Schindler v. Sofamor, Inc.

• Decision Date: 23 April 2001
• Citation: 774 A.2d 765
• Parties: Dorothy T. and Robert E. SCHINDLER, Appellants, v. SOFAMOR, INC., Sofamor Danek Group, Inc., Somepic Technologies, Stuart Pharmaceutical Company, Appellees.
• Court: Pennsylvania Superior Court

774 A.2d 765

Dorothy T. and Robert E. SCHINDLER, Appellants, v. SOFAMOR, INC., Sofamor Danek Group, Inc., Somepic Technologies, Stuart Pharmaceutical Company, Appellees.

Superior Court of Pennsylvania.

Argued October 3, 2000.

Filed April 23, 2001.

Jonathan W. Miller, Philadelphia, for appellant.

Murray S. Levin, Philadelphia, for Stuart Pharmaceutical, appellee.

Before STEVENS, LALLY-GREEN, and OLSZEWSKI, JJ.

LALLY-GREEN, J.:

¶ 1 Appellants, Dorothy T. and Robert E. Schindler, appeal from the order dated February 15, 2000, granting judgment notwithstanding the verdict (JNOV) in favor of Appellee Stuart Pharmaceutical Company (Stuart). We affirm.

¶ 2 On December 15, 1994, Appellants filed a complaint against Stuart and other parties.¹ The complaint alleged that Stuart distributed a defectively-designed spinal fixation rod that broke after it was surgically implanted in Mrs. Schindler's spine.² The case proceeded to a four-day trial in December 1998. The trial court summarized the evidence as follows.

In January 1963, Plaintiff, Dorothy Schindler, was diagnosed with scoliosis, which is a curvature of the spine. Between 1963 and 1988, Mrs. Schindler was treated by a chiropractor. In 1988, Mrs. Schindler began to experience intense leg and back pain and went to see Richard A. Balderston, M.D., an orthopedic surgeon. Dr. Balderston informed Mrs. Schindler that her spine had curved to 74 degrees and that she would need back surgery in order to improve.

In November 1988, Mrs. Schindler underwent posterior and anterior fusion surgery. A Cotrel-Dubosset ("CD") spinal fixation device was placed in Mrs. Schindler's spine. The device consists of a series of hooks and rods which are used to stabilize and align the spine until fusion occurs. In January 1989, an x-ray revealed that one of the hooks implanted in Mrs. Schindler's spine had not set properly. Surgery was performed to repair the hook. After the surgeries, Mrs. Schindler's curve was reduced by 30 degrees and she became asymptomatic. Between 1989 and 1993, Mrs. Schindler testified that she felt good and that her activities resumed with no problems. In February 1993, while attending an exhibition baseball game, Mrs. Schindler experienced sharp lower back pain and was unable to walk out of the stadium. After that date, Mrs. Schindler began to experience pain and numbness in her legs and back.

Mrs. Schindler saw Dr. Balderston again in July 1993. An examination revealed that Mrs. Schindler's spine had not fused at the T11-T12 and T8-T9 sites. At this point of non-fusion, an x-ray revealed that one of the CD rods implanted in Mrs. Schindler's spine had fractured. Dr. Balderston informed Mrs. Schindler that she would have to undergo surgery to repair the rod. Surgery was performed in September 1993. The CD rods were removed and three new rods were placed in Mrs. Schindler's back....

Plaintiffs claimed that the knurled surface of the CD Rod was a design defect, which caused it to prematurely fracture.

Trial Court Opinion, 2/15/2000, at 2-3 (citations omitted). Specifically, Appellants claimed that the CD Rod was not fit for its intended use because it broke before the spine had fused.

¶ 3 Appellants presented the following evidence in support of this proposition. First, Mrs. Schindler testified that she was under the impression that the rod would be in her back for the rest of her life. N.T., 12/7/98, at 1.53.³ Next, Dr. Ronald Rosenfeld, an orthopedic surgeon, testified that Mrs. Schindler's initial surgery took place in two phases. In the first phase, the discs between the vertebrae are scraped out and filled with bone; "the objective here is to obtain a solid fusion mass." Id. at 1.167. The second phase took place one week later. In this phase, the bone is scraped, the rods are inserted and tightened, then additional bone is laid on top of the first bony mass "in order to try to get the bone to create a solid bone fusion." Id. at 1.168.

¶ 4 On September 9, 1993, doctors discovered that a rod had broken and that the bone had not fused (a condition known as pseudoarthrosis) at that site.⁴Id. at 1.170. Pseudoarthrosis brought about increased movement and higher forces at the site of the broken rod. Id. at 1.214, 1.221. The broken rod allowed abnormal spinal movement, which caused further degeneration of the spine and the need for a fourth operation, which in turn brought about a chronic back condition. Id. at 1.181, 1.225-1.226. Dr. Rosenfeld further testified that a spine should fuse within a year after implantation, and preferably within six months. Id. at 1.226. When asked if the spine is not going to fuse at all if it has not fused within one year, Dr. Rosenfeld responded: "I don't know that that's an absolute. I don't have enough experience to answer that. But I would say if it doesn't fuse in a year the chances of it fusing in and of itself are much decreased and something should likely be done to encourage that spine to fuse." Id. Various options for encouraging the spine to fuse include externally-applied electronic bone stimulation and ultrasonic bone growth stimulators. Id. at 1.227. When asked if instrumentation will inevitably break if there is no fusion, Dr. Rosenfeld responded: "Repeated stress forces on metal given an infinite amount of time will cause breakage. It's a question of the degree of force and the timeline." Id. at 1.227. Dr. Rosenfeld acknowledged that sometimes spines do not fuse, for reasons that are not clear. Id. at 1.198.

¶ 5 Dr. Robert M. Rose, Appellants' expert in engineering, metallurgy, orthopedic implants, and spinal instrumentation, testified that the rod was defective because of its knurled surface. In other words, the rod would not have failed if the surface had not been knurled. N.T., 12/8/98, at 2.24-2.25. The knurled surface concentrates the stresses in the metal, and the knurling process itself can also create stresses and peeling that ultimately lead to fractures. Id. at 2.36-2.38. According to Dr. Rose, the important factor in causing the metal to break was repeated stress on the knurled surface: "Now whether or not there was a pseudoarthrosis present does not change my conclusion that it would not have failed if the knurls were absent." Id. at 2.70. When asked on cross-examination whether "a proper fixation device serves its purpose if it aligns the spine for the time that it takes for fusion to occur," Dr. Rose responded: "That would be a successful limitation [sic], yes. If it keeps the spine aligned until fusion occurs then the surgeon has succeeded in his objective. I can't comment on the clinical results that would come of the fusion but, yes, the purpose of all that metal is to try to hold things together and hold them aligned until you can get fusion." Id. at 2.100; see also, id. at 2.112 (the rod would not have served its purpose if it fails before fusion occurs). The knurls were placed on the rod for improved holding power. Id. at 2.102. However, Dr. Rose testified that "most probably" the CD Rod system could be redesigned to use smooth rods. Id. at 2.111.

¶ 6 The jury found in favor of Appellants and awarded $1,585,000.00. On December 21, 1998, Stuart filed post-trial motions seeking JNOV and/or a new trial. On February 15, 2000, the trial court granted JNOV. The court ruled as a matter of law that the rod was not unreasonably dangerous. Specifically, the court found that the rod was safe for its intended use:

The rod's surface was knurled, or grooved. The knurling provided improved holding power and was not decorative. Plaintiffs claimed that the knurled surface of the rod caused it to prematurely break. Plaintiff's expert opined that smooth metallic surfaces last longer than any metallic surfaces which have been altered. Thus, Plaintiffs claimed that the knurled surface was a design defect.

An examination of the record clearly reveals that the CD Rod was not unreasonably dangerous for its intended use. The intended use of the rod was to stabilize the spine until fusion occurred. If fusion is to occur in an individual, it will occur within one year of surgery. The rod was never intended to last indefinitely in the absence of fusion. The testimony at trial established that all implants will eventually fracture in the event of non-fusion.

Mrs. Schindler's surgery took place in January 1989 and fusion should have occurred by January 1990. Therefore, the CD Rod had served its intended purpose if it stabilized Mrs. Schindler's spine within the one year following her January 1989 surgery. Plaintiffs do not claim that the rod failed to align Mrs. Schindler's spine in the year following the surgery. The rod did not break until July 1993, four and a half years after the surgery and three and a half years after the point that fusion should have occurred. The CD Rod fulfilled its intended use in providing stabilization for an additional three and a half years past its intended use.

Trial Court Opinion, 2/15/2000, at 5 (citations omitted). This appeal followed.⁵

¶ 7 Appellants raise three issues on appeal:

1. Does a review of the testimony under the correct standard demonstrate that the back rod was unsafe for its intended use?

2. Did the lower court violate the proper standard of review when it granted a judgment notwithstanding the verdict on the basis of testimony that was contradicted?

3. Did the lower court err as a matter of law when it considered on a motion for judgment notwithstanding the verdict whether or not the back rod was unreasonably dangerous?

Appellants' Brief at 3.

¶ 8 Appellants' three issues are closely interrelated; as such, we will address them together. Appellants argue that the trial court misapplied the standard for awarding JNOV because the court did not construe all factual inferences in favor of Appellants. They reason as follows. First, they presented evidence that the purpose of the CD Rod was to stabilize the spine until fusion took place. Next, it is undisputed...