Supreme Court: FDA-Approved Medical Devices Not Subject to State Lawsuits
State courts are not the proper place to sue medical device companies if their product has federal approval, the U.S. Supreme Court has ruled.
According to the New York Times, the top court overwhelmingly rejected an appeal by a man who claimed that a defective catheter used on him during a 1996 angioplasty violated New York state law.
The device, made by Minneapolis-based Medtronic, had received U.S. Food and Drug Administration approval, making it exempt from liability under individual state laws, the Times reported. The Wednesday U.S. Supreme Court ruling confirmed federal appeals courts' decisions that denied the plaintiff's standing to sue in the NY state court system.
Charles Riegel was severely injured in 1996 while undergoing an angioplasty when the catheter burst. Riegel and his wife maintained that the device's design violated New York State law. Riegel died a number of years after the injury, but his wife continued the lawsuit, the Times said.
Medtronic was protected under the Medical Device Amendments of 1976, Justice Antonin Scalia wrote in the majority decision, according to the Times. The federal law keeps states from imposing on medical devices "any requirement which is different from, or in addition to, any requirement applicable under this chapter," Scalia wrote.
The reason for this, Scalia added, was because the FDA sometimes has to weigh some possible bad outcomes against a device or drug's overall benefits, the newspaper said. "It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives," he wrote. He cited one case where the F.D.A. approved a ventricular device for children "even though the survival rate of children using the device was less than 50 percent."
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Bird Flu Outbreak Puts Vietnam on High Alert
A new H5N1 bird flu outbreak that has killed thousands of birds in three northern provinces in Vietnam has put the country on high alert. Seven of Vietnam's 64 provinces and municipalities that have reported H5N1 virus outbreaks within the past 21 days are now on the watchlist, Agence France-Presse reported.
"We will go on nationwide red alert on the risk of bird flu over the next few days," Bui Ba Bong, Vietnam's Deputy Minister of Agriculture and Rural Development, was quoted as telling the Thanh Nien daily newspaper.
"Preventing and fighting H5N1 outbreaks in poultry is extremely urgent and important in preventing and curbing H5N1 outbreaks among humans," he said, AFP reported.
Vietnam's government also reported the country's third human victim of bird flu this year. The 27-year-old man from northern Ninh Binh province died Feb. 14. That brings Vietnam's human death toll to 50 since the virus first appeared in the country a few years ago. Worldwide, it's believed the H5N1 virus has killed 228 people.
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Luxembourg Poised to Legalize Euthanasia
Luxembourg appears poised to become the third European country to legalize euthanasia, which is currently legal in the Netherlands and Belgium.
In a close vote, Luxembourg's parliament passed a bill to allow doctors to help patients end their lives. The bill still has to be approved in a second reading to take effect, Agence France-Presse reported.
The bill places strict regulation on the use euthanasia. For example, a doctor will have to consult with a colleague to confirm that a patient is suffering from a "grave and incurable condition."
Under the bill, a national commission dominated by doctors and officials would conduct a case-by-case review to ensure adherence to all legal conditions and procedures, AFP reported.
The country's medical community was mostly against the bill, which sparked passionate debate in Luxembourg, where Catholic values remain strong.
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Study Identifies Emerging Infectious Disease Hot Spots
Latin America, tropical Africa and South Asia are the most likely locations for the emergence of infectious diseases in the future and require closer monitoring, says a study by American and British researchers.
They made the conclusion after analyzing a database of 335 emerging infectious disease events that occurred between 1940 and 2004, CBC News reported. The study appears in the Feb. 21 issue of the journal Nature.
The researchers wrote that "that human population density was a common significant independent predictor of emerging infectious disease events," and noted that this finding "supports previous hypotheses that disease emergence is largely a product of anthropogenic and demographic changes and is a hidden cost of human economic development."
They recommended that richer developed countries provide resources to ensure proper infectious disease monitoring in poorer, less-developed nations, CBC News reported.
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One Cigarette Can Cause Tobacco Addiction
In some people, smoking a single cigarette can trigger tobacco addiction, says a New Zealand study that included 96,000 youngsters, ages 14-15. The participants provided information about whether they smoked and whether they felt the need to continue smoking.
As expected, regular smokers said they felt the urge to continue smoking. But the researchers were surprised to find that 46 percent of those who smoked less than one cigarette a month said they had the urge to continue smoking, Agence France-Presse reported.
And among those who said they had trouble suppressing the urge to smoke, 10 percent had the urge within two days of smoking their first cigarette and 25 percent within one month of their first cigarette.
The study authors concluded that "these data suggest that smoking one cigarette in total can prompt a loss of autonomy," AFP reported.
The findings were published Wednesday in the journal Addictive Behaviors.
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Anger Slows Injury Recovery
People who can't control their anger take longer to recovery from injury, says a University of Ohio study in the journal Brain, Behavior, Immunity.
Researchers inflicted minor burns on the arms of 98 volunteers and then monitored the healing process for eight days, Agence France-Presse reported. Before the burns were inflicted, the participants underwent psychological tests to determine where they ranked on an anger scale.
The study found that people who had trouble controlling expressions of anger were four times more likely to need more than four days for their burn wounds to heal than those who were able to control their anger.
Participants unable to control their anger also had higher secretions of the stress hormone cortisol, which may partly explain their longer healing time, the researchers said.
They suggested that anger control therapy could help certain patients heal more quickly after injury or surgery, AFP reported.
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Feeding May Affect Preterm Infants' Brain Development
The type of nutrition preterm infants receive during the first few weeks of life may have a major impact on brain development, says a U.K. study in the journal Pediatric Research.
Preterm infants who were fed enriched formula milk in the first few weeks after birth consistently did better on childhood IQ tests than other preterm babies, and the difference continued into the teenage years, BBC News reported.
The research team from Great Ormond Street Hospital for Children and the UCL Institute of Child Health in London also found that the infants who were fed the enriched formula had better development of a part of the brain called the caudate nucleus, which is associated with memory and learning.
Previous studies have noted an association between nutrition and behavior, but this is one of the first studies to suggest that feeding early in life may affect brain structure, the researchers said according to BBC.
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