Miss. SC dismisses claim over broken spinal cord stimulator

By Jessica M. Karmasek | Oct 7, 2010


JACKSON, Miss. (Legal Newsline) - The Mississippi Supreme Court has affirmed a lower court's ruling in favor of a medical device manufacturer whose spinal cord stimulator was faulty, claims a man who suffered injuries after it broke.

In the Court's opinion, filed Sept. 30, a Lee County circuit court did not err in granting summary judgment in favor of Advanced Neuromodulation Systems, Inc., or ANS, the manufacturer and distributor of the spinal cord stimulator at issue.

ANS manufactures a stimulator known as a GenesisXP Implantable Pulse Generator System, or GenesisXP. The device uses low-intensity electrical impulses to interfere with pain signals sent to the brain to prevent pain to a patient.

Most are used for chronic intractable pain of the trunk or limbs. While these devices may be either partially or totally implantable in a patient, the GenesisXP at issue is a totally implantable device.

In February 2005, ANS shipped a GenesisXP, a Quattrode lead, and a Patient Programmer of the GenesisXP to North Mississippi Medical Center, Inc., for William Sanders.

Following his surgery, Sanders filed a complaint against ANS, North Mississippi Medical Center, Inc., or NMMC, Dr. Benjamin Wiseman, and John Does one through five in the Circuit Court of Lee County. Sanders alleged that he had an operation on Sept. 14, 2005 at NMMC to remove the left lead of a spinal cord stimulator. During the surgery, the left lead of the stimulator broke, allegedly causing Sanders' injury and damages.

ANS filed its answer and affirmative defenses. Thereafter, the company filed a motion for summary judgment and memorandum in support of its motion.

On Jan. 14, 2009, the trial court heard arguments on ANS' motion for summary judgment. Following the arguments, the court determined that Sanders' claims were barred by the Medical Device Amendments, or MDA, preemption clause and issued an order granting summary judgment in favor of ANS.

Following the lower court's decision, Sanders appealed the state's high court.

The Court ruled that the trial court was correct in finding that the GenesisXP was a Class III medical device, and as such, Sanders' claims were barred because the claims were subject to federal preemption.

According to the Court, the record shows that the FDA regulates medical devices pursuant to the federal Food, Drug and Cosmetic Act. 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."

The record also has a FDA public notice. The FDA again designated ANS' stimulator as a Class III device in its public notice of denial of petition to reclassify the device. The FDA stated that ANS could not place the device into commercial distribution unless it was reclassified or subjected to premarket approval. ANS sought premarket approval. In 2002, the FDA approved ANS' application for premarket approval.

Associate Justice David A. Chandler, who authored the Court's opinion, said that it found "no genuine issue to any material fact" as to whether the GenesisXP is a Class III device.

"Sanders' claims challenge the safety and effectiveness of a Class III device that has received premarket approval by the FDA, imposing requirements that are different or in addition to MDA federal requirements," Chandler wrote. "Therefore, the trial court did not err by barring Sanders' claims under the MDA."

From Legal Newsline: Reach Jessica Karmasek by e-mail at jessica@legalnewsline.com.

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