Friday, January 29, 2010

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.

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.

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Thursday, January 28, 2010

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

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:,0,1928030.story

Wednesday, January 27, 2010

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.


"In a letter sent Jan. 22 to Johnson & Johnson's CEO William Welson, and obtained by, 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.

Tuesday, January 26, 2010

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.


Avandia Lawsuits in North Carolina/South Carolina? Heart Attack/Stroke

There is a 3 year Statute of Limitations in N.C. and S.C.:

From several sites:

Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received for
rosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks of rosiglitazone, the large number of reports alleging serious and fatal injuries associated with rosiglitazone further reinforces concerns about its cardiovascular safety. The company, GlaxoSmithKline, told us it believed most reports were generated by lawsuits.

In February 2010 the FDA announced it was conducting an overall safety review of
rosiglitazone and would present its findings to a special advisory committee meeting in July.

"Rosiglitazone should be removed from the market," concluded Dr. David Graham and Dr. Kate Gelperin, both epidemiologists with the FDA. Linkavandia

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.


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.


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Monday, January 25, 2010

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.

Friday, January 22, 2010

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.

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.


Wednesday, January 20, 2010

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.


Tuesday, January 19, 2010

Quick Tech Take:

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

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 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

Monday, January 18, 2010

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:

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 This e-mail address is being protected from spambots. You need JavaScript enabled to view it .


Shazi Visram
Imminent Mother-to-be
Founder and CEO

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.


Sunday, January 17, 2010 Voluntary Nationwide Recall of Body Building Products

Northborough, MA – January 15, 2010 –, Inc. ("") 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 that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised 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 cannot independently confirm the FDA's concerns, that any one or more of the Recalled Products in fact contain these ingredients, 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. 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 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. is an internet retailer and did not manufacture or formulate these products.’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’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.

Monday, January 11, 2010

New Seroquel Print Ad has 5 PAGES of Disclaimers

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

Saturday, January 09, 2010

Powerful Opinion Piece on Georgia's Victims of Medical Wrongdoing

This is a must read. I take it whole cloth from

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.

Friday, January 08, 2010

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.


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.

Thursday, January 07, 2010

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.

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Tuesday, January 05, 2010

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.


FDA: 26 New Drugs in 2009; 25 in 2008

:Original raster version: :Image:Food and Drug...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.

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