Sanders v. Advanced Neuromodulation Sys., Inc.


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Docket Number: 2009-CA-00594-SCT

Supreme Court: Opinion Link
Opinion Date: 09-30-2010
Opinion Author: Chandler, J.
Holding: Affirmed.

Additional Case Information: Topic: Personal injury - Federal preemption - Medical Device Amendments - Class III device - 21 C.F.R. § 882.5880
Judge(s) Concurring: Waller, C.J., Carlson, P.J., Dickinson, Randolph, Lamar, Kitchens and Pierce, JJ.
Non Participating Judge(s): Graves, P.J.
Procedural History: Summary Judgment
Nature of the Case: CIVIL - PERSONAL INJURY

Trial Court: Date of Trial Judgment: 04-03-2009
Appealed from: LEE COUNTY CIRCUIT COURT
Judge: James L. Roberts
Disposition: The trial court granted summary judgment in favor of Advanced
Case Number: CV 07-141(A)L

  Party Name: Attorney Name:   Brief(s) Available:
Appellant: William Sanders




D. L. JONES, JR.



 
  • Appellant #1 Brief

  • Appellee: Advanced Neuromodulation Systems, Inc. LEAH NICHOLS LEDFORD  

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    Topic: Personal injury - Federal preemption - Medical Device Amendments - Class III device - 21 C.F.R. § 882.5880

    Summary of the Facts: William Sanders filed a complaint against Advanced Neuromodulation Systems, Inc., North Mississippi Medical Center, Inc., Dr. Benjamin Wiseman, and John Does one through five. Sanders alleged that he had an operation at NMMC to remove the left lead of a spinal-cord stimulator. Sanders’s causes of action included negligent manufacture of the spinal-cord stimulator by ANS; distribution of a defective and dangerous product in commerce by ANS, NMMC, and Dr. Wiseman; and strict liability for injuries resulting from the manufacture, sale, and distribution of a defective product by ANS. ANS filed a motion for summary judgment which the court granted. Sanders appeals.

    Summary of Opinion Analysis: The trial court found that Sanders’s claims against ANS were barred by the Medical Device Amendments preemption clause. The trial court barred the claims because the FDA regarded the spinal-cord stimulator as a class III device, and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), preempted state-law claims challenging the safety and effectiveness of class III devices. Preemption is proper where Congress explicitly preempts state law; where preemption is implied because Congress has occupied the entire field; or where preemption is implied because there is an actual conflict between federal and state law. Sanders argues that the GenesisXP is a class II device as defined by federal regulations. He also argues that the trial court erred by basing its decision on a FDA order which was inconsistent with the FDA’s own regulations. That order effectively designated the GenesisXP as a class III device. ANS argues that federal regulations have not addressed a totally implantable spinal-cord stimulator. Nevertheless, ANS maintains that, because the device had been introduced into the market after May 28, 1976, pursuant to the FDCA, it automatically received a class III designation. ANS concedes that no regulation exists for a totally implantable spinal-cord stimulator. However, ANS argues that its device is distinguishable from the implanted spinal-cord stimulator defined in 21 C.F.R. § 882.5880 because the GenesisXP is totally implantable, meaning that the receiver and transmitter are both implanted, whereas the spinal-cord stimulator described in the regulation has an implanted receiver and an external transmitter for transmitting the stimulating pulse. The trial court did not err by finding that the GenesisXP was a class III medical device, and as such, Sanders’s claims were barred, because the claims were subject to federal preemption. The record shows that the FDA regulates medical devices pursuant to the FDCA. The federal government amended the FDCA in regard to medical devices with the MDA. This act provided that devices introduced after May 28, 1976, automatically received a class III designation. It was undisputed that the GenesisXP was introduced after May 28, 1976. The GenesisXP, pursuant to the MDA, was classified as a class III device. In an attempt to have the GenesisXP reclassified from a class III device to a class II device, ANS petitioned the FDA in 1999. The record contains the FDA’s denial of ANS’ request at reclassification. In its 2001 denial letter, the FDA unequivocally stated that the stimulator was “automatically classified into class III.” Sanders does not dispute the FDA documentation; rather he relies on the definition of the stimulator as described in 21 C.F.R §882.5880. The regulation does provide a class II designation for spinal-cord stimulators that have an internal and external component. However, as the evidence shows and as the FDA was aware, the GenesisXP is a fully implantable device. Further, the FDA order, the notice of denial of petition, and the premarket approval correspondence all make clear that the FDA itself considered ANS’ GenesisXP stimulator to be a class III device.


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