Shoulder Pain Pump Manufacturers Defied FDA & Caused Patient Injuries
Shoulder pain pump manufacturer, McKinley Medical, now the Stryker Corporation, asked the U.S. Food & Drug Administration (FDA) if it could use its medical device for off-label purposes. The FDA said no, but it and other manufacturers ignored that ruling – which has caused hundreds to contract PAGCL and subjected them to product liability lawsuits.
“We're going to do it anyway”
That's basically what shoulder surgery pain pump manufacturers said to the FDA's denial. Rhett Klok, a South Carolina attorney for over 15 years whose practice focuses in medical health litigation including medical devices, pharmaceuticals and medical malpractice, explained:
McKinley sought FDA approval for its pain pump for use in the space between the shoulders. During that process, the FDA requested McKinley provide the scientific basis to prove this application of the device would cause no harm between the shoulder space or the glenohumeral space. McKinley didn’t conduct any of that research and as a result, they never got the authorization to use the device in that manner. No manufacturer has since ever provided the scientific basis for the safe and effective use of this product for that application in the shoulder space.
Manufacturers encouraged doctors to use these devices in off-label ways after surgeries by paying them as consultants and attending medical seminars where they would tell doctors about the benefits of using the devices in those ways.
So what they did, and why we have a problem now, is that these various companies pushed the off-label use through their marketing one way or the other or through consultants who were acting as proxies for them. The practice became widespread and then we had the reported cases of PAGCL, or Postarthroscopic Glenohumeral Chondrolysis.
Goal was to expand market share
Klok says that these manufacturers used a legal technicality with the approved use to basically slingshot themselves into an off-label/non-approved practice to expand market share and increase profits over verifying the safety and effectiveness of the patient. He told us:
These manufacturing company's' customers are doctors, hospitals and healthcare providers. That’s who they market to. The actual users or the patients are referred to as end users and are not the customer. They’re not the client. These companies are interested in expanding market share. However, in some devices and some circumstances, they make the wrong decisions guided by the market forces to market products beyond their intended and safe application – and this is one such case.