Smith v. Sofamor, S.N.C.

• Decision Date: 11 May 1998
• Docket Number: No. 96-C-956-S.,96-C-956-S.
• Citation: Smith v. Sofamor, S.N.C., 21 F.Supp.2d 918 (W.D. Wis. 1998)
• Parties: Richard D. SMITH, Plaintiff, v. SOFAMOR, S.N.C., Defendant.
• Court: U.S. District Court — Western District of Wisconsin

21 F.Supp.2d 918

Richard D. SMITH, Plaintiff, v. SOFAMOR, S.N.C., Defendant.

No. 96-C-956-S.

United States District Court, W.D. Wisconsin.

May 11, 1998.

Jean Brown, Hausmann-McaNally, S.C., Milwaukee, WI, for Plaintiff.

Thomas J. Arenz, Whyte Hirschboeck Dudek, S.C., Milwaukee, WI, for Defendant.

MEMORANDUM and ORDER

SHABAZ, Chief Judge.

Plaintiff Richard Smith commenced this products liability and fraud action against the defendant Sofamor, S.N.C., alleging that he was injured when a defective orthopedic bone screw device manufactured by the defendant was attached to his spine during a spinal fusion operation. The matter was referred to the District Court for the Eastern District of Pennsylvania for purposes of multi-district pretrial litigation, MDL Docket No. 1014, and was returned to this Court after completion of discovery and resolution of non-case specific legal issues. The matter is presently before the Court on defendant's case specific motion for summary judgment as contemplated by the MDL transfer order. Jurisdiction is based upon 28 U.S.C. § 1332.

FACTS

The following facts are undisputed for purposes of the presently pending motion or are facts most favorable to the plaintiff.

Plaintiff experienced significant low back pain with radiation down his right leg and occasional left side discomfort as early as 1987. He was diagnosed as having spondylolisthesis at lumbar level L4-L5 in April 1991. Spondylolisthesis is a forward displacement of one vertebra over another, usually the fifth lumbar vertebra over the body of the sacrum or the fourth lumbar vertebra over the fifth. Plaintiff underwent numerous treatments including prescription pain medication and physical therapy, heat and ice packs, ultrasound treatments and epidural injections. These conservative measures failed to relieve his low back pain.

Plaintiff met separately with Drs. Manz and Narotzky in November 1992. Narotzky again diagnosed plaintiff with spondylolisthesis at the fourth and fifth lumbar vertebrae. Both doctors recommended that plaintiff undergo instrumented fusion surgery. After discussion with both doctors plaintiff consented to fusion surgery.

Spinal fusion surgery is a method of placing bone graft material between two mobile segments of the spine to knit them together as one bony unit and eliminate motion between the segments. Fusion surgery can be performed with or without the use of spinal instrumentation for internal fixation. With or without the aid of internal fixation instruments there is a risk that the fusion will not occur. The failure of fusion is referred to as pseudarthrosis.

Internal fixation instruments are used to provide stability to decrease motion between segments of the spine to allow the bone fusion to knit together. Internal fixation devices act as an internal splint. If a solid fusion is obtained, the device is no longer providing structural support and can be removed. If a solid fusion is not obtained at some point in time the internal fixation device will fail. Internal fixation devices may be attached with hooks, wires or bone screws. When the bone screws are employed they are screwed into the pedicles of a vertebra and connected to rods or plates to stabilize movement between the vertebrae to which they are connected. Defendant manufactures an internal fixation device known as the Cotrel Dubousset System ("CD System") consisting of a variety of rods, bone screws, hooks and connectors which are adapted by the surgeon to fit the patient as appropriate.

Plaintiff's treating physicians Manz and Narotsky worked together as a team performing fusion operations. Narotsky has performed over one thousand spine fusion operations at all levels of the spine using internal fixation devices in approximately eighty percent of those operations. Most of his operations involve the use of pedicle screw and rod systems. Manz has performed approximately 400 lumbo-sacral fusion operations. Nearly all of these were instrumented operations using bone screws.

On January 6, 1993 Manz and Narotsky performed an anterior/posterior fusion operation at the L4-5 level on the plaintiff. They used defendant's CD System attaching it to the plaintiff's vertebrae by the use of pedicle bone screws at L4 and L5. Plaintiff was discharged from the hospital on January 11, 1993.

Plaintiff's back pain was less after the surgery than before. Plaintiff reported that back pain interfered with his sex life although he had no problem obtaining an erection and reached climax fifty percent of the time. Approximately nine months after the first surgery plaintiff again began experiencing severe pain. A second surgery was performed on plaintiff by Drs. Manz and Narotsky on October 10, 1994. During the second surgery the CD System was removed and the fusion site explored. Fusion was found to be solid on the left but not on the right. The defendant's rods and pedicle screws were removed and replaced with a different manufacturer's fixation device which was secured with new bone screws placed in the same holes.

There is no evidence that the screws broke, failed, produced inflammation or infection in plaintiff. One of the defendant's screw had a slight angulation or "subtle bend". Doctor Manz did not say anything about the condition of the device after surgery and provided one of the screws to plaintiff.

A third surgery was performed in April 1996 at which time the new hardware was removed and the fusion was observed to be complete.

A. Yale Gerol is plaintiff's only expert offered to provide evidence that defendant's CD System caused injury to plaintiff. His opinion, contained in his expert report of May 12, 1997, consists of the following: "Upon review of the medical records of Mr. Richard Smith, it is my opinion that this patient received no benefit whatsoever from the use of the pedicle screw instrumentation in his fusion surgeries. It is my further opinion to a reasonable degree of medical certainty that the pedicle screw instrumentation has resulted in impotence and increased pain and deterioration of his condition."

Gerol was deposed on September 17, 1997 on the topic of plaintiff's injury. Gerol has not met, examined or spoken with the plaintiff. He reviewed portions of plaintiff's medical records. He testified that he generally believed that the spinal fusion operations, with or without the use of an instrument such as the CD System, were ill advised in most cases of low back pain. However, he offered no opinion concerning any negligence on the part of plaintiff's doctors in choosing to perform fusion on plaintiff.

Gerol identified three categories of problems with the use of pedicle screws. First, there is a potential adverse reaction by the body to the presence of a foreign body so close to the spinal canal; second, improper screw placement can damage nearby nerves; third, the screws or device can loosen or fail necessitating another invasive operation.

With specific regard to plaintiff, Gerol testified that the first fusion surgery was ill advised based on his condition. He further testified that plaintiff experienced a burning and numbness in his thigh after the operation because the bone graft was improperly taken from plaintiff's hip. "But there isn't any evidence that the screws broke, failed, produced any inflamation or produced any infection."

Harold L. Alexander also submitted an expert report addressing generally the problems associated with pedicle screws. Inaccurate placement impinging nerves, mechanical failure, osteoporosis leading to late screw migration, infection and inflamation were identified by Alexander as potential problems with pedicle screws. Based on scientific studies twelve percent of patients undergoing fusion surgery employing a pedicle screw device have a screw improperly placed.

MEMORANDUM

Defendant moved for summary judgment arguing principally that the evidence was insufficient to establish a defect in its product and that there was insufficient evidence of medical causation to support any claim against it. Because the Court now concludes that there is insufficient evidence as a matter of law to support its finding that defendant's device was the cause of any injury to the plaintiff, the Court does not reach the question of the existence of a defect, nor does it address any other issues raised by the defendant.

Summary judgment is appropriate when, after both parties have the opportunity to submit evidence in support of their respective positions and the Court has reviewed such evidence in the light most favorable to the nonmovant, there remains no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Rule 56(c), Federal Rules of Civil Procedure.

A fact is material only if it might affect the outcome of the suit under the governing law. Disputes over unnecessary or irrelevant facts will not preclude summary judgment. A factual issue is genuine only if the evidence is such that a reasonable factfinder could...