Honda Motors Inc. has issued another recall to replace of more than 430,000 faulty airbag deflators that could rupture, causing death or harm to the driver. This is the third recall Honda will issue for this problem. The latest recall applies to 2001 and 2002 model-year Accord, Civic, Odyssey, CR-V, Pilot and 2002 Acura TL and CL vehicles in the United States.
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Yamaha Motor Corp. USA is recalling at the insistence of the Consumer Product Safety Commission 120,000 recreational vehicles. Two models were involved in 46 deaths and countless serious injuries.
The Consumer Product Safety Commission targeted the Rhino 450 and 660 models vehicles as unreasonably dangerous without significant alterations to the defects that caused the serious injuries and 46 deaths inflicted on consumers since fall of 2003.
Most of the injuries and deaths were due to rollovers. The design changes will reduce the risk of rollovers, improve handling and keep riders' limbs inside the vehicles.
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House Energy and Commerce Committee ranking Republican Rep. Joe L. Barton of Texas asked for clarification from the Food and Drug Administration (FDA) this week concerning deaths related to the blood thinner heparin. His letter called into question the adequacy of the agency's review of the deaths. He highlighted previous correspondence from the FDA he received in October that tied two cases of heparin-related deaths to drugs produced by American Pharmaceutical Partners (APP). The APP heparin was not tested for contaminants, according to a FDA letter. FDA spokeswoman Karen Riley gave no substantive response but said "the agency looks forward to clarifying the issue with Barton."
How can the United States Supreme Court or President Bush seriously think that it is a good idea to preempt private law suits against pharmaceutical companies based upon FDA approval. Surely this approach to rights reserved to states and individuals can't be removed in such a cavalier fashion.
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Delta Enterprise Corp., children's product maker, has recently recalled almost 1.6 million cribs linked to two infant deaths. This has led to a string of recalls of other cribs and bassinets made by other manufacturers.
The defective cribs include problematic hardware used on cribs sold from 1995 to 2005. The hardware includes safety pegs and spring pegs, respectively, for two different cribs. This hardware is what causes serious hazard and injury if not properly installed. If the drop side of the crib falls and disengages, this creates a gap that can entrap and suffocate infants.
Delta's recall is said to be huge--one of the largest in the recent series of recalls by the Consumer Product Safety Commission (CPSC).
What are your feelings about cribs having such dangerous problems? Cribs have been around for a long time and the design isn't rocket science. Have any of you had similar experiences?
Acomplia (rimonabant), is being pulled off the European market. Apparently, the obesity drug that once looked to be a big hit for Sanofi-Aventis, is too risky.
The European Medicines Agency (EMEA), the Food and Drug Administration's (FDA) counterpart, announced that "the benefits of Acomplia no longer outweigh its risks," particularly the "psychiatric side effects."
Some say the drug has always included side effects--particularly depression. According to the AP (10/24), a study cited by the EMEA revealed "[that] obese or overweight patients taking Acomplia were at approximately double the risk of developing psychiatric disorders than those taking a placebo." Other side effects can include increased blood pressure, panic attacks or psychiatric problems such as anxiety.
Records indicate that Acomplia has been prescribed to 97,000 people in the U.K. and the drugmaker claims that 700,000 worldwide have used the drug. It has been linked to five deaths and 720 adverse drug reactions in Britain since its 2006 launch.
Sanofi has agreed to pull the drug from shelves and be complaint with EMEA and healthcare professionals.
Why is it that Europe seems to always be one step ahead of the United States concerning product safety?
I recently settled a case in which a young contestant was required to go without sleep and keep his hand flat on a Nissan truck until the last contestant was standing. The contest was called "Hands on a Hardbody" He eventually left the contest, broke into a K-Mart, forced the trigger lock out of a shotgun and committed suicide. There was no effective exit strategy to assure safety for contestants although many instances had taken place over the years concerning insane behavior. One woman jumped the fence and ran out in traffic. She had to be tackled by her boyfriend. One contestant argued with his father because he thought he was in Oklahoma although the contest was in Longview Texas. One contestant thought he was pushing daisies down on the hood of the pickup. The examples are endless. Simply put, I argued that minimal protection should have been provided to the contestants to assure they were not a danger to themselves or others. This result of sleep deprivation has been known for decades and studied at length by scientists. The North Koreans used sleep deprivation and stress to break down soldiers in the Korean conflict. It wasn't that the soldiers just got tired, they went into a mental breakdown.
Sleep deprivation combined with stress and stimulants have been used casually in contests as well as work environments. It is simply dangerous and negligent to do so.
Studies have shown:
Patients suffering from insomnia reported a four-fold higher rate of attempted suicide.
The risks of only 24 hours of sleep deprivation are substantial and render an individual in a state of impairment comparable to being intoxicated
More than 80% of people are suffering from hallucinations by 48 hours of sleep deprivation
An important recent study done by the University of California, Berkeley, and Harvard Medical School was published in Current Biology showing objective radiological findings correlating with symptomatic changes in subjects who are sleep deprived. The emotional part of the brain (amygdala) is dramatically different in the images. The amygdala , which alerts the body to protect itself in times of danger, goes into overdrive on no sleep, according to the study. This consequently shuts down the prefrontal cortex, which commands logical reasoning, and thus prevents the release of chemicals needed to calm down the fight-or-flight reflex.
The study showed that sleep deprivation excessively boosts the part of the brain most closely connected to depression, anxiety and other psychiatric disorders.
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Fentanyl is a opiate 100 times more powerful than morphine. Originally this drug was put out as Duragesic® made by Johnson & Johnson. Although originally it was used in operations, it later was applied in patches for patients with chronic serious pain. Numerous generic versions of the fentanyl patch, including Sandoz (manufactured by Alza), Mylan, Watson and Actavis hit the market. Although intended for only serious pain symtoms, some doctors prescribed it to those not needing such a potent medication. "Fold-over defects" and "stringer leakers" have caused leakage from the patches to over-medicate and kill patients.
A second Public Health Advisory regarding fentanyl pain patches has been issued, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."
Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic® and Sandoz brands. Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl transdermal system CII patches sold in the United States are being voluntarily recalled.
Once again, patients have relied vainly on the FDA, pharmaceutical companies and their treating physicians for a good faith review of the medications prescribed.
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