Medtronic Infuse Bone Graft Preemption Lawsuit

A medtronic infuse bone graft preemption lawsuit: federal vs. state law. In particular, the medtronic infuse bone graft preemption lawsuit is usually grappling with the issue of whether the laws of the state are preempted under federal law.

Recently, the California courts have issued two opinions related to the medtronic infuse bone graft preemption lawsuit issue.

In the Stengel v. Medtronic, Inc., 704 F. 3d 1224 – Court of Appeals, 9th Circuit 2013, the court concluded that the such a state-law claim is not preempted and reversed the district court.  The facts of this case –

  1. Stengel sued Medtronic under state law when a medical device manufactured by Medtronic rendered Richard permanently paraplegic
  2. Medtronic moves to dismiss – Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”) preempts state-law claims.
  3. Complaint was amended to add a new state-law negligence claim – alleges Medtronic vilates state-law duty of care by failing to report known risks associated with use of its medical device to the Food and Drug Administration (“FDA”)
  4. The MDA required Medtronic to report those risks to the FDA
  5. Medtronic contended that the MDA also preempted the Stengels’ new negligence claim
  6. The district court held that the MDA preempted all of the Stengels’ claims, including the new negligence claim. Stengel v. Medtronic, Inc., No. CV 10-318-TUC-RCC, 2010 WL 4483970, at *3-4 (D.Ariz. Nov. 9, 2010).
  7. Stengel’s appeal – The central question in this appeal is whether the MDA preempts a state-law claim in which the state-law duty of care “parallels” a federal-law duty imposed by the MDA.
  8. Court concludes that such a state-law claim is not preempted and reverse the district court

In Coleman v. Medtronic, Inc., Cal: Court of Appeal, 2nd Appellate Dist., 5th Div. 2014, the court concluded that Coleman may allege causes of action for negligence and strict liability in a manner that avoids federal preemption.  The facts of this case –

  1. April 2009, Coleman underwent Posterior Fusion surgery of his L3-L5 vertebrae. His surgeon used Infuse in an off-label manner
  2. Coleman began suffering numbness and pain after the surgery. CT scans showed the collagen sponge had leaked rhBMP-2 and unwanted bone growth had encased the nerves in Coleman’s spine
  3. Coleman sues Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, Medtronic), alleging he suffered painful complications after a spinal surgery in which Infuse, Medtronic’s federally-approved bone fusion medical device, was used in an “off-label” manner
  4. Coleman’s alleges Medtronic defectively manufactured Infuse, promoted off-label uses of Infuse without adequately warning of the associated risks, and failed to take available steps to warn Coleman of the risks of such uses
  5. The trial court sustains that the case preempted by federal law
  6. Court concludes Coleman may allege negligence and strict liability in a manner that avoids federal preemption

Medtronic manufactures and sells Infuse, a medical device used in surgery to strengthen the spines of individuals with degenerated vertebral discs. Infuse consists of an absorbable collagen sponge, rhBMP-2 (a manufactured version of a protein found in small quantities in the human body), and a titanium threaded fusion cage. During surgery, the doctor infuses the collagen sponge with liquid rhBMP-2 and inserts the sponge into the cage to both stabilize the spine and maintain spacing between the vertebrae during the fusion process. Unfortunately, some potential problems may be connected to the use of the medtronic infuse bone graft during spinal surgery.  Some the potential problems may include:

  • Difficulty Breathing
  • Difficulty Swallowing
  • Difficulty Speaking
  • Compression of the Airway
  • Respiratory Depression
  • Paralysis
  • Nerve Damage
  • Death

For more information on Medtronic’s Infuse Bone Graft, click here.

If you or your loved one has are suffering a side effect/injury from use of the infuse bone graft – off label – in neck cervical spine surgery, please seek and consult with your healthcare provider as soon as possible.  And, if you have been injured and want to talk to a infuse bone graft lawyer and/or file a low medtronic infuse bone graft lawsuit, contact us.

FREE CASE REVIEWContact Us At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases.  We are here to help with your medtronic infuse bone graft lawsuit.  If you are suffering a side effect or injury from the off-label use of the medtronic infuse bone graft in neck or cervical spine surgery and would like your case evaluated, contact our office at 1.844.329.5955.