A California court of appeals recently reversed a previous decision that prevented a Medtronic bone fuse injury lawsuit from going forward. The plaintiff’s negligence and liability case was revived, however Medtronic now plans to bring the case to the state’s Supreme Court. Medtronic lawyers at Pintas & Mullins Law Firm review this decision and the cases it is based on.
The plaintiff, John Coleman, sued Medtronic for negligence and failure to warn concerning its product the Infuse Bone Graft. The labelling, design, and manufacturing methods for this product were approved by the FDA, which is why Medtronic is attempting to argue that the case is federal, rather than state issue.
Coleman claims that Medtronic fraudulently misrepresented the Infuse Bone Graft, both to the FDA and the public, by failing to file adverse event reports. The court of appeals agreed with Coleman, stating that Medtronic was required under California law to file all adverse event reports with the FDA, in accordance with the U.S. Food, Drug, and Cosmetic Act (FDCA).
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A similar case was brought to court about a year ago, known as Stengel v. Medtronic. In this case the plaintiff, Richard Stengel, also claimed that Medtronic was negligent in failing to file adverse event reports associated with its pain pump products. This case was brought all the way to the U.S. Supreme Court, where it is currently ongoing.
Ambiguous Supreme Court Decision
The confusion in both Stengel and Coleman rests in a 2001 decision by the U.S. Supreme Court in the case of Buchman Co. v. Plaintiffs’ Legal Committee. The justices in that case ruled that state-law claims that a company defrauded the FDA while seeking approval for a medical device was not allowed based on the FDCA Medical Device Amendments.
What this case left unclear was whether or not plaintiffs could still sue when companies failed to report adverse events after the device was approved by the FDA. At issue is the scope of Buchman; whether is applies exclusively to fraud prior to FDA approval (pre-market failure to warn), or if plaintiffs could still sue based on fraud after federal approval (post-market failure to warn). Legal experts believe the Supreme Court will soon take up the issue and make a clear distinction.
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Back to Coleman; along with his failure to report claims, the California court of appeals also revived his claims that Medtronic marketed the Infuse Bone Graft for off-label uses, which is considered a negligence claim. The Infuse Bone Graft is only approved to be implanted by a surgeon through an abdominal incision, to strengthen vertebral discs.
During Coleman’s procedure, the device was inserted through his back, after which he developed extremely painful and unwanted bone growth. He now argues that Medtronic negligently promoted the device to be implanted through a back incision to surgeons and concealed adverse events associated with this method.
Specifically, Coleman cites several consulting agreements with leaders in the medical community, which he believes Medtronic used to boost sales despite high complication rates. In recent years there has been a flood of litigation surrounding Medtronic’s Infuse and pain pump products. Claims in the majority of these cases are more or less the same: that Medtronic promoted the products for off-label uses, and failed to report adverse events to federal, state, and local authorities.
Our team of Medtronic attorneys is currently investigating cases of patient injury from the company’s medical devices. If you or a loved one was seriously injured during or after surgery using a Medtronic device, contact our firm for a free legal evaluation immediately.