Morris v. Biomet, Inc.

• Decision Date: 30 September 2020
• Docket Number: Case No. GJH-18-2440
• Citation: 491 F.Supp.3d 87
• Parties: Charlotte MORRIS, Plaintiff, v. BIOMET, INC., et al., Defendant.
• Court: U.S. District Court — District of Maryland

491 F.Supp.3d 87

Charlotte MORRIS, Plaintiff,

v.BIOMET, INC., et al., Defendant.

Case No. GJH-18-2440

United States District Court, D. Maryland, Southern Division.

Signed September 30, 2020

Jill Rombro Marenberg, Scott B. Goldstein, Saiontz and Kirk PA, Baltimore, MD, Michael J. Miller, Tayjes M. Shah, Pro Hac Vice, The Miller Firm LLC, Orange, VA, for Plaintiff.

James A. Frederick, Goodell DeVries Leech and Dann LLP, Baltimore, MD, Matthew T. Albaugh, Pro Hac Vice, Faegre Baker Daniels LLP, Indianapolis, IN, for Defendant.

MEMORANDUM OPINION

GEORGE J. HAZEL, United States District Judge

Plaintiff Charlotte Morris brought this products liability action against Defendants Biomet Orthopedics, LLC, Biomet, Inc. Biomet Manufacturing LLC f/k/a Biomet Manufacturing Corps., and Biomet U.S. Reconstruction, LLC (collectively, "Biomet") based on injuries related to an artificial hip implant

manufactured by Biomet that was used during Plaintiff's February 2008 right total hip replacement surgery. ECF No. 1. Specifically, Plaintiff alleges claims of manufacturing defect, failure to warn, negligence, design defect, fraudulent concealment, breach of implied warranties, breach of express warranty, and punitive damages. Id. Currently pending before the Court are Biomet's Motion to Exclude Plaintiff's Expert John I. Waldrop, M.D. ("Motion to Exclude Expert Testimony"), ECF No. 226, and Biomet's Motion for Summary Judgment, ECF No. 228.¹ No hearing is necessary to resolve the pending motions. See Loc. R. 105.6 (D. Md. 2018). For the following reasons, Biomet's Motion to Exclude Expert Testimony is granted, in part, and denied, in part, and Biomet's Motion for Summary Judgment is granted, in part, and denied, in part.

I. BACKGROUND²

A. Total Right Hip Replacement Surgery

On March 19, 2002, Plaintiff sought treatment from Dr. Michael A. Jacobs for left hip, knee, and back pain. ECF No. 228-3 at 2–3.³ Dr. Jacobs diagnosed Plaintiff with significant degenerative joint disease

of the left hip and degenerative disc disease in the L-spine, and he recommended a left total hip replacement. Id. at 3. On June 19, 2002, at MedStar Good Samaritan Hospital, Dr. Jacobs performed a total left hip replacement on Plaintiff, for which he chose a DePuy metal-on-metal hip implant. Id. at 4–6.

On November 8, 2005, Plaintiff sought treatment from Dr. Jacobs for right lower back and buttock pain, id. at 7, and in November 2007, Dr. Jacobs observed end-stage osteoarthritis

in Plaintiff's right hip and symptoms of spinal stenosis and stiffness in her back, and he recommended surgery, id. at 8. On February 6, 2008, at MedStar Good Samaritan Hospital, Dr. Jacobs performed a right hip replacement on Plaintiff for which he chose a Biomet M2a Magnum metal-on-metal hip implant (the "Biomet Device"). Id. at 9–10. Plaintiff did not participate in the selection of her implant and trusted Dr. Jacobs to choose the device. ECF No. 228-4 at 3.

B. The Biomet Device

The Biomet Device is a metal-on-metal hip joint replacement. See ECF No. 228-7 at 2. It contains three components: a femoral head, a taper insert, and an acetabular cup

. Id. The head and acetabular cup components are made from cobalt chrome molybdenum (CoCrMo) alloy, and the taper insert is made of a titanium alloy. See id. The acetabular cup, which is seated in the hip, is treated with a porous coating of titanium alloy. Id.

Biomet included a package insert, or Instructions for Use ("IFU"), with the Biomet Device. See ECF No. 228-7. The IFU for Plaintiff's Biomet Device included possible adverse effects of using the device, including:

1. Material sensitivity reactions. Implantation of foreign material in tissues may result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and dislocation from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis

or osteolysis may be a result of loosening of the implant. Further, there has been a report regarding an association between articulating surfaces of: 1) CoCrMo alloy on CoCrMo alow, 2) CoCrMo alloy on polyethylene, and 3) Titanium alloy on polyethylene in hip replacements and increased genotoxicity. This report, however, did not assess either the clinical relevance of the data or make any definite conclusions as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data. The report further cautioned that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from the hip replacement. A low incidence of metal hypersensitivity has been reported with failed metal-on-metal implants. The clinical relevance of these findings is unclear, and it is not known whether metal hypersensitivity causes implant failure.

2. Early or late postoperative infection and allergic reaction.

4. Loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.

10. Fretting and crevice corrosion may occur at interfaces between components.

11. Wear and/or deformation of articulating surfaces.

15. Elevated metal ion levels have been reported with metal-on-metal articulating surfaces. Although mechanical testing demonstrates that metal-on-metal articulating surfaces produce a relatively low amount of particles, the total amount of particulate produced in vivo throughout the service life of the implants remains undetermined. The long-term biological effects of the particulate and metal ions are unknown.

ECF No. 228-7 at 2. Dr. Jacobs does not specifically recall whether he read the IFU prior to Plaintiff's implantation surgery, ECF No. 228-8 at 7–8, but it was his standard practice to familiarize himself generally with the indications received from the manufacturer, such as the surgical technique, which would include reviewing the IFU, id. at 4.

C. Revision Surgery

After Plaintiff's right hip surgery

, Dr. Jacobs continued to see her once a year for routine follow-up appointments. ECF No. 228-8 at 5. On September 9, 2010, approximately two and a half years after her surgery, Plaintiff complained of right hip clicking, which Dr. Jacobs was able to reproduce upon examination. ECF No. 228-3 at 14. At the time of his examination, Dr. Jacobs suspected that the clicking was a soft tissue band catching. Id. The treatment plan involved seeing Plaintiff in a year if she was asymptomatic, but if the clicking became a problem or she developed any further symptoms, she was to have Dr. Jacobs evaluate her sooner. Id.

On September 19, 2011, Dr. Davis Hahn, Plaintiff's oncologist, ordered her to undergo a CT scan

of her abdomen and pelvis, which showed a low-density fluid collection, or pseudotumor, near her right iliopsoas muscle. Id. at 15–16. Dr. Hahn noted that "it seems fairly clear that Mr. Morris does not have a malignancy in her right pelvis causing the iliopsoas mass but simply has a degenerating right hip metal-on-metal prosthesis which is releasing cobalt and also causing a marked bursal reaction ..." Id. at 17. He also noted that her "cobalt level came back 41 which is in the toxic range." Id. Dr. Jacobs also suspected that the pseudotumor was related to a metal-metal hypersensitivity. Id. at 18. Based on his concern that Plaintiff was experiencing a reaction to metal ions, Dr. Jacobs recommended revision surgery. ECF No. 228-8 at 6.

On November 15, 2011, at MedStar Good Samaritan Hospital, Dr. Jacobs performed revision surgery on Plaintiff's right hip. ECF No. 228-3 at 19–20. Before her surgery, Plaintiff had a cobalt level elevated at 58 and a chromium level at 19.6—both in the toxic range. ECF No. 229-5 at 2. During revision surgery, Dr. Jacobs discovered damage to Plaintiff's abductor muscle, noting that "the anterior half of the abductor was off and in a kind of thick fibrous membrane" and that "[i]t looked like the posterior abductor was also off and it was adherent to the fascia." ECF No. 228-3 at 19. Dr. Jacobs also noted that there was "marked metalosis [sic] of the entire hip" and that the acetabulum "was black from metalosis [sic]." Id. Dr. Jacobs removed the damaged tissue and the Biomet Device's femoral head and acetabular cup

. Id. at 20. Upon dislocation, the femoral head was "not visibly damaged" and the acetabular cup was "not visibly loose." Id. Dr. Jacobs found "excellent bone behind the cup" and implanted a new Zimmer shell polyethylene liner and a new head. Id. at 19–20. No complications were reported during surgery. See ECF No. 228-3 at 19–20. Tests performed on January 20, 2012, a couple months after Plaintiff's surgery, showed that her cobalt level had decreased to 9.2 and her chromium level had decreased to 10.1. ECF No. 229-7 at 2.

D. Post-Revision Treatment

After her initial right hip revision surgery, Plaintiff suffered a series of right hip dislocations

for which Dr. Jacobs performed close reductions on February 13, 2012 and May 19, 2012. Id. at 21–24. On August 21, 2012, at MedStar Samaritan Hospital, Dr. Jacobs performed a second right hip revision surgery on Plaintiff. Id. at 25–26. After her second revision surgery, Plaintiff developed an infection and subsequently underwent several irrigation and debridement ("I&D") procedures, temporary implantation of an antibiotic spacer, and wound vacuum-assisted closure ("V.A.C.") to cure the infection. Id. at 27–43. In May 2013, Dr. Jacobs evaluated Plaintiff, noting that she "look[ed] fantastic" and that he "aspirated about 3 mL of what looked to be benign fluid," suggesting that her infection was resolved. Id. at 44.

On July 2, 2013, Dr. Jacobs performed another...