King v. Danek Medical3/28/2000
-fits-all' mass of qualifications warranting his elevation to expert rank in those other areas." Id. at *4.
In this cause, the plaintiffs contend that, in arriving at his conclusions, Dr. Alexander applied "basic principles of biomechanics, biomaterial and biomechanical engineering." However, the plaintiffs do not address the fact that other courts, when presented with similar opinions, have concluded that they require competency in areas where Dr. Alexander has no expertise. We have similar concerns, for many of his opinions offered in this case seem to be only a rewording of those rejected by other courts. In Edgar v. Danek Medical, Inc., No. 96-2451- CIV-T-24A, 1999 WL 1054864, at *2 (M.D. Fla. Mar. 31, 1999), the court, assessed the evidence, including testimony of Dr. Alexander, that Danek TSRH hardware was defective in either manufacture or design, and concluded that " laintiffs' evidence on this point is indeed threadbare." For similar holdings by other courts, see Menges v. Depuy Motech, Inc., 61 F. Supp. 2d 817 (N.D. Ind. 1999), and Uribe v. Sofamor, S.N.C., No. 8:95CV464, 1999 WL 1129703, at *9-10 (D. Neb. Aug. 16, 1999). We note, as have other courts, that Dr. Alexander's recitation of defects in a generic pedicle screw device fails to show that the same defects existed in the Danek internal fixation devices implanted into King and Little.
2. Plaintiffs' Documents
Further, we find unhelpful to our consideration many of the documents upon which the plaintiffs place substantial reliance. The plaintiffs put these documents in the record without first having them authenticated or explained by a knowledgeable person or by utilizing a request for admissions. However, in their briefs, the plaintiffs make arguments based upon their own interpretation of the meaning and significance of these documents, which, with the plaintiffs' exhibit numbers from the trial court, consist of the following:
9. May 2, 1990, letter from the FDA to James Ritter of Warsaw Orthopedic, Inc. (sent by certified mail - returned receipt requested).
10. August 11, 1993, "Warning Letter" from the FDA to Danek.
11. December 21, 1993, FDA report styled "Update on Pedicle Screws."
12. June 22, 1993, letter from the FDA to the Buckman Company, regarding the Compact Cotrel-Debousset Spine System.
14. May 1993 report of Michael C. Sherman, Director of Product Development, styled "Top Tightening TSRH Engineering Issues."
15. April 13, 1993, meeting minutes of the Orthopedic Surgical Manufacturers Association.
16. March 12, 1993, draft of Proposed Guidelines for Lumbar Fusion of the Washington State Medical Association Industrial Insurance Advisory Committee.
18. December 7, 1987, letter from the FDA to Norex USA, Inc. regarding the Cotrel-Dubousset Universal Instrumentation for Spinal Surgery.
19. May 6, 1986, letter from the FDA to Warsaw Orthopedic regarding Intrapeduncular Segmental Fixation - The Luque System.
20. August 11, 1993, "Warning Letter" from the FDA to Danek regarding pedicle screws.
22. Advertisements for the DHS Hip Screw System manufactured by Synthes.
23. July 11, 1988, letter from Danek to Dr. John Herring.
25. February 12, 1993, letter from the Department of Neurosurgery at Lackland Air Force Base to Danek.
26. November 12-15, 1993, program brochure for a "State of the Spine from A to Z" seminar in Puerto Rico, sponsored by the Spinal Science Advancement Foundation and the University of Wisconsin at Madison.
27. January 24, 1994, letter from the Practical Anatomy and Surgica
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