Block v. Woo Young Med. Co.

• Decision Date: 28 March 2013
• Docket Number: Civil No. 09–1332 (JRT/JJK).
• Citation: 937 F.Supp.2d 1028
• Parties: Mary J. BLOCK, Plaintiff, v. WOO YOUNG MEDICAL CO. LTD., a Hong Kong company, Defendant.
• Court: U.S. District Court — District of Minnesota

937 F.Supp.2d 1028

Mary J. BLOCK, Plaintiff,

v.WOO YOUNG MEDICAL CO. LTD., a Hong Kong company, Defendant.

Civil No. 09–1332 (JRT/JJK).

United States District Court,

D. Minnesota.

March 28, 2013.

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

Charles H. Cole, Schuyler, Roche & Crisham, PC, Chicago, IL, Stephen P. Laitinen, Larson King, LLP, St. Paul, MN, for Defendant.

MEMORANDUM OPINION AND ORDER

JOHN R. TUNHEIM, District Judge.

Plaintiff Mary J. Block brings this action against Woo Young Medical Co. Ltd. (“Woo Young”), alleging that a Woo Young pain pump that was inserted into the intra-articular space of her shoulder joint following surgery caused serious cartilage damage. Block brings a negligence claim against Woo Young under North Carolina law. Woo Young has moved for summary judgment and to exclude four of Block's experts. For the reasons explained below, the Court will deny Woo Young's motions.

BACKGROUND

I. SURGERY AND ITS ALLEGED RESULTS

On June 20, 2003, Block underwent arthroscopic shoulder surgery. (Am. Compl. ¶ 5, Dec. 24, 2010, Docket No. 173.) After Block's surgery, her surgeon, Dr. Kevin Speer, provided her with a Woo Young Accufuser pain pump that administered bupivacaine (also known as marcaine). ( See Ex. 1 (Dep. of Kevin Speer 22), Dec. 28, 2012, Docket No. 290.) He placed the pump in the intra-articular space of Block's shoulder. ( See id. 24.)

Block claims that she developed a degenerative joint disease called chondrolysis in her glenohumeral joint (i.e., shoulder joint), after the surgery. (Am. Compl. ¶¶ 5, 20.) Chondrolysis is the complete or nearly complete loss of cartilage in the joint, an irreversible and painful condition. ( Id. ¶ 20.)

II. THE ACCUFUSER

Woo Young's Accufuser is a portable pain pump, a delivery mechanism for the continuous flow of medication. ( See Def. Mem. in Support, Ex. 2, August 26, 2012, Docket No. 265.) In 2000, the Accufuser received 510(k) clearance ¹ from the Food and Drug Administration (“FDA”) to market pain pumps “for general infusion use[,]” including intravenous, percutaneous, subcutaneous, intra-arterial and epidural use and use in the intraoperative (soft tissue/body cavity) site. ( Id.) The general approved uses for the pump included pain management for pre-operative, perioperative, and postoperative surgery. ( Id.)

The FDA did not provide Woo Young with 510(k) clearance to market pain pumps for intra-articular use in connection with orthopedic, as opposed to general, surgeries. There is no indication in the record that Woo Young requested this specific clearance. However, the FDA had denied other companies' requests to receive 510(k) clearance to market pain pumps for such orthopedic indications.

III. DR. SPEER

Dr. Speer began to use pain pumps for postoperative pain relief after consulting with orthopedic surgeons and his anesthesiology colleagues. (Speer Dep. 19–20, 27.) Dr. Speer testified that he learned about this use for pain pumps from “orthopedic surgeons collaborating and talking about shared patient experiences and trying to expound on how they can do things better and what works and what doesn't.” ( Id. 20.) He also stated that he inquired about his colleagues' experiences with pain pumps “over time in different settings.” ( Id.)

Dr. Speer recalls speaking to sales representatives regarding pain pumps. ( Id. 38.) These representatives told Dr. Speer about their experience and about whether doctors were using pain pumps. ( Id.) The representatives directed Dr. Speer to doctors who were using the pain pumps so that he could target his inquiries to those doctors. ( Id.) Dr. Speer does not recall the names of the sales representatives with whom he spoke or the companies for which they worked. ( Id.)

Dr. Speer did not perform independent research on pain pumps before using them on his patients, beyond his conversations with other doctors. ( Id. 21.) Dr. Speer believed that his use of the pain pumps was approved by the FDA, based on talking to his colleagues, but he did not conduct any independent assessments of FDA clearances for the pumps. ( Id. 26–27.) Dr. Speer stated, however, that he would take independent action to determine the FDA clearance for a device “if, after talking to my colleagues or in the other means of me getting the information that I seek, I f[ound] it to be inadequate or incomplete.” ( Id. 25.)

Dr. Speer has no recollection of the brand of pain pump that he used during Block's surgery. ( Id. 27.) He believes he always used the same brand of pump that was provided by the hospital. ( Id. 27–28.) Dr. Speer testified that he did not pay attention to the packaging on the pump. ( Id. 29–30.) He did not state explicitly if he read any labels on pain pumps, however. Dr. Speer also stated that he had never heard of an “orthopedic kit” for a pain pump. ( Id. 37.)

Around 2002, Dr. Speer first became aware of a patient who had developed chondrolysis of the shoulder after arthroscopic surgery. ( Id. 40.) He then saw the problem occur in other patients. ( Id. 41.) It was not until years later that he became aware that the problem might be due to the use of pain pumps. ( Id. 41–42.) Dr. Speer still has not formed an opinion on what caused Block's chondrolysis. ( Id. 43–44.) Furthermore, in his opinion, any reports of a suggested association between the use of bupivacaine in the intra-articular space through pain pumps and chondrolysis did not arise until 2006, 2007, or 2008. ( Id. 46.)

Dr. Speer's deposition is silent on the question of whether he would have heeded warnings concerning risks of cartilage damage associated with intra-articular pain pump use, from sales representatives or others, although it is clear that he sought information about the use of the pumps.

By 2006, 2007, or 2008—or possibly sometime prior to those years—Dr. Speer had stopped using pain pumps in the shoulder joint. ( Id.) Woo Young stated at oral argument that Dr. Speer stopped using pain pumps after he became aware of a potential link between chondrolysis and the intra-articular use of the pumps.

IV. CAUSES OF CHONDROLYSIS

The parties present conflicting views on the causes of chondrolysis. Woo Young claims that physicians could not explain exactly how or why chondrolysis occurred at the time of Block's surgery and that physicians still cannot do so today. ( See, e.g., Def. Mem. in Supp., Ex. 3 at 3.) Block disagrees and argues that the use of pain pumps to deliver intra-articular medications such as bupivacaine is cytotoxic to chondrocytes and is the primary cause of chondrolysis in certain patients. (Decl. of Thomas B. Powers, Ex. 6 at 3, Oct. 1, 2012, Docket No. 280.) Block points to medical literature, which, according to her experts, shows that cartilage cells are fragile and susceptible to damage when exposed to a variety of foreign substances. Block argues that a competent review of the medical literature existing at the time of Block's surgery would have revealed the potential risks posed by using the pump near cartilage.²

V. OFF–LABEL MARKETING

The parties also dispute whether Woo Young engaged in off-label marketing and whether this marketing had any effect on Dr. Speer. Block points out that, in 2002, Woo Young entered into an exclusive distributor agreement with McKinley Infuser, LLC, for McKinley to sell Woo Young's products as part of a “pain kit for orthopedic surgery.” (Powers Decl., Ex. 1 (Dep. of Woo Young Medical at 56–57), Ex. 2.) According to Block, this evidence shows that Woo Young marketed its product for orthopedic use.³

VI. TESTING OF PAIN PUMP

Woo Young knew that its pain pumps would be used to infuse medication into patients' bodies. (Powers Decl., Ex. 1 at 31.) Woo Young admits that it did not test the pain pump for the use of anesthetics that would be infused into the body through the pain pump. ( Id. at 30.) It also did not request that any other company conduct such testing. ( Id. at 32.) It also appears that Woo Young did not conduct a review of the medical literature related to this topic. ( Id. at 29–30.)

SUMMARY JUDGMENT

I. STANDARD OF REVIEW

Summary judgment is appropriate where there are no genuine issues of material fact and the moving party can demonstrate that it is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a). A fact is material if it might affect the outcome of the suit, and a dispute is genuine if the evidence is such that it could lead a reasonable jury to return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A court considering a motion for summary judgment must view the facts in the light most favorable to the non-moving party and give that party the benefit of all reasonable inferences that can be drawn from those facts. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).

II. NEGLIGENCE

Block's only remaining claim against Woo Young is a negligence claim. ⁴ She has narrowed this negligence claim to an allegation that Woo Young negligently failed to warn Dr. Speer about the possibility that Block could suffer cartilage damage if a pain pump was used to continuously infuse anesthetics into her intra-articular joint space.⁵ The parties agree, for the purposes of this motion, that North Carolina law applies. Thus, the Court must determine if Woo Young is entitled to summary judgment on Block's failure to warn claim under North Carolina law. The Court will address each of Woo Young's arguments for summary judgment in turn.

A. Sale for Orthopedic Use

First, Woo Young claims that it cannot be held liable for the failure to warn because there is no evidence that it ever sold its pumps to orthopedic surgeons to be used near cartilage. Under North Carolina law, a manufacturer is not liable if its product is altered or modified after it leaves the manufacturer and...