Painbuster Shoulder Pump Lawsuit Results in Defense Verdict

Three lawsuits filed over shoulder chondrolysis allegedly caused by the Painbuster pain pump have resulted in defense verdicts, after a federal jury in Oregon rejected arguments that I-Flow Corp. and DJO should be held liable for the shoulder damage experienced by three plaintiffs who received the pain management device after arthroscopic shoulder surgery.

The Painbuster shoulder pump lawsuits were brought by Danny E. Arvidson, Juan A, Huerta, and Christina McClellan; all of whom alleged that I-Flow and DJO negligently designed the pain pump and failed to adequately warn about the risk of problems when the Painbuster was used to deliver pain medication directly into the shoulder joint, which has been associated with the destruction of shoulder cartilage.

On October 15, a federal jury in the U.S. District Court for the District of Oregon returned three verdicts in favor of the defendants, finding that at the time each of the plaintiffs received the Painbuster, the warnings were adequate,

The Painbuster is a continuous infusion device manufactured by I-Flow and distributed by DJO. The plaintiffs alleged that the companies marketed the device for intra-articular use following shoulder surgery, even though the FDA had not approved it for that purpose.

Studies have found that the intra-articular use of shoulder pain pumps to deliver medication directly into the joint space can lead to the development of shoulder chondrolysis, a regenerative disease that causes loss of cartilage in the joint. Symptoms of the condition include a decreased range of motion, pain, as well as popping and grinding of the joint, which tend to develop during the months after use of the pain pump as use of the shoulder increases following the arthroscopic surgery.

In addition to the Painbuster, other pain pumps from different manufacturers, including Stryker Corp., Breg, DePuy, Inc. and Smith & Nephew, Inc., have also been linked to cartilage damage after arthroscopic shoulder surgery.

In November 2009, the FDA required manufacturers of the pumps and the local anesthetics used with the devices to add new warnings about the risk of chondrolysis from should pain pumps. The warnings were designed to alert healthcare professionals that the use of pain pumps following shoulder surgery to infuse medication directly into the joint increases the risk of chondrolysis, particularly involving the shoulder.

In January 2010, an Oregon jury awarded $4.75 million to a plaintiff who filed an I-Flow shoulder pain pump lawsuit over the On-Q Painbuster. According to prior reports, I-Flow shoulder pain pump settlements have been reached in a number of other cases.