Lawsuits you should know about

The FDA and CDS have warned consumers not to eat any varieties of Nestle Toll House prepackaged, refrigerated cookie dough due to the risk of contamination by E. coli virus.  This is due to 66 reports of illness from 28 states since March 2009.  Twenty five people were hospitalized, while seven people suffered a severe complication known as Hemolytic Uremic Syndrome (HUS).  Young children and the elderly are at an especially  high risk of developing HUS, which can lead to kidney damage and possibly even death, although no deaths have been reported yet.

The FDA has advised anyone who has prepackaged, refrigerated Nestle Toll House cookie dough they should throw it away.  It is not advised to cook the dough, because even though cooking will kill the bacteria a person could get the bacteria on kitchen surfaces or his or her hands and still get sick.  If you have eaten this prepackaged, refrigerated cookie dough and experience symptoms like abdominal cramping, vomiting, or diarrhea you should seek medical attention immediately.
As of June 21, 2009 and according to the Nestle website the only products included in this recall are prepackaged, refrigerated cookie dough products.  You can visit the website to see the press release issued by the Nestle company by clicking here.

If you are an asthma patient, you may be interested in knowing that the Food and Drug Administration (FDA) has issued a public health advisory for certain asthma inhalers.  The inhalers Advair Diskus, Foradil Aerolizer, and Serevent Diskus are long-acting beta 2-adrenergic agonists (LABA).

These inhalers help relax the muscles around the airways of the lungs.  However, the FDA is warning doctors that these specific inhalers should not be the first medication used to treat asthma as, while they may decrease the chances of an asthmatic episode, they may make episodes more severe.  The FDA believes that these inhalers should only be used if other asthma medications have failed to treat the symptoms.

The FDA has asked the manufacturers to include a warning label on the inhalers to caution patients that use of the inhalers may increase the chances of a severe, even deadly, asthma episode.  It has also asked that manufacturers include a medication guide with each prescription that includes wording approved by the FDA that warns of the potential risks.

One study showed an increased chance of death in those using the LABA inhaler versus those using a placebo.  Thirteen deaths occurred out of 13,176 patients using Serevent while only three deaths occurred out of 13,179 patients taking the placebo.  While the number of deaths was small, the FDA is still believes patients should know of the risk.

Since the FDA’s public health advisory was issued, the manufacturers of both Advair Diskus and Serevent Diskus have updated their labels to include the new warnings.

The FDA is advising that “if you are currently using one of the inhalers listed in the public health advisory, do not stop using it without first consulting with your physician.  If wheezing becomes worse while using the inhaler, consult your physician immediately”.

The Food and Drug Administration (FDA) issued a warning to consumers today to stop taking Hydroxycut products.  Hydroxycut products are marketed as a weight loss supplement.  It is made by Iovate Health Sciences, Inc. and distributed by Iovate Health Sciences USA, Inc. of Blasdell, NY.

Iovate has agreed to recall their products after findings that some of the products may cause serious liver injuries.  There have been 23 reports of liver injury reported to the FDA.  The problems reported include signs of liver injury (jaundice, brown urine, elevated liver enzymes, vomiting, light-colored stools, excessive fatigue, weakness, stomach pain, itching, and loss of appetite), seizures, cardiovascular disorders, rhabdomyolysis, (muscle damage which can lead to kidney failure), and in extreme cases, liver damage resulting in a liver transplant.  A 19 year old male consumer of one the products has reportedly died.

If you have been taking Hydroxycut and experience any of the symptoms above, you should contact your physician as soon as possible.

While the reported cases are rare, they do exist and the FDA is asking consumers to immediately stop taking Hydroxycut products to avoid any potential dangers.

Consumers reporting the injuries have been taking the following Hydroxycut products as the recommended doses:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

All the products listed above are involved in the recall.   While all are not involved in the reported cases, Iovate agreed to a recall of all products.  Return unused portions of the product to the retailer

Hydroxycut Cleanse and Hoodia products are not a part of the recall as they contain different ingredients.

Evenflo Co., in cooperation with the US Consumer Products Safety Commission, have  announced a voluntary recall of approximately 643,000 Envision high chairs and expanded a recall of 90,000 Majestic high chairs. 

The company is recalling the high chairs due to risks from falls and choking hazards.  In the Envision high chair models, recline fasteners and screws can loosen and fall out, causing the seat back to recline or even detach unexpectedly, leading to a risk of injury from falls.  There is also a choking risk from the detached screws and fasteners.  The high chairs were manufactured in China and sold in stores from December 2002 to April 2006.

The recall involves all Envision high chairs, including the following models:   2891321, 2891321A, 2891333, 2891351, 2891351A, 2891365, 2891375, 2891403, 2891403A, 2891466, 2891466A, 2891478, 2891536, 2891536A, 2891573, 2891586, 2892351 and 2892351A.

You can read more about this recall on the MSNBC web site by clicking here.

Setton Pistachio, of Terra Bella, Inc., a California Company, has voluntarily recalled bulk roasted pistachio nuts because of potential contamination with the Salmonella organism.  The recall names specific lots of bulk roasted shelled pistachios and tote bags of roasted in-shell pistachios sold to wholesale customers in 2,000pound, 1,700 pound, 1,800 pound and 1,000 pound sizes.  The affected nuts were shipped on or after September 1, 2008.
 
There is an additional recall off Setton Farms brand roasted salted shelled pistachios in 9 oz. film bags that have the UPC code 034325020252 and have a “best before” date between 1/16/10 and 1/19/10.  This product was distributed in SC, GA, FL, NC, VA, TN and KY.  Consumers who think they have this product should return what they have to the place of purchase for a refund.  There is also a toll free number consumers can call for more information – 888-228-3717.
 
This is a voluntary recall and is not related to the recent recalls of peanuts and peanut butter.  It’s the first time in the 13 year history of sales of Setton Pistachio that pistachio nuts are being recalled by them.
 
Salmonella is an organism that can cause nausea, fever, diarrhea, vomiting and abdominal pain.  In young children, the eldery, or those with weakened immune systems infection with the Salmonella organism can be serious, or even fatal.

The pet store chain Petland, Inc. is the defendant in a lawsuit filed against the company by the Humane Society of the United States on Monday, March 16, 2009 in the US District Court in Phoenix, AZ.  Other pet owners who say they purchased sick puppies from Petland are also parties in the suit.  The lawsuit seeks class action status and challenges the companies’ conduct under the federal racketeering statute and under consumer protection laws of 20 states.

The lawsuit alleges that Petland intentionally misled thousands of customers who purchased puppies at their stores.  According to the lawsuit Petland led their customers into believing the puppies purchased came from the finest breeders in the country.  According to the Humane Society many of the puppies sold by the store were bred in puppy mills in filthy conditions with inadequate care or socialization.

The plaintiffs are seeking changes in how the puppies are bread, to stop what they call unfair and deceptive sales practices, and financial damages to help cover the veterinary costs associated with the purchased puppies.

An executive of Petland stated these were false accusations, and the store in fact only offers “healthy, happy and well-socialized pets” for sale to their customers.

A few months ago I had to have a colonoscopy performed.  I was young so it came as a surprise to me that I needed one.  I received an informational preparation package from my surgeon and part of the instructions is to perform a bowel or colon cleansing prior to the procedure.  The product that was recommended for me to use was Fleet Phospho-Soda.  I followed the doctor’s instructions to the letter and purchased it, used it according to the directions provided and had my colonoscopy.  A few days ago I saw a commercial on television that stated there possibly could be a link between the use of oral sodium phosphate products (like this one) for colon cleansing prior to a colonoscopy and kidney problems.

I decided to research this topic on the internet and I have found out that the Fleet product was recalled on December 11, 2008 after a Safety Alert was issued by the FDA that consumers should not use this product for colon cleansing prior to a colonoscopy due to the high risk of kidney failure associated with the use of this product.  The FDA is also now requiring all prescription colon cleansing products to carry a black box warning.  A black box warning is a type of warning that appears on the inserts for prescription drugs and carries the name “black box” because of the black border that surrounds the information.  Fleet Phospho-Soda is not a prescription drug so a black box warning was not placed on the drug information contained with the product.

As far back as May, 2005 the FDA had warned the use of oral sodium phosphate bowel cleansing products could cause kidney problems, especially in patients who already had impaired kidney function, kidney disease, or who were dehydrated.  (Having experienced a bowel cleansing personally let me tell you it is nearly impossible to not get dehydrated after it – you drink, and drink, and drink even more but what goes in must come out.)  Patients who were taking drugs like ACE inhibitors or ARBs were also at a higher risk of experiencing kidney problems.

The FDA has confirmed that at least 21 users of oral sodium phosphate bowel cleansing solutions have developed Acute Phosphate Nephropathy which can lead to renal failure, dialysis treatment, the need for a kidney transplant, or in severe cases, death.

The FDA has announced that bowel cleansing preparations (as the ones used prior to a colonoscopy) should only be available as a prescription remedy.   The FDA has stated that the use of Fleet Phospho-Soda in low doses as a laxative is safe.  The possible danger of kidney problems arises when oral sodium phosphate products are used in higher doses for colon or bowel cleansing.

The outbreak of salmonella has resulted in hundreds of people in 43 states getting ill and at least six deaths.  Most deaths occurred in the elderly, who may have weakened immune systems.  Salmonella is the leading cause of food poisoning in America and exhibits symptoms such as fever, diarrhea, and abdominal cramping.  Peanut Corp, says its peanut butter is not sold directly to consumers, but to institutions, food service industries, and private label food companies.

Products are being removed from shelves and Kellogg is advising consumers to destroy the following products:

Austin® Quality Foods Cheese Crackers with Peanut Butter - all sizes
Austin® Quality Foods Cheese & Peanut Butter Sandwich Crackers – all sizes
Austin® Quality Foods Mega Stuffed Cheese Crackers with Peanut Butter - all sizes
Austin® Quality Foods PB & J Cracker Sandwiches - all sizes
Austin® Quality Foods Super Snack Pack Sandwich Crackers
Austin® Quality Foods Chocolate Peanut Butter Sandwich Crackers – all sizes
Austin® Quality Foods Toasty Crackers with Peanut Butter - all sizes
Austin® Quality Foods Reduced Fat Cheese & Peanut Butter Sandwich Crackers
Austin® Quality Foods Reduced Fat Toasty Crackers with Peanut Butter Sandwich Crackers
Austin® Quality Foods Cookie/Cracker Pack
Austin® Quality Foods Variety Pack
Keebler® Cheese & Peanut Butter Sandwich Crackers - all sizes
Keebler® Toast & PB’n J Flavored Sandwich Crackers - all sizes
Keebler® Toast & Peanut Butter Sandwich Crackers - all sizes
Famous Amos® Peanut Butter Cookies (2- and 3-ounce)
Keebler® Soft Batch Homestyle Peanut Butter Cookies (2.5-ounce)

Dilantin is a brand name of the generic drug phenytoin sodium that is manufactured by Pfizer.  It is used to lessen the runaway brain activity seen in epileptic patients when suffering a seizure by reducing the electrical conductance among brain cells. 

Phenytoin sodium was the first modern antiepileptic drug developed and has been in use since 1938.  Dilantin was proved for use by the Food and Drug Administration (FDA) in 1982.  Like most drugs, there are common side effects such as constipation, dizziness, headache, nausea, and vomiting.  However recently, there has been concern that the use of Dilantin can result in Stevens Johnson Syndrome (SJS) and the more severe version of it, Toxic Epidermal Necrosis Syndrome (TENS).  This is due to an increase in reports of patients who have taken Dilantin being diagnoses with SJS.

SJS is a skin disease that is typically the result of an allergic reaction to an over the counter medication.  The cell death that SJS causes results in the epidermis separating from the dermis and it can be fatal in about 15% of the sufferers.  SJS symptoms begin with a fever, sore throat, and headaches like a cold or flu, but soon, the patient begins suffering from skin lesions and blisters.  Because patient’s skin becomes so blistery, they are often treated in burn units.  If the lesions adhere to the lungs, SJS can cause death.

The FDA issued an alert in November 2008 about the potential risk of SJS for Asian patients using phenytoin therapy that have tested positive for human leukocyte antigen (HLA) B*1502 allele.  The Stevens Johnson Foundation is concerned that the FDA is not monitoring the potential for adverse drug reactions closely enough because less than one percent of the deaths due to drug reactions are reported.  The doctors may not be reporting it to the FDA because it is not required, but also because they misdiagnosis the SJS and don’t realize it could be drug related.

Others are concerned that Dilantin use can result in liver damage, irregular heartbeats, decreased blood pressure, and birth defects.  A study done at the University of Florida in Gainesville shows that Dilantin use by the mother during pregnancy may result in a lower IQ in the infant.

Many that have taken Dilantin and suffered from SJS or any other adverse side effects have filed suit against Pfizer.  The family of Agnes Davis filed suit against ten different companies that are involved in the making, labeling, testing, marketing, and distribution of phenytoin sodium.  The lawsuit, which was filed in August 2008, claims that Davis had a severe reaction to phenytoin and it resulted in her death.

A recall has been announced by the U.S. Consumer Product Safety Commission for OKK Trading’s Army Figures, 7 ½ inch plastic Army men dressed in fatigues and carrying guns. The recall is due to the fact that the surface paint contains an extremely high amount of lead, so much so that it violates federal standards.

The figures, which were manufactures in China, were sold through dollar store retailers between June 2008 and September 2008 for $1 each.

While no injuries related to the use of these toys have been reported, consumers who purchased them are encouraged to contact OKK Trading for a full refund or replacement. OKK Trading can be contacted by phone at (877) 655-8697 between the hours of 9 a.m. and 5 p.m. PT Monday through Friday or on their web page.