Surgical pain pumps became popular among orthopedic surgeons in the 1990’s as an alternative to longer hospital stays and prescription narcotics. The pain pumps, a post surgical medical device that delivers local anesthetics to the area through a plastic tube, were used to alleviate pain after joint surgery, particularly shoulder surgery. However, some of the patients who received pain pumps have developed an ailment known as chondrolysis where the cartilage in the joint dies, leaving joint bones to grind on each other.
According to an article in the NY Times, some studies have linked chondrolysis to the insertion of these pain pumps. In spite of their popularity, the pain pumps were never authorized by the FDA for such use. Those who are critical of the pain pumps note that by exposing cartilage to local anesthetics for up to 72 hours, the medications used to soothe pain turn toxic and lead to the deterioration of the cartilage. Last November, the FDA issued a warning about the pain pumps so as to discourage doctors from using them in joints.
The NY Times article stated, “In late 2006, after a handful of studies indicated that the pain pumps might be causing chondrolysis, the I-Flow Corporation, the largest pump manufacturer, changed its directions in package inserts to advise doctors to avoid placing the pump catheters in joints. In 2007, I-Flow posted a bulletin on its Web site notifying physicians of the risk.
The first lawsuits against pain pump companies were filed about two years ago. It is difficult to know the exact number of suits, but I-Flow reported in November that it was a defendant in 191 chondrolysis cases involving 412 patients. Of those, the company said, 80 suits were dismissed. Kay Jackson, a spokeswoman for the Kimberly-Clark Corporation, which purchased I-Flow last year, declined to comment, citing the pending litigation.
AstraZeneca, which until 2006 sold a local anesthetic that was used in the pumps, is a defendant in 68 active cases, said Tony Jewell, a company spokesman. AstraZeneca did not promote the drug, bupivacaine, for use in pain pumps inserted in the joint, nor did it seek approval for such a use, he said.