Health complications, lawsuits and more
Overview of spinal fusion lawsuits
People sue over failed spinal fusions for a number of legal reasons. The most popular reasons for this type of lawsuit are the following:
- The surgeon was negligent while performing surgery
- A surgical implant was marketed as safe and effective when the manufacturer knew it wasn’t (see Medtronic’s Infuse Bone Graft, below, which describes what happened when this injection was marketed for conditions the FDA had not approved)
- A surgical implant’s defects were related to its design, marketing or manufacture
- The manufacturer knew or should have known about the defects
- The manufacturer failed to warn patients about the implant’s defects and potential harm
Conduct on the part of the surgeon or hospital would fall under two areas of law called “negligence” and “medical malpractice”. When the failure is on the part of the manufacturer (for example, a medical device company that offers a troublesome product), this is called “products liability” or “ defective products”.
There are many opportunities for these situations to arise, as low back pain is the leading cause of disability globally, and up to 80% of the population will experience back pain sometime in their life. Often this is linked to that person’s occupation or posture; however, sometimes it is because of a structural defect in the spinal column that must be corrected for pain to recede.
Common spinal procedures (open lumbar laminectomy and fusion; anterior cervical discectomy and fusion (ACDF); microdiscectomy; and posterior cervical laminectomy and fusion) are a last resort. When medication, lifestyle changes, physical therapy and other interventions do not work, pain management physicians will likely raise the possibility of surgery. Patients should think very hard about whether they want to proceed, because spinal fusions are permanent. Did you know that the failure rate (when a surgery doesn’t work and leads to “failed back surgery syndrome”) is 20%? That is one in five people. The risk increases when more than one vertebrae level is fused.
Injuries, risks and complications after failed spinal fusions
A failed spinal surgery means that the procedure did not correct the medical issue; sometimes, intervention can even make symptoms worse. The range of injuries that can arise after a failed spinal fusion is quite large, because not only do these procedures operate directly on the spine, but the area in question is close to the spinal cord. The slightest mistake can damage nerves, which can result in paralysis, the need for assisted breathing, and more.
Additional risks and complications of a spinal fusion include (but are not limited to):
- Chronic pain
- Broken or defective spinal implants, such as pedicle screws
- An incomplete spinal fusion
- Pressure on a spinal nerve
- Scar tissue
- Failed surgery
- Blood clots
- Sexual dysfunction
- Nerve damage
- Injury to surrounding tissues and blood vessels
- Poor healing
- Pain at bone graft site
- Peripheral neuropathy
- Spinal cord damage
- Retrograde ejaculation
- Anaesthesia complications
Existing litigation for spinal fusion medical devices
The main target in spinal fusion litigation is Medtronic. For instance, the Food and Drug Administration approved Medtronic’s Infuse Bone Grafts for spinal fusions in 2002. Infuse Bone Grafts are concentrated synthetic proteins with the long name of “recombinant human bone morphogenetic proteins,” or rhBMP-2. In 2015 it was approved by the FDA for use in lumbar procedures that also require the use of a “cage” to reinforce the spinal column while the vertebrae fuse. Prior to this approval, titanium cages were implanted; after that, Infuse was approved for use with certain polyetheretherketone (PEEK) cages.
Infuse Bone Grafts do not come without potential risks, which include:
- Male sterility
- Urinary problems
- Nerve and bone injuries
- Increased possibility of cancer
Unfortunately, this was used on children. This proved to be a poor choice because children’s bones are still growing.
Worse than that is the revelation that Medtronics paid off their own doctors so there would be no disclosure of these potential risks. Patients also claim that Medtronics used deceptive marketing to tout the wonders of their product and that its use actually has a very narrow application. They were investigated by the Senate Finance Committee and subpoenaed by the Department of Justice. Up to half of patients who received this treatment experienced serious medical complications, which had gone unreported by Medtronic in 13 studies. One of them, as noted by two plaintiffs in a class action lawsuit against Medtronic and its subsidiaries, is heterotopic bone growth – or bone growth outside of the skeleton.
There were approximately 10,000 lawsuits filed against Medtronic by patients who had been injected with Infuse Bone Grafts. Medtronic has settled around 4,000 of the claims and plans to settle the remaining lawsuits. This is expected to bar future claims of this kind.
Other types of lawsuits around spinal fusions are medical malpractice claims for unnecessary surgeries and negligence claims for botched procedures (even one by professional wrestler Hulk Hogan), products liability, and wrongful death.
FDA actions regarding spinal fusion medical devices
The FDA issued a public health warning in 2008 regarding Medtronic’s Infuse Bone Grafts for use in cervical fusions, as the injection caused swelling of neck and throat tissue; compression of the airway and neurological structures in the neck; and difficulty swallowing and breathing.
In 2015, they updated this warning to include the effects of bone grafts (AKA recombinant bone growth proteins and synthetic peptides) on children. Injections can cause excess bone growth and crowd organs.
What to do if your spinal fusion is causing issues
As a spinal fusion patient, you are undoubtedly in close contact with your medical professionals and know whether to rule out routine issues that can arise. Speaking with your doctor is always a good first step, because while back pain might automatically mean a bad day for your spine, to your doctor it could mean something else – like kidney stones, for example. Make sure it’s not something serious.
Second, talk to an attorney. Each state has a statute of limitations (AKA the time in which to file a legal claim). Once you are past that window of time, you can no longer file. Some states only offer one year for personal injury lawsuits, so do this as soon as you know there’s a problem. A lawyer can preserve your claim.
For a case like this, you will need a lawyer versed in personal injury, medical malpractice and possibly products liability. If you have not met with an attorney, consider looking through the Enjuris directory for someone in your state who can help.
Background on spinal fusion surgeries
Who needs a spinal fusion?
Spinal fusion surgeries connect two or more vertebrae in your spinal column to reduce pain, improve stability or fix deformities. This surgery eliminates movement in that area and is a permanent solution.
Conditions that might require a surgical fusion are:
- Bone fracture
- Herniated (damaged) disc
- Spinal deformities
- Spinal instability
- Spondylolysis (a defect in the vertebral connections)
If a vertebrae is broken, the fracture calcifies while that person heals. A spinal fusion is meant to emulate that natural process. This can be done with screws, rods or metal plates, along with cadaver bone or synthetic material. The metal pieces hold the bones together while it heals.
Of course, if part of the spine is immobilized, it’s going to change the way the spine moves. Perhaps you will no longer be able to turn your neck or your lower back no longer bends. This change in body mechanics places stress on the vertebrae above and below the fusion, which can cause further degeneration. This unfortunate phenomenon is called the “ladder effect”.
Spinal procedures can be conducted on the cervical (upper), thoracic (middle), lumbar (low back), or the sacral (tail). Patients undergoing cervical fusions for herniated discs usually also need a simultaneous discectomy procedure, which removes the damaged disc. Fusions in the thoracic region, or the middle of the spine, are less common.
How are spinal fusions performed?
Spinal fusions can be performed from the posterior (back) or anterior (front). It is considered a far easier task to perform these surgeries from an anterior perspective, as there is less muscle through which to cut.
Once the patient is under general anaesthesia, the surgeon will make an incision to access the damaged discs and vertebrae. This is usually in your neck or back right over the spine or along each side of the spine; conversely, it might be in the abdomen or throat to provide anterior access.
After the incision is made, bone graft is prepared. This is taken either from the patient’s pelvic region or from a cadaver. There are now also synthetic materials to encourage bone growth. This material is inserted between vertebrae and is meant to fuse them together. Rods, screws or metal plates may also be implanted to stabilize the area. Once this is complete, the surgeon will close the incision.
Recovery from spinal surgery takes months. There will likely be redness, tenderness, increased pain (at least for the first few weeks), muscle tightness, discharge from the incision site, shaking, fevers and chills.
The history of spinal fusions
Spinal fusions can be traced back to the 5th century BCE. The Greeks of the Classical Era performed rudimentary, crude spinal fusions that laid the groundwork for the modern lumbar fusion. Back then, they were meant to treat spinal deformities resulting from tuberculosis infections. Its application spread to include other conditions like degenerative disc disease and scoliosis because doctors noticed patients’ back pain decreased after these procedures.
The surgery was not further developed during the Dark Ages, a time in which medicine was intertwined with religion and mysticism. It was not until 1839 that Jules Guerin conducted the first fusions for patients with scoliosis. While he reported success, detractors were quick to note the numerous revision surgeries his patients required. This led to a groundbreaking lawsuit that banned Guerin from practicing medicine. Surgical intervention on scoliosis patients would not occur again until the 20th century.
Dr. Lewis Sayre, a proponent of clean hospitals and improved sanitation, also made splashes in the world of orthopedics. He used plaster casts to improve curvature of the spine. Society did not accept surgeries as a practice until the 1900s, so further invasive surgery only began to develop after that. Surgeons tried many methods, such as lateral pressure on body casts, wrapping wires around the spinal column for stability (some doctors used celluloid bars, steel or silk wiring).
Spinal interventions became very necessary in the 1900s because of the tuberculosis epidemic. Very often, a form of tuberculosis emerged in a patient’s vertebrae. Dr. Russell Hibbs, the surgeon-in-chief at New York Orthopedic Hospital, opened a clinic devoted to tuberculosis patients and began performing spinal fusions to treat these deformities. When the shiny newness of the surgery faded, patients began reporting poor recoveries. Even though surgical and bracing techniques have only become more refined, failed fusions are still a distinct possibility.
Ready to inquire about a spinal fusion lawsuit?
If you feel your complications and pain after a spinal fusion may warrant a lawsuit, these resources will be helpful:
- Tips on finding a qualified personal injury attorney - where to look
- Choosing a personal injury attorney – interview questions
- Negotiating lawyers fees - how do accident lawyers charge? Are there any hidden costs?
- Search our directory for a lawyer near you