Hardison v. Biomet, Inc.
| Decision Date | 27 July 2020 |
| Docket Number | CIVIL ACTION NO. 5:19-cv-00069-TES |
| Parties | GAIL DEAN HARDISON, Individually as Surviving Spouse and GAIL DEAN HARDISON as Executor of the Estate of Lynwood Wilson Hardison, Jr., Plaintiff, v. BIOMET, INC., et al., Defendants. |
| Court | U.S. District Court — Middle District of Georgia |
Lynnwood Hardison filed suit on May 30, 2017, concerning an allegedly defective artificial hip implant and complications he suffered from it.1 [Doc. 1]. Defendants (collectively referred to as "Biomet") are corporate entities that design, manufacture, market, promote, and sell the hip implant known as the Biomet M2a Magnum Hip System ("M2a Magnum"). [Doc. 66-1, ¶¶ 7—17].
Mr. Hardison's case is among thousands filed against Biomet. [Doc. 33, p. 1]. On October 2, 2012, the Joint Panel on Multidistrict Litigation ("JPML") consolidated the first actions involving Biomet's M2a Magnum and the M2a-38 artificial hip implantsinto a Multi-District Litigation action ("MDL") for coordinated pretrial proceedings. [Id.]; See In re: Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 896 F. Supp. 2d 1339, 1340 (J.P.M.L. 2012); see also 28 U.S.C. § 1407. The JPML assigned the MDL to Judge Robert Miller, Jr. of the United States District Court for the Northern District of Indiana. Id. After extensive pretrial proceedings, Judge Miller transferred this particular matter to the Middle District of Georgia on February 22, 2019 [Doc. 50],which the court docketed on March 4, 2019. [Doc. 51]. The parties then engaged in case-specific discovery not covered in the MDL. [Doc. 62].
Now at the summary judgment stage, Plaintiff and Biomet filed five Daubert motions in limine seeking to exclude portions of the testimony of each other's expert witnesses. See [Doc. 109]; [Doc. 110]; [Doc. 111]; [Doc. 118]; [Doc. 119]. Additionally, Biomet has moved for summary judgment on all of Plaintiff's claims, primarily relying on the Court granting its Daubert motions. [Doc. 108]. Thus, it only makes sense that the Court discuss its decisions on the various Daubert motions before diving into the motion for summary judgment.
As described in detail below, the Court GRANTS in part and DENIES in part Biomet's motion for summary judgment [Doc. 108] and Biomet's motions to exclude testimony from Dr. Gannon [Doc. 109], Ms. Truman [Doc. 110], and Dr. Shapiro [Doc. 111]. Further, the Court GRANTS in part and DENIES in part Plaintiff's motion to exclude portions of Dr. Kurtz's testimony [Doc. 118] and DENIES Plaintiff's motion toexclude portions of Dr. Bauer's testimony [Doc. 119] as outlined in this Order.
BACKGROUND
In order to better explain its decisions and to put the opinions in their proper factual context, the Court provides a summary of the facts and allegations. The Court will also discuss additional facts as they become relevant to the Court's analysis of the admissibility of the parties' witnesses and summary judgment arguments.
Mr. Hardison received a M2a Magnum artificial hip implant on February 4, 2009, at the age of 56. [Doc. 108-2, p. 84]. Mr. Hardison first sought treatment for right hip and groin pain from Dr. Pope on December 16, 2008. [Id., p. 90]; [Doc. 135-3, ¶ 9]. During that visit, Dr. Pope noted Mr. Hardison was an "obese gentleman" who suffered from multiple conditions, including diabetes, hypertension and sleep apnea. [Doc. 108-2, p. 90]. Additionally, he noted that Mr. Hardison underwent lumbar spinal surgery in 2007. [Id., pp. 57, 90]. After finding more conservative treatments had failed, Dr. Pope recommended total hip replacement surgery and chose to use the M2a Magnum. [Id., pp. 90—91].
The M2a Magnum is a metal-on-metal ("MoM") implant and operates similarly to a functioning human hip. A physician must prescribe the hip implant as it is not commercially available. [Doc. 108-6, p. 2].
Biomet included an Instructions for Use ("IFU") inside the M2a Magnum packaging meant to advise the operating surgeon of the risks and adverse side effectsassociated with the device. [Id.]. Under "Warnings", the IFU stated, "[e]xcessive activity, trauma and weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear." [Id.]. Dr. Pope did not recall reading this package insert. [Doc. 108-8, Pope Depo., p. 36:10-13].
Mr. Hardison experienced no complications during the hip replacement surgery. [Doc. 108-2, p. 86]. During his follow-up appointment on July 28, 2009, Dr. Pope noted his hip appeared "well healed[,]" but Mr. Hardison complained "about some lower back pain." [Id., p. 92]. After the hip implant surgery, Mr. Hardison's wife stated his hip pain lessened, and he was able to perform activities like dancing. [Doc. 136-7, Hardison Depo., p. 76:5—23].
However, Mr. Hardison's pain management issues continued, and, in the years following his surgery, Mr. Hardison received treatment for hip and lower back pain, often associated with falls. See [Doc. 139-1, p. 17 ()]; [Doc. 108-2, pp. 29—30 ()]; [Doc. 139-1., p. 30 ()].2
In 2014, Mr. Hardison continued to experience pain in his hip, leg, and lower back. [Doc. 108-2, p. 14]. Due to the continued pain, Mr. Hardison underwent a sacroiliac joint arthrodesis on December 29, 2014. [Doc. 139-1, pp. 37—38]; [Doc. 108-2, pp. 106—107].
Also in 2014, Mr. Hardison's blood tests revealed increased cobalt and chromium levels on two occasions. [Doc. 139-1, pp. 33—36]. In 2015, Mr. Hardison experienced an increase in right hip and lower back pain. [Id., pp. 42—50]; [Doc. 108-2, p. 63]. Mr. Hardison then saw Dr. Flandry for this continued and increased pain. In August 2015, Dr. Flandry performed exploratory surgery for repair of his abductor muscles and found "metallosis staining of the pseudo capsule but no evidence of pseudotumor." [Id., pp. 62—63].
Dr. Raurk then examined Mr. Hardison and performed revision surgery on Mr. Hardison's right hip on October 20, 2015. [Id., pp. 65—67]. Dr. Raurk indicated the evidence pointed to "metal on metal bearing surface wear reaction and soft tissuereaction to that." [Id., p. 65] After this revision surgery, Mr. Hardison developed a post-operative infection and required follow-up surgeries. [Id., pp. 71—76].
While his health did initially show some improvement after the revision surgery, Mr. Hardison's health continued a downward trajectory until his death on May 3, 2019. [Doc. 139-1, p. 209]. Medical records suggest Mr. Hardison suffered from several medical issues at this time, including morbid obesity, cellulitis of the right lower leg, diabetes, hypertension, chronic pain, moderate malnutrition, and suspected respiratory insufficiency. [Doc. 108-2, p. 8]. The listed immediate causes on Mr. Hardison's Death Certificate were respiratory failure and chronic obstructive pulmonary disease. [Id.].
Mr. Hardison filed suit against Biomet on May 30, 2017. See [Doc. 1]. After Mr. Hardison's death, Gail Dean Hardison, his wife, was substituted as the plaintiff, filing suit as executor of the estate of Mr. Hardison and individually as surviving spouse. [Doc. 65]. In Ms. Hardison's Amended Complaint, she asserts claims for: (1) Strict Liability - Design; (2) Strict Liability - Failure to Warn; (3) Breach of Express Warranty; (4) Violation of the Georgia Fair Business Practices Act ("GFBPA"); (5) Negligence (design, manufacturing, and warnings), (6) Negligent Misrepresentation; (7-8) Breach of Implied Warranties; (9) Loss of Consortium; and (10) Wrongful Death. See generally [Doc. 68]; see also [Doc. 135-3, ¶ 84]. Plaintiff seeks double or triple damages, attorneys' fees, and punitive damages. [Doc. 68, pp. 34—35]; [Doc. 135-3, ¶ 85].
In sum, Plaintiff claims the release of cobalt and chromium debris and metal ions into Mr. Hardison's body—caused by the device failure—resulted in "significant harm [to her husband], including but not limited to physical injury and bodily impairment, debilitating lack of mobility, conscious pain and suffering, elevated metal ion levels, and loss of earnings." [Doc. 68, ¶¶ 1, 62, 87]; [Doc. 135-3, ¶ 90].
Plaintiff served her expert reports designating Dr. Jeffrey Shapiro (an orthopedic surgeon), Dr. Francis Gannon (a pathologist), and Mari Truman (a professional engineer), as her retained case-specific experts. [Doc. 108-13]; [Doc. 135-3, ¶ 91]. Plaintiff also designated Dr. George Kantor as Plaintiff's retained common-issue expert. [Doc. 108-13]; [Doc. 135-3, ¶ 92]. Plaintiff's common-issue expert did not perform any case-specific analysis of Plaintiff's case. [Doc. 108-13]; [Doc. 135-3, ¶ 93]. Plaintiff did not identify any non-retained treating expert nor disclose that any non-retained expert would provide any causation opinion. [Doc. 108-13]; [Doc. 135-3, ¶ 94].
Biomet requests that the Court exclude Plaintiff's case-specific experts' causation (as well as other) opinions and grant its motion for summary judgment. [Doc. 108]; [Doc. 109]; [Doc. 110]; [Doc. 111]. Further, Plaintiff seeks to exclude portions of two of Biomet's expert witnesses' testimony. [Doc. 118]; [Doc. 119].
DISCUSSION
Rule 702 of the Federal Rules of Evidence provides:
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...
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