Medtronic Inc. is facing a medical device lawsuit by a patient’s family for fatal off label use of Infuse bone graft.

1. Medtronic Medical
Device Infuse Facing
Off Label Lawsuit
Medtronic Inc. is facing a medical device lawsuit by a dead
“...Another accusation is patient’s family for fatal off label use of Infuse bone graft.
that Medtronic pays doc-
A lawsuit was filed by the family of a woman who suffered fatal
tors generous fees if they respiratory distress when the hospital and doctor used Infuse Bone Graft
write articles, promote, for her neck surgery. The Infuse Bone Graft is not approved by the FDA
and use Infuse Bone for neck surgery. Just weeks before the FDA sent out an alert about how
Graft for off label use.” dangerous the off label use Infuse Bone Graft is for neck surgery.
In another twist of fate: Shareholders sue Medtronic for
omissions that falsely inflate the company’s stock price.
For more information contact: Shareholders are suing Medtronic because it misinformed investors
Anapol Schwartz P .C. about the profitability of Infuse Bone Graft because sales depended on
(866) 735-2792 applications that were not approved by the Food & Drug Administration
Thomas R. Anapol, Esquire or (FDA). This important detail was omitted from investors and also wrongly
Michael H. Monheit, Esquire inflated the stock prices.
©2012 All Rights Reserved.
MEDICAL DISCLAIMER: This PDF is not designed to and does not provide medical advice, professional diagnosis, opinion, treatment or services or otherwise engage in the practice of
medicine, to you or to any other individual. Please use this information to help in your conversation with your physician. This is general information and always seek the advice of your
physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard or delay seeking professional medical advice or treatment
because of content found in the PDF, website, or newsletter.
ATTORNEY DISCLAIMER: This PDF is dedicated to providing general public information regarding legal rights. None of the information on this PDF is intended to be formal legal
advice, nor the formation of a lawyer or attorney client relationship. Please contact a Lawyer for information regarding your particular case. This PDF is not intended to solicit clients
outside the states of Pennsylvania, New Jersey, Ohio, West Virginia and Arizona.

2. Is it any surprise that Medtronic is being investigated by the U.S.
Department of Justice (DOJ) for questionable business practices?
Medtronic, the second largest medical device maker, is being investigated
by the DOJ because a whistleblower claimed that Medtronic sales
personnel were in the operating room encouraging the doctor to use
the Infuse Bone Graft for the neck surgery. Another accusation is that
Medtronic pays doctors generous fees if they write articles, promote, and
use Infuse Bone Grant for off label use.
What happened to business and medical ethics?
According to the Wall Street Journal, Medtronic claimed no wrongdoing
but agreed to pay $40 million to settle claims made in two whistleblower
lawsuits filed by former employees. This led to the investigation of the off-
label use of Infuse Bone Graft.
Infuse Bone Graft Medical
Device
“The FDA has
received at least 280
reports of Infuse bone
graft side effects,
and about 75% of the
reports involved off-
label use, particularly
in the cervical spine.”
The Medtronic Infuse bone graft is a genetically engineered
liquid protein that helps the body to grow its own bone. It
includes a bioengineered protein manufactured by Wyeth, called
bone morphogenetic protein (BMP).
How is Infuse used? The Infuse bone implant is surgically placed between
spinal vertebrae soaked in a sponge-like material and enclosed in a metal
cage. BMP causes bone growth that replaces damaged disks by filling the
gaps between vertebrae. Infuse is meant to eliminate the painful procedure
of harvesting bone from elsewhere in the body.
Copyright © 2004–2012 All rights reserved. Anapol Schwartz P
Read more information online at www.anapolschwartz.com.
.C. Medtronic Medical Device Infuse ||

3. In 2002, the FDA improved Infuse for the lower lumbar spine.
The FDA has only approved the Infuse bone stimulator for use in the
lower lumbar spine, as Medtronic has not provided data establishing that
it is safe and effective in other areas of the spine. However, since it was
introduced in 2002, the medical device has been widely used off-label in
the cervical spine.
The FDA has received at least 280 reports of Infuse bone graft
side effects, and about 75% of the reports involved off-label
use, particularly in the cervical spine. The close proximity
of the cervical spine to airway structures has led to serious
complications, many requiring emergency medical treatment.
Life-threatening cervical bone graft complications typically occur within 2
to 14 days after surgery. Some patients require insertion of feeding tubes,
tracheotomies, anti-inflammatory drugs, and additional surgery to drain the
implant site. Some patients are less fortunate; they suffocate to death.
Infuse Wrongful Death
Lawsuit Eligibility FAQs
Can I afford a wrongful death lawsuit?
The question should be: How can I not afford to file a wrongful death
lawsuit? You must file. It will not bring your loved one back but will bring
just due and hold the negligent parties responsible. The consultation is
free. If you decide to retain the law firm and they decide to be retained, you
pay no out of pocket expenses until your lawyer wins the case.
How does the Infuse work?
For lower back fusion surgery, the surgeon mixes Infuse powder with
sterile water and applies it to collagen sponges. The surgeon puts the
sponges in small metallic cages and places them between the vertebrae.
The thimble-like cages stabilize the spine while bone tissue grows between
the vertebrae.
What can Infuse treat?
It is approved to treat a spinal condition called Degenerative Disc Disease,
as well as open fractures of the tibia?. It is also approved for use in two
dental bone grafting procedures - sinus augmentation and localized
alveolar ridge augmentation?
Copyright © 2004–2012 All rights reserved. Anapol Schwartz P
Read more information online at www.anapolschwartz.com.
.C. Medtronic Medical Device Infuse ||

4. What are the precautions with Infuse bone graft?
The medical device has not been tested in patients who are women of
child-bearing age; who are nursing babies; who have had the device
implanted previously; who have liver or kidney problems; who have
osteoporosis, AIDS, autoimmune diseases or have had radiation therapy.
There have not been enough studies as to how effective the Infuse medical
device is for people over 65 years of age.
Why are medical devices like Infuse bone stimulator used off
label?
There is no law against off-label but it generally happens with older,
generic medications that find themselves useful in new ways. However,
Medtronic’s Infuse has only been on the market for six years; not old and
not generic.
Is my family eligible for an Infuse wrongful death lawsuit?
If your loved one has been seriously impacted by the Infuse bone graft
device, whether off label or used to treat the approved symptoms; you may
be eligible for a medical malpractice and/or personal injury lawsuit. If a
loved one has died from the Infuse bone graft device, you may be eligible.
Every state has different statute of limitations regarding personal injury
and wrongful death lawsuits. Do not wait too long as you may miss your
opportunity to file a lawsuit. Contact Anapol Schwartz Law Firm to find out
if you can move forward.
Copyright © 2004–2012 All rights reserved. Anapol Schwartz P
Read more information online at www.anapolschwartz.com.
.C. Medtronic Medical Device Infuse ||