Articles Posted in Federal Preemption Law

According to the report of this Illinois Appellate Court (1st District) decision, new ground is being broken in a lawsuit brought by Senayda Norabuena against Medtronic Inc. The suit, which was first dismissed on motion, involved the use of a Medtronic medical device implanted in a spinal fusion surgery.

The appeals panel for the 1st District held that the lawsuit, brought by Norabuena and her husband, against Medtronic involved parallel state law claims that are not pre-empted by federal law.

The justices found the plaintiffs’ pleadings were insufficient and ordered Cook County Circuit Court Judge John P. Callahan Jr. to grant them leave to file an amended complaint.
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In 2009, Gary Williamson was a postal worker who sought damages under the Federal Tort Claims Act (FTCA) for medical malpractice on the part of the Department of Veteran Affairs in the treatment of injuries he suffered in his right foot. Williamson usually worked a walking route, walking up to 8 miles each day on the job. He was also doing other physical activities, including running and CrossFit, which could have contributed to the severity of his injury.

Because of his injuries, Williamson eventually received benefits under the Federal Employees’ Compensation Act (FECA): $79,379.66 in temporary total disability net compensation from March 20, 2010 through Oct. 25, 2012; $27,801.27 for medical expenses; and $19,974.19 as a lump-sum “scheduled award.” This federal statute is the federal law for workers injured on the job. This is the federal version of the workers’ compensation act that most states have, including Illinois.

In addition to the benefits he was receiving by way of FECA, Williamson sought damages under the Federal Tort Claims Act for medical malpractice by the V.A. for the treatment of his injuries, which included two unsuccessful surgeries. The U.S. District Court judge denied the government’s motion for summary judgment. On appeal, the Sixth Circuit reversed that order, denying the motion for summary judgment.
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In an important constitutional issue in this medical negligence and medical records case, the dispute was whether patients in the state of Florida have the right to access records under the Florida Constitution and its Amendment 7, specifically records relating to “adverse medical incidents.” These records are considered privileged and confidential under the Federal Patient Safety and Quality Improvement Act (“the Federal Act”) such that the Florida law was preempted by this federal law.

In the appeal of this case, it was concluded that adverse medical incident reports requested by patients pursuant to the Florida Amendment 7 to its constitution was not preempted by the Federal Act. The lower court in Florida held that the Federal Act did preclude access to medical records in the state of Florida, but the Florida Supreme Court reversed, holding that the Federal Act was never intended as a shield for the production of documents required by Amendment 7 and other provisions of Florida law. The court also stated that provisions of Florida law are not preempted by the Federal Act, which set up a voluntary system for hospitals to improve patient’s safety.

In this case, Southern Baptist Hospital of Florida cannot shield documents and medical records not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the Florida Act.
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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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