Articles Posted in Federal Civil Procedure

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The U.S. Court of Appeals for the Seventh Circuit in Chicago has affirmed a district court’s order dismissing a medical negligence case brought against the Department of Veteran Affairs.

Jerome Augutis underwent reconstructive surgery on his right foot at Illinois’ Edward Hines Jr. Veterans Administration Hospital in July 2006. Because of complications during the surgery, the doctors amputated Augutis’s right leg below the knee on Sept. 22, 2006. 

Augutis maintained that the amputation was the result of negligent treatment. He filed an administrative complaint with the Department of Veteran Affairs in July 2006. His claim was denied in September 2010 and Augutis filed a request for reconsideration in March 2011. 

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In a 9th Circuit decision handed down in January 2013, the court of appeals found that the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetics Act were not a wedge to prevent a plaintiff from making a state negligence claim against Medtronic. In a series of previous cases dating back to 2008, defendants, manufacturers and distributors of medical devices were armed with preemption defenses as a result of the cases of Riegel v. Medtronic, Inc. and bolstered by Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal.  Because of the conflicts in the different U.S. Circuit Courts, there is a good possibility that the U.S. Supreme Court will take up these cases to clarify this litigation and rectify the conflict in the districts.

In the Stengel v. Medtronic case, the 9th Circuit held that the plaintiff’s claim of state law negligence for the defendant’s choosing not to report known risks of its product to the FDA, was not expressly nor impliedly preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.

In the Stengel case, Stengel had a Medtronic pump implanted in his abdomen to control pain he had in his back. Unfortunately, an inflammatory mass formed at the tip of the pump’s catheter that caused permanent paraplegia. 

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