A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints.

The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries.  The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain relief for shoulder, knee and other joint surgery patients.

As with drugs and other medical devices, the theory sounded very good, but, as the FDA told manufacturers, testing would be required in order to safely market the devices for placement in the joints.

Pain pump manufacturers ignored the FDA by conforming labels to FDA requirements and then sending their marketing force out to promote the off label use inside joints. So, sales forces were sent out by each manufacturer in a frenzied effort by each to gain market share. What the manufacturers did not do is any meaningful studies on the results of injecting pain medicine directly into patient joints.

Effectively what pain manufacturers decided is to allow the public to be the guinea pigs for testing and not to tell physicians the pumps had not been approved for in joint placement.

When manufacturers were caught and it was clear their untested devices were causing devastating injuries to young, active people, they were slow to pull the devices or to alert physicians. Instead, they spent their energies trying to find ways to bury discredit the findings. Finally, as the result of lawsuits, they were forced to alert physicians and to withdraw their devices from use inside joints.

Sadly, the pain pump manufacturers’ decision to discourage the unapproved use they had previously promoted was far too late for hundreds, perhaps thousands, of innocent victims.

Now, relatively young people in the age group of 20 to 55 will be forced to undergo multiple surgeries in attempts to correct the devastating damage done by the unapproved use of the pain pumps. Many patients will be forced to experience full joint replacements and, because of their young ages, possibly one, two or three additional joint replacements or revision surgeries during their life will be required.

It seems pretty clear to any informed person that chondrolysis, a relatively rare condition before pain pump use was promoted, has now resulted in significant increases in damaged cartilage. Chondrolysis is a condition in which the cartilage is essentially destroyed and the patient is left with no protection inside the joint. In plain terms, imagine pouring battery acid on the cartilage inside a patient’s joint and you have the damage caused by pain pumps inserted inside the joint. The results are severely damaged joints and hundreds of thousands of dollars in medical care.

Tags: Breg, Chondrolysis, FDA, fda requirements, McKinley, pain pump, pain pumps, pump manufacturers, Stryker

This entry was posted on Monday, January 25th, 2010 at 11:36 am and is filed under Defective Design, Mass Torts, Product Defect. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response.