this procedure should seek legal advice immediately.
About the Medtronic Bone Graft Procedure
During many
surgical procedures, bone grafts must be harvested from the patient’s hip in
order to be used on other parts of the body. The Medtronic Infuse procedure was
created to help provide doctors and surgeons with an alternative to this
procedure. It was both sold and marketed with this specific intention and
should typically be used to help with the replacement of spinal disks when they
have become damaged. The procedure was approved for the purpose of stimulating
this bone growth and was not approved for other uses. This is why so many
instances of this bone graft lawsuit have arisen. It has, however, been used in
other procedures, such as spine procedures involving the neck. As a result, a
number of patients have experienced complications and negative side effects.
When the FDA gave
Medtronic its approval in the year 2002, it was for a very specific number of
uses. The procedure was intended all along to see a limited scope of use.
Specifically, this procedure was authorized for use in the lower back or the
lumbar spine region. It was also cleared for various dental and oral
procedures. Other uses were also approved by the Food and Drug Administration. They
ruled that it could be used for the treatment of tibial fractures, as well as
for diseases which cause degenerative discs in the spine and for sinus-related
issues.
However, problems
arose when Medtronic began to allegedly suggest that physicians should use
their bone stimulation project in ways that were decidedly off label. Use of
the Infuse procedure in the cervical spine alone helped to create over $3
billion in sales for the company. The product works with the help of a
synthesized human protein which stimulates bone growth in specific parts of the
human body. This way, surgeons working with bone growth and graft procedures
can give themselves more control over where the bones actually re-grow
themselves.
Complications Arise from Use in the Cervical
Spine
The use of the
Medtronic Infuse product off label has caused some serious negative side effects,
especially when used in the cervical spine. Some of the issues experienced have
been very serious and have included problems like difficulty speaking and
swallowing, airway compression, nerve damage and respiratory issues, all of
which can potentially lead to death. As it has been noted by the FDA, the
majority of these serious bone graft complications set in within two days to
two weeks after surgery. In some cases, these complications have required
things like the need for feeding tubes, medications designed to combat
inflammation, a tracheotomy, respiratory support and even further surgery.
rhBMP Not Cleared for Use in the Cervical Spine
by FDA
The synthetic
protein used by the Infuse bone graft procedure is known as rhBMP. After
receiving nearly 40 complaints detailing various complications, the FDA issued
a warning about uses other than those for which Medtronic Infuse was
specifically cleared. The FDA specifically warned that the product was not
cleared for use in the cervical spine and additionally noted that it was not
approved as being safe to use in this area.
Many patients who
filed these reports had experienced a variety of alarming problems such as
difficulty when trying to swallow or breathe. The Medtronic procedure had
apparently resulted in the patients’ airways becoming compressed. This often
required emergency medical attention. Invasive procedures like tracheostomies
were required and feeding tubes needed to be used in more than just a couple of
instances. In late 2008, it was reported by the Wall Street Journal that nearly
200 events were reported to the FDA in which various patients experienced very
severe complications after off label use of this particular bone graft
procedure.
Investigations into a Conflict of Interest
Adding fuel to
the Medtronic Infuse lawsuit is the revelation that there may very well have
been a significant conflict of interest present in doctors who were
administering the procedure, writing very favorable reports about it or both
may have been paid to do so by the company itself. During its investigation,
the Wall Street Journal learned that the medical product manufacturer had paid
a surgeon nearly $800,000 over the course of three years to falsify a study in
which the Infuse Bone Graft procedure was said to have incredibly positive
results. Not only did the report contain blatantly false information, but the
signatures of its co-authors were completely forged. In an attempt at dodging
blame, Medtronic insisted its payments were related to work that that had
concerned product development and speeches at corporate events.
Another troubling
incident concerns payments of nearly $100,000 per year made by Medtronic to a
doctor who insisted that the FDA should not focus on the off label use of
Medtronic Infuse as the organization had been concerned about this before even
approving the product in the first place.
Senate Investigates Use of the Medtronic Bone
Graft
Helping the cause
of plaintiffs in the multiple spinal fusion lawsuit iterations existing is the
fact that the United States’ Senate investigated many of the surgeons who had
been paid as consultants for the manufacturer. The committee demanded that
Medtronic turn over documents including financial records and other
communications so that it could be ascertained whether or not surgeons were
intentionally failing to report complications that been associated with the
procedure and could lead to issues like spinal fusion. According to this recent
investigation, whose data has been the inspiration for many instances of the
Medtronic Infuse lawsuit, doctors were failing to report complications that
appeared as early as clinical trials.
Employee Files Medtronic Lawsuit, Others Follow
Suit
The first
lawsuits involving Medtronic and the Infuse bone graft product were filed by
former employees, who claimed that the company had been incentivizing doctors’
use of the product, as well as other similar products relating to spinal graft
procedures. These cases were settled, however.
In 2008, a much
more serious Infuse lawsuit was filed in which wrongful death was claimed. A
woman from California had gone into a coma following her surgical procedure and
later died. The lawsuit stated that Medtronic had not properly warned the
patient of the risks that came with the use of their product in the neck, a use
which had also not been approved by the FDA.
Another Infuse
lawsuit involved a patient who required an emergency tracheotomy after the use
of the Infuse bone graft caused severe neck and throat swelling. Yet another
bone graft lawsuit was filed by a woman who claimed the company was promoting
their bone graft product for off label use in a fraudulent way. Yet another
Florida woman filed a graft lawsuit when she experienced uncontrolled spinal
bone growth which caused her to experience nerve compression and severe pain.
If you believe
you have been the victim of Medtronic’s Infuse bone graft project, you may
submit your information for a free case review. This can help you to learn
whether you are eligible for compensation following adverse side effects.
