Top Class Actions  |  April 8, 2014

Category: Legal News

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infuse bone graft spinal surgeryConsumers have legal rights, but they can be limited when it involves certain government regulatory activities. That, a federal judge wrote, is why the number of allegations in one Infuse bone graft lawsuit was reduced from eight to two.

The Infuse bone graft is a product patented and marketed by Medtronic and was approved by the U.S. Food and Drug Administration for use in spinal fusion surgery in the lumbar region near the base. However, Missouri Laura Blankenship alleges in a Medtronic Infuse lawsuit that her surgeon used the product in the cervical section, around the shoulders and the neck.

Blankenship alleges that the surgeon opted for the Infuse bone graft during her spinal surgery because Medtronic had engaged in “improper promotion” for “off-label uses” of Infuse, and that Blankenship would not have acceded to the procedure had she known of the differences. Her lawsuit included counts of manufacturing and design defects, negligence and strict liability.

Judge Carol E. Jackson ruled that all of those must be dismissed because the regulations and duties of the FDA pre-empt those of a consumer or patient. The manufacturing and design defect claims were rejected because, Jackson wrote, the spinal surgery device met the standards for its approved usage.

Similarly, the failure to warn count failed because of the count’s reliance on a defective design or negligence claim. Citing another court decision, Jackson added that any negligence regarding Infuse bone graft complications would fail if “based solely on illegal off-label promotion” because the legality of that marketing remains under the FDA’s purview. Her Infuse bone graft lawsuit identified several instances where “Medtronic employees or agents knowingly or recklessly provided inaccurate or misleading information.”

These two counts are not pre-empted by the FDA because they rely on additional literature and marketing materials that Medtronic chose to provide to consumers and medical professionals. However, there are heightened pleading requirements to sufficiently allege fraud, similar to the heightened standards that would be required to file an Infuse bone graft class action lawsuit where numerous plaintiffs to join together in legal action.

The Infuse bone graft lawsuit is Laura Blankenship v. Medtronic Inc., et al., Case No. 13-cv-1087, U.S. District Court, Eastern District of Missouri.

In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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