Krumpelbeck v. Breg Inc.

• Decision Date: 27 December 2010
• Docket Number: No. 1:09–cv–91.,1:09–cv–91.
• Citation: 759 F.Supp.2d 958
• Parties: Rachel KRUMPELBECK, Plaintiff,v.BREG, INC., et al., Defendants.
• Court: U.S. District Court — Southern District of Ohio

759 F.Supp.2d 958

Rachel KRUMPELBECK, Plaintiff,

v.BREG, INC., et al., Defendants.

No. 1:09–cv–91.

United States District Court, S.D. Ohio, Western Division.

Dec. 27, 2010.

Ronald E. Johnson, Jr., Paul J. Schachter, Penny Unkraut Hendy, Schachter & Hendy, PSC, Ft. Wright, KY, Stephanie M. Day, Brett Colbert Goodson & Company Ltd., Cincinnati, OH, for Plaintiff.Kim M. Schmid, Barry J. Koopmann, Monica K. Gould, Molly J. Given, Bowman and Brooke LLP, Minneapolis, MN, Nancy Ann Lawson, Dinsmore & Shohl, Cincinnati, OH, for Defendants.

ORDER THAT: (1) DEFENDANT BREG, INC.'S MOTION FOR SUMMARY JUDGMENT (Doc. 49) BE GRANTED; AND (2) THIS CASE BE CLOSED

TIMOTHY S. BLACK, District Judge.

This civil action is before the Court on Defendant Breg, Inc.'s motion for summary judgment (Doc. 49) and the parties' responsive memoranda (Docs. 52, 63, 64, 71).

I. BACKGROUND FACTS

Plaintiff underwent arthroscopic surgery on her shoulder. After the surgery, her physician prescribed and implanted the catheter of a Breg Pain Care infusion pump to administer local anesthetic for pain control. Plaintiff alleges that as a result of the pump, she developed chondrolysis ¹ and has suffered serious progressive, permanent, and incurable injury.

Plaintiffs complaint asserts seven counts against Defendant: (1) strict liability—design defect; (2) strict liability-warning defect; (3) strict liability—nonconformance with representations; (4) negligence; (5) breach of express warranty; (6) breach of implied warranty; and (7) negligent misrepresentation and fraud.² Defendant challenges Plaintiff's ability to prove these claims on one basic premise: Defendant was under no duty to warn of the risk of chondrolysis because it was reasonably unaware of the risk, and even if it did have a duty to warn, Plaintiff cannot show that a failure to warn caused her chondrolysis.

II. UNDISPUTED FACTS

1. On February 1, 2005, Plaintiff Rachel Krumpelbeck dislocated her right shoulder while playing basketball. (Pl.'s Dep. at 36).

2. On March 3, 2005, Plaintiff underwent arthroscopic surgery on her right shoulder. (Doc. 1 at ¶ 27). The surgery was performed by Dr. Paul Favorito. (Doc. 55 at 26).

3. Following surgery, Dr. Favorito prescribed and applied a Breg Pain Care 4200 pain pump to provide continuous infusion of anesthetic into Plaintiff's shoulder joint to manage her postoperative pain. (Doc. 55 at 28–29, 56–57, 107, 117–118; Doc. 1 at ¶ 27). Through the Breg Pain Care 4200 and its catheter, Dr. Favorito infused 200 ml of 0.5% Marcaine with epinephrine into Plaintiff's shoulder joint at a rate of 2 ml per hour. (Doc. 55 at 30, 56, 67–68; Doc. 1 at ¶ 29).

4. Dr. Favorito testified that he had enjoyed good experiences with pain pump use for his patients in terms of pain relief. (Doc. 55 at 57). He found that because of their use of a pump, patients for whom he prescribed pain pumps following surgery consumed fewer oral narcotics. ( Id. at 57).

5. Plaintiff claims that she subsequently developed glenohumeral (shoulder) chondrolysis and was diagnosed with that condition in December 2007. (Doc. 1 at ¶ 30).

6. The Pain Care 4200 is a portable infusion pump-a delivery mechanism for the continuous flow of pain medication. The device contains a 200 cc fluid reservoir, and the fluid put into the reservoir flows out of the fluid reservoir and through the catheter at the rate of 2 ccs per hour. (Special 510(k): Device Modification for the Pain Care 4200 at 3, Doc. 71, Ex. 4).

7. Breg's Pain Care pumps are class II devices. ( Id.) ³

8. Breg prepared and filed with the FDA a 510(k) submission for the Pain Care 4200. ( Id.)

9. On April 4, 2002, the FDA cleared the Pain Care 4200, which allowed Breg to legally distribute the device in the United States according to the following indications for use: “The Pain Care 4200 is indicated to provide continuous infusion of a local anesthetic for the post-operative management of pain.” (FDA clearance letter (April 4, 2002) at 1–3, Doc. 51, Ex. 4).

10. Based upon the FDA's action, Breg was cleared to market its device in accordance with the cleared indicated use. ( Id. at 2).

11. Chondrolysis is the rapid loss of joint cartilage following some chemical, mechanical, infectious, immunological, or thermal insult. (Doc. 51, Ex. 5).

12. At the annual meeting of the American Academy of Orthopaedic Surgeons (“AAOS”) on March 23, 2006, Dr. Brent Hansen discussed for the first time the development of chondrolysis and a possible relationship to “higher flow rate” (4.16 ccs per hour) pain pumps used in the intra-articular space of the shoulder. (Tr. of B. Hansen Podium Presentation (Mar. 23, 2006) at 6–7, Doc. 71, Ex. 5).

13. Dr. Hansen noted during the presentation that “we're not sure what the exact etiology is,” and, in conclusion, stated that “chondrolysis may be related to high rate volume intraarticular pain pump catheters with bupivacaine and epinephrine.” ( Id. at 2, 7).

14. This AAOS annual meeting occurred more than one year after Plaintiffs surgery. ( Id. at 1).

15. Dr. Hansen stated in his follow-up article that “[t]he cause of [postarthroscopic glenohumeral chondrolysis] is unknown, it “has yet to be etiologically defined,” and he noted that “[i]t is likely that other unrecognized factors are also involved.” ( See Brent P. Hansen, et al., Postarthroscopic Glenohumeral Chondrolysis, Am. J. Sports Med. 35:10:1628, 1632–33 (2007), Doc. 51, Ex. 6).⁴

16. Dr. Hansen's article—the first article in the world literature articulating a possible association between postarthroscopic glenohumeral chondrolysis and continuous intra-articular infusion of anesthetic via pain pump—was not in print until October 2007, more than two years after Plaintiffs surgery. ( Id.) ⁵

17. Dr. Favorito, one of Plaintiff's non-retained expert witnesses in this case, believes that the first time he became aware of post-arthroscopic glenohumeral chondrolysis (“PAGCL”) was upon reading the Hansen article in October 2007. (Doc. 55 at 28).

18. Dr. Favorito can point to no scientific studies or articles published by March 2005 noting a possible association between the infusion of anesthetic into the shoulder joint and chondrolysis. (Doc. 55 at 100).

19. Dr. Favorito can point to no scientific studies or articles published by March 2005 concluding that the infusion of anesthetic into the shoulder joint causes chondrolysis. (Doc. 55 at 100).

20. Dr. Favorito agrees that as of March 2005, there were no publicly available peer-reviewed articles, abstracts, case reports, case series, books, or treatises in which someone concluded that the intra-articular continuous infusion of anesthetic caused chondrolysis. (Doc. 55 at 111).

21. Dr. Favorito admits that even today, no peer-reviewed published articles state that the infusion of anesthetic into the shoulder joint causes chondrolysis. (Doc. 55 at 14–25).

22. Dr. Favorito's August 25, 2008 report regarding Plaintiff corrects a prior misrepresentation by Plaintiff's counsel, and states: “1 wanted to make one clarification about a statement you made in the second paragraph on July 11, 2008. I neither stated nor implied at our meeting on July 1st that Breg promoted the use of the pain pump intra-articularly for better pain relief.” (Doc. 71, Exs. 6, 7; Doc. 55 at 18–19).

23. According to Plaintiff's expert, Dr. Samer Hasan, orthopedic surgeons performing a high volume of shoulder arthroscopies first became aware of a potential association between the use of a pump to deliver the continuous infusion of local anesthetics and the development of glenohumeral chondrolysis “sometime between October 2007 and [June 2010].” (Doc. 71, Ex. 9 at 229). Prior to October 2007, according to Dr. Hasan, there were no peer-reviewed articles noting a possible association between the infusion of anesthetic into the shoulder joint and chondrolysis. ( Id. at 230–231).

III. DISPUTED ISSUES OF FACT

1. The intra-articular use of pain pumps can cause chondrolysis. (Doc. 54 at 117–118); Doc. 52, Ex. 45, E. Fester and F. Noyes, Postoperative Chondrolysis of the Knee: 3 Case Reports and a Review of the Literature, AM. J. SPORTS MED. (Jun 17, 2009) (E-pub ahead of print); Doc. 52, Ex. 46, B. Busfield and D. Romero, Current Concepts: Pain Pump Use After Shoulder Arthroscopy as a Cause of Glenohumeral Chondrolysis, 25(6) J. ARTHROSCOPIC RELATED SURG. 647–652 (June 2009); Doc. 52, Ex. 44, M. Slaubaugh, et al., supra; Doc. 52, Ex. 53, Zink v. SMI Liquidating, Inc., 2:08–cv–95, Memorandum Opinion and Order, Doc. 148, 5 (E.D. KY 5/07/10) (noting that defense expert Dr. Damon Petty has admitted that it is “well described and accepted in the [orthopedic] community” that intra-articular pain pump use can cause chondrolysis).

2. Plaintiff Rachel Krumpelbeck developed chondrolysis as a result of her intraarticular use of a Breg pain pump. (Doc. 71, Ex. 8 at 27–28: “[I]n Miss Krumpelbeck's case ... each of the other causes were systematically excluded leaving no other explanation for the chondrolysis in Miss Krumpelbeck's shoulder but the intra-articular pain pump that was placed in her shoulder at the time of her index surgery on March 3, 2005 as being the cause.”).

3. The FDA has never approved any pain pump for use in the joint space. (Ex. A, FDA Information for Healthcare Professionals—Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine): “The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.”).

4. The FDA did not approve or clear any of the Breg Pain Care pain pumps, including the Pain Care 4200, for use in the joint space or for orthopedic surgery. (Doc. 52, Exs. 1, 2, 7, 9, 16).

5. The FDA refused to approve the Breg Pain Care pain pumps, including the Pain Care 42000, for use in the joint space or orthopedic use under the 510(k) process because no prior device had been...