Prohaska v. Sofamor, S.N.C.

• Decision Date: 31 March 2001
• Docket Number: No. 97-CV-292C.,97-CV-292C.
• Citation: 138 F.Supp.2d 422
• Parties: Donna PROHASKA and Thomas Prohaska, Plaintiffs, v. SOFAMOR, S.N.C., f/k/a Sofamor, S.A.; Sofamor, Inc.; Sofamor-Danek Group, Inc., Defendants.
• Court: U.S. District Court — Western District of New York

138 F.Supp.2d 422

Donna PROHASKA and Thomas Prohaska, Plaintiffs, v. SOFAMOR, S.N.C., f/k/a Sofamor, S.A.; Sofamor, Inc.; Sofamor-Danek Group, Inc., Defendants.

No. 97-CV-292C.

United States District Court, W.D. New York.

March 31, 2001.

COPYRIGHT MATERIAL OMITTED

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Levin, Fishbein, Sedran & Berman (Fred Longer, of counsel), Philadelphia, PA, for Plaintiffs.

Pepper, Hamilton LLP (Philip H. Lebowitz, of counsel), New York City, for Defendants.

DECISION AND ORDER

CURTIN, District Judge.

INTRODUCTION

On April 18, 1997, plaintiff Donna Prohaska ("Mrs. Prohaska,")¹, a New York resident, brought this diversity action against Sofamor, S.N.C. (f/k/a Sofamor, S.A.), Sofamor, Inc., and Sofamor-Danek Group, Inc. Mrs. Prohaska alleges that she has suffered severe and permanent physical harm arising from defects in the Cotrel-Dubousset ("C-D") internal fixation system,² manufactured by Sofamor S.N.C., that had been implanted in her spine. Item 1. The device consisted of rods placed alongside and affixed to the posterior spine by means of screws which were attached to the pedicles³ of her spine. Defendants filed an answer on September 25, 1997. Item 2.

This action was one of over 2,000 cases filed nationwide in which plaintiffs alleged they were injured by pedicle screw devices. Pursuant to an Order of the Judicial Panel on Multidistrict Litigation, this case⁴ was transferred to the United States District Court for the Eastern District of Pennsylvania, where it was consolidated with the other cases and docketed as part of In Re Orthopedic Bone Screw Products Liability Litigation, MDL Docket No. 1014. While the case was in that court, the parties completed all factual discovery and all generic expert discovery, i.e., discovery of general expert opinion regarding "the overall science associated with the use of screws in pedicles of the spine...." In re Orthopedic Bone Screw Products Liability Litigation, M.D.L. 1014, 1998 WL 118060 at *6 (E.D.Pa.1998). The case was remanded to this court on January 22, 1999 for disposition on the merits. On January 28, 2000, defendants filed a motion for summary judgment with supporting exhibits (Items 13, 17, 18, 19, 20, 21, 22, 23) and a motion to strike the opinion of plaintiffs' expert, Dr. Austin (Items 14, 15, 16). On May 17, 2000, plaintiffs filed a response opposing the motions (Items 30, 31, 32, 33, 34); defendants filed a reply on May 6, 2000 (Items 36, 37, 38), and plaintiffs filed an unopposed motion for leave to file a sur-reply (Item 39) on June 30, 2000.

The court heard oral argument on defendants' motion for summary judgment and motion to strike the opinion of plaintiffs' expert on November 3, 2000. Having considered the parties' arguments, summary judgment is granted to the defendants on all causes of action.

BACKGROUND

Plaintiff Donna Prohaska, born on June 27, 1947, had known she had curvature of the spine since age 13. In October 1976, she was diagnosed with severe thoracolumbar scoliosis. Item 20, Exh B, DDP-009-000028, DDP-007-000010. In November 1977, her right shoulder was an inch higher than the left, and she had a leg length discrepancy of about one-half inch. Id., DDP-009-000026. In 1984, x-rays revealed that Mrs. Prohaska's spine curve became more pronounced at 66 degrees. Id., DDP-007-000010. Her diagnosis at the time was idiopathic adolescent scoliosis. Id. By 1984, she was diagnosed with idiopathic adolescent scoliosis, degenerative arthritis, and respiratory compromise. Id., DDP-007-000010. She also had the onset of osteoarthritis and osteoporosis, and was becoming shorter. Item 20, Exh D; Exh B, DDP-206-000030, DDP-007-000010. In the hopes of addressing the problem, on June 29, 1984, she underwent spinal fusion surgery with Harrington segmental spinal instrumentation, which Dr. Charles Nash placed along the length of her spine. Item 20, Exh B, DDP-007-000017. After surgery afforded a reduction in the curvature of her spine, Mrs. Prohaska was placed in a body cast. When the cast was removed, doctors noted disc narrowing, mild spondylotic changes, and lateral spurs. Id., DDP-007-000032. In 1985, Mrs. Prohaska complained of irritation and back discomfort and, in 1986, described occasional radiating pain tingling into both lower extremities, toes, and fingers. Id., DDP-007-000007, DDP-009-000023. On a visit to Dr. Nash's office on June 9, 1987, Mrs. Prohaska complained of "some aches and pains along with tingling and pulling along the heel areas bilaterally." Id., DDP-007-000006. Because of Mrs. Prohaska's continued pain and because the fusion was stable, Dr. Nash felt it was appropriate to remove the Harrington instrumentation. The explantation took place on April 28, 1988. Id., DDP-007-000006, DDP-007-000016, DDP-204-000240.

In May 1991, Mrs. Prohaska was referred to Dr. Edward Simmons, one of Buffalo's leading spine surgeons. She complained of persistent fatigue and noted that her back pain had continued to increase since the removal surgery. Id., DDP-002-000003, DDP-002-000014; Exh. C, p. 208. She experienced flare-ups that made it difficult to work as a singer and choir conductor. Item 20, Exh. B., DDP-002-000014. Dr. Simmons noted her degree of scoliosis was increasing, and surmised that her lower back pain may be due to possible pseudarthrosis⁵ and degenerative changes at the L3-4 and L4-5 levels. Id., DDP-002-000015. Dr. Simmons referred her to a physical therapist. She had difficulty tolerating the therapeutic and conditioning exercises, and was eventually discharged due to erratic attendance. Id., DDP-004-000005, DDP-004-000006. In 1991, Mrs. Prohaska was found to be disabled under the Social Security Act, although she did not begin receiving benefits until 1993. Item 20, Ex. D, p. 5.

Mrs. Prohaska continued to meet with Dr. Simmons and reported that her pain was worsening and was aggravated by walking, lifting, and prolonged sitting. Item 20, Ex. C, p. 205. Dr. Simmons suggested the possibility of another fusion surgery. Id., p. 210. Mrs. Prohaska agreed to undergo the surgery. During a pre-surgery hospital visit on December 10, 1991, Mrs. Prohaska stated that she experienced pain in her lower back radiating to her neck and shoulder. She claimed that the pain had gradually worsened, that she had numbness and tingling in both thighs, arm, toes, and fingers, arthralgia, and irritable bowel syndrome. Item 20, Exh. B, DDP-203-000011, 13-16. On December 16, 1991, she signed an informed consent form authorizing Dr. Simmons to perform a lumbar two-four fusion with C-D instrumentation. Item 20, Ex. E. She said that Dr. Simmons never talked to her about the instrumentation that would be implanted, although she assumed that "as long as I was having a fusion that something would probably be in there to stabilize the spine." Item 20, Exh. C, p. 212. The surgery took place at Buffalo General Hospital on December 17, 1991. When he attached the C-D construct to Mrs. Prohaska's spine, Dr. Simmons used six screws, including Sofamor 36031L vertebral pedicle screws, in Mrs. Prohaska's lumbar pedicles. Item 20, Ex. H, DDP-203-000034. Her condition on discharge was good. Item 20, Exh. B, DDP-203-000003.

In March 1992, x-rays showed the instrumentation in good position and the fusion consolidating well. Id., DDP-002-000009. Mrs. Prohaska underwent another regimen of physical therapy which she had difficulty tolerating. Id., DDP-004-000013. Since the surgery, Mrs. Prohaska complained of burning back pain, continual and uncontrollable diarrhea, and chronic pain throughout her torso, arms, and legs. Id., DDP-206-000013; Exh. C, p. 230, 231; Exh. D; Schedule H(c), (k), (s). In the winter or spring of 1992, Mrs. Prohaska began to suspect that the surgery did not work. During a visit to Dr. Simmons' office, she saw x-rays of her spine, which showed the instrumentation, and she asked him "[C]an't all of those screws be causing all of this problem?" Dr. Simmons responded in the negative. She then asked why she was having so many more problems with this surgery than with previous ones, and he answered, "I had to rotate your spine.... I had to literally turn it, so your recovery time is going to be longer." Item 20, Exh. C, p. 233.

In 1994, Mrs. Prohaska joined a back support group called Citizens Against Pedicle Plates and Screws (CAPPS). Id., p. 237. Because her pain continued, she met with Dr. Menkowitz in December of 1995. He told her that the instrumentation was causing her pain, and Mrs. Prohaska agreed to undergo explant surgery. Id., p. 256. When the explanation surgery took place on December 20, 1995, the fusion was found to be solid. Item 17, ¶ 43; Testimony of Dr. Austin, Item 20, Exh. I, p. 46.

Mrs. Prohaska was seen by Dr. John Noe in March 1994, who diagnosed her with fibromyalgia.⁶ Dr. Simmons concurred in an April 1994 letter to another doctor. Item 20, Exh. L, p. 4. On May 22, 1996, Dr. Frederick Elliot diagnosed Mrs. Prohaska as suffering from arachnoiditis.⁷ Id., p. 5.

Standard for Summary Judgment

Summary judgment is appropriate where the evidence shows that "there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R.Civ.P. 56(c). To avoid summary judgment, the non-moving party must present evidence such that "a reasonable jury could return a verdict for the non-moving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). While the movant bears the initial burden of showing that no genuine issue of material fact exists, he need not negate every allegation made by his opponent's case. Movant's motion should be granted if a showing is made that the non-moving party has failed to establish one of the elements essential to her cases. Celotex v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

DISCUSSION

Mrs. Prohaska has filed several claims against defendants, including Fraudulent...