Lawsuits Filed Over Shoulder Pain Pump InjuriesJan 23, 2009 | Parker Waichman LLP A variety of pain-pump makers are being sued over claims that the medical devices caused pain and permanent damage. The nine patients in Arizona are asking for $68 million in damages, reports BizJournal.
But these nine patients are only a small handful of the approximately 100 lawsuits across the country that allege similar, permanent problems with the devices, said BizJournal. The plaintiffs in the Arizona case allege that the device makers neglected to alert those in the medical community that implantation with these devices could lead to painful and permanent cartilage damage. BizJournal also said that the device makers did not advise physicians that the U.S. Food and Drug Administration (FDA) refused them clearance—on a number of occasions—to market the device for use in the shoulder joint.
The use of intra-articular pain pumps in shoulder surgeries has been associated with a condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL): Deterioration of cartilage in the shoulder following such procedures. Once damaged, cartilage cannot repair itself. An intra-articular pain pump catheter is placed into the shoulder joint and remains in the joint for several days to deliver pain medication to the shoulder.
PAGCL is one of the most common complications that can follow shoulder surgeries. In 2006, a paper was presented at a meeting of the American Academy of Orthopedic Surgeons showing evidence that the use of intra-articular pain pumps could be responsible for this extremely painful and life-altering condition. PAGCL symptoms include pain at the shoulder when it is in motion or at rest, increased shoulder stiffness, popping or grinding when the shoulder is in motion, decrease in range of motion, and a loss of strength in the joint. PAGCL is usually diagnosed with an x-ray showing the narrowing of the shoulder joint space. Treatment for this condition is further surgery; however, many patients never regain full use of their shoulder joint.
BizJournal explained that while the FDA approved the pump for use in shoulder tissue, it was never approved for direct joint injection. Worse, the FDA finally admitted it approved the wrong indication for use, not noticing the error for five months and only because another manufacturer was seeking approval for its version of the device. PR NewsWire also noted that, according to the lawsuit, none of the manufacturers conducted safety tests on the devices to determine efficacy and safety and that this information was also withheld from orthopedic surgeons.
Last year, the American Academy of Orthopaedic Surgeons (AAOS) issued a statement alerting surgeons of the risk associated with these devices when implanted directly into the joint, adding that articular cartilege can be affected by toxins from anesthetics used—such as bupivicane and lidocaine—when delivered in this manner. This month, Health Canada published a "Canadian Adverse Reaction Newsletter," urging surgeons to refrain from using post-operative pain pumps for continuous infusion of the joint space with local anesthetics.
The pain pump manufacturers being sued are:
- Breg Inc., Vista California
- Curlin Medical Inc., Huntington Beach, California
- DJ Orthopedics Inc., Vista, California
- I-Flow Inc., Lake Forest, California
- McKinley Medical LLC , Denver, Colorado
- Moog Inc., East Aurora, New York
- Sgarlato Labs, Campbell, California
- Sorenson Medical Products Inc., West Jordan, California
- Stryker Corp., Kalamazoo, Michigan