Breg Pain Pump Settlement Reached in Lawsuit Over Chondrolysis

A settlement agreement has been reached in a pain pump lawsuit that alleged two young Ohio women each had the cartilage in their knee destroyed as a result of chondrolysis from the use of a Breg pump and its painkilling drugs.

The Breg pain pump settlement was reached in a lawsuit filed by Colleen McClain and Brittany Hamilton, both 21 and from Lewis Center, Ohio. The pain pump used following the girls’ surgery was manufactured by Breg, Inc., and other companies named in the complaint allegedly manufactured the drugs used in the pumps.

Trial was scheduled to begin in the case on April 4, but the parties notified the court last week that a settlement was reached with the help of a federal mediator. Details of the agreement have not been released.

According to the complaint, the plaintiffs received a Breg pain pump for pain management following knee surgery, which allegedly destroyed the cartilage in their knees and may require both to undergo total knee replacement surgery. Hamilton’s surgery was in September 2005 and McClain’s surgery was in February 2006. Dr. Randy Wroble was the orthopaedic surgeon in both cases, but he was not a defendant in this product liability lawsuit.

Studies have found that the intra-articular use of the pain pumps to deliver pain medications directly to the joint space 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 joint increases following the arthroscopic surgery.

Similar lawsuits over pain pump problems have been filed by hundreds of people throughout the United States against Breg and the manufacturers of other pain pumps, such as Stryker Corp., I-Flow Corp., DJO Inc., DePuy, Inc. and Smith & Nephew, Inc. The complaints all allege that the manufacturers failed to adequately research their devices or warn about the risk of chondrolysis from pain pumps.

Most of the complaints involve claims for damage to the shoulder when the pain pumps were used following arthroscopic surgery.

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

UPDATE 3/24/2011: An earlier version of this story indicated that defendants named in the original complaint filed by Colleen McClain and Brittany Hamilton included Breg, Inc., Hospira Inc., Abbott Laboratories, Inc. and Astrazeneca Pharmaceuticals LP. According to a statement from Hospira Public Affairs, the court dismissed both Hospira and Abbott in July 2009 and the companies did not participate in any respect in the settlement of this case.