The litigation over shoulder pain pumps and their link to PAGCL, or Postarthroscopic glenohumeral chondrolysis, is heating up. At the heart of the matter is the U.S. Food & Drug Administration’s (FDA) specific instructions to pain pump manufacturers not to point the pumps directly into a patient’s shoulder joint space. However, manufacturers ignored the FDA and did it anyway.

Product liability lawsuits forge ahead

Frank Woodson, an Alabama attorney whose firm represents patients injured by pain pumps, told us that pain pump product liability lawsuits are forging ahead – and that the FDA’s involvement is a key issue. He explained:

There are several available methods to provide post-surgical pain relief to patients after they have shoulder surgery such as oral medications or shots into the shoulder tissue. Pain pumps placed in the joint space create the risk of chondrolysis or the loss of the cartilage.

So, when the manufacturers went to the FDA in the late 1990s and asked for approval to place the catheter directly into the joint space and were denied, that should have been the end of it and we never should have seen these injuries occurring.

To the FDA’s credit, they said no. They said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.

They never studied it and they never obtained FDA approval. There was literature available indicating that the pain medication used in the pumps was toxic to cartilage before they even sought approval and before they ever told physicians to use it.

Large verdicts expected

Many pain pump attorneys (link to ) expect that juries will return large verdicts in pain pump cases because manufacturers should never have told doctors to use these devices in a way that contradicted the FDA. Woodson said, “So, all of those things were there in place and they should never have gone forward with advising doctors to use it in the manner in which they did. I think that when juries hear that evidence, they’re going to return verdicts against these companies and award compensation to the victims.”

Pharmaceutical companies may also be liable

We asked Woodson whether pharmaceutical companies that supplied the drugs used in the pain pumps are also being brought into the litigation. He told us:

They are, when you can find them. One of the issues that I think that the attorney’s representing pain pump victims are seeing is that the hospitals and/or the surgical centers, wherever you had the surgery performed, sometimes do not do the best of jobs tracking what medications that they placed into the pain pumps.

Now, it may seem surprising that a medication could be placed into somebody’s body and they can’t tell you what it is. But I can tell you for a fact that from the medical and billing records that sometimes it is impossible to determine who manufactured the medicine.

However, if you can determine that AstraZeneca’s medicine was used in the pain pump, it is likely they’re going to be added as a defendant because they knew from the medical literature that their medicine was toxic to cartilage. So, if they knew that their medicine was going to be used in pain pumps that were going to be placed intra-articularly into that joint space, then they’re just as liable as the pain pump manufacturers.