Medtronic Infuse Bone Graft Lawsuit Demands $2 Million in Damages
Texas resident Tracy Olson is suing Medtronic, Inc. for $2 million in damages, alleging Infuse bone graft problems during her spinal fusion surgery left her with severe personal injuries and economic losses. She filed her product liability claim in the U.S. District Court, Southern District of Texas (Corpus Christi) on November 19, 2013.
Her Medtronic Infuse bone graft lawsuit levels two counts against the defendant, including strict products liability – manufacturing defect and breach of express warranty.
The plaintiff is also asking the court to order punitive damages against Medtronic, based on the allegation that its conduct was “malicious, intentional and outrageous and constitutes a willful and wanton disregard for the rights and safety of others.”
Olson claims to have incurred substantial hospital expenses due to her Infuse bone graft complications and, as a result, has suffered lost wages, a diminished earning capacity, and pain and suffering.
Medtronic Infuse bone graft lawsuit allegations
Court documents show that Olson had a transforaminal lumbar fusion surgery on September 6, 2007, and at the time, was implanted with an Infuse bone graft. The Infuse bone grafting material produced by Medtronic is made of Bone Morphogenetic Proteins (BMP), which use manufactured versions of naturally occurring proteins. In spinal fusion surgeries such as the plaintiff’s, bone grafts are used to replace, augment or repair chronic damage to parts of the spinal column.
Similar to dozens of other patients who have taken legal action against Medtronic, Olson argues that her Infuse bone graft failed on multiple levels. Allegations in her suit claim that fusion had failed to occur on the L4 and L5 vertebrae, and that Medtronic hardware had failed as well. The latter was discovered during corrective surgery in April 2012, when surgeons found that two screws had fractured inside her body. However, the claimant’s doctors had to leave the broken screws in place in order to conserve as much bone as possible.
Ms. Olson accuses Medtronic of downplaying the dangerous side effects of Infuse bone graft complications, and over-promoting its product to physicians and their patients. The plaintiff and her surgeon used the Infuse bone graft as intended, but were not sufficiently warned about potential problems, according to the suit, which labels the product as “defectively manufactured.”
History of overstating efficacy, downplaying risks
The lawsuit states that Medtronic breached its duty to ensure the bone graft was safe for human use, and in doing so, placed a defective product in the stream of commerce.
FDA approved since 2002, the Infuse bone graft has been blamed for serious and life-threatening injuries and complications, such as:
- Sterility in males
- Ectopic bone formation
- Implant displacement
- Difficulty swallowing, speaking or breathing
- Bone loss
- Urinary problems
- Chronic leg and back pain
To date, more than 100 patients who suffered complications from Medtronic Infuse bone graft surgery have filed lawsuits in an attempt to secure fair compensation for medical expenses, lost income, emotional trauma, diminished earning capacity and other non-economic losses.
Many of the claims have arisen from disastrous consequences with “off-label” procedures, which account for the majority of all Infuse bone graft surgeries. Just last year, Medtronic agreed to pay $85 million to resolve claims that 85.2 percent of company profits were derived from unapproved or off-label uses of its Infuse bone graft.
- FDA, INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device - P000058, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083423.htm
- Medtronic, Addressing Safety Concerns with INFUSE Bone Graft, https://www.infusebonegraft.com/pdf/Just%20The%20Facts%20Safety%20Reprint.pdf