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.”

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A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints.

The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries.  The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain relief for shoulder, knee and other joint surgery patients.

As with drugs and other medical devices, the theory sounded very good, but, as the FDA told manufacturers, testing would be required in order to safely market the devices for placement in the joints.

Pain pump manufacturers ignored the FDA by conforming labels to FDA requirements and then sending their marketing force out to promote the off label use inside joints. So, sales forces were sent out by each manufacturer in a frenzied effort by each to gain market share. What the manufacturers did not do is any meaningful studies on the results of injecting pain medicine directly into patient joints.

Effectively what pain manufacturers decided is to allow the public to be the guinea pigs for testing and not to tell physicians the pumps had not been approved for in joint placement.

When manufacturers were caught and it was clear their untested devices were causing devastating injuries to young, active people, they were slow to pull the devices or to alert physicians. Instead, they spent their energies trying to find ways to bury discredit the findings. Finally, as the result of lawsuits, they were forced to alert physicians and to withdraw their devices from use inside joints.

Sadly, the pain pump manufacturers’ decision to discourage the unapproved use they had previously promoted was far too late for hundreds, perhaps thousands, of innocent victims.

Now, relatively young people in the age group of 20 to 55 will be forced to undergo multiple surgeries in attempts to correct the devastating damage done by the unapproved use of the pain pumps. Many patients will be forced to experience full joint replacements and, because of their young ages, possibly one, two or three additional joint replacements or revision surgeries during their life will be required.

It seems pretty clear to any informed person that chondrolysis, a relatively rare condition before pain pump use was promoted, has now resulted in significant increases in damaged cartilage. Chondrolysis is a condition in which the cartilage is essentially destroyed and the patient is left with no protection inside the joint. In plain terms, imagine pouring battery acid on the cartilage inside a patient’s joint and you have the damage caused by pain pumps inserted inside the joint. The results are severely damaged joints and hundreds of thousands of dollars in medical care.