VERDICTS & CASE STUDIES

In the case of Kilpatrick v. Breg, Inc., the Eleventh Circuit affirmed in a published opinion the rulings of Judge K. Michael Moore of the United States District Court for the Southern District of Florida excluding the general and specific causation testimony of plaintiff expert Gary Poehling, M.D., and granting summary judgment for pain pump manufacturer Breg, Inc.

Kilpatrick stands alone as the first appellate decision to reject the causation theories of plaintiffs in pain pump litigation waged against infusion pump and anesthetic manufacturers by a self-described "consortium" of plaintiffs' lawyers across the country; several hundred cases are currently pending. By rejecting unscientific, unreliable causation theories, Kilpatrick deals a serious blow to the consortium's industry-wide attack grounded in speculative and inconclusive science suggesting an unconfirmed association between continuous infusion of local anesthetic by pain pump and the development of post-arthroscopic glenohumeral chondrolysis, a condition marked by the deterioration of cartilage in the shoulder joint following arthroscopic surgery. Bowman and Brooke Life Science litigation partners Kim M. Schmid and John D. Sear represented Breg in the appeal argued May 14 in Miami.

District Court Proceedings

Plaintiff Douglas Kilpatrick underwent arthroscopic surgery in October 2004 on his right shoulder to repair a tear of his labrum, the ring of tissue that surrounds the shoulder socket. To alleviate post-operative pain, Kilpatrick's surgeon prescribed a Breg pain pump and inserted the catheter of the device into the shoulder cavity to continuously infuse the joint with the local anesthetic bupivacaine for 48 hours. At the end of the 48-hour period, the catheter was removed. Two years later, Kilpatrick was diagnosed with glenohumeral chondrolysis, the complete deterioration of the cartilage in the glenohumeral (shoulder) joint.

Represented by the Florida firm of Searcy, Denney, Scarola, Barnhart & Shipley PA, Kilpatrick sued Breg in the United States District Court for the Southern District of Florida, asserting six counts against Breg, ranging from strict liability design defect, failure to warn, and violation of the Florida Deceptive and Unfair Trade Practices Act. To establish his claims, Kilpatrick needed to prove both general and specific causation-that the continuous infusion of anesthetic into the shoulder joint via delivery by the Breg pump could and did cause his chondrolysis. Kilpatrick retained and disclosed orthopaedic surgeon Gary Poehling, M.D., to offer causation testimony. As expected, Dr. Poehling opined that Kilpatrick's use of the Breg pump to deliver anesthetic into the shoulder joint could and did cause his chondrolysis.

There was no dispute that Dr. Poehling is a highly qualified, skilled surgeon, author, teacher, and physician, but the methodology he used to reach his causation conclusions failed to satisfy the requirements of Fed. R. Evid. 702 and the United States Supreme Court's trilogy of expert testimony admissibility decisions: Daubert v. Merrell Dow Pharms., Inc., Joiner v. Gen. Elec. Co., and Kumho Tire Co. v. Carmichael. Because Dr. Poehling reached his conclusions through scientifically and medically unreliable methodology, Breg moved to exclude his general and specific causation testimony. And, because Kilpatrick could not prove his claims without expert testimony, Breg moved for summary judgment. On June 26, 2009, Judge Moore granted both of Breg's motions and dismissed the case.

Appeal

Kilpatrick appealed Judge Moore's rulings, claiming that Judge Moore erred in the way he analyzed and determined the inadmissibility of Dr. Poehling's testimony. Kilpatrick argued that Judge Moore improperly focused on conclusions rather than methodology, improperly considered reliability when no new or novel methodology was involved, and improperly considered only the individual studies upon which Dr. Poehling relied and not the studies in combination. The Eleventh Circuit properly rejected Kilpatrick's arguments as inconsistent with Daubert, Joiner, and its own settled precedent. In doing so, the court established several significant points that will reinforce our defense of pain pump, medical device, and toxic tort litigation going forward.

First, and most importantly for the defense of pain pump claims, the Eleventh Circuit appropriately concluded that the seminal peer-reviewed article in the study of the cause of post-arthroscopic glenohumeral chondrolysis, Brent P. Hansen et al., Postarthroscopic Glenohumeral Chondrolysis, 35 Am. J. Sports Med. 1628-34 (July 2007), is nothing more than a non-statistical, non-epidemiological case series that identifies a possible association between pump use and the development of post-arthroscopic chondrolysis, recognizes the need for further study, and, on its face, does not reliably support or establish causation:

In sum, the Hansen study was merely a compilation of case reports without any statistical context. Such studies lack control and thus do not provide as much information as controlled epidemiological studies do . . . Causal attribution based on case studies must be regarded with caution.

Recently, plaintiffs in pain pump litigation have argued that the Hansen article is really an epidemiologic retrospective cohort study, not simply a case series report, even going so far as to commission letters to the editors of peer-reviewed journals on the topic. The Eleventh Circuit's sage analysis of that study should go far toward deflecting the attempt by the plaintiffs' consortium to recast the study into something it clearly is not.

Second, the Eleventh Circuit agreed with the District Court that Dr. Poehling could not reliably depend upon a rabbit study, a 2-patient case report, or an in vitro tissue study to support his causation conclusions. The court recognized that those studies contained significant limitations that made extrapolation from them to a conclusion of causation medically and scientifically unreliable. According to the court, "all of the articles merely stated potential associations and speculated that such pain pumps medically cause glenohumeral chondrolysis," but "none of the articles explained the mechanism by which bupivacaine damaged human cartilage."

Third, the Eleventh Circuit explained that an expert need not always "rely on articles that draw a direct, concrete, and absolute causal connection," but must do more than Dr. Poehling did in this case-rely upon literature that was itself speculative and self-limiting and denounced the type of sweeping conclusions offered by Dr. Poehling.

Fourth, the Eleventh Circuit agreed with Judge Moore that Dr. Poehling's failure to consider or explain the background risk for glenohumeral chondrolysis-the risk of occurrence of the condition independent of the use of pain pumps-further degraded the reliability of his testimony. Because even Dr. Poehling's own writings acknowledged the existence of idiopathic chondrolysis-chondrolysis of unknown origin-his failure to explain or account for background risk seriously undermined the reliability of his analysis and testimony.

Fifth, the Eleventh Circuit agreed with Judge Moore that Dr. Poehling failed reliably to analyze specific causation. Dr. Poehling purported to conduct a differential diagnosis to reach his conclusion that Kilpatrick's use of a pain pump caused his chondrolysis, but he did not reliably employ that methodology because he did not consider all potential causes-indeed, he could not consider all potential causes, because the cause of chondrolysis remains unknown even today. Dr. Poehling, the Eleventh Circuit explained, had to resort to the logical fallacy of post hoc ergo propter hoc-the use of the pump caused Kilpatrick's chondrolysis because it preceded Kilpatrick's chondrolysis. The Eleventh Circuit emphasized that the perceived temporal relationship between a suggested cause and the onset of a condition does not reliably support or establish causation.

Finally, the Eleventh Circuit rejected Kilpatrick's invitation to follow McClellan v. I-Flow Corp., ___ F. Supp. 2d ___, 2010 WL 1753261 (D. Or. Apr. 29, 2010), and Schott v. I-Flow Corp., ___ F. Supp. 2d ___, 2010 WL 1008478 (S.D. Ohio Mar. 16, 2010), two cases in which the courts denied Daubert motions to exclude causation testimony based upon largely the same body of scientific evidence. Those courts decided the cases under the law of circuits (Sixth and Ninth) that take a more expansive approach to the admissibility of this type of testimony.

Ultimately, the district and circuit courts in Kilpatrick did nothing more than comply with the Supreme Court's mandate to make certain that an expert employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. Dr. Poehling no doubt knows good medical and scientific methodology, but simply chose not to employ it when he became a litigation expert for Kilpatrick. The Eleventh Circuit, therefore, quite properly affirmed Judge Moore's exclusion of Dr. Poehling's testimony and entry of summary judgment for Breg.