It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness.

The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission for “limited humanitarian” use of its bone growth products, OP-1 implant and OP-1 Putty, used in spinal and long bone surgeries.

The Stryker products were only supposed to be sold in limited quantities and were only approved for use in treatment of certain rare diseases. It may be hard to believe that Stryker reportedly invented a number of other uses for these products and promoted them to physicians.

Stryker is one of the companies, together with Breg and IFlow, who are being sued over doing this same thing with pain pumps. It has become clear in the pain pump litigation that manufacturers knew that the FDA would require clinical trials (and resulting cost overhead for the manufacturer) in order to promote the use of pain pumps directly into joint spaces. Although manufacturers knew that use of the pumps in the joint spaces was prohibited without prior clinical trials, they promoted that use to physicians anyway. In fact, some of the manufacturers went so far as to promote the use and also promote methods that would allow for higher charges if the pain pump was used the way manufacturers were promoting it.

Now, these same manufacturers are trying to argue in the pain pump litigation that no good scientific studies exist that supports the causal relationship between pain pump use in joint spaces and a devastating condition called chondromalacia. Effectively, manufacturers are trying to convince judges to dismiss lawsuits based on their violation of the FDA requirements and their failure to conduct the scientific studies which the FDA would have required had the manufacturers complied with the law.

So, when selling potentially dangerous drugs and medical devices, apparently the theory is do not ask for permission; reap the profits; and pay for forgiveness later.

Patients who undergo shoulder, knee and ankle surgery often experience significant pain; particularly immediately post surgery. To try and manage that pain, physicians have often employed the use of pain pumps. These pumps inject pain killer into the body in a regulated fashion to minimize pain, while controlling the tendency toward addiction.

The pain pump is attached to a catheter, which was routinely inserted into the soft tissue near the affected joint. This use of the pump worked fine until the manufacturers of these devices started recommending that physicians could insert the catheter directly into the affected joint space and provide a much higher degree of pain relief. This was, of course, welcome news for physicians who always want to attempt to relieve or minimize the suffering of their patients. So all was good, then?

What pain pump manufacturers failed to tell physicians is that the Food & Drug Administration had never reviewed, let alone approved, the use of the pumps directly into the joint space. What the manufacturers should have known is that at least one of the manufacturer’s, McKinley Medical, asked the FDA to permit insertion of the devices into the joint space and the FDA asked for proof of efficacy. As far as we know, no data or evidence was presented to the FDA. Soon after this, Stryker Corporation purchased the exclusive rights to the pain pump from McKinley. (more…)