Pain pumps are medical devices, approximately the size of a cell phone, that are used to manage post-operative pain. These devices are used following surgery to deliver, by way of a catheter, continuous doses of pain relief medication. The pump delivers anesthetic pain medication directly into the operative site for a period ranging from 12 hours to five days, depending on the device brand and recommendation of the physician. Prior to 2000, it was common for doctors to use pain pumps in muscle tissue following shoulder surgery. After 2000, they began inserting pain pump catheters into the shoulder joint space (synovial space).
Soon thereafter, reports in the medical literature emerged, describing cases of chondrolysis in patients after shoulder surgery. Glenohumeral chondrolysis is a painful and permanent condition that results from the disintegration of the cartilage covering the bones in the synovial joint. The loss of cartilage causes severe pain, both in movement and at rest, as well as stiffness, decrease in range of motion, and a significant loss of strength. Injured patients usually require additional surgeries, including complete shoulder joint replacement.
Recently, Doctors Brent Hanson and Charles Beck published a review of 12 of their own patients who developed chondrolysis following shoulder surgery between August 2003 and March 2005. All 12 patients had received pain pumps with infusions of bupivacaine and epinephrine directly into the synovial cavity. The authors noted that they had not experienced chondrolysis in any of their patients before this time frame. Describing chondrolysis as a “devastating complication” for which there is no effective treatment, the authors found that the incidence of this condition among their patients was “startlingly high.” Of those who received pain pump therapy in the synovial space with bupivacaine and epinephrine, 63% developed chondrolysis. The authors emphasized the importance of this information to the orthopedic community at large and concluded:
We have identified a concerning and strong association between post arthroscopic chondrolysis and intra-articular pain pump catheter use with bupivacaine and epinephrine… Until further investigation has been done, the authors recommend that the use of intra-articular pain pump catheters in combination with bupivacaine with or without epinephrine be avoided in all joints with an intact cartilage surface. Furthermore, the effective treatment of chondrolysis remains elusive. We believe that further investigation of the possible association of pain pump use with chondrolysis is warranted.
In 1998, prior to licensing its product to one pain pump manufacturer, Stryker Corporation, McKinley Medical, LLP asked the FDA for permission to let it market its pain pumps for infusion into the synovial cavity. McKinley told the FDA that using the pain pump in this manner posed no harm to the joint space. In response, the FDA asked McKinley for safety and efficacy studies to support this new marketing claim. Later, the FDA approved labeling indications for the pump to be used for continuous infusion of a local anesthetic “directly into the intraoperative site,” but not into the synovial cavity.
Thus, when Stryker obtained the rights to market McKinley’s pain pumps, it knew or should have known that there were no adequate studies to support the safety of pain pumps when used to administer bupivacaine directly, under continuous pressure, to the shoulder joint space. More importantly, Stryker knew or should have known that the FDA had rejected this new proposed use of McKinley’s pain pumps.
Stryker’s marketing strategy is especially relevant and important because the company was recently prosecuted for paying orthopedic surgeons hundreds of thousands – if not millions – of dollars for using its hip and knee replacement products exclusively. Stryker engaged in this illegal scheme from at least 2002 – 2006, during the same timeframe that surgeons began using pain pumps in the shoulder joint. Stryker has lots of answering to do relating to its marketing of the pain pumps as well as how little it spent on scientific studies to determine the safety of pain pumps and bupivacaine in humans.
Until surgeons were warned – and it appears that most have still not been warned – they had no way of knowing this new use of pain medicine was dangerous. Not only were surgeons denied knowledge of the dangers of using pain pumps in this manner, but they were strongly encouraged to use them by the device companies. When the manufacturers learned of the specific adverse outcomes of using their pain pumps in this new way they should have sounded the alarm immediately. Instead, they recklessly pushed this new use of their products to expand their market and make more profits. Because an alarm was never sounded, ‘Dear Doctor’ letters were never sent out, and no attention was called to the problem. Some surgeons unknowingly continue, to this very day, to use these pumps in this perilous way.
Our firm is currently investigating and litigating cases of this type throughout the country. We are working with firms in Oregon which have a case set for trial in September of this year. Ted Meadows is the contact attorney in these cases. If you need additional information, feel free to contact Ted or his Legal Assistant, Kathy Farmer at 800-898-2034. You can also contact Ted by email at firstname.lastname@example.org
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