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Infuse Bone Graft Lawsuit Hits Dead End Over Procedural Technicality

US-Supreme-CourtThe majority of medical product liability cases are filed in federal district courts. Accordingly, the Federal Rules of Civil Procedure apply to each case from the initial complaint to the final appeal. These rules were enacted by Congress and are perpetually being amended and updated, requiring the savvy litigator to remain constantly abreast of the applicability of the rules to a particular lawsuit.

Unfortunately, a recent Infuse bone graft lawsuit against Medtronic was dismissed with prejudice by Judge H. Russel Holland of the U.S. District Court for the District of Arizona – meaning the plaintiff is hereafter barred from ever bringing the same lawsuit to court again.

Without weighing the merits of the case, and before the allegations ever reached the ears of a jury, Medtronic successfully argued against the form of the plaintiff’s complaint – citing Federal Rules of Civil Procedure 8(a) and 9(b). As a result, Judge Holland dismissed plaintiff’s case after the second attempt at an amended complaint, highlighting the plaintiff’s failure to assert relevant factual allegations as to her adverse experience with the Infuse bone graft.

Medtronic bone graft lawsuit

The plaintiff’s experience began in 2010 when she underwent a posterolateral lumbar fusion (i.e., spinal fusion surgery) during which time the surgeon utilized an Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device. The device contains two main components: a “metallic spinal fusion cage” and a bone graft kit, which encourages the re-growth of bone following a surgical procedure. In 2002, the Food and Drug Administration approved the product for “anterior lumbar interbody spinal fusion surgeries.” However, the plaintiff’s procedure involved the off-label use of the bone graft product, as her procedure was classified as a “posterolateral approach.”

In 2013, the plaintiff began to experience unrelenting back pain, particularly in the area of the bone graft. Following a CT Scan, she was diagnosed with “bony overgrowth” and a cyst near the metallic spinal fusion cage.

Other cases pending against Medtronic allege severe complications with Infuse bone grafts including including chronic back and leg pain, sexual dysfunction, bone degeneration and the development of cancer.

Litigation ensues against Medtronic

In February, 2014, the plaintiff and her husband sued Medtronic, citing falsified and distorted marketing tactics to entice doctors to utilize the Infuse bone graft product for uses other than those approved by the FDA. After filing the complaint, Medtronic motioned to dismiss most of the claims, primarily due to the preclusions found in the Medical Device Amendments of 1976. However, the court granted the plaintiff an opportunity to amend her complaint with regard to the remaining viable claims, which included alleged off-label promotion, misrepresentations and deceptive trade practices. These claims were subsequently re-pled in the plaintiff’s first amended complaint, and dismissed upon the court’s findings that the allegations were still improperly drafted.

The plaintiff was given one more chance to amend the complaints, and submitted a second amended complaint shortly thereafter. This time, the court noted that the plaintiff had not properly pled her fraud claims, which are subject to the “heightened pleading requirements” found in Federal Rule of Civil Procedure 9(b). This rule requires any complaint alleging fraud to contain specific details of the fraudulent scheme, including examples and evidence of the misconduct.

Moreover, the court found that the plaintiff failed to adhere to Federal Rule of Civil Procedure 8(a), which requires “a short and plain statement of the claim showing that the pleader is entitled to relief.” According to the court, the plaintiff’s complaint has “pages and pages of irrelevant factual allegations,” and failed to concisely plead facts to support her claim.

  1., Federal Rule of Civil Procedure 8,
  2., Two main approaches to spinal fusion,
  3., FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion,