Legal experts following shoulder pain pump litigation say that liability against the manufacturers over the Class II medical devices' links to PAGCL, or postarthroscopic glenohumeral chondrolysis, is strong. We asked one such expert to explain how manufacturers are defending these product liability cases, the significance of Class II medical devices and why preemption is not an issue.

California Lawyer Jeff Milman

Jeff Milman, a California attorney whose practice represents injured pain pump victims, provided answers to the following questions about the ongoing pain pump litigation:

Question: How are the manufacturers defending these cases?

Answer: The manufacturers are defending these as they would any product liability case. They’re trying to draw the distinction that it’s not their product which is the cause of these people’s chondrolysis or underlying pathology. They’re also attacking the experts the plaintiffs use by saying that the science is in its infancy and shouldn’t be permitted to be presented to a jury. Finally, they are looking for other reasons why the patient might have these problems besides the obvious, which is the pain pump issue, and of course the nature and extent of medical treatment, etc.

So, there’s no new real defenses. It’s the standard ones. However, I think the liability against the manufacturers is pretty strong. Sometimes they’ll try and point the finger at the anesthetic manufacturer, but that’s been held to somewhat of a minimum.

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Question: Pain pumps are classified as Class II medical devices. Can you define that and explain why it's significant?

Answer: Medical devices are classified into categories. If you are a Class II medical device, you are not subject to the pre-market notification requirements of the FDA. In other words, instead of having to show that a product is safe using human clinical trials, you merely have to show that it is 'substantially equivalent' to a device that has already been FDA-approved under a pre-market approval process. So what you do is you put these devices on the market saying, 'This is just like what the FDA has already approved.'

So, the seminal point is these shoulder pain pumps did not go through a pre-market approval process. They didn’t need to submit the manufacturers’ substantial safety data to the FDA. Now what’s important is the FDA originally approved these pain pumps for the insertion of analgesic, meaning anesthetic, into the muscle, skin or nerve tissue, not – I repeat, not – the cartilage, not the shoulder joint. So in June of 1998, McKinley Medical sought FDA approval to add synovial cavities, which is the area surrounding the bone and the joint, as part of what these pumps should be allowed to do. The FDA denied the approval.

Nevertheless, the manufacturers of these pain pumps touted the benefits that it’s better pain relief than taking systemic narcotics. You need less medication, you have a quicker return to normal, decreased complications, etc. So the bottom line is with touting those benefits and despite the FDA denying that use, they still marketed these to the medical profession saying that if you place them into a shoulder – or sometimes the knee joint – in the glenohumeral joint space, for example, that would benefit the patient. However, as we know, that’s exactly the opposite of what's happening. As we’ve come to learn, the injury of glenohumeral chondrolysis, or PAGCL, is very significant.

Question: How does the preemption argument apply to these cases?

Answer: It doesn't. These are Class II medical devices, meaning there’s no preemption if it did not have to go through all the bells, whistles and hoops that a Class I does. In other words, this particular class of pain pumps didn’t have to go through FDA scrutiny and extensive human trials. It was basically grandfathered in by saying, 'It’s substantially equivalent,' to a device that’s already been FDA-approved. Where the twist occurs is that the FDA didn’t even approve these for this particular usage.

Prescribed a shoulder pain pump post surgery and diagnosed with PAGCL? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. [Sponsored link]