MASSDEVICE ON CALL — Kimberly-Clark subsidiary I-Flow filed a lawsuit against Kentucky surgeon Dr. Bruce Holladay for off-label use of a pain pump that allegedly resulted in injury to a patient, raising the spectre of a slippery slope of physicians held liable in patient injury lawsuits.
Holladay performed reconstructive surgery on a patient in 2007, implanting a pain pump in the patient’s shoulder. When the patient later complained of shoulder pain, he was diagnosed with chondrolysis, a condition in which continuous administration of certain anesthetics can result in the destruction of cartilage.
The patient sued I-Flow Corp., alleging that the company was aware of the risks and failed to warn doctors and patients that some uses of the pump weren’t FDA-cleared, American Medical News reported.
While the patient’s attorney argued that Holladay was not at fault and should not be held liable, I-Flow disagreed and filed a claim against him for allegedly failing to follow the pumps directions and heed warnings.
Holladay has claimed that he wasn’t aware that the way in which he used the pump was not approved by the FDA,
"It’s kind of an honor system," the patient’s attorney, Ronald Johnson, told American Medical News. "The FDA does not have a bunch of officers that can run around and double-check that sales reps" are telling doctors everything they need to know. "The whole system is built around this foundation of honesty. What is most disturbing about this case is that I think it’s going to make doctors question if that foundation even exists anymore."
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