Thursday, February 18, 2010

Chesley: Toyota Apologies Are Not Getting Dangerous Cars Off Roads

/PRNewswire/ -- With the latest news that Toyota may recall its 2009 and 2010 Corollas because of power steering defects, Toyota has now admitted to defects in its vehicles' accelerator, braking and steering systems - the three most important aspects of operating a motor vehicle.

Stanley M. Chesley of the Cincinnati-based law firm of Waite, Schneider, Bayless & Chesley Co., L.P.A. - whose firm has filed a major RICO class action against Toyota for deceiving its customers and dealers about these mounting defects - stated that "when your Toyota's accelerator, brakes and steering are all defective, what you really have is a failure of your car's electronic controls, which function as the car's brain and central nervous system."

Congressman Bart Stupak recently amplified Chesley's suspicion, noting that Toyota's internal documents made clear that, as far back as 2002, Toyota was aware that electronic control system problems may be causing sudden acceleration. Despite this Congressional investigation, however, Toyota continues to bar investigators from examining its electronic control technology.

Now, with Toyota's recall of a staggering 11 million vehicles, Toyota's president and CEO, Akio Toyoda, yesterday indicated that he won't come to the U.S. to testify at upcoming congressional hearings on the recalls.

Chesley stated, "No one is above the law. Presidents of tobacco companies, and even U.S. Presidents, have testified before congressional committees. Akio Toyoda's grand apologies from 6,000 miles away don't release him from appearing before Congress and they don't explain Toyota's nearly decade-long cover up of these defects."

According to news sources, Toyota's faulty engineering and sloppy quality control - all of which stem from decision-making at Toyota's Japanese headquarters - have caused at least 39 confirmed deaths, countless injuries and billions of dollars in economic damage to Toyota drivers. As Chesley remarked, "for Toyota's CEO to even consider refusing to appear before Congress, particularly when he's looking to the United States to make Toyota the world's largest car manufacturer, is outrageous."

Chesley filed the RICO class action, in part, because the evidence continues to disprove Toyota's statements about the defects' causes. All of this evidence highlighting Toyota's deception underscores the company's pattern of corrupt and fraudulent practices, which is what RICO, the federal racketeering statute, prohibits.

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Wednesday, February 17, 2010

FDA Warns About Serious Side Effects From Maalox Product Mix-Ups

/PRNewswire/ -- The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. Both Maalox Total Relief and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available without a prescription as over-the-counter liquid medications.

The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox" and will change the drug's packaging to avoid further confusion.

"Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," says Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis' efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future."

Maalox Total Relief's active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.

Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused. Due to this confusion, NCH has agreed to:

-- Change the name of Maalox Total Relief to one that does not include
the root name Maalox as well as change the product label design;
-- Conduct an educational campaign with outreach to healthcare
professionals and consumers regarding different Maalox products and
ways to select the appropriate Maalox brand product; and,
-- Actively monitor and report adverse events associated with the use of
Maalox brand products.


"The FDA is concerned about the public health impact of medication mix-ups for products that have the same names or portions of the same name, but contain different active ingredients," said Ms. Holquist. "We want companies to consider the potential for name confusion when choosing names for their drugs."

The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient's symptoms.

Any Maalox side effects or other product problems should be reported to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-332-1088.

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New Study Concludes No Effects From BPA on Nervous System

/PRNewswire/ -- The American Chemistry Council (ACC) today commented on a significant study published online in the scientific journal Toxicological Sciences. Quotes below may be attributed to Steven G. Hentges, Ph.D., ACC's Polycarbonate/BPA Global Group:

"This new study, which exposed pregnant rodents to a range of BPA dietary doses from low to high, concluded that BPA had no effects on brain development or behavior in their offspring that had been exposed to BPA in utero and throughout development. The robust study was conducted by highly qualified researchers at WIL Research Laboratories.

"This study follows on the heels of a recent low-dose study by EPA that also explored the potential effects of BPA at very early stages of life in rodents and that found even low doses of BPA did not affect the brain, reproduction or development. Both of these studies - examining potential effects on brain development and behavior at low doses - address the areas of "some concern" which the National Toxicology Program had previously identified as appropriate for additional research.

"Regulatory agencies from around the world have concluded that the science supports the safety of BPA for people of all ages in its current uses. Plastics made with BPA contribute to the safety and convenience of everyday life because of their durability, clarity and shatter-resistance. Can liners made with BPA are essential components to help to protect the safety of packaged foods and preserve products from spoilage and contamination."

Background on the study

The study is titled "Developmental Neurotoxicity Study of Dietary Bisphenol A in Sprague-Dawley Rats," (Donald G. Stump, et al.). In the study, pregnant female rats were exposed to BPA via direct consumption of the diet at dosage levels that spanned the range from low doses, as used in some published studies reporting developmental neurotoxicity, to a high dose that was anticipated to result in systemic toxicity in the pregnant rat (0, 0.01, 0.1, 5, 50, and 150 mg/kg/day). The offspring, exposed to BPA in utero, via milk while nursing and via direct consumption through the diet once they started to feed, were studied for functional or morphological effects on their nervous systems. The study concluded that there were no neurologic or neurobehavioral effects related to BPA at any dose tested.

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Tuesday, February 16, 2010

If You Purchased Dannon's Activia or DanActive Branded Products, You May be Entitled to Cash from a Class Action Settlement

/PRNewswire/ -- The following statement is being issued by Blood, Hurst & O'Reardon, LLP regarding Gemelas v. The Dannon Company.

For more information call 1.888.418.6122. Do NOT call Dannon.

A proposed settlement has been reached in a class action lawsuit about Dannon's advertising for Activia® and DanActive® branded products ("Products") and their benefits from "probiotic" bacteria. The lawsuit claims the advertising was not true. Dannon stands by its advertising and denies it did anything wrong. However, Dannon has settled to avoid the cost and distraction of litigation. If you're a Class Member, you could receive up to $100. A federal Court authorized this notice. Before any money is paid, the Court will have a hearing to decide whether to approve the settlement.

You're a Class Member if you purchased, not for resale purposes, the Products in the United States at anytime up until April 23, 2010.

A $35,000,000 fund, and possibly more, will be created to reimburse Class Members for the Products they purchased, and to pay related expenses. Details about how much you may receive are available at www.DannonSettlement.com.

To ask for cash and remain in the Class, you must mail or submit a completed claim form online by October 1, 2010. If you do not wish to participate in the settlement, you may exclude yourself from the Class by May 24, 2010. Or you may stay in the Class and object to the settlement by May 24, 2010. Visit the website for important information about these options.

The Court will hold a hearing on June 23, 2010 to consider the settlement and Class Counsel's request for $10,000,000 in attorneys' fees, plus expenses. You don't have to attend the hearing. For more information, visit www.DannonSettlement.com.

CLAIM FORMS MUST BE POSTMARKED OR SUBMITTED ONLINE BY OCTOBER 1, 2010 - VISIT WWW.DANNONSETTLEMENT.COM For a full list of the Products, see www.DannonSettlement.com

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Sunday, February 14, 2010

Toxic Sunday Morning Humor...

Avoid cutting yourself when slicing vegetables by getting someone else to do the chopping.

Avoid arguments with the Mrs. about lifting the toilet seat by using the sink.

A mouse trap, placed on top of your alarm clock, will prevent you from rolling over and going back to sleep after you hit the snooze button.

If you have a bad cough, take a large dose of laxatives; then you'll be afraid to cough.

You only need two tools in life - WD40 and Duct Tape. If it doesn't move and should, use the WD40. If it shouldn't move and does, use the duct tape.

And... if you can't fix it with a hammer, you've got an electrical problem.

DAILY THOUGHT: Some people are like slinkies; not really good for anything but they bring a smile to your face when pushed down the stairs.

Remember, everyone seems normal until you get to know them.

-- Rec'd the above via email & had to pass along.

Thursday, February 11, 2010

Headache May Linger Years Later in People Exposed to World Trade Center Dust, Fumes

/PRNewswire/ -- Workers and residents exposed to dust and fumes caused by the collapse of the World Trade Center on September 11, 2001 frequently reported headache years later, according to research released today that will be presented at the American Academy of Neurology's 62nd Annual Meeting in Toronto April 10 to April 17, 2010.

"We knew that headaches were common in people living and working near the World Trade Center on and immediately after 9/11, but this is the first study to look at headaches several years after the event," said study author Sara Crystal, MD, with the NYU School of Medicine in New York City.

The study involved 765 people who were enrolled in the Bellevue Hospital World Trade Center Environmental Health Center seven years after the building collapse and who did not have headaches prior to 9/11. Of those, about 55 percent reported having exposure to the initial World Trade Center dust cloud.

Headaches in the four weeks prior to enrollment were reported by 43 percent of those surveyed, suggesting that headache is a common and persistent symptom in those exposed to World Trade Center dust and fumes. People caught in the initial dust cloud were slightly more likely to report headaches than those not caught in the dust cloud, which may indicate that greater exposure may be associated with a greater risk of developing persistent headache. People with headaches were also more likely to experience wheezing, breathlessness with exercise, nasal drip or sinus congestion and reflux disease after 9/11.

"More research needs to be done on the possible longer-term effects of exposure to gasses and dust when the World Trade Center fell," Crystal said. "We also need additional studies to understand the relationship between headaches, other physical symptoms, and mental health issues."

More data will be presented by Crystal at the 62nd AAN Annual Meeting.

The study was supported by the National Institutes of Health.

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Wednesday, February 10, 2010

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.

For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

“Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”

The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.

In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.

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