When the Federal Drug Administration first approved Medtronic Infuse Bone Grafts in 2002, they did so with the limitations that they only be used in the lumbar spine and for oral and dental procedures. In particular, the FDA granted the approval for the use in degenerative disc disease of the lumbar spine. Looking for more profits, however, Medtronic allegedly encouraged physicians to use their bone grafts in the cervical spine (neck). This generated more than $3 billion dollars for the biotech manufacturer.
Unfortunately, the patients who received these bone grafts paid the price for Medtronic’s astonishing profits. Since they have been used in the cervical spine, patients have reported serious and debilitating problems, including:
- Difficulty breathing;
- Difficulty swallowing or speaking;
- Compression of the airway;
- Respiratory Depression;
- Nerve Damage; and
These complications required extensive hospital stays, the need for respiratory support, tracheotomies, insertion of feeding tubes, and additional costly surgeries.
Additional side effects from off-label use of Infuse include:
- Ongoing or chronic radiating pain in the legs or arms (i.e., radiculopathy or radiculitis);
- Sterility, retrograde ejaculation, or other urogenital injuries in male patients;
- Ectopic bone growth or uncontrolled bone growth in the spinal canal;
- Nerve injuries causing chronic pain; and
- Acute severe neck swelling several days after surgery resulting in death or permanent injury in cervical spinal cases
Warnings Issued a Little Too Late for Many
After more than 38 separate complications arose, the FDA issued a warning in 2008 against the use of off-label Medtronic Infuse Bone Graft use. In 2011, the US Senate Finance Committee began investigating surgeons who were actually paid consultants for Medtronic. It is their belief that these surgeons may have failed to report complications associated with Medtronic’s Infuse Bone Graft. There are even reports that these complications showed during clinical trials but were not properly reported in an attempt to obtain approval.
Medtronic Lawsuits – Just the Tip of the Iceberg
There have been several lawsuits against the manufacturer – both by former employees and by patients and their families. In 2008, a wrongful death lawsuit was filed on behalf of a California woman who died after the product sent her into a coma after surgery.
Medtronic is a large manufacturer of medical devices with products that are routinely used around the world. They have a responsibility to manufacture products that are safe, effective, and that are thoroughly tested. In addition, they have an ethical and legal responsibility to adhere to the strict guidelines the FDA has set forth. Unfortunately, they failed to do so and patients throughout the State of Washington and across the United States have paid the price.
The lawsuits against Medtronic are continuing to escalate. If you or someone you love has received a bone graft and has experienced complications as a result, it is important to contact an experienced Washington personal injury attorney immediately. In addition to Medtronic’s infused bone graft, there are also class action lawsuits against Medtronic for a variety of faulty medical devices, including pacemakers, defibrillators, drug pumps, neuro-stimulators, shunts, and stent grafts.
Contact Phillips Law Firm for a Free Medtronic Infuse Case Review
If you or someone you love has suffered a major complication because of a Medtronic medical device, it is important to know that you are not alone. You may be entitled to compensation for your pain and suffering, lost wages, medical expenses, and decreased quality of life. Learn more about filing a Medtronic lawsuit by calling the experienced Washington Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our Washington class action lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation. Remember our no fee promise. If we do not recover anything for you, you do not owe us an attorney fee.