Over the past several years, lawyers in our Mass Torts Section have been working on cases involving infusion pain pumps. The cases involve patients who had shoulder surgery and were given an infusion pain pump to treat post-surgical pain. These types of pumps had been used for years in general surgery, but never in orthopedic surgery. A pump would be filled with a two to three day supply of pain medication which delivers the pain medication to the surgical site by catheter. The problem was created when these catheters were placed in the intra-articular space of the shoulder joint, rather than in the tissue. The pain medication was toxic to the articular cartilage and literally “killed it.” Many patients were left with bone-on-bone conditions in their shoulder which are very painful.
A former FDA official has testified in a deposition that these pumps were never approved for orthopedic surgery, much less for the catheter to be placed in a joint space where no tests had ever been conducted by the pump manufacturers. These companies simply decided to sell to this large market without any real proof of safety for that particular use.
Lawyers in our firm learned in a deposition and during phone calls with Defense counsel that the United States Department of Justice is conducting an ongoing investigation of some of the pump manufacturers. Although we do not know for sure the purpose of the investigation, we believe the investigation may involve off-label marketing of the devices for unapproved uses. If so, that is a crime under federal law. Many patients across the country fell victim to the conduct of these companies and will suffer a great deal of pain during their lifetimes with limited use of their shoulder. If you want more information on this subject, contact Frank Woodson, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.