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March 31, 2001


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



On April 18, 1997, plaintiff Donna Prohaska ("Mrs. Prohaska,")*fn1 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,*fn2 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 pedicles*fn3 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 case*fn4 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.


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 pseudarthrosis*fn5 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 explantation 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.*fn6 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.*fn7 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).


Mrs. Prohaska has filed several claims against defendants, including Fraudulent Marketing and Promotion, Negligent Misrepresentation, Strict Liability, Liability Per Se, Negligence, and Breach of Implied Warranty of Merchantability. Mr. Prohaska asserts a claim for Loss of Consortium. Although plaintiffs' response brief addresses allegations of fraud perpetrated against the FDA, plaintiffs never pleaded a Fraud-on-the-FDA count in their complaint and never amended their complaint to so plead. The parties entered into a stipulation filed in this court on March 10, 2000 that the only claims asserted by plaintiffs were those contained in their April 13, 1997 complaint. Item 27.

A. Procedural issues

1. Res Judicata/Collateral Estoppel

On December 9, 1994, Donna and Thomas Prohaska filed a complaint in the New York State Supreme Court, Niagara County, against Buffalo General Hospital. Stuart Medical Specialty, Inc., Danek Medical, Inc., Sofamor Danek Group, Inc., and Sofamor, Inc. Plaintiffs complained of injury to Donna Prohaska resulting from implantation of the C-D spinal fixation device. The causes of action pled included Negligence, Fraud and Misrepresentation, Strict Liability, Express Warranties, Punitive Damages, and Failure to Warn. Item 20, Exh. N. On July 1, 1997, plaintiffs and defendants signed a Stipulation Discontinuing Action, in which the action was "discontinued with prejudice on the merits." Item 20, Exh. O.

The doctrine of res judicata, or claim preclusion, holds that "a final judgment on the merits of an action precludes the parties or their privies from relitigating issues that were or could have been raised in that action." Monahan v. New York City Dep't of Corrections, 214 F.3d 275, 284-85 (2d Cir. 2000) (citations omitted). "Whether or not the first judgment will have preclusive effect depends in part on whether the same transaction or series of transactions is at issue, whether the same evidence is needed to support both claims, and whether the facts essential to the second were present in the first." Id. Res judicata bars a second, federal court action involving the same claims between the same parties as the first, state court matter. Restatement (Second) of Judgments § 24(1) (1982).

Given that plaintiffs discontinued the state court action on the merits, they are barred from maintaining this federal court action involving the same claims between the same parties. In addition, they are barred from asserting additional claims against those same parties that could have been raised in the state court action. Plaintiffs do not offer any rebuttal to defendants' res judicata argument. Thus, the claims against defendants Sofamor-Danek Group, Inc. and Sofamor, Inc. are dismissed on the basis of res judicata. The only remaining defendant in this action is Sofamor, S.N.C., f/k/a Sofamor, S.A.

2. Statute of Limitations

New York applies a three-year statute of limitations to personal injury and strict liability actions, CPLR § 214, a six-year statute of limitations to actions based on fraud, CPLR § 213, and a four-year statute of limitations for breach of warranty of merchantability. Defendants claim that this action by plaintiffs is time-barred by the statute of limitations.

a. Discovery Argument

Plaintiffs and defendants agree that the statute of limitations prescribed by CPLR § 214-c(2) governs implantations. Section 214-c provides that the three-year period within which an action to recover damages for personal injury shall be computed from the date of discovery of the injury by the plaintiff or from the date when plaintiff should have discovered the injury by exercising reasonable diligence. The parties differ on what the correct discovery date is.

In addition, defendants argue that CPLR § 214-c(4), which allows an additional one-year extension of the statute of limitations upon discovery of the cause of the injury if discovery of the cause occurred less than five years after discovery of the injury itself, is inapplicable. Asserting that the filing of the December 9, 1994 action in state court was the latest date on which Mrs. Prohaska could claim she discovered the screws were causing her injury, and that date occurred within five years of her injury, she had one additional year, until December 9, 1995, to commence this suit. Since she sat on her rights until April 13, 1997, the date of the filing of the federal court suit, her claims are time barred.

Plaintiffs contend that New York applies a three-year statute of limitations for personal injury actions, which begins to run when plaintiff realizes she suffered at the hands of another and that her injury was due to a human cause. Concerning the date of discovery, plaintiffs deny that Mrs. Prohaska "very quickly realized that the surgery did not work" and testified that in the winter or spring of 1992, she began to "suspect" her surgery did not work. Item 31, ¶ 56. When she asked Dr. Simmons about it, he dismissed the hardware as the cause of the problem. Item 20, Exh. C, p. 233. Plaintiffs also point out that Mrs. Prohaska testified that two or three months following her surgery, she had "no idea" as to what was the cause of her pain. Id., pp. 232-33.

In addition, plaintiffs claim that the statute of limitations in this suit was tolled from Dec. 30, 1993 to Feb. 22, 1995 pursuant to the class-action tolling rule. They cite American Pipe & Construction Co. v. Utah, 414 U.S. 538, 94 S.Ct. 756, 38 L.Ed.2d 713 (1974), and Crown Cork & Seal Co. v. Parker, 462 U.S. 345, 103 S.Ct. 2392, 76 L.Ed.2d 628 (1983), in support of this claim. Further, plaintiffs argue that the "two-injury rule"*fn8 is applicable to extend the statute of limitations. In response, defendants assert that American Pipe does not apply to save plaintiffs' claims and that the two-injury rule is inapplicable.

A genuine issue of material fact exists as to when Mrs. Prohaska "discovered" her injury. Because there is a difference in discovery dates pointed to by both plaintiff and defendant, such a finding would otherwise bar summary judgment for defendants on this issue. However, if it can be shown that discovery of Mrs. Prohaska's injury occurred within a time frame where the plaintiffs' complaint would still be time-barred, this issue could be determined as a matter of law.

Plaintiffs' contentions about time of discovery relate to the time when Mrs. Prohaska suspected the instrumentation caused her injury, that "her medical problem was `caused' by something extrinsic to her biology." Braune v. Abbott Laboratories, 895 F. Supp. 530, 545 (E.D.N.Y. 1995). Plaintiffs do not consider Mrs. Prohaska's awareness of a new type of pain as indicating `discovery.'

Defendants counter that the Braune reasoning was rejected by the New York Court of Appeals in Wetherill two years later. In Wetherill, an injury was deemed discovered, and the statute of limitations would begin to run on the date the physical condition forming the basis of the personal injury action became known to the plaintiff, regardless of whether the cause of injury was known at that point. Id. at 509, 514, 655 N.Y.S.2d 862, 678 N.E.2d 474.

On page 26 of their memorandum of law (Item 30), plaintiffs state that Mrs. Prohaska "was unaware of her injury until sometime after the spring of 1992." This is the only direct statement by plaintiffs concerning the discovery of the injury. Even so, it is phrased in the negative, which creates ambiguity. Given Mrs. Prohaska's testimony, and resolving all ambiguities and drawing all reasonable inferences in her favor as the nonmoving party on summary judgment, it is reasonable that she discovered her injury by summer or fall of 1992. On a June 19, 1992 doctors visit, she attributed her back pain to the pedicle screws and said she thought she had an "infected spine." Item 20, Exh. B, DDP-202-000004. See also Item 20, Exh. D; Schedule B, # 26; Schedule H, (f), (g), (h), (i), (k), (l), (n), (o), (p), (q), (r), (s), (t), (x). Given these facts, her claims relative to the three-year statute of limitations are time-barred under CPLR section 214-c(2).

CPLR § 214-c(4) also does not help Mrs. Prohaska. As defendants point out, it is undisputed that Mrs. Prohaska was aware of the cause of her injury by December 9, 1994, when she filed the State Court action. Because the alleged cause of her injury was discovered within five years of that injury, she had one additional year, until December 9, 1995, to commence suit. In re Pfohl Brothers Landfill Litigation, 68 F. Supp.2d 236, 247, 248 (W.D.N.Y. 1999). Because the federal suit was filed in 1997, the provisions of CPLR § 214-c(4) also do not assist Mrs. Prohaska.

Since Mrs. Prohaska's claims would be time-barred pursuant to CPLR § 214-c(2) and (4), it is necessary to analyze whether the second injury rule and federal class-action tolling rule might save her causes of action.

b. Second-Injury Rule

The second-injury rule provides that

Where the statute of limitations has run on one exposure-related medical problem, a later exposure-related medical problem that is `separate and distinct' is still actionable under New York's second injury rule. Under the rule, diseases that share a common cause may nonetheless be held separate and distinct where their biological manifestations are different and where the presence of one is not necessarily a predicate for the others development. . . . The progression of a single disease or condition into a more serious or debilitating form does not, however, give rise to an actionable second injury.

The flaw in plaintiffs' argument is that they have not offered any expert evidence to show that either fibromyalgia or arachnoiditis is separate and distinct from the various conditions that Mrs. Prohaska suffered from prior to her December 1991 implantation, or from each other. Further, they have not discounted that these injuries may be progressions of her condition into a more debilitating form. Plaintiffs expert, Dr. Austin, does not characterize Mrs. Prohaska's arachnoiditis as a separate and distinct injury, but as part of a "chronic pain syndrome" package. In his report, he opined:

It is my opinion that the patient's fibromyalgia and her arachnoiditis cause her to have a chronic pain syndrome which . . . causes her to have a permanent and total disability. . . . In conclusion, it is my opinion that her chronic pain syndrome is caused by the failure of the instrumentation to withstand the forces of bending, twisting, reaching, etc., and she is now left with arachnoiditis and fibromyalgia.

Item 20, Exh. P, p. 2.

In addition, plaintiffs offer a conclusory statement that arachnoiditis is a separate and distinct injury and occurred at a later date than the fibromyalgia. Item 30, p. 26. In Humphreys v. Humphreys, 949 F. Supp. 1014, 1020 (E.D.N.Y. 1997), the District Court granted summary judgment on statute of limitations grounds because plaintiffs allegations were unsupported by evidence that the two sets of injuries were unrelated. For these reasons, the court finds the second injury rule does not apply to extend the statute of limitations.

c. Class-Action Tolling

On December 30, 1993, a class action suit against Sofamor, S.N.C., entitled Zampirri v. Sofamor, S.N.C., 93-CV 7074 (E.D.Pa.), was filed in federal district court. Item 20, Exh. 29. Plaintiffs claim Mrs. Prohaska "was a putative member of the class." Item 30, p. 24. Class certification was denied on February 22, 1995. Item 20, Exh. 30. Orthopedic Bone Screw Products Liability Litigation, MDL1014, 1995 WL 273597 (E.D.Pa. Feb. 22, 1995). Plaintiffs contend that the class action rule tolls the statute of limitations from the time of filing until the resolution of a motion for class certification, and cite American Pipe & Construction Co. v. Utah, 414 U.S. 538, 94 S.Ct. 756, 38 L.Ed.2d 713 (1974); and Crown, Cork & Seal Co., Inc. v. Parker, 462 U.S. 345, 103 S.Ct. 2392, 76 L.Ed.2d 628 (1983), in support of their position.

American Pipe stands for the proposition that "the commencement of the original class suit tolls the running of the statute [of limitations] for all purported members of the class who make timely motions to intervene after the court has found the suit inappropriate for class action status." American Pipe, 414 U.S. at 553, 94 S.Ct. 756. Crown Cork expanded the rule in holding that "the filing of a class action tolls the statute of limitations as to all asserted members of a class whether they choose to intervene or file `individual actions' following the denial of class certification." Korwek v. Hunt, 827 F.2d 874, 877 (2d Cir. 1987).

Defendants proffer two arguments against class-action tolling: (1) in diversity cases, under Erie v. Tompkins, state statutes of limitations, not federal class-action tolling rules, apply, and (2) even if class-action tolling did apply, it would not save plaintiffs' claims.

Defendants cite Ragan v. Merchants Transfer & Warehouse Co., 337 U.S. 530, 533, 69 S.Ct. 1233, 93 L.Ed. 1520 (1949) for the proposition that, in this common law personal injury action based upon diversity of citizenship, New York substantive law, including statute of limitations rules, applies. This view is confirmed in 17 Moore's Federal Practice 3d, § 124.03, "Determining Scope (Pertinence) of Federal Rule Under Rules Enabling Act Test," pp. 19-20, which notes:

State statutes of limitations are substantive rules of law for Erie purposes. When jurisdiction is based on diversity of citizenship, a federal court is obliged to apply a state statute of limitations. In addition . . . state rules that are an integral part of the statute of limitations, such as tolling rules, apply to state claims brought in federal court.

See also Ellenbogen v. Rider Maintenance Corp., 794 F.2d 768, 772-73 (2d Cir. 1986) ("In a diversity case, the rule of Erie . . . intends that the outcome should be the same in federal court as if the litigation were tried in state court."). If federal class-action tolling is not applicable, plaintiffs' claims are time-barred.

Secondly, defendants point out that in New York, "class action tolling is inapplicable where, during the pendency of the class action petition, the plaintiff files his/her own individual lawsuit," citing Wahad v. City of New York, 1999 WL 608772 (S.D.N.Y. Aug. 12, 1999). Item 36, p. 5. Wahad explores the reasoning behind American Pipe's tolling provision: If plaintiffs were not protected by the tolling, they would be compelled to file their own motions to intervene in order to preserve their rights to participate in the litigation. This would "frustrate the efficiency and economy goals of [Rule 23] class action litigation." Wahad, 1999 WL 608772 at *5 Wahad also noted that American Pipe/Crown Cork relied on the existence of the class prior to a decision on certification to protect their rights, and the only efficient way to protect a plaintiff who has justifiably relied is to grant a toll. Id. at *6. Otherwise, if the class was not certified and the statutes of limitations had expired, the plaintiff who had relied upon the class action would be unprotected.

These notions of efficiency and reliance are integral to class-action tolling. But in this case, similar to Wahad, plaintiffs ...

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