Old HIV Drug Linked to Liver Problems

Didanosine, the second drug approved for the treatment of HIV infections and one of the oldest weapons in the AIDS armamentarium, has been found to produce rare cases of potentially fatal liver disease in patients taking it for long periods, the Food and Drug Administration announced Monday. Didanosine, marketed by Bristol-Myers Squibb under the brand names Videx and Videx EC (an extended release version), was approved by the FDA in 1991, joining AZT as the only drugs then approved to treat HIV. It is a reverse transcriptase inhibitor, blocking the action of the key enzyme used by HIV in replicating. It has limited value when used alone because the virus rapidly mutates to overcome it, and is thus generally used in drug cocktails.

Source: http://latimesblogs.latimes.com/booster_shots/2010/02/old-hiv-drug-found-to-produce-rare-liver-problem-fda-says.html

Frobers: 10 Most Misleading Drug Ads

Says the site:

There's a fine line between promoting a new drug and presenting a misleading picture of its risk and benefits. The FDA's division of drug marketing, advertising and communications regularly singles out companies that use questionable language to imply or suggest their drug is superior to similar treatments. It also watches closely for the omission of risk and side effect information. Here are 10 of the most misleading drug ads that were slapped with FDA warning letters in the last year.

http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety_slide.html?partner=yahootix

Walmart Princess and Frog Recall: High levels of Cadmium

FAF Inc. Recalls Children’s Necklaces Sold Exclusively at Walmart Stores Due to High Levels of Cadmium

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, 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.

Name of Product: Children’s Metal Necklaces

Units: About 55,000

Importer: FAF Inc., of Greenville, R.I.

Hazard: The recalled necklaces contain high levels of cadmium. Cadmium is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled jewelry is shaped as a metal crown or frog pendant on a metal link chain necklace in a crown hinged box. The packaging has the words, “Disney” and “The Princess and the Frog” on it and contains the following model numbers and UPC codes:
Crown Model # 4616-4187 UPC # 72783367144
Frog Model # 4616-4190 UPC # 72783367147

Cadmium poisoning is an occupational hazard associated with industrial processes such as metal plating and the production of nickel-cadmium batteries, pigments, plastics, and other synthetics. The primary route of exposure in industrial settings is inhalation. Inhalation of cadmium-containing fumes can result initially in metal fume fever but may progress to chemical pneumonitis, pulmonary edema, and death.[24]

Cadmium is also a potential environmental hazard. Human exposures to environmental cadmium are primarily the result of the burning of fossil fuels and municipal wastes.[25] However, there have been notable instances of toxicity as the result of long-term exposure to cadmium in contaminated food and water. In the decades leading up to World War II, Japanese mining operations contaminated the Jinzu River with cadmium and traces of other toxic metals. As a consequence, cadmium accumulated in the rice crops growing along the riverbanks downstream of the mines. The local agricultural communities consuming the contaminated rice developed Itai-itai disease and renal abnormalities, including proteinuria and glucosuria.[26] Cadmium is one of six substances banned by the European Union's Restriction on Hazardous Substances (RoHS) directive, which bans certain hazardous substances in electronics.

Cadmium and several cadmium-containing compounds are known carcinogens and can induce many types of cancer.[27]

Research has found that cadmium toxicity may be carried into the body by zinc binding proteins; in particular, proteins that contain zinc finger protein structures. Zinc and cadmium are in the same group on the periodic table, contain the same common oxidation state (+2), and when ionized are almost the same size. Due to these similarities, cadmium can replace zinc in many biological systems, in particular, systems that contain softer ligands such as sulfur. Cadmium can bind up to ten times more strongly than zinc in certain biological systems, and is notoriously difficult to remove. In addition, cadmium can replace magnesium and calcium in certain biological systems, although these replacements are rare.

Source is wiki. http://en.wikipedia.org/wiki/Cadmium#Toxicity

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall

Audience: Hospital risk managers, Laboratory managers

[Posted 01/28/2010] FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.

The device separates the red blood cells from plasma to determine the patient’s hematocrit. These recalled devices were distributed from January, 1999 through November, 2009. Hospitals, clinics and laboratories who have the listed centrifuge/rotor combination should immediately stop using the plastic rotors and contact Hettich to have these affected rotors replaced with metal rotors. The centrifuges can be identified by reading the model number on the front of the instrument or the name tag on the rear of the centrifuge; the rotors have the model numbers 2076 or 2050 stamped on them.

The recall notice is here.

Starbucks Water Bottle Recall

Put down the water bottle and no one gets hurt:

WASHINGTON, DC – 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 products. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Glass Water Bottles

Units: About 11,000 in the United States and 1,200 in Canada

Importer: Starbucks Coffee Company, of Seattle, Wash.

Hazard: The glass water bottle and/or its stopper can shatter when the consumer is removing or inserting the stopper, posing a laceration hazard to consumers.

Incidents/Injuries: The firm has received 10 reports of either glass stoppers or water bottles shattering, including eight reports of hand lacerations.

Description: This recall involves clear glass water bottles with SKU number 11003503. The 20-ounce water bottles have the words “Glass Water Bottle” printed on a blue label affixed to the bottle.

Sold at: Starbucks company-operated stores and at Starbucks locations in Safeway and Target stores nationwide during January 2010 for about $9.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop using the glass water bottles and return the product to the Starbucks location where purchased to receive a full refund. Starbucks is also offering a complimentary beverage, of any size, to consumers upon return of the glass water bottles.

Consumer Contact: For additional information, contact Starbucks at (877) 492-6333 between 8 a.m. to 11 p.m. ET Monday through Friday, or visit the firm’s Web site at www.starbucks.com

California Trial: Is Botox Safety for Cerebral Palsy Treatments?

Opening arguments in a negligence lawsuit by Dee Spears against Botox manufacturer Allergan Inc. are set for today in Orange County.

At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.

It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.

The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker's own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

More at the source: http://www.latimes.com/news/local/la-me-botox27-2010jan27,0,1928030.story

Meridia Banned in Europe - Statistics

The Europeans banned the drug because the FDA found that an extra 1 percent or more of users develop heart problems after taking it. There were 86,000 European users in the past year, the BBC reported, which means that 860 have damaged hearts because of Meridia.

Source here.

There's a tussle brewing between Tylenol maker Johnson & Johnson and makers of a shipping about the foul odor problem that is at the root of a recent recall of Tylenol and other products.

An undisclosed number of containers of Tylenol, Motrin and other over-the-counter drugs were recalled earlier this month after consumers complained of feeling sick from an "unusual" odor.

From cnn.com:

"In a letter sent Jan. 22 to Johnson & Johnson's CEO William Welson, and obtained by CNNMoney.com, the National Wooden Pallet and Container Association (NWPCA) said McNeil's statement has "caused immense damage to the industry."

The chemical in question is called "2,4,6-tribromoanisole" or TBA. It results from a breakdown of another chemical called "tribromophenol" or TBP, which is used in some countries as a preservative on wooden pallets But TBP is not approved for use in the United States.

"There are more than 1.2 billion pallets in service in the United States each day. To the best of our knowledge, wood pallets and containers have never been the source of either TBA or TBP," NWPCA president Bruce Scholnick said in the letter."

for more, go hererecalle.

Trucking News: Federal Government Bans Truckers and Bus Drivers from Texting

The government Tuesday formally barred truckers and bus drivers from sending text messages while behind the wheel, putting the federal imprimatur on a prohibition embraced by many large trucking and transportation companies.

"We want the drivers of big rigs and buses and those who share the roads with them to be safe," said U.S. Transportation Secretary Ray LaHood. "This is an important safety step, and we will be taking more to eliminate the threat of distracted driving."

Although both houses of Congress are considering bills restricting texting and 19 states have banned the practice, LaHood said existing rules on truckers and bus drivers give him authority to issue the prohibition. LaHood said drivers of commercial vehicle caught texting could be fined up to $2,750.

source:http://www.washingtonpost.com/wp-dyn/content/article/2010/01/26/AR2010012602031.html

Huber Needles Recalled

More than two million Huber needles -- about a third of the number used in the U.S. with implanted ports to treat chronic diseases -- have been recalled, the FDA announced.

The needles can cut the resealing silicone septum of the ports and possibly send slivers of the material into the body, with the potential to cause embolisms and other damage, according to Mary Brooks, RN, of the FDA's Center for Devices and Radiological Health.

The material could also lodge in the needle, restricting the flow of medication to the patient.


The recall affects needles made between January 2007 and August 2009 by Japan's Nipro Medical Corp. and imported by Exelint International Corp., of Los Angeles.

The recalled needles have lot numbers that begin with either 07, 08, or 09, and one of the following product codes or catalog numbers:

* Exel/Exelint Huber Needles Product Codes/Catalog Numbers: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922,26923, 26924, and 26925
* Infusion Sets Product Codes/Catalog Numbers With/Injection Site: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, and 27950R
* Infusion Sets Product Codes/Catalog Numbers Without/Injection Site: 27954R, 27955R, 27958R, and 27959R
* Exel/Exelint "SecureTouch +" Safety Huber Sets Product Codes/Catalog Numbers: 37854S, 37855S, and 37858S

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198676.htm

Texting: NTSB Finds that Train Engineer's Texting Caused Rail Wreck

Amazing. What will it take to end this?

The NTSB crash report says phone records show Sanchez sent more texts on the job than on weekends. That wasn’t his only violation of company policy. Sanchez invited friends into the cab, and even told them where to hide in case inspectors came on board. He’d been reprimanded for various problems nearly half a dozen times.

Source and the whole sad story here.

Endocsopy Claims Settled in Vegas

A judge has ruled 18 people who contracted hepatitis C from the Endoscopy Center of Southern Nevada can receive a settlement in their cases against Dr. Dipak Desai.

Judge Allan Earl said each of those 18 patients will each receive an undisclosed amount of money for their case. The money will be paid by the Nevada Mutual Insurance Company.

The settlement with 18 former patients of the clinics blamed for the outbreak was made by Nevada Mutual Insurance Co. on behalf of doctors and nurse anesthetists who handled their treatment.

Source

Verdict in a Pain Pump Injury Case

A jury has ordered a medical device company to pay a Portland, Oregon man and his wife $4.75 million, finding I-Flow Corp. liable for damaged cartilage in Matthew Beale's right shoulder.

According to Beale's lawsuit, I-Flow encouraged surgeons to use a pain pump in an unapproved and unsafe manner for patients recovering from shoulder-joint surgery. A pain pump delivers pain medication via a catheter to the affected spot.

I-Flow and other manufacturers face similar lawsuits alleging that such pumps have caused severe cartilage deterioration, called chondrolysis, in patients around the country.

Source.

Florida Appellate Decisions of Note

Bryant v. Tarma, 21 So.3d 137: Florida does not allow the owner of a single cause of action to split it into more than one lawsuit. Plaintiff brought separate suits - one for property damage, another for injuries - which could only be brought in one action.

SunTrust Bank v. Electronic Wireless Corp., 34 FLW D2461 (Fla. 3d DCA 11/25/09): It is not proper to quash service on the basis that a Summons did not provide information in Spanish and Creole. The FCP's Form 1.902, suggests but does not mandate other languages within the Summons.


Dr. Navarro's Vein Centre of Palm Beach, Inc. v. Miller, 34 FLW D2395 : A Plaintiff who had brought suit versus a doctor, claiming injuries caused by laser hair removal must comply with Florida's medical malpractice pre-suit requirements.

Diaz-Hernandez v. State Farm Fire & Cas. Co., involved an insured who was denied coverage for UM benefits because he failed to join the at fault, uninsured mortorist in an action against the UM carrier, so as to obtain a judgment against the uninsured motorist. The Court held that such requirement violated Florida's UM statute and created unenforceable requirements.

GlucoPro Insulin Syringes Voluntarily Recalled

A voluntary nationwide recall of all GlucoPro Insulin Syringes (Nipro Medical Corporation) is now proceeding according to the FDA.

The alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program, notes that syringes may have needles that detach from the syringe.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection," the FDA states.

To date, no injuries have been reported, the manufacturer states in a written release.

The recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). The syringes were distributed throughout the United States and Puerto Rico. The manufacturers are recommending that consumers who have these syringes stop using them and return them to the seller for reimbursement.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198445.htm

Savella Raises Concerns at Public Citizen

Public Citizen has ased the FDA pull the fibromyalgia drug Savella from the market.Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.

In its petition to the FDA, Public Citizen said that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal." This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

Savella, also known by its generic name milnacipran, was found in two studies to possiblly increase blood pressure, heart rate and suicidal thoughts.

http://www.citizen.org/publications/release.cfm?ID=7723

Meridia: Heart Attack Warning Added to Label; Banning urged n Europe

The FDA is warning doctors that weight loss pill Meridia may increase the risk of heart attack and stroke in patients with a history of heart problems.

The FDAis adding new labeling to the drug, stressing that it should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.

Meridia was introduced into the market in 1997 as a weight loss pill. It's Sibutramine, and can be found as sibutramine hydrochloride monohydrate.

The European Medicines Agency advised doctors to stop prescribing medicines containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States.

"The risks of these medicines are greater than their benefits," EMEA said in a statement.

The European Commission will consider the recommendation for suspension of marketing approval.

Source

.

Merck: Did it Hide Vioxx Data?

A recent study published in the Archives of Internal Medicine has revealed that information about heart risks from pharmaceutical giant Merck's Vioxx drug was available in 2000, four years before the Merck pulled the drug from the market. Because the information was not published and made public, Merck may have sat on it until a later clinical trial openly revealed that the drug was causing strokes and heart attacks.

A Merck spokesman, denied the claims that any link could be observed and complained about the methods used by researchers to come to this conclusion, despite acceptance of the findings following a rigorous peer review process.

Find the abstract here.

FDA About to Weigh in on Tanning Beds

he Food and Drug Administration has finally decided to consider stricter warnings about use of the devices and the risk of cancer. The study released by WHO revealed that use of tanning beds by individuals before the age of 30 increases the risk of melanoma, the deadliest type of skin cancer, by 75 percent.


The FDA says its advisors will hold public hearings on tanning bed safety in March, and that the topics of discussion will be the possibility of stricter regulations, increased cancer warning requirements, and possibly reclassifying tanning beds as a more controlled type of medical device. The current FDA classification for tannings beds puts them on par with bandages.

Source

Quick Tech Take: PDFmyURL.com

PDFmyURL will make a PDF file when you type in a web address. If you just want a PDF of a URL, PDFmyURL.com is a breeze.

From the site:

Simply link the text or image you want people to use for downloading a specific page/url like this:

http://pdfmyurl.com?url=www.opentracker.net


http://pdfmyurl.com/

Recall: Tylenol, Children's Tylenol, Eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph's aspirin

From the company website:

Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature. A small number of the product lots being recalled were associated with the complaints of an unusual moldy, musty, or mildew-like odor, and some of these lots were found to contain trace amounts of TBA. In December 2009, McNeil Consumer Healthcare also recalled all lots of TYLENOL® Arthritis Pain 100 count with EZ-OPEN CAP related to this issue. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints.

In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets. We will continue to closely monitor and evaluate the situation and consult with the FDA.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

http://www.mcneilproductrecall.com/

FDA Warns: Watch out for Counterfeit Alli

Preliminary tests by the FDA revealed that the counterfeit version does not contain orlistat — the active ingredient in the product — but instead contains sibutramine.
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The counterfeit Alli has been sold over the internet in 60-mg capsules as part of a 120-count refill kit.

The FDA warns that sibutramine should not be used in certain patient populations or without physician consent because it may counteract with other medications.

Differences in packaging between the counterfeit and authentic product include:

* Missing lot code on outer cardboard packaging
* Expiration date with the month, day and year (e.g., 06162010) whereas the authentic Alli expiration date includes only the month and year (e.g., 05/12);
* Packaging in a plastic bottle with a slightly taller and wider cap with coarser ribbing;
* Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “Sealed for your protection” and;
* Larger capsules with a white powder, instead of small white pellets.

Link to the FDA post here: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm

Recall of HappyBaby Products, and the Company's Reply

A well reasoned plain english letter to the public that's timely and worth a read:

I want to be the first to tell you about a voluntary recall we’ve issued for our recently released HAPPYTOT Stage 4 and the new HAPPYBABY Stage 1 and Stage 2 pouch products. In the past few days, we’ve learned of a minor manufacturing issue that has caused a packaging defect that could lead to product spoilage. These products were only shipped in mid-December to a total of 250 stores, but we can never be too careful in letting people know.

There have been no illnesses at all related to this voluntary recall, and while the packaging defect could lead to the development of spoilage, there is no danger or health threat involved based on our thorough investigation and lab results. We’re asking that you don’t feed these products to your child and instead return them to the place of purchase for a full refund. We are voluntarily recalling all packages produced in the last batch, of which we believe there to be a packaging defect that could have affected less than half of one percent. Those products with the defect could swell up and leak. If you have fed any product to your child, we have no indication at all from extensive lab testing that you should be concerned.

We caught this problem early on and are erring on the side of caution—that’s how we work at Nurture, Inc. Because the safety and health of our young children are our first concern and because we’re committed to upholding the highest quality standards possible, we’ve decided to voluntarily remove these items from distribution until we can learn more about what is causing the issue.

As a mother-to-be who’s expecting my first child literally in the next few days, I am even more intensely aware of how important it is to serve your children the healthiest and safest food available on the market. Please know that we are taking every step to fix this situation and are working quickly to ensure that these new and incredibly popular pouch products will soon be available to your family. We need to take it one step at a time to make doubly sure our high standards for our product integrity is upheld. Despite this hiccup, our dedication to your family’s safety and health is unwavering.

For more information about the recall and for instructions to determine if your products are included, click here. Also see our list of Frequently Asked Questions as well as lists of the Target and Whole Foods stores at which these pouches were sold. Please don’t hesitate to call us directly with any questions you might have at 718-852-7606 or info@happybabyfood.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Sincerely,

Shazi Visram
Imminent Mother-to-be
Founder and CEO

http://www.happybabyfood.com/index.php?option=com_content&view=article&id=186:voluntary-recall-of-new-pouch-products-due-to-packaging-defect&catid=52&Itemid=135

FDA Issues Update on BPA

Bisphenol A (BPA) is an industrial chemical that has been present in many hard plastic bottles and metal-based food and beverage cans since the 1960s.

Studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

In the interim:

* FDA is taking reasonable steps to reduce human exposure to BPA in the food supply. These steps include:
o supporting the industry’s actions to stop producing BPA-containing baby bottles and infant feeding cups for the U.S. market;
o facilitating the development of alternatives to BPA for the linings of infant formula cans; and
o supporting efforts to replace BPA or minimize BPA levels in other food can linings.
* FDA is supporting a shift to a more robust regulatory framework for oversight of BPA.
* FDA is seeking further public comment and external input on the science surrounding BPA.

FDA is also supporting recommendations from the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.

FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.

Georgia Court of Appeals Alliows Electronic Filing

The Georgia Court of Appeals has begun accepting briefs electronically this week.

Chief Judge M. Yvette Miller said the court expects to allow additional types of electronic filings, such as motions and requests for extensions or oral argument, by the end of January.

E-filing is required by the 11th U.S. Circuit Court of Appeals and the Northern District of Georgia, as well as in many Fulton State Court and some Fulton County Superior Court cases.

Source.

MuscleMaster.com: Voluntary Nationwide Recall of Body Building Products

Northborough, MA – January 15, 2010 – MuscleMaster.com, Inc. ("MuscleMaster.com") announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products").

FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While MuscleMaster.com cannot independently confirm the FDA's concerns, that any one or more of the Recalled Products in fact contain these ingredients, MuscleMaster.com is undertaking this voluntary recall out of an abundance of caution and in deference to FDA’s stated concerns.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

MuscleMaster.com is recalling the following products:

Advanced Muscle Science Dienedrone, 60 caps
Advanced Muscle Science Liquidrone, 60 ml
Anabolic Formulation M1, 4AD, 60 caps
Anabolic Formulations 1, 4 AD, 60 caps
Anabolic Xtreme Hyperdrol X2
Anabolic Xtreme 3-AD, 90 caps
BCS Labs Testra-Flex, 90 caps
Competitive Edge Labs M-Drol, 90 Caps
Competitive Edge Labs P-Plex, 90 caps
Competitive Edge Labs X-Tren, 90 caps
4Ever Fit D-Drol, 60 caps
Gaspari Novedex XT 60 Caps
Gaspari Halodrol Liquigels, 60 gels
iForce 1,4 AD BOLD 200, 60 Caps
iForce MethaDROL, 90 caps
iForce Dymethazine, 60 caps
Monster Caps, 60 caps

MuscleMaster.com has not received any complaints of illness or injury regarding these products. FDA is concerned the products may present a safety risk to consumers who ingest them. MuscleMaster.com is an internet retailer and did not manufacture or formulate these products. MuscleMaster.com’s decision to implement this recall is not, and should not be construed as, an admission that their decision to sell these products was in violation of the law. In addition it is not, and should not be construed as, an admission that these products are not in compliance with the law. This recall is solely a reflection of MuscleMaster.com’s deference to the FDA’s stated concerns with these products.

Recall of Motrin, Benadryl and Rolaids

Varieties of Motrin, Rolaids and Benadryl- over the counter medications in wide use across the country- are now also being recalled for the “moldy, musty smell” and ensuing illness experienced by some consumers.

The products were recalled due to contamination with a substance that causes vomiting, nausea, diarrhea and other gastrointestinal symptoms. The FDA claims that McNeil knew of the issue with 2,4,6-tribromoanisole, thought to stem from exposure to storage pallets, for more than a year but did not take adequate measures to inform the public of the dangers posed by the affected medication.

New Seroquel Print Ad has 5 PAGES of Disclaimers

Yes you read that right ... from the folks over at bnet.com, take a gander at it - PDF Alert:

http://i.bnet.com/blogs/seroquel-ad.pdf?tag=content;selector-perfector

If a drug has five full pages of "information" or disclosure, or waivers, etc. what does that tell you about taking it? Ask your doctor.

Company Will Not Recall Ozone Generators

A California company won't recall something that isn't "broke" or so says the company rep.

The FDA said Applied Ozone Systems, in Auburn, Calif., claims its ozone generator devices treat cancer, AIDS, hepatitis, herpes and other infections and diseases.

Chuck Ankeney, owner of the company, said he is selling the ozone generators as water purifiers and he's not claiming they are medical devices.

"You do a recall on something that's broke. You don't do it on their claims," he said. "It's all based on misinformation and lies." Source here.

His company has not responded to an FDA letter dated Dec. 21. In the letter, the FDA requests that the company recall its AOS-1M ozone generator and AOS-1MD ozone generator devices.

The company's Web site says these devices, which sell for $750 and $1,200, can be used for colon cleansing, killing bacteria and viruses as well as wound healing. The company states only at the end of a Web page that the generators are not sold as medical devices.

Here is information from the page

Hurricane Katrina: Lawsuit based on Death of Hospital Patient Proceeds in Louisiana

Once the power blinked out, Althea LaCoste's lungs were on their own. She struggled to breathe without the help of a respirator, and even a team of nurses hand-bagging air into her ailing lungs couldn't save her, according to court documents. LaCoste, 73, died before she could be evacuated from Pendleton Memorial Methodist Hospital in the chaotic days after Hurricane Katrina.

LaCoste's death 4½ years ago is at the center of a civil lawsuit being heard here that could have far-reaching implications for hospitals across the country. The lawsuit against Methodist Hospital is the first civil suit alleging negligence of a hospital staff in Katrina's aftermath.

Here is the article: Link.

I disagree with a hospital industry's statement in that article that:"A verdict against the hospital would open up a Pandora's box for other unrelated incidents," Also, a professor remarked: "The LaCoste lawsuit could make hospitals across the country liable if their power gets knocked out by snowstorms, tornadoes or other calamities, says Edward Sherman, a Tulane University law professor following the case."

Here, you have a case not relating to medical malpractice, in a state where the laws are different that those of any other state. As one authority explains: Great differences exist between Louisianan civil law and common law found in all other American states. Property, contractual, business entities structure, much of civil procedure, and family law are still strongly influenced by traditional Roman legal thinking. Louisiana law retains terms and concepts unique in American law: usufruct, forced heirship, redhibition, and lesion beyond moiety are a few examples.

Second, it's one thing to read the pleadings, the issues, and the allegations/admitted facts. It's quite another to suggest that a snowstorm that knocks out power will now cause liability to arise in say Iowa because of one jury verdict in Louisiana.

If you do nothing else this year, read The Great Deluge. It's a detailed look at what happened just before, during, and after Katrina not only in New Orleans but in the Gulf South.

Powerful Opinion Piece on Georgia's Victims of Medical Wrongdoing

This is a must read. I take it whole cloth from http://georgiajustice.blogspot.com/:

In Georgia, Middle Ground for Victims of Medical Wrongdoing?
How many hoops should you have to jump through to get justice? It's a fair question that many people struggle with. Yesterday, the CEO of a Georgia medical services company suggested - in an opinion piece submitted to a GA newspaper - that to be sure that Georgians who have been harmed by negligent medical care are worthy of justice we should subject them to one more hoop. Not coincidentally, it's a hoop that benefits only medical professionals and insurance companies – the only two interest groups that profit when injured patients are prevented from securing justice.

What the author of the opinion has proposed is that, instead of allowing victims of medical malpractice the same Constitutional Right to Trial by Jury enjoyed by all other Georgians, people harmed by medical wrongdoing/malpractice would have to get permission to have a jury trial from a “screening panel” comprised of members of the medical and insurance industries, the same industries that want to avoid compensating injured patients. This approach is wrong and adds an unnecessary, ineffective layer to our civil justice system.

The fact is all medical malpractice cases brought in Georgia have already been through multiple screening hoops. The first hoop is that you have to have had something very bad happen as a result of malpractice. Your next hoop is that you have to find a lawyer willing and able to take your case. That lawyer will tell you that there is another, special hoop that protects only professionals charged with negligence. In order to pass through that hoop, the patient must find a medical professional willing to publicly criticize their colleague and sign a document swearing that malpractice happened. So far your case has been screened three times: Something bad happens. You find a lawyer who will invest in helping you find justice. And, you find another doctor who agrees that there was malpractice and is willing to say so. Then there’s a fourth screening before you can have a jury hear your case: the judge must screen the case, too.


Our Founding Fathers created the world's best independent screening panels when they imbedded the right to a trial by jury in our Constitution. You are entitled to a jury of your peers, not a two step process, the first of which is a trial by jury of the defendant's colleagues. We trust the people of our communities to fairly resolve our disputes when we are unable to resolve them ourselves.

The CEO cites an approach tried in Maine as being the right fit for us here in Georgia. He fails to mention that this approach is regularly criticized by the Supreme Court of Maine as being inadequate and harmful to the people of Maine. He cites, as a reason for needing “screening panels,” a Georgia case involving a plastic surgeon who carelessly destroyed the blood supply to a woman’s face and left her horribly disfigured. He suggests that this woman – who was horribly injured through no fault of her own and who successfully navigated all of the legal hurdles to hold the wrongdoer accountable for herself and other patients – has not done enough. He says she needs to clear yet another hurdle to prove herself worthy of a jury trial. The suggestion is outrageous and it serves no purpose but to deny those who have been harmed their fair measure of justice.


Why should patients who have been harmed by medical malpractice have to go through two trials when everyone else only has to go through one? Why should medical professionals get special treatment? It's a question with an obvious answer: They shouldn't.

Risperdal and Invega Lawsuits filed

Lawsuits have been filed n behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.

The drugs are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson.


Risperdal and Invega are antipsychotic drugs with similar chemical structures and side effects, Sheller said. In children and adolescents, Risperdal is FDA-approved for treatment of schizophrenia, bipolar mania, and symptoms of autism.

From Drugs.com:

Important information about Risperdal

Risperdal is not for use in psychotic conditions related to dementia. Risperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not give Risperdal to a child without a doctor's advice.

While you are taking Risperdal, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking this medication. Risperdal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of Risperdal. Stop using this medication and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

There may be other drugs not listed that can affect this medication. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Philips Issues Voluntary Recall Notice: Avalon Fetal Monitors

The Food & Drug Administration prompted Philips Healthcare (AEX:PHI) to issue a voluntary recall notice on four models of its Avalon fetal monitor after receiving complaints that the devices were providing inaccurate readings.

The Dutch company, which houses its U.S. headquarters in Andover, Mass., received numerous complaints about Avalon monitor models FM20, FM30, FM40 and FM50.

Philips did not believe a recall was necessary, but the federal watchdog agency compelled it to provide further instructions on how to use the devices properly and issued a voluntary recall notice in the January edition of Patient Safety News, which is sent out to healthcare providers.


Here's the Notice: PDF Alert.

Tysabri: Four More Cases of PML

Biogen Idec Inc (BIIB.O) said on Wednesday that four more patients taking its multiple sclerosis drug Tysabri had developed a potentially deadly brain infection known as PML in November, bringing the total to 28.

The biotech company said it will release the number for December soon.

Progressive multifocal leukoencephalopathy (PML), also known as progressive multifocal leukoencephalitis, is a rare and usually fatal viral disease that is characterized by progressive damage (-pathy) or inflammation of the white matter (leuko-) of the brain (-encephalo-) at multiple locations (multifocal).(Via Wiki



Source here.

Faulty Catheters Recalled

Plymouth-based Ev3 Inc. has recalled several models of a catheter that may crack during medical procedures and cause serious injury, according to the Food and Drug Administration.

The federal agency said the recall of Ev3's Trailblazer support catheter was initiated Nov. 6, 2009, but the recall notice was posted on the FDA's website today.

The FDA, citing eight models and 27 lots of the Trailblazer catheter, gave the recall its most-serious designation -- Class 1 -- which means there is "reasonable probability that use of these products will cause serious adverse health consequences or death."

The FDA said the devices were manufactured from Sept. 11 to Sept. 29, 2009, and distributed from Sept. 21 to Oct. 27, 2009.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196266.htm

FDA: 26 New Drugs in 2009; 25 in 2008

Image via Wikipedia

Federal regulators approved 26 new medicines in 2009 compared with 25 in 2008, though several key drugs that were expected to reach store shelves didn't.

The U.S. Food and Drug Administration approved 26 first-of-a-kind medicines in 2009, more than in any of the prior four years, according to an analysis by the research firm Washington Analysis.

New products include two drugs to treat advanced kidney cancer: GlaxoSmithKline's (GSK) Votrient and Novartis AG's (NVS) Afinitor. Also approved were a new blood thinner from Eli Lilly & Co. (LLY) and Daiichi Sankyo Co. (4568.TO), called Effient, and a medicine from Sanofi-Aventis SA (SNY), Multaq, that restores heart rhythm.

Effient and Multaq are being closely watched by analysts as they can be used to treat large populations and have the potential to be billion-dollar-a-year drugs.

Source here.

Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The “black box” in “black box warning” refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

OsmoPrep Lawsuits Filed

Four plaintiffs filed a complaint in North Carolina claiming that the use of a Salix Pharmaceuticals drug led to kidney damage.

The case revolves around the drug OsmoPrep, which is used to cleanse the intestines in preparation for a colonoscopy. A statement claims the parties sustained a variety of serious kidney injuries and that some of the injuries resulted in the need for dialysis. The statement says that the medical name for the plaintiffs’ condition is called acute phosphate nephropathy.

The U.S. Food and Drug Administration placed a “black box” warning – the most severe admonition possible – on OsmoPrep in December 2008. The FDA said that OsmoPrep and another Salix bowel cleanser, Visicol, carry the risk of kidney damage.

Source here.

Twitter: Value for your Law Practice?

Image via CrunchBase

I just completed my first year using Twitter.com. Twitter is -- reduced to its most basic - a real time scroller (like the ones you see on FOX News and CNN) for the goings on in life - news, rumors, gossip, etc. That holds true today. The news on Urban Meyer's resignation came to me via Tweet on my iPhone.

I had heard and read from many who said Twitter was an "absolute must" for a law firm or lawyer. After one year, I can't say it's a must. I am able to assess it and make these conclusions:

1.Twitter as a breaking news source: Quite good. I follow Anderson Cooper and others. On Twitter you were able to get a near ring-side seat for events ranging from the attacks in Mumbai to the ridiculous balloon boy.

2.Twitter for expanding your blog's visibility: For me, this one gets a partial grade of a C, as I think it's to be developed. This blog is ranked highly among lawyer blogs in terms of popularity (even in my niche). Twitter has given my blog a little push when I 'tweet' about a new blog post. Increasing my visibility as a lawyer is of course a goal. Where the end result for me and my firm's visibility is Google results. I have seen a small uptick.

3.Twitter for gaining new clients or potential clients:I practice consumer law - helping those who were injured because someone else was at fault in some act. I can tell you that Twitter had zero effect in developing clients. I first started - naively to be candid - to believe that Twitter would be mechanism for business development. Not so. In the future? Maybe. Just not now for me at least. If you're a personal injury lawyer who has actually developed clients from Twitter, I want to hear from you. If you're a personal injury lawyer, you make a mistake if you think Twitter will increase your client base.

With several different websites for my firm, I will tell you that websites (and blogs) will be by far the best way to spend your time if you you hope to develop business from the web for the near future.

On this blog earlier this year, I posted what one lawyer thought of Twitter:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.

That is simply not the case in the PI area.


I have switched from believing that (in my field) Twitter would work to increase my client base, to one where I decided to follow other lawyers with helpful news and information. This leads to the next item:

4. Twitter as a resource: I have been able to locate vendors and support persons thanks to Twitter. I did so by actively seeking someone to, for example, help me with service of process in a Pacific state.I was able to find a vendor for office products. Could I have used Google to accomplish the very same thing? Probably, but I wanted to see what Twitter could or could not do.

I have tried to use Twitter to refer a number of matters, and it's just not there yet. In my practice, groups like the AAJ and my state bars are the best source for me to find someone to assist on a legal matter. According to Lextweet.com, there are 5856 lawyers with some form (inactive or active) of Twitter account. One list serve I belong to has more than 7,000 member subscribers.

It's probably too early to give Twitter a ringing endorsement, and too early to pan it. For me it's one more piece of my overall business effort. The 'ground war' is going to meetings, having lunches and visits with lawyers, and joining affinity groups in my city. The "air war" is my web presence, and Twitter will likely be a part of that effort.


This is my list of items so far. I'll be updating with more items later.

Comparison of Free Online Storage Sites

I've been checking out online backup storage for my office, and I have found many possible solutions. Worth checking out is a post on Lifehacker that compares many of the sites.

Take a look here, and good luck with your selection.

Recall of Tylenol Arthritis Pain Caplets

A voluntary recall of Tylenol Arthritis pain caplets is being expanded because of consumer reports of a moldy odor.

The recall affects the 100-count bottles. The FDA says the recall is specific to bottles with the distinctive red "EZ open" cap.

It's based on consumer reports of a foul smell on the medicine associated with nausea, stomach pain, vomiting and diarrhea.

The pills’ musty odor comes from trace amounts of a chemical known as 2, 4, 6-tribromoanisole, according to the company, which is believed to be from the breakdown of another chemical in wooden pallets used to transport and store the drug

From NPR: How A Bone Disease Grew To Fit The Prescription (Fosamax)

Interesting read at NPR about Osteoporosis and Fosamax. Osteoporosis is a disease that causes bones to become thinner, more porous and break more easily. It mostly affects elderly women, who can be devastated by a fall that breaks their hip. One in five elderly women who break a hip will die within a year. Osteopenia, it turns out, is a slight thinning of the bones that occurs naturally as women get older and typically doesn't result in disabling bone breaks.

NPR writes: "This is the story of how pills for osteopenia ended up in one person's
medicine cabinet, and in the medicine cabinets of millions of women like her all over the United States.

Read it here.

FDA: No Cancer Link to Vytorin

The FDA says an extensive data review shows there's no evidence that Merck's cholesterol drug Vytorin causes cancer, a suspicion raised last year by a patient study.

Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer.

The FDA says it's examined all of the data from the study that first raised the alarm about a possible risk. It also has reviewed interim data from two very large studies that are still in progress.

Source here.

Nestle Gets FDA Letter Regarding Boost

In an early December letter to Nestle, the FDA told the company that it had mislabeled its Boost drink, which comes in flavors like chocolate, vanilla and strawberry, “as a medical food for the medical condition of ‘failure to thrive’ and also for ‘pre/post surgery, injury or trauma, chronic illnesses.’”

The FDA informed that federal guidelines explain that “medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”



Source here.

IKEA High Chair Recall

IKEA Home Furnishings is recalling LEOPARD Highchairs sold exclusively at IKEA stores nationwide from October 2009 to November 2009. The snap locks used to secure the seat to the frame can break and allow the seat and child to drop through the frame, posing a fall hazard. Detached snap locks can pose a choking hazard.

This recall involves all colors of the LEOPARD highchairs sold as a seat and a frame individually. The seat and tray has an adhesive label affixed to the underside with the words LEOPARD and “Made in Italy,” an eight-digit article number and a five-digit supplier number (19589).

Consumers should return the highchairs to any IKEA store for a full refund.

Consumers can also contact IKEA at (888) 966-4532 anytime, or visit at www.ikea-usa.com. More info at www.recalls.org.

Polaris ATV Recall

Polaris Industries Inc. is recalling 2009-2010 Polaris All-Terrain Vehicles (ATVs) sold nationwide from February 2009 to November 2009. The front suspension ball joint stem can separate from the steering knuckle and cause the rider to lose steering control, posing a risk of injury or death.

This recall involves model year 2009 and 2010 Polaris Sportsman ATVs with certain VIN numbers. A list of the recalled ATVs can be found at www.recalls.org.

AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency

AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.

The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.


The link is here.

Prempro Verdict: $8 Million

A Philadelphia jury in January 2007 awarded Mary Daniel compensatory damages of $1.5 million in her lawsuit against Pfizer’s Wyeth subsidiary over its Prempro menopause treatment. The panel recommended she get more than $8 million in punitive damages if an appeals court found she was entitled to such an award because of bad conduct by the company, people with direct knowledge of the figure said.

The $8 million figure was sealed pending an appeal. A judge in Philadelphia refused last month to make it public. A Pennsylvania appellate court heard arguments in Wyeth’s challenge to the verdict on Dec. 1. Wyeth wants the jury’s $1.5 million compensatory award thrown out. Daniel’s lawyers are seeking to have punitive damages added to it.

Source and more here.

Does Chelation Therapy Cause Heart Injuries?

Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany; kidney damage; decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.

M-Drol and P-Plex -Link to Liver Injuries?

Both M-Drol and P-Plex were supplements were marketed on the Internet by a company in Galveston, Texas called TF Supplements.

Some say that the main ingredients in M-Drol and P-Plex are methylated compounds known to cause liver damage. It has been claimed that the supplements were manufactured by a company called Competitive Edge Labs, a foreign corporation working in Virginia. Making and distributing the supplements is not against the law.

If you took either or both of these and have liver injuries now, call us.

Law Tech: 2009's Most Useful Tech Items

Here are tech apps/hardware that I think are "best" when it comes to helping my office in the practice and business of law:

1.iPhone- I'm old enough to remember when computers for lawyers were a rarity. In 1991 I remember an older partner literally yelling at me that "computers are for secretaries!" when he saw a PC on my desk. Could anyone today imagine practicing law without one?

I'd put the iPhone on the list of essential tools. If you don't have one, in my opinion you are at a disadvantage. Apps for it are key - Dragon dictate, access to key documents, email with PDF capability, the ability to fill out, sign and annotate any PDF document while away from the office (Zosh), and more. The blog iPhoneJD.com is a must read. If you're one of those dinosaurs who proudly proclaims that you only use your phone to make calls, well, the meteor is headed your way, and it has an Apple logo on it. If you have a smart phone like a BBerry, at least you're getting closer.


2.Speak Write: This is a transcription service. A transcript is processed by trained professionals located in the U.S. and Canada, without the use of voice recognition software. You can dictate from anywhere and receive your completed work via email, 24 hours a day, 7 days a week, in about 3 hours. Since you can dictate using a variety of methods, no special equipment or software is required; you can be signed up and dictating within minutes. Speak-write.com


3.Scansnap:


Especially for smaller firms like ours, the Fujitsu ScanSnap scanner takes the complication out of document imaging with one-touch ease of use. It's the size of a football, is sturdy (I've dropped it twice), lightning fast, and relatively inexpensive. I've taking it to document reviews and have been able to have 1000's of pages scanned while reviewing papers.



4.Google Desktop: Google Desktop is desktop search software made by Google for Mac OS X, Linux, and Microsoft Windows. The program allows text searches of a user's e-mails, computer files, music, photos, chats, and Web pages viewed.

We have indexed the documents on our servers, and now can search our "google-style" for items. Cost? Free.





5.Dual Monitors: More and more you are seeing dual monitors. I have two, and it helps a great deal. Using dual monitors allows you to eliminate scrolling and window switching. You may not even be aware of how often you are moving things around now. It’s very easy to get used to two monitors and to determine the best way for you to work with them.

On my desk, our client database and contacts are on one monitor, and my work items are on another.

I also have two 23" monitors, and that's been a great help as well.

6.RingCentral: RingCentral Office delivers a virtual PBX, VoIP phone service and IP phone as one complete system. It's cheap, and here is how I use it: I sign up for an account, and then use that number to track any google ad words buy we use. At any one time, I may have 2-4 web sites active with either google ad buys or simply as informational sites. It helps me measure the success of the site separate and apart from any emails or forms filled out. It's cheap, easy to use and yes, there's a free app for that for the iPhone. On the iPhone it looks like this:



7.Phonetag: From their site: PhoneTag automatically converts your voicemail into text and delivers it directly to your mobile phone, Blackberry, Goodlink enabled phone and/or your email account; so you can read your voicemail.

I love it.

There you have it. Email me if any of those help.

SCOTUS to review Texting Privacy Ruling

The Supreme Court has granted certiorari regaarding a federal appeals court in California that reading text messages sent on devices provided by the employer violated the worker's privacy rights and amounted to an "unreasonable search" barred by the U.S. Constitution. The case is City of Ontario v. Quon, 08-1332.

The city appealed to the Supreme Court, saying employers typically have policies in place establishing that workers have no expectation of privacy in electronic communications on employer-owned equipment.

The PDF opinion may be found here.

Source here.

Roman Blind Recall

The federal government - via the CPSC - has issued a recall of Roman Blinds that they could suffocate kids.

For the first time, the safety commission now recommends using only cordless window treatments in any home where children live or visit, such as a grandparent's house or day care center.


From USA Today:

HOW TO MAKE KIDS SAFER

1. Install only cordless window treatments in all homes where children live or visit, especially in children's bedrooms.

2. Move all cribs, beds and furniture away from windows.

3. If not using cordless shades, cut the ends of pull cords, so that the loop can't form a noose.

4. Don't allow cords to dangle. Wrap cords around a hook that's high off the floor out of a child's reach.

5. If using Roman shades with hidden strings on the back side, raise the shades high enough so children can't reach them.

Another Recall on an OTC Cold Remedy

The FDA reports that P&G has made a voluntary recall of specific lots of their Vicks brand nasal spray in the US, Germany and the UK.

The recall comes as a result of P&G finding the bacteria B. cepacia in these particular batches. There have been no reports of illness, and most healthy individuals should not be effected from this bacteria; however, the bacteria could cause serious illness in those with compromised immune systems such as those with Cystic Fibrosis or other chronic lung conditions.

The lot number in the US that is being recalled is 9239028831, which is for Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml Nasal Spray.

Antidepressants May Raise Women's Stroke Risk

That, according to a report released this week.You may find the abstract at the Archives of Internal Medicine.

Older women who ingest such antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.

"But statistical significance can be different from clinical significance," stressed Dr. Jordan W. Smoller, an associate professor of psychiatry at Harvard Medical School, and lead author of a report in the Dec. 14 issue of Archives of Internal Medicine. "It is possible that a statistically detectable effect may not be a problem for most people." Source.

The Report's conclusion: "In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality."

FDA Warning on Steris Sterilizer

The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" stamp and should not be used.

The product, called System 1, is used to sterilize medical tools such as endoscopes, bronchoscopes and other devices. It is used in hospitals, outpatient surgical centers and some physicians' offices.

Source here.

Alka Seltzer Recall

Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some lack warnings of possible drowsiness. The recall applies to Alka-Seltzer Plus Day & Night Liquid Gels. Bayer blamed the label omission on human error and said steps are being taken to prevent this from happening again.

Consumers who purchased packages from lot 296939L can contact Bayer for a refund at (800) 986-3307.


I like the product, and a thumbs up for Bayer's effort to recall the product.

Dietary Supplement Recall

Atlas Operations Inc. is recalling dietary supplements for sexual enhancement sold under about 37 brand names. The products might contain an ingredient not declared on their labels. The undeclared ingredient is similar to a Food and Drug Administration-approved drug used to treat erectile dysfunction, making these recalled products not approved drugs.

The interaction of the ingredient with some prescription drugs could lower blood pressure to dangerous levels. No illnesses or incidents have been reported, according to the Pompano Beach, Fla., company.

The products are being sold as dietary supplements online and in retail stores throughout the nation. Laboratory results found that products tested from certain batches of these brands contain the undeclared ingredient: Rock Hard, 72 Hours, Stamin It, Finally On Demand, Sexual Surge, Staminil and Vierect.

The recalled products have the following numbers in the middle of their lot codes: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 or 807.

AP source here, FDA here.

Slim-Fast Recall

Image via Wikipedia

The Food and Drug Administration (FDA) has issued a nationwide recall on cans of Slim-Fast ready to drink beverages because of a possible contamination with Bacillus cereus, a microorganism that can cause infected people to suffer from diarrhea, nausea and vomiting.


The recall involves all Slim-Fast ready to drink beverages in cans, regardless of flavor, best-by date or UPC number, the FDA said. No other Slim-Fast products are affected by the recall.

The company is in the process of identifying and correcting the production issue and will resume production and shipment as soon as the problem is remedied.

Consumers who have recently purchased ready to drink Slim-Fast beverages in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund.

Source here.

FDA Investigating Brain Scans

Federal health regulators are investigating reports of dangerous radiation levels at two more California hospitals, following earlier unsafe medical scans at a Los Angeles facility.

The Food and Drug Administration is probing the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, Calif. The brain scans are used to diagnose strokes.

For more, go here, the NYT Online.

First Gadolinium Trial Set to Begin in early 2010

On Monday a suit against Bayer Healthcare will begin in January, in front of San Francisco Superior Court Judge Curtis Karnow.

Peter Gerber's lawsuit accuses Bayer of negligently designing, testing and marketing Magnevist, a drug used to help doctors read MRIs, is one of hundreds of suits in California and elsewhere alleging that diagnostic drugs containing gadolinium have caused nephrogenic systemic fibrosis. And according to Gerber's lawyer, his suit is the first to be scheduled for trial.

Magnevist is a contrast agent used to improve magnetic resonance imaging. In 2007 the U.S. Food and Drug Administration requested that gadolinium-based agents such as Magnevist carry boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

Most patients with NSF have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis. Many patients have taken immunosuppressive medications and have other diseases, such as hepatitis C. Four of the five gadolinium contrast agents approved by the U.S. Food and Drug Administration have been principally implicated in NSF, including Omniscan, Multihance, Magnevist, and OptiMARK.

The first cases of NSF were identified in 1997.

Source here.

Trucking: Speed Limits to in crease

Image via Wikipedia

A new law takes effect next month increasing the speed limit for semi truck drivers from 55 to 65 miles per hour, but there are differing opinions on whether the new law is a good one.


"If everyone goes the same speed, it has to be safer," he said. "I think it's been proven other states' accident rates went down and I think it will also take a lot of pressure off the drivers. I don't think a lot of people want to go faster because of the threat of a speeding ticket."

More here.

FDA Fails to make safety changes Post Vioxx

The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.

That's according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

More from the AP story.

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

Lawsuit: Denture Cream Caused Illness

From the Denver Post:

Doctors and specialists spent two years testing Rae Ann Schmaltz, initially believing she had multiple sclerosis but later looking for anything, including tropical diseases and Lou Gehrig's disease. She endured endless poking and prodding, including 160 blood tests, urine tests, MRIs, even spinal taps. All were negative.

And then, prodded by Schmaltz's 19-year-old daughter, they looked in her mouth.

Doctors now believe Schmaltz suffers from a copper deficiency caused by an abundance of zinc found in the Poligrip she used to secure her dentures.

For more, go here.

Federal Rules of Civ. Pro.: Computation of Time/Date Changes on 12/9/09

From the Judicial Conference Report:

“The principal simplifying change in the amended time-computation rules is the adoption of a “days-are-days” approach to computing all time periods. Under some of the current rules, intermediate weekends and holidays are omitted when computing short periods but included when computing longer periods. By contrast, under the proposed rules amendments, intermediate weekends and holidays are counted regardless of the length of the specified period. Other changes in the amended time-computation rules clarify how to count forward when the period measured is after an event (for example, 21 days after service of a motion) and the deadline falls on a weekend or holiday; and how to count backward when the period measured is before an event (for example, 14 days before a scheduled hearing) and the deadline falls on a weekend or holiday. The proposed amendments also provide for computing hourly time periods, to address recent legislation affecting court proceedings in which deadlines are expressed in hours (for example, 72 hours for action)."

Here is a list:

* The one-day period in Rule 6(c)(2) becomes seven days. The adjustment would extend the time for a party to serve any affidavit opposing a motion to seven days before a hearing.
* The one-day period in Rule 54(d) becomes 14 days. The increased time period corrects an unrealistic short time period for the clerk to give notice before taxing costs.
* The three-day period in Rule 55 becomes seven days.
* Five-day periods in Rules 32, 54, and 81 become seven days.
* The five-day period in Rule 6(c)(1) becomes 14 days. The adjustment extends the time for a party to serve a written motion and notice of hearing before the scheduled hearing date.
* Ten-day periods in Rules 12, 14, 15, 23, 38, 59(c), 62, 65, 68, 72, 81, and Supplemental Rule C become 14 days.
* Ten-day periods in Rules 50, 52, and 59(b), (d), and (e) become 28-day periods. The adjustment extends the present inadequate time allowed to prepare and file postjudgment motions. To prevent unfair results from these unrealistic short time periods, courts have avoided the rule by delaying entry of judgment or permitting timely filing of a barebones motion but permitting the brief to expand the stated grounds.
* The less-than-11-day period in Rule 32 becomes less than 14 days.
* Twenty-day periods in Rules 12, 15, 27, 53, 71.1, 81, Forms 3, 4, and 60, and Supplemental Rules B, C and G become 21 days.
* Rule 6(b)’s reference to provisions for extending the times set by enumerated provisions in Rules 50, 52, 59, and 60, and Rule 59(c)’s reference to a 20-day extension are eliminated.
* The timing provisions in Rules 56(a) and (c) are replaced by new provisions that recognize authority to set deadlines for summary-judgment motions by local rule or by court order and, in default of a local rule or court order, that allow a motion to be made at any time until 30 days after the close of all discovery. The new provisions also establish default times for response and reply.

Vicks Nasal Spray Recall

The Procter & Gamble Company has announced it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action. The company's analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 (Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray) and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at 877-876-7881

FDA Recalls Dietary Supplement

The FDA recalled three types of dietary supplements known as RockHard Weekend after the supplements were found to contain ingredients related to the active ingredients found in Viagra. The ingredient, sulfoaildenfil, was not listed by the company on the packaging label.

Sulfoaildenfil could cause serious injury or even death in some individuals. Sulfoaildenfil may interact with nitrates, an ingredient found in medicines that treat diabetes, heart disease, high blood pressure, and other conditions. This interaction may cause the person’s blood pressure to drop to dangerously low levels and could result in death.

RockHard Weekend is made by RockHard Laboratories and distributed nationwide. The products involved in the recall could have been purchased at several national retailers, gas stations and local markets. They were sold in both pill and liquid form. The Food and Drug Administration (FDA) recall includes the Blister Pack, 3ct. Bottle and 8ct Bottle.

Blair Expands Recall of Robes, Jackets and Tops

A Pennsylvania clothing company has expanded a recall of highly flammable bathrobes, as a Connecticut woman says the company's negligence led directly to her mother's fiery death. Blair LLC, based in Warren, Pa., initially recalled 162,000 of its chenille robes in April, as it announced that it had received reports of three deaths blamed on the robes' extreme flammability.


Blair and the Consumer Product Safety Commission (CPSC) have expanded that recall, as six additional deaths are linked to at least four types of chenille robes and other chenille products produced by the same manufacturer.

The expanded recall covers around 300,000 items. Products covered by the recall include full length women's chenille robes, women's chenille jacket, women's chenille lounge jackets, and women's chenille tops.

Recalled robes bear the item numbers 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. According to the CPSC, the items are one-piece garments made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

Affected items were sold both in Blair catalogs and on the company's website, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009.

Vertebral Body Replacement Recall - Georgia/Florida News

I wrote about the recall in a prior post. Here's the lot information:

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

• Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm – 19 mm
• Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm – 25 mm
• Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm – 29 mm
• Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm – 33 mm
• Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm – 44 mm
• Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm – 52 mm
• Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm – 71 mm
• Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm – 84 mm
• Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm – 97 mm
• Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
• Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Vertebral Body Replacement Recall

Our office is investigating these claims:

FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.


Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.



The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

FDA: Alcohol and Caffiene -Safe Together?

The FDA has contacted nearly 30 makers of caffeinated alcoholic beverages that it will look into the legality and safety of the products.

The FDA has not approved the use of caffeine in alcoholic drinks, so the drinks can only be lawfully marketed if the substance is "Generally Recognized As Safe," or GRAS. For a substance to be GRAS, there has to be evidence of it's safety.

Source here.

My question- what happens to Bourbon and Cokes? Irish Coffee? Will some be relegated to seeking out Rum and Caffeine Free Diet Coke?

FDA issues Class I recall of Edwards Lifesciences aortic catheter

The FDA has issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.

The device is a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall.

The recalled devices, model numbers EC1001 and EC65, were manufactured between August, 2008 and August, 2009 and distributed from November, 2008 through September, 2009.


Source here.

Thank you Veterans

Today I hope folks will take a moment to say thank you to those veterans who have served our country in good times and bad, in the USA and elsewhere. They stand ready to make the ultimate sacrifice for our country.

In our groups of friends, I'm lucky to call one of our active military a friend. Whether it's a simply greeting, or something more elaborate is up to you.

Thank you from our family to those who served and serve now.



The above photo is from this article -

The State of Georgia is moving aggressively to help refugees of the nation of Georgia who suffered because of the recent hostilities with Russia. Twelve hundred pounds of emergency supplies were packed at Dobbins Air Reserve Base, destined for the more than 9,000 permanently displaced refugees living in tents and makeshift shelters in Georgia.

The supplies consist of medicines and medical supplies, medical protective clothing, and landmine first aid kits. The humanitarian assistance supplies are being donated by US Aid for International Development, US Public Health Service, and the Georgia National Guard.

This delivery is made possible by the coordinated effort of the Atlanta-Tbilisi Sister City Committee with the help of the Georgia National Guard.

Assisting in the packaging of the humanitarian aid was Letha Nesbitt, Subcommittee Chairman for Humanitarian Aid for the Atlanta-Tbilisi Sister City Committee and members of the Georgia Army and Air National Guard.

Recall of Certain Lots of Tylenol Arthritis

Good to see the folks at McNeil Consumer Healthcare taking a pro-active stance. From their site:

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is initiating a voluntary recall of a limited number of product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP. McNeil is initiating the recall after identifying an uncharacteristic smell or taste associated with these lots that led to a small number of consumers reporting nausea and related symptoms. This recall includes five product lots only (Full list of lot numbers provided below), and does not include any other lots of TYLENOL® Arthritis Pain Caplet 100 count with EZ-OPEN CAP or any other TYLENOL® Arthritis Pain products. McNeil is implementing this recall as a precaution.

Consumers who purchased TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com. Consumers who have medical concerns or questions should contact their healthcare provider.

Link: http://www.jnj.com/connect/news/all/20091106_120000

Last week, the Georgia Court of Appeals issued an opinion holding that State Farm, as a UIM carrier could pursue UM subro against a tortfeasor even though the insured had
signed a Limited Release.

Will this decision make it more difficult to settle a claim if the UM carrier doesn't waive subrogation? Stay tuned.

Excerpts from the decision:

The issue in this case is whether an uninsured motorist insurer can sue a tortfeasor for subrogation after the tortfeasor has been released from personal liability except to the extent that insurance coverage, other than the tortfeasor's personal liability policy, exists. Because we answer this question in the affirmative, we affirm the judgment of the trial court.

Accusure Insulin Syrine Recall

Accusure insulin syringes (Qualitest Pharmaceuticals, Inc) distributed nationwide from January 2002 through October 2009 are being voluntary recalled because of the possibility of detachment of the needles from the syringes.

The current recall is an expansion of a recall made in August for syringes produced between January 2007 and June 2008 as a result of the manufacturer receiving a complaint about a syringe not included in the first recall.

According to Carole Ben-Maimon, MD, senior vice president of corporate strategy for the manufacturer, the recall affects about 250 million syringes, although she told Medscape Medical News that many of those syringes have already been used. "It is not clear how many are still in circulation," she said.

"If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection," according to a statement from MedWatch, the FDA's safety information and adverse event reporting program.

"All Accusure Insulin Syringes regardless of lot number are subject to this recall," a company press release states. Lot numbers are found on the white paper backing of each individual syringe, according to the US Food and Drug Administration report.

The distributed syringes are of the following descriptions and NDC numbers: 28 G, 1/2 cc, NDC 0603-6995-21; 28 G, 1 cc, NDC 0603-6996-21; 29 G, 1/2 cc, NDC 0603-6997-21; 29 G, 1 cc, NDC 0603-6998-21; 30 G, 1/2 cc, NDC 0603-999-21; 30 G, 1 cc, NDC 0603-7000-21; 31 G, 1/2 cc, NDC 0603-7001-21; and 31 G, 1 cc, NDC 0603-7002-21.

For more go here.

Recall: Madol,Tren, Turinsabol and Andro

The business Bodybuilding.com has recalled 65 dietary supplement products sold online that may contain steroids, says the U.S. Food and Drug Administration.

The national and international recalls announced by the Boise, Idaho-based company include all lots and expiration dates of dietary supplements that might contain ingredients that are or should be classified as steroids, including "Superdrol," "Madol," "Tren," "Turinabol," and "Androstenedione."

From emaxhealth.com:

The FDA states they have conducted a two-year investigation in which products bought from bodybuilding.com were later tested positive for steroids. Unlike foods and drug products, dietary supplements are not approved for safety or efficacy by the FDA before they hit the market. Instead, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it is up to the manufacturer to make sure the product is safe. The FDA can only take action after the products are on store shelves.

The FDA conducted an investigation on September 24 at the Boise, ID warehouse and informed the company that that it believes that the recalled products may contain anabolic steroids. The following ingredients were called into question: superdrol, madol, tren, androstenedione, and turinabol. Anabolic steroids are considered controlled substances in the United States.

Most of the recalled items are taken for body mass and muscle building, and include brand names such as Advanced Muscle Science, Competitive Edge Labs, Diabolic Labs, IDS, Kilo Sports, and Myogenix. A full list of recalled lots is available on the both the FDA website and on bodybuilding.com.

Bodybuilding.com says that it has not yet had an opportunity to independently confirm the FDA’s concerns, but that they are focused conducting the voluntary recall as a precaution to protect the health of its customers. The company also states that it has contacted the manufacturers of the products and has received assurances that each is in compliance with federal law and do not contain unlawful ingredients.

Link here.

Prempro Verdict Appeal

Pfizer Inc. doesn’t have to pay more than $27 million in punitive damages to an Arkansas woman who blamed her breast cancer on the company’s menopause drugs, an appeals court ruled in ordering a new trial on the award.

The U.S. Court of Appeals in St. Louis today upheld a jury’s March 2008 finding that the hormone-replacement drugs helped cause Donna Scroggin’s cancer and its award of actual damages. The three-judge panel also backed a judge’s decision to throw out the punitive award to Scroggin, who alleged two Pfizer units ignored or downplayed the risks of the drugs.

“Scroggin presented sufficient evidence to submit the question of punitive damages to the jury,” the appeals court said in its 41-page ruling. “The evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct within the meaning of Arkansas law.”

Source and more at the link.

Levaquin

You may have seen more information about Levaquin®, which is an Ortho-McNeil-Janssen pharmaceutical, also called a fluoroquinolone, prescribed for the treatment of lung, sinus, skin and urinary tract infections in adults. Levaquin® has been associated with medical complications serious enough to have required FDA involvement.


Reports of Levaquin® Complications

Although the increased risk of tendonitis and tendon rupture has been noted on fluoroquinolone drug labeling for several years, the FDA has continued to receive reports of tendon disorders and ruptures among patients, and incidents of side effects often go unreported or are misdiagnosed as rheumatoid arthritis. In July 2008, the FDA announced a mandatory black box warning label for fluoroquinolone drugs, including Levaquin®, that highlights and strengthens the warning for increased risk of tendonitis and tendon rupture.

The reported symptoms related to the use of Levaquin® include:
· pain
· swelling
· inflammation
· bruising and tears in tendons such as the Achilles,
shoulder, hand or legs

The risk of developing fluoroquinolone-associated tendon disorders or tendon rupture increases in individuals over the age of 60, individuals taking corticosteroid drugs and recipients of kidney, heart and lung transplants. Tendon ruptures and injuries are often debilitating and may affect use of the injured limb.

Prempro Verdict - Don't Ask I Can't Tell You

A Philadelphia jury awarded punitive damages to an Illinois woman who said Wyeth's Prempro hormone replacement therapy caused her breast cancer, but the world will have to wait at least another month before anyone knows how much.

As the jury in Common Pleas Court was nearing a verdict on how much to award to punish Wyeth, which last week completed a merger with Pfizer Inc., company lawyers asked Judge Sandra Mazer Moss to seal the amount until a verdict is reached in a similar case also being tried in Philadelphia. The judge agreed.



Wyeth's attorneys George McDavid and Michael Scott argued that a public announcement of punitive damages in the Barton case could bias jurors in the other case, referred to as Kendall v. Wyeth.

Barton's attorney, Zoe Littlepage, argued that the public's right to know outweighed those concerns and that Wyeth had failed to prove damage, not just speculate that it could occur. Littlepage also said she feared that Wyeth would use the tactic to delay repeatedly as 9,000 cases involving Pfizer/Wyeth menopause drugs make their way through the courts.

Source is right here.

Friday Link: New Georgia Family Law

I don't usually link to others' blogs, but my good friend C.J. Remboldt has a family law blog that is worth a read. You can find her blog here.

Here's a post from her blog:

GA Trial Court Lacks Authority to Modify Terms of Child Support Order

A GA trial court may not deny a child support contempt hearing because the Temporary Protective Order, ordering father to pay child support, would expire before the hearing date because a trial court lacks authority to modify the terms of a child support order nor may it forgive any child support in arrears.

To find her mediation practice, go here.

Georgia Supreme Court rules against State Senator in Accident Case

State Sen. Cecil Staton did not prevail before the Georgia Supreme Court this week.

The court said Staton, a Republican from Macon, was not entitled to additional coverage ($200,000) in coverage after a truck accident near Rome that broke his leg. Staton contended he should be allowed to “stack” $100,000 policies on three vehicles owned by his company, Smyth & Helwys Publishing, even though only one of the three cars was actually in the crash.

Read the opinion here.

Zometa Verdict in Montana

A Missoula jury on Wednesday awarded $3.2 million to a woman suing the maker of a bone-strengthening drug in a decision that could have a bearing on hundreds of cases against the company nationwide.

Peggy L. Stevens, 57, of Missoula filed suit against Novartis Pharmaceuticals Corp., alleging the company should have disclosed health risks associated with the bone-strengthening drug called Zometa.

Stevens developed dental and jaw-related problems after taking the drug for several years.

Stevens' attorneys said the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures. Symptoms include pain, loosening of teeth, exposed bone and infection.

Source here.

Safety Investigation of Certain Medical Device Power Cords

The power cords on a variety of medical devices may cause sparking, charring, and fires, according to reports received by the FDA.

Device manufacturer Hospira has recalled all affected power cords, while Abbott Nutrition has recalled its Flexiflo Quantum Entreal Pumps, used for feeding patients through tubes.

To date, the FDA has received 122 reports of faulty power cords involving devices manufactured by these two companies, whose investigators found that the power cord prongs contain a black bridge, which may crack and fail at or inside the plug.

Additional risks from the device failure include electrical shock, delay in setup and therapy, interruption of therapy, and device failure.

The FDA said the cords, manufactured by the Electri-cord Manufacturing Company, are used on other devices made by other companies, and the agency has launched an investigation to identify them.

The FDA warned practitioners to monitor the condition and make of their devices' electrical cords, particularly in oxygen-rich environments where device sparking may cause fires.

Source here.

FDA Checking Claims on Food Labels

U.S. regulators are
examining the growing number of nutrition claims found on the
front of food packages after complaints that they give a
misleading picture of their health benefits, officials said in
a warning to food companies on Tuesday.

The Food and Drug Administration is trying to determine if
any claims violate federal food labeling rules and "will take
enforcement action against any egregious examples," FDA
Commissioner Margaret Hamburg told reporters.

FDA officials also are developing a proposed regulation to
define nutritional criteria for claims made on the front of
food packages, Hamburg said.

The FDA is acting as companies increasingly add nutrition
claims to the front of packages to catch the attention of
hurried shoppers who might not read the detailed facts about a
food's content on the back, she added.

"Some nutritionists have questioned whether this
information is more marketing-oriented than health-oriented,
and judging from some of the labels that we have seen, we think
this is a valid concern," Hamburg said.

Link to the source here.

Defective Women's Robes Recalled (Blair LLC)

Blair LLC. has reported 162,000 of its defective products -- women's robes -- after six women reportedly died when the chenille robes caught fire. Some of the robes caught fire while cooking, according to an MSNBC news report. The U.S. Consumer Product Safety Commission (CPSC) issued an alert stating that women who own these robes should stop using them. CPSC and Blair initially announced their voluntary recall in April citing three reports of robes catching fire, including one report of second-degree burn injuries. This second product recall notice comes now after the company received reports of six deaths due to the robes catching fire.

The recalled Blair robes were made in Pakistan and include the following item numbers -- 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They were sold through Blair catalogs and on the company's Web site as well as Blair stores in Pennsylvania and Delaware from January 2003 through March 2009.

We're investigating these awful tragedies.

Vytorin Litigation

An amended lawsuit filed over the Schering-Plough pension plan alleges that executives at the company suspected as early as 2005 that the “Enhance” Vytorin trial was a bust. Citing a “confidential informant,” it also names.

The Plaintiffs claim: "Defendants had intimate knowledge of, or an active role in, improper business activities that allowed Schering-Plough to artificially inflate and manipulate the Company’s earnings."

More at bnet, here.

Trials

I've been a little scarce on here for the past couple of weeks. Was preparing for multiple trials, and actually went to trial last week on a case. I'll discuss the trial in a later post.

For those lawyers who read this blog, I will tell you a few key items from the trial: Always prepare a Trial Notebook for the Judge. Include in it a Trial Brief. A short statement of the facts, the key statutes and cases, with a copy of all. It helped once again for me. An informal poll seems to suggest that less than 2/3's of lawyers I know prepare one. Big mistake.

Another: Submit only those Jury Instructions you absolutely need. The Court has its standard ones, of course. I submitted seven, and the Court agreed to read six of them. Opposing counsel submitted more than 40.

More later.

MDL Update: Hydroxycut, Chantix, and Yasmin

The MDL Joint Panel has been busy the last couple of weeks. The JPML had ordered the Iovate (Hydroxycut) MDL to the Southern District of California. The Order may be found here. It's MDL 2087.


An MDL as to Chantix will be sent to Judge I. Johnson in the USDCT of Alabama. The Order may be found at the same link as above. MDL 2092 is the number.

For Yasmin, the MDL is in Ohio.

McDonald's Hot Coffee Documentary 10/13/09 in Atlanta

Remember the film Super-Size Me? That film opened up the eyes of consumers. More people than ever found themselves concerned with the nutritional content—or lack thereof—in fast food. Six weeks after the film premiered, McDonald’s discontinued their “Super-Size” option. The fast-food chain began offering more salads and an adult happy meal in an attempt to appear healthier.



The film was the 10th highest grossing documentary film of all time. Millions saw it. And it changed minds.



Tomorrow’s film screening of “Hot Coffee” also involves McDonalds… but in a different way. Stella, of the now infamous Stella Awards based on the hot coffee McDonalds case, is actually interviewed in this film as it completely debunks the myths surrounding the case. Through additional personal stories, interviews and hard facts, the film illustrates how the media distorted the truth about the McDonald's coffee case, duped the American public and protected corporate interests, endangering our civil justice system.



This 26 minute short of what will be a feature film was chosen by IFP as a Spotlight documentary and is showing around the nation. The film is made by a Trial Lawyer/filmmaker in Oregon. And most importantly, on a grand scale, the film could change hearts and minds.



Please make every effort to attend the screening at tomorrow, Tuesday October 13th at 7:30 at LandMark Theaters in Midtown

Georgia Supreme Court holds SOL Tolled while Traffic Citation Pending

The Supreme Court held yesterday that O.C.G.A. § 9-3-99 tolls the statute of limitations for any tort action from the date of the defendant’s traffic offense until the prosecution of the traffic offense becomes final or is terminated, as long as that time does not exceed six years. See Benke v. Parker, S08G2078, S08G2082, Sept. 28, 2009.

A violation of one of the Uniform Rules of the Road, such as the rule that a OCGA § 16-2-1 (a) provides that “[a] ‘crime’ is a violation of a statute of this state in which there is a joint operation of an act or omission to act and intention or criminal negligence.” A driver must not follow another vehicle too closely. Doing so is a is a misdemeanor, OCGA §40-6-1 (a), and a misdemeanor is “any crime other than a felony.”

To impose a more stringent definition of “crime” within the context of the statute would render superfluous its language that the statute of limitation is tolled from the date of the alleged crime “or the act giving rise to such action in tort” until the prosecution or other termination of such crime “or act.”

Find the opinion online here.

Exjade and the FDA

The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal haemorrhage, and deaths in patients with myelodysplastic syndrome (MDS) compared with patients without these conditions.

Source here.

Januvia/Sitagliptin: Pancreatitis Risk?

The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia/Sitagliptin and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.

From the FDA site:


FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009.

It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis.

Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.



More from the source, at Forbes:Here.

Tylenol Infants and Children Recall (Certain Lots)/More

It’s a voluntary recall, which according to NY Pediatrician Dr. Seth Gordon came because “examination of bulk raw material detected that one of the inactive ingredients contained gram-negative bacteria Burkholderia cepacia (B. cepacia). The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product.”

There are also raised that the carton labeling for Junior TYLENOL® Meltaways (160mg) may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Some may assume two tablets are standard and this is not the case.

In addition, some Children’s TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children’s TYLENOL® Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children’s TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child’s age and weight.

Source here.

Tylenol Infants and Children Recall (Certain Lots)

From tylenol.com

You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA). The company is implementing this voluntary recall at the warehouse and retail levels, because examination of one of the inactive ingredients did not meet internal testing requirements. However, the packaged product, shipped to retailers by the company, has met all specifications.

These actions do not apply to Children's Tylenol Meltaways and Junior Strength Tylenol Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOL® liquid products.

If you have any of the potentially affected products in your home and have questions you can contact the McNeil Consumer Call Care Center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time.)

Parents and caregivers who have given the product to their child or infant and have concerns should contact their child's health care provider.

The full list of affected products is below. Consumers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If you have more questions, please contact our consumer call center at 1-800-962-5357.
UPC # Code # Lot # Product Description
300450391049 3910400 SBM041, SBM067, SCM037, SDM027, SEM109 Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
300450296047 2960400 SBM042, SCM015, SCM036, SDM034 Children's Tylenol Suspension 4oz. Grape
300450407047 4070400 SBM043, SBM044, SCM029 Children's Tylenol Suspension 4oz. Bubble Gum
300450493040 4930400 SBM045, SCM011, SCM030, SDM035 Children's Tylenol Suspension 4oz. Strawberry
300450122407 1224000 SBM064, SCM033, SDM020 Infant’s Tylenol Grape Suspension Drops 1/4oz.
300450186157 1861500 SBM065, SCM005, SCM006, SDM032 Infant's Tylenol Suspension 1/2oz. Cherry
300450166043 1660400 SBM066, SCM068 Children's Dye Free Suspension 4oz. Cherry
300450123046 1230400 SBM068, SCM035, SCM070, SCM080, SDM005 Children's Tylenol Suspension 4oz. Cherry
300450249043 2490400 SBM069, SBM070, SCM081, SDM006 Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
300450122155 1221500 SCM012, SCM067, SDM007, SDM068 Infant's Tylenol Suspension Drops 1/2oz. Grape
300450386045 3860400 SCM013, SCM014, SCM069 Children's Tylenol Plus Flu 4oz. Bubble Gum
300450387042 3870400 SCM016, SFM024 Children's Tylenol Plus Cold Suspension 4oz. Grape
300450247049 2470400 SCM017 Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
300450122018 1220100 SCM082, SDM039, SDM040 Infant's Tylenol Suspension Drops 1oz. Grape
300450167019 1670100 SCM083, SCM084, SDM008 Infant's Tylenol Dye Free Suspension 1oz. Cherry
300450123015 1230100 SDM064 Children’s Tylenol Pediatric Suspension 1oz. Cherry
300450186300 1863000 SDM038, SDM009 Infant's Tylenol Suspension Drops 1oz. Cherry
300450390042 3900400 SDM033 Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
300450122100 1221000 SDM078 Infant's Tylenol Drops 1oz. Grape
350580144183 1221800 SCM034 Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
350580123034 1230300 SDM028 Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

Seroquel Litigation News

A federal judge in Orlando, Florida, ordered AstraZeneca to unseal certain sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians’ names on privacy grounds.

For more, go to the Bloomberg site here.

FDA Bans Flavored Cigarettes

The FDA this week banned cigarettes with fruit, candy or clove flavors.

Authorized by the Family Smoking Prevention and Tobacco Control Act enacted in June, the ban represents an effort to reduce an easy entry point for youth into smoking and tobacco addiction. Some cigarette makers favored and others opposed giving the FDA this new authority.

Smoking is the leading preventable cause of death in the U.S., the government says.

The FDA also is considering bans on menthol cigarettes and other flavored tobacco.

Source here.

Flooding in Atlanta

It's bad here. Real bad. A North Georgia city has been evacuated because of levee failure fears. The above pic is of downtown Atlanta during rush hour today.

Study Finds a Possible Link Between Denture Cream and Imbalance

From ABC.com:

Thirty- four million Americans rely on dentures to replace their missing teeth. But a small number of denture wearers have had difficulty with balance and walking -- a medical mystery that some experts have linked to their denture creams.

More here.

Necrosis Caused by Intra-arterial Injection of Promethazine: Case Report

I found this report after hearing more about the recent black box warning issued by the FDA regarding Promethazine:

"The first reported cases of intra-arterial promethazine (Phenergan) injection causing complications were in the late 1960s." There have been literature reports of adverse outcomes after accidental intra-arterial injections of drugs since the 1940s.

The study presented two cases of intra-arterial promethazine injection that led to digital necrosis. Both cases eventually led to amputations.


The study may be found here.

STLA Meeting in Asheville Sept. 24 and 25, 2009

This week the Southern Trial Lawyers Association meets in Asheville, N.C.

The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states. We do not engage in political activity or fundraising of any kind.

STLA here.

FDA warns about eyelash thickener claims

The FDA has warned Allergan Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product.

In a letter dated Sept. 10 and posted to the FDA Web site Wednesday, the agency said the Latisse site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness.

For more, go to fda.gov.

Promethazine Gets Black Box Warning for Tissue Damage/Amputation Risk

Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

More here.

GA Supreme Court to Hear Oral Argument on Damages Caps on 9/14

Supreme Court to Hear Oral Arguments on Caps on Damages
Statute is challenged after a medical malpractice victim’s face
literally falls off after surgery

Atlanta, GA-- On Tuesday, September 15, 2009, the Georgia Supreme Court will hear oral arguments regarding the constitutionality of the provision that caps the amount of damages a victim of medical malpractice can secure from a jury. The plaintiffs in the case of Betty Nestlehutt and Bruce Nestlehutt v. Atlanta Oculoplastic Surgery, P.C., will argue that the Georgia Supreme Court should uphold the trial court judge’s finding that O.C.G.A. § 51-13-1, as enacted in 2005, is unconstitutional.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

“Betty Nestlehutt was the face of her real estate business,” said Malone. “Her face was so horrifically disfigured that she was no longer able to even leave her house. Photographs of her disfigurement are even too gruesome for public distribution. The damage is permanent. Years later she has to wear layers of special makeup to try to give the appearance of normalcy.”

After hearing the testimony and considering all of the evidence, a jury of 12 returned with a verdict in the Nestlehutts’ favor which included a recovery of money damages for her past and future medical expenses, for damage to her relationship with her husband and $900,000 in “non-economic” damages for the devastation of her quality of life. The verdict exceeded the $350,000 cap on noneconomic damages enacted as part of SB 3 in 2005. Judge Diane Bessen declared unconstitutional the statute capping a jury’s verdict and now her decision, upon the defendant’s appeal, is before the Supreme Court.

“Judge Bessen’s order appropriately concluded that a one-size fits all predetermined cap on damages violates several protections guaranteed by the Georgia Constitution,” said Malone. “Her order balances the rights of all Georgians, young and old, rich and poor, and restores the guarantees set forth by our Constitution that were stripped away in 2005.”

Judge Bessen’s order declares the caps on damages provision unconstitutional because it violates three basic constitutional tenets: the right to trial by jury, the separation of powers doctrine and equal protection of the laws.

Under SB 3, the jury’s deliberation regarding the amount of damages to be awarded is preempted by a legislatively imposed cap—no matter how severe or catastrophic the case before them. Historically, a jury had the ability to decide the fate of its peers constrained only by the particular facts of an individual’s case, as the Founding Fathers intended. Thomas Jefferson once said, “I consider trial by jury as the only anchor yet imagined by man, by which a government can be held to the principles of its Constitution.”

In her order, Judge Bessen wrote:

A limit or cap on noneconomic damages, however, invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury. If the amount of noneconomic damages awarded by the jury exceeds the statutory cap, this Code section automatically and arbitrarily reduces the verdict, without consideration of the evidence, the record, or any other fact produced at trial and found by the jury. The limitations imposed by O.C.G.A. 51-13-1 render the right of the jury to assess damages meaningless… The cap so interferes with the determination of the jury that it renders the right of a jury trial wholly unavailable.

Additionally, Judge Bessen also found that the cap on damages violates the Separation of Powers Doctrine contained in the Georgia Constitution. Three other states’ supreme courts, with similar constitutional provisions, also have struck down caps on damages on this basis. The Georgia Constitution states that: “The legislative, judicial and executive powers shall forever remain separate and distinct, and no person discharging the duties of one, shall, at the same time, exercise the functions of either of the others.” One distinct function of the judicial branch is that judges have the exclusive right to award to a party a “remittitur” – or a new trial – if a judge finds that a verdict is either excessive or inadequate. Judge Bessen’s order declares the cap on damages statute to be a “legislative remittitur” and that the legislature has unconstitutionally invaded the exclusive role of the judiciary to find facts and control judgments.

“Equally important,” the judge writes, “it does so without the option of a new trial for the injured plaintiff. As such, it unduly encroaches upon the judiciary’s constitutional right and prerogative to determine whether a jury’s assessment of damages is either too excessive or too inadequate within the meaning of the law.”

The third violation of the Constitution Judge Bessen found was that a cap on damages violates the Equal Protection provisions of the Georgia Constitution which state: “No persons shall be denied the equal protection of the laws.” To examine this violation, Judge Bessen explored whether there was a “rational relationship” between the government’s purpose and its enacted statute which treats similar parties in very different, unequal ways.

The rational relationship test basically states that a statute may be valid as long as it has a rational relationship to a governmental purpose. In the case of SB 3, the government’s stated purpose was to “promote predictability and improvement in the provision of quality health care services and the resolution of healthcare claims..., assist in promoting the provision of healthcare liability insurance by insurance providers…, [and addressed concerns about] medical providers and facilities leaving the state and the cost of malpractice awards.” For a law to be valid, a rational relationship to those goals must be proven. Judge Bessen found that the cap on damages failed the rational relationship test completely.

In holding the cap on damages provision unconstitutional, Judge Bessen wrote:

After review, this Court finds that there is no rational relationship between statute and the expressed government interest. Most obviously, it is a complete contradiction to state that the overall quality of healthcare would be improved by shielding negligent healthcare providers from liability. In fact, as recognized by other courts, a cap on noneconomic damages actually diminishes tort liability for healthcare providers and diminishes the deterrent effect of tort law… There is absolutely no evidence that these objectives are achieved by imposing a financial burden on the most victimized of plaintiffs… Based on current statistics, limiting noneconomic damage caps is not rationally related to the state purpose of reducing medical malpractice insurance rates… it appears that this statute was enacted arbitrarily, based upon speculation and conjecture rather than empirical data.

Finally, Judge Bessen found that the cap on damages violates Equal Protection because it creates different classes of victims—those injured by healthcare providers and those injured by others and those who are catastrophically injured and those who are less severely injured. Judge Bessen penned, “The cap’s greatest impact falls on those who are most severely injured, and creates classes of fully compensated victims and those only partially compensated… Similarly, the noneconomic damages cap discriminates against low-income individuals who are unable to prove large economic damages but nonetheless may sustain large noneconomic damages.”

The President of the Georgia Trial Lawyers Association, Chris Clark, has been following this case closely.

“As a trial lawyer, I represent the person, who, through no fault of their own, has been injured—sometimes severely. They miss work, accrue medical bills and—often most important to them—they suffer a loss of the quality of life that they once had,” said Clark. “Betty Nestlehutt’s severe disfigurement – which she had no part in creating – has diminished her quality of life and, in turn her husband’s and her family’s. Judge Bessen’s order was fair, upheld our Constitution, and reflected the rule of law that has stood firm since the inception of this nation.”

The argument on Tuesday was prepared by Malone and attorneys Darren Summerville of Bird Law Group, P.C. and Michael Terry of Bondurant, Mixson & Elmore, LLP. AARP, Voices for Georgia’s Children, Georgia Women for a Change and Georgia Watch all filed Amicus Briefs in support of Betty and Bruce Nestlehutt.

Conmed Recall of Surgical Instruments

Medical device maker Conmed Corp. on Wednesday issued a voluntary recall of certain surgical instrument products, saying the devices may self-activate and cause injury in rare cases.

Conmed said the recall affects certain model numbers of its PRO5 and PRO6 series battery hand pieces manufactured before May 31, 2008.

The recall also affects certain lots of the MC5057 Universal Cable manufactured before Dec. 1, 2006, the company said.

The company estimated the pretax cost of the recall at $6 million. The expense will be factored into the company's financial results during the quarter ending Sept. 30.

Source here.

Penumbra Catheter Recall

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.

Source here.

Window Blinds Recall

The Consumer Product Safety Commission is announcing a major recall on several types of winder blinds and shades. Here are three of the largest recalls.

The first set of shades on our recall list is the kind that rolls up. It's called the Oval Roll-Up Blinds. There is the potential for a child to be strangled in the pull cord.

The Consumer Product Safety commission is recalling more than four million of the blinds.They were sold national retail stores across the country.

The second recall is for bamboo shades called Matchstick Bamboo Roman Shades. They too could strangle a young child if that child gets caught in the inner cord. They were sold at Target stores nationwide.

The third recall is for the Melina Roman Blind which can also catch a child around the neck. The problem here is the exposed inner cord. These shades were sold at IKEA stores.

go to the cpsc site for more.

Levaquin and Link to Vision Problems?

From the journal Opthamology:

According to World Health Organization criteria, the relationship between fluoroquinolone therapy and diplopia is “possible.” This causality assessment is based on the time relationship of drug administration and ADR development, the multiple positive dechallenge and rechallenge reports, and the plausible mechanism by which diplopia could occur: Possible tendinitis of the extraocular muscles.

Link here:

http://www.ophsource.org/periodicals/ophtha/article/S0161-6420%2809%2900655-1/abstract

Zyprexa: Allegations that Lilly Paid Docs to Prescribe it

From Bloomberg:

Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

More at the link above.

Fosamax: Jury Deliberations Marked by Threats and Intimidation?

From CNNMoney.com I can tell you I've never heard of any Judge offering to have court officers escort jurors home:

A U.S. judge called for a daylong "cooling off" period in a product-liability case over Merck & Co.'s (MRK) osteoporosis drug Fosamax after jury deliberations became tense on Wednesday.

U.S. District Judge John F. Keenan suspended deliberations until 11:15 a.m. EDT Friday and offered to have court security officers escort individual jurors to the subway after two separate notes were sent out of the jury room Wednesday afternoon about the tenor of the deliberations.


Outside the presence of the jury, the judge said that he would declare a mistrial in the case if a verdict isn't reached by 5:30 p.m. EDT Friday.

The article notes that one juror had complained of threats.

Actiq Deaths

Actiq is a powerful narcotic painkiller in the form of a lollipop that is manufactured by Cephalon, Inc. The drug is delivered to the bloodstream by a lollipop-like lozenge; when placed against the inner cheek, pain is relieved in minutes. Actiq is also administered by transdermal patches and by injection. The active ingredient, fentanyl citrate, is a highly addictive narcotic which is approximately 80 times more potent than morphine.

The FDA approved the Actiq lollipop in 1998 for treatment of severe pain in cancer patients. However, Actiq is apparently being prescribed to thousands of people for off label treatment of non-cancer related pain. It has been estimated that in the first half of 2006 approximately 99% of the 187,076 Actiq prescriptions filled in the U.S. were not for cancer patients.

The Actiq lollipop has been associated with the deaths of at least 127 people. There have been another 91 FDA reported incidents of severe side effects. Side effects have ranged from dehydration to respiratory problems along with further issues associated with the highly addictive nature of the narcotic. Forty-seven of the deaths have been linked to addiction, misuse, or overdose. Two deaths have reportedly involved children who mistook the Actiq lollipop for candy.

College Football Arrives

Tailgating at Ole Miss in the Grove

My passions are typically every day ones - my labs, the outdoors. This week (Thursday, actually) is the start of the real passion/religion 'down here' in the South - big time college football. My team? The Gators.



What's it like for me and others in SEC Country? Here is a comparison of North v. South College Football:


Stadium size
North: College football stadiums hold 20,000.
South: High school football stadiums hold 20,000.

Fathers
North: Expect their daughters to understand Sylvia Plath.
South: Expect their daughters to understand pass interference.

Campus décor
North: Statues of Founding Fathers.
South: Statues of Former Coaches.

Homecoming queen
North: Also a physics major.
South: Also Miss America.

Heroes
North: Rudy Guiliani.
South: Bear Bryant, Steve Spurrier, Eli Manning.

Getting tickets
North: Five days before the game, you walk into the ticket office on campus and purchase tickets.
South: Five months before the game, you walk into ticket office on campus and put your name on waiting list for tickets.

Parking
North: An hour before game time, the university opens the campus for game parking.
South: RVs sporting their school flags begin arriving on Wednesday for the weekend festivities.

Game day
North: A few students party in the dorm and watch ESPN on TV.
South: Every student wakes up and rushes over to where ESPN is broadcasting “GameDay Live” to get on camera and wave to the fans up North who wonder why “GameDay Live” is never broadcast from their campus.

Tailgating
North: Raw meat on a grill, beer with lime in it, listening to local radio show with truck tailgate down.
South: 30-foot, custom pig-shaped smoker fires up at dawn. Cooking accompanied by live performance by Dave Matthews Band, who come over during breaks.

Getting to the stadium
North: You ask, “Where’s the stadium?” When you find it, you walk right in.
South: When you’re near it, you’ll hear it. On game day, it becomes the state’s third largest city.

When National Anthem is played
North: Stands are less than half full, and less than half of them stand up.
South: 93,000 fans, all standing, sing along in perfect four-part harmony.

Announcer
North: Neutral and paid.
South: Announcer harmonizes with the crowd in the fight song, with a tear in his eye because he is so proud of his team.

After the game
North: The stadium is empty way before the game ends.
South: Another rack of ribs goes on the smoker. Planning begins for next week’s game.

Fans
North: Women comment "My, what a rough sport."
South: Women scream "DON'T JUST TOUCH HIM, TAKE HIM DOWN!"

Womens' Attire

North: Chapstick in their back pocket and a
$20 bill in their front pocket.

South: Louis Vuitton bag and a fifth of bourbon, barnoculars.

North: Fans wear a team tshirt.
South: Fans wear a team tshirt, pants, shoes, face paint, and sunglasses.

Vehicles:
North: Cars and trucks have a removal window flag.
South: Cars and trucks are custom painted w/ team colors, Flat screen TV, portable
satellite, and Honda generator.

Alumni
North: Take prospects on sailing trips
before they join the law firm.
South: Take prospects on fishing trips so
they don't leave for the NFL their senior year.


In case you have made it this far, a special lagniappe, this video:

Steam Dietary Supplement Recalled

Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Brand Name Size Lot EXP. UPC

STEAM 1 Bottle – 5 Capsules 90260 6 11 8 52263 30033 1

No illnesses have been reported to the company to date in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

The FDA has been apprised of this action.

Stella Awards, Part II

Good stuff from my friend Jere Beasley:

The annual Stella Awards list, a list of the years seven “most outlandish lawsuits and verdicts in the U.S.,” is nothing more than a fraud on the public. The so-called awards deal primarily with fiction, and many of the lawsuits listed never happened. The examples of what they describe as frivolous lawsuits are at best gross misstatements. The Stella Awards are just part and parcel of the carefully planned efforts designed to destroy the civil justice system. Once these awards are announced, they take on a life of their own. That’s because of the Internet. Unfortunately, the media never bothers to investigate the validity of the cases mentioned in the awards, and then write stories that keep the myths alive.

An example of how these myths orginate is this year’s runaway First Place Stella Award winner. Mrs. Merv Grazinski, of Oklahoma City, Oklahoma, who supposedly purchased a new 32-foot Winnebago motor home, was the winner. On her first trip home, from a football game, having driven on to the freeway, she set the cruise control at 70 mph and calmly left the driver’s seat to go to the back of the Winnebago to make herself a sandwich. Not surprisingly, the motor home left the freeway, crashed and overturned. Also not surprisingly, Mrs. Grazinski was supposed to have sued Winnebago for not putting in the owner’s manual that she couldn’t actually leave the driver’s seat while the cruise control was set. It was reported that an Oklahoma jury had awarded the woman $1,750,000 plus a new motor home. It was also said that Winnebago actually changed their manuals as a result of this suit, just in case Mrs. Grazinski has any relatives who might also buy a motor home. The e-mail that announced the award concludes: “Are we, as a society, getting more stupid?”

The truth is that this sort of nonsense relating to a Winnebago lawsuit never even happened. But, the media bought the story hook, line, and sinker, and never even bothered to check it out. Scores of articles – the vast majority buying the Winnebago story as gospel truth – resulted across the country. Apparently, few journalists bothered to do any research to determine whether they were true. Among outlets falling for the hoax were the New York Daily News, CNN and U.S. News & World Report. In fact, the story actually spread around the world. Readers in Canada, England, Australia, Ireland, New Zealand and even Vietnam heard about this fictitious lawsuit that never happened. To his credit, Los Angeles Times reporter Myron Levin, who wanted to learn more about the lawsuit, called Winnebago and found out there was no Grazinski lawsuit. He also learned that the company had not changed the owner’s manual to avoid a swarm of copycat claims as claimed by the Stella awards.

The next time an “Internet tale” makes you believe things are even worse than you thought, check it out. Especially when the story suggests that the American court system is stacked against wealthy Corporate America. If you want to check out the “Stella Awards” and decide for yourself whether they are on the level, a good place to go is www.snopes.com, an excellent site that investigates urban myths. Simply search for “Stella Awards” and find out if the lawsuit stories are true or false.

Stella Awards -Fabricated

The Stella Awards® were inspired by Stella Liebeck, the Plaintiff in the McDonald's coffee case. Some folks may know that The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body,
including her inner thighs, perineum, buttocks, and genital and groin areas. She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement treatments, sought to settle her claim for $20,000, but McDonalds refused.

There are many debunked jury "award" reports linked to the claimed awards.

From their own site:

"Many stories are going around the 'net saying they are "The Stella Awards". Many of these stories are false, made-up, or (sometimes) true stories with false elements added to them.

The sad part: despite these stories having been debunked years ago, they not only still circulate, but many reporters, columnists and radio "personalities" still talk about them as if they were true, which says a lot about their professionalism. In many outrageous cases, these lazy "news" people will even link to this site as the source of these silly lies."


Claimed Cases -Status:

Kathleen Robertson of Austin, Texas, was awarded $780,000 by a jury after breaking her ankle tripping over a toddler who was running amuck inside a furniture store. The owners of the store were understandably surprised at the verdict, considering the misbehaving tyke was Ms. Robertson's son. Fabricated.

Carl Truman, 19, of Los Angeles won $74,000 and medical expenses when his neighbor ran his hand over with a Honda Accord. Mr. Truman apparently didn't notice someone was at the wheel of the car whose hubcap he was trying to steal. Fabricated.

Terrence Dickson of Bristol, Penn., was exiting a house he finished robbing by way of the garage. He was not able to get the garage door to go up because the automatic door opener was malfunctioning. He couldn't re-enter the house because the door connecting the house and garage locked when he pulled it shut. The family was on vacation, so Mr. Dickson found himself locked in the garage for eight days. He subsisted on a case of Pepsi he found, and a large bag of dry dog food. Dickson sued the homeowner's insurance claiming the situation caused him undue mental anguish. The jury agreed to the tune of half a million dollars and change.Fabricated.

Jerry Williams of Little Rock, Arkansas, was awarded $14,500 and medical expenses after being bitten on the buttocks by his next door neighbor's beagle. The beagle was on a chain in its owner's fenced-in yard, as was Mr. Williams. The award was less than sought after because the jury felt the dog may have been provoked by Mr. Williams who, at the time, was shooting it repeatedly with a pellet gun. Fabricated.

A Philadelphia restaurant was ordered to pay Amber Carson of Lancaster, Pennsylvania $113,500 after she slipped on a spilled soft drink and broke her coccyx. The beverage was on the floor because Ms. Carson threw it at her boyfriend 30 seconds earlier during an argument. Fabricated.

Kara Walton of Claymont, Delaware, successfully sued the owner of a nightclub in a neighboring city when she fell from the bathroom window to the floor and knocked out her two front teeth. This occurred while Ms. Walton was trying to sneak through the window in the ladies room to avoid paying the $3.50 cover charge. She was awarded $12,000 and dental expenses. Fabricated.

The "winner" every year: In November, Mr. Grazinski purchased a brand new 32 foot Winnebago motor home. On his first trip home, having joined the freeway, he set the cruise control at 70 mph and calmly left the drivers seat to go into the back and make himself a cup of coffee. Not surprisingly, the Winnie left the freeway, crashed and overturned. Mr. Grazinski sued Winnebago for not advising him in the handbook that he could not actually do this. He was awarded $1,750,000 plus a new Winnebago. Fabricated.

Don't be fooled into believing all that you read on the web.

Katrina: New Orleans Four Years Later

It's easy for many to simply forget that Katrina hurt much more than New Orleans. It devastated parts of lower Mississippi and damaged coastal Alabama as well.

I flew out of New Orleans the weekend before Katrina hit. I was there this weekend, on the 4th Anniversary of the storm's passing. In between, I have been back to New Orleans more than 25 times in the last four years. I was there for the first Mardi Gras post storm, and walked the fairgrounds for the 1st Jazz Fest after the storm.

I spent time reading about the city. Reading about its history, about the history of the French Quarter. I walked (and ran) its streets post storm. I went to St. Bernard Parish, saw the Lower 9th's destruction, as well as that of East New Orleans.

This is a city that deserves to be rebuilt just as much - more so - than the cities being rebuilt in Iraq by the US Military. Sure, the politics of the city are god awful. The spirit of the people though, is coming back. At least in areas away from where the flooding was at its worst.

In case you are wondering, the Central Business District is coming back. Surely the economy has hurt the rebuilding of the CBD. The Garden District is looking much better, where thankfully the damage was not as severe. The Quarter is seemingly back to its nearly normal tawdry self.

The area between the Port and the edges near Canal Street are hit and miss, but there is development.

I won't rant about what happened, didn't happen, or which politician was most incompetent (not on these pages, anyway). I will simply say this: Go. Visit the city. Eat at its 100+ year old restaurants. Take a walking tour of the Quarter, which while universally known as the French Quarter, has most of its standing buildings being of Spanish origin. Have a two hour plus dinner at Antoine's, or Bayona. Drive - like I just did - from the edge of the city out to the south and west, taking Highway 90 through cajun country.

I'll be back to my favorite city in America soon. Join me?

Image via Wikipedia

Diet Drug Reviewed by FDA: Orlistat (Xenical)

The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli.

As a result of those reports, the FDA said it had initiated a safety review of the product, which works by blocking the absorption of ingested dietary fats.

Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older.

The FDA said that in addition to the 32 reported cases, orlistat safety "was discussed at the CDER Drug Safety Oversight Board in April 2009, and the FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time."

Source here.

Tamifoxen News

A report recently released suggests that a drug used to prevent the recurrence of breast cancer may have a rare but dangerous side effect: increasing the odds that long-term users may develop an uncommon but aggressive new tumor.

The report was called into question right away, noting clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks.

For more, go here.

Sports and the Law

A few items of interest for me, given my love of sports. Always a fun read when law intersects with Sports:

Delaware Lottery and NFL? Scratch that.

"In a rare move, the appellate court not only found that a lower court judge had erred in refusing to issue a preliminary injunction, but declared that the answer to the ultimate question in the case was indisputably clear -- and that a permanent injunction must be issued.

Lawyers for Delaware had urged the appellate court to greenlight the new lottery, arguing that it was protected under a PASPA exemption that grandfathered in the existing sports betting statutes in four states.

But lawyers for the sports leagues argued that Delaware was strictly limited to restarting the sort of sports betting it had conducted for a few months in the mid-1970s -- a multi-game football pool limited to betting on at least three NFL games at once.

Delaware should be blocked from launching a sports lottery at three racetracks or "racinos" that allows for single-game betting on any sport other than games played by Delaware college teams."

Read more here at the source.

FSU and NCAA: Judge says NCAA must publicly release FSU documents

Circuit Judge John C. Cooper said he'd give the NCAA two days from when he signs a written order next week to turn the documents over to The Associated Press and other media, which filed a public records lawsuit.

NCAA lawyers said they will appeal to block the release.

The documents focus on Florida State's appeal of an NCAA plan to strip coaches and athletes of wins in 10 sports.

That includes football coach Bobby Bowden, who stands to lose 14 victories. It would dim his chances of again becoming major college football's winningest coach. Bowden has 382 victories -- one behind Penn State's Joe Paterno.

The NCAA said in a statement it was "very disappointed this court has determined the NCAA's private records could be transformed to public records."

Source here.

Atlanta Spirit Lawsuit:

"Boston-based partner Steve Belkin had asked his Atlanta Spirit partners to buy out his 30 percent stake in the two teams back in August 2005, a process that was supposed to take 125 days. Ever since, the Spirit has been embroiled in a high-profile legal battle that has lasted nearly four years and earned the group a reputation as the most fractious ownership in North American professional sports.

Their arguments wound through the Maryland circuit court system and finally to the Maryland Court of Special Appeals, which overturned the lower court’s ruling as too vague.

The ruling, issued Monday afternoon, tossed out the initial purchase and sale agreement to buy out Belkin and keeps him in the partnership as a minority owner. The partners are now placed back in precisely the same position they were in before August 2005. The judge’s decision came after a trial that began in February and wrapped in early May.

“We won on every single point,” Spirit co-owner and NBA Governor Michael Gearon Jr. said in a statement released by the team. “The court did exactly what we asked it to do. We are back under the operating agreement which we think is a good agreement. We no longer have any obligation to buy out Belkin nor does Belkin have any right to purchase the Hawks and Thrashers.”

Read the whole story here at the AJC site.

Yaz & Yasmin Injury, Georgia

Our office is investigating claims of injury related to the birth control pills known as Yaz or Yasmin:

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.




Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

* Deep Vein Thrombosis (DVT): Deep vein thrombosis commonly affects the leg veins (such as the femoral vein or the popliteal vein) or the deep veins of the pelvis. Occasionally the veins of the arm are affected (if spontaneous, this is known as Paget-Schrötter disease). The most serious complication of a DVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE). DVT is a medical emergency, present in the lower extremity there is 3% chance of a PE killing the patient.

* Pulmonary Embolism (PE): Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in the body through the bloodstream (embolism). Usually this is due to embolism of a thrombus (blood clot) from the deep veins in the legs, a process termed venous thromboembolism. A small proportion is due to the embolization of air, fat or amniotic fluid.

* Heart Arrhythmia: An irregular heartbeat is an arrhythmia (also called dysrhythmia). Heart rates can also be irregular. A normal heart rate is 50 to 100 beats per minute. Arrhythmias and abnormal heart rates don't necessarily occur together. Arrhythmias can occur with a normal heart rate, or with heart rates that are slow (called bradyarrhythmias -- less than 60 beats per minute). arrhythmias can also occur with rapid heart rates (called tachyarrhythmias -- faster than 100 beats per minute). In the United States more than 850,000 people are hospitalized for an arrhythmia each year. There are types of this condition:

Premature atrial contractions; Premature ventricular contractions (PVCs); Atrial fibrillation; and Atrial flutter, among others.

* Heart Attack/Myocardial Infarctions and
* Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.

Xolair- Investigate for Link to Cardiac Problems?

In Canada news:

The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems.

The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab.

The early data point to a disproportionate increase in cardiovascular problems among people treated with Xolair compared with those who did not take the drug. The reported problems include heart attacks, abnormal heart rhythms, heart failure, fainting, mini-strokes and blood clots.

That's part of an article you can find here.

Cellcept Warning Label Updated

A warning of a risk of pure red cell aplasia (PRCA) has been added to the label and prescribing information for mycophenolate mofetil (CellCept).

Drug manufacturer Roche reported 41 cases of PRCA in patients given mycophenolate mofetil. In 16 of the cases, reduction of the dose or discontinuation resolved the condition.

The mechanism causing the side effect is unknown, but the manufacturer noted that some of the cases were also receiving other immunosuppressants, which may have contributed to the aplasia's development.

"When PRCA occurs in a patient on multiple immunosuppressants, the relative contribution of the drugs to PRCA and the prophylaxis of rejection must be considered before a decision is made to discontinue a drug," according to the letter to healthcare professionals sent by Roche announcing the new warning.

Other adverse effects reported with mycophenolate mofetil include increased likelihood of opportunistic infection, fetal damage in pregnant women, and lymphoma in patients taking the drug as part of an immunosuppressive regimen.

From Medpage Today.

What Should a Solo/Small Firm Focus on to build a practice?

I have been reading on several sites the opinions of what a solo lawyer or small law office should do when it comes to building a client base. There can never be a set list of what is important, but I do shudder when (at least in the consumer law/personal injury field) I see people blindly touting Social Networks as the key to all things, or a key building block. They're wrong.

On twitter, someone posted this: Solo/small should focus on social networking, blogging, thought leadership and niche focus more than "advertising." Doing so is folly. What matters on any list, at least for my areas of law noted above?

1.Competency: Knowing the area of the law- Really knowing it. Because if you say you do, and you don't, a potential client will learn of it. Sometimes, while you talk to that person at an event.

2.Networking: Live, real world networking. Not Twitter, not Facebook. Affinity groups, volunteering, law associations, meetings, conventions. Shaking hands, taking people to lunch or breakfast.

3a.Web presence- Each day I am amazed/appalled at what some lawyers/firms try to pass off as a web site. No phone number on page one. Impossible to locate office address. Spend the time building a website. Keep it current. One firm's website I saw listed under "Recent News" an article from April ... of 2008 ... as the lead news story.

3b.Learning Google Adwords: Most lawyers will mention how many hours are spent preparing for a deposition in a case, but simply slough off Google and internet advertising. Learn it. Google Adwords training can be done over time. Even if all you do is put up a google ad with your name or firm name, limited to your state, you must do it. I bet that what one Gen Y staffer calls a "kick ass" website for your firm, with Google, will generate more work than all SN sites you work on combined.

4.Blogging- This site for me is an outlet, sort of my office without the suit jacket and tie. I blog about law, pharma, and more - even the loss of my beloved dog. After three years, it's not uncommon for our office to receive 50+ emails or calls a month from the blog. With zero cost (thanks blogger!) to run and zero advertising.

5.Marketing to current clients:Good work is nice, but the last thing I need to hear is a person telling me, "I didn't know you practiced that type of law, or I would have told my brother/neighbor/pastor about you." We send out to every client a glossy "important papers" folder, a current (and not cheap) 8 1/2 by 11 Calendar, and more. Each year, new Calendar. In fact, when we miss a couple, I get the call asking "Where's my calendar?" We're working a birthday cards now.

6.List Servers: Speaking only for trial lawyers, our list servers are terrific sources of information as well as work. I contribute from time to time, I read daily, and I offer to assist. If you don't have one for your practice, dig. ABA and a State Bar may be a good start.

Way down on my list is Social Networks like Facebook and others. I no longer use two of them to build my office's work.

The Twitter post mentioning "thought leadership." Jargon. Worthless. How many of you reading this blog post even know what that means. That makes no list. For now.

Social Networks? Sure. I spend 1-5% now on it. I like Twitter- For the rapid rush of information. In certain areas- news, entertainment - great. For law? Not so much at least in my vast area - consumer law and injury practice. I spend time on it.

The point of all this is - learn by doing. I think SN will perhaps be like a yellow pages ad- a good but small part of your practice.

If you think I am wrong when it comes to SN on any list, I'd love to hear from you. Tell me your area of practice, and please - PLEASE- don't merely mention how you now have 1 or 2 clients from SN. If you have a practice where more than 15% have come from SN, my guess is you're a lawyer in tech, IP, or Entertainment.

Actos and Avandia News

A large study from British Columbia, Canada is pointing to an increased fracture risk with thiazolidinediones (TZDs), used in the treatment of type 2 diabetes [1]. The study, which reviewed fracture risk in more than 84 000 patients receiving either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) vs a sulfonylurea, found that both men and women are at increased risk of broken bones when taking a TZD and hints that pioglitazone may be more strongly associated with fracture risk. Two years ago, the FDA requested that a warning on fracture risk be added to the pioglitazone labeling.

The study appears in the August 10/24, 2009 issue of the Archives of Internal Medicine.

"Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty," Dr Colin R Dormuth (University of British Columbia, Vancouver) and colleagues write.

Dormuth et al point out that the research linking fractures to TZD use has not been entirely consistent, with some trials (but not all) suggesting different effects for the two commercially available TZDs and others pointing to a different degree of risk according to gender.

www.segeorgialaw.com

Permax Information

Earlier in 2007, the FDA announced that Permax (generic: pergolide) was withdrawn. There are additional drugs in the same class that can be substituted.


Studies had been released linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson's patients taking Permax had moderate to severe heart valve troubles. An additional study, by German doctors, established that users of Permax were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies can be found in the New England Journal of Medicine.

Avandia - Diabetes Drug- Heart Attack Link?

Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks.

Several published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

If you believe you were injured because of your use of Avandia, talk with me.

Fosamax: First Trial Approaches

Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial this week. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three cases to go this summer.


The Fosamax plaintiffs claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, or ONJ.

The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.

Merck says the drug is safe and effective.

Fentanyl Patch Recall News

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between April 2, 2009 and May 20, 2009. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No serious injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Anyone who has 100 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly. Anyone with 100 mcg/hr Fentanyl Transdermal System patches being recalled should call 888-345-2656, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using fentanyl patches who have medical questions should contact their healthcare providers.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

Source here.

Courts: Remand Order Worth a Read

Below is a link to a recent US District Court Order regarding a case that had been removed from a State Court (in Alabama) to a Federal Court based on diversity as well as Defendants' claim that the jurisdictional amount had been met.

The Federal Court Judge assigned to the case wrote:

"The question [before the Court[ is whether this specific settlement demand, given all the evidence presented, established by a preponderance of that evidence that the amount in controversy exceeds $75,000 ... The defendants insist that the plaintiffs’ demand of $155,000 must meet this standard simply because the demand was made. The proper assessment of settlement offers is not so facile. “While [a] settlement offer, by itself, may not be determinative, it counts for something.” Burns v. Windsor Insurance Co., 31 F.3d 1092, 1097 (11th Cir. 1994). What it counts for, however, depends on the circumstances."

The case may be found here.

What Should a Solo/Small Firm Focus on to build a practice?

From the FDA:

The U.S. Food and Drug Administration announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are:
- Botox (new established name: onabotulinumtoxinA)
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
- Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drug’s “generic” name). Neither the brand names nor the formulations of the products have changed.

Tort Reform Champion Loses Med Mal Case

I pulled this from my good friend Chris Hellum's blog, analabamalawyer

"Elliott Kaplan is a prominent Kansas City attorney. For years, he railed against judges, juries, and trial attorneys. He was well known as one of the founders of the modern tort reform movement in America. He was named "Legal Reform Champion" by the American Tort Reform Association.

In a cruel twist of fate, it appears he may have reaped what he sowed.

According to its website, The American Tort Reform Association was founded in 1986 by the American Council of Engineering Companies and shortly thereafter, the American Medical Association followed them. They have worked to enact tort reform legislation in 45 states. They have led grassroots efforts which have resulted (they claim) in 85% of Americans believing that frivolous lawsuits clog our courts.

Their efforts have paid off, perhaps to the detriment of one of their own. According to the National Practitioner Data Bank, the number of U.S. malpractice payments in 2008 was the lowest since creation of the federal National Practitioner Data Bank, which has tracked payments since 1990.

WHAT HAPPENED TO LAWYER KAPLAN

Lawyer Kaplan was diagnosed in 2003 with pancreatic cancer by his doctor in Kansas City. Kaplan sought the best care money could buy. He went to the Mayo Clinic in Rochester, MN. There he was again diagnosed with pancreatic cancer.

To save his life, he underwent a Whipple resection, a highly invasive surgery that can cause more harm than good. It was only after the surgery that the diagnosis was determined to be wrong, that he only suffered from pancreatitis, and that the Whipple resection made the condition worse, leaving him debilitated and a broken man.

Believing that the doctor had committed malpractice, Kaplan sued the pathologist alleging negligence in the diagnosis. He assembled an army of attorneys to represent him. Unfortunately, the jury found against Kaplan and awarded him no damages. He has moved for a new trial. The motion is currently pending.

I certainly feel for Lawyer Kaplan. Unfortunately, he and the organization which he was a "Champion", foster the belief that all lawsuits are frivolous and that they compromise access to affordable health care, punish consumers by raising the cost of goods and services, chill innovation, and undermine the notion of personal responsibility.

I don't know if his lawsuit was meritorious or not. If it is, then I pray that justice will prevail. I do know that his organization, the American Tort Reform Association, has perpetuated the belief among most Americans that all lawsuits are frivolous. The beneficiaries of this belief are not injured or defrauded people, but the insurance companies and large corporations who fund these organizations."


Chris Hellums can be reached at Chrish@pdkhlaw.com

Denture Cream Issues: Fixodent and Poligrip

Approximately 35 million Americans use denture creams and several of the popular adhesives, such as Fixodent and Super PoliGrip, have been linked to serious and debilitating injuries caused by excess levels of zinc contained in the products that may enter the body.

Some users may have suffered from neuropathy or other injuries caused by zinc poisoning, which could cause symptoms like:

* Paralysis
* Numbness
* Loss of Sensation
* Tingling or Pain in Hands or Feet
* Muscle Weakness
* Loss of Balance
* Difficulty Walking
* Unexplained Pain or Weakness

The makers of each product believe their products work as advertised.

Blair Robe Recall - Important News

Women’s Chenille Robes Recalled by Blair Due to Burn Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, 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.

Name of Product: Full Length Women’s Chenille Robes

Units: About 162,000

Retailer: Blair LLC, of Warren, Pa.

Hazard: Some robes fail to meet federal flammability requirements and present a risk of serious burns to consumers if they are exposed to an open flame.

Incidents/Injuries: Blair has received three reports of the robes catching on fire, including one report of second-degree burns.

Description: The recall involves the Full Length Women’s Chenille Robe with the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment’s neckline. This is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe’s sewn in label states: “100% Cotton, RN 81700, Made in Pakistan”. Robes with other item numbers are not included in the recall.

Sold at: Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

Manufactured in: Pakistan

Remedy: Consumers should stop wearing the garment immediately. Contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise.

Court Decisions: Sealed Container Defense Rejected in AL as to Retailers

News regarding an Alabama Supreme Court decision, and cases are before the Court on a certified question from the United States District Court for the Northern District of Alabama. The USDCT concluded that it was not clear under Alabama law whether claims alleging the breach of the implied warranties of merchantability and fitness for a
particular purpose are subject to the defense of the sealed-container doctrine.

Supreme Court held that they were not. Opinion here.

Medtronic Recalls Lots of Paradigm® Quick-Set® Infusion Sets in the United States

Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

More about the recall here.

segeorgialawblog.com

Image by TeecNosPos via Flickr

I'm working on a new blog for Southeast Georgia. I've been litigating in Brunswick, Glynn County, Woodbine, Folkson, Camden County and other cities there for nearly a half decade, and have opened an office there.

For a dose of segeorgia flavor, visit that blog.

News from A Friend's Firm: Lawsuit in MD

I count Rick Kuykendall as one of those lawyers whom I trust. He's with the Murphy Firm in Baltimore, and there is this news this week:

The Murphy Firm of Baltimore and Henry & Associates of Largo have announced the filing of a 12-count civil suit that charges Prince George's county officials and some of the County's correctional and law enforcement officers with responsibility for the 2008 death of 19-year-old Ronnie L. White, who, the suit states, was “assaulted and killed by the very same correctional officers who were supposed to be there to insure his safety.”

White died of a broken neck and asphyxiation 34 hours after he was received in custody by the Prince George's County Correctional Center. Following an autopsy, the Office of the Chief Medial Examiner for the State of Maryland ruled that White's death was a homicide.

The suit, filed on behalf of White's mother, Angela L. White, states that Ronnie White’s death was “the direct result” of excessive force and gross negligence by County officials, and that his constitutional and civil rights were violated. The suit is seeking $153,600,000 in compensatory and punitive damages.

Link here
.

We talked this morning, and he said his real issue front and center today is making sure his daughter Amalee Kuykendall gets to college on time. I worry about that day as well!

Weight Loss Supplements Recalled

The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

Here's the product list:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

Dietary Supplement Recall

Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx.

An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil. Benzamidenafil is in the same pharmacologic class as the phosphodiesterase type 5 (PDE5) inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved and poses a threat to consumers because it may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the most susceptible to adverse effects from this product.

Source here.

FDA To Discuss Liver Risks With Tylenol,Other Painkillers

Image via Wikipedia

The FDA will be taking a look at painkillers such as Tylenol next week.




The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America.


Acetaminophen is found in more than 100 products, including many prescription drugs administered by pharmacies. Much of its popularity is because - when taken at recommended doses - acetaminophen does not cause stomach discomfort or bleeding, unlike other drugs commonly used to reduce pain and fever, such as aspirin, ibuprofen and naproxen.

When, however, it's taken over the maximum amount of 4 grams per day, acetaminophen can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure (ALF), and even death; a problem not caused by other over-the-counter painkillers.

Despite efforts since the early 1990s to reduce the incidence of acetaminophen-related liver damage, liver injury from acetaminophen overdose remains a serious public health problem. Source.



You'll be able to see the FDA at work by logging on to FDAAdvisoryCommittee.com


Source here.

Problems With Homeopathic Remedies?

An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.


According to reports:

The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. At least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.

Source here.

Given recent recalls of over the counter products, it's imperative that consumers carefully read the label of products like Zicam and others.

Zicam Recalled

Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.

Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered. Officials have not yet determined if the condition is permanent, and fear the intranasal gel spray may be damaging nerves. The FDA expressed concern that consumers are using Zicam for a minor, “self-limiting condition” (such as a cold) and inadvertently risk damaging their quality of life permanently.

The affected products have been pulled from store shelves across the country and the FDA have advised that all remaining product should be discarded and not used for any reason.

Source here.

Zyprexa news

From Public Citizen and other sources:

Eli Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the FDA showing Zyprexa was not effectively alleviate dementia symptoms in older patients, the company started to market the drug to such patients, so says documents unsealed in insurer suits against the company.

Lilly has pleaded pleaded guilty earlier this year to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

Source here.

Liberty National Life Insurance News: Florida Licensure At Risk?

Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.

Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied.

The OIR order to Liberty National gives the company 21 days to provide proof that it didn't violate state laws that prohibit discrimination.

Liberty National, based in Birmingham, Ala., didn't return a call from The Miami Herald asking for comment on Thursday's order.

According to OIR's order, 52.6 percent of Haitian applicants were denied compared to 18.2 percent of other foreign-born applications. For instance, although Liberty National's life insurance application asks if consumers have lived in the United States for more than a year, it applied a selective 10-year residency requirement to customers born in certain countries such as Haiti or Colombia.

TRAVEL CONCERN

Applicants with plans to travel to such countries as Haiti, Liberia or Honduras were also denied.

Investigators reviewed some 7,000 applications and found 1,149 violations, including 1,053 involving discriminatory practices.

Read more here.

Calrcon Skin Product: Partial Recall and Warning

he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Link here.

Recent Avandia Medical Article

Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.

The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures.


You can find the article here.

Graves Disease Drug: Increased Risk for Liver Injury?

The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.

The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication. In the pediatric population, the FDA said there were one death and six transplants linked to PTU use.

"Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy," the FDA said.

Source here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

412(i) Tax Shelter Litigation

My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:

Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself). These groups will use insurance brokerages and sub-agents (licensed in the various states) to sell the policies themselves.

HOW THESE PLANS WORK:

In the late 1990’s, the individuals and groups above devised a scheme to sell abusive tax shelters under the auspices of Section 412(i) of the tax code. A 412(i) is a defined benefit pension plan. It provides specific retirement benefits to participants once they reach retirement and must contain assets sufficient to pay those benefits. A 412(i) plan differs from other defined benefit pension plans in that it must be funded exclusively by the purchase of individual life insurance products. To create a 412(i) plan, there must be a trust to hold the assets.

The employer funds the plan by making cash contributions to the trust, and the Code allows the employer to take a tax deduction in the amount of the contributions, i.e. the entire amount. The trust uses the contributed funds to purchase some combination of life insurance products (insurance or annuities) for the plan. As the plan participants retire, the trust will usually sell the policies for their present cash value and purchase annuities with the proceeds.

The revenue stream from the annuities pays the specified retirement benefit to plan participants. These defendants (with the aid and knowledge of the insurance companies) used the traditional structure and sold life insurance policies with excessively high premiums. The trust then uses the large cash contributions to pay high insurance premiums and the employer takes a deduction for the sum of those large contributions. As you might expect, these policies were designed with excessively high fees or “loads” which provided exorbitant commissions to the insurance companies and the agents who sold the products.

The policies that were sold were termed Springing Cash Value Policies. They had no cash value for the first 5-7 years, after which they had significant cash value. Under this scheme, after 5-7 years, and just before the cash value sprung, the participant purchases the policy from the trust for the policy’s surrender value. In theory, you have a tax free transaction.

The IRS does not recognize the tax benefit of such a plan and has repeatedly issued announcements indicating that such plans are contrary to federal tax laws and regulations. These plans were targeted to high net worth individuals, including doctors, dentists, corporate executives, and professional athletes.

Read more at his blog, here.

Bausch and Lomb Settles Fungal Infection Lawsuits

Image via Wikipedia

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

Read more from this article here.

Reglan: JPML Hearing held in Louisville, KY

A motion to form an MDL, or Multidistrict Litigation, was argued yesterday before the JPML sitting in Louisville, Kentucky. There are at least 15 Reglan lawsuits pending in 11 different district courts throughout the United States.

Reglan is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying.

Request for Reglan lawsuit consolidation was opposed by the attorneys for companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.

Life Investors Insurance Class Action: Deadline Looms

Our firm is currently representing consumers who have cancer insurance policies with Life Investors Insurance Company of America as well as Transamerica.

Good and honest people bought cancer policies for a simple reason - To provide for a reimbursement amount of “actual charges” to be paid when incurred or billed. When claims were submitted, we believe that these two companies do not pay the “actual charges.” Instead, these insurers will pay a discounted amount for those same cancer treatments, contrary to the terms of the policy. We are pursuing individual cases.

Many people who bought a cancer insurance policy may have a received recently a class action notice in the case of Runyan v. Life Investors Insurance Company of America / Transamerica. The time period that applies to any policy bought during the years 2004 - 2006.

In our experience, the class action relief asked for is simply not an adequate remedy. As we see it, the Runyan class settlement is inadequate relief for policyholders.

We believe that “opting out” of the class action may be more appropriate to protect their individual rights. Alternatively, filing an objection to the class may be even more appropriate. We are currently evaluating both of these options for these policyowners, but we are nonetheless accepting cases for those who wish to either opt out or object to the class settlement in its entirety. The deadline to exclude yourself from this class is June 29, 2009.

The deadline to object to the settlement is June 29. 2009.

Tech: PDF For Lawyers

The site, that is. http://www.pdfforlawyers.com/ Is worth a look. Tips include: "Using Acrobat to put Exhibit stamps on digital documents." Also, learn how to OCR with the ScanSnap to create searchable PDF files at just the push of the “scan” button…


Worth your time. We use the Scansnap at work, and it's a must have.

Hydroxycut Lawsuit; Hypertensive retinopathy associated with Hydroxycut Usage

Here's a report on the use of performance-enhancing and weight-loss supplements is prevalent in the United States. The report notes that with new restrictions placed on such products, companies have been marketing caffeine-based ephedra-free herbal supplements.


The report notes, "less is known about the potential side effects of these products. We present the case of a 42-year-old, previously healthy man who developed malignant hypertension and hypertensive retinopathy while taking Hydroxycut, a caffeine-based ephedra-free supplement."

Find the abstract here.

Flomax and Cataracts

Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

It's not the first time that Flomax (tamsulosin) has been linked to cataract complications. A study in 2005 found that men taking Flomax or other alpha-blockers before cataract surgery had complications during and immediately after the procedure. The U.S. Food and Drug Administration called for stronger warnings about the drug, and Boehringer Ingelheim Pharmaceuticals, which makes Flomax, sent warning letters to doctors about the potential problems.

In the new study, 7.5 percent of the men who had taken Flomax in the two weeks before cataract surgery had a serious complication, compared with 2.7 percent of those who had not taken the drug, for a 2.3 times greater risk.

Read more at this source, here.

Reglan: FDA Video from YouTube

Interesting that the FDA now uploads video to youtube.com

Hydroxycut Lawsuit Filed in Georgia State Court

Our office filed in Georgia State Court a lawsuit where a consumer claims she suffered an injury related to her use of Hydroxycut. The multi-count lawsuit claims, among other things, what most would expect: Negligence, Breach of Warranty, and other claims of wrongdoing.

We don't file class actions in my office, believing that the best way to seek some measure of justice for someone is to make a specific claim for each person in separate lawsuits. Other lawyers may go the class action route; it's just not for me.

I will post a few pages of the Complaint filed in the next day or so.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

David Hodge: $17 Million Dollar Verdict in AL on 5/13/09

A guy who I consider a friend is David Hodge, a Birmingham, Alabama lawyer. Not too excitable, loves Bama football, family man, dog man like me.

David went to Hale County, which is right here:





His firm's client was Chapman Logging. The case involved the sale of a defective logging skidder equipped with a Cummins engine. David's firm is found here pdkhlaw.com. A skidder looks like this:

Image via Wikipedia

I know what you're thinking: How in the world did the jury come back with that verdict? I'm thinking the same thing, but will have to hear more about it tomorrow. Well done. I will tell you this - if you run across David Hodge in any case, take a get ready pill.

That Pesky Drug known as Cheerios

Image via Wikipedia

Sometimes you just shake your head in amazement. This warning letter from the FDA to the CEO of General Mills (never mind that people are getting ill or dying from bad foods):

(FDA source)

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:

The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

If you can ...ummm ...stomach the rest of that letter, you are a better person than I.

Lawyer Etiquette: Is Your Blackberry Use Hurting your Reputation?

Image by Getty Images via Daylife

I attended a meeting of lawyers this month, and when about 5-6 of us were sitting together talking shop, one member of the group brought up a good subject. As we talked, that same person started typing away on his Blackberry. He was so distracted, he missed two questions posed to him. I was to be candid appalled. It was rude and insensitive. I didn't know this person very well, but I will remember him now for that mistake.

I went searching on the web for a quick list of suggestions that I lawyers could read to help them when using a Blackberry, since at least 50% of its users forget basic courtesies:

From the Legalease Blog:


1. If you are attending an event, meal, meeting or presentation, turn off your electronic devices. If you put MUST keep them on, turn them to silent or vibrate, do not place them on the table so that the vibration disturbs those around you;

2. If you are awaiting an important call or email, consider not attending the event so that you can attend to your important business;

3. If it is imperative that you attend the event, be sure that you keep your focus or attention on the event. Advise your companions at the outset that you are waiting for an urgent call, and sit near the door. Leave the room or the table discreetly if you absolutely MUST check your email or voice mail or return a call or email;

4. Remember that those around you are forming an impression of you AT ALL TIMES; if you are with a client and are checking your BlackBerry, reading emails, surfing the web, the client is going to think that you don't care about them and that they are not important to you;

5. Be aware that if you are replying to important emails while at dinner, a networking event or another meeting, you are not presenting your best self either at the event or in the email. Not only are you unable to devote your complete attention to the event and the people you are with, but you are also unable to devote your full attention to the email message. You may be making a poor impression on two groups of people at the same time.

6. Even if your device is under the table or you think you are being discreet others in the room are well aware of what you are doing. Regardless of what you think, you are NOT getting away with it!

7. The smaller the meeting, the more noticeable your behavior. But even in large meetings, be mindful of those around you, since they will certainly be aware of your behavior, so if your boss or an important client or colleague is sitting near you, refrain from checking your BlackBerry. And if the presenter, meeting facilitator or your boss is standing, seated on a dais or is behind you, they will be aware of your behavior even in a large room.

8. Reconsider your definition of what is an 'urgent' matter and what can wait. Think about your priorities, not just in the short term (answering this email immediately as opposed to 10 minutes from now), but also in the long term (if the client thinks I'm rude, I may lose the account).

There's more at the link above.

Take heed, lawyers!

Autism: Are Children able to "Recover?"

A close friend has a child with autism, and the frustrations, worries and concerns are etched on his face when we get together. I could never imagine what he and his family must address each day.

From several sources, including Yahoo, this article:

"Leo Lytel was diagnosed with autism as a toddler. But by age 9 he had overcome the disorder. His progress is part of a growing body of research that suggests at least 10 percent of children with autism can "recover" from it — most of them after undergoing years of intensive behavioral therapy.

Skeptics question the phenomenon, but University of Connecticut psychology professor Deborah Fein is among those convinced it's real.

She presented research this week at an autism conference in Chicago that included 20 children who, according to rigorous analysis, got a correct diagnosis but years later were no longer considered autistic.

Among them was Leo, a boy in Washington, D.C., who once made no eye contact, who echoed words said to him and often spun around in circles — all classic autism symptoms. Now he is an articulate, social third-grader. His mother, Jayne Lytel, says his teachers call Leo a leader.

The study, funded by the National Institute of Mental Health, involves children ages 9 to 18.

Autism researcher Geraldine Dawson, chief science officer of the advocacy group Autism Speaks, called Fein's research a breakthrough."

Read the rest here.

Hydroxycut: UPC Codes Released today (Georgia, Alabama, Florida)

Here's news on the Universal Product Codes related to the Hydroxycut products:

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

The UPC numbers being added to the May 1 list are as follows:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US K