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Matthews & Associates is a law firm of trial lawyers, investigators, consul- tants and medical personnel. We help people harmed by negligence, greed or incompetence. With more than 100 years of combined legal experience, our lawyers have practiced in nearly all 50 states and P.R.. We have the resources to handle any personal injury case.

Matthews & Associates
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Houston, Texas  77098

Toll free:  888-520-5202

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Matthews Legal News

Medtronic's Infuse trouble

A Company compromised

 

Medtronic tainted Infuse Studies

Company's Health trumps Patients'

 

Infuse Trouble Off Label

Side Effects from off-label use


Medtronic Infuse Lawsuit

Infuse Side Effects

Infuse Bone Graft is a metallic, thimble-sized cage device filled with genetically engineered human protein implanted in the body to generate new bone growth. Infuse was created in the hope that it would help stabilize the spine after spinal fusion surgery. It has worked for thousands of people when used for the purpose for which it was approved; off-label use, however, has led to some serious "side effects."

The FDA approved Infuse Bone Graft in 2002 only for use in lower spinal surgery to promote bone growth. Medtronic, however, has promoted Infuse to doctors for non-FDA-approved surgeries, which include cervical or lumbar fusion. Such unapproved or off-label uses have caused serious, sometimes life-threatening problems that include:

  • Uncontrolled bone growth
  • Ectopic bone growth
  • Inflammatory cyst formation
  • Increased cancer risk (esp. pancreatic, breast and prostate)
  • Paralysis
  • Difficulty swallowing, speaking, breathing
  • Retrograde Ejaculation
  • Death
  • Sterility
  • Respiratory failure
  • Nerve damage
  • Erectile Dysfunction
  • Additional surgeries to remove unwanted bone formation
  • Bone dissolution
  • Worsened back and radiating leg pain

Contact an Infuse Lawyer today if you suffer after having received off-label use of Infuse.

Off-Label Uses and Marketing Issues

Off-label marketing occurs whenever a drug maker markets a drug for a purpose not approved by the FDA. Medtronic’s off-label promotions of Infuse and subsequent injuries reported as a result of those off-label uses have left the company vulnerable to litigation from victims of those off-label uses.

Medtronic also trained medical staffs to perform surgical procedures using Infuse in the neck (off label). The company also allegedly paid doctors millions to write articles promoting off-label use of Infuse and to publish that pro-Infuse propaganda in medical journals. All of this marketing for off-label uses behind the curtain was done without the FDA’s ever having approved Infuse for surgeries on the neck and cervical spine.

Free Legal Case Review: If you or a loved one suffers from Infuse side effects, contact us for a free legal consultation regarding a potential legal case.

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Contact an Infuse Bone Graft Lawyer

Our lawyers specialize in drug litigation, and have been fighting Big Pharma successfully for many years. Choosing Matthews & Associates to work your potential Infuse side effects claim grants access to the highest level of legal help in the land. Contact us for a free legal case review.