I-Flow has agreed to settle five lawsuits from plaintiffs who say the company’s pain pump device used during shoulder repair surgery caused them to develop a painful and debilitating condition known as chondrolysis. The announcement follows a ruling by a federal judge in Ohio who rejected efforts to have the cases dismissed. The lawsuits had been consolidated for a trial that was scheduled to begin late last month. All of the plaintiffs alleged that the pain pumps manufactured by I-Flow to infuse pain medication into the shoulder joint during and after arthroscopic surgery destroyed the shoulder cartilage, causing chondrolysis.
I-Flow had tried to prevent evidence from being included in the trial that would have been used to form the basis of punitive damage claims. That evidence allegedly included information that I-Flow’s chief executive officer was advised, prior to the plaintiffs’ injuries, to issue a warning that the pumps should not be used for shoulder surgery. Instead, I-Flow continued to instruct surgeons to use the pain pumps with local anesthetics for shoulder surgery, a use that was never approved by the Food and Drug Administration (FDA).
In November 2009, the FDA required manufacturers of pain pumps as well as the makers of local anesthetics used in the devices to add new warnings about the risk of chondrolysis. The warnings also alerted health care professionals not to use the pumps with local anesthetics.
There are at least 150 shoulder pain pump lawsuits pending against I-Flow and other manufacturers of pain pump devices from plaintiffs who allege that the devices caused them to develop chondrolysis of the shoulder. All lawsuits claim the manufacturers failed to warn patients and their doctors of the risk of chondrolysis.