Archive for November, 2011

Ready Pac Bagged Salad Recall: E. coli Food Poisoning

About 5,379 cases of Ready Pac bagged salads using Romaine lettuce have been recalled due to the risk that they may be contaminated with E. coli. The affected salads were also sold under the Trader Joe and Safeway labels. 

The Ready Pac salad recall was announced by the FDA on November 16, after E. coli O157:H7 was detected in the Romaine lettuce during a random sample test by the manufacturer, Ready Pac Foods, Inc., of Irwindale, California. There have been no E. coli food poisoning reports connected to the potentially contaminated salads.

The recall affects the following products:

  • § 10 oz. Ready Pac Caesar Romaine, UPC: 0-77745-00202-6
  • § 9.25oz Ready Pac Santa Fe Caesar Complete Salad, UPC: 0-77745-21404-7
  • § 10oz. Ready Pac Classic Caesar Complete Salad, UPC: 0-77745-20566-3
  • § 10oz. Ready Pac Bella Romaine, UPC: 0-77745-21407-8
  • § 10oz. Dining In Classic Caesar Salad Kit, UPC: 0-11225-02530-3
  • § 10oz. Raley’s Caesar Romaine, UPC: 0-46567-71642-8
  • § 10oz. Trader Joe’s Romaine Salad, UPC: 0013-2145
  • § 16oz. Trader Joe’s Very American Salad, UPC: 0020-7225
  • § 10oz. Safeway Farms Caesar Romaine, UPC: 0-21130-98350-6
  • § 9oz. Safeway Farms Hearts of Romaine, UPC: 0-21130-98358-2
  • § 10oz. Safeway Farms Complete Caesar Supreme, UPC: 0-21130-33677-7
  • § 10.25oz Safeway Farms Complete Southwestern Ranch, UPC: 0-21130-33679-1

All of the affected bagged salads have a Best If Used By date of NOV 18. They were sold in Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nebraska, Nevada, New Mexico, Oregon, South Dakota, Texas, Washington, and Wyoming.

The company warns retailers to check their inventory because there could still be affected bagged salads on store shelves.

Consumers who have purchased the affected bagged salads should record the Use-by Date and UPC number, discard the salad and can receive a full refund by calling a Ready Pac Consumer Affairs representative at (800) 800-7822.

E. coli O157:H7 is one of the more common causes of food poisoning in the United States. When left untreated, it can lead to dehydration and potentially life-threatening illness. While most healthy adults recover from food poisoning caused by E. coli within a few weeks, young children and the elderly could be at risk for more severe illness. If the toxin enters the blood stream, E. coli could also lead to kidney failure known as Hemolytic-Urenia Syndrome (HUS).

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Smucker’s Natural Peanut Butter Recall Issued Due to Salmonella Risk

About 3,000 jars of chunky Smucker’s natural peanut butter have been recalled due to a risk of salmonella contamination. 

The Smucker’s peanut butter recall was announced by the FDA on November 16, after the company detected the bacteria during routine sampling. Reportedly, there have been no cases of salmonella food poisoning linked to the potentially contaminated peanut butter.

The recall affects 16 oz. jars of Smucker’s Natural Peanut Butter Chunky, with a UPC of 5150001701 and Best-If-Used-By dates of August 3, 2012 and August 4, 2012. The UPC code is located on the side of the jar’s label below the bar code.

An estimated 3,000 jars were distributed to stores, and another 16,000 were stopped before distribution. The affected jars could have been purchased between November 8 and November 17.

This is the second peanut butter recall this year, following a Skippy peanut butter recall in March.

A massive peanut recall in 2008-2009 by Peanut Corporation of America was linked to more than 700 salmonella food poisoning illnesses and nine deaths. In 2007, millions of jars of Great Value and Peter Pan peanut butter were recalled by Con Agra Foods after they were linked to over 625 cases of salmonella in 47 states, including several deaths.

Salmonella, also known as salmonellosis, is one of the most common causes of food poisoning in the United States, producing symptoms like high fever, persistent diarrhea, dehydration, vomiting, severe abdominal cramps and pain. The first symptoms usually begin to surface between 12 hours and 3 days after consuming the salmonella infected food.

For most healthy adults, salmonella symptoms pass within a few days to a week. However, in some cases severe illness can persist for longer and lead to more serious health problems. Those who are most susceptible to serious injury include the elderly, infants and those with chronic conditions, such as HIV/AIDS, diabetes or weak immune systems.

The FDA recommends that consumers who have the affected jars of peanut butter retain proof of purchase and discard them immediately. They can contact Smucker’s for a replacement coupon by calling (888) 550-9555.

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Lawsuit Over Brain Injury From Auto Accident Results in $10.6M Verdict

A California jury has awarded $10.6 million to a man who suffered a traumatic brain injury (TBI) as a result of an auto accident with farm equipment on a rural highway. 

The lawsuit was filed by Matthew Cole, 38, who was injured as a result of a collision that occurred at 4:30 in the morning, while he was riding as a passenger in a pick-up truck on his way to work in Palo Alto, California.

According to the complaint, Cole and his brother were on Shoemake Avenue, a rural 55-mph two-lane highway, when their vehicle collided with farm equipment that occupied their lane.  A farmer was blocking the lane while loading trailers with grapes from his property, which adjoined the highway.

At the time of the collision, it was dark outside, but the defendant argued at trial that the lights and reflective tape on the backside of the tractor were enough to be seen.  A cross complaint was also filed against an independent contractor who had allegedly given the farmer instructions to use Shoemake Avenue during the harvesting process.

As a result of the accident, Cole suffered a traumatic brain injury, which resulted in more than $620,000 in medical bills and an estimated $2 million in future medical expenses.

A traumatic brain injury, also known as a TBI or head injury, is one of the leading causes of death and permanent disability worldwide.  About 1.4 to 1.7 million people suffer a brain injury trauma every year, often resulting in permanent and debilitating disability that requires substantial expenses for treatment and day-to-day care.

Automobile accidents and truck accidents account for approximately 20% of all traumatic brain injuries, according to recent estimates.

Following trial in Stanislaus County Superior Court in California, the jury awarded Cole $10,651,423.13 in damages, representing past and future medical expenses, more than $2.5 million in lost earning capacity and $5.5 million in past and future non-economic damages.

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Johnson’s Baby Shampoo Harmful Chemicals Being Removed

Under intense pressure from consumer watchdog groups and concerned parents, Johnson & Johnson has announced that it is reformulating all of its baby shampoos, lotions and other products to get rid of preservatives that may release formaldehyde.

On Thursday, Johnson & Johnson sent a letter to the Campaign for Safe Cosmetics alerting its director, Lisa Archer, of their decision to change its products and remove potentially harmful chemicals that have raised concerns among consumers.

In the letter, the company wrote that it believes the products are safe with the preservatives, but said that it was important that the company listen to its customers and maintain a bond of trust between them.

It will take about two years for the company to change all of its products worldwide, but the baby shampoo products will be reformulated sooner. The company said it is also trying to get its suppliers to reduce the amount of 1,4-dioxane and is in discussions with stakeholders about requests to disclose its fragrance ingredients.

The letter comes just two weeks after the Campaign for Safe Cosmetics called for a boycott of Johnson & Johnson baby shampoo in order to force the company to remove quaternium-15 and 1,4-dioxane. Quaternium kills bacteria, but releases formaldehyde, which is a known human carcinogen. Johnson & Johnson maintains that the amount of formaldehyde in an entire bottle of its baby shampoo is equivalent to the amount one consumes when they eat an apple or pear.

The Campaign for Safe Cosmetics has pointed out that bottles of Johnson & Johnson’s Baby Shampoo sold in several nations, including Japan and the U.K., do not contain formaldehyde, but shampoo sold to parents of children in the U.S., Australia, Canada, China and Indonesia have continued to contain the cancer-causing agents. The chemicals are not listed on the label.

Since there are formaldehyde free versions of Johnson’s Baby Shampoo sold in some countries, the Campaign for Safe Cosmetics has argued that it is not necessary for versions containing the chemicals and potentially endangering children to be sold in any country. The group was joined by several other organizations, including the Breast Cancer Fund, the Environmental Working Group and others, in urging Johnson & Johnson to make this firm commitment to remove the potentially harmful chemicals from Johnson’s Baby Shampoo and other products.

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Malpractice Risk May Be Increased by Electronic Medical Records

A new report suggests that while there are many benefits to electronic medical records, there may be a hidden risk of medical malpractice as well.

The Institute of Medicine (IOM) released a report on Tuesday, “Health IT and Patient Safety: Building Safer Systems for Better Care“, which calls for a new plan to minimize patient safety risks associated with electronic medical records. The efforts could eventually lead to FDA regulations and oversight over electronic medical records, the IOM notes.

Many medical experts have long hoped that the use of electronic or digital medial records would reduce medical mistakes and prescription errors, helping healthcare providers avoid preventable injuries and reduce their exposure to the risk of medical malpractice lawsuits.

Having the records available electronically could prevent misreading of hand-written data, flag potentially dangerous drug combinations and alert physicians and health care professionals to health conditions that might complicate other procedures.

However, some studies have shown that many of the expected benefits are not materializing as rapidly as expected, if at all, and the IOM report highlights other dangers that could increase the malpractice risk due to electronic records.

The IOM states that one of the problems with electronic medical software, which the report refers to as Health IT, is that there are no set standards and little tracking of their effectiveness. There have been cases of poorly written software that could increase patient safety risks.

“Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns,” the IOM report states. “Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human-computer interactions or loss of data have led to serious injury and death.”

The IOM recommends that the U.S. Department of Health and Human Services publish a plan within 12 months that would minimize patient safety risks and report annually on the implementation progress of that plan. But, the report says, if a plan cannot be created in that time span, oversight of Health IT should be turned over to the FDA, which would create new electronic medical records regulations. IOM recommended that the FDA get ahead of the problem and begin mapping out those potential regulations just in case.

In either scenario, the IOM called for the federal government to work with the private sector in order to get a better understanding of the impact of health IT on patient safety.

In February of this year, a report by researchers from Johns Hopkins published in the Archives of Internal Medicine found no consistent link between the use of electronic records and the quality of care. The only category that showed marked improvement from electronic medical record use was diet counseling in high-risk adults.

A different study published in late December 2010 in the American Journal of Managed Care did find overall improvements in serious medical care when hospitals used electronic health records, but found a decrease in quality when the electronic record-keeping systems were new.

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Acetaminophen Side Effects May Increase Asthma Risk: Study

A new study claims that a correlation between Tylenol and acetaminophen use and increasing rates of asthma among children is strong evidence that the drug’s side effects increase the risk of the breathing disorder.

According to research published online by the medical journal Pediatrics (PDF), as use of Tylenol and other acetaminophen products increased, so did childhood asthma, and when use leveled off, asthma rates did as well.

The findings include data from numerous studies and the report’s author is recommending that children with asthma or at risk of developing asthma be kept away from the nearly ubiquitous painkiller.

The study’s author is Dr. John T. McBride, director of the Robert T. Stone Respiratory Center and vice chair of the pediatrics department at Akron’s Children’s Hospital. He concluded that with mounting evidence of acetaminophen health risks, drug makers should have to prove it is safe, as opposed to researchers having to prove acetaminophen, the primary ingredient in Tylenol and other painkiller medications, is dangerous.

McBride reviewed data from a number of acetaminophen studies before determining that young children who took acetaminophen more than once a month may face three times the risk of developing asthma, and those who took it more than once a year, but less than once a month may face a 61 percent increased risk. Older children who took acetaminophen more than once a month faced 2.5 times the increased risk of developing asthma.

McBride notes that between 1980 and 2003 the rate of pediatric asthma increased from 3.6% to 5.8% in the United States. Similar increases were noted worldwide. The increase coincides with the revelation that aspirin had links to Reye syndrome and the subsequent rise of the use of acetaminophen. As acetaminophen use peaked and leveled off, so did asthma rates, McBride concludes.

“I need further studies not to prove that acetaminophen is dangerous but, rather, to prove that it is safe,” McBride concludes. “Until such evidence is forthcoming, I will recommend avoidance of acetaminophen by all children with asthma or those at risk for asthma and will work to make patients, parents, and primary care providers aware of the possibility that acetaminophen is detrimental to children with asthma.”

Acetaminophen is a pain killer and anti-inflammatory medication found in a number of over-the-counter and prescription drugs. It is also widely marketed for use among infants and children for the treatment of fever, aches and pain.

Asthma is a chronic condition where the airways could occasionally constrict and become inflamed, causing breathing problems. This can cause symptoms like wheezing, shortness of breath, chest tightness and coughing, which can be life-threatening in severe cases.

This is the second study this year to link the condition to acetaminophen. In April, researchers in New Zealand published findings indicating that that risk of a child developing asthma or breathing problems was 21% higher when the mother took acetaminophen during pregnancy.

In 2009, Canadian researchers also linked acetaminophen to increased asthma risk for children. Their analysis suggested that children who were given acetaminophen before they were one year old had a 47% increased chance of developing asthma, pregnant women who used acetaminophen were 28% more likely to have a child with asthma, and children who took acetaminophen were 60% more likely than other children to be diagnosed with asthma within the year following the medication’s use.

Side effects of acetaminophen have also been linked to liver damage at high doses, causing the FDA to announce earlier this year that it is limiting the amount of acetaminophen in combination painkillers to ensure that the dosage does not exceed 325 mg in each pill. The limitations came after increased concern over acetaminophen liver damage.

In recent years, a number of individuals throughout the United States have filed an acetaminophen lawsuit against the manufacturers of Tylenol, alleging that the drug makers have known that the medication may increase the risk of liver damage, liver necrosis and liver failure, but continued to market it as a safe medication with insufficient warnings for consumers.

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Nursing Home Lawsuit Filed Over Malnutrition, Dehydration and Infection

A lawsuit has been filed against a California nursing home home and a home health care service provider for allegedly allowing an elderly woman to suffer malnutrition, dehydration, infection and injuries from a fall.

The nursing home lawsuit was filed by Billie Walter against Petaluma Health and Rehabilitation and Accentcare Home Health of California, Inc. on behalf of her mother, Elizabeth Walter. The complaint also names Petaluma’s owners and operators; EHC Management, LLC and Evergreen at Petaluma LLC.

According to allegations raised by the family, Elizabeth Walter suffered severe injuries as a result of negligent care in the nursing home and during home nursing care.

Walter was injured in a fall that occurred at home while under the care of Accentcare on February 15, causing her to be transferred to Petaluma for nursing care. The lawsuit alleges that the fall occurred because Accentcare caretakers left her unattended, knowing that she suffered dementia and increased fall risks.

While she was at Petaluma, Walter additionally suffered malnutrition, dehydration and contracted serious infections due to a lack of appropriate nursing home care, the lawsuit claims.

She was subsequently hospitalized on March 12 due to her deteriorating health and health care professionals informed the state that they suspected she had been abused while in the nursing home.

The lawsuit also claims that Petaluma employees told Walter’s daughter that she would receive care from specialists that were supposedly on-staff, but whom she claims to have later discovered did not actually exist.

The complaint charges Petaluma and Accentcare with nursing home abuse, fraud, neglect and negligence.

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