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Medtronic Denied Federal Preemption in Infuse Bone Graft Lawsuit

This week, a federal judge ruled to deny Medtronic’s motion to dismiss a personal injury lawsuit regarding its Infuse Bone Graft product, declaring it unjust that pharmaceutical manufacturers should be granted liability immunity under federal preemption laws. According to the judge, Medtronic’s illegal promotion of the medical device for off-label use released the government from any obligation to provide immunity, states a recent article in the Minneapolis Star Tribune.

Medtronic Infuse is a bone graft product which the company promoted for off-label (non-FDA approved) use in cervical surgery. It is permissible for doctors to use medical products in an off-label capacity, but it is not legal to advertise a product for non-approved purposes.

Medtronic is currently facing a mounting number of personal injury lawsuits brought by plaintiffs in state and federal courts who claim to have been seriously injured when the product was used off-label. Injuries attributed to cervical use of Infuse include:

  • Paralysis
  • Excessive bone growth around the spine
  • Airway compression
  • Nerve compression
  • Retrograde ejaculation
  • Cancer
  • Urinary retention

Medtronic attempted to claim federal immunity in these suits based on claims that the device was approved by the FDA. However, plaintiffs claim that it was the non-approved, off-label use of Infuse which lead to their often catastrophic injuries.

Medtronic personal injury lawsuits have been bolstered by recently uncovered evidence that the company paid $210 million to doctors and study authors to paint a more favorable picture of Infuse. It was also discovered that the company encouraged employees to falsify study results before publication in an effort to promote off-label use of Infuse.

According to the medical device lawyers at the Flood Law Group, parties harmed by off-label use of Infuse could be entitled to substantial compensation for medical bills and other damages. To learn more about potential plaintiffs’ rights in Medtronic Infuse lawsuits, contact us to schedule a legal consultation.