Why Didn’t Pain Pump Manufacturers Warn Consumers About PAGCL?

That’s the question many shoulder surgery patients would like to know – especially 35 year old Douglas Kilpatrick, whose shoulder pump lawsuit against BREG Inc. begins in a few months in Key West, Florida. Kilpatrick, and hundreds of others who have filed lawsuits, allege that manufacturers such as BREG have known about the relationship between pain pumps and a painful condition known as PAGCL, but have done little to warn consumers – leaving them with a condition that has no cure.

No cure for PAGCL

Postarthroscopic Glenohumeral Chondrolysis, or PAGCL, is debilitating condition which may become permanent and cause loss of mobility. It typically occurs within three to 12 months after shoulder surgery. Symptoms may include shoulder pain whether in motion or at rest; clicking, popping or grinding of the shoulder; shoulder stiffness or weakness and decreased range of motion. The worst part of PAGCL is that there is no known cure – so patients who contract it may have to live with it for the rest of their lives.

Pain pumps never approved for treatment

Although hundreds of people have been injured by pain pumps, most don’t realize that the U.S. Food & Drug Administration (FDA) never approved pain pumps to be pointed directly into a patient’s shoulder cavity – which is what causes PAGCL. Product liability lawyers familiar with the pain pump litigation say that a company called McKinley Medical requested FDA permission to promote the pump devices to be pointed directly into a patient’s intra-articular space, or the synovial cavity. Even though the FDA rejected its request, pain pump manufacturers such as Stryker, DJO Inc., I-Flow and BREG Inc., knew pain pumps were being used in this way (and some allege that they advocated that usage), but did nothing to warn consumers about the risks of contracting PAGCL.

First trial begins in July 2009

Although one pain pump manufacturer recently settled a pain pump case for an undisclosed amount, Douglas Kilpatrick’s case is the first trial of a pain pump lawsuit involving the development of shoulder chondrolysis after arthroscopic surgery. The 35-year-old Key West charter fishing company owner had to undergo a total replacement of his right shoulder in November 2006 and doctors say that he will likely require several more shoulder replacements in his lifetime. The trial begins in July 2009.