I-Flow pain pump maker sues doctor for using product
Posted on Dec 19, 2011
In a very surprising turn of events I-Flow, the manufacturer of pain pumps that have been implicated in causing severe cartilage damage to patients who used the devices for pain relief following joint surgery, has sued one of the doctors that used its product. In a case filed in Kentucky, I-Flow filed a third party lawsuit against Dr. Bruce Holladay for using the pump to infuse local anesthetic into the joint space of a patient, alleging that such a use was off label and not approved by the FDA. I-Flow marketed and promoted the pump to be used in joint space followingn surgery since 1999 despite the fact that the FDA repeatedly refused to approve such a use because of the absence of any data to show that it was safe. In October of 2006, I-Flow added a warning to its label for the pain pump recommending that it not be used in the joint because of the risk of cartilage damage. I-Flow withheld this information from the medical community from October 2006 until August of 2007. During this time, Dr. Holladay used the pump in several surgeries in the joint space without any knowledge that the warning had been added to the label. It is shocking that I-Flow would make this important change to its warnings about a medical device, not tell the doctors about the change, and then sue a doctor who used the product in this manner. This case is set for trial on March 20, 2012 in front of Judge Bartlett in Kenton County Circuit Court. Plaintiffs are represented by attorney Ron Johnson.
Read More About I-Flow pain pump maker sues doctor for using product...