The opinion of the court was delivered by: Karen E. Schreier Chief Judge
ORDER DENYING IN PART AND GRANTING IN PART DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
Defendant, Breg, Inc., moves for summary judgment. Plaintiff, Kelly Koch, resists Breg's motion. Breg's motion is denied in part and granted in part.
In the light most favorable to Koch, the nonmoving party, the facts are as follow:
Breg manufactures the Breg Pain Care 3200 pump, commonly referred to as a pain pump. The pain pump was cleared by the FDA for sale to medical professionals for general surgery applications pursuant to the 510(k) process.*fn1 It uses a drip mechanism that infuses an anesthetic, such as bupivacaine, at a rate of 4cc's per hour. It also allows the patient to administer a bolus*fn2 dose of the anesthetic.
In 1985, Nole et al. wrote an article that explained the toxicity of local anesthetics to articular cartilage. Roberta Nole, et al., Bupivacaine and Saline Effects on Articular Cartilage, Arthroscopy: The Journal of Arthroscopy and Related Surgery (1985). Breg designed the pain pump so that bupivacaine, an anesthetic, could be dispensed in the shoulder's joint space, or intraarticularly, where the bupivacaine would come into direct contact with the cartilage in the shoulder. Breg also told doctors to insert the pain pump in the shoulder's joint space, or intra-articularly. Breg did not warn about the potential damage to the cartilage that might result from having the pain pump administer the bupivacaine directly into the shoulder's joint space.
On August 8, 2005, Koch underwent arthroscopic surgery of his right shoulder. After the surgery, a high volume pain pump manufactured by Breg was inserted in his shoulder's joint space. The pain pump was used for purposes of alleviating Koch's pain by administering bupivacaine. Approximately six months after the surgery, Koch began experiencing pain and stiffness in his right shoulder. Koch was subsequently diagnosed with glenohumeral chondrolysis.*fn3 Koch brought suit against Breg, alleging various strict liability and negligence claims. Breg moves for summary judgment.
Summary judgment is proper "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). The burden is initially placed on the moving party to establish the absence of a genuine issue of material fact and that the party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986) ("[A] party seeking summary judgment always bears the initial responsibility of . . . demonstrat[ing] the absence of a genuine issue of material fact." (internal quotations omitted)).
Once the moving party has met its initial burden, the nonmoving party "may not rely merely on allegations or denials in its own pleading[.]" Fed. R. Civ. P. 56(e)(2). Rather, the nonmoving party must, "by affidavits or as otherwise provided in this rule[,] set out specific facts showing a genuine issue for trial." Id. For purposes of summary judgment, the facts, and inferences drawn from those facts, are "viewed in the light most favorable to the party opposing the motion." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986) (quoting United States v. Diebold, Inc., 369 U.S. 654, 655 (1962)).
I. Koch's Negligence Claims
Koch alleges that Breg "knew or reasonably should have known that the pain pump and the anesthetic medication used in it could cause serious injury to patients when used in the joint space as directed." Docket 1 at 5. Koch also alleges that Breg failed, in various ways, to disclose and warn about the dangers of the intra-articular use of the pain pump in the shoulder. Docket 1 at 5-6. Koch also alleges that Breg negligently designed the pain pump to be inserted "directly into the shoulder joint, which infused commonly used medications that were associated with damage to articular cartilage." ...