Trickett v. Advanced Neuromodulation Systems, Inc.

• Decision Date: 21 February 2008
• Docket Number: Civil Action CV207-016.
• Citation: 542 F.Supp.2d 1338
• Parties: Sandra Kay TRICKETT, Plaintiff, v. ADVANCED NEUROMODULATION SYSTEMS, INC., Defendant.
• Court: U.S. District Court — Southern District of Georgia

542 F.Supp.2d 1338

Sandra Kay TRICKETT, Plaintiff, v. ADVANCED NEUROMODULATION SYSTEMS, INC., Defendant.

Civil Action CV207-016.

United States District Court, S.D. Georgia, Brunswick Division.

February 21, 2008.

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Ashleigh Ruth Madison, Robert Bartley Turner, Savage & Turner, PC, Savannah, GA, for Plaintiff.

Christopher H. Smith, Dennis B. Keene, Hunter, MaClean, Exley & Dunn, PC, Savannah, GA, for Defendant.

ORDER

ANTHONY A. ALAIMO, District Judge.

Plaintiff, Sandra Kay Trickett, brought the above-captioned case against Defendant, Advanced Neuromodulation Systems, Inc., ("ANS"), asserting claims for strict product liability, breach of warranty, negligent design, and negligent failure to warn in connection with a medical device manufactured by Defendant. Additionally, Plaintiff asserts claims for breach of contract and intentional misrepresentation that arise from alleged representations made by Defendant's representatives.

Presently before the Court is ANS's motion for summary judgment. For the reasons set forth below, Defendant's motion will be GRANTED IN PART and DENIED IN PART.

BACKGROUND

Defendant is the manufacturer of spinal cord stimulators that are only available to patients through a physician's prescription. This action involves one of Defendant's products, the rechargeable ANS Eon Implantable Pulse Generator ("IPG"),¹ that was surgically implanted into Plaintiff.

Plaintiff suffers from chronic pain. Attempting to manage her pain, Plaintiff sought treatment from Dr. Gary Kaufmann in the fall of 2005. Dr. Kaufmann suggested the trial use of a spinal cord stimulator. After a successful trial periods in January 2006, Dr. Kaufmann implanted a permanent IPG and two lead wires² into Plaintiffs spinal column ("January Procedure").

While Plaintiff did receive some relief from the IPG, she began to experience problems. Specifically, Plaintiff reported feeling an "off/on" sensation every hour on the hour. Further, Plaintiff was distressed at the amount of time necessary to recharge the IPG's battery.³ Plaintiff reported these problems to Dr. Kaufmann and her ANS patient programming representative Paul Dawson.

Dawson contacted Defendant's technical support team seeking to diagnose the cause of Plaintiffs "off/on" sensation, However, the exact cause could not be determined. Dr. Kaufmann and Dawson both opined that the problem was the battery and advised Plaintiff that a second surgery was needed. Plaintiff underwent a second surgery to have the pulse generator/battery replaced ("May Procedure"). The lead wires were not replaced.

After the May Procedure, Plaintiff continued to experience the "off/on" sensation and reported a new problem, an occasional jolt or shocking sensation powerful enough to bring her to her knees. Thereafter, Dr. Kaufmann consulted with ANS representatives Dawson and David Bull. Because no explanation could be found for Plaintiffs symptoms, it was proposed by Bull that Plaintiff undergo another revision surgery to replace the entire IPG system including the lead wires.⁴

In October 2006, Plaintiff had her IPG system replaced ("October Procedure") by Dr. Mark Gold.⁵ Plaintiff reported having the same problems after the October Procedure. Plaintiff also complained to Dr. Kaufmann that charging the battery was now taking four hours a day.

The replacement IPG remains implanted in Plaintiff, and it continues to be used to manage Plaintiffs pain. Plaintiff alleges that she has been injured by the IPG, including: the "off/on" sensations occurring every hour, occasional electric shocks, and having to recharge her IPG's battery for longer than anticipated.

Plaintiffs breach of contract claims arise from alleged statements made by Defendant's representatives regarding Defendant reimbursing Plaintiff for expenses she incurred for all three of the' IPG procedures performed. According to Plaintiff, the first representation was made after the May Procedure by Dawson. Plaintiff alleges that Dawson promised that Defendant would reimburse Plaintiff for her "out of pocket" costs incurred from the first two procedures.

The second alleged representation occurred prior to the October Procedure. According to Dr. Kaufmann, Bull agreed that Defendant would be responsible for certain financial costs involved with the October Procedure. Defendant's Senior Manager of Technical Support, Sabrina Goldman, sent Dr. Kaufmann a letter dated September 20, 2006 ("September Letter"), detailing those specific costs and confirming the agreement.

Upon receiving the various bills for the October Procedure, Plaintiff sent them to Defendant. After discovering those bills had not been paid, Plaintiff called Goldman on January 19, 2007. During this phone conversation, Goldman told Plaintiff that there were discrepancies with the bills. Allegedly, Goldman also denied having knowledge of the September Letter. Goldman then told Plaintiff that Defendant's legal team determined that ANS was not obligated to pay the bills, and that the bills would not be paid by Defendant. In order to prevent the bills from being sent to collection agencies, Plaintiff made arrangements to submit the, bills to her health insurance company, Humana Gold, for payment.

Prior to Plaintiff filing suit, ANS had not paid any of the bills outlined in the September Letter. On February 15, 2007, ANS paid Dr. Kaufmann the physician's fee incurred during the October Procedure. All other bills specified in the September Letter were paid by Plaintiffs health insurance.

DISCUSSION

As to Plaintiffs tort claims, Defendant's main argument for summary judgment is based on the fact that Plaintiffs experts have failed to identify a specific defect in the IPG. Defendant maintains that because of this failure Plaintiff cannot show that the IPG was the proximate cause of her injuries. As to Plaintiffs breach of contract claims, Defendant asserts that any offers made by Defendant's representatives were gratuitous offers for which ANS has no liability.

I. SUMMARY JUDGMENT STANDARD

Federal Rule of Civil Procedure 56(c) provides for summary judgment "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Facts are "material" if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

The Court must view the facts in the light most favorable to the non-moving party, Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986), and must draw "all justifiable inferences in his favor ..." United States v. Four Parcels of Real Prop., 941 F.2d 1428, 1437 (11th Cir.1991) (en banc) (internal quotation marks omitted).

The nonmoving party is required to identify specific facts which demonstrate that there is a `genuine issue for trial and may not rest on the allegations or denials in its pleadings.' Anderson, 477 U.S. at 248, 106 S.Ct. 2505. However, in order to survive a motion for summary judgment, the nonmoving party need only present evidence from which a jury might return a verdict in its favor. If such party does so, there is a genuine issue of fact that requires a trial. Id. at 257, 106 S.Ct. 2505.

II. STRICT PRODUCT LIABILITY AND NEGLIGENT DESIGN

Defendant contends that summary judgment is proper on the issues of strict liability and negligent design because Plaintiffs experts could not determine a specific defect in the product. Defendant highlights the fact that Plaintiffs experts were not able to determine the cause of Plaintiffs symptoms. Defendant argues that, due to the lack of this evidence, Plaintiff will not be able to prove "to a reasonable degree of medical certainty that the cause of the injury complained of was attributable to some defect in the device," making summary judgment appropriate. Dkt. No. 75, Def. Mot. at 10 (quoting Wheat v. Sofamor, S.N.C., 46 F.Supp.2d 1351, 1358 (N.D.Ga. 1999)). On the issue of causation, Defendant admits that Plaintiffs "off/on" sensation is caused by a design feature of the IPG. Dkt. No. 75 at 12.

In order to recover from a manufacturer under Georgia's strict liability statute,⁶ the plaintiff must show that "the product, when sold was not merchantable and reasonably suited to the use intended and its condition when sold is the proximate cause of the injury sustained." Williams v. Am. Med. Sys., 248 Ga.App. 682, 683, 548 S.E.2d 371 (2001) (quoting Center Chem. Co. v. Parzini, 234 Ga. 868, 869, 218 S.E.2d 580 (1975)). The plaintiff is not required to show that the manufacturer was negligent. Id.

In cases that allege manufacturing defects or inadvertent design defects,⁷ "it is not necessary for the plaintiff to specify precisely the nature of the defect. He must show that the device did not operate as intended and this was the proximate cause of his injuries." Williams, 248 Ga.App. at 683, 548 S.E.2d 371 (emphasis added) (citing Firestone Tire & Rubber Co. v. King, 145 Ga.App. 840, 842, 244 S.E.2d 905 (1978)). Therefore, Plaintiffs experts' inability to determine a specific defect in the IPG is not fatal to Plaintiffs claims.

In the instant case, there is evidence that the IPG did not operate as intended. Defendant's expert, Benjamin Tranchina, and Dr. Kaufmann both testified that the IPG is intended to be used to deliver high frequency stimulation. Further, both men testified that the IPG is designed to come on very slowly and gradually so that the patient would normally not feel the voltage surge. Dkt. No. 92, Ex. D at 36; Dkt. No. 75, Ex. A3 at 76. Tranchina also testified that while Plaintiff does use...