Since 2005, Dr. Bailie says he has seen dozens of patients come to him months after surgery with worsening pain and limited mobility. The diagnosis was chondrolysis, a condition in which the cartilage in the shoulder joint wears away leaving bone to rub against bone. There is no cure for chondrolysis and in some cases, total shoulder replacement is required.

But what could be causing his patients’ shoulders to worsen? Several studies began pointing to the same likely culprit – the pain pump device used during and after surgery to deliver medication into the joint space. As the anesthetic dripped onto the cartilage, the cartilage began wearing away over the course of weeks or months, sometimes longer.

Doctors soon realized that the way pain pump manufacturers were instructing them to use the devices was never approved by the Food and Drug Administration (FDA). In fact, the FDA had rejected the use on more than one occasion, saying more tests needed to be conducted to determine the safety of such use.

Now hundreds of patients injured by the pain pumps are suing manufacturers of the pain pumps, insisting the companies should have done more to warn surgeons of the potential risks. Lawyers say the manufacturers disregarded patient safety in an effort to bolster sales, but pain pump manufacturers argue more research is needed to determine if the cases of chondrolysis were actually caused by pain pump use.

SOURCE: Pain Pumps › Doctor ‘lost sleep’ over chondrolysis in patients

The culprit was not the surgery itself but the device used to deliver pain medication to the wound site. Used properly, as approved by the Food and Drug Administration (FDA), the pain pumps were hardly dangerous. But pain pump manufacturers began advising surgeons to use the pain pumps differently, by inserting the catheter directly into the shoulder joint space. Over time, the pain medication was toxic to the cartilage, resulting in chondrolysis.

In 2008, a petition was filed for a multidistrict litigation (MDL) to consolidated the lawsuits pending against the manufacturers of pain pumps. MDLs help coordinate the litigation that is pending in federal courts across the country involving the same allegations or same parties. The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL and where to transfer the cases. The judicial panel denied the initial petition requesting an MDL. Many more lawsuits have been filed in federal courts across the country and the panel may revisit its initial decision.

“Denial of the MDL  may be a good thing for patients and consumers because there are already cases that are going to trial,” Woodson says. Several of those cases were settled right before or after the opening statement and others were resolved on a confidential basis in early 2009.

“These are substantial injury cases. This is a very severe injury that should not have occurred,” Woodson says. “Most of these people did not know what occurred to them until they started seeing advertisements from lawyers for these cases. So, that’s the first time that they had any inkling in their mind that there could have been a connection between the use of a pain pump and what’s ultimately happened to their shoulder.

“I’d advise (individuals who believe they may have been injured by the pain pump) that people  see an attorney as soon as possible. ”

SOURCE: Pain Pumps › Pain pump makers may be liable for injury after shoulder surgery