In the last ten to fifteen years, manufacturers of medical devices known as "pain pumps" have been frequently used after orthopedic surgery, most commonly during shoulder operations. The pumps are installed using a catheter and then left in place for two to three days for postoperative pain control.
The problem started when doctors began placing pain pump directly into the joint space, at the encouragement of the device manufacturers. A handful of orthopedic surgeons began noticing a sharp increase in the occurrence of what used to be a very rare condition known as post-arthroscopic glenohumeral chondrolysis (PAGCL). PAGCL is the degeneration of cartilage in joint space that follows a progression from inflammation and pain to degeneration of the surface bone, and in some cases, the eventual need for total joint replacement. Patients experience joint stiffness, weakness, pain, clicking, popping, grinding and decreased range of motion. There is almost nothing you can do to relieve the pain of PAGCL, short of total joint replacement. Now there is an alarming increase in the number of cases, particularly in very young, active adults such as athletes.
The Food & Drug Administration has approved the use of pain pumps, but only when injections occur in the soft tissue surrounding joints. The manufacturers of pain pumps have applied multiple times to the FDA, attempting to gain approval for use of pain pumps directly into the joint space. Each time the FDA has denied those requests, with a specific direction that they should not be used directly in the joints themselves.
In 2005, the orthopedic surgeons who'd discovered the link between pain pumps and the destruction of cartilage sent the information to all pain pump manufacturers. Some of that research indicated that 60% of people who had pain pumps placed in the joint space developed PAGCL. Even with these alarming statistics, no products warnings were implemented by the manufacturers at that point. Two years later, the studies that were sent to the manufacturers in 2005 were published in orthopedic medicine journals. The manufacturers still continued encouraging doctors to use pain pumps in the joint space when they should've been warning them of the dangers instead.
In 2008, the American Academy of Orthopedic Surgeons issued a statement alerting
surgeons of the serious risks associated with pain pump devices used in the joint space. Not long after those warnings were issued, the first of many pain pump lawsuits were filed against the manufacturers for fraud, breach of warranty, products liability, failure to warn and marketing the pain pumps for a use specifically denied approval by the FDA. Trials in pain pump lawsuits have won multi-million dollar verdicts in Ohio and Oregon. There are now over 150 suits on file in 20 different states.
If you or someone you know has experienced the destructive effects of a pain pump, consult an attorney with the knowledge and experience to help you with your claim against the manufacturers. The attorneys at Tatlow, Gump, Faiella & Wheelan, LLC offer free consultations. Contact us at 800-264-3455 or visit our website for more information.