Alerts and Updates
Pain Pumps: The Next Medical Device Litigation Wave?
May 2, 2008
Some in the plaintiff's personal injury bar are focusing on an article that appeared in The American Journal of Sports Medicine in October 20071 as a harbinger of the next wave of defective medical device cases. The medical journal article discusses an association between shoulder "pain pumps" and a rare condition, Postarthroscopic Glenohumeral Chondrolysis (PAGCL). The condition, which is characterized by a loss of cartilage in the shoulder joint, can be catastrophic for patients in that PAGCL has no established effective treatment.
While many of the study's participants underwent additional surgery to eliminate their symptoms, the surgery was not successful in eliminating all of their symptoms. There is no cure for PAGCL. The pain pump devices, which are attached at the shoulder to deliver anesthetic medication through a catheter, are often used following arthroscopic shoulder surgery to assist patients in pain management. Arthroscopic surgery is a minimally invasive procedure designed to lessen the amount of trauma to the affected area as well as reduce pain and recovery times in contrast to conventional surgery.
The American Journal of Sports Medicine article identified 12 cases of PAGCL in a retrospective study of 177 shoulder arthroscopies performed in 152 patients over a 19-month period. In each of the 12 cases, a Stryker pain pump was employed postoperatively. While the authors offered their experience with the phenomenon, the cause of this devastating condition was not determined. A number of theories, including the type of injection material (bupivacaine with epinephrine used in the pumps), have been postulated. Other possibilities have been discussed, but none of the explanations was satisfactory to the authors based on the results of the series.
Although the symptoms manifested themselves within three to five months after the procedures, the authors theorize that the insult that caused the loss of articular cartilage occurred either at the time of the surgery or shortly thereafter. The patients' symptoms were characterized by pain, a loss of active range of motion, crepitus and stiffness. On x-ray, a loss of the glenohumeral joint space was noted. The median age of those affected in the study was approximately 30 years of age.
To date, a small number of lawsuits have been filed in the Federal District Courts in Oregon and Alabama against several manufacturers of the pumps including Stryker Corp., DonJoy, Inc. and I-Flow Inc. The suits have included claims for design defect and a failure to warn as well as negligence claims.
Various prominent plaintiff firms are highlighting these devices to potential clients on their websites. The interest in this litigation is fueled by the seriousness of the injury as well as the belief among some in the plaintiff's bar that they will not face a preemption challenge to these cases.
For Further Information
If you have questions about this Alert or would like more information, please contact Beatrice O'Donnell, any other member of the Products Liability and Toxic Torts Practice Group or the attorney in the firm with whom you are regularly in contact.
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