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PROHASKA v. SOFAMOR
March 31, 2001
DONNA PROHASKA AND THOMAS PROHASKA, PLAINTIFFS,
SOFAMOR, S.N.C., F/K/A SOFAMOR, S.A.; SOFAMOR, INC.; SOFAMOR-DANEK GROUP, INC., DEFENDANTS
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
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
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.
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.
Defendants cite Wetherhill v. Eli Lilly & Co., 89 N.Y.2d 506,
655 N.Y.S.2d 862, 678 N.E.2d 474 (1997) for support that the date of the
"discovery of the injury" under
CPLR 214-c(2) is the date the plaintiff discovered the primary condition
on which the claim is based, i.e., when the plaintiff knew about the
medical condition forming the basis of her claim. Id. at 509, 511,
655 N.Y.S.2d 862, 678 N.E.2d 474. They cite references in the record
wherein Mrs. Prohaska remarked upon her increased pain since the December
17, 1991 operation. Item 20, Exh. D, Questionnaire Responses; Schedule
H(c), (k), (s); Exh. B, 206-000013; Exh. C, pp. 230-31. In January 1992,
Mrs. Prohaska wondered whether the cause of her pain was the
instrumentation, since "something didn't seem right almost immediately.
. . ." Item 20, Exh. D, Questionnaire Response # 26; Exh. C, p. 233-34.
She felt the burning pain by March 1992, "within the first several
months" since surgery, and described that burning pain as "different" in
nature from the other pain she had experienced. Item 20, Exh. C, p. 231.
Based on these facts, defendants assert that Mrs. Prohaska discovered her
injury by January 1992 at the latest, and that her claims were
time-barred by 1995 at the latest.
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
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
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.
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.
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 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 ...