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March 29, 1999


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, dated 9/19/92.

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.

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.



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 ...

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