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SITA v. DANEK MEDICAL
March 29, 1999
MICHAEL SITA AND BEVERLY SITA, PLAINTIFFS,
DANEK MEDICAL, INC., RESPONDENT.
The opinion of the court was delivered by: Trager, District Judge.
This is one of two thousand actions filed by five thousand
plaintiffs nationally against the makers of surgical screw
systems used by orthopedic surgeons in certain types of spinal
surgeries. The plaintiffs here are Michael Sita ("Sita"), now
57 years old, and his wife, Beverly Sita. Sita alleges claims
of per se negligence arising out of alleged violations of
21 U.S.C. § 301, strict products liability, fraud, negligent
misrepresentation, breach of express*fn1 and implied
warranties, negligent infliction of emotional distress, and
conspiracy to defraud. He seeks compensatory and punitive
damages as well as equitable relief. Mrs. Sita seeks monetary
damages for loss of consortium. Defendant has moved for summary
judgment on all claims.
Plaintiff Michael Sita has suffered from severe back and leg
pain since 1987 when medical examination revealed bulging discs
at the L3-4 and L4-5 vertebrae. Sita's complaints of radiating
lower and upper back pain and of back spasms continued into
1990 when an MRI of Sita's lumbar spine confirmed the presence
of desiccated and bulging discs at both the L3-4 and L4-5
vertebrae. In 1991, Sita complained of numbness and burning in
his back and right leg.
In May 1992, Sita aggravated his back condition in a
work-related accident when he was injured by a runaway golf
cart at the Nassau Country Club while attempting to stop it. As
a result of his on-the-job accident, plaintiff sought worker's
compensation. When he first saw a doctor two weeks after the
1992 accident, he was unable to stand due to severe pain and
numbness in his back and legs. By June 1992, plaintiff was able
to walk with a cane, but did so with a severe limp. In August
1992, Sita reported spasms, pain in his head, neck, back, right
arm, hand, leg, knee and foot, numbness in his leg and foot,
and difficulty walking, bending, sleeping, lifting and moving.
Starting in July 1992, plaintiff underwent a course of
physical therapy. According to the records of plaintiff's
physical therapist, aspects of that therapy only aggravated
Sita's condition, while the remaining treatments did not appear
to alleviate Sita's pain. Def. Aff. in Supp. of Summary
Judgment, at Exh.A. On September 1, 1992, Sita expressed to his
physical therapist that "I have had no relief [from] physical
therapy. Surgery is my only answer." Rec. of Physical Therapy,
dated 9/1/92. His severe pain prompted an emergency room visit
to North Shore University Hospital on September 9, 1992. At
that time, he could "barely" walk and was admitted to the
hospital. See North Shore Univ. Hospital Discharge Summary,
In December 1992, Sita came under the care of Dr. Arthur
Weber, now deceased, who was an orthopedic surgeon affiliated
with New York Spine Specialists in Lake Success, New York. On
Sita's first visit to Dr. Weber, Sita described numbness in his
right leg which "almost never" went away. Rec. of Pl. Visit to
Dr. Weber, dated 12/3/92. Initially, Dr. Weber prescribed a
course of non-surgical treatments that included the use of
non-steroidal anti-inflammatory medications and lumbar body
support. See id. This treatment, however, proved to be
ineffective. Dr. Weber then ordered an EMG, the results of
which suggested a right radiculopathy of the L3-4 vertebrae. He
linked plaintiff's symptoms to the L3-4 disc (and a suspected
L4-5 degenerative disc) which was "exquisitely painful" on
discogram. Rec. of Pl. Visit to Dr. Weber, dated 2/23/93. These
tests convinced Dr. Weber that fusion surgery from the L3 to
the L5 vertebrae was appropriate.
On May 7, 1993, Dr. Weber performed instrumented spinal
fixation surgery at the Long Island Jewish Medical Center,
during which he implanted components of the Texas Scottish Rite
Hospital ("TSRH") Spinal System in Sita's spine. The TSRH
System, distributed by defendant Danek, consists of screws,
hooks, rods, transverse traction devices, connectors, and other
components that allow surgeons to customize constructs. Its
purpose is to immobilize the spine while bone graft material
placed between the affected vertebrae grows together to form a
solid, bony fusion. Dr. Weber used a surgical technique called
"pedicle fixation" to attach the TSRH construct to Sita's spine
with six screws in the pedicles of the L-3 to L-5 vertebrae.
See Long Island Jewish Medical Center Rec. of Operation, dated
5/7/93. The "pedicles" are the two rearward facing bony arches
on either side of the vertebral body that support the lamina.
See Dorland's Illust. Med. Dictionary, at 1819 (28th ed. 1994)
(diagram of vertebra).
Within days of the surgery, Sita had a "dramatic relief of
symptomology" and the TSRH construct was holding his spine
"rigidly and firmly." Rec. of Pl. Visit to Dr. Weber, dated
5/18/93. Two months later, x-rays revealed "excellent
positioning of hardware and good evidence of fusion." Rec. of
Pl. Visit to Dr. Weber, dated 7/15/93. However, approximately
three months after the surgery, plaintiff began complaining of
aching pain and discomfort, whereupon Dr. Weber advised
plaintiff that "the bone graft would take approximately one
year to heal." Rec. of Pl. Visit to Dr. Weber, dated 8/5/93.
Dr. Weber subsequently determined that, due to plaintiff's
weight (between 185 and 200 pounds), an additional anterior
(front) spinal surgery would be necessary to support
plaintiff's back and alleviate his discomfort. See Id. While
some patients need only a single posterior surgery, in persons
weighing 200 pounds or more, a second, anterior surgery is
generally required. See id.
On November 8, 1993, plaintiff underwent an anterior spinal
fusion. This procedure did not make use of the TSRH or any
other Spinal System. At subsequent visits to Dr. Weber on
January 13 and February 10, 1994, plaintiff offered no specific
complaints of pain. On plaintiff's visit to Dr. Weber on March
10, 1994, plaintiff complained of "some mild back discomfort."
Rec. of Pl. Visit to Dr. Weber, dated 3/10/94. X-rays of
plaintiff's spine taken on that day (10 months after Sita's
initial surgery) indicated that one of the TSRH screws had
fractured. Dr. Weber observed that even though the screw had
fractured, the bone graft remained in position and, as long as
the graft healed, the broken screw "[would] not be much of a
problem." Rec. of Pl. Visit to Dr. Weber, dated 3/10/94.
At plaintiff's following visit, a little more than a month
later, Dr. Weber noted that he thought that plaintiff was
"unduly concerned about the broken screw." Rec. of Pl. Visit to
Dr. Weber, dated 4/7/94. On May 5 and June 1, 1994, Dr. Weber
noted that despite continued complaints of pain and discomfort
in Sita's lower back region, the bone graft from plaintiff's
first surgery had gone on to fuse. As of August 4, 1994, the
bone graft from the second surgery had not yet fused, though
Dr. Weber expected that it would.
In September 1994, Dr. Weber had a long discussion with Sita
about the fact that Sita wanted to join a class action suit
against the makers of spine screws. At plaintiff's next visit
on November 10, 1994, plaintiff began to complain of additional
symptomatology. Dr. Weber noted that, in light of the lawsuit,
plaintiff's new complaints appeared to be subjective and
expressed concern that, as a result of plaintiff's involvement
in the lawsuit, "everything [was] becom[ing] tainted." Rec. of
Pl. Visit to Dr. Weber, dated 11/10/94. Dr. Weber informed Sita
that his complaints were "not a consequence of the hardware or
anything else," but rather were the result of the difficulty
his own body was having in healing bone. Id. On November 23,
1994, Dr. Weber concluded that while plaintiff had some
"intermittent pain and discomfort on his low back region," much
of that pain and discomfort was "due to inactivity." Rec. of
Pl. Visit to Dr. Weber, dated 11/23/94. Dr. Weber advised Sita
that he should return to some form of work, something plaintiff
had been unable to do since his accident,
but that he could not do heavy lifting. Sita, however, did not
return to work.
In connection with his worker's compensation claim, plaintiff
sought the medical opinion of Dr. Seymour Einhorn on May 16,
1995. Dr. Einhorn stated that "[o]ne could not tell whether
there was any fusion at [the L3-4 and L4-5] levels on x-ray."
Einhorn Letter, dated 5/16/95. Dr. Einhorn noted numerous
complaints of pain and diagnosed "post multilevel degenerative
disc disease" and, despite his earlier finding that one could
not tell whether fusion had occurred, Dr. Einhorn diagnosed
pseudarthrosis (non-union or the failure of bone to fuse) at
multiple levels of the lower lumbar spine. At that time, Dr.
Einhorn did not, in any way, indicate that the TSRH
instrumentation was a cause of plaintiff's pain. At plaintiff's
or his counsel's request, however, Dr. Einhorn examined
plaintiff again on September 25, 1997, and reviewed plaintiff's
existing medical records. Upon review of those records, Dr.
Einhorn concluded that "the broken pedicle screw is a
contributing factor in the patient's pain and neurological
impairment, as well as causing the fracture of the
corresponding pedicle resulting in additional associated
complications and impairment." Einhorn Letter, dated 9/29/97.
Dr. Martin Lehman, plaintiff's treating physician since
January 1995, stated that Sita's current problems "followed
injuries sustained at work." Lehman Letter, dated 1/10/95. Dr.
Lehman, describing x-rays of plaintiff's lumbosacral spine,
repeatedly referred to "the area of fusion" suggesting that the
the bone graft from the first surgery had, in fact, fused.
See Lehman Letters, dated 1/10/95 — 1/3/97.
In November 1995, another orthopedic specialist, Jean-Jaques
Abitbol, M.D., examined plaintiff on behalf of the Worker's
Compensation Board.*fn2 Dr. Abitbol noted that the area where
the TSRH construct was located was "completely healed" and that
the components of the TSRH System remained in good position.
Abitbol Medical Rec., dated 11/3/95. Fusion had not, however,
occurred on the anterior (front) of the spine, where TSRH
instrumentation was not used.
Defendant Danek's TSRH System utilized in plaintiff's surgery
was accompanied by a package insert that detailed the specific
risks of fusion surgery, including: "non-union (or
pseudarthrosis)," "bending, loosening and/or breakage," "loss
of neurological function, appearance of radiculopathy, and/or
development of pain," "infection," "paralysis," and "death."
The package insert noted that additional surgery might be
necessary "to correct some of these anticipated adverse
reactions." The package insert further provided:
A successful result is not always achieved in
every surgical case. This fact is especially true
in spinal surgery where many extenuating
circumstances may compromise the results. The TSRH
Spinal System is only a temporary implant and
should only be used to augment spinal fusion. . . .
No spinal implant can withstand body loads
without the support of bone. In this event,
bending, loosening, dissembly and/or breakage of
the device(s) will eventually occur.
TSRH Package Insert in Use in 1993.
Under the New York law of products liability, which the
parties agree is
controlling, a plaintiff may assert that a product is defective
because of: (i) a mistake in manufacturing; (ii) improper
design; or (iii) failure to provide adequate warnings regarding
the use of the product. See Voss v. Black & Decker Mfg. Co., 59
N Y2d 102, 106-07, 463 N.Y.S.2d 398, 401, 450 N.E.2d 204
(1983). Here, plaintiff does not allege a defect in the
manufacturing of the cracked TSRH spinal screw, but claims,
instead, that the design of the TSRH System was defective and
that the warnings provided were inadequate.
In order to survive a motion for summary judgment on a cause
of action for strict products liability, a plaintiff must offer
sufficient evidence upon which a reasonable jury could base the
conclusion that: (i) a product was "defective" in that it was
not reasonably safe for use in the manner intended; (ii) a
product's defect was a "substantial factor" in causing the
plaintiff's injury or damages; (iii) at the time of the
occurrence of the injury, the product was being used "for the
purpose and in the manner normally intended;" (iv) the defect
could not have been discovered by the plaintiff and its danger
perceived by the exercise of reasonable care; and (v) the
plaintiff's injury or damage could not have been averted by the
exercise of reasonable care. Id. at 106, 463 N.Y.S.2d at 401,
450 N.E.2d 204; Fane v. Zimmer, 927 F.2d 124, 128 (2d Cir.
1991) (citation omitted). It is also well-settled that in New
York, "whether the action is pleaded in strict products
liability, breach of warranty or negligence," the plaintiff in
a products liability case bears the burden of establishing
"that a defect in the product was a substantial factor in
causing the injury." Tardella v. RJR Nabisco, Inc., 178 A.D.2d 737,
576 N.Y.S.2d 965, 966 (3rd ...