Huggins v. Stryker Corp.

• Decision Date: 25 March 2013
• Docket Number: Civil No. 09–1250 (JRT/JJK).
• Citation: 932 F.Supp.2d 972
• Parties: Robert L. HUGGINS, Plaintiff, v. STRYKER CORPORATION and Stryker Sales Corporation, Defendants.
• Court: U.S. District Court — District of Minnesota

932 F.Supp.2d 972

Robert L. HUGGINS, Plaintiff,

v.STRYKER CORPORATION and Stryker Sales Corporation, Defendants.

Civil No. 09–1250 (JRT/JJK).

United States District Court, D. Minnesota.

March 25, 2013.

Thomas B. Powers, Williams Love O'Leary & Powers, PC, Beaverton, OR; and Yvonne M. Flaherty, Lockridge Grindal Nauen PLLP, Minneapolis, MN, for plaintiff.

Hall Marston, Sedgwick LLP, Los Angeles, CA; and Timothy P. Griffin, Leonard Street and Deinard, PA, Minneapolis, MN, for defendants.

MEMORANDUM OPINION AND ORDER

JOHN R. TUNHEIM, District Judge.

Plaintiff Robert L. Huggins brings claims against medical device companies Stryker Corporation and Stryker Sales Corporation (collectively, “Stryker”). Huggins alleges that pain pumps manufactured and distributed by Stryker, which a surgeon inserted into Huggins' shoulder following surgery in February 2002, caused chondrolysis (a condition involving rapid cartilage degeneration) in his shoulder. Huggins advances various product liability theories, sounding in both strict liability and negligence. This matter is currently before the Court on Huggins' motion to transfer, Stryker's motion for summary judgment, and Stryker's motion to exclude certain proposed expert testimony.

First, the Court will deny Huggins' motion to transfer. The balance of relevant factors does not sufficiently favor transferring the action to the District of Oregon. Second, the Court will deny Stryker's motion for summary judgment. A reasonable jury could find that Stryker should have known at the time of Huggins' surgery that continuous infusion of anesthetics into the shoulder joint using a pain pump could cause cartilage damage. The Court will also find that Stryker is not entitled to summary judgment on the basis of the statute of limitations. Finally, the Court will deny Stryker's motion to exclude expert testimony for the reasons described below.

BACKGROUND

I. HUGGINS' SURGERIES

Dr. A. Brooke Benz performed arthroscopic surgery on Huggins' shoulder on February 21, 2002. (Decl. of Tim Griffin, Ex. 16, June 28, 2012, Docket No. 175.) There is no dispute that Dr. Benz inserted a Stryker pain pump ¹ into Huggins' shoulderjoint following the operation. ( Id.) Dr. Benz noted that the “articular surfaces ... were in good condition.” ( Id.) On December 5, 2002, Dr. Benz performed a second shoulder surgery on Huggins and observed severe loss of cartilage on the humeral head and glenoid, which he described as “kind of global” and as “grade 3 degenerative changes.” (Griffin Decl., Ex. 17.) Huggins' experts opine that the continuous infusion of anesthetics supplied by the pain pump after the first surgery caused chondrolysis, a painful and somewhat debilitating condition involving rapid cartilage degeneration. ( See Decl. of Thomas B. Powers, Ex. 8 (Report of Dr. Robert Litchfield) at 11–12, July 19, 2012, Docket No. 180.)

II. REGULATORY HISTORY, DEVELOPMENT, AND MARKETING OF PAIN PUMPS

Stryker (and Stryker's predecessor, McKinley Medical) received 510(k) clearance ² from the FDA to market pain pumps for certain uses. (Decl. of Jennifer Hoffman ¶ 3, June 28, 2012, Docket No. 176.) The pain pumps were cleared for “intraoperative” use. ( Id.) However, the FDA denied McKinley Medical's attempt to modify the 510(k) clearance in 1998 by adding use in the “synovial cavity”—i.e., the intra—articular joint space—to the list of approved uses. (Powers Decl., Exs. 15–16.) The FDA reviewer explained that there was no predicate device that featured an indication for use in the synovial cavity and that the applicant needed to demonstrate that the different indication did not raise “new safety or effectiveness issues.” (Powers Decl., Ex. 16.) Huggins alleges that the FDA rejected a similar attempt by Stryker in 2001 to obtain clearance for a specific indication for use in the synovial cavity. ( See Powers Decl., Ex. 13 (Dep. of Nicole Petty and Robert F. Pomper) 98:19–99:3.)

Huggins alleges that Stryker failed to conduct a review of the medical literature to assess the risks of continuous infusion of anesthetics into the intra-articular space prior to marketing pain pumps to orthopedic surgeons. ( See Powers Decl., Ex. 4 (Dep. of Rodney D. Parker) 45:17–48:13.) Huggins also alleges that Stryker failed to conduct or commission safety tests that would identify whether intra-articular pain pump use posed a risk of cartilage damage. ( Id. 43:5–46:9.)

Huggins has provided a variety of pieces of evidence regarding Stryker's marketing of pain pumps. For example, a surgeon who was a consultant to Stryker testified in a prior action that Stryker sales representatives communicated to surgeons that pain pumps could be used in the joint space. (Powers Decl., Ex. 30 (Dep. of Dr. Lonnie Paulos) 33:15–34:10.) Huggins' experts also summarize numerous internal documents from Stryker that discussed intra-articular pain pump use and discussed marketing pain pumps to orthopedic surgeons. ( See Powers Decl., Ex. 12 (Report of Dr. Peggy Pence) at 54–58.) Further, in 2000, Stryker considered designing a pain pump that had two separate catheters, one of which was specifically intended for the joint space. (Powers Decl., Ex. 33 (filed under seal).) ³

III. MEDICAL LITERATURE

The first peer reviewed article explicitly recognizing a potential causal link between pain pumps and chondrolysis appeared in July 2007. See Brent P. Hansen et al., Postarthroscopic Glenohumeral Chondrolysis, 35 Am. J. Sports Med. 1628 (2007). Stryker maintains that there is still uncertainty regarding the causes of chondrolysis. However, on the basis of a growing body of literature and case reports, the FDA issued a notice on November 13, 2009, that chondrolysis had been repeatedly reported in connection with intra-articular pain pump use and the FDA encouraged health care professionals to not use pain pumps “for continuous intra-articular infusion of local anesthetics after orthopedic surgery.” (Powers Decl., Ex. 25.)

For purposes of the present case, the relevant question is not what is known about the risks of pain pumps today, but what was known about the risks of pain pumps at the time of Huggins' first surgery in February 2002. Huggins' primary evidence regarding the scope of scientific knowledge at the time of his surgery is provided by Drs. Stephen Badylak, Carl Basamania, and Peggy Pence. These experts review the scientific literature and opine that, prior to 2002, the literature was sufficient to put a medical device manufacturer on notice that continuous infusion of anesthetics over a period of multiple days into the intra-articular joint space could cause serious cartilage damage. (Badylak Report at 2–6; Powers Decl., Ex. 10 (Addendum to General Causation Report of Dr. Carl Basamania (“Basamania Addendum”)) at 3–6; Pence Report at 59–61.)

Huggins' experts discuss the general anatomical and physiological properties of joint spaces and cartilage that were familiar to the scientific community prior to 2002. ( See, e.g., Badylak Report at 2–4.) They explain that articular cartilage is fragile and that exposing it to any solution may damage it. ( See, e.g., Basamania Addendum at 5 (“[L]ong before the introduction of pain pumps to the market, the tenuous and delicate nature of cartilage and its intraarticular environment was well documented.”).) The experts also discuss specific articles published between 1933 and 2002 that they contend demonstrated the risk of cartilage damage posed by continuous injection of anesthetics. (Badylak Report at 3–6; Basamania Addendum at 3–6; Pence Report at 59–61.) Many of the articles involved substances other than anesthetics, but the experts explain why each article is relevant to their conclusion. Generally speaking, the articles highlight the risks of exposing articular cartilage to foreign solutions and suggest that the risks increase as the length of exposure increases. The experts focus on the following articles ⁴:

(1) J. Albert Key, The Production of Chronic Arthritis by the Injection of Weak Acids, Alkalies, Distilled Water, and Salt Solution in Joints, 15 J. Bone & Joint Surgery 67 (1933). The Key study found that exposing rabbit joints to various water and saline solutions for an extended period of time, through multiple injections, damaged cartilage.

(2) Brian F. Reagan et al., Irrigation Solutions for Arthroscopy, 65 J. Bone & Joint Surgery 629 (1983). The Reagan study analyzed different irrigating solutions for arthroscopic surgery and found that saline solutions harmed the metabolic process of cartilage cells. It also suggested that there “is probably little reason for concern” with respect to standard arthroscopy because “[t]he procedure takes fifteen to forty-five minutes” and “[s]upport of chondrocyte metabolism during such a short exposure ... is probably not a crucial issue.” Id. at 631 (emphasis added).

(3) Roberta Nole et al., Bupivicaine and Saline Effects on Articular Cartilage, 1 Arthroscopy 123 (1985) (“Nole”). The Nole study involved bupivacaine, the anesthetic that Dr. O'Connell used in Healey's pain pumps. The authors' state that “[b]upivacaine itself seems to be fairly well tolerated by articular cartilage.” Id. at 126. However, the authors also note that “[c]onsidering the toxicity of bupivacaine to certain other cell types ..., the possibility of long-term effects must be considered even though there is no clinical evidence of this as of yet” and also that “further studies should be made to find optimal ways of administering local anesthetics into human joints” because “adult human articular cartilage has no blood supply of its own and will be directly affected by whatever solution is injected into a joint.” Id.

(4) John P. Fulkerson & Thomas F. Winters, Jr., Articular Cartilage Response to Arthroscopic Surgery, 2 Arthroscopy 184 (1986) (“Fulkerson”). The Fulkerson article is a literature review that found that bupivacaine had well documented toxic effects on a variety of tissues....