Pain Pump Manufacturers Trials and Tribulations for 2010 and 2011

Brenda Fulmer

Attorney
(866) 735-1102 Ext 703

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Jurors from around the country will be let in on a dirty little secret in 2010. In state and federal courtrooms across the country next year, jurors will hear testimony about how the seemingly-innocuous use of a pain pump following minor joint surgery has turned the worlds of many young, athletic patients upside down. A number of plaintiffs have filed individual lawsuits against pain pump (I-Flow, Don Joy, Stryker, Moog, Breg, and others) and anesthetic drug manufacturers (Astra-Zeneca, Abbott, and others) after suffering catastrophic cartilage damage as a result of intra-articular injection of pain medications. The post-operative pain pumps were commonly, but not exclusively, used in shoulder surgeries from 1999 through 2007. In 2006 and 2007, a number of physicians and scientists (sadly, not the manufacturers) started raising concerns about post-operative destruction of cartilage. These scientists noted a direct association between the use of the pumps and anesthetic drugs such as Marcaine, bupivacaine, and ropivacaine, with symptoms emerging about six to eight months post-operatively in their patients. Pain pump-induced cartilage damage is now known as chondrolysis and is referred to as Post-Arthroscopic Glenohumeral Chondrolysis (or PAGCL) when it involves the shoulder joint. This condition usually results in multiple, otherwise unnecessary, surgeries and, ultimately, joint replacement.

Evidence gathered in the pain pump cases demonstrates that the manufacturers aggressively promoted use of the post-operative pain pumps for shoulder as well as other joint surgeries, such as knee, ankle, and foot surgeries, and even went so far as to provide instructions to physicians as to how to word their operative reports and code their billing statements in order to obtain the highest level of reimbursement from insurers. The primary selling point for intra-articular use of the pain pumps was that it would avoid a patient taking narcotic pain medications for a few days after surgery. Given the devastating injuries now known to be caused by use of the pain pumps, this trade-off seems inconceivable.

The evidence shows that pain pump manufacturers conducted no meaningful investigation or evaluation of the long-term safety risks to patients who used these devices for joint surgeries. Even basic research at the time, however, would have shown that bathing a joint with anesthetic drugs that were already known to be toxic to chondrocytes would likely result in the destruction of healthy cartilage. Now, the manufacturers are trying to use their failure to conduct FDA-required testing to argue that they could not have foreseen the devastating injuries inflicted on patients, especially in light of the concerted efforts that were made to bury their heads in the sand when evidence of chondrolysis were brought to their attention. The manufacturers are also trying to avoid liability by arguing that the current state of the scientific evidence is insufficient to demonstrate the relationship between chondrolysis and the pain pumps, yet this alleged lack of science appears to be more of an issue within the courtroom as opposed to outside the courtroom, where the medical community, scientists, the medical literature, and even medical textbooks now have concluded that intra-articular injection of anesthetics by pain pumps into joints causes chondrolysis or cartilage destruction.

Trials against pain pump and anesthetic drug manufacturers have been scheduled or will shortly be scheduled in the following venues:

A number of additional lawsuits have been filed in state and federal courts across the nation and should be scheduled for trials shortly. The Defendants rejected early efforts to coordinate the litigation at the national level, which has permitted the Plaintiffs to obtain a number of trial settings in numerous jurisdictions. No pain pump case has yet gone to verdict, with confidential settlements being reached in the first cases set for trial.