Jones v. Novartis Pharm. Corp., Case No.: 2:13–CV–624–VEH

• Decision Date: 26 January 2017
• Docket Number: Case No.: 2:13–CV–624–VEH
• Citation: 235 F.Supp.3d 1244
• Parties: Ernesteen JONES, Plaintiff, v. NOVARTIS PHARMACEUTICALS CORPORATION,Defendant.
• Court: U.S. District Court — Northern District of Alabama

235 F.Supp.3d 1244

Ernesteen JONES, Plaintiff,

v.NOVARTIS PHARMACEUTICALS CORPORATION,Defendant.

Case No.: 2:13–CV–624–VEH

United States District Court, N.D. Alabama, Southern Division.

Signed January 26, 2017

Leah O. Taylor, Tammy M. Smith, Taylor & Taylor, Birmingham, AL, for Plaintiff.

Catherine Stolar, Andrew L. Reissaus, Robert E. Johnston, Stephen A. Klein, Hollingsworth LLP, Washington, DC, Frederick G. Helmsing, Jr., Edward S. Sledge, III, McDowell Knight Roedder & Sledge LLC, Mobile, AL, for Defendant.

MEMORANDUM OPINION AND ORDER

VIRGINIA EMERSON HOPKINS, United States District Judge

I. INTRODUCTION

This case comes before the court on Defendant Novartis Pharmaceutical Corporation ("Novartis" or "NPC")'s Motions To Strike Expert Testimony. Novartis has moved to exclude the testimony of the following experts:

? Dr. Suzanne Parisian ("Dr. Parisian"), the "Parisian Motion" (doc. 108);¹

? Dr. William B. Hinshaw ("Dr. Hinshaw"), the "Hinshaw Motion" (doc. 112);

? Dr. Wayne A. Taylor ("Dr. Taylor"), the "Taylor Motion" (doc. 116);

? Dr. James Worthen ("Dr. Worthen") and Dr. Timothy Mark Ricketts ("Dr. Ricketts"), collectively in the "Non–Retained Experts Motion" (doc. 118).

II. PROCEDURAL HISTORY

Plaintiff Ernesteen Jones ("Jones") initiated this lawsuit against Novartis on April 4, 2013 (doc. 1), alleging that she developed atypical femur fractures ("AFF")² as a result of taking Novartis' medication Reclast

, which is a type of bisphosphonate ("BP") drug. Jones was prescribed Reclast by Dr. Thomas Traylor, her treating physician for her osteoporosis. (Doc. 54) at 2, ¶ 9.³ She was administered an annual five milligram Reclast injection, as prescribed, on February 10, 2009, March 16, 2010, and March 17, 2011. Id. at 2, ¶ 8.

On October 26, 2011, Jones's right femur fractured

, requiring surgery. Id. at 3, ¶¶ 13–14. In early 2012, Jones began experiencing pain in her left thigh. Id. at 3, ¶ 16. After a bone scan revealed a stress fraction on her left femur, she had surgery on her left femur to prevent a complete fracture. Id. at 3, ¶¶ 17–18.

Jones has asserted the following claims against Novartis: violations of the Alabama Extended Manufacturer's Liability Doctrine ("AEMLD") (Count 1, id. at 6–9); failure to warn (Count II, id. at 10); negligence and wantonness (Count III, id. at 10–12); and breach of warranty of merchantability. (Count IV, id. at 13).

III. STANDARD FOR THE ADMISSIBILITY OF EXPERT TESTIMONY

A. General Requirements—Judge as Gatekeeper

Regarding expert testimony, the Federal Rules of Evidence provide:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

FED. R. EVID. 702 (2011). Rule 702 must be read in conjunction with three seminal decisions by the Supreme Court related to expert testimony: Daubert v. Merrell Dow Pharmaceuticals, Inc. , 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) ;Gen. Elec. Co. v. Joiner , 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) ; and Kumho Tire Co. v. Carmichael , 526 U.S. 137, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).

All rulings on Daubert motions are reviewed under an abuse of discretion standard. See, e.g., Joiner , 522 U.S. at 141, 118 S.Ct. at 517 ("All evidentiary decisions are reviewed under an abuse-of-discretion standard."). "An abuse of discretion can occur where the district court applies the wrong law, follows the wrong procedure, bases its decision on clearly erroneous facts, or commits a clear error in judgment." United States v. Estelan , 156 Fed.Appx. 185, 196 (11th Cir. 2005) (citing United States v. Brown , 415 F.3d 1257, 1266 (11th Cir. 2005) ).

In Daubert , the Supreme Court established that district judges act as "gatekeepers" for expert testimony. 509 U.S. at 592–93, 113 S.Ct. at 2796. The district court judge must assess the proffered testimony and make a preliminary determination about the scientific validity of the expert's reasoning and methodology. Id.

As another district court in this Circuit has stated,

Federal Rule of Evidence 702, read together with the trilogy of Supreme Court opinions that led to the Rule's revision in 2011, compels the district courts to perform a "gatekeeping" function when determining the admissibility of expert scientific and technical evidence. See, e.g. , United States v. Abreu , 406 F.3d 1304, 1306 (11th Cir. 2005) (quoting United States v. Frazier , 387 F.3d 1244, 1260 (11th Cir. 2004) ). "This function inherently requires the trial court to conduct an exacting analysis of the foundations of expert opinions to ensure they meet the standards for admissibility under Rule 702." Id. (internal quotation omitted).

Broussard–Wadkins v. Maples , 895 F.Supp.2d 1159, 1165 (N.D. Ala. 2012), aff'd sub nom. Broussard v. Maples , 535 Fed.Appx. 825 (11th Cir. 2013).

The burden under Rule 702 rests squarely with the proponent of the expert witness:

The proponent of the expert testimony carries a substantial burden under Rule 702. "The burden of laying the proper foundation for the admission of the expert testimony is on the party offering the expert, and admissibility must be shown by a preponderance of the evidence." Allison v. McGhan Med. Corp. , 184 F.3d 1300, 1306 (11th Cir. 1999) (citing Daubert , 509 U.S. at 592 n. 10, 113 S.Ct. 2786 ). Thus, the proponent must demonstrate that the witness is qualified to testify competently, that his opinions are based on sound methodology, and that his testimony will be helpful to the trier of fact. See, e.g., Frazier , 387 F.3d at 1260 ("The burden of establishing qualification, reliability, and helpfulness rests on the proponent of the expert opinion...."); McCorvey v. Baxter Healthcare Corp. , 298 F.3d 1253, 1257 (11th Cir. 2002) ; Maiz [v. Virani] , 253 F.3d [641,]at 664 [ (11th Cir. 2001) ].

See Cook ex rel. Estate of Tessier v. Sheriff of Monroe Cty., Fla. , 402 F.3d 1092, 1107 (11th Cir. 2005).

B. The Eleventh Circuit Test for Admissibility

The Eleventh Circuit has established a three-part inquiry for district courts to follow in performing their gatekeeper role. For evidence to be admissible under Rule 702, the district court must find that:

(1) the expert is qualified to testify competently regarding the matters he intends to address;

(2) the methodology by which the expert reaches his conclusions is sufficiently reliable as determined by the sort of inquiry mandated in Daubert ; and

(3) the testimony [will] assist[ ] the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue.

Hendrix ex rel. G.P. v. Evenflo Co., Inc. , 609 F.3d 1183, 1194 (11th Cir. 2010) (citing United States v. Frazier , 387 F.3d 1244, 1260 (11th Cir. 2004) ). The party offering the testimony must meet each prong by a preponderance of the evidence. Id.

1. Prong One: The Expert Must Be Qualified To Testify to the Relevant Issue

To meet Prong One, a party must show that the expert has sufficient "knowledge, skill, experience, training, or education" to form a reliable opinion about the relevant issue. Hendrix , 609 F.3d at 1193. Experience in a particular field is not enough to qualify an expert; the expert must have experience with the issue before the court. See id. at 1201.

The Sixth Circuit, in a similar case, concluded that a district court did not abuse its discretion in excluding the testimony of the plaintiff's expert. See Thomas v. Novartis Pharms. Corp. , 443 Fed.Appx. 58, 63 (6th Cir. 2011). The expert in Thomas was "an experienced maxillofacial surgeon who ha[d] treated several patients suffering from osteonecrosis of the jaw

." Id. However, the expert had not established his credentials to "diagnose the cause of [the plaintiff's] osteonecrosis... which [was] the salient issue his opinion was offered to establish."

Id.

2. Prong Two: The Expert's Opinion Must Be Sufficiently Reliable

To meet Prong Two, the party proffering the expert's testimony must show that the expert's opinion is sufficiently reliable. A district court has substantial discretion in deciding how to test the reliability of an expert's testimony. Rink v. Cheminova, Inc. , 400 F.3d 1286, 1292 (11th Cir. 2005). "This deferential abuse of discretion standard is applied stringently, even if a decision on expert testimony is ‘outcome determinative.’ " Chapman v. Proct e r & Gamble Distrib., LLC , 766 F.3d 1296 (11th Cir. 2014) (citing Joiner , 522 U.S. at 142–43, 118 S.Ct. at 517 ).

Pursuant to the second Daubert prong, the court should consider the following factors: "(1) whether the expert's methodology can be tested; (2) whether the expert's scientific technique has been subjected to peer review and publication; (3) whether the method has a known rate of error; and (4) whether the technique is generally accepted by the scientific community." Rink , 400 F.3d at 1292 (citing Quiet Tech. DC–8, Inc. v. Hurel–Dubois UK Ltd. , 326 F.3d 1333, 1341 (11th Cir. 2003) ). However, these factors are not exhaustive and a court "should consider any additional factors that may advance its Rule 702 analysis." Quiet Tech . , 326 F.3d at 1341.

C. Legal Standard for Causation Experts

In the Eleventh Circuit, other than in a small number of cases where the medically community generally recognizes and agrees upon the toxicity of the substance at issue to the injury alleged, both general and specific causation must be established through expert testimony if the Plaintiff's claims require proof of causation:

For analyzing cases involving alleged toxic substances, we have delineated two categories. McClain v. Metabolife

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