A federal court has granted summary judgment to the defendant. Kilpatrick v. Breg, Inc., No. 4:08-cv-10052 (S.D. Fla. 6/26/09), in what appears to be the first substantive decision to come out of the multiple suits alleging that a pain pump medical device damages patients.
Judge Michael Moore ruled in favor of medical device manufacturer Breg, finding that the plaintiff, who alleged damage to his shoulder cartilage, did not provide enough reliable expert evidence to link the condition to the defendant’s shoulder pain pump.
Plaintiff Kilpatrick underwent arthroscopic shoulder surgery in 2004 after an orthopedic specialist discovered a tear in his shoulder socket. To help with post-operative pain, the surgeon inserted a pain pump into plaintiff’s shoulder, which would allow the doctor to administer an anesthetic via a catheter in the patient’s arm.
The surgeon injected bupivacaine into the pump’s attached catheter and further filled it with 100 ccs of anesthetic, which was to be delivered into Kilpatrick’s shoulder over the next 48 hours.
Plaintiff alleges that he began experiencing severe pain in his shoulder in 2006. An orthopedic surgeon diagnosed the pain as glenohumeral chondrolysis, a deterioration of the cartilage, and Kilpatrick underwent shoulder replacement surgery.
He then brought suit, alleging negligence, strict products liability, and violations of Florida’s Deceptive and Unfair Trade Practices Act. Kilpatrick claimed that using the Breg pain pump to administer local anesthetic directly into his shoulder joint caused him to develop post-arthroscopic glenohumeral chondrolysis.
Breg argued, and plaintiff apparently did not contest, that the case should be treated like a toxic tort case for purposes of the Daubert inquiry, in that plaintiff had to offer proof of both general and specific causation.
The summary judgment motion focused first on general causation, and the ability of plaintiff’s expert to opine adequately under Daubert that the device can cause this type of injury. The causes of chondrolysis remain disputed, and experts in the medical community have pointed to autoimmune deficiencies, certain kinds of sutures, thermal energy procedures and contrast dyes made from gentian violets as possible risk factors. Plaintiff’s expert admitted it was a still developing science.
Plaintiff’s expert relied on several published studies to attempt to show causation, which were not directly on point, and the Court found that his extrapolations from the studies were not warranted either.
None of the articles were based on controlled, randomized epidemiological studies of human beings, which are the best evidence. “Significantly, none of the articles explains the mechanism by which bupivacaine damages cartilage, each has important limitations that Poehling does not take into account, and none of them offers an ultimate conclusion as to the general causation of glenohumeral chondrolysis,” the court noted.
At most they suggest a possible association. Association is not causation. As for the animal studies, the expert did not explain the possible differences in dose-response relationship between humans and rabbits, an important factor to consider in evaluating whether an alleged exposure caused an adverse effect.
Poehling’s concession that the current state of medical literature is still unsettled about the cause of the plaintiff’s condition seriously undermines the reliability of his methodology, the court concluded. His methodology had no known rate of error, and thus all he had was a hypothesis that “may be exactly right,” but that currently is “merely plausible, not proven.”
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.