Manufacturers have been aware of the problems that arise when their pain pump devices are pointed directly into a patient’s shoulder for several years. Not only have they not warned patients, but they may have ignored instructions from the U.S. Food and Drug Administration (FDA).

FDA approval never given

Ted Meadows, an attorney from Alabama who represents patients injured from shoulder pain pumps, explained that the FDA never approved the way that pain pumps are often used (pointed directly into the shoulder cavity) – which has resulted in a painful condition known as Postarthroscopic Glenohumeral Chondrolysis, or PAGCL. He explained:

In 1998, a company called McKinley Medical was selling pain pumps and apparently sent a letter to the FDA asking for approval to promote the pain pump device to be pointed directly into the intra-articular space, or the synovial cavity. McKinley sought approval to promote it in such a fashion and the FDA told them to provide some safety and efficacy data. From what we can tell, that data was never provided to the FDA.

The FDA later approved some labeling indications for other uses, but not to point the catheter directly into the synovial cavity. So, it wasn’t as if they told the company to go and do studies and then never weighed in again. The FDA actually did come back, weigh in on use and they did not allow the company to promote it in that fashion.

The problem with using this method

According to Meadows, using pain pumps in this method has been directly linked to cases of PAGCL. He explained, “There’s not so much of a problem if they just point the pain pump or catheter into the general surgical area without pointing into the joint space. However, when you point it directly into the joint space, that’s when you start seeing people who end up with chondrolysis, because the medication causes the death of the chondrocytes (cells found in cartilage).”

Manufacturers Should Have Known

Meadows told us that pain pump manufacturers such as Stryker, DJO Inc., I-Flow and BREG Inc. have not recalled or provided any product advisories on the devices. He said, “I-Flow is the only one that I know of so far that’s posted anything about a relationship between pain pumps and chondrolysis. However, even their bulletin downplays it and points at a list of other potential causes. Stryker doesn’t seem to have written or posted anything on the topic. I don’t know what they’re telling doctors at this point, but we’ve not seen anything – and that’s quite disturbing. Since Stryker purchased McKinley Medical, they had to have known about [these problems] when they purchased the company.”

Lawsuits filed

Several lawsuits have been filed against pain pump manufacturers – including the Stryker Corporation, who purchased McKinley Medical in 2000. According to Meadows, “There is a case filed in Oregon State Court that’s set for trial in September. There’s another multi-plaintiff case filed in Oregon State Court, and a group of cases filed in Oregon federal court. I am working with the lead lawyers prosecuting the Oregon cases. There is also a class action filed in Utah and the most recent filing was a case in Indiana.”

If you have experienced any of these conditions after using a pain pump, contact an attorney to discuss your situation. For a free, no-obligation consultation with a qualified attorney whose practice focuses in this area of law, please click here.