Amanda Antell  |  August 18, 2014

Category: Legal News

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Hospital holding handsTwo spinal surgery patients from Arizona and Nevada are suing the companies behind a medical device called the Infuse Bone Graft, which they contend was illegally promoted off-label to treat back pain, resulting in severe and permanent injuries.

Plaintiffs Brett Scovil and Leigh Scovil are suing Medtronic Inc., Vertelink, and Wyeth, a subsidiary of Pfizer, for promoting, inventing, marketing, and designing the Infuse Bone Graft and LT-Cage, a device they say caused them permanent injuries such as heterotopic bone growth (in which bone tissue forms outside the skeleton) and nerve damage.

Both patients had the Infuse Bone Graft implanted during spinal fusion surgery and thereafter suffered severe physical, emotional and economic injuries as a result, according to the Infuse Bone Graft lawsuit.  They claim they were unaware that their injuries were caused by the device until recently, causing them to file this complaint.

Lawsuit Details Severe Spinal Surgery Complications

According to the Infuse Bone Graft lawsuit, Brett Scovil on Oct. 24, 2006, had the Infuse Bone Graft implanted while undergoing a two-level anterior lumbar interbody fusion procedure without the LT-Cage component, which is considered off-label because the device was used on multiple vertebral levels. Soon after the spinal fusion surgery, Scovil started experiencing increased back pain again, but was merely prescribed pain medication by his physician, the lawsuit says. It was not until the spring of 2013 that his physicians diagnosed him with uncontrolled bone growth where Infuse had been used, after examining medical imaging of the plaintiff’s back.

Likewise, Leigh Scovil had the Infuse Bone Graft implanted into him to correct cervical spine pain, which is a surgery not approved to be treated by Infuse. He had the Infuse Bone Graft implanted sometime before 2012, but had started complaining about increasing back pain after the surgery. Leigh Scovil had used the same surgeon as Brett Scovil to implant the device and consulted him about the pain soon after. Kaplan and another physician both told Leigh Scovil that his pain was being caused by the Infuse Bone Graft, and he was suffering from nerve damage and unexpected bone growth.

Both patients have since undergone corrective measures to fix the unexpected bone growth, but are both filing the Infuse Bone Graft lawsuit against the manufacturing companies for the damages inflicted on them. At the time they were recommended the Infuse Bone Graft, their surgeon had been unaware of the side effects that could occur from using the device for off-label purposes, according to the lawsuit. They alleged the defendant companies caused the plaintiffs and their surgeons to believe that this device could be used for these purposes, and had failed to mention any possible ill side effects.

The plaintiffs are suing Medtronic, Vertelink, and Wyeth for negligence, false advertising, concealing information, and misrepresenting a product.

This case is Leigh Scovil and Brett Scovil v. Medtronic Inc., et al., Case No. 2:14-cv-00213-APG-VCF, in the U.S. District Court of Arizona.

Overview of Medtronic Infuse Bone Graft Complications

The Infuse Bone Graft was approved by the FDA in July 2002 to be used in spinal surgery. Instead of having to harvest bone marrow from a different part of the patient’s body, the Infuse Bone Graft is implanted into the patient’s spine by the surgeon, which is advertised to allow controlled bone growth and shorter hospital recovery time. However, it has been discovered that Medtronic had also advertised the Infuse to be used for off-label purposes.

It has been reported that when used for off-label procedures, Infuse can potentially cause a number of severe injuries, which include but are not limited to:

  • Difficulty breathing, speaking and swallowing
  • Chronic pain requiring daily medication to manage
  • Excessive bone growth
  • Nerve damage
  • Male sterility and other uro-genital injuries
  • Back and leg pain
  • Radiculitis  (pain that spreads through the spinal nerves)
  • Implant displacement
  • Retrograde ejaculation  (occurs when semen enters the bladder)
  • Male sterility
  • Cancer
  • Infection
  • Osteolysis  (degeneration of bone tissue)
  • Ectopic none formation (unwanted bone in the spinal canal)
  • Death

Over 1,000 Infuse bone graft lawsuits have been filed by patients seeking compensation for these injuries. Medtronic has already agreed to pay $22 million to settle close to 950 of these lawsuits.

In general, Infuse Bone Graft lawsuits are filed individually by each plaintiff and are not class actions.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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