On November 30, several attorneys representing a number of plaintiffs with crippling chondrolysis renewed their application to consolidate more than 150 federal lawsuits. They are asking that their Multidistrict Litigation (MDL) petition be consolidated in the US District Court for the District of Minnesota.
Last summer the US Judicial Panel on Multidistrict Litigation denied a request to create a MDL for all federal shoulder pain pump cases, explaining that the indeterminate number of pain pumps and companies made centralization an inappropriate option. Instead, the panel advised attorneys to pursue other avenues to avoid duplicative discovery and inconsistent pretrial rulings in cases throughout the country.
Now attorneys say MDL alternatives are not an option because shoulder pain pump manufacturers are not cooperating. Hundreds more cases have been filed nationwide, thereby increasing the need for coordinated pretrial litigation.
This renewed request came just weeks after an FDA report reiterated that it had never approved "any infusion devices with an indication for use in intra-articular infusion of local anesthetics" (insertion of catheters into the joint space). The agency also said that new safety warnings for pain pumps and the anesthetics that go in them will be required.
Lawsuits allege that shoulder pain pump makers did not perform any studies to determine if pumping large doses of anesthetic into a shoulder joint was safe. Rather, the manufacturers encouraged surgeons to insert catheters directly into the shoulder joint space, despite evidence at a meeting of the American Academy of Orthopedic Surgeons back in 2006. At that time, shoulder pain pumps were linked to Postarthroscopic Glenohumeral Chondrolysis (PAGCL), an extremely painful, debilitating condition resulting in a destruction of the patient's shoulder cartilage. And again in 2007, an article in the American Journal of Sports Medicine cited the 2006 evidence.
The FDA approved pain pumps only for insertion of medications intravenously, intra-arterially, subcutaneously, and epidurally into the muscle, skin, or nerve tissue. But at the suggestion of pain pump manufacturers, orthopedic surgeons began inserting catheters into the joint space in 2000.
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Stryker has already been prosecuted for paying millions of dollars to orthopedic specialists to use its products exclusively. I-Flow sent out a bulletin to physicians in 2007, listing other causes than pain pumps for chondrolysis, but it neglected to mention that the FDA had rejected the marketing of pain pumps that injected these drugs directly into the synovial cavity. DJO, the maker of the DonJoy® Pain Control Device, has assets of nearly $200 million and is continuing to earn healthy profits for its shoulder pain pump.
To this day, some surgeons are still using these pain pumps despite FDA warnings, because the manufacturers have not issued appropriate warnings to the medical community.