I-Flow Pain Pump in the Spotlight Following Shoulder Injury Lawsuit VerdictFeb 5, 2010 | Parker Waichman LLP
I-Flow is facing more scrutiny following a jury's decision that one of its pain pumps caused an Oregon man to suffer a severe shoulder injury. Matthew Beale, a Portland father of four, was awarded $5.5 million last month for his injury.
The Beale shoulder pump trial was being closely followed by lawyers involved in similar suits, as it was viewed as a good gauge on how juries will rule in other pain pump injury cases. Many prominent surgeons testified at Beale’s trial that it was now generally accepted in the orthopedic community that pain pumps were the cause of the chondrolysis cases seen after surgeries like Beale’s.
Commonly called intra-articular pain pumps, device like the one made by I-Flow are used after surgeries to deliver local anesthetics to a specific area through a plastic tube. Such pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. However, they were never actually approved by the Food & Drug Administration (FDA) for use in joint surgery.
Lawsuits have been filed around the country by people who claim they developed Post Arthroscopy Glenohumeral Chondrolysis (PAGCL), following the use pain pumps, such as the one manufactured by I-Flow, after shoulder surgery. PAGCL is a relatively rare condition in which joint cartilage in the shoulder dies. PAGCL can cause a lifetime of pain and disability. The condition has ended athletic careers, and in the most severe cases, victims have had to undergo joint replacement surgery.
In 2007, the American Journal of Sports Medicine showed a direct link between PAGCL and the use of pain pumps during shoulder surgery. Other studies have produced similar findings. In November 2009, the FDA issued a warning about the association between chondrolysis and pain pumps. At the time, the agency said it had reviewed 35 reports of the condition in patients given continuous intra-articular infusions of local anesthetics with pain pump devices. Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries, the FDA said. At the time the FDA issued the warning, it ordered manufacturers of local anesthetics and pumps to change labels to discourage doctors from such uses.
I-Flow, one of the largest manufacturers of pain pumps, submitted requests to receive FDA approval for the use of one of its pain pump for shoulder surgeries three times, but those were rejected. Despite the FDA’s stance, such devices were increasingly used off-label in joint surgeries.