Mack v. Stryker Corp.

• Decision Date: 14 August 2012
• Docket Number: Civ. No. 10–2993 (PAM/JJG).
• Citation: 893 F.Supp.2d 976
• Parties: Carol MACK and Aaron Mack, Plaintiffs, v. STRYKER CORPORATION, and Stryker Sales Corporation, Defendants.
• Court: U.S. District Court — District of Minnesota

893 F.Supp.2d 976

Carol MACK and Aaron Mack, Plaintiffs,

v.STRYKER CORPORATION, and Stryker Sales Corporation, Defendants.

Civ. No. 10–2993 (PAM/JJG).

United States District Court, D. Minnesota.

Aug. 14, 2012.

Colin P. King, Dewsnup, King & Olsen, Jessica A Andrew, Paul M. Simmons, Dewsnup, King & Olsen, Salt Lake City, UT, Yvonne M. Flaherty, Lockridge GrindalNauen PLLP, Minneapolis, MN, for Plaintiffs.

Hall Marston, Sedgwick LLP, Los Angeles, CA, Timothy P. Griffin, Brian W. Thomson, Leonard Street and Deinard, PA, Minneapolis, MN, Wayne A. Wolff, Sedgwick LLP, San Francisco, CA, Vaughn A. Crawford, Snell & Wilmer LLP, Phoenix, AZ, for Defendants.

MEMORANDUM AND ORDER

PAUL A. MAGNUSON, District Judge.

This matter is before the Court on Defendants' Motion for Summary Judgment, Defendants' Motion to Exclude the Testimony of Dr. Stephen Trippel Re “Safety Testing” and State of the Scientific Literature for Notice, and Plaintiffs' Motion to Limit or Exclude Defendants' Experts as Cumulative. For the reasons that follow, the Court grants Defendants' Motion for Summary Judgment and denies the remaining Motions as moot.

BACKGROUNDA. Mack's Surgery

Plaintiff Carol Mack had arthroscopic shoulder surgery at Allina Hospital in Fridley, Minnesota on August 1, 2002. Dr. Paul Diekmann performed the surgery. After surgery, Dr. Diekmann implanted in Mack's shoulder a pain pump sold by Defendant Stryker Corporation.¹ The pump was designed to deliver anesthetic, in this case bipuvicaine, directly into to the surgically repaired shoulder. The pump was implanted so that bipuvicaine was injected directly into the glenohumeral joint space in Mack's shoulder.² Mack ultimately experienced a complete degradation of the cartilage in her shoulder, a condition known as chondrolysis.³ Dr. Diekmann prescribed the pain pump in the intra-articular joint space to approximately ten patients between 2000 and 2003. (Andrew Decl. Ex 23 (Docket No. 85) at 16, 21 (Diekmann Dep.).) Mack is the only patient of the ten that experienced cartilage damage. ( Id. at 21.) Dr. Diekmann assumed that it was safe to use pain pumps in the intra-articular joint space because “at that time intra-articular injections of local anesthetic were a common way of treating short-term pain, and ... slow, continuous injection at that time was not seen to be any different than a frequent continuous injection.” ( Id. at 73.)

Mack contends that Stryker's pain pump, and in particular the continuous infusion of pain medication directly into the shoulder joint space, is the “probable cause” of her chondrolysis. (Andrew Decl. Ex. 25–B at 13 (Kurzweil Report II).) She also alleges that Stryker should have known that intra-articular placement of the pain pump could cause cartilage damage, and that Stryker nonetheless encouraged physicians to use its pump in ways that were likely to cause such damage.

Mack and her husband brought a nine-count Second Amended Complaint, which alleges negligence, design defect, failure to warn, fraud, negligent misrepresentation, breach of express warranty, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, and loss of consortium. Mack subsequently agreed to voluntarily dismiss the fraud, misrepresentation, and warranty claims. The essence of Mack's claim is that Stryker is liable for failing to adequately explore whether it was safe to use the pain pump in the glenohumeral joint because Stryker knew that its product was being used in that manner. For purposes of its Motion for Summary Judgment, Stryker does not dispute that Mack's chondrolysis was caused by use of its pain pump.

B. FDA Process

In 1998, Stryker's predecessor, McKinley Medical, sought clearance to market its pain pump for use in the “synovial cavity” under section 510(k) of the Federal Food, Drug, and Cosmetic Act. ( See Andrew Decl. Ex. 33.) The FDA ultimately approved McKinley's device for general intraoperative use, but did not specifically give clearance for synovial cavity infusion because there was no “substantially equivalent” predicate device on the market for the same intended use. (Andrew Decl. Ex. 28 at 37 (Pence Report); Andrew Decl. Exs. 59–60.) In 1999, Stryker and McKinley entered into a supply agreement under which Stryker had the exclusive right to sell McKinley's pain pumps in the United States. (Pence Report at 34–35; 38.) In September 2000, Stryker purchased the intellectual and commercial rights to McKinley's pain pump products. ( Id. at 35.) In 2001, Stryker filed a 510(k) application requesting clearance for use in the synovial cavity for the newest version of its pain pump. ( Id. at 38.) The FDA again approved the device for general intraoperative use, but did not specify use in the joint space. (Andrew Decl. Ex. 61 at 3.) Although the FDA letter does not address the reason for not approving this use, the parties agree that it was due to the lack of a predicate device. The parties also agree that at the time of Mack's surgery, the pain pump was FDA-cleared for the following use: “Intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.” (Andrew Decl. Ex. 60 at 3.)

Although the parties disagree about the extent to which Stryker marketed its pain pump for use in the joint space, there is evidence in the record that Stryker actively marketed its product for this use to orthopedic surgeons and orthopedic surgery centers. ( See Andrew Decl. Ex. 30 ¶ 10 (Paulos Decl.).) According to Dr. Lonnie Paulos, an orthopedic surgeon who served as a consultant to Stryker, “Stryker's marketing efforts included specific directions and instructions on how and where to place the pain pump catheter directly into the orthopedic joint space, such as the shoulder joint and the knee.” ( Id.)

C. Relevant Scientific Knowledge

The record establishes that physicians commonly used pain pumps in the intra-articular joint space following orthopedic surgery beginning in the 1990s. It is undisputed that at the time of Mack's surgery there was no published literature specifically linking chondrolysis to intra-articular pain pump use. Plaintiff's causation expert, Dr. Stephen Trippel, testified that prior to June 2005, there were no articles drawing such a connection:

Q. And can you identify, Dr. Trippel, in one article where the author has concluded—let's talk about through 2005, June 23, 2005—where the author wrote that some patient had experienced an outcome that affected their cartilage and they attributed it to any local anesthetic administered to the patient in any way or manner?

A. Well, ... [t]he answer to the question is no.

(Griffin Decl. Ex. 13 (Docket No. 76–2) at 445 (Trippel Dep.); see also Griffin Decl. Ex. 15 (Docket No. 76–2) at 132 (Kurzweil Dep.) (testifying that the first clinical report associating the use of continuous infusion of local anesthetic through a pain pump as a potential cause of chondrolysis was published in 2007).) Dr. Trippel testified that an article in 2004 accurately explained the then-current understanding of the causes of glenohumeral chondrolysis. (Trippel Dep. at 447–49 (referencing Petty, Damon H., et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy, 32(2) Am. J. Sports Med. 509–15 (2004).)) Specifically, Dr. Trippel acknowledged that as of 2004, the medical community did not attribute the growing instances of glenohumeral chondrolysis to the intra-articular use of pain pumps:

Q. This—This is the conclusions by Dr. Petty in the paper, and I think you read part of it, and it goes as follows: “Glenohumeral chondrolysis is a rare and disturbing complication of routine shoulder arthroscopy. The disease pathophysiology is currently not understood.” I assume that means how it evolves?

A. Correct.

Q. “Although thermal energy is suspected to play a role, it cannot explain known caused of glenohumeral chondrolysis in which no thermal energy was involved.” That's accurate?

A. Yes.

( Id. at 447.) When asked whether Petty and his co-authors attributed chondrolysis to pain pump use, Dr. Trippel responded: “No, they didn't.” ( Id. at 448.) Dr. Trippel further acknowledged that the Petty article accurately reported the state of scientific knowledge on the causes of glenohumeral chondrolysis in 2004. ( Id. at 449.)

Stryker contends that it first became aware of cases of chondrolysis that developed after intra-articular pain pump use in August 2005, three years after Mack's surgery. Mack presents no evidence to the contrary and concedes that Stryker did not have actual knowledge that intra-articular use of its pain pump could cause cartilage damage at the time of Mack's surgery. Instead, Mack argues that at the time of her surgery there was sufficient published literature that, if properly studied, would have put Stryker on notice that this use of pain pumps could cause cartilage damage. Mack, principally through Dr. Trippel, relies on the following twelve articles in support of this contention.

• In 1933, Dr. J. Albert Key published an article reporting that continuous injection of weak acids, alkalies, distilled water, and salt solutions caused arthritis in rabbit knees. The severity of the arthritis increased with the number of injections administered over a period of weeks. The study did not test the impact of anesthetics. Key, Albert J., The Production of Chronic Arthritis By the Injection of Weal Acids, Alkalies, Distilled Water, and Salt Solution into Joints, 15 J. of Bone & Joint Surgery 67–84 (1933). ( See Andrew Decl. Ex. 26–A at 8–9 (Trippel Report).)

• In 1983, Brian Reagan published an article finding that saline solutions applied to bovine cartilage for one, two, five, and eight hours inhibited cartilage health. The study also showed that other solutions containing more nutrients were not as harmful as saline. The study did not test the impact of anesthetics on cartilage health. Reagan, Brian...