Samarah v. Danek Med., Inc.

• Decision Date: 26 August 1999
• Docket Number: No. 95-2560-JWL.,95-2560-JWL.
• Citation: 70 F.Supp.2d 1196
• Parties: Dawood K. SAMARAH, Plaintiff, v. DANEK MEDICAL, INC., a wholly owned subsidiary of Sofamor Danek Group, Inc., Defendants.
• Court: U.S. District Court — District of Kansas

70 F.Supp.2d 1196

Dawood K. SAMARAH, Plaintiff, v. DANEK MEDICAL, INC., a wholly owned subsidiary of Sofamor Danek Group, Inc., Defendants.

No. 95-2560-JWL.

United States District Court, D. Kansas.

August 26, 1999.

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COPYRIGHT MATERIAL OMITTED

William P. Ronan, Cloon, Bennett & Ronan, Overland Park, KS, for Dawood K. Samarah, plaintiff.

Stephen S. Phillips, Philip H. Lebowitz, Pepper, Hamilton & Scheetz, Philadelphia, PA, W. Russell Welsh, Jessica A. Shulman, Polsinelli, White, Vardeman & Shalton, Kansas City, MO, for Danek Medical, Inc., defendants.

MEMORANDUM AND ORDER

LUNGSTRUM, District Judge.

In this products liability action, plaintiff Dawood Samarah claims damages for injuries he allegedly sustained after defendants' bone screw fixation construct was surgically inserted into plaintiff's spinal pedicles in an effort to effect vertebral fusion. Plaintiff's claims are substantially identical to those asserted in numerous other actions filed by plaintiffs across the country claiming damages allegedly resulting from the manufacture and sale of orthopedic bone screw constructs. On August 4, 1994, the cases were consolidated by the Multidistrict Litigation Panel and transferred to the Honorable Louis C. Bechtle of the Eastern District of Pennsylvania for the resolution of several pretrial matters common to all such "bone screw" actions. On October 1, 1998, the case was remanded to this court, and the matter was reopened for further proceedings. Presently before the Court is defendants Danek Medical, Inc. and Sofamor Danek Group, Inc.'s (collectively "Danek's")¹ motion for summary judgment (doc. 30). For the reasons set forth below, defendants' motion for summary judgment is granted, and plaintiff's complaint is dismissed in its entirety.

I. Background

The following facts are undisputed. Plaintiff is a 35 year-old male, who has experienced pain in his left leg since the early 1980's. At some point in 1982, plaintiff underwent lumbar surgery while in Damascus, Syria. After relocating to Wichita, Kansas in 1984, plaintiff began to experience lower back pain, and the pain in his left leg returned. As a result, plaintiff visited Dr. Bernard Poole, an orthopedic surgeon. Dr. Poole recommended that plaintiff undergo spinal disc surgery, and the surgery was performed shortly thereafter. No bone screw device was utilized during that surgery.

Plaintiff's 1984 back surgery was apparently successful in alleviating plaintiff's back pain for almost ten years. Indeed, between 1985-1992, plaintiff's medical records are largely devoid of any subjective complaints of back pain or discomfort. In late 1992, however, plaintiff began to experience a dull pain in his lower back and leg. Plaintiff's condition progressively worsened. Plaintiff sought medical assistance in an effort to alleviate his steadily increasing back pain, and was admitted to St. Joseph Medical Center by B.A. Sayeed, M.D. A battery of medical tests performed in March 1993 indicated that plaintiff suffered from arachnoiditis, possible lower lumbar spinal stenosis, and chronic left L5 radiculopathy.

Defendants' TSRH device consists of screws, hooks, rods, transverse traction devices, connectors and other components which may be customized, for spinal fusion surgery purposes, on a patient-by-patient basis. The TSRH construct, once surgically inserted, is intended to immobilize the diseased portion of the patient's spine by connecting adjacent spinal vertebrae with steel rods or plates. The rods or plates are anchored to the patient's spine by metal screws which are themselves inserted into the spinal pedicles.² Bone graft material, often in the form of small chips taken from the patient's hip bone, is then packed between and alongside the TSRH device. If spinal fusion surgery is successful, the grafted bone material eventually fuses together to form a solid bony mass that stabilizes the diseased portion of the spine.

On March 5, 1993,³ plaintiff elected to undergo spinal fusion surgery. Defendants' TSRH bone screw construct was surgically implanted at that time. Because plaintiff's operative report indicated that the left side pedicles were too small to be instrumented, Dr. Poole inserted a pedicle screw device unilaterally, on the right side pedicles only, at the L5-S1 level.

According to plaintiff's medical records, a follow-up visit on March 14, 1994 revealed "excellent sound fusion," and plaintiff was enjoying marked, asymptomatic improvement. On June 29, 1994, however, plaintiff began to experience lower back pain and tingling in his legs. The pain and tingling were so severe that plaintiff was unable to sleep through the night. In July 1994, after a garage door opener⁴ fell on him, plaintiff visited Michael P. Estivo, D.O., complaining of constant lower back pain and pain in both legs. According to Dr. Estivo, X-rays of plaintiff's spine revealed that the TSRH construct remained in good position. Given plaintiff's previous history of back operations, and due to the presence of scar tissue formation from plaintiff's previous surgeries, Dr. Estivo did not recommend any further surgery at that time.

In September 1994, plaintiff visited William Shapiro, M.D., a neurosurgeon. On September 28, 1994, Dr. Shapiro implanted a temporary epidural neurostimulator ("TENS") unit in an effort to relieve plaintiff's lower back and leg pain. Shortly thereafter, Dr. Shapiro referred plaintiff to Jacob Armani, M.D., a spine surgeon. Dr Armani's examination revealed no evidence of fusion at the L5-S1 level. After discussing the matter at length with plaintiff, plaintiff elected to have the TSRH construct removed, and on December 15, 1994, the TSRH device was explanted from plaintiff's spinal column. According to Dr. Armani's operation report, plaintiff was found to have gross motion between L5 and S1, and there was no evidence of bony fusion. Dr. Armani testified later that, during the surgery, he observed no sign of breakage, bending, or stripping of the TSRH hardware.

Plaintiff's medical records indicate that he experienced significant relief from his back pain following the removal of the pedicle bone screws, although some of the leg numbness plaintiff had experienced prior to the operation continued to affect plaintiff's right leg after surgery. In July 1995, however, plaintiff's back pain recurred, and on September 14, 1995, a left lumbar discectomy at L4-5 was performed.

Plaintiff originally filed his complaint with this court on December 19, 1995. As set forth above, the case was consolidated with many other similar cases by the Multidistrict Litigation Panel and transferred to the Eastern District of Pennsylvania for coordinated pretrial proceedings pursuant to 28 U.S.C. § 1407. Danek moves for summary judgment on each of plaintiff's claims, arguing that no material issues of fact exist for trial.

II. Legal Standard

Summary judgment is appropriate if the moving party demonstrates that there is "no genuine issue as to any material fact" and that it is "entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). In applying this standard, the court views the evidence and all reasonable inferences therefrom in the light most favorable to the nonmoving party. Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 670 (10th Cir. 1998) (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)). A fact is "material" if, under the applicable substantive law, it is "essential to the proper disposition of the claim." Id. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). An issue of fact is "genuine" if "there is sufficient evidence on each side so that a rational trier of fact could resolve the issue either way." Id. (citing Anderson, 477 U.S. at 248, 106 S.Ct. 2505).

The moving party bears the initial burden of demonstrating an absence of a genuine issue of material fact and entitlement to judgment as a matter of law. Id. at 670-71. In attempting to meet that standard, a movant that does not bear the ultimate burden of persuasion at trial need not negate the other party's claim; rather, the movant need simply point out to the court a lack of evidence for the other party on an essential element of that party's claim. Id. at 671 (citing Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)).

Once the movant has met this initial burden, the burden shifts to the nonmoving party to "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 256, 106 S.Ct. 2505; see Adler, 144 F.3d at 671 n. 1 (concerning shifting burdens on summary judgment). The nonmoving party may not simply rest upon its pleadings to satisfy its burden. Anderson, 477 U.S. at 256, 106 S.Ct. 2505. Rather, the nonmoving party must "set forth specific facts that would be admissible in evidence in the event of trial from which a rational trier of fact could find for the nonmovant." Adler, 144 F.3d at 671. "To accomplish this, the facts must be identified by reference to affidavits, deposition transcripts, or specific exhibits incorporated therein." Id.

Finally, the court notes that summary judgment is not a "disfavored procedural shortcut;" rather, it is an important procedure "designed to secure the just, speedy and inexpensive determination of every action." Celotex, 477 U.S. at 327, 106 S.Ct. 2548(quoting Fed.R.Civ.P. 1).

III. Discussion

A. Kansas Product Liability Act

Under Kansas law, product liability claims are governed by the Kansas Products Liability Act ("KPLA"), codified at K.S.A. § 60-3301 et seq. See K.S.A. § 60-3301 et seq. The underlying purpose of the KPLA is "to consolidate all product liability actions, regardless of theory, into one theory of legal liability." Patton v. Hutchinson Wil-Rich Mfg. Co., 253 Kan. 741, 756, 861 P.2d 1299, 1311 (1993). Thus, under K.S.A. § 60-3302(c), ...