West Palm Beach Personal Injury Lawyer - Intra-articular

FDA Warns About Pain Pumps -- Manufacturers Knew

John Hopkins — Mon, 16 Nov 2009 09:14:20 GMT

Sometimes law and science do not make close bed fellows; particularly where one or the other is trying to understand their respective meaning.

The FDA has come forward to warn about continuous intra-articular infusion of pain medication. This is the practice of using a pump to provide continuous infusion of pain medication to a surgical site. These devices began being used in abdominal surgeries and, predictably, that singular use did not provide manufacturers with sufficient market availability (profit). So, many manufacturers such as Breg, Strytker and IFlow began to promote the use of the pumps in shoulder, knee and ankle surgeries.

The explanation given by the manufacturers was that providing continuous pain medication to the place where you just operated gave the patient an easier recovery time. Doctors do, in fact, care about their patients and, so this manufacturer explanation had real attraction to doctors. Some of the manufacturers went further and demonstrated to doctors ways in which they could code the procedures and receive additional compensation if they used a pain pump. To doctors who often are forced to fight with insurance companies for a fair payment, this, too, seemed attractive.

What manufacturers “forgot” to tell doctors is they had not conducted competent testing of the use they were promoting. The manufacturers forgot to tell doctors that the FDA required clinical trials before use of the pain pumps intra-articularly could be permitted. The manufacturers forgot to tell doctors that no clinical testing had been done on the very tissue, cartilage, into which the pain pumps would be injecting medication.

When pain manufacturers saw the first study come out potentially linking destruction of cartilage to the use of pain pumps, they quickly retreated from their recommended application and circled the wagons. They knew that because they had sponsored no meaningful research of their own, interest would quickly evaporate for studying the problem if they stopped recommending intra-articular use. After all, why study something that will not happen anymore?

Pain pump manufacturers also hoped that the lack of research would shield them from liability by arguing to courts that insufficient scientific evidence existed to relate use of the pain pumps with complete destruction of joints in relatively young people. Sadly, by using a legal theory called “Daubert”, some courts have, in fact, bought into the manufacturers’ ingenuous arguments. Manufacturers argue that courts should ignore, as insufficient, the testimony of surgeons who, for 30 and 40 years, have seen no destruction of cartilage until they started using pain pumps in the way recommended by manufacturers.

Originally posted at InjuryBoard by John Hopkins

Post-Operative Pain Pump Use in Knees Discouraged

Brenda Fulmer — Wed, 17 Jun 2009 11:49:56 GMT

A new study published in The Journal of Bone & Joint Surgery discourages surgeons from using post-operative pain pumps undergoing knee surgery, concluding that there are equally effective ways to manage post-operative pain that would not subject patients to such significant potential harm. The authors of the study from Wansbeck General Hospital in Ashington, England concluded that surgeons could avoid the “possible chondrotoxic insult” to knee cartilage by utilizing local anesthetics around the portals rather than “intra-articular infiltration.”

Use of post-operative pain pumps, such as those marketed by Breg, Stryker, I-Flow, and Don-Joy, have come under great scrutiny lately as a number of patients have developed chondrolysis or destruction of their cartilage after the pain pump catheters were placed into the joint spaces of patients and then bathed in local anesthetics such as bupivacaine and marcaine. Lawsuits against the manufacturers of the pain pumps and the anesthetic drugs are pending in state and federal courts across the nation. The stories of these plaintiffs are quite compelling, as many are very young, health patients who underwent surgery to correct minor sports-related injuries and are now facing a lifelong series of joint replacement surgeries and disability.

The authors of this study noted:
Intra-articular bupivacaine is widely used as a local anesthestic in arthroscopic surgery, either as a single agent or to supplement regional or general anesthesia. A growing number of laboratory studies have demonstrated the potential toxicity of bupivacaine to articular cartilage. Most recently, Chu et al demonstrated that exposure of human chondrocytes in vitro to 0.5% bupivacaine for just 15 minutes resulted in cell viability of only 41%. Gomoll et al examined a rabbit shoulder in vivo and showed significant histopathological and metabolic changes in articular cartilage following continuous intra-articular infusion of bupivacaine. Recent reports have also implicated the use of bupivacaine in post-operative chondrolysis in the human glenohumeral and ankle joints.

This latest study adds further evidence to the mounting pile of studies, case reports, animal data, and adverse event reports documenting widespread development of chondrolysis in young, otherwise healthy patients who utilized a post-operative pain pump with delivery of anesthetic drugs directly into their joint space after surgery. The Food & Drug Administration is currently investigating these reports as well, and at least some of the manufacturers are now, for the first time, warning surgeons that intra-articular placement of the pain pump catheter may present a risk to patients.

Originally posted at InjuryBoard by Brenda Fulmer

What Doctors Are Saying About Chondrolysis, Pain Pumps and Intra-articular Anesthesia

Armand Rossetti — Tue, 25 Nov 2008 14:32:15 GMT

Doctors have been associating catheter delivered intra-articular pain pump anesthesia with cartilage cell toxicity. It has now become increasingly evident that pain pump infused anesthesia is detrimental to all cartilage found in articular joints. Six medical doctors had a chance to review a case presentation entitled, Bilateral Shoulder Chondrolysis Following Arthroscopy; a Report of Two Cases (Greis, et al.), and here is the substance of their letters to the Editor of the Journal & Bone Joint Surgery:

Drs. James A. Turner and Hugh Clarke At Queen Alexandria Hospital, Portsmouth, UK:

The well known Hansen study provided a substantial association between bupivicaine with epinephrine and post arthroscopic gleno humeral chondrolysis (PAGCL)

Scientific investigators (Chu, et al.) exposed canine chondrocytes (cartilage cells) to bupivicaine and caused cell damage after only 15 minutes

Another in vitro study (Piper, et al.) compared the effects of bupivicaine and ropivicaine (0.5%) on human cartilage cells and found that after 30 minutes of treatment, chondrocytes exposed to bupivicaine showed a higher rate of cell death

Yet another study (Karpie, et al.) showed that more cartilage cells were dying when exposed to 2% instead of 1% lidocaine

While some studies differed in the rate of cell death after exposure to anesthetic preparations, if epinephrine (a blood vessel constrictor) was part of the preparation, the cell death rate was significantly higher.

Drs. Turner and Clark concluded the following:

“Despite some variance, all the above studies including the case report add to the growing evidence to support the hypothesis that bupivicaine and lidocaine cause chondrocyte cell death. We support the authors caution against the use of a bupivicaine infusion into the shoulder and suggest that if it is going to be used, a concentration of 0.25% or even 0.125% will minimise (Br.) the risk of damage, and that epinephrine should not be added.

On a more general note, we would also caution that a single injection of lidocaine or bupivicaine into any other joint poses a risk a chondrolytic effect. We recommend use of soft tissue infusion of local anaesthetic into the skin incisions rather than the joint itself to obviate any risk.”

Drs. Jonathan C. Levy and Mark Frankle of Holy Cross Orthopaedic Institute in Florida:

According to Regan et al., there have been reports of chondrolysis following shoulder arthroscopy where intra-articular pain pumps were never used. Conversely, there are also many patients who received treatment with intra-articular pain pumps that never developed chondrolysis

Proper evaluation is multifaceted and should involve comprehensive differential diagnoses, including inflammation, arthritis, inflammation due to bioabsorbable implants, infections, foreign body induced arthropathy, radio frequency ablation injury and chemical toxicity

However, Drs. Levy and Frankle still cautioned against using intra-articular pain pump anesthesia, stating the following:

“Until the individual and cumulative effects of these factors are clarified, efforts should be made at avoiding chondral injury and chondrocyte toxicity. As discussed in our recent experience with this patient population, we have modified our current practice of shoulder arthroscopy in effort to avoid potential contributors to chondrolysis. We, therefore, no longer use intra-articular pain management catheters. We minimize the use of the thermal probe in the intra-articular space…"

Drs. Patrick E. Greis and Robert T. Burks of the University of Utah (Authors) in response to Drs. Levy and Frankle:

Doctors should always consider differential diagnoses for the cause of chondrolysis following shoulder arthroscopy. Bacterial infection might be a factor in some cases

Chondrolysis may be multifactorial and further investigation is necessary to fully understand the problem

However, there is a very convincing amount of literature that associate the delivery of anesthetic with indwelling catheterization and resulting cartilage cell death

The results of one study (Hansen, et al.) showed that 36% of patients with in dwelling catheter delivery of bupivicaine suffered cartilage cell death while none of the patients who were treated without catheterization experienced cartilage problems

Another study (Levy, et al) confirmed Hansen’s results

Drs. Greis and Burks concluded the following:

“In addition to the recent clinical data, the basic science work on bupivacaine and lidocaine chondrocyte toxicity makes the argument for this as a prime causal agent compelling. The purpose of our case report was to call attention to this as an issue, in an effort to stop the use of indwelling intra-articular catheters with bupivacaine infusions following shoulder arthroscopy. We feel there is more than enough information available, at this time, to make this recommendation. We agree with the recommendations by Drs. Levy and Frankle to try and minimize other potential causative factors in chondrolysis, but hope to bring attention to what we feel is a major player in this problem so as to hopefully avoid further potential harm.”

Thus, despite slight differences of opinion, the consensus among all of the doctors is that the use of intra-articular pain pump anesthesia is a treatment risk that is too high to take.

Originally posted at InjuryBoard by Armand Rossetti