Products Liability
What Is a Shoulder Pain Pump?
A shoulder pain pump is a delivery vessel that allows doctors to deliver medication directly to the site of the shoulder surgery. Pain pumps are Class II medical devices regulated by the FDA. Shoulder pain pumps were approved in 1998 when a pain pump manufacturer submitted a premarket notification to the FDA to sell a pain pump designed for post-operative shoulder pain. These pain pumps are disposable devices implanted after shoulder surgery to deliver anesthetic pain medication through a catheter to the surgical site. Typically, shoulder pain pumps are removed within five days of surgery after the need for pain relief subsides.
What Are Shoulder Pain Pump Claims About?
Plaintiffs claim is that shoulder pain pumps cause a narrowing of the joint space and/or a condition called “glenohumeral chondrolysis,” a loss – sometimes a total loss – of cartilage in the shoulder joint. This is a painful and often disabling condition. They further allege that the manufacturers of pain pumps knew that pain pumps were unreasonably dangerous and defective and that the manufacturer should have warned patients and, more importantly legally, warned patients’ doctors that there was a serious risk that continuous injection of these anesthetics by shoulder pain pumps can cause serious and permanent damage to the shoulder joint cartilage.
The claimsalso argue that the manufacturers encouraged use of pain pumps in a manner what was not approved by the FDA. The FDA approved the device for use in tissue around the shoulder as opposed to inside the shoulder joint itself.Some manufacturers of the shoulder pain pumps allegedly intentionally failed to notify doctors that such intra-articular use of pan pumps was rejected by the FDA. Accordingly, Plaintiffs allege strict liability, negligence, breach of warranty, fraud, negligent misrepresentation, and unfair trade practices.
What Is the Problem Caused by Shoulder Pain Pumps?
Some experts contend that anesthetic from pain pumps destroys the shoulder’s cartilage cells (chondrocytes) which causes deterioration of the shoulder cartilage. Patients injured by pain pumps develop a condition called “chondrolysis,” which is the complete or nearly complete loss of cartilage in the shoulder joint. It is irreversible, disabling, and extremely painful. These patients typically require additional surgeries, including complete shoulder joint replacement. Orthopedic surgeons agree that “the prognosis for these shoulders is grim” (Petty, D.H. et al., Glenohumeral Chondrolysis After Shoulder Arthroscopy, Am. J. Sports Med. 32:(2)509 (2004)).