Amanda Antell  |  July 29, 2014

Category: Legal News

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Medtronic-Infuse-Bone-GraftArizona plaintiffs Debra and Patrick Martin filed a bone graft lawsuit against Medtronic Inc. for the injuries Debra allegedly suffered from using their Infuse Bone Graft System.

Debra alleges that as a direct result of choosing to use the Infuse bone graft, she suffered serious back pain and other serious injuries.

Debra’s doctor had recommended the Infuse bone graft to treat her spinal condition after listening to Medtronic’s marketing campaign, she says in her Infuse lawsuit.

Medtronic allegedly failed to mention that the its bone graft product was not officially approved by the U.S. Food and Drug Administration (FDA) to be used for all of the procedures it was recommended for, also known as “off-label” uses.

While it is not illegal for physicians to use drugs or medical devices for unapproved purposes, it is illegal for medical device makers to advertise their products for those purposes. Medical experts typically warn against using medical devices or drugs for off-label purposes, because it increases the chances of sustaining serious complications or injuries.

That is exactly what the Martins charge Medtronic of doing in her Infuse bone graft lawsuit.

According to the Infuse lawsuit, Debra’s surgeon was unaware of any potential Infuse bone graft side effects that could occur from using the device, and she claims that she never would have agreed to use the Medtronic’s bone graft system if she had known about the possible dangers.

Debra claims in her Medtronic lawsuit that she suffered from nerve injuries, uncontrolled bone growth, osteolysis, and the possible need for revision surgery.

For being directly responsible for manufacturing, selling, distributing, and marketing an allegedly dangerous product, the Martins are suing Medtronic. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

Overview of Infuse Bone Graft Complications

The Infuse Bone Graft is used for specific lower spinal surgeries that involve damaged discs or similar damages. It gained approval from the FDA in 2002, with more than 100,000 patients undergoing spinal fusion surgery with Infuse bone graft.

Medtronic is the largest medical device maker in the United States, but has been recently slammed with severe allegations of deceptive and false marketing, in Infuse bone graft lawsuits. Medtronic has been accused of marketing the Infuse to be used for off-label surgeries, which had allegedly led to severe injuries.

The Infuse bone graft is made from a bioengineered liquid that is designed for the specific purpose of spinal fusion surgery. This allows the surgeon to help regulate bone growth, and erases the need to use the patient’s own bone or a donated cadaver bone.

Many experts believe that the success of the Infuse bone graft was based on the fact that it is a safe alternative to harvesting bone particles from the hip for these spinal surgeries. When used for the approved purposes, patients report success and healthcare providers praise the device.

However, when the device was reportedly used for off-label purposes, patients claim that they suffered severe Infuse bone graft side effects that required multiple revision surgeries and extended hospital stays.  These bone graft complications included:

  • Difficulty breathing, swallowing or speaking
  • Compression of the airway
  • Respiratory depression
  • Nerve damage
  • Death
  • Swelling of the neck and throat
  • Infection
  • Bone injury
  • Infertility
  • Cyst formation
  • Cancer

 

Medtronic is currently facing hundreds of Infuse bone graft lawsuits, alleging the company to be directly responsible for their injuries because of their marketing decisions.

This Medtronic Bone Graft Lawsuit is Debra and Patrick Martin v. Medtronic Inc., Case No. 14-cv-00385, in the U.S. District Court for the District of Arizona.

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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