Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Betty J. Steinman and Richard Steinman,*Fn1 v. Spinal Concepts

September 22, 2011


The opinion of the court was delivered by: William M. Skretny Chief Judge United States District Court



In this diversity action, Plaintiff Betty Steinman, claims that Defendant, Spinal Concepts, Inc. ("Spinal Concepts"), is strictly liable for its design and manufacture of an allegedly defective medical device, the SC-AcuFix Anterior Cervical Plate System ("AcuFix System"), which was surgically implanted in her spine. Steinman further claims that Spinal Concepts negligently designed the AcuFix System, failed to provide adequate warnings, and breached implied warranties. Jurisdiction is proper under 28 U.S.C. § 1332.*fn3

Three motions are presently before this Court: (1) Spinal Concepts' motion to exclude the testimony of both Steinman's expert witness and her treating physician (Docket No. 72); (2) Spinal Concepts' motion for summary judgment (Docket No. 46); and (3) Steinman's motion for summary judgment. (Docket No. 64.) For the following reasons, Spinal Concepts motion to exclude is denied, and its motion for summary judgment is granted in part and denied in part. Further, Steinman's motion for summary judgment is denied.


Much of the relevant background is undisputed. On December 18, 2000, Steinman, in the course of her employment as a home-healthcare worker, slipped and fell as she was getting out of her car. (Plaintiff's Statement of Undisputed Facts ¶¶ 1-2; Docket No. 65.*fn4

When several treatments proved unsuccessful, she was referred to Dr. William Capicotto, who diagnosed her with a cervical herniation in her spine at her C5-C6 vertebrae, and severe injuries to her C6-C7 vertebrae.*fn5 (Id. ¶¶ 7-12.) Dr. Capicotto recommended surgery, where he would attempt to fuse the C5 to the C7 vertebra with the use of the AcuFix system. The system consists of a plate and four screws that are specifically designed for this type of procedure. (Id. ¶¶ 12, 17-18, 37.) Performing the surgery on May 3, 2002, Dr. Capicotto made an incision in the front of Steinman's neck and removed her herniated discs and the C6 vertebra. (Capicotto Declaration ¶ 18; Docket No. 69.) He then inserted a piece of bone into the space created by the removal of the C6 and connected the C5 to the C7 vertebra with the AcuFix plate and screws, intending that the C5 would eventually fuse to the C7. (Id.) According to Dr. Capicotto, this is a routine procedure. (Id. ¶ 19.)

Initially, the surgery appeared to be a success, alleviating Steinman's pain.

(Plaintiff's Statement of Undisputed Facts ¶¶ 13, 20.) Steinman's X-rays in the months following the surgery also indicated that she was healing properly. (Id. ¶ 21-23.) At some point after an August 5, 2002 visit with Dr. Capicotto, however, Steinman began to experience a new, severe pain. (Id. ¶ 24.) She was not able to get an appointment until December. (Id. ¶ 26.) At that time, Dr. Capicotto took another set of X-rays, which revealed that the bottom two screws, those located in her C7 vertebra, had fractured. (Id. ¶ 28.) Steinman tried to live with the pain, but it ultimately became too much, and she decided to have surgery to remove the plate and broken screws. (Id. ¶ 30.) In the course of this surgery, Dr. Capicotto was able to remove the plate, two fully intact screws, and two fragmented screws. He decided to leave the remaining screw fragments in her C7 vertebra, instead of trying to dig them out. (Id. ¶ 32.)

Although her pain decreased after the second surgery, it did not subside entirely. (Id. ¶ 34.) On March 6, 2007, she underwent a third surgery on her spine, this one performed by Dr. Christopher Hamill.*fn6 This surgery did not fully alleviate Steinman's pain either, and she continues to experience a moderate amount of cervical pain to this day. (Id. ¶ 36.)


A. Motion to Exclude Plaintiff's Witnesses

Steinman has named Ronald Parrington, P.E., a metallurgical engineer, as her expert witness. In short, Spinal Concepts argues that Parrington's testimony is insufficiently reliable under Rule 702 of the Federal Rules of Evidence and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed. 2d 469 (1993) because he has no education or training with respect to medical devices or biomechanics. Spinal Concepts also moves to exclude the testimony of Steinman's treating physician, Dr. Capicotto, arguing that his opinion is not based on scientific knowledge.

1. Legal Standard

The admissibility of expert testimony is governed by Rule 702 of the Federal Rules of Evidence, which reads:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

The proponent of expert testimony has the burden of demonstrating by a preponderance of the evidence that the testimony is competent, relevant, and reliable. See Daubert, 509 U.S. at 592, n.10; Koppell v. New York State Bd. of Elections, 97 F. Supp. 2d 477, 479 (S.D.N.Y .2000); Bourjaily v. United States, 483 U.S. 171, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987)). If the expert is deemed competent (otherwise referred to as "qualified"), the trial court must then determine, pursuant to its "gatekeeping" function, whether the proffered expert testimony is "relevant" and "reliable." See Fed. R. Evid. 702 (Advisory Committee Notes, 2000 amendment) (noting that trial judges have "the responsibility of acting as gatekeepers to exclude unreliable expert testimony").

Evidence is relevant if the testimony tends to make the existence of any fact that is of consequence to the determination of the action more probable or less probable.

Amorgianos v. Nat'l R.R. Passenger Corp., 303 F.3d 256, 264 (2d Cir. 2002). If the evidence is relevant, the trial court must then determine "whether the proffered testimony has a sufficiently reliable foundation to permit it to be considered" by the trier of fact. Id. at 265. Expert testimony may be considered reliable if: (1) the testimony is based on sufficient facts or data; (2) the expert's technique or methodology in reaching the conclusion is considered reliable; and (3) the expert has applied the methodology reliably to the facts of the case. Fed. R. Evid. 702. None of these factors are determinative. Id. (Advisory Committee Notes, 2000 amendments); see also Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 150-51, 119 S.Ct. 1167, 143 L.Ed.2d 238 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.