In an unprecedented move, I-Flow, LLC, a subsidiary of the Kimberly Clark corporation, filed a cross claim against a doctor for using its medical device in the way that it instructed all doctors to use it. The orthopaedic surgeon was strong-armed into using the product by I-Flow who discovered that he was using a competitor product at St. Elizabeth hospital in northern Kentucky. The hospital was a party to a buyer's group agreement that included the I-Flow product. When I-Flow discovered that doctors were using a different type of pain pump at the hospital it sought to enforce the terms of the buying agreement and force the hospital to only supply the physicians with I-Flow products. In an attempt to appease I-Flow, the hospital and the doctors agreed to a trial run where they would use I-Flow pain pumps in comparison to the competitor product. Dr. Holladay only used the I-Flow pumps in 4 surgeries in April of 2007. What he did not know is that I-Flow had changed the label of their pain pump to warn against using it in joint surgery because there was a risk that such use could destroy all cartilage in the joint. I-Flow changed this warning in October of 2006, but did not alert its sales force or any physicians until August 2007. By that time, the surgeons at St. Elizabeth hospital had already used the pumps in joint surgeries. At least two of those patients did go on to develop severe cartilage loss in their shoulder joint. One such patient, Lucas Frietsch, filed a lawsuit against I-Flow and Dr. Holladay for his injuries. When the proof in the case made it clear that I-Flow concealed the new information about the possibility of cartilage loss from the doctors, Lucas and his lawyers realized that Dr. Holladay was not negligent and as much of a victime of I-Flow's wrongdoing. They promptly dropped Dr. Holladay from the lawsuit. But, I-Flow was determined to blame the doctor for the injury to Luke's shoulder. I-Flow hired an orthopaedic surgeon from Dallas Texas named Wayne Burkhead to testify that Dr. Holladay was negligent because he used the pain pump in a shoulder surgery and filled the reservoir of the pump to its capacity of 270 milliliters. Dr. Burkhead opined that such acts were negligent despite the fact that I-Flow issued catheter placement guides that instructed physicians to use the pump in the shoulder joint, and provided the physicians with studies where 270 milliliters of the drug were used. I-Flow's lawsuit against Dr. Holladay is the first time that the pain pump manufacturers have stooped to suing the doctors who they decieved. The pain pump was never FDA approved for use in the human joint space, yet I-Flow concealed this fact from the doctors. To turn around and sue the doctor for using the pump in the way that it instructed him to is really beyond belief.
Category: Pain Pumps
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