FDA Warns About Pain Pumps -- Manufacturers Knew
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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.