Lawsuits Continue Over Shoulder Pain Pumps Inserted To Treat Post Surgical Pain
Lawsuits over shoulder surgery pain pumps which are inserted and used to treat post-surgical pain continue against manufacturers such as Breg; DJO; SMI Liquidating, also known as Sorensen Medical; I-Flow; Moog; McKinley Medical; Stryker Corporation; Oratec Interventions; B. Braun Medical; Sgarlato Laboratories and DePuy. Our South Carolina legal expert explains why these medical devices are so dangerous, how they've been linked to PAGCL and provides an update on the ongoing litigation.
South Carolina Attorney Rhett Klok
Rhett Klok, a South Carolina attorney for over 15 years whose practice focuses in medical health litigation including medical devices, pharmaceuticals and medical malpractice, told us that the shoulder surgery pain pump which we’re talking about in this litigation is different than the self-administering pain pump or morphine pump. He explained:
This device is inserted and used to treat post-surgical pain. It’s portable and usually the doctor will implant the catheter in the space between the joints of the shoulder, which is the post-humeral space between the shoulder.
The device will then infuse the anesthetic which can be various anesthetic drugs or painkiller drugs that provide local anesthesia and relief from pain. Usually it is an automatic, continuous flow and there are several pump sizes that are used. These devices are temporary and meant to be used between two and five days, sometimes a little more, maybe up to eight days.
Why these devices are dangerous
The reason why it’s dangerous is putting the catheter in the space between the joints of the shoulder, which is basically the ball and socket space, according to Klok, who says that this use of the device was never authorized by the FDA. He told us:
It is what’s known as an off-label use and the FDA had always cautioned that manufacturers have to demonstrate why it was safe and why it wouldn’t cause any damage to that part of the body before they could apply for a change of use for the product.
The manufacturers, in effect, never did that and marketed these pain pumps for that specific off label use. What came out subsequently were a couple of articles that demonstrated that certain anesthetics with prolonged use, between two to five days of use, would cause deterioration of the cartilage in that area. So all of a sudden, you would have bone-on-bone grinding because the cartilage has disappeared or eroded as a result of the use of the pain pump – leaving patients in worse condition than they were before the shoulder surgery.
Klok says that it can cause patients to have shoulder reconstruction in its worst manifestation. However, he says that the clearest problem is anywhere between right after surgery and up to eight months later where you can develop a condition called PAGCL, or Postarthroscopic Glenohumeral Chondrolysis, which is basically the dissolution of the cartilage space between the shoulder.
An MDL, or multidistrict litigation, on shoulder pain pump lawsuits was denied by a federal court. Manufacturers objected to the MDL because there were too many differences between pain pumps and individual manufacturers. However, Klok says that a new MDL could be granted if both sides ask the court to consolidate them. In fact, he says that there is a move afoot to try to reinstate an MDL if the defendants would agree to it. He explained:
Right now these lawsuits are filed in various states which have their own consolidated groups which are managing the cases on their own. For discovery purposes, each state is conducting its own workup. To my knowledge, this litigation is taking place throughout the country and each state’s law is being applied to these cases as they come up. Sometimes they get consolidated for purposes of investigating the manufacturers together. However, each case stands on its own.
If you've been injured due to shoulder pain pump, contact an experienced shoulder pain pump attorney to discuss your situation and evaluate your options. You may be entitled to compensation for your injuries.