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FDA Issues Warning letter to Device Maker Medtronic

Sep 30, 2013

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to device maker Medtronic Inc. regarding its Northridge, California diabetes facility.

The letter, received on September 19, stemmed from the regulator’s inspection of the premises. Amanda Sheldon, director of public relations for Medtronic's diabetes division, emailed a statement to explaining that the FDA’s warning letter involved procedures covering "corrective and preventative action, complaint handling processes, process validation, process monitoring, design control and general good manufacturing processes."

Medtronic has been making headlines in recent months over allegation of serious injuries tied to its Infuse bone graft product. While the device maker has sought to use preemption bids to get Infuse-related lawsuits dismissed, courts deny those requests, pointing out that because Medtronic has promoted Infuse for unapproved uses — and the product was then used in unapproved, off-label ways in these cases — the device maker is not protected under preemption.

Preemption is legal concept that has protected a number of medical device makers in liability lawsuits brought over devices that have received FDA approval, previously reported.

In response to one Medtronic preemption request, G. Murray Snow, U.S. District Court for Arizona, wrote that the preemption’s protection “vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not been reviewed by the FDA but has been promoted by the manufacturer…. Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device,” previously reported.

Infuse is a synthetic—genetically engineered—recombinant human Bone Morphogenetic Protein (rhBMP-2) that received FDA approval in 2002 for specific uses. Specifically, Infuse was designed to stimulate spine growth in patients suffering from lower spinal degenerative disease; Infuse was approved for use in one type of spinal surgery and some dental procedures. Infuse is not approved for use on the upper, or cervical spine; however, the bone graft product is broadly used in off-label procedures. On July 1, 2008 the FDA issued a notification warning about the product’s ties to serious complications when used in cervical spinal fusions.

Medtronic’s marketing of Infuse has been the focus of increasing controversy. Concerns have been raised over the way in which Infuse research was conducted, including that it was Medtronic-funded. Medtronic has been accused of promoting Infuse off label, of minimizing the device’s risks, and of overstating the product’s benefits. This led to a Senate probe, the agency warning, and at least two independent studies.

Also, According to a Stanford University study published in the September 4, 2013, edition of The Journal of Bone & Joint Surgery, a large dose—at least 40 milligrams—of Infuse is tied to increased risks of new cancer.

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