It was announced earlier this month that two California medical malpractice cases against a spinal surgeon were settled in late July 2016 for $4.25 million and $4.2 million, respectively. The spinal surgeon was alleged to have failed to disclose to two of his spinal surgery patients that he had financial ties to the manufacturer of the medical device used during their surgeries and that he used its products in an unsafe manner for “off-label” purposes during their surgeries.
The two California medical malpractice plaintiffs alleged that the defendant surgeon failed to disclose to them that he received royalties for using Medtronic products, including Medtronic’s Infuse Bone Graft product used during both of their surgeries, and that he consulted for Medtronic (the spinal surgeon allegedly received in excess of $275,000 from Medtronic from 2004 to 2013 for consulting fees, speaking fees, and for royalty payments). One of the California medical malpractice plaintiffs further alleged that he was unaware that a Medtronic sales representative was allowed in the operating room during his surgery.
One of the plaintiffs alleged that the defendant spinal surgeon used Medtronic’s Infuse Bone Graft product in his cervical spine even though the FDA only approved the product for use in the lumbar spine (the FDA had warned health care providers the year before the plaintiff’s spinal surgery that inserting Infuse Bone Graft into the cervical spine could be fatal). The plaintiff alleged that as a result of the Infuse Bone Graft material being inserted into his cervical spine, he sustained bone overgrowth that led to permanent nerve damage and that he suffers from chronic pain despite subsequent surgeries performed to address the issue.
The other plaintiff alleged that he consented to spinal surgery only after the defendant spinal surgeon agreed that he would personally perform his surgical procedure. The plaintiff alleged that the defendant spinal surgeon was not present and allowed an inexperienced assistant to perform the surgery during the first critical hours of the procedure, during which the assistant operated at the wrong level.
One of the plaintiffs alleged that Medtronic had improperly promoted the off-label use of its Infuse Bone Graft product in the cervical spine, which reportedly led to a confidential settlement between the plaintiff and Medtronic (off-label use by a health care provider is not illegal but a medical device manufacturer cannot promote such off-label use).
It has been reported that the defendant spinal surgeon was previously found to have failed to report almost $460,000 that he had received from pharmaceutical companies, as a result of an investigation by the U.S. Senate in 2009.
If you or a loved one were injured as a result of a medical device or product in the United States, you should promptly consult with a medical device claim attorney who may investigate your medical device claim for you and represent you in a claim against a medical device manufacturer, if appropriate.
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