Opinion ID: 76033
Heading Depth: 2
Heading Rank: 4

Heading: The Warning of Risk

Text: 14 Neither the PCA pump itself nor its user's manual contained a written label warning that third parties should not activate the PCA pump on behalf of the patient to whom it is prescribed. However, through its own sales force and its medical products distributor Bimeco, defendant Bard educated the GBMC staff about the risk of third-party activation and provided patient brochures to the GBMC staff advising that only the patient should press the PCA button. 15 More specifically, Bimeco sales representatives performed in-service training to GBMC's doctors and nurses, and representatives from defendant Bard often attended that training. Frank Burdette, a Bimeco employee who performed training at GBMC since 1994, stated that [a]s part of this in-service training, it was my routine practice to tell the physicians and nurses in the Pain Service and at GBMC that only the patient should push the pump button, unless otherwise ordered by a physician. To illustrate why family members should not operate the pump, Burdette would relate an anecdotal report about a family member who oversedated a patient by pushing the patient button. 16 In 1997 and prior thereto, Burdette also gave the doctors and nurses at GBMC copies of a patient brochure about the PCA pump, which initially was prepared by defendant Bard in 1988 and later used by defendant Baxter. That brochure, entitled Controlling your own pain relief — single-handedly, stated, Important Note: You should be the only person to press your PCA button because only you know if you need it. (emphasis in the original). However, that brochure did not mention or warn what might happen if that directive were ignored. The brochures were provided to GBMC to be used with patients at the doctor's discretion. Nurse Susan Rhodes, who instructed Brown on the use of her PCA pump, confirmed that the patient brochure was used as part of the instruction to patients at GBMC. 17 Another Bimeco representative, Mark Jungers, also performed in-service training at GBMC during the early 1990s. Like Burdette, Jungers routinely told the staff at GBMC that only the patient should push the PCA pump activation button and shared the story about a family member oversedating a patient. Jungers further testified that he too gave copies of the defendants' patient brochures to the doctors and nurses at GBMC.