Pain Pumps and a Lack of "Reliable" Scientific Evidence

Pain pump manufacturers did it wrong. If we are practical, the conclusion is inescapable… pain pump manufacturers have been sued in hundreds of cases because they deserved it. They gambled…they were caught… and they should pay patients who have suffered devastating injuries. Opinion? I suppose, but let’s look at the facts and you decide.

The manufacturers would tell you they are the victims of trial lawyers and that no scientific data exists that will reliably relate use of their pain pumps to a condition called chondrolysis. In fact, pain pump manufacturers across the country have been telling judges, opposing counsel and anyone else they can that any evidence their pumps caused chondrolysis is simple coincidence, happenstance, accident. In other words, do not look at the little man behind the curtain; listen only to the “great and mighty Oz”.

Is this true? Has the mighty Oz spoken? No and yes. The mighty Oz is certainly speaking, but the truth is certainly not found in the Land of Oz.

Pain pumps work, at least as sold by the manufacturers, by the use of a catheter attached to a pump at one end and inserted into the joint space at the other end. Pain medications, typically marcaine or bupivacaine, are inserted in the pump and injected into the joint space over a period of 48 to 72 hours. Based on this design and the use promoted by pain pump manufacturers, what is the one thing, amongst all others, you would want to know? Go ahead, you know, say it — right, you would want to know if it is safe to inject these drugs into the joint for the length of time suggested.

Did pain pump manufacturers conduct studies to determine whether using their pain pumps in the ways they recommended would cause injury to patients? They did not. I know, I was shocked, too. That’s right, they sold the product, recommended to physicians the way to use the product, but they never studied what complications to which patients might be subjected.

In 1985, a study was conducted, which gauged the effect of bupivacaine on articular cartilage. As a result of that study, the investigators determined that increasing concentrations of bupivacaine caused damage to cartilage. They recommended further study. Did pain pump manufacturers know about this study in 2000? Of course they did.

A study was published in June of 2009, Postoperative Chondrolysis of the Knee; 3 Case Reports and a Review of the Literature, by Eric Fester et al. In that study, the authors review all the literature relating chondrolysis to pain pump use and their own findings in (3) patients.

In their study, through their own experience, training, and a review of the available literature, they concluded that chondrolysis suffered by their patients was caused by the use of pain pumps with bupivacaine. The conclusions drawn by these researchers are interesting:

“In summary, there is currently a significant amount of in vitro and in vivo evidence that the use of pain pumps with bupivacaine and epinephrine may lead to significant chondrolysis when placed into a joint. We agree with Bruce Reidel that one contemplating the use of intra-articular medications must be confident with their morbidity. Until this association between intra-articular pain pumps and chondrolysis is better understood and characterized, we do not recommend the use of intra-articular pain pumps. Also, further research is necessary on the potential deleterious effects of single bupivacaine joint injections, as well as other local anesthetics placed intra-articularly.”

So, let’s say it is 2000 and you want to market a device that that you are going to recommend be inserted directly into the joint. You know a few things. For example, you know there is cartilage in the joint. You know that cartilage has things called Chondrocytes. Let’s “give the devil his due” and say that you only know about a 1985 study in which the investigators said injecting bupivacaine directly into an area where cartilage is located can cause damage to the Chondrocytes and lead to “chondrotoxicity”. In other words, a 1985 study tells you that your drug of choice; used in your medical device; used in the way you are going to tell physicians to use it; will very likely will cause cartilage death.

So, do you build the device, market the device and keep your fingers crossed that, since only one study exists, no one will be able to put two and two together? Do you place patients, mostly young, in a position in which they could be at risk for suffering injuries requiring complete joint replacement? Or, do you actually conduct testing and studies to determine if your “new” idea for long term exposure of cartilage to bupivacaine will be dangerous? Do you conduct trials required under FDA regulations for a new application of a medical device or do you try and get your device “passed” by the FDA by not mentioning the application for the device that you intend to market?

Do you gamble? Do you risk young patient’s joints?

See, now how hard was that really? So, should pain pump manufacturers pay for their gamble? Go ahead, say it… you know…of course they should.

And if we have not set forth sufficient common sense above: