Wheat v. Sofamor, S.N.C.

46 F.Supp.2d 1351

Pauline E. WHEAT and Wilmon Wheat v. SOFAMOR, S.N.C., et al.

John S. Phillips, Jr., and Janet S. Phillips v. Sofamor, S.N.C., et al.

Michael Knight and Debra Knight v. Sofamor, S.N.C., et al.

Deborah Sanders and David Sanders v. Sofamor, S.N.C., et al.

No. Civ.A.1:96-CV3163RWS.

No. Civ.A.1:96-CV3164RWS.

No. Civ.A.1:96-CV3166RWS.

No. Civ.A.1:96-CV3169RWS.

United States District Court, N.D. Georgia, Atlanta Division.

April 28, 1999.

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F. Glenn Moffett, Jr., Moffett Law Firm, Atlanta, GA, for plaintiffs.

Lori Gail Baer, Clifton Miller Iler, Elizabeth Bertschi, Alston & Bird, Atlanta, GA, Anthony C.H. Vale, Pro Hac Vice, Stephen S. Phillips, Pro Hac Vice, Pepper Hamilton, Philadelphia, PA, for defendants Sofamor, S.N.C. and Sofamor-Danek Group.

Ben Kingree, III, Carter & Ansley, Atlanta, GA, Carl A. Henlein, Pro Hac Vice, Douglas W. Langdon, Pro Hac Vice, Susan Wettle, Pro Hac Vice, Ann E. Eberle, Pro Hac Vice, Steven M. Crawford, Pro Hac Vice, Brown Todd & Heyburn, Louisville, KY, for defendants Stuart Medical, Inc. and Youngwood Medical Specialties, Inc.

MEMORANDUM OPINION AND ORDER

STORY, District Judge.

The above cases are all product liability actions for the recovery of injuries allegedly resulting from defective bone screw devices. The Court has jurisdiction pursuant to 28 U.S.C. § 1332.

In Civil Action No. 1:96-CV-3163-RWS, the following motions are pending: Sofamor Defendants' Motion for Summary Judgment [18-1], Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [19-1], Sofamor Defendants' Motion to Exceed Page Limitation [21-1], Sofamor Defendants' Motion to Exclude the Testimony of Antonio Aldrete [21-2], and Sofamor Defendants' Motion for Oral Argument on Motion to Exclude [22-1]. As a preliminary matter, Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [19-1], Sofamor Defendants' Motion for Oral Argument on Motion to Exclude Testimony [22-1], and Sofamor Defendants' Motion to Exceed Page Limitation [21-1] are GRANTED.

In Civil Action No. 1:96-CV-3164-RWS, the following motions are pending: Sofamor Defendants' Motion for Summary Judgment [20-1], Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [21-1], Sofamor Defendants' Motion to Exceed Page Limitation [23-1], Defendants' Motion to Exclude the Testimony of Antonio Aldrete [23-2], and Sofamor Defendants' Motion for Oral Argument on Motion to Exclude Testimony [24-1]. As a preliminary matter, Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [21-1], Sofamor Defendants' Motion for Oral Argument on Motion to Exclude Testimony [24-1], and Sofamor Defendants' Motion to Exceed Page Limitation [23-1] are GRANTED.

In Civil Action No. 1:96-CV-3166-RWS, the following motions are pending: Defendants Youngwood Medical and Stuart Medical's Motion for Summary Judgment [23-1], Sofamor Defendants' Motion for Summary Judgment [24-1], Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [25-1], Sofamor Defendants' Motion to Exceed Page Limitation [27-1], Sofamor Defendants' Motion to Exclude the Testimony of Antonio Aldrete [27-2], and Sofamor Defendants' Motion for Oral Argument on Motion to Exclude Testimony [28-1]. As a preliminary matter, Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [25-1], Sofamor Defendants' Motion to Exceed Page Limitation [27-1], and Sofamor Defendants' Motion for Oral Argument on Motion to Exclude Testimony [28-1] are GRANTED.

In Civil Action No. 1:96-CV-3169-RWS, the following motions are pending: Defendants Youngwood Medical and Stuart Medical's Motion for Summary Judgment [23-1] and Sofamor Defendants' Motion for Summary Judgment [24-1], Sofamor' Defendants Motion for Oral Argument on Motion for Summary Judgment [25-1], Sofamor Defendants' Motion to Exceed Page Limitation for Motion to Exclude [28-1], Defendants Sofamor's Motion to Exclude the Testimony of Antonio Aldrete [28-2], and Sofamor Defendants' Motion for Oral Argument on Motion to Exclude [29-1]. As a preliminary matter, Sofamor Defendants' Motion for Oral Argument on Motion for Summary Judgment [25-1], Sofamor Defendants' Motion to Exceed Page Limitation for Motion to Exclude [28-1], and Sofamor' Defendants' Motion for Oral Argument on Motion to Exclude [29-1] are GRANTED.

After conducting a hearing on February 2, 1999 and reviewing the entire record, the Court enters the following Order.

I. FACTUAL BACKGROUND

The factual background of each of the above-identified cases is sufficiently set out in the record of the respective cases. Generally, each plaintiff sustained some kind of back injury and eventually underwent back surgery which included instrumentation manufactured by the Sofamor Defendants. Each Plaintiff's spouse has a loss of consortium claim. The cases identified above all involve the expert testimony of Dr. Antonio Aldrete. However, the Phillips and Wheat cases involve the Texas Scottish Rite Hospital Spinal System ["TSRH"], while the Knight and Sanders cases involve the Cotrel-Dubousset ["CD"] system. The Sanders and Knight cases also include the distributor of the CD system, Stuart Medical, Inc. and Youngwood Medical Specialities, Inc. The Complaints contain claims for strict liability based on a design defect, a manufacturing defect, and the failure to warn; negligence based on the aforementioned allegations and the failure to seek FDA approval; and fraud based on the alleged misbranding, improperly labeling, and promotion of an off-label use of an FDA approved device.

II. LEGAL ANALYSIS

A. Defendants' Motion to Exclude Testimony of Aldrete¹

1. Qualifications

Plaintiffs identified J. Antonio Aldrete as their sole case-specific expert on causation and liability. Defendants seek to exclude Aldrete's testimony based on Aldrete's qualifications and methodology.

Rule 702 provides:

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. (emphasis added)

Fed.R.Evid. 702. "The competency of an expert witness is a matter addressed largely to the discretion of the trial judge and the district court's qualification of an expert will be sustained unless clearly and manifestly erroneous." Berdeaux v. Gamble Alden Life Ins. Co., 528 F.2d 987, 990 (5th Cir.1976)² (citations omitted).

The Court has serious concerns regarding Aldrete's qualifications. Aldrete is an anesthesiologist; he is board certified in anesthesiology and pain management. Aldrete is not an orthopedist and has never practiced in the area of orthopedics. Aldrete has treated approximately 45 patients who have instrumentation and he has participated, as an anesthesiologist, in approximately 1,000 instrumented spinal fusion³ surgeries.⁴ However, his experience is in the area of pain management rather than the structure and purpose of implant devices and fixation systems. Aldrete has not conducted any studies or collected any data which would lead him to an independent assessment of the effect of instrumentation on the development of fusion in spinal fusion surgery. See Everett v. Georgia-Pacific Corp., 949 F.Supp. 856, 857 (S.D.Ga.1996) (where witness sought to testify on cause of plaintiff's medical condition, witness was not qualified as expert because witness practiced in the area of family medicine and surgery and possessed no specialized knowledge or training in the field of toxicology; expert must, at a minimum possess some specialized knowledge about field in which he is to testify); McLendon v. Georgia Kaolin Co., 841 F.Supp. 415 (M.D.Ga.1994) (economic geologist not qualified to testify about quantity, quality, or value of kaolin where geologist had minimal work experience with kaolin evaluation, lacked knowledge of treating kaolin, did not know outer limits of uses of kaolin and had no knowledge of royalties used in kaolin leases); but see Smith v. Ortho Pharmaceutical, Corp., 770 F.Supp. 1561 (N.D.Ga.1991) (trial court found physician qualified to give expert testimony although his area of expertise was a different subject area).

Plaintiffs cite McCullock v. H.B. Fuller Co., 61 F.3d 1038 (2nd Cir.1995) for the proposition that an expert witness is not required to be a specialist in the specific subject area of which the testimony is offered. In McCullock, the plaintiff claimed her exposure to and inhalation of fumes from the defendant's hot-melt glue caused throat polyps, hoarseness, irritation and thickening of her vocal cords. In that case, an ear, nose, and throat doctor was qualified to testify on the plaintiff's throat ailment and its causes.⁵ However, in the case at bar, Aldrete does not specialize in back ailments, their causes, or orthopedics. Aldrete's specialty relates only to addressing the symptom of pain. It is not clear that Aldrete has knowledge in the area of the causes of back pain to the extent that it results from defective bone screws.

Aldrete's accolades and scholarly works relate to anesthesiology rather than orthopedics or biomechanical engineering. Furthermore, Aldrete has not written or published an article on the use of spinal instrumentation. Consequently, the Court has serious concerns regarding Aldrete's qualifications. In light of the Court's concerns, the Court finds there is an issue of fact, and Defendants' motion is denied to the extent that it is based on Aldrete's qualifications.

2. Relevance and Reliability

Federal Rule of Evidence 702, as explained by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 2794-95, 125 L.Ed.2d 469 (1993), and its progeny, controls determinations regarding the admissibility of expert testimony. Expert...