King v. Synthes (U.S.A.)

532 F. Supp. 2d 828, 2006 U.S. Dist. LEXIS 97226, 2006 WL 5187651
CourtDistrict Court, S.D. Mississippi
DecidedMarch 31, 2006
Docket1:03-cr-00087
StatusPublished
Cited by1 cases

This text of 532 F. Supp. 2d 828 (King v. Synthes (U.S.A.)) is published on Counsel Stack Legal Research, covering District Court, S.D. Mississippi primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
King v. Synthes (U.S.A.), 532 F. Supp. 2d 828, 2006 U.S. Dist. LEXIS 97226, 2006 WL 5187651 (S.D. Miss. 2006).

Opinion

ORDER GRANTING SUMMARY JUDGMENT

HENRY T. WINGATE, Chief District Judge.

Before this court are the following motions: (1) a motion to exclude the testimony of plaintiffs’ expert submitted by defendant Synthes (U.S.A.) (“Synthes”) [docket # 44-1]; (2) a motion for summary judgment offered by Synthes [docket # 44-2]; (3) a motion to extend time to respond to defendant’s motions to exclude and for summary judgment filed by plaintiffs Phillip W. King and Sylvia B. King (“the Kings”) [docket # 46-1]; and (4) a motion to extend time for discovery submitted by the Kings [docket # 51-1]. For the reasons explained below, this court grants defendant’s motions to exclude the testimony of plaintiffs’ expert and for summary judgment, and terminates plaintiffs’ motions to extend time as moot.

Pertinent Facts and Procedural History

On or about November 3, 1999, a tree fell on Mr. King’s left arm and resulted in a comminuted fracture of his left humerus. On February 28, 2000, Felix H. Savoie III, M.D. (“Dr.Savoie”), an orthopedic surgeon, placed a Synthes humeral nail (“Synthes Rod”) in Mr. King’s left arm and secured it with two interlock screws. The Kings contend that the nail broke in January 2001, and resulted in Dr. Savoie’s replacing it with a larger rod on January 24, 2001. The Kings further contend that this second surgery led to Mr. King’s arm being infected, which resulted in the second rod being removed and replaced with two additional rods. Because the Kings contend that the Synthes Rod was the genesis of Mr. King’s subsequent misfortunes, they filed suit against defendant Synthes in the Circuit Court of Lincoln County, Mississippi, on December 31, 2002.

Synthes removed this action to this federal forum on January 23, 2003. This court has jurisdiction over this dispute pursuant to diversity jurisdiction, Title 28 U.S.C. § 1332. 1 The Kings are each adult resident citizens of Mississippi, and *830 Synthes is a Pennsylvania corporation with its principal place of business there. Additionally, the amount in controversy here exceeds the jurisdictional threshold of $75,000.00, exclusive of costs and interest. Consequently, this court applies the substantive law of, Mississippi to this dispute. A district court applies the law of the forum state where the cause of action occurred unless, with respect to some particular issue, some other state has a more significant relationship to the occurrence or to the parties. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). Neither the Kings nor Synthes disputes that this court has subject-matter jurisdiction over them and this ease or that the substantive law of Mississippi applies.

The crux of the motions before the court do not center around the facts articulated above; rather, the gravamen of the argument is whether the Kings’ expert can provide testimony before a finder of fact. The plaintiffs’ only expert, Edward W. Reese, Ph.D. (“Dr.Reese”), professes to be an expert of the rules and regulations of the United States Department of Health and Human Services Food and Drug Administration (“FDA”), as promulgated under Title 21 of the Code of Federal Regulations. As he explained in his testimony before this court and as provided in his curriculum vitae, Dr. Reese worked as director of technical services for Medtronic, Inc., from 1971 to 1980; as manager of manufacturing operations for Astro-Med, Inc., from 1981 to 1983; and vice president of operations for Angiomedics from 1983 to 1986. These companies were involved in the design and manufacture of medical devices, but none designed or manufactured the systems at issue in the matter sub judice. Dr. Reese worked in research and development for these companies, supervised an engineering design department, and performed managerial duties. In 1986, he founded his own company, Genesis Medical, Inc., which advertises itself as a company that “determines if a causal relationship exists between a suspect medical device and the manufacturer, distributor, physician, hospital, and/or patient.” Edward W. Reese, Genesis Medical, Inc., http://www.genesismed.com (last visited Oct. 19, 2004).

Dr. Reese earned his undergraduate degree from Metropolitan State University in St. Paul, Minnesota, in 1988, with a major in management. In 1989, he received his masters degree in management from Cardinal Stritch University in Milwaukee, Wisconsin. Additionally, in 1993, he received a doctorate in medical technology studies from the Union Graduate School (now known as The Union Institute) in Cincinnati, Ohio. In testimony before this court, Dr. Reese was asked about his doctoral program, which he acknowledged was a self-study program that did not have significant course work. Furthermore, Dr. Reese stated that the subject matter of his doctorate was unique and that no institution in the United States offered a traditional program in the area of medical technology studies. Regarding the professional background of the committee that reviewed his doctoral course work, Dr. Reese acknowledged that none had a doctorate in his area of expertise — medical technology studies — and that one of his advisors actually had a background in English.

Dr. Reese has submitted a five-page written opinion in this case, dated April 22, 2004, relying primarily upon documents provided to him by plaintiffs’ counsel. Dr. Reese’s conclusions are summarized as follows: (1) a design or manufacturing defect of the Synthes Rod likely caused Mr. King’s injury and could have been avoided; (2) Synthes’ device was mislabeled; (3) Synthes did not adequately test its rod; and (4) Synthes failed to comply with certain FDA regulations.

*831 Relevant Law and Application

Expert Testimony

In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the United States Supreme Court set out the criteria that district courts are to follow in assessing challenged expert testimony offered under Federal Rules of Evidence 702. 2 As the Court stated, “Proposed testimony must be supported by appropriate validation— 1.e., ‘good grounds,’ based on what is known. In short, the requirement that an expert’s testimony pertains to ‘scientific knowledge’ establishes a standard of evidentiary reliability.” Id. at 590, 113 S.Ct. 2786. Accordingly, the Supreme Court then held that a trial court has a duty to screen expert testimony for both its relevance and reliability. Id. An expert’s opinion must have a “reliable basis in the knowledge and experience of his discipline.” Id. at 592, 113 S.Ct. 2786. Specifically, this court must determine that the reasoning and methodology underlying the testimony is scientifically valid and that the reasoning and methodology can properly be applied to the facts in issue.

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Bluebook (online)
532 F. Supp. 2d 828, 2006 U.S. Dist. LEXIS 97226, 2006 WL 5187651, Counsel Stack Legal Research, https://law.counselstack.com/opinion/king-v-synthes-usa-mssd-2006.