I-Flow ON-Q PainBuster Lawsuit Filed Over Shoulder Chrondrolysis

An Alabama man and his parents are suing I-Flow over problems with it’s On-Q Painbuster, alleging that the pain pump destroyed the cartilage in his shoulder when he was a teen. 

The pain pump lawsuit was filed on May 14, by Joseph E. Sasser and his parents, Charles and Dana Sasser, in U.S. District Court for the District of Columbia.

According to the complaint (PDF), Sasser received an I-Flow On-Q Painbuster to deliver medication directly to his shoulder joint immediately following arthroscopic surgery in 2005, when he was 15. Five years later, Sasser was diagnosed with severe shoulder chondrolysis, involving a permanent loss of cartilage, which was allegedly caused by side effects of the On-Q PainBuster pump. This has left him with continuing joint pain, grinding sensations and a decreased range of motion.

The On-Q Painbuster is a continuous infusion device manufactured by I-Flow and distributed by DJO, which has been widely used “off-label” in recent years to deliver pain medication for 48-72 hours, directly into the shoulder joint space following arthroscopic surgery.

Studies have found that such intra-articular use of shoulder pain pumps can lead to the development of 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.

A number of similar shoulder pain pump chondrolysis lawsuits have been filed in state and federal courts throughout the United States against I-Flow and other manufacturers, including Stryker Corp., Breg, DePuy, Inc. and Smith & Nephew, Inc. All of the complaints involve similar allegations that the manufacturers ignored signs that the pain pumps may cause substantial damage to the shoulder joint, continuing to promote intra-articular, despite a failure to obtain FDA approval for such use.

“I-Flow made Mr. Sasser and other patients like him unknowing, unwilling and unconsenting test subjects of the safety of intra-articular use of its pumps,” the lawsuit claims. It goes on to state that I-Flow had information regarding the damage the pumps did to cartilage, but kept much of that information to itself, failing to adequately warn doctors or patients about the health risks.

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. A defense verdict was reached in another Painbuster trial in October 2010.