antiquity
11-28-2002, 07:36 PM
Maker of Misused Medical Device Isn't Liable
Megan Rhyne
The National Law Journal
11-27-2002
A Georgia woman who, with her sister, accidentally gave her mother a morphine overdose by following what she said were nurse's instructions can't collect damages from the maker of the medical device the women used.
The 11th U.S. Circuit Court of Appeals ruled on Nov. 12 that a Georgia legal rule imposes no duty on the manufacturer of a pain-medication delivery device to warn patients or third parties about the danger of a nonpatient using it. The decision affirmed a grant of summary judgment. Ellis v. C.R. Bard Inc., Nos. 01-15182, 02-10332.
The mother, Mary Ruth Brown, underwent knee replacement surgery at Georgia Baptist Medical Center, now the Atlanta Medical Center. Afterward, to relieve her pain, a doctor prescribed a pump to deliver a dose of morphine each time she pushed a button.
As Brown slept in the hospital, her two daughters, following directions given without authorization by a nurse, pressed the pump button to keep her from waking in pain.
The next morning, Brown went into cardiac arrest and suffered a brain injury from a morphine overdose. She now requires 24-hour care and is confined to her bed or a wheelchair.
The family settled a suit against the hospital for $8 million.
Brown's daughter Donna Ellis also sued the pump's manufacturer, C.R. Bard Inc., and Baxter Healthcare Corp., which acquired Bard's assets and continued making a similar pump. Ellis said the pump was inadequately labeled and the manufacturer had a duty to warn third parties about the danger of having someone other than the doctor or patient use it.
The federal court, hearing the case because of diversity jurisdiction, analyzed Georgia's "learned intermediary rule," which says the manufacturer of a prescription drug is not normally required to warn patients of dangers in its use. Georgia case law permits extending the rule to devices, it said.
The court said that the pump had no label that warned third parties not to activate the pump. But it said that the dangers of third-party use were well known in the medical community.
RISK WAS KNOWN
It said that "each doctor and nurse involved with Brown's medical care ... was aware that only the patient should activate the ... pump unless a doctor instructed otherwise." The lack of a warning on the pump did not violate the Food, Drug and Cosmetic Act, the court found.
Ellis' attorney, Andrew Kirschner of Atlanta's Kirschner and Venker, said the decision eviscerates the federal statute.
"This decision completely undoes the entire federal regulatory scheme for prescription drugs," Kirschner said. "It authorizes ad hoc oral warnings to stand in lieu of written instructions."
But Richard Saver, assistant professor at the Health Law and Policy Institute at the University of Houston, does not see the case as breaking new ground.
"It's consistent with the restatement of products liability, which says that warnings about prescription drugs and devices must be given directly to consumers only when the manufacturer has reason to believe the learned intermediary will not be in a position to reduce the risk of harm," Saver said.
He said that the case clarifies that all risks, both avoidable and so-called unavoidable, are to be weighed by the learned intermediary.
Baxter Healthcare's attorney, Maja Eaton of Chicago's Sidley Austin Brown & Wood, said that there was ample evidence that the defendants advised the medical community of the danger of third-party activation.
"This is a good decision," she said. "The 11th Circuit was very firm in its view that the federal device labeling law was consistent with the learned intermediary rule."
http://www.law.com/jsp/article.jsp?id=1036630500046
Megan Rhyne
The National Law Journal
11-27-2002
A Georgia woman who, with her sister, accidentally gave her mother a morphine overdose by following what she said were nurse's instructions can't collect damages from the maker of the medical device the women used.
The 11th U.S. Circuit Court of Appeals ruled on Nov. 12 that a Georgia legal rule imposes no duty on the manufacturer of a pain-medication delivery device to warn patients or third parties about the danger of a nonpatient using it. The decision affirmed a grant of summary judgment. Ellis v. C.R. Bard Inc., Nos. 01-15182, 02-10332.
The mother, Mary Ruth Brown, underwent knee replacement surgery at Georgia Baptist Medical Center, now the Atlanta Medical Center. Afterward, to relieve her pain, a doctor prescribed a pump to deliver a dose of morphine each time she pushed a button.
As Brown slept in the hospital, her two daughters, following directions given without authorization by a nurse, pressed the pump button to keep her from waking in pain.
The next morning, Brown went into cardiac arrest and suffered a brain injury from a morphine overdose. She now requires 24-hour care and is confined to her bed or a wheelchair.
The family settled a suit against the hospital for $8 million.
Brown's daughter Donna Ellis also sued the pump's manufacturer, C.R. Bard Inc., and Baxter Healthcare Corp., which acquired Bard's assets and continued making a similar pump. Ellis said the pump was inadequately labeled and the manufacturer had a duty to warn third parties about the danger of having someone other than the doctor or patient use it.
The federal court, hearing the case because of diversity jurisdiction, analyzed Georgia's "learned intermediary rule," which says the manufacturer of a prescription drug is not normally required to warn patients of dangers in its use. Georgia case law permits extending the rule to devices, it said.
The court said that the pump had no label that warned third parties not to activate the pump. But it said that the dangers of third-party use were well known in the medical community.
RISK WAS KNOWN
It said that "each doctor and nurse involved with Brown's medical care ... was aware that only the patient should activate the ... pump unless a doctor instructed otherwise." The lack of a warning on the pump did not violate the Food, Drug and Cosmetic Act, the court found.
Ellis' attorney, Andrew Kirschner of Atlanta's Kirschner and Venker, said the decision eviscerates the federal statute.
"This decision completely undoes the entire federal regulatory scheme for prescription drugs," Kirschner said. "It authorizes ad hoc oral warnings to stand in lieu of written instructions."
But Richard Saver, assistant professor at the Health Law and Policy Institute at the University of Houston, does not see the case as breaking new ground.
"It's consistent with the restatement of products liability, which says that warnings about prescription drugs and devices must be given directly to consumers only when the manufacturer has reason to believe the learned intermediary will not be in a position to reduce the risk of harm," Saver said.
He said that the case clarifies that all risks, both avoidable and so-called unavoidable, are to be weighed by the learned intermediary.
Baxter Healthcare's attorney, Maja Eaton of Chicago's Sidley Austin Brown & Wood, said that there was ample evidence that the defendants advised the medical community of the danger of third-party activation.
"This is a good decision," she said. "The 11th Circuit was very firm in its view that the federal device labeling law was consistent with the learned intermediary rule."
http://www.law.com/jsp/article.jsp?id=1036630500046