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Defective Products

FDA Sets Limit for Acceptable Amount of Arsenic in Baby Cereal

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Cereal can contain arsenic from the grains it uses, but rice cereals are often higher in this toxic substance. The FDA has issued a limit for the amount of arsenic that can be found in rice cereal for infants. It is the first limit the agency has set up for arsenic in any food.

Arsenic in Baby Cereal

Rice is a grain with a high absorption rate for arsenic. It can end up with 10 times more of the metal than other grains. Because rice cereal is usually one of the first solid foods given to babies, it can have a significant impact on development.

Babies may eat multiple servings of rice cereal in a day, which can lead to exposure to inorganic arsenic, which is toxic. It can damage the neurodevelopmental system and harm their IQ.

Arsenic in rice cereal isn’t a new issue. Testing revealed that over 60 percent of rice cereals and other products have arsenic in them back in 2012. Since then, agencies have called for limits on the amount found in these products. Now, eight years later, the FDA has determined a limit of 100 parts per billion for arsenic in infant rice cereal. Other agencies have called for a lower limit.

While this limit is important news to manufacturers of baby cereal, it’s not enforceable. It is voluntary for manufacturers to follow these guidelines. The FDA conducted tests in 2018 on baby rice cereals, looking at the amount of arsenic present. About three-fourths of the products were at or below the new 100 ppb limit.

While critics believe this is an important first step to controlling the amount of arsenic that enters an infant’s system, they say more still needs to be done. Other products should be included, according to consumers advocates. Apple Juice is another product of concern. Experts believe it should be treated the same as drinking water with a limit of 10 ppb.

The Dangers of Arsenic

According to consumer advocates, limits should be given for all heavy metals, including lead and cadmium. The goal should be lower to reduce risk for children.

Arsenic is a natural element, which means it occurs in nature. It can get into the food supply through the soil as well as in the water and air. Contamination can happen with mining or fracking. Volcanoes that erupt can create an increase in arsenic at the surface of the earth.

Long-term exposure of arsenic has been linked to certain types of cancer and skin disorders. Even short-term exposure can lead to nausea and vomiting and other side effects. Young children have a higher risk for learning and development issues, which is why the FDA monitors products for infants and younger people at a higher rate than with other products.

It is important for parents to be aware of these risks and to determine which products are safest for their children. The effects from exposure to arsenic may not be seen right away, but they may be serious.

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Defective Products

Bayer Settles 90% of U.S. Essure Claims for 1.6 Billion

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About 90 percent of the more than 39,000 lawsuits filed against Bayer over Essure injuries have been resolved by a $1.6 billion settlement. Bayer said in a statement that the settlement resolves most filed and unfiled cases and that it continues to work with plaintiff’s lawyers to resolve the remaining cases.

FDA Actions and Essure Injury Complaints

The settlement comes after years of complains of adverse events involving the metal coils which are placed in the fallopian tubes. Some of these complaints say that the coils can perforate the tubes, tear the uterus, and that the coils can break causing little metal shards to migrate elsewhere in the body. Women have also complained of heavy bleeding, pain, and other side effects that the patients were forced to undergo hysterectomy.

In 2018, the U.S. Food and Drug Administration placed restrictions on the device and required patients to review the Patient- Doctor Discussion Checklist and sign prior to being implanted with the birth control device. Bayer made the decision to stop selling Essure in the United States not long after citing declining sales.

Post-Market Surveillance Reports

The required 522 study, a post-marketing surveillance plan, was also extended by the FDA from three to five years. The FDA published the first spreadsheet of Essure adverse events on August 11, 2020, which includes events that Bayer knew or learns of during the period of November 2016 to November 2020.

The first spreadsheet includes more than 1,400 events including pain, device fragments, pregnancy, and organ perforations, including 1376 reports of serious injury, 53 reports of death and 24 reports of malfunction.

Essure Lawsuit Settlement

Many of the plaintiffs alleged in court filings that Bayer knew or should have known about the risk of adverse events, including organ perforation, device breakage, and device migration. They also allege that Essure birth control was improperly design and can break and migrate after being implanted. They accused Bayer of misrepresenting the efficacy and safety of the contraceptive device and Women who suffered Essure injuries alleged in court filings that Bayer concealed the risks and dangers of the device from the FDA, the medical community and from the women who relied on the device.

Many of the terms of the settlement are confidential, and Bayer did not admit to any wrongdoing in the court filings.

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Covid-19

Risk for COVID-19 Goes Up for Vapers

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A new study shows the correlation between COVID-19 and young adults who are vaping. This includes teens as well. According to the study, the risk for developing the infection was five times higher if the person vaped regularly.

The study also indicated an increase of seven times the risk for young adults who vape and smoke tobacco cigarettes. The study was published in the Journal of Adolescent Health. Because of this information, the government has asked the US Food and Drug Administration (FDA) to remove all e-cigarettes from the market until after the pandemic has been dealt with.

E-cigarettes and Damage to the Lungs

Experts are concerned about the high numbers. They want young adults and teens to be aware that e-cigarettes and vaping devices aren’t safe. They come with serious harm that is real.

The evidence isn’t astounding, but it is important. It is well-known that e-cigarettes can harm the lungs as well as the immune system. In 2019, there were numerous cases of a mysterious lung illness associated with vaping. Many people got sick from the illness after vaping, and several people died.

There is another correlation between vaping and COVID-19. According to researchers, the SARS-CoV-2 virus that causes COVID-19 needs a pathway to get into the body’s cells. It is believed that e-cigarettes might make the pathway easier to access.

Another risk is that teens and young adults often share vaping devices. If one person is positive for COVID-19, the next person using that device could become infected as they inhale the virus right into their lungs. Exhaling from the vaping device could also cause people nearby to become infected.

The government is interceding in light of this news. The Subcommittee from the US House Committee on Oversight and Reform is calling on the FDA to get these products out of the hands of consumers. The subcommittee is the Economic and Consumer Policy.

This information goes along with a study from China that showed smokers in that country developed more serious symptoms and had to be hospitalized more often than other patients.

Young People Who Vape and Smoke are At Risk

An online survey was handed out in early May to teens and young adults under the age of 25. About half of the 4300 surveyed admitted to using e-cigarettes. The study showed that those who vaped had about three times the likelihood for being tested for COVID-19. Those who vaped and smoked had a five times higher rate of developing symptoms of the virus. These symptoms include coughing and fever as well as difficulty breathing and feeling fatigued.

Many young adults are already hooked on vaping and e-cigarettes. However, there are some programs that are tailored just for younger adults.

Some researchers also say that a direct correlation between e-cigarettes and COVID-19 hasn’t been made. While they believe that tobacco products do cause damage to the respiratory system and increase the infection rate, they cannot say for a fact that it causes an increased risk directly. However, all can agree that it appears that those young people who are using e-cigarettes are at a high risk for developing the coronavirus and possible complications.

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Car Accidents

New Report Shows Automated Driving Systems Not Equal to Human Drivers

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Automated systems have progressed quickly in the automotive industry. Vehicles can park and even drive without the assistance of drivers in some cases. However, a new study by AAA indicates that these systems still aren’t as reliable and safe as human drivers.

Flawed Systems

According to the report by AAA, the current automation systems are limited. They still require drivers to pay attention and not rely on them completely as they drive to prevent accidents. Researchers conducted tests of vehicle automation systems, including Ford CoPilot 360 and GM Super Cruise. These systems help the driver by performing steering, braking and acceleration at least partially without human intervention.

Research indicates that the systems aren’t always consistent in their performance. Some vehicles failed to stay within the designated lane and would occasionally steer too close to traffic coming from the other direction. Many of these systems have lane monitoring to keep vehicles in the correct lane.

The systems also come with automatic braking for emergencies or stopped traffic. AAA found that sometimes the vehicles may brake abruptly, not giving the vehicle behind them enough time to stop, resulting in a rear-end collision. These systems are also supposed to recognize obstacles to avoid accidents. However, some tests showed that they didn’t adjust direction to avoid a disabled vehicle that was in the roadway.

The manufacturers don’t claim perfection when it comes to the systems. In fact, they often include the shortcomings of the vehicle in the owners’ manuals. However, drivers often expect perfect performance when they drive. They rely solely on the automated systems rather than paying attention to the situation.

Based partly on the results of the study, AAA is asking manufacturers to improve these systems, often known as Level 2 systems, before they add them to new models. This isn’t the first test done of automated systems. The results are similar to other studies done by the Insurance Institute for Highway Safety (IIHS). Consumer Reports has also seen similar results in evaluations of systems.

The Testing

AAA used five vehicles for testing:

  • 2019 Ford Edge
  • 2019 BMW X7
  • 2019 Cadillac XT6
  • 2020 Subaru Outback
  • 2020 Kia Telluride

All models feature active driving assistance. All but the Cadillac and Ford models were tested on the AAA closed test track. Those two models had limitations on location and speed. All five models were tested on a round trip between Los Angeles and San Francisco, which totaled 800 miles. They were driven on interstates as well as local highways.

All five models have problems with being able to stay in the correct lane. They fared well on the closed track, except for some left bias, which would put them closer to oncoming traffic. All five had issues on curving roads and hills.

While AAA admitted that some models worked better in various situations than others, none could be completely relied upon. The researchers recommend that drivers continue to pay attention and use the systems as assistance, but not to rely on them to do the job alone.

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