Mcclellan v. I-Flow Corp.

• Decision Date: 29 April 2010
• Docket Number: Civ. 07-1671-AA,Civ. 07-1318-AA,Civ. Nos. 07-1309-AA,Civ. 08-0478-AA,Civ. 09-0342-AA,Civ. 09-0378-AA,Civ. 09-0146-AA,Civ. 08-0588-AA,Civ. 08-1419-AA,Civ. 07-1310-AA
• Citation: 710 F.Supp.2d 1092
• Parties: Christina McCLELLAN, Plaintiff, v. I-FLOW CORPORATION, a Delaware corporation; DJO, L.L.C., a Delaware corporation; DJO Incorporated, a Delaware corporation; and Pacific Medical, Inc., a California corporation, Defendants.
• Court: U.S. District Court — District of Oregon

710 F.Supp.2d 1092

Christina McCLELLAN, Plaintiff,

v.I-FLOW CORPORATION, a Delaware corporation; DJO, L.L.C., a Delaware corporation; DJO Incorporated, a Delaware corporation; and Pacific Medical, Inc., a California corporation, Defendants.

Civ. Nos. 07-1309-AA, 07-1310-AA, 07-1318-AA, 07-1671-AA, 08-0478-AA, 08-0588-AA, 08-1419-AA, 09-0146-AA, 09-0342-AA, 09-0378-AA.

United States District Court,

D. Oregon.

April 29, 2010.

Jeffrey B. Wihtol, Robert H. Beatty-Walters, Miller & Wagner, LLP, Portland, OR, for Plaintiff.

William Kelly Olson, Mitchell Lang & Smith, Portland, OR, for Defendants.

OPINION AND ORDER

AIKEN, Chief Judge:

In these related products liability actions, plaintiffs allege that they developed glenohumeral chondrolysis, the rapid and permanent loss of cartilage in the shoulder joint, after medical devices known as "pain pumps" were used to administer local anesthetics during and after arthroscopic surgery. Plaintiffs each seek non-economic damages of $4,500,000 and economic damages ranging from $1,050,000 to $1,500,000 (or damages to be proven at trial), and against certain defendants, punitive damages. Several plaintiffs also seek damages for loss of consortium.

Before the court are defendants' motions to exclude the general causation testimony of nine expert witnesses: Stephen Badylak, M.D.; Carl Basamania, M.D.; Charles Beck, M.D.; Jason Dragoo, M.D.; Sander Greenland, PhD; Frederick Matsen, M.D.; John Swanson, M.D.; Stephen Trippel, M.D.; and Martin Wells, PhD.¹ Defendants contend that the testimony of these experts is unreliable, irrelevant, and inadmissible under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Defendants also move to strike the testimony of Drs. Basamania and Matsen for failing to disclose information relevant to their expert opinions in violation of Federal Rule of Civil Procedure 26(a)(2)(B). Plaintiffs oppose the motions and, in turn, move to exclude the testimony of two defense expert witnesses, William Stetson, M.D. and Wayne Burkhead, Jr., M.D.

On November 17 and 18, 2009 and March 17, 2010 the court heard oral argument and brief testimony on the parties' motions after submission of extensive briefing. For the reasons set forth below, defendants' motions are granted with respect to the testimony of Frederick Matsen, M.D., Sander Greenland, PhD, and Martin Wells, PhD, granted in part with respect to Carl Basamania, M.D., and denied in all other respects. Plaintiffs' motions are denied.

BACKGROUND

The glenohumeral joint is the ball-and-socket joint of the shoulder. A fibrous capsule encases the joint space, an area surrounding the joint that contains articular cartilage and synovial tissue. Articular cartilage is the thin layer of tissue that covers the ends of bones in the joint and provides a smooth, gliding surface to enable the bones to move. Unlike other types of tissue, articular cartilage has no nerves or blood supply and receives nutrients from synovial fluid within the joint space. Synovial tissue produces the synovial fluid which carries and diffuses nutrients into articular cartilage cells (chondrocytes) to continually renew the matrix of cartilage. In other words, synovial fluid is the "lifeblood" of articular cartilage. Trippel Expert Report, p. 4.

Glenohumeral chondrolysis is a very rare condition that results from the rapid and permanent destruction of articular cartilage in the shoulder joint. "Simply described, chondrolysis is the degeneration of cartilage cells, ending in cell death." D.J. Solomon et al., Glenohumeral Chondrolysis After Arthroscopy: A Systematic Review of Potential Contributors 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 not renewed, the cartilage matrix wears away with normal use of the joint until no protective tissue remains. The bones of the joint then rub against one another, causing debilitating pain and stiffness. Treatment options for chondrolysis are few, as shoulder joint replacement surgery has met with limited success. See J. Levy et al., Young Patients with ShoulderChondrolysis Following Arthroscopic Shoulder Surgery Treated with Total Shoulder Arthroplasty, 17 J. Shoulder Elbow Surg. 380, 387 (May 2008) ("After nonoperative measures are exhausted, there are few options available for the patient who presents with chondrolysis after shoulder arthroscopy.").

Very few cases of chondrolysis were reported until the late 1990s when researchers described several patients who developed glenohumeral chondrolysis after receiving injections of gentian violet, a color contrast dye, during open surgery. See K. Tamai et al., Chondrolysis of the Shoulder Following a "Color Test"-Assisted Rotator Cuff Repair, 68 Acta Orthop. Scand.. 401(Aug.1997); Y. Nakagawa et al., Glenohumeral Osteoarthritis Following a "Color Test" During Rotator Cuff Repair, 57 Bull Hosp. Jt. Dis. 216 (1998). Case reports during this time also identified a surgical irrigation solution and an acrylic bone cement as likely causes of cartilage destruction in the knee and hip joints. C. Douw et al., Clinical and Pathological Changes in the Knee After Accidental Chlorhexidine Irrigation During Arthroscopy: Case Reports and Review of the Literature, 80 J. Bone & Joint Surg. 437 (May 1998); A. van Huyssteen & D. Bracey, Chlorhexidine and Chondrolysis in the Knee, 81 J. Bone & Joint Surg. (U.K.) 995 (Nov.1999); W. Leclair et al., Rapid Chondrolysis After an Intra-Articular Leak of Bone Cement in Treatment of a Benign Acetabular Subchondral Cyst: An Unusual Complication of Percutaneous Injection of Acrylic Cement, 29 Skeletal Radiol 275 (May 2000).

Still other cases of articular cartilage damage were reported after the use of radiofrequency devices (known as thermal devices or wands) and suture anchors during arthroscopic surgery. See R. Edwards et al., Thermal Chondroplasty of Chondromalacic Human Cartilage, 30 Am. J. Sports Med. 90 (Jan.2002); W. Levine et al., Chondrolysis Following Arthroscopic Thermal Capsulorrhaphy to Treat Shoulder Instability, 87 J. Bone & Joint Surg. 616 (Mar.2005); see also G. Athwal et al., Osteolysis and Arthropathy of the Shoulder After Use of Bioabsorbable Knotless Suture Anchors, 88 J. Bone & Joint Surg. 1840 (Aug.2006); C. Good et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy with Thermal Capsulorrhaphy, 23 Arthroscopy 797 (July 2007); B. Coobs & R. LaPrade, Severe Chondrolysis of the Glenohumeral Joint After Shoulder Thermal Capsulorrhaphy, 38 Am J. Orthop. E34 (2009).

In 2004, surgeons reported three cases of glenohumeral chondrolysis in young athletes following arthroscopic shoulder surgeries. Thermal devices were used during two of the surgeries, and one patient reportedly received a pain pump infused with bupivacaine and epinephrine, though the report is unclear whether the pain pump was placed intra-articularly. D. Petty et al., Glenohumoral Chondrolysis After Shoulder Arthroscopy: Case Reports and Review of Literature, 32 Am. J. Sports Med. 509, 511 (Mar.2004). The authors suspected that thermal devices played a role in two of the three cases of chondrolysis but made no findings with respect to pain pump use. Id. at 514.

Beginning in 2003, Dr. Charles Beck, an orthopedic surgeon in Utah, observed that several of his patients developed chondrolysis after he performed arthroscopic surgeries and inserted pain pumps to administer bupivacaine and epinephrine directly into the shoulder joint. Dr. Beck eventually reviewed the medical records of patients involved in 152 shoulder arthroscopies and determined that chondrolysis developed in 12 of 19 (or 63%) of shoulders that received intra-articularcontinuous infusion of anesthetics via pain pump, while no cases of chondrolysis were reported in shoulders that were not treated with a pain pump.

In July 2005, Dr. Beck presented his findings to a group of orthopedic surgeons. He and a colleague, Dr. Brent Hansen, wrote a paper analyzing his research, and in July 2007 their paper was published in the American Journal of Sports Medicine. See B. Hansen & C. Beck, Postarthroscopic Glenohumeral Chondrolysis, 35 Am. J. Sports Med. 1628 (July 2007) [hereinafter Hansen/Beck Study]. Physicians and researchers have published additional reports of glenohumeral chondrolysis after arthroscopic surgery and discussed potential causes of the disease, including the use of pain pumps for continuous infusion of local anesthetics. See, e.g., P. Greis et al., Bilateral Shoulder Chondrolysis Following Arthroscopy, 90 J. Bone & Joint Surg. 1338 (June 2008); S. Anderson et al., Chondrolysis of the Glenohumeral Joint-Abstract, 24 J. Arthroscopy Supp. e13 (Apr.2008); A. McNickle et al., Postsurgical Glenohumeral Arthritis in Young Adults, ---Am. J. Sports Med. ---- (June 2009); M. Saltzman et al., Postsurgical Chondrolysis of the Shoulder, 32 Orthopedics 215 (June 2009); D. Bailie & T. Ellenbecker, Severe Chondrolysis After Shoulder Arthroscopy: A Case Series, --- J. Shoulder Elbow Surg. ---- (Jan.2009).

Further, researchers have conducted in vitro and animal studies on the chondrotoxicity of local anesthetics. N. Dogan et al., The Effects of Bupivacaine and Neostigmine on Articular Cartilage and Synovium in the Rabbit Knee Joint, 32 J. Int'l Med. Res. 513 (Sept.2004); C. Chu et al., In Vitro Exposure to 0.5% Bupivacaine is Cytotoxic to Bovine Articular Chondrocytes, 22 Arthroscopy 693 (July 2006) [Chu I]; A. Gomoll et al., Chondrolysis After Continuous Intra-Articular Bupivacaine Infusion, 22 Arthroscopy 813 (Aug.2006) [Gomoll I]; J. Karpie & C. Chu, Lidocaine Exhibits Dose- and Time-Dependent Cytotoxic Effects on Bovine Articular Chondrocytes In Vitro, 35 Am. J. Sports. Med.. 1621 (Oct.2007); S. Piper & H. Kim, Comparison of Ropivacaine and Bupivacaine Toxicity in Human...