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Month: February 2011

Toyota to recall 2.2 million cars over pedal troubles

Toyota Motor Corp. recalled 2.17 million vehicles in the United States on Thursday to address accelerator pedals that could become entrapped in floor mats or jammed in driver’s side carpeting.

The world’s No. 1 auto company said more than half of the vehicles under recall are being added to a massive 2009 recall that fixed gas pedals getting trapped in the floor mat.

Toyota has now recalled more than 14 million vehicles globally over safety problems since 2009. U.S. regulators said earlier this month that electronic flaws were not to blame for reports of sudden, unintended acceleration.

The Japanese automaker said it would add three models to the 2009 pedal entrapment recall: about 600,000 4Runner SUVs from the 2003-2009 model years; 761,000 RAV4 compact SUVs from the 2006-2010 model years; and 17,000 Lexus LX 570s from the 2008-2011 model years.

The recall also includes 372,000 RX 330, RX 350 and RX 400H vehicles from the 2004 through early 2007 model years and 397,000 2004-2006 Toyota Highlander SUVs and hybrid versions to replace floor carpet covering and retention clips on the driver’s side that could interfere with the accelerator pedal arm.

Toyota also recalled 20,000 2006 through early 2007 GS 300 and GS 350 all-wheel drive vehicles to change the shape of a plastic pad embedded in the driver’s side floor carpet that could cause pedal interference.

Toyota spokesman Brian Lyons said the company was unaware of any accidents or injuries related to the new recalls.

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B.O.B. Trailers recalls about 357,000 strollers

B.O.B. Trailers recalls about 357,000 strollers

B.O.B. Trailers Inc., of Boise, Idaho is recalling about 337,000 single and double strollers in the United States and about 20,000 in Canada.

A drawstring on the stroller can get wrapped around a child’s neck, posing a strangulation hazard. The firm has received one report of an 11-month-old who got entangled in the cord at her neck. She was freed by her mother.

The recall involves a number of models of single and double strollers, which were sold at REI and other stores nationwide and on the Web at Babiesrus.com, Target.com and Amazon.com between April 2002 and February 2011.

Consumers should immediately stop using the recalled strollers and remove the drawstring. More information can be found from the Consumer Product Safety Commission and at the company’s website: www.bobcanopy.com.

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Cellphone Use Tied to Changes in Brain Activity

Researchers from the National Institutes of Health have found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna, raising new questions about the health effects of low levels of radiation emitted from cellphones.

The researchers, led by Dr. Nora D. Volkow, director of the National Institute on Drug Abuse, urged caution in interpreting the findings because it is not known whether the changes, which were seen in brain scans, have any meaningful effect on a person’s overall health.

But the study, published Wednesday in The Journal of the American Medical Association, is among the first and largest to document that the weak radio-frequency signals from cellphones have the potential to alter brain activity.



“The study is important because it documents that the human brain is sensitive to the electromagnetic radiation that is emitted by cellphones,” Dr. Volkow said. “It also highlights the importance of doing studies to address the question of whether there are — or are not — long-lasting consequences of repeated stimulation, of getting exposed over five, 10 or 15 years.”

Although preliminary, the findings are certain to reignite a debate about the safety of cellphones. A few observational studies have suggested a link between heavy cellphone use and rare brain tumors, but the bulk of the available scientific evidence shows no added risk. Major medical groups have said that cellphones are safe, but some top doctors, including the former director of the University of Pittsburgh Cancer Center and prominent neurosurgeons, have urged the use of headsets as a precaution.

Dr. Volkow said that the latest research is preliminary and does not address questions about cancer or other heath issues, but it does raise new questions about potential areas of research to better understand the health implications of increased brain activity resulting from cellphone use.

“Unfortunately this particular study does not enlighten us in terms of whether this is detrimental or if it could even be beneficial,” Dr. Volkow said. “It just tells us that even though these are weak signals, the human brain is activated by them.”

Most major medical groups, including the American Cancer Society, the National Cancer Institute and the Food and Drug Administration, have said the existing data on cellphones and health has been reassuring, particularly a major European study released last year by the World Health Organization that found no increased risk of rare brain tumors among cellphone users.

When asked to comment on the latest study, the leading industry trade group, CTIA – The Wireless Association, released a statement emphasizing recent studies that have shown no elevated cancer risk associated with cellphone use.

“The peer-reviewed scientific evidence has overwhelmingly indicated that wireless devices, within the limits established by the F.C.C., do not pose a public health risk or cause any adverse health effects,” said John Walls, vice president of public affairs for the trade group, adding that leading global health groups “all have concurred that wireless devices are not a public health risk.”

But the new research differed from the large observational studies that have been conducted to study cellphone use. In Dr. Volkow’s study, the researchers used brain scans to directly measure how the electromagnetic radiation emitted from cellphones affected brain activity..

The randomized study, conducted in 2009, asked 47 participants to undergo positron emission tomography — or PET — scans, which measure brain glucose metabolism, a marker of brain activity. Each study subject was fitted with a cellphone on each ear and then underwent two 50-minute scans.

During one scan, the cellphones were turned off, but during the other scan, the phone on the right ear was activated to receive a call from a recorded message, although the sound was turned off to avoid auditory stimulation.

Whether the phone was on or off did not affect the overall metabolism of the brain, but the scans did show a 7 percent increase in activity in the part of the brain closest to the antenna. The finding was highly statistically significant, the researchers said. They said the activity was unlikely to be associated with heat from the phone because it occurred near the antenna rather than where the phone touched the head.

In the past, any concerns about the health effects of cellphones have been largely dismissed because the radiofrequency waves emitted from the devices are believed to be benign. Cellphones emit nonionizing radiation, waves of energy that are too weak to break chemical bonds or to set off the DNA damage known to cause cancers. Scientists have said repeatedly that there is no known biological mechanism to explain how nonionizing radiation might lead to cancer or other health problems.

But the new study opens up an entirely new potential area of research. Although an increase in brain glucose metabolism happens during normal brain function, the question is whether repeated artificial stimulation as a result of exposure to electromagnetic radiation might have a detrimental effect.

Although speculative, one theory about how an artificial increase in brain glucose metabolism could be harmful is that it could potentially lead to the creation of molecules called free radicals, which in excess can damage healthy cells. Or it may be that repeated stimulation by electromagnetic radiation could set off an inflammatory response, which studies suggest is associated with a number of heath problems, including cancer.

Among cancer researchers and others interested in the health effects of cellphones, the study, listed in the medical journal under the heading “Preliminary Communications,” was met with enthusiasm because of the credibility of the researchers behind it and the careful methods used.

“It’s a high-quality team, well regarded, and if nothing else they’re showing that radiation is doing something in the brain,” said Louis Slesin, editor of Microwave News, a newsletter on the health effects of electromagnetic radiation. “The dogma in the cellphone community says that it doesn’t do anything. What she’s shown is that it does do something, and the next thing to find out is what it’s doing and whether it’s causing harm.”

Dr. Ronald B. Herberman, former director of the Pittsburgh Cancer Institute and now chief medical officer for the Intrexon Corporation, a biotechnology company in Germantown, Md., said, “I think it’s a very well-designed study, and they have clearly shown that there is biologic activity being induced in the nerve cells in the region where the antenna is the closest.” Dr. Herberman said skeptics about the risks of cellphones have focused on the fact that the type of radiation they emit is too weak to break chemical bonds and cannot plausibly be implicated in cancer. However, the new research suggests a potentially different pathway for cancer and other health problems to develop.

“I think it’s an important new direction to go in for biologists to start delving deeper into sorting out what might be going on,” Dr. Herberman said.

In an editorial accompanying the Journal article, Henry C. Lai, a University of Washington professor of bioengineering who has long raised concerns about cellphone safety, said he hoped the data would broaden the focus of cellphone research and health.

“The bottom line is that it adds to the concern that cellphone use could be a health hazard,” said Dr. Lai. “Everybody is worried about brain cancer, and the jury is still out on that question. There are actually quite a lot of studies showing cellphone radiation associated with other events, like sleep disturbances. But people have not been paying a lot of attention to these other types of studies.”

Dr. Volkow said future research may even show that the electromagnetic waves emitted from cellphones could be used to stimulate the brain for therapeutic reasons. She said the research should not set off alarms about cellphone use because simple precautions like using a headset or earpiece can alleviate any concern.

“It does not in any way preclude or decrease my cellphone utilization,” she said.

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Antipsychotics During Pregnancy May Harm Newborns, FDA Says

Johnson & Johnson’s Risperdal and Eli Lilly & Co.’s Zyprexa are among more than 20 antipsychotic drugs that U.S. regulators said may pose risks to newborns when taken by mothers during pregnancy.

The Food and Drug Administration updated labeling for antipsychotic drugs to show potential side effects to children born to mothers on the medicines in the third trimester, the agency said today in a drug safety communication.

The labeling change is the first in six years to cover all drugs in the class known as atypical antipsychotics. The medications, used for conditions such as schizophrenia and bipolar disorder, may cause abnormal muscle movements and withdrawal symptoms in newborns, the FDA said. Symptoms can include tremor, sleepiness and difficulty with breathing or feeding.

“In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays,” the FDA said.

Bristol-Myers Squibb Co.’s Abilify, AstraZeneca Plc’s Seroquel and Novartis AG’s Clozaril are among the other antipsychotic drugs cited in the FDA notice.

The change has been implemented to standardize labeling language, Sandy Walsh, an FDA spokeswoman, said today in an e-mail. The agency made “the labels consistent regarding an issue most prescribers have known about for a long time,” she said.

Reported Symptoms

The FDA received 69 reports through Oct. 29, 2008, of abnormal muscle movement or withdrawal among newborns whose mothers took antipsychotic drugs, according to the safety notice. While most cases were “confounded by other factors” such as premature birth and the use of other medications, some suggest side effects “may occur with antipsychotics alone,” the agency said.

Patients who become pregnant shouldn’t discontinue antipsychotic drugs without consulting their doctors, because stopping the medications abruptly “can cause significant complications for treatment,” the FDA said.

The labeling change for the entire drug class was the first for atypical antipsychotics since 2005, when the FDA required the addition of a boxed warning to show risks to older patients with dementia, Walsh said.

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IKEA Recalls to Repair Cribs Due to Mattress Support Collapse; Cribs Pose Entrapment and Suffocation

WASHINGTON, Feb. 17, 2011 /PRNewswire-USNewswire/ — The U.S. Consumer Product Safety Commission and Health Canada, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of product: SNIGLAR cribs

Units: About 20,000 in the United States and 6,000 in Canada

Distributor: IKEA Home Furnishings, of Conshohocken, Pa.

Hazard: The four bolts provided with some SNIGLAR cribs to secure the mattress support are not long enough. This can cause the mattress support to detach and collapse, creating a risk of entrapment and suffocation to a child in the crib.

Incidents/Injuries: None reported

Description:

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Why Tort Reform is a bad thing

The Oklahoma Senate Judiciary Committee recently passed five bills to “protect Oklahomans, our doctors and our businesses from frivolous lawsuits.” Oh, if only it were true. But it’s not.

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None of the five bills, Senate Bills 862-866, addresses or even mentions “frivolous” claims. Instead, the five are directed at legitimate claims — claims an injured plaintiff wins. A lawsuit an injured Oklahoman wins is, by any definition, not frivolous. Instead of regulating frivolous claims, each of the bills simply reduces the accountability of one who has caused or inflicted harm.

The bills provide protection for wrongdoers who cause injuries to innocent victims. They protect drunken drivers and companies that make defective products, for example. They make wrongdoers less accountable for their conduct. Why should Oklahoma favor a wrongdoer over an innocent victim?

Let’s say a defective Toyota causes an accident resulting in brain damage to a 16-year-old girl. As a result of her injuries, she can no longer play sports or take care of herself, but she is aware of what her life was like before she was injured. SB 863 would limit to $250,000 the amount this young lady could recover for the loss of her ability to enjoy her life. The artificial limit doesn’t discourage filing frivolous lawsuits; it simply protects Toyota.

If our young victim’s family was lucky enough to have health insurance that cover her catastrophic medical bills, then Toyota wouldn’t have to pay them. SB 864 would allow Toyota to reduce its responsibility by the amount of a benefit provided by the victim’s family. Reducing the amount Toyota has to pay doesn’t discourage frivolous lawsuits; it just protects Toyota.

Maybe Toyota is able to put half of the blame on the driver of its defective car. SB 862 would require the automaker to pay only half of the damages the jury awards. If that driver can’t pay her half of the damages, the loss gets shifted to our innocent victim, instead of to Toyota, one of the wrongdoers. Limiting Toyota’s responsibility doesn’t discourage filing frivolous lawsuits; it simply protects Toyota.

Why would Oklahoma pass laws that would protect Toyota instead of protecting one of our own? Toyota doesn’t manufacture cars here, and these five bills don’t give it incentive to start. The bills will not attract jobs or spur our economy. They will not fund education or raise our graduation rates. They will not fix our roads or prisons. They will not protect any Oklahoma children from abuse or neglect.

The bills approved by the judiciary committee will change the way Oklahoma has held people accountable for their actions since statehood. Who should be accountable, the wrongdoer or the victim? We should all ask our elected officials: Why should Oklahoma protect Toyota?


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Johnson & Johnson unit recalls 70,000 syringes of antipsychotic drug Invega due to cracks

NEW YORK (AP) — A unit of Johnson & Johnson has recalled 70,000 syringes of its antipsychotic drug Invega Sustenna after finding that some of the pre-filled syringes may have cracks which possibly could affect the drug’s sterility.

Janssen, a unit of Johnson & Johnson, said in a letter to pharmacists and health care providers Friday that the voluntary recall affects lots of its 234-milligram-strength injections. The crack is completely covered by the label and is not detectable by the user.

The company said in the letter posted on its website that there have been no reports of adverse effects or infection since the product launched and no reports of leakage associated with cracked syringe barrels. No other strengths of the drug or products marketed by Janssen are affected.

Invega was approved in December 2006 to treat schizophrenia. The drug is related to Risperdal, a former blockbuster antipsychotic that lost patent protection in 2008. Janssen markets Invega in the United States for New Brunswick, N.J.-based J&J. Janssen said the recall impacts most available inventory of the 234-mg strength drug, but it expects to resume shipping product in early March and returning to normal levels of product availability in April.

This is the latest recall for Johnson & Johnson, which in the past year has recalled millions of bottles of children’s Tylenol and other pain relievers and cold medicines for children and adults, as well as some 1 Day Acuvue contact lenses sold abroad. The company has been conducting reviews at its manufacturing sites.

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Nearly 800,000 Dorel Child-Safety Seats Are Recalled

Almost 800,000 child seats are being recalled because their harnesses may not hold the child securely, the National Highway Traffic Safety Administration said Monday.

The recall covers a wide range of booster, convertible and infant seats, including some sold as part of a stroller travel system, made by the Dorel Juvenile Group of Columbus, Ind. The action was prompted by the safety agency, which began an investigation of the restraints last year after receiving several consumer complaints that the restraining straps on the seats had loosened.

A Safety 1st Alpha Omega convertible car seat, model No. 22469, one of the models affected by the Dorel Juvenile Group recall. A Safety 1st Alpha Omega convertible car seat, model No. 22469, one of the models affected by the Dorel Juvenile Group recall.

The restraints were sold under the brand names Safety 1st, Maxi-Cosi, Cosco and Eddie Bauer, Julie Vallese, a Dorel spokeswoman, said in a telephone interview. They were manufactured from May 1, 2008, to April 30, 2009. A list of the affected models can be found here.

In a filing with N.H.T.S.A., Dorel said, “There have been no reports of center front adjuster failure in real world crashes, no injuries and no deaths reported to the company.”

Dorel said it had received 143 complaints of the front harness loosening and was conducting the recall even though it feels there was no safety defect. Instead, it told the agency the restraints “exhibited performance issues.”

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