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Jones v. Synthes USA Sales

August 19, 2010


The opinion of the court was delivered by: Pisano, District Judge


Plaintiffs Robert and Krista Jones have brought this product liability action against Defendants Synthes USA Sales, LLC and Synthes USA Products, LLC ("Synthes") for physical injuries stemming from Defendants' allegedly defective surgical screws. Plaintiffs allege claims of negligence, product liability, breach of warranty and consumer fraud. This Court has original jurisdiction to hear this dispute pursuant to 28 U.S.C. § 1332 because this case is a civil action between citizens of different states and the amount in controversy exceeds $75,000.

Presently before the Court is Defendants' summary judgment motion and motion to preclude the testimony of Plaintiffs' expert. The Court heard oral arguments on May 24, 2010. For the reasons set forth herein, the Court grants Defendants' summary judgment motion.

I. Background*fn1

Defendants Synthes manufactures the Anterior Tension Band ("ATB") which is a prescription medical device consisting of a metallic plate and four cancellous bone screws. ATB is used for spinal fusion surgery for the treatment of lumbar and lumbosacral spine instability. Spinal fusion surgery involves an attempt to fuse two vertebrae together whereby the ATB provides fixation during the expected bony fusion process. Each ATB package comes with an insert that reads "FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON" and communicates the following warnings:

* [T]hese implants are intended only to assist healing and not intended to replace normal body structures.

* If there is delayed union or nonunion of bone in the presence of weight bearing or load bearing, the implant could eventually break due to metal fatigue.

* Factors such as the patient's weight, activity level, and adherence to weight-bearing or load bearing instructions have an effect on the stresses to which the implant is subject, and therefore on the life of the implant. It is important to note that these implants may break at any time if they are subjected to sufficient stress.

* These devices can break when subjected to the increased loading associated with delayed union or non union.

* If healing is delayed or does not occur, the implant could eventually break due to metal fatigue.

* Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a fracture has healed, particularly in young active patients.

Plaintiff Robert Jones is a forty-six year old corrections officer with a history of lower back pain with radiation stemming from injuries he sustained during his employment. After increasing back pain, in March of 2004, Plaintiff began treatment with Dr. Marc Levine of the Trenton Orthopaedic Group and was diagnosed with degenerative disc disease. After Dr. Levine determined the extent of Plaintiff's pain levels, he recommended anterior lumbar interbody fusion to reduce the pain. On July 22, 2005, Dr. Levine performed the fusion surgery on Plaintiff using Defendants' ATB. From August 2005 through May 2006, Plaintiff had multiple check-up appointments with Dr. Levine who noted that Jones was "doing quite well overall." On September 8, 2005 and October 24, 2005, x-rays showed that the instrumentation was in place and Plaintiff reported that his pain had "dramatically improved." Additionally, despite the onset of back pain with numbness and tingling, an x-ray showed on April 18, 2006 that the instrumentation was still in place.

In late April or early May, while bending over a drawer, Plaintiff felt something pop in his back, heard an audible snap, and felt sensations of extreme pain. On May 11, 2006, an x-ray showed a failure of the left S1 screws of the ATB system with breakage within the bone. Dr. Levine believed that the lack of complete bony fusion post-surgery had allowed ongoing micromotion which fatigued the hardware causing the screws to fail. On August 4, 2006, Dr. Levine performed a posterior spinal surgery on Plaintiff. After the second surgery, Plaintiff continued to complain of lower back pain and pain going down both legs.

On March 12, 2008, Plaintiffs filed their complaint in the Superior Court of New Jersey, Law Division, Mercer County. On April 28, 2008, the case was removed to the United States District Court pursuant to 28 U.S.C. §1441(a).

II. Discussion

A. Summary Judgment Standard

To prevail on a motion for summary judgment, the moving party must establish "that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). The district court must determine whether disputed issues of material fact exist, but the court cannot resolve factual disputes in a motion for summary judgment. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986).

In determining whether a genuine issue of material fact exists, the court must view the facts in the light most favorable to the non-moving party and extend all reasonable inferences to that party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Stephens v. Kerrigan, 122 F.3d 171, 176-77 (3d Cir. 1997). The moving party always bears the initial burden of demonstrating the absence of a genuine issue of material fact, regardless of which party ultimately would have the burden of persuasion at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Once the moving party has met its opening burden, the non-moving party must identify, by affidavits or otherwise, specific facts showing that there is a genuine issue for trial. Id. at 324. Thus, the non-moving party may not rest upon the mere allegations or denials of its pleadings. Id. "[T]he plain language of Rule 56(c) mandates the entry of summary judgment, after ...

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