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11th Circuit Affirms Expert Exclusion In Shoulder Pain Pump Case

ATLANTA - (Mealey's) A panel of the 11th Circuit U.S. Court of Appeals on Aug. 12 affirmed the exclusion of a plaintiff expert in a case against the manufacturer of a drug infusion pump (Douglas C. Kilpatrick v. Breg, Inc., No. 09-13813, 11th Cir.).

Douglas C. Kilpatrick underwent shoulder surgery in which a pump made by Breg Inc. was used to inject local anesthetic into his shoulder for 48 hours.  Two years later, Kilpatrick was diagnosed with glenohumeral chondrolysis, a permanent breakdown of cartilage that required a total shoulder replacement.

In 2009, the U.S. District Court for the Southern District of Florida in 2009 granted Breg's motion to exclude the sole causation expert, Dr. Gary Poehling, and granted summary judgment.

The 11th Circuit panel said the District Court judge did not abuse his discretion.  "The law of this Circuit is clear that the district courts are given broad discretion with wide latitude in conducting a Daubert [Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993)] analysis and concluding that methodologies based on speculative literature and temporal proximity analysis such as the type relied upon by Dr. Poehling are not sufficient to pass Daubert review," the panel wrote.

The panel said that the court did not err by refusing to admit Poehling on his qualifications alone and by conducting a review of his scientific methodology.  It said the trial court considered medical literature on which Poehling relied, both in whole and in part, and found that it could not support Poehling's conclusions.

Poehling was unable to establish a direct causal link between the use of shoulder pain pumps and chondrolysis, the panel said.  In addition, the panel said the District Court correctly noted that none of the medical articles cited by Poehling, or Poehling's opinion, took into account the background risk of chondrolysis.

Poehling's differential diagnosis of the cause of Kilpatrick's injury did not include a comprehensive list of potential causes, including idiopathic causes, the panel said.

[Editor's Note:  Full coverage will be in the Aug. 19 issue of Mealey's Emerging Drugs & Devices. In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-100819-021Z.  For all of your legal news needs, please visit]

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For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at