South-Western Legal Studies in Business

Learned Intermediary Rule Applies to Medical Devices in Some Instances
Description Appeals court affirmed that a medical device maker was not liable for misuse of a device that resulted in serious injury. The problem resulted from allowing a non-qualified person to use the medical device. The device maker was shielded from liability in such instance.
Topic Torts
Key Words Product Liability; Medical Device; Warning; Learned Intermediary Rule
C A S E   S U M M A R Y
Facts Mary Brown was operated on for knee replacement surgery. Due to the pain after surgery, while she was still in the hospital, the anesthesiologist prescribed the Bard Ambulatory Patient Controlled Analgesia Infusion Pump to help administration of morphine. The pump was set at the prescribed level of no more than 8 milligrams of morphine per hour. A nurse, without authority to do so, told Brown's daughter than she could press the pump to deliver more morphine to prevent pain. The daughter, who was staying in the room, pushed the pump too much causing a morphine overdose that left her mother with permanent brain damage. Brown's guardian, Ellis, sued the pump maker, Bard, for inadequate warning. The trial court dismissed the suit and awarded costs to Bard; Ellis appealed.

Affirmed. The learned intermediary rule provides that the maker of a prescription drug is not normally required to warn a patient of the dangers in its use. Warning the prescribing physician is usually sufficient. That rule applies to medical devices in instances such as this. The failure of the hospital staff to act properly, by allowing a family member to operate the pump, did not operate to create or extend the manufacturer's duty to warn. The warning materials and instructions were adequate for trained medical personnel; the maker was not liable.

Citation Ellis v. C.R. Bard, Inc., --- F.3d --- (2002 WL 31501163, 11th Cir., 2002)

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