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PORTLAND, Ore. -- An Oregon federal jury on Oct. 15 returned three defense verdicts in a trial against the manufacturer of a drug infusion pump and a distributor (Christina McClellan v. I-Flow Corporation, et al,, No. 07-1309, Juan Huerta v. I-Flow Inc., et al., No. 07-1310-AA, Danny Arvidson v. DJO, LLC, et al., No. 08-478, D. Ore.).
In separate verdicts, the jury in the U.S. District Court for the District of Oregon found that plaintiffs Christina McClellan, Danny Arvidson and Juan A. Huerta did not prove by a preponderance of evidence that the PainBuster continuous infusion drug pump made by I-Flow Corp. and distributed by DJO LLC was defective due to inadequate warnings or that the defendants negligently failed to warn them of the defect.
The jury did not have to decide the remaining questions about percentage of liability and economic and noneconomic damages.
McClellan, Arvidson and Huerta each underwent arthroscopic shoulder surgery after which their surgeons used a PainBuster pump to continuously deliver local anesthetic drugs through a catheter and into the operative site for pain relief. Afterward, the plaintiffs said they experienced damage to the articular cartilage of their shoulders - a permanent condition known as glenohumeral chondrolysis - as a result of the local anesthetic.
The plaintiffs alleged that the defendants marketed the drug pumps for post-operative use in shoulder surgery even though the devices were not approved for that use and even though the defendants knew that use could cause permanent injury. They noted that the Food and Drug Administration had rejected I-Flow's request to approve the pumps for use in shoulder surgery.
I-Flow and DJO argued that the FDA cleared the PainBuster for use in orthopedic surgery, that they did not know at the time of the surgery that the use could cause injury and that claims against them are barred by the learned intermediary doctrine. They argued that the surgeon was the sole and exclusive cause of the plaintiffs' injuries.
Chief Judge Ann L. Aiken denied defense motions for a mistrial and judgment as a matter of law.
The trial began Sept. 20 and lasted 17 days. The jury began deliberating Oct. 15 and returned its verdict later in the day.
Another distributor, Pacific Medical Inc., was voluntarily dismissed as a defendant after the plaintiffs rested their case.
[Editor's Note: Full coverage will be in the Oct. 21 issue of Mealey's Emerging Drugs & Devices. In the meantime, the verdict form and jury instructions are available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Verdict form. Document #28-101021-018V. Jury instructions. Document #28-101021-017J. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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Mealeysonline.com - Document #28-101021-018V
Mealeysonline.com - Document #28-101021-017J
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