Why These Pain Pumps Failed

What are Shoulder Pain Pumps?

Shoulder pain pumps are small, portable medical devices used to manage post-operative pain. They are used after surgery by surgeons to deliver, through a catheter, continuous doses of anesthetic drugs directly into the incision site. These shoulder pain pumps, manufactured and distributed by I-Flow, Stryker, Breg, Sgarlatto, Curlin, Moog and McKinley Medical, among others, are typically useful devices to control pain.

What is the Injury in Most Shoulder Pain Pump Lawsuits?

Continuous injection of these anesthetics directly into the shoulder can cause serious and permanent damage to the shoulder joint cartilage. The anesthetic kills the shoulder cartilage cells (chondrocytes) which progressively erodes the cartilage. Patients injured by pain pumps develop a condition called "chondrolysis," which is the complete or nearly complete loss of cartilage in the shoulder joint. It is irreversible, disabling, and extremely painful. These patients typically require additional surgeries, including complete shoulder joint replacement. Orthopedic surgeons understand how devastating this process is-the medical literature reports that "the prognosis for these shoulders is grim" (Petty, D.H. et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy, Am. J. Sports Med. 32:(2)509 (2004)). The Petty study looked at 152 arthroscopic shoulder surgery patients. All but 12 of the patients who used shoulder pain pumps developed chondrolysis.

What is Glenohumeral Chondrolysis After Shoulder Arthroscopy?

Glenohumeral Chondrolysis After Shoulder Arthroscopy (Post-Arthroscopic Glenohumeral Chondrolysis, or "PAGCL") occurs when the cartilage in the shoulder joint deteriorates. Cartilage is a dense tissue that cushions the bones of a joint. If cartilage is lacking, the bones will grind together. The result is extreme pain, and sometimes chronic arthritis. Accordingly, PAGCL is extremely painful and can cause life-long disability.

PAGCL is not immediately identifiable. Cruelly, patients enjoy preliminary success with therapy, but the progress is illusory. Soon, the patients have compromised cartilage leading to shoulder joint space narrowing that causes bone-on-bone friction. This leads to decreased motility, joint popping and pain that can sometimes be debilitating.

What Did the Shoulder Pain Pump Manufacturers Do to Test These Pain Pumps for Safety?

To add insult to injury, the manufacturers of these pumps did not perform a single study to determine whether the pumps were safe to use near cartilage. They did not adequately search the medical literature to find studies that demonstrated the dangers anesthetic drugs posed to cartilage. Furthermore, some manufacturers applied to the FDA numerous times for approval to place the pump's catheter in the intra-articular joint space-right next to the cartilage. The FDA denied those applications not once, but three times, for safety reasons. Regardless, the manufacturers continued to promote their shoulder pain pumps. Why? Shoulder pain pumps are incredibly profitable for medical device companies, even factoring in the cost of hiring lawyers to defend the shoulder pain pump lawsuits that have ensued. This desire for profit distracted shoulder pain pump manufacturers from focusing on the obvious: these devices can cause severe injury when the pumps are used to anesthetize areas near joint cartilage, like the shoulder.