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Shapiro & Appleton

Off-Label Marketing of Pain Pumps for Unapproved Uses Causes Injuries

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Shoulder injuries can happen to almost anyone. They can occur in athletes, car accident victims or even people who perform manual labor. The solution for many people is shoulder surgery. However, shoulder pain after surgery can be irritating and hard to deal with. Many people want to get back to their normal routine as fast as possible and try to minimize the pain.

One such technique that was prescribed by doctors to reduce pain after shoulder surgery was a pain pump. Simply put, the pump holds 2-3 days of pain medication and delivers the medication through a catheter. Sounds simple enough. And pain pumps have been around for quite a while for relieving discomfort from general surgery.

However, no tests have ever been done to prove the safety or effectiveness of these pain pumps for orthopedic surgery. What is the difference? The difference and the problem was created when these catheters were placed in the intra-articular space of the shoulder joint, rather than in the tissue. The pain medication is toxic to the articular cartilage and literally "killed it." Many patients were left with bone-on-bone conditions in their shoulder which are very painful.

So now this leaves many people with permanent shoulder pain and they may even be worse off than before the shoulder surgery. As a
Virginia (VA) medical malpractice attorney, it blows my mind that these pump manufacturers decided to sell to this large market without FDA approval and without a single test to prove their product safe for orthopedic surgery, much less for the catheter to be placed in a joint space. The companies simply decided to sell to this large market without any real proof of safety for that particular use.

Manufacturers of medical devices are supposed to be creating products to help people not hurt people. The very nature of their business in dealing with things that go inside people's bodies should make them even more cautious. The Department of Justice appears to agree with me and is now
investigating the off-label marketing of pain pumps for unapproved uses. If the investigation proves that this is the case then that  may be a crime under federal law and manufacturers could be liable.

We have worked on many defective medical device cases that were similar to this issue. One such surgical product is the
DePuy hip replacement. The company manufactured artificial joints that failed to fit properly and the procedure left patients experiencing more pain than before the operation.


CT

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