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Hardesty, Tyde, Green & Ashton, P.A. blog
Wednesday, December 13, 2006
Allstate Insurance Caught in Groundless Rate Increase
Florida regulators allowed Allstate Insurance Co. a substantial rate increase even though they had applied for a much larger increase earlier this year. The Allstate rate increase was the latest in a list of increases by major insurance companies such as State Farm and Nationwide. Interestingly, there have been a slew of increase application that are not accompanied by any documentation or evidence of validity. Rather than face the scrutiny of proving the need for the increase Allstate simply reduced their requested amount thereby pulling the wool over the regulators eyes while overcharging Floridians.
http://http://www.jacksonville.com/apnews/stories/121206/D8LVIB5G0.shtml
http://http://www.jacksonville.com/apnews/stories/121206/D8LVIB5G0.shtml
posted by
Attorney W. Marc Hardesty
at
7:06 PM
Suicide Risk for Anti - Depressants
New warnings regarding the potential lethal effects of anti depressants were issued today by the Food and Drug Administration. The risk of suicide by patients 25 years of age and younger was dramatically higher than older patients prescribed such well know medications as Zoloft, Prozac, Paxil and Effexor. It is vitally important to question the prescribing physician regarding these risks and to note and report any unusual behavior or indications of suicidal behavior immediately. The warning are detailed in the link below. http://http://today.reuters.com/news/articlebusiness.aspx?type=tnBusinessNews&storyID=nN13457204&imageid=∩=&from=business
posted by
Attorney W. Marc Hardesty
at
3:50 PM
Thursday, December 07, 2006
Fire at Sea
There are very few events that rival the risk of injury or death more than a uncontrolled fire on a boat or ship. The risk of explosion due to fuel, the toxic smoke and the limited evacuation areas all contribute to the catastrophic events that can occur. Fire fighting capability is crutial to avoiding disaster. Unfortunately some manufactures have constructed faulty products that fail when you need them most. The latest failure is listed on the United States Coast Guard web site, Please review: Alerts
Fire Extinguisher Recall
PRODUCT SAFETY RECALL STRIKE FIRST CORPORATION OF AMERICA SERVICE BULLETIN #002
Strike First has determined that the valve stem seat in a number of its 2.5 and 5 lb fire extinguishers assembled between December 2002 and February 2004 may prevent the extinguisher from discharging properly when the lever is activated. As a result of this condition, Strike First has initiated a fire extinguisher retro-fit program for these units. RETRO-FIT KITS ARE AVAILABLE FREE OF CHARGE BY CONTACTING YOUR LOCAL STRIKE FIRST DISTRIBUTOR, OR BY CONTACTING STRIKE FIRST DIRECTLY.
For details visit; http://www.strikefirstusa.com/serv_bull_002.htm
Fire Extinguisher Recall
PRODUCT SAFETY RECALL STRIKE FIRST CORPORATION OF AMERICA SERVICE BULLETIN #002
Strike First has determined that the valve stem seat in a number of its 2.5 and 5 lb fire extinguishers assembled between December 2002 and February 2004 may prevent the extinguisher from discharging properly when the lever is activated. As a result of this condition, Strike First has initiated a fire extinguisher retro-fit program for these units. RETRO-FIT KITS ARE AVAILABLE FREE OF CHARGE BY CONTACTING YOUR LOCAL STRIKE FIRST DISTRIBUTOR, OR BY CONTACTING STRIKE FIRST DIRECTLY.
For details visit; http://www.strikefirstusa.com/serv_bull_002.htm
posted by
Attorney W. Marc Hardesty
at
7:02 PM
Risks with Cosmetic Anesthetic Creams
The Food and Drug Administration (FDA) yesterday, 12/05/2006 issued a warning to public regarding the use of compounded or mixed anesthetic creams used in salons or day spa type facilities for cosmetic procedures such as laser hair removal, tatoos and skin conditions. Knowing the source and checking the legitimacy of the facility used is paramount to the patients safety. FDA News
FOR IMMEDIATE RELEASEP06-192 December 5, 2006
FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams
The Food and Drug Administration (FDA) is warning five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients. Firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.
FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats. Two deaths have been connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.
"Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high‑potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. FDA is advising consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.
Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.
These creams contain high doses of local anesthetics including lidocaine, tetracaine, benzocaine, and prilocaine. When different anesthetics are combined into one product, each anesthetic’s potential for harm is increased. This potential harm may also increase if the product is left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic, or other dressing.
The risk of harm is even greater in small children, patients with pre-existing heart disease, and patients with severe liver disease.
FDA-approved topical anesthetic products are commercially available and properly labeled, and are regularly used in health-care settings. However, some pharmacies create their own standardized versions of these products, often including combinations of ingredients and ingredients at higher strengths than found in FDA-approved products, and often lacking appropriate warnings or directions for use.
The five firms warned by FDA have stated that they produce their topical anesthetic creams as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA‑approved drug. This kind of compounding follows a physician’s decision that his or her patient has a special medical need that cannot be met by FDA‑approved drugs.
FDA normally permits such traditional pharmacy compounding and the agency’s action is not targeting this practice. By contrast, FDA is concerned that the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution.
Consumers and health care professionals should notify FDA of any complaints or problems associated with compounded drugs, including compounded topical anesthetic products. These reports may be made to MedWatch, FDA’s voluntary reporting program, by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/report.htm.
FOR IMMEDIATE RELEASEP06-192 December 5, 2006
FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams
The Food and Drug Administration (FDA) is warning five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients. Firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.
FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats. Two deaths have been connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.
"Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high‑potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. FDA is advising consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.
Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.
These creams contain high doses of local anesthetics including lidocaine, tetracaine, benzocaine, and prilocaine. When different anesthetics are combined into one product, each anesthetic’s potential for harm is increased. This potential harm may also increase if the product is left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic, or other dressing.
The risk of harm is even greater in small children, patients with pre-existing heart disease, and patients with severe liver disease.
FDA-approved topical anesthetic products are commercially available and properly labeled, and are regularly used in health-care settings. However, some pharmacies create their own standardized versions of these products, often including combinations of ingredients and ingredients at higher strengths than found in FDA-approved products, and often lacking appropriate warnings or directions for use.
The five firms warned by FDA have stated that they produce their topical anesthetic creams as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA‑approved drug. This kind of compounding follows a physician’s decision that his or her patient has a special medical need that cannot be met by FDA‑approved drugs.
FDA normally permits such traditional pharmacy compounding and the agency’s action is not targeting this practice. By contrast, FDA is concerned that the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution.
Consumers and health care professionals should notify FDA of any complaints or problems associated with compounded drugs, including compounded topical anesthetic products. These reports may be made to MedWatch, FDA’s voluntary reporting program, by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/report.htm.
posted by
Attorney W. Marc Hardesty
at
4:14 AM
Saturday, December 02, 2006
Seat Belt Use is Critical
Seat belt use is a critical first step in saving lives in motor vehicle crashes. Many states including Florida have enacted seat belt laws requiring seat belt use. The results have been significant in the prevention of ejection type injuries or death. This link contains the latest government statistics on seat belt usage. http://www-nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/RNotes/2006/810677.pdf
The use of a seat belt often becomes a critical issue in a personal injury or wrongful death case. Insurance companies almost always try and establish lack of or improper use of a seat belt to limit or avoid their obligation to crash victim for their injuries. If you are involved in a car or truck accident it is extremely important that the investigating officer and documents in the accident report that the vehicles seat belts were used. Inaccuracy of this important fact can damage a victims claim for injuries even though the driver of the other vehicle caused the crash.
The use of a seat belt often becomes a critical issue in a personal injury or wrongful death case. Insurance companies almost always try and establish lack of or improper use of a seat belt to limit or avoid their obligation to crash victim for their injuries. If you are involved in a car or truck accident it is extremely important that the investigating officer and documents in the accident report that the vehicles seat belts were used. Inaccuracy of this important fact can damage a victims claim for injuries even though the driver of the other vehicle caused the crash.
posted by
Attorney W. Marc Hardesty
at
3:41 AM
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