Monroe v. Zimmer U.S. Inc.

• Decision Date: 14 February 2011
• Docket Number: No. CIV. S–08–2944 FCD/EFB.,CIV. S–08–2944 FCD/EFB.
• Citation: 766 F.Supp.2d 1012
• Parties: Sara MONROE, Plaintiff,v.ZIMMER U.S. INC., Zimmer, Inc., and Does 1 through 25, Defendants.
• Court: U.S. District Court — Eastern District of California

766 F.Supp.2d 1012

Sara MONROE, Plaintiff,

v.ZIMMER U.S. INC., Zimmer, Inc., and Does 1 through 25, Defendants.

No. CIV. S–08–2944 FCD/EFB.

United States District Court, E.D. California.

Feb. 14, 2011.

Stewart C. Altemus, Altemus & Wagner, Redding, CA, Paul J. Schachter, PHV, Penny Hendy, PHV, Ronald E. Johnson, PHV, Jr., Schachter, Hendy and Johnson, Fort Wright, KY, for Plaintiff.

Brian J. Mooney, Gordon & Rees LLP, San Francisco, CA, Catherine L. Manske, Gordon & Rees LLP, Sacramento, CA, Michael J. Kanute, PHV, Baker & Daniels, LLP, Chicago, IL, for Defendants.

MEMORANDUM AND ORDER

FRANK C. DAMRELL, JR., District Judge.

This matter is before the court on defendants Zimmer US, Inc. and Zimmer Inc.'s (“defendants”) motion for summary judgment pursuant to Federal Rule of Civil Procedure 56 and defendants' motion to exclude the testimony of Martin T. Wells (“Wells”) pursuant to Federal Rule of Evidence 702.¹ For the reasons set forth below, defendants' motion for summary judgment is GRANTED in part and DENIED in part and defendants' motion to exclude Wells' testimony is DENIED.

BACKGROUND ²

Plaintiff Sara Monroe (“plaintiff”) alleges that use of a Zimmer Ambulatory Pump (“ZAP”) ³ caused her to lose cartilage in her shoulder, resulting in unbearable pain and suffering. (Complaint, filed Oct. 16, 2008.) Plaintiff raises claims under California law for: (1) general negligence; (2) negligent products liability; and (3) strict products liability. As to the claim of general negligence, plaintiff alleges that defendants negligently designed, manufactured, and distributed a defective ZAP and negligently failed to warn doctors and patients that use of the ZAP in shoulder joints was unsafe.

1. Overview ⁴A. Anatomy of the Shoulder and the Glenohumeral Joint

The ball-and-socket joint of the shoulder is called the glenohumeral joint. The area surrounding the glenohumeral joint contains articular cartilage and synovial tissue. Articular cartilage is a thin layer of tissue that covers the ends of bones in the joint and provides a smooth, gliding surface that enables the bones to move. Articular cartilage receives its nutrients exclusively from synovial fluid within the joint space.

B. Glenohumeral Chondrolysis

Articular cartilage cells are known as chondrocytes. is the destruction of these cells. Glenohumeral refers to rapid and permanent destruction of in the shoulder joint. See D.J. Solomon et al., Chondrolysis After Arthroscopy: A Systematic Review and Causal Pathways, 25 Arthroscopy: J. Arthroscopic & Related Surg. 1329, 1330 (Nov. 2009). Cartilage cell death may occur from the inability of chondrocytes to maintain or produce cartilage matrix. Id. If the cartilage matrix is not renewed, it wears away with normal use of the joint until all of the protective tissue is gone. This results in the bones of the joint rubbing against one another, causing debilitating pain and stiffness.

C. Pain Pump

A pain pump is a medical device designed to deliver targeted doses of pain management medication to a specific part of the body. A pain pump consists of a fluid reservoir that contains one or more pain medications, a mechanism that pumps the pain management medication to the patient, and a catheter that delivers the pain management medication to a specific part of the body.

2. Plaintiff's Medical History

On May 18, 2007, plaintiff's orthopedic surgeon, Dr. Richard Cross (“Cross”), performed surgery on plaintiff's left shoulder. (Deposition of Dr. Richard Cross [“Cross Dep.”], filed Sep. 23, 2010 [Docket # 80], Ex. C at 23:5–7.) ⁵ The surgery involved decompression of the acromion and a resection of the distal clavicle. ( Id. at 23:16–21; DUF ¶ 5.) Prior to the surgery, on May 10, 2007, Cross injected plaintiff's left shoulder with the anesthetic Marcaine.⁶ (Cross Dep. at 12:3–7.) During the surgery, Cross found that plaintiff had a “degenerative or arthritic and/or arthritic acromioclavicular joint” and “some impingement in her shoulder or crowding of her acromion.” ( Id. at 23:10–13.) Cross noted that these issues were “not unusual” for a patient of plaintiff's age with plaintiff's medical background. ( Id. at 23:25–24:4.)

Also on May 18, 2007, Cross used a radio frequency probe on plaintiff's glenoid, within the glenohumeral joint. ( Id. at 71:15–25.) He used this probe, at a low frequency, to smooth a mild amount of damaged cartilage. ( Id.) Cross noted that this damage was typical wear and tear damage for someone of plaintiff's age. ( Id.)

Following the surgery on plaintiff's left shoulder, a ZAP was inserted into the subacromial space of plaintiff's left shoulder for a minimum of two days. ⁷ (DUF ¶¶ 7–8, 10; Cross Dep. at 30:4–7.) A fluid pathway from the ZAP catheter to plaintiff's glenohumeral joint should not have been present at this time; however, it is possible that such communication occurred. (DUF ¶ 9; Cross Dep. at 54:2–25.)

After plaintiff's surgery, she was involved in an altercation where she was punched in her left shoulder. (DUF ¶¶ 11–12.) This altercation delayed plaintiff's treatment and led to Cross injecting corticosteroids into plaintiff's glenohumeral joint. (DUF ¶¶ 14–15.)

On August 31, 2007, Cross performed a second surgery on plaintiff's left shoulder. (DUF ¶ 16.) During this surgery, Cross noted a lesion, labral tearing, and an onset of degenerative changes in the articular cartilage of plaintiff's glenoid. (DUF ¶ 17.) Cross also noted a Hill–Sachs lesion of the humerus during this surgery. (DUF ¶ 18; Cross Dep. at 52:11–25–53:1–5.) As he did during the first surgery, Cross used a radio frequency probe onthe cartilage of plaintiff's glenoid. (DUF ¶ 20.)

During plaintiff's surgery on August 31, 2007, a ZAP was inserted directly into plaintiff's glenohumeral joint.⁸ (DUF ¶ 21.) The ZAP remained in plaintiff's shoulder for six days. (Cross Dep. at 62:7–21.) After this surgery, plaintiff received two additional injections of corticosteroids into her glenohumeral joint. (DUF ¶ 22.)

After receiving the injections, plaintiff complained to Cross of increased pain and decreased range of motion in her shoulder. (Cross Dep. at 68:21–24.) Cross ordered an x-ray, which revealed global loss of cartilage in plaintiff's shoulder. ( Id. at 69:2–6.) Plaintiff was subsequently diagnosed with chondrolysis in her left shoulder. (DUF ¶ 23.)

3. CausationA. Specific Causation

Testimony on the issue of the specific cause of plaintiff's injury comes from plaintiff's treating physician, Cross. Plaintiff disclosed Cross as a non-retained expert. (DUF ¶ 25.) Cross admits that he is not an expert on the development of chondrolysis, nor is he an expert on whether chondrolysis is caused by pain pumps. (DUF ¶ 26.) As discussed below, Cross states that he implemented the “differential diagnosis” method to determine the cause of plaintiff's injury.

Initially, Cross believed that plaintiff's chondrolysis resulted from her altercation. (DUF ¶ 27; Cross Dep. at 74:11–21.) It was not until January 24, 2008 that Cross determined that plaintiff's chondrolysis was “possibly” due to the ZAP. (Cross Dep. at 74:24–25–75:1–5.) Cross testifies that this change occurred because he was not previously aware of an association between chondrolysis and pain pump use. ( Id. at 75:17–19.) Cross testifies that he is not entirely sure, but he believes that a “blurb” on the internet drew his attention to potential problems associated with the use of pain pumps. ( Id. at 75:24–25–76:1–4.) Once he became aware of this potential association, Cross reports that it “clicked” for him, that the pain pump may be the cause of plaintiff's chondrolysis. ( Id. at 76:4–7.) During his deposition, defendants' counsel asked Cross if he ever formed an opinion that the pain pump was a substantial factor in causing plaintiff's chondrolysis. ( Id. at 77:21–23.) Cross responded “[t]hats a good question. And I would say I think I have. I think I have, but it's not science. It's an opinion ... it's my gut feeling with [plaintiff].” ( Id. at 77:24–25, 78:2–3.)

Cross later elaborated on his thought process, discussing how he considered other factors that could have caused plaintiff's injury but ultimately ruled them out, eventually deciding that the pain pump may have been a significant cause of plaintiff's injury. ( Id. at 78:4–25–79:1–13.) Cross also testified that, “if I could do it all over again, I never would've put a pain catheter in her. Whether we would've had this problem or not, who's to say? ... Certainly you can argue that point.” ( Id. at 80:13–18.) Eventually, in response to questioning from plaintiff's counsel, Cross testified that it was his opinion, based on his review of medical literature, many years of orthopedic experience, and clinical experience with plaintiff, that the pain pump was “the most probable cause” of plaintiff's chondrolysis.⁹ ( Id. at 102:21–25–102:1–11.) B. General Causation

1. Dr. Dragoo

One of plaintiff's two retained experts on the issue of general causation is Dr. Jason Dragoo (“Dragoo”), a professor of Orthopedic Surgery at Stanford University. (Decl. of Dr. Dragoo [“Dragoo Report”], filed Feb. 19, 2010 [Docket # 29], Attachment 7 at ¶ 1.) Dragoo reviewed retrospective studies, case reports, and an in vivo animal study. Dragoo also conducted an in vitro human study, using articular cartilage from human knees and a “culture system” designed to replicate the normal physiology of the shoulder. (Dragoo Report ¶¶ 14–17.) Based on the results of his study and his review of prior studies, Dragoo determined, with a reasonable degree of medical certainty, that intra-articular pain pump usage can cause cartilage degeneration. ( Id. at ¶ 31.)

2. Dr. Wells

Wells, the Chair of the Department of Statistical Sciences at Cornell University, is plaintiff's other expert on the issue of general causation. (Decl. of Martin T. Wells, Ph.D. [“Wells Report I”], filed Feb. 19, 2010 [Docket # 29], Attachment 3 at ¶ 2.) Wells reviewed epidemiological...