More Listeria and Salmonella Concerns

September 30, 2011, by Ronald V. Miller, Jr.

Concerns with produce containing Listeria monocytogenes have plagued the nation since August, as affected cantaloupes have been reported to have caused at least 72 illnesses, including up to 16 deaths. This has made it the deadliest food outbreak in the United States in more than a decade. Today, we add Romaine lettuce to the list of concerns.

True Leaf Farms is voluntarily recalling 2,498 cartons of chopped romaine because of the potential of contamination with Listeria. The recalled product was shipped between September 12th and 13th, to wholesale food service distributors in 19 states and Alberta, Canada. The states include Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Minnesota, Missouri, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee and Vermont. The romaine affected by this recall has a “use by date” of 9/29/11, and is labeled with the bag and box code B256-46438-8.

Further produce recalls include Andrew Williamson Fresh Produce who is voluntarily recalling one lot of organic grape tomatoes. This time, the possible health risk is from Salmonella. The affected produce is that which is sold under the Limited Edition® and Fresh & Easy labels. The recalled organic grape tomatoes are packaged as follows:


  • 10.5 oz. plastic “clam shell” containers, UPC barcode: 033383655925
  • 7 oz. plastic “clam shell” containers, UPC barcode: 20025465
The containers also have the words, "LIMITED EDITION" and "Product of Mexico" printed on the label.

While the recall originally only applied to Canada and eighteen states within the U.S., the scope of the recall has now expanded to all states in the U.S. (and continues to include Canada), as the company recognized some customers may have distributed the organic grape tomatoes beyond the original recalled areas.

New Product Recalls: Drop Side Cribs, Wooden Table Toys, and Brushcutters

September 30, 2011, by Ronald V. Miller, Jr.

Shermag has recalled for repair, three models of their cribs due to due to potential entrapment, suffocation and fall hazards. While there have been no reports of injury, the Consumer Product Safety Commision (CPSC) and Shermag are aware of twenty-one incidents involving drop-sides that have failed or detached. According to the CPSC, the drop-side rail hardware on the cribs can break or fail, and allow the side to detach from the crib. If and when this occurs, a hazardous gap can be created between the drop-side rail and the crib mattress. It is possible for infants and toddlers to become entrapped, as well as poses a risk for suffocation and strangulation. Additionally, children can fall out of the crib when the drop-side rail falls or detaches from the crib. These cribs were sold between September 2004 and December 2008, and could have been purchased from The Land of Nod or other baby specialty stores. Consumer are instructed to stop using these cribs immediately and contact the firm to request a free repair kit that will immobilize the drop-side.

It was a unanimous vote by the Consumer Product Safety Commission in December of 2010 that lead to the ban on the manufacture, sale and resale of the drop-side cribs, after the deaths of more than 30 infants and toddlers over the past ten years. Though the ban went into effect in June of this year, many of these cribs can still be found in homes today.

Next to be recalled this week, Musical Wooden Table Toys by Battat. These toy table have green painted surfaces, with colorful instruments affixed to the top. The instruments on the table include a xylophone, cymbal, drum and two drumsticks. The recall has been issued after the CPSC and Battat received nine reports of loose and/or detached pegs. The small pegs on the xylophone toy can loosen and detach, posing a choking hazard to young children. No injuries have been reported, and consumers should immediately take the recalled toys away from children and contact Battat to receive a free replacement product.

Yesterday, we informed you of two other childrens' toys to be recalled this week, as one posed a choking hazard, and one had concerns regarding excessive levels of lead paint.

Lastly, Husqvarna Professional Products has recalled their RedMax brushcutter / trimmer as it poses a fire hazard. It is possible for the fuel tanks to allow leakage at the fuel cap, posing a fire hazard to consumers, though there have been no reports of injury or fire. The affected brushcutter / trimmer is a RedMax model TR2350S. The recalled brushcutters have shaft serial numbers ranging from 10215377 to 10625892, and engine serial numbers ranging from 10115390 to 10425910. The model number and shaft serial number are located on a label on the shaft, halfway between the trimmer head and the engine. The engine serial number is located on the bottom of engine between the two screws that secure fuel tank to the engine.

Toy Recalls: Little Tikes and Toy Cars

September 29, 2011, by Ronald V. Miller, Jr.

Today, the U.S. Consumer Product Safety Commission (CPSC) announced a recall of about 1.7 million Little Tikes toy tool sets and trucks, due to the potential choking hazard from the toy nails. This is the second time that the toy nails have been recalled.

The current voluntary recall involves another eleven models of Little Tikes' Workshop and tool sets. The toy nails are about 3-1/4 inches (8 cm) long by 1-1/4 inch (3 cm) in diameter. They are red or blue and have a large round head. Below the nail head, there is a plastic ridge that is slightly smaller than the nail head, and about an inch in diameter. The CPSC has provided the models, complete with a picture of the toy, for easier determination of the recalled toys.

Sadly, this was not the only toy recall yesterday. The CPSC also recalled a number of toy cars because of contains excessive levels of lead. You can understand the mistake: we have only understood the risks associated with lead and children for, you know, 40 years now.

The affected recalled toy cars are found in packages of four or six toy cars, which are painted in silver, black or blue, and have red stickers with "super," "max" and "racing" labeled on the top and sides of the cars. The 4" plastic car sets have item numbers "43835" and "43836" printed on a white label on the back of the cardboard packaging. "Gallop X" or "RACING CARS" is also printed on the product packaging. The recalled toy cars were sold exclusively at Mega Wholesale stores throughout Miami, Florida from September 2010 through January 2011. The CPSC has also provided pictures of these recalled toys. You can see pictures of these cars here and here.

More Listeria Concerns - This Time It's Spinach

September 28, 2011, by Ronald V. Miller, Jr.

Publix Super Markets is issuing a voluntary recall for spinach dip as it may be contaminated with Listeria monocytogenes. The 16-ounce containers of prepackaged spinach dip were sold at Publix grocery stores, and have a UPC of 41415-00062, and use by date of OCT 10 C1. The problem was discovered as a result of routine testing conducted by Publix.

There have been no reported illness to date from the potentially tainted spinach, though the Listeria pathogen can take up to two months to manifest with symptoms. Listeria has been a major concern for the past two months, as cantaloupes have caused illnesses in a reported fifty-five individuals, as well as responsible for eight deaths.

This is, by far, not the first time that we have had an issue with spinach. It was in 2006 that spinach was the cause for the death of three people. At that time, it was an outbreak of food-borne illness caused by Escherichia coli (E. coli) bacteria that was found in uncooked spinach. The outbreak first appeared in September, and by December 23, 2006, at least two hundred individuals were reported with symptoms from consuming the affected spinach, and spread across twenty six states.

Although other brands of spinach were implicated in the outbreak, Dole baby spinach was discovered to be the cause of many of the sicknesses reported throughout the country. This was the second outbreak linked to a Dole product in a twelve month period. Previously, an E. coli outbreak was linked to Dole bagged salads. As a result, several lawsuits were filed against Dole. Why file the claims so quickly? I don't know the fact, but I have a longstanding theory.


Anti Depressant Birth Defect Lawsuit

September 26, 2011, by Ronald V. Miller, Jr.

Our firm is reviewing SSRI antidepressant birth defect lawsuits for all SSRIs, including Zoloft, Prozac, and Celexa. (We are specifically not reviewing Paxil cases. If you have a potential Paxil birth defect lawsuit, you should contact another lawyer.) If your child suffers from a birth defect and you were taking an antidepressant, call 800-553-8082 or get a free online consultation from a lawyer here.

Approximately one fifth of pregnant women are affected by depression and 3.7% are reported to use anti-depressants during the first trimester. Discontinuing the use of anti-depressants may result in depressive episodes and relapse, putting both the mother and fetus at risk. Since 1990, SSRI antidepressants have been used during pregnancy and are now recommended as first-choice antidepressants in many countries. Recently, there have been concerns surrounding the use of serotonin reuptake inhibitors (SSRIs) and serious birth defects. SSRIs are a group of anti-depressants which includes Paroxzetine, Sertaline, Citalopram and Fluoxetine among others. Fluoxetine is known under the trade names of Prozac, Fotex and Sarafem.

Serotonin reuptake inhibitors have been associated with newborn withdrawal and birth defects including persistent pulmonary hypertension of the newborn (PPHN), cardiovascular malformations, anencephaly, craniosynostosis, omphalocele and autism spectrum disorder. SSRI antidepressants are known to pass through the placenta to the fetus.

PPHN is a life-threatening condition which occurs at a rate of 0.1-0.2% of births and has a 10% rate of death. It usually occurs in full or post term babies and is a condition where babies have high blood pressure in their lung blood vessels resulting in a deficiency of oxygen in their blood. Though usually associated with C-sections, diabetes and asthma, recently exposure to SSRIs inutero have been linked to PPHN. This observation has been documented in peer reviewed journals by several researchers. The rate of risk is estimated to be approximately 3.5%.

Continue reading " Anti Depressant Birth Defect Lawsuit " »

More Cantaloupe Recalls

September 26, 2011, by Ronald V. Miller, Jr.

Cantaloupe recalls are back in the news this week, as Carol’s Cuts of Kansas recalls 594 pounds of fresh cut cantaloupe, due to Listeria concerns. The recall affects their 5-pound chunk trays, as well as their 8-ounce mixed fruit medley.

We previously reported of the trouble stemming from Jensen Farms, of Holly, Colorado. Illnesses first started appearing on August 14, 2011, from people reporting to have consumed cantaloupe. Since then, it is reported that fifty-five people have fallen seriously ill from eating the tainted cantaloupe, with a death toll of eight. Of those who have died, two were in Colorado, one in Maryland, four in New Mexico, and one in Oklahoma. From the information provided, those who have fallen ill range from 35 years old to 96, with a median age of 78. Most of those with the illness are over 60 years of age, or have health conditions that weaken the immune system.

This is the first Listeria outbreak in the U.S. linked to cantaloupe, however it is not the first time that cantaloupes have been in question.

In August of this year, Del Monte filed suit against the FDA over a cantaloupe recall dating back to March 2011. At that time, Del Monte voluntarily recalled 4,992 cartons of cantaloupes due to Salmonella concerns. The recall was implemented after a notification from the FDA that there was an epidemiologic link between the cantaloupes and approximately 12 reported cases of Salmonella Panama. Del Monte, the largest importer of cantaloupes into the United States, put on hold the production and distribution of their product that contained cantaloupes from the affected farm. The FDA investigation ultimately found no connection between Del Monte Fresh cantaloupes and any cases of Salmonella Panama, and issued a notice ending the recall on July 29, 2011 (though the CDC maintained that its investigations pointed to imported Del Monte cantaloupes as the source of an outbreak). As such, Del Monte filed suit against the FDA.

In its complaint, Del Monte says its cantaloupes were wrongly blamed for the outbreak. Of the several reasons given for their contention, they allege that the FDA and other public health officials concluded that the outbreak illnesses were associated with eating cantaloupes, without ever having tested any cantaloupes to determine whether they contained Salmonella. They further allege that the FDA did not adequately account for the possibility that any allegedly contaminated cantaloupes came from sources other than Del Monte. The complaint says the retailer (Costco) sold cantaloupes from three other suppliers, in addition to Del Monte, but the FDA never investigated the other vendors to determine if they were a potential source of Salmonella contamination.

This month, Del Monte added the State of Oregon to their lawsuit.


ATV Recall Leads to Fine

September 23, 2011, by Ronald V. Miller, Jr.
Bad Boy Hides ATV Defect, Gets Punished Feds Say

The U.S. Consumer Product Safety Commission (CPSC) announced today that Bad Boy Enterprises has been a bad boy and has agreed to pay a civil penalty of $715,000. (That was a pun that obviously had to happen. It is the second-largest fine the agency has levied against a maker of off-road vehicles.) Bad Boy continues deny responsibility. I'm not entirely sure how based on the facts.

The settlement resolves CPSC staff allegations that Bad Boy Enterprises failed to immediately report, as federal law requires, a product defect involving Classic Buggies off-road utility vehicles with Series brand and SePex brand electric motors. The problem? Sudden acceleration in these ATVs that caused injuries to riders. Bad Boy apparently knew about it and buried it under the rug, quietly fixing some while keeping the defect from the feds for years.

The off-road utility vehicles with Series motors were sold between 2003 and June 2007 and the off-road utility vehicles with a SePex motors were sold between 2007 and June 2010. Both the Series and SePex off-road utility vehicles could suddenly accelerate during use or while the ignition is in the idle position, creating a runaway vehicle situation.

In 2008, Bad Boy Enterprises implemented a repair program for the SePex off-road utility buggies to address the sudden acceleration defect without notifying the Commission. The firm did not report to the Commission until August 2009. Once the chickens came home to roost, Bad Boy issued the ATV recall for the vehicles sudden acceleration on October 21, 2009.

Continue reading " ATV Recall Leads to Fine " »

Bicycle Recall - Bridgeway and Specialized Bicycle Components

September 23, 2011, by Ronald V. Miller, Jr.

There have two bicycle recalls this week, both of which pose fall hazards.

Yesterday, the U.S. Consumer Product Safety Commission, announced a voluntary recall of specific bicycles from Bridgeway International and Specialized Bicycle Components, Inc.

Specialized Bicycle Components has recalled certain bicycles that are equipped with Advanced Group carbon forks. The recall affects approximately 14,200 bicycles. There have been two reported instances involving the bicycles brakes. The brake component, housed within the bicycle's carbon fork, can disengage from the fork and allow the brake assembly to contact the wheel spokes while rotating, thus posing a fall hazard.

This recall involves the following 2011 model bicycles that are equipped with Advanced Group carbon forks:

  • Sirrus Expert
  • Sirrus Comp
  • Sirrus Elite
  • Vita Expert
  • Vita Comp
  • Vita Elite
  • Vita Elite Step Thru
  • Tricross Sport
  • Tricross
  • TricrossComp

All bicycles involved in the recall have the brand name "Specialized" on the lower front frame tube. The model name is on the top tube. These bicycles were sold at authorized specialized retailers nationwide, and were sold between June 2010 and August 2011. These bicycles range in price between $700 and $2,000. Consumers who own one of the recalled bicycles are encouraged to immediately stop riding these bicycles, and return them to an authorized Specialized retailer for a free repair or replacement carbon fork.

The next recall, also due to concerns with a fall hazard, affects bicycles by Bridgeway International. There have been reports that it is possible for the bicycle chain to break, causing the rider to lose control and fall.

This recall affects the men's 26" hybrid "NEXT Power X" bicycles. The bicycles are red or orange, with "Power X" and "Suspension" printed on the frame. Model numbers 611M and LBH2611M2 are included in this recall. The model number is located on the frame between the pedals. These bicycles were sold at Walmart stores between February 2011 and July 2011, and retailed for approximately $100. Consumers should immediately stop using the recalled bicycle and contact the company for a free repair.

Continue reading " Bicycle Recall - Bridgeway and Specialized Bicycle Components " »

Subaru Recall

September 21, 2011, by Ronald V. Miller, Jr.

Over 500,000 Subaru cars will get a recall notice. What is the problem? The better question may be what is not the problem. A loose moon roof glass that could come off while the vehicle is in motion, windshield wiper motors that may catch fire, and corroded control arms that could cause drivers to lose control are some of the problems with these Subarus. Funny, do a search for Subaru recall on this post. You can't find anything. Now, everything is falling in at once.

The bulk of this Subaru recall is for 300,000 2002-2007 Impreza, 2003-2008 Forester and 2005-2006 Saab 9-2X cars that were sold in cold states that use salt on the roads. (Ford had the same problem that also led to a recall.)

This recall impacts cars in the following states: Massachusetts, Maryland, Michigan, New Hampshire, New York, Pennsylvania, Vermont, Wisconsin, Connecticut, Delaware, Iowa, Illinois, Indiana, Maine, Minnesota, Missouri, New Jersey, Ohio, Rhode Island, West Virginia and the District of Columbia.

Subaru is also recalling another nearly 200,000 vehicles - 2010-2011 Outback and Legacy vehicles - because they have components inside the wiper motor bottom cover that have a tendency to overheat. The overheated wiper motor bottom cover may melt and catch fire.

Finally, Subaru will recall other Outback and Legacy vehicles - some of which are subject to the wiper recall above - because of a problem with the adhesive to secure the glass on the moon roof. This is not a minor problem: the moon roof glass may detach causing the chaos you would expect if a moon roof falls off.

Hopefully, Subaru saved up all of its problems and we won't be hearing from them on the recall front for a while.

Bunk Bed Recall

September 20, 2011, by Ronald V. Miller, Jr.

American Woodcrafters is recalling 180 bunk beds. The guard rails on upper bunks can crack and cause the mattress and its support rails to collapse. The feds generously call this a "fall hazard." American Woodcrafters has received two reports of cracked guard rails in these Indonesian made bunk beds, causing the mattresses and support rails to collapse. Thankfully, there were no injuries in either case.

This recall involves upper guardrails on twin-over-twin bunk beds and twin-over-double bed loft designs. The beds have a permanent label attached to the headboard or the footboard with the American Woodcrafters logo; SKU numbers, 1800-977 or 1800-969; PO Numbers: 103276, 103432, or 300038; and the manufacturing date. These bunk beds were made from October 2010 to June 2011. The cost of the beds was somewhere between $600 and $1,000.

If your kids just bought a bunk bed - as my daughter just did - you should check it out. Consumers should immediately stop using the upper beds and contact American Woodcrafters or their furniture dealer to arrange for the free replacement of upper bunk guard rails.

For additional information, call American Woodcrafters at (888) 429-7265 or visit the company's website. The recall information does not jump out at you on their homepage but there is a link off to the right if you are looking for it. I give them a C+ for conspicuity. Of course, you have to grade this on a curve.

www.american-woodcrafters.com

Wrongful Death Suit Filed over Fatal Crash

September 20, 2011, by Ronald V. Miller, Jr.

A wrongful death lawsuit has been filed against a municipality in Washington after a fatal car accident stemming from a police chase.

The woman that caused the crash was drunk. The lawsuit claims that the police were negligent in chasing the woman because of the risks posed by the chase.

This issue of how far the police should take a chase is gaining new steam in recent years as more eyes are policing the police than ever before. One problem in many jurisdictions: limits on liability against police who are responding to an emergency.

It is a tough issue. You want police to catch the bad guys but you don't want them killing the rest of us in the process. Hard balance.

Queso Fresco Casero Cheese Recall

September 19, 2011, by Ronald V. Miller, Jr.
Del Bueno Recalls Cheese After Listeria Report

Del Bueno will recall all 16oz. size packages of their Queso Fresco Casero Fresh Cheese. The recall is for product that is date stamped September 14, 2011. It has been determined that the recalled product has the potential to be contaminated with Listeria monocytogenes.

Listeria monocytogenes was the culprit for two recalls last week. First, avocado products from Fine Mexican Food Products were recalled, followed by cantaloupes from Jensen Farms, Inc.

The recalled cantaloupes proved to be far more of a concern though, as Federal officials say that the contaminated fruit may be linked to two deaths and twenty-two reported illnesses.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Unlike most other bacteria, Listeria monocytogenes can continue to grow in foods in the refrigerator. The bacteria can live for years in food processing factories. Listeria has been found in raw foods, including uncooked meats and vegetables, as well as processed foods that become contaminated after cooking, such as hot dogs and deli meat. As is the case in today's reported recal, unpasteurized milk and cheeses are also likely to contain the bacteria.

Continue reading " Queso Fresco Casero Cheese Recall " »

Zofran Labeling Change

September 16, 2011, by Ronald V. Miller, Jr.

The FDA has notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug, Zofran. Zofran is an antiemetic used to prevent nausea and vomiting following chemotherapy, radiation therapy, or surgery. Zofran is a serotonin 5-HT3 receptor blocker that works by blocking a chemical thought to be a cause of nausea and vomiting. Its effects are thought to be on both peripheral and central nerves.

It has been determined that Zofran may increase the risk of developing prolongation of the QT interval of an electrocardiogram. This can lead to an abnormal and potentially fatal heart rhythm. The labels are being revised to include a warning to avoid use by patients with congenital long QT syndrome, as these patients are at particular risk for Torsade de Pointes, a specific and rare variety of ventricular tachycardia that exhibits distinct characteristics on an electrocardiogram (ECG).

For more information, visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272041.htm

Zofran is one of many recent medications that the FDA has announced labeling changes to. Previously this week, we passed along forty-five medication labeling changes that took place in August. For a detailed list of those changes, visit http://www.accidentinjurylawyerblog.com/2011/09/august_2011_medication_label_c.html

Even More Food Recalls - It's Been a Busy Week

September 16, 2011, by Ronald V. Miller, Jr.

From undeclared milk, to undeclared sulfites....It is Huipu Chinese Wolfberry that is the focus of the most recent FDA recall. Strong America Ltd NY is recalling its 5.28 ounce packages of Huipu Chinese Wolfberry, because they contained undeclared sulfites.

Sulfites have been used for centuries, mainly as food additives, but can also occur naturally in foods such as fermented beverages and wines. They are often used as preservatives in dried fruits and dried potato products.

Sulphites are known to increase asthma symptoms in approximately 5% of asthmatics. Consumers who have severe sensitivity to sulfites run the risk of the serious or life-threatening allergic reactions if they consume this product. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. More than 10mg could result in anaphylactic shock in sensitive individuals.

This has been a very busy week for food recalls. I referenced several recalls just yesterday, and concluded my thoughts with hopes that yesterday would be the last for the week. The end of the week....so close, yet so far away. Maybe next week will be food recall free.

It is also worth noting that we pass these recalls along for general interest. Our law firm does not handle food recall cases.

Chantix Heart Attack Lawsuit

September 16, 2011, by Ronald V. Miller, Jr.
Add Heart Attack and Stroke to the Long List of Problems Reported by Chantix Users

With powerful evidence from a new Chantix study, heart attacks and strokes have been added to the potential risks associated with Chantix. Plaintiffs' lawyers are now filing Chantix heart attack and stroke lawsuits around the country. If you have had a heart attack while taking Chantix, you can get more information at 800-553-8082 or get a free online evaluation of your potential claim.

Chantix has been a controversial drug from day one and consumer advocates have long been pushing for its removal from the very beginning. It has been associated with a number of side effects, including increased risk for aggressive and suicidal behavior, diabetes, and a host of other ailments. Some consumer complaints have been proven, some have been disproven, and the jury is still out on others. But now the data is showing something else new that Pfizer will also probably ignore: Chantix increases the risk of heart attack or stroke.

Continue reading " Chantix Heart Attack Lawsuit " »

Birth Control Recall – Unintended Pregnancies

September 16, 2011, by Ronald V. Miller, Jr.

Birth Control Lawsuits

Qualitest Pharmaceuticals is voluntarily recalling multiple lots of birth-control pills due to a packaging error. The error could lead to incorrect dosing, and possibly, unintended pregnancies.

The recall affects certain lots of the following pills: Cyclafem (7/7/7 and 1/35), Emoquette, Gildess FE (1.5/30 and 1/20), Orsythia, Previfem and Tri-Previfem. or a complete list of the recalled lots.

The company says the error caused the weekly tablet orientation to be reversed and obscuring the lot number and expiration date on certain packages. Essentially, select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. Women, who do not receive the proper daily regimen of the drug, could be at risk for inadequate.

The company reports that it is investigating the source of the error. In the meantime, consumers exposed to affected packaging should begin using a nonhormonal form of contraception immediately. Pharmacies are being instructed to contact consumers who have received affected products, however, should consumers have questions or concerns, they should consult their health-care provider or pharmacist.

Earlier this month, UC Irvine research revealed that women who use contraceptives such as birth control pills, experience memory changes. It was reported that their ability to remember the gist of an emotional event improves, while women who do not use the contraceptives better retain the details. Despite the fact that more than 100 million women use birth control pills, there are only a handful of studies focused on the cognitive effects.

Behind the Vaginal Mesh Lawsuits: Pelvic Prolapse Problems

September 15, 2011, by Ronald V. Miller, Jr.
Did Transvaginal Mesh Manufacturers Let Down Women with POP in Exchange for Profits?

Pelvic organ prolapse (POP) is the condition that began the chain of events that have led to about half of the vaginal mesh lawsuits that have been filed around the country. Plaintiffs' lawyers contend that woman who have suffered through POP have been hit with a second injustice. The difference between these two injustices is that the latter could have been prevented if vaginal mesh manufacturers put safety ahead of profit.

Pelvic organ prolapse is a condition where the organs in the pelvic region, such as the uterus, bowel or bladder may protrude into the vagina due to a weakness in the network of muscles, ligaments, and skin around the vagina. The resulting symptoms vary dependent on the type of prolapse and may include pain, prolapse sensation and bowel, bladder and sexual problems.

Types of prolapse include cystocele (prolapse of the bladder), enterocele (herniated small bowel, often occurring following a hysterectomy), rectocele (prolapse of the rectum), prolapse uterus and vaginal vault prolapse. Prolapse of the bladder often causes the urethra to prolapse as well. The term urethrocele refers to a urethral prolapse and cystourethrocele refers to when both the bladder and urethra prolapse. These conditions often result in stress urinary incontinence (SUI) (leakage caused by activities such as laughing, sneezing, coughing, exercise, etc.).

Certainly, these are stressful conditions for women who are trying to lead normal, active lives. The idea of a transvaginal mesh surgery to put the condition to bed once and for all was very appealing to women and their doctors looking for an answer. It seemed also too good to be true. And for many woman, it was.

Continue reading " Behind the Vaginal Mesh Lawsuits: Pelvic Prolapse Problems " »

This Week's Food Recalls

September 15, 2011, by Ronald V. Miller, Jr.

While this week began with a focus on undeclared milk, the latter part brings about a new batch of food recalls, for various issues.

Falcon Trading Company, Inc./SunRidge Farms has announced the voluntary recall of their All Natural Milk Chocolate Cranberries, as they may contain Toffee and/or Peanuts. No illnesses have been reported in connection with the recalled product, but symptoms may include: hives, tingling in the mouth, swelling in the tongue and throat, difficulty breathing, abdominal cramps, vomiting or diarrhea, eczema or rash, coughing or wheezing, loss of consciousness or dizziness. This recall does not include all distributed products, only the 6.5 oz and the 10 pound packages of their All Natural Milk Chocolate Cranberries.

Next on this week's list of recalls are avocado products from Fine Mexican Food Products, Inc. (FMP). While there are no reported illnesses with this product either, FMP is recalling them out of an abundance of caution. The affected products include 12/2 lb. Frozen Avocado Pulp and IQF 8/3 lb. IQF Avocado Halves that have been distributed since June of 2010. There is a possibility that these products may be contaminated with Listeria Monocytogenes. Also recalled for potential Listeria, Jensen Farms of Holly, Colorado has recalled their shipments of Rocky Ford whole cantaloupes due to potential Listeria. Listeria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Symptoms may include: high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Last to be recalled, as of this blog entry anyway, are the 10 pound containers of Fresh Hot Basil herb, distributed by Sanith Ourn Farm. The recalled products were shipped to Washington, Oregon, and Rhode Island, only, and pertains to shipments made on August 23, 2011 and August 30, 2011. Retailers may have bundled or wrapped the hot basil in small foam trays, prior to placing on retail shelves. This too, has no reported illnesses, however it has the potential to be contaminated with Salmonella. Salmonella, has we have written before, is a dangerous organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Symptoms can include fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections and arthritis.

Earlier this week, there was also a chocolate recall that we wrote about on Monday.

Of course, the week's not over. But hopefully summarizing the week early will make these the last food recalls of the week......whoops, we spoke too soon....

Consumers who have purchased any of these products should return them immediately to the location from which the items were purchased.

Weehoo Bike Trailers Recall

September 14, 2011, by Ronald V. Miller, Jr.

Weehoo will recall approximately 2700 Weehoo iGo bicycle trailers the company made between April 2011 and July 2011. The problem is a parent's worst nightmare with these things: their child becomes unhitched and goes into traffic or somewhere else that is unsafe.

Apparently, the receiver on the trailer's seat post hitch can crack. If it cracks, it might cause the trailer to detach, posing fall and crash hazards to the child being pulled along.

I have a bike trailer but I have no idea what the name of it is as I type this post. The particular trailer has a steel frame with an adjustable seat for passengers 38 to 52 inches tall, two pedals with straps, an enclosed sprocket and chain, a 20-inch wheel, two pannier pockets, a flagpole and a flag. The seat, pannier pockets, and flag are made of red, heavy-duty nylon.

Did you get all of that? Unless you have a ruler, probably not. But the pannier pockets and the flag have the word "Weehoo" and the logo printed on them in reflective material. The bike trailers in this recall have the letter "D" on the underside of the iGo frame, by the pedals.

Curious, I did a quick search to see if I could find any lawsuits that lead to an appellate opinion regarding a bike trailer. I could not find any (although I wonder if I missed any because the court used a different term than "bike trailer.")

Volkswagen Jetta Recall: Hot Exhaust Pipe

September 13, 2011, by Ronald V. Miller, Jr.

Volkswagen will recall over 30,000 Volkswagen Jetta sedans from the 2011 and 2012 model years. The decorative exhaust-pipe tips have allegedly caused leg burns to people who accidentally touched them.

Burns may be more likely because the part may extend beyond the length of the original factory-installed exhaust pipes. This extra extension increases the risk of inadvertent contact with a person’s leg.

We knock a lot of companies on this blog. Here, Volkswagen is probably going above and beyond the call of duty with this recall. Sure, I realize it sticks out more than most but exhaust pipes are hot and if you touch one, expect to get burned.

Chocolate Recall? Say It Ain't So!

September 13, 2011, by Ronald V. Miller, Jr.

Chocolate Decadence will recall several of their chocolate products because they may contain undeclared milk. Anyone having an allergy to milk, or a severe sensitivity to milk, runs the risk of having a serious or even life-threatening allergic reaction if they consume these products. Symptoms may include hives, wheezing, vomiting, anaphylaxis and digestive problems, such as bloating, gas or diarrhea.

Chocolate Decadence is only one of several companies recently to pull products off the shelves that may contain undeclared milk. Earlier this week, Watkins Incorporated recalled more than 1,500 units of its individual 7.7 ounce containers of SoyNilla, because it contains an undeclared milk ingredient. This recall was initiated after it was discovered that it was distributed in a package that did not disclose the presence of milk.

Continue reading " Chocolate Recall? Say It Ain't So! " »

Cochlear Implant Recall

September 12, 2011, by Ronald V. Miller, Jr.

Cochlear is voluntarily recalling its Nucleus CI500 range of implants. It is Cochlear's first ever recall. Approximately 25,000 people worldwide have received a Nucleus CI500 implant.

Cochlear says that the failure rate is less than 1%. The company will not speculate on what underlying fault caused the problem, and said the company would continue selling an older but similar implant as a replacement.

The news crashed Cochlear's stock. I don't know if Cochlear screwed up. I'm not sure if even Cochlear knows yet. If they did, I would not be surprised if they fessed up and paid anyone who was harmed. I think - and believe me, I could be proven wrong - that Cochlear is a good company that will figure out what happened and make things as right as they can. Maybe I have read too many "Cochlear miracle" stories. But I think this is a decent company that will be back.

Drug Swallower Wrongful Death Lawsuit Leads to $1.3 Million Settlement

September 12, 2011, by Ronald V. Miller, Jr.

The City of Chicago has reached a $1.3 million settlement in a lawsuit filed over the death of a man who swallowed a bag of drugs during an arrest.

Cue the tort reformers narrative: man swallows drugs on purpose and sues the city. You can hear it already. But all people, including those who are taking drugs, are human beings. Video surveillance shows the man in obvious distress and the police officers just completely ignored him. Because they have drugs, apparently, someone can suffer right in front of you and die without catching your attention. That is just beyond awful and the City of Chicago did the right thing by acknowledging this and settling this case.

August 2011 Medication Label Changes

September 12, 2011, by Ronald V. Miller, Jr.

Last month brought changes to forty-five (45) medical product labels, with changes to the prescribing information to include any of the following areas: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

For a complete detailed accounting of the label changes, please refer to the following summary.
By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

Continue reading " August 2011 Medication Label Changes " »

Medtronic SynchroMed II Recall

September 12, 2011, by Ronald V. Miller, Jr.

Medtronic and the FDA have announced a Class I recall of the SynchroMed II Infusion system. This recall inclueds models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

The Infusion pumps are designed to contain and administer prescribed drugs to a specific site of the body, drugs such as morphine sulfate, ziconotide and baclofen, which are used for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. The pumps are also indicated for delivery of floxuridine and methotrexate, for the treatment of primary or metastatic cancer.

This recall relates to the formation of a film within the pump battery. It has been determined that this problem can lead to the sudden loss of therapy, and the return of the underlying symptoms and/or therapy withdrawal symptoms. The FDA only issues Class I recalls when there is a reasonable probability that use of a defective medical device will cause serious injury or death.

Medtronic pumps were the subject of a Class I recall previously in August 2007. At that time, it was Medtronic's implantable infusion pumps that were the subject of the recall. It was determined that these pumps were stalling at an unusually high rate, putting patients at risk of serious injury or even death.

Medtronic has encouraged patients to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.

Vaginal Mesh Implants: FDA Advisory Committee Conclusions

September 12, 2011, by Ronald V. Miller, Jr.

The FDA Obstetrics & Gynecology Devices Advisory Committee supports tougher premarket testing of vaginal mesh products and reclassifying these medical devices as Class III devices which means vaginal mesh makers can no longer end-run elaborate testing by availing themselves to the FDA's 510(k) approval process under which a mesh device is "substantially equivalent" to other pelvic organ prolapse (POP) surgical mesh products already on the market. In other words, the FDA is going to actually require these device manufacturers to test the products properly before putting them inside a woman. How revolutionary!

This came out of an advisory committee's meeting in Maryland last week to discuss the debacle that is the use of surgical mesh for treatment of pelvic organ prolapse and stress urinary incontinence. Since 2008, the FDA has received 2874 adverse event reports of complications following surgery, with 1503 adverse event reports associated with vaginal mesh implants used in POP repair and 1371 associated with stress urinary incontinence repair. The device manufacturers making these vaginal mesh devices keep asking for more time to forestall the inevitable: the conclusion that, on balance, the risk is not worth the benefits.

Continue reading " Vaginal Mesh Implants: FDA Advisory Committee Conclusions " »

Cargill Turkey Recall: Part 2

September 12, 2011, by Ronald V. Miller, Jr.

Cargill jumps back on the recall train with a second recall of ground turkey products yesterday after a test showed salmonella in a sample from the same Arkansas plant tied to a recall issued last month.

This recall is smaller than the 36 million pounds of ground turkey that Cargill recalled last month. The toll from that recall was high: 107 sick and one dead. No illnesses have yet been tied to this recall of 185,000 pounds of ground turkey products.

What is a bit disconcerting is that Cargill had said after the first recall that it added two additional anti-bacterial washes to its processing procedure and put in place "the most advanced sampling and monitoring system in the poultry industry." Is that really true? If it is, the "most advanced" in the industry is still unsafe. That's a daunting prospect. Salmonella already kills most of the 3,000 people who die each year of food poisoning.

Honda Pilot Recall: Seat Belt Defect

September 10, 2011, by Ronald V. Miller, Jr.

Honda will recall 310,773 Honda Pilot SUVs from model years 2009 through 2011.

The recall is to fix a potential defect in how their seat belts are sewn together.

The Honda Pilot's stitching that attaches the end of the driver’s and front passenger’s lap belt may be missing or incomplete, causing the seat belt to come loose from the anchor. Accordingly, Pilot drivers may not have a safe seatbelt if they get into a car accident. Honda received two complaints about detached seatbelts.

At no charge (but expect the dealer to tell you that you need new tires, an oil change, etc.), Honda dealers will inspect the Pilot's defective seatbelt.

Off-Road Motorcycle Recall

September 9, 2011, by Ronald V. Miller, Jr.

There is a recall for over 6,000 off-road motorcycles. The problem is a defect in the handlebar clamps that may create a fall hazard for motorcyclists. The motorcycle handlebar clamp can develop cracks for no reason, causing the handlebars to move from their set position. This, in turn, can cause the motorcyclist to lose control of the vehicle. Obviously, this can lead to a motorcycle accident.

The manufacturer, KTM, has received a report of one incident in which a rider was hospitalized from injuries received in a crash after the handlebar clamps cracked and failed to secure the handlebars.

You can learn more about this motorcycle recall here.

Target Resistance Band Recall

September 9, 2011, by Ronald V. Miller, Jr.

Target will recall almost 500,000 exercise cords after two users suffered serious eye injuries. The recall covers about 447,000 Embark model cords of various styles and colors, the U.S. Consumer Product Safety Commission said Thursday.

Target has received three reports of these Chinese made resistance band users getting struck in the eye by the anchor ball that attaches to a door. Two of the incidents involved permanent vision loss.

Resistant cords are all the rage now. They are cheap, lightweight and easy to transport. They probably work too. But, obviously, if they break, the cord is coming at you and your eyes at great speed.

Continue reading " Target Resistance Band Recall " »

Pottery Barn Doll Recall

September 8, 2011, by Ronald V. Miller, Jr.

Pottery Barn will recall 82,000 toy dolls imported by Pottery Barn Kids. Hair loops and headbands on the dolls may pose a strangulation hazard. The company has received one report of a loop found around a 21-month-old child's neck, but no reports of injuries.

Tort Reform in Pennsylvania: More Proposed Anti-Victim Legislation

September 8, 2011, by Ronald V. Miller, Jr.

Max Kennerly writes about a lot of new bills being proposed in Pennsylvania. Any legislature can propose a bill and there is always someone in every legislature - on both sides of the aisle - who likes to put out radical bills so they can brag to their constituents about how crazy they are. Still, these proposed bills do not give you a warm fuzzy feeling about the political climate right now for injury victims.

Ultimately, I think the problem is that people want jobs or more stability in their jobs and that fear distracts them from thinking about the unlikely possibility that they will be seriously injured and want to be compensated for those injuries. Politicians love blaming personal injury lawyers because they are an easy target. Often, the people throwing the punches don't really feel like oppressing tort victims is going to solve anything but they can't resist grabbing the low hanging fruit of blaming lawyers. To make matters worse, we have a minority of personal injury lawyers who are more than willing to live up to the stereotype.

Simply Thick Infant Formula/Breat Milk Thickening Gel

September 7, 2011, by Ronald V. Miller, Jr.

The parents of an infant in Texas who died after taking SimplyThick has filed a wrongful death claim against the manufacturer.

Simply Thick is a thickening agent which is added to either breast milk or formula, in order to assist infants in swallowing. On May 20, 2010, the Food and Drug Administration issued a warning that Simply Thick may cause necrotizing enterocolitis (NEC), if fed to premature infants. NEC is a life-threatening condition characterized by the inflammation and death of intestinal tissue. The thickening gel should not be given to infants born before 37 weeks gestation who are currently receiving hospital care, or by those who have been discharged from the hospital within the past 30 days.

A year later, on June 4, 2011, Simply Thick, LLC voluntarily recalled its thickening gel, manufactured at the Stone Mountain, Georgia plant. At that time, the FDA was aware of fifteen cases in which premature infants who were fed Simply Thick developed NEC. These fifteen cases, sadly, included two deaths.

Simply Thick lawsuits claim that this company knew - or should have known - that this product could cause harm to premature babies. Thankfully, I do not think we are talking about a large number of cases. But one death of an infant is one too many.

As of today, Simply Thick is again shipping of its product in limited quantities. The company, cautions, however, that it is still NOT to be fed to premature infants, and has been labeled as such.

If Crohn's Disease or Rheumatoid Arthritis Wasn't Already Enough

September 7, 2011, by Ronald V. Miller, Jr.

If having Crohn's Disease, Rheumatoid Arthritis, or so many other countless ailments that plague so many of us today is not enough, now there is one more thing to be concerned about.

The FDA has notified healthcare professionals that the boxed warning for all Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. The label will now include consistent information about the risk for serious infections and the associated disease-causing pathogens.

The first TNFa was marketed in 1998, however thirteen years later, we are learning that patients treated with these blockers are at increased risk for developing serious infections involving multiple organ systems and sites. These infections may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens. It is recommended that the risks and benefits be considered prior to initiating therapy in patients with chronic or recurrent infection, and patients with underlying conditions that may predispose them to infection.

Perhaps in another thirteen years, the need for these types of medications will be all but gone. In the meantime, by reporting adverse events and side effects, the makers of the TFNa blockers need to continue to keep patients and their doctors informed about the risks and benefits of these treatments so that patients can make an informed choice.

Night Light Recall

September 6, 2011, by Ronald V. Miller, Jr.

Night lights give you a feeling of safety. But probably not these night lights.

Approximately 10,000 LED night lights imported from China by Corvest Acquisition have been recalled These lights may "overheat, smolder, and melt which may cause minor burns to consumers." There have been five reports of the lights overheating, but no injuries occurred.

The LED night light contains flame retardant elements, plugs into an electrical outlet, has a white or blue LED bulb, and a clear bulb cover. "Model SBD01", the number "E314462" and "Made in China" are stamped on the back of the night light's plastic white base. The night lights measure about 1 3/4 inches wide by 3 3/4 inches high.

Honda Recall: Honda Is Literally Taking Water

September 6, 2011, by Ronald V. Miller, Jr.

Last month, I pointed out that Honda has been sitting in the back row of "year of the car recall" of 2010.

Well, now Honda steps up, issuing a recall of 1 million vehicles across the globe to fix electrical and software glitches. In some of these Honda cars, water can accumulate on the passenger windows, which can "degrade the [power window] switch's electrical contacts and potentially cause a fire." In other vehicles, a bug in the manual transmission software can cause the motor to rotate in the opposite direction of the engine.

BMW Recall

September 2, 2011, by Ronald V. Miller, Jr.

BMW has issued a recall of 241,000 cars in the U.S. due to a defect in the vehicles' rear lights. The recall covers BMW 325i, 325xi, 330i and 330xi cars, model years 2002-2005. Apparently, the car rear light may intermittently fail which obviously increases the risk of a rear end car accident.