Christiansen v. Wright Med. Tech. Inc. (In re Wright Med. Tech. Inc., Conserve Hip Implant Prods. Liab. Litig.)

• Decision Date: 31 August 2015
• Docket Number: MDL Docket No. 2329.,No. 1:13–cv–297–WSD.,1:13–cv–297–WSD.
• Citation: 127 F.Supp.3d 1306
• Parties: In re WRIGHT MEDICAL TECHNOLOGY INC., CONSERVE HIP IMPLANT PRODUCTS LIABILITY LITIGATION. Robyn Christiansen, Plaintiff, v. Wright Medical Technology Incorporated and Wright Medical Group, Inc., Defendants.
• Court: U.S. District Court — Northern District of Georgia

127 F.Supp.3d 1306

In re WRIGHT MEDICAL TECHNOLOGY INC., CONSERVE HIP IMPLANT PRODUCTS LIABILITY LITIGATION.Robyn Christiansen, Plaintiff,

v.Wright Medical Technology Incorporated and Wright Medical Group, Inc., Defendants.

MDL Docket No. 2329.

No. 1:13–cv–297–WSD.

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

Signed Aug. 31, 2015.

OPINION AND ORDER

WILLIAM S. DUFFEY, JR., District Judge.

I. INTRODUCTION

On February 27, 2012, the United States Judicial Panel on Multidistrict Litigation (the "Panel") ordered the centralization of five actions pending in five districts, involving alleged defects in Wright Medical Technology Inc.'s Conserve line of hip implant products. (In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, 1:12–md–2329 ("MDL"), [1] (the "February 27, 2012, MDL Order")). Most of the plaintiffs' claims focus on the alleged propensity of the metal-on-metal design of the Conserve products "to generate high levels of metal debris, causing metallosis in the surrounding tissue [and to] fail early (including loosening of the acetabular cup )." (Id. at 1).

On May 23, 2013, the Court ordered that any plaintiff whose case is subject to transfer to the MDL was allowed to file their claims directly in the MDL. (MDL [86] ). The Court approved an Abbreviated Short Form Claim ("Short Form Complaint") to facilitate the filing of cases.¹ On January 30, 2013, Plaintiff Robyn Christiansen ("Plaintiff")² filed her Short Form Complaint in the MDL. (MDL [404] ).

The parties identified ten (10) cases they proposed to submit to the Bellwether trial process (the "Bellwether Nominees."). (MDL [1037] at 1). Plaintiff's case was selected as the first Bellwether case to be tried.

II. BACKGROUND OF PLAINTIFF'S CASE

A. Plaintiff's Allegations

Plaintiff's Short Form Complaint [1]³ names Defendants Wright Medical Technology, Inc. ("Wright Medical") and Wright Medical Group, Inc. ("WMG") (together, "Defendants") as defendants in this action. On October 6, 2014, Plaintiff filed her First Amended Complaint [10] and, on October 10, 2014, she filed a Second Amended Complaint [11] ("Second Amended Complaint").

Plaintiff alleges that, on April 24, 2006, she was implanted with the Wright Conserve Hip Implant System (the "Conserve Hip Implant System" is sometimes referred to as the "Conserve implant"). (Second Am. Compl. ¶ 13).⁴ A hip joint can be replaced by an artificial replacement system implanted to replace the body's natural joint. The typical replacement joint

consists of four separate components: (1) a femoral stem, (2) a femoral head, (3) an acetabular shell, and (4) a liner. To replace a patient's hip joint, a surgeon hollows out a patient's femur bone and implants a femoral stem. Then a metal ball is fixed on top of the femoral stem to become the new femoral head. The surgeon also reams out the acetabulum and fits an artificial acetabular shell into the bone. Then ... a liner made of polyethylene would be inserted into a titanium acetabular shell, and the new femoral head (made of metal or ceramic) would rotate inside the shell, creating a metal-on-polyethylene or ceramic-on-polyethylene articulation.

(Id. ¶ 15).

Plaintiff asserts that the Conserve Hip Implant System "omits the polyethylene liner and instead puts the Cobalt–Chromium metal Conserve femoral ball directly in contact with a Cobalt–Chromium metal Conserve acetabular cup." (Id. ¶ 16). The "movement of this artificial joint [Plaintiff claims] produces metal-on-metal wear debris, and the amount of toxic metal debris produced increases as a patient's activity increases." (Id. ).

Dr. Lynn G. Rasmussen ("Rasmussen") has provided Plaintiff with orthopedic medical treatment since 1995. (Id. ¶¶ 20–21). In 1995, Rasmussen completed a total hip revision surgery on Plaintiff's left hip, utilizing a ceramic femoral ball and a polyethylene liner in a metal acetabular shell. (Id. ¶ 21).

Rasmussen later told Plaintiff she met the criteria for a total hip replacement of her right hip, and recommended replacement with the Conserve Hip Implant System. (Id. ¶¶ 22–23). Plaintiff alleges that Rasmussen made this recommendation based on information he received from Defendants, specifically: (1) that the Conserve implant was a good option for active patients, such as Plaintiff; (2) that the Conserve implant "should [last] longer than a hip replacement utilizing a polyethylene liner because the cobalt-chromium cup was touted to last longer than a polyethylene liner;" and (3) "that there were no known issues with Cobalt and Chromium ions." (Id. ¶ 23).

Based on Rasmussen's recommendation and the information provided by Defendants, Plaintiff elected a total hip replacement of her right hip using the Conserve Hip Implant System. (Id. ¶ 24). On April 24, 2006, "Dr. Rasmussen implanted the following Conserve [implant] components: a Wright Conserve Plus Cup, a Wright ProFemur RAZ Stem, a Wright ProFemur Neck, and a Conserve Total A–Class head, into [Plaintiff's] right hip...." (Id. ¶ 25).

Plaintiff claims that, on or about October 24, 2012, she was doing yoga "when she felt and heard a crunching sound and then felt immediate, severe pain in her right hip and groin." (Id. ¶ 27). Plaintiff alleges the pain prohibited her from ambulating without assistance, and she called Dr. Rasmussen's office. (Id. ). Rasmussen saw Plaintiff on October 25, 2012. (Id. ¶ 28).

Rasmussen diagnosed Plaintiff as having a loose and displaced acetabular cup in her right hip replacement, which required revision surgery.⁵ (Id. ). The surgery was performed on October 29, 2012. (Id. ¶ 29). During the surgery, Rasmussen noted signs of a "metalosis [sic] reaction of her hip, with an inflammatory synovium" and he "removed the displaced acetabular component [and] soft tissue that had been damaged by the metal debris." (Id. ).

Plaintiff "endured a painful recovery from her right [hip] revision surgery and continues to suffer from injuries of a permanent and lasting nature and discomfort as a result of the failed Conserve Hip Implant System[,] takes ibuprofen on a daily basis, [and although] she has been able to return to many of her activities, she can no longer run." (Id. ¶ 30). Plaintiff alleges that she "requires continuous medical monitoring and treatment as a direct and proximate cause of her failed Conserve Hip Implant System." (Id. ¶ 31).

Plaintiff asserts that the design of the Conserve Hip Implant System was defective and dangerous because it omits a liner separating the cobalt/chromium acetabular cup from the cobalt/chromium femoral head, resulting in the creation of metal-on-metal wear debris. (Id. ¶ 16). She claims that the "Conserve Thin Shell, marketed as the Conserve Plus Cup," which was used in her 2006 implant, "was not cleared for marketing until 2012." (Id. ¶ 17). Prior to 2012, Plaintiff claims this component was sold to the public pursuant to an "internal Wright letter to file" that Defendants "knew was inappropriate and in violation of FDA requirements." (Id. ).

Plaintiff asserts claims for: (1) Strict Product Liability (Design Defect) (Count I); (2) Strict Product Liability (Failure to Warn) (Count II); (3) Negligence (Design Default and Failure to Warn) (Count III); (4) Fraudulent Misrepresentation (Count V); (5) Fraudulent Concealment (Count VI); and (6) Negligent Misrepresentation (Count VII). (Id. ¶¶ 32–109).⁶ Plaintiff seeks compensatory damages, punitive damages, and prejudgment interest. (Id. at 42).

B. Pending Motions⁷

1. Daubert Motions

On January 15, 2015, Defendants filed their: (1) Motion to Exclude the Expert Testimony of Lance A. Waller, Ph.D. [49] ("Waller Motion"); (2) Motion to Exclude the Expert Testimony of Jay M. Vincelli, MSc, and John D. Jarrell, Ph.D., PE [50] ("Vincelli Motion"); (3) Motion to Exclude the Expert Testimony of Reed Ayers, Ph.D. [51] ("Ayers Motion"); and (4) Motion To Exclude Testimony Relating to Metallosis [52] ("Metallosis Motion")⁸ (together, the "Daubert Motions").⁹

2. Motions for Summary Judgment

On January 9, 2015, Plaintiff filed her Motion for Partial Summary Judgment [20] ("Plaintiff's MSJ"). Plaintiff argues that Defendants are, as a matter of law, foreclosed from arguing that the Medical Device Amendment of 1976 preempts Plaintiff's design defect claims. Plaintiff also argues that Defendants provided false and misleading information to Rasmussen and, for that reason, the learned intermediary defense does not apply. Also on January 9, 2015, Defendants filed their Motion for Summary Judgment [24].

On March 31, 2015, the Court held a teleconference to discuss the pending motions. The Court noted that Plaintiff's MSJ generally raised and advanced arguments in anticipation of claims and arguments Plaintiff expected would be raised in Defendants' summary judgment motion. To facilitate the efficient consideration of the motions, particularly the preemption and learned intermediary defenses, the Parties and the Court agreed that the Parties would submit substitute summary judgment briefs in which Plaintiff would raise her preemption and learned intermediary arguments in her response to Defendants' summary judgment motion.

On April 7, 2015, Defendants refiled their Motion for Summary Judgment [140] ("Defendants' MSJ"), and, on April 23, 2015, Plaintiff filed her Response in Opposition to Defendants' MSJ [143].¹⁰ The filing of Defendants' motion for summary judgment and Plaintiff's response addressing all of the arguments raised by Defendants in their summary judgment motion succinctly presented the Parties' arguments and helped the Court to evaluate each party's position.

On January 9, 2015, Defendant WMG filed its separate Motion for Summary Judgment [38] ("WMG's MSJ") on grounds applicable only to WMG.¹¹

The Court first considers the Daubert Motions.

III. DAUBERT MOTIONS

A. Legal Standard

The admissibility of expert opinions is governed by Rules 702 and 703 of the Federal Rules of Evidence.

1. Rule 702

Rule 702 of the Federal Rules of...