Articles Posted in Products Liability

This week, a Food and Drug Administration panel will review the effect of the flu medicine Tamiflu on the brain. 55 children in the United States reportedly exhibited abnormal behavior and other brain effects after taking the medication. 22 of the cases included serious symptoms, such as delirium, convulsions, and delusions.

Globally, more than 1800 children who have taken Tamiflu showed similar effects worldwide. Five children in Japan died because of psychiatric or neurological problems. Seven adults died because of neuropsychiatric problems.

75% of the 48 million prescriptions for Tamiflu are administered in Japan. Last March, the Japanese government issued a warning that Tamiflu’s use be restricted in young people.

There is no concrete evidence to show that Tamiflu causes problems in the brain or abnormal behavior. Terry Hurley, a spokesperson for drugmaker Roche Laboratories, says flu patients who have not taken Tamiflu also showed these symptoms. However, if a child or adult was injured from taking Tamiflu, he or she may have grounds to file a dangerous drug claim or lawsuit against Roche Laboratories.

Tamiflu is Roche’s number nine best-selling drug and, according to the Tamiflu Web site, it is the “number one doctor-prescribed flu medicine.” The FDA has recommended Tamiflu for use in children and adults over age one. Tamiflu is used as a flu vaccine and to treat flu symptoms.

FDA safety reviewers are recommending that Tamiflu labels be updated to include information about possible neuropsychiatric side effects.

The FDA’s review of Tamiflu comes a little over one month after the makers of several infant cold medicines voluntarily recalled infant cold medicines Dimetapp, Robitussin, Pediacare, Triaminic, Little Colds, and Tylenol because of accidental overdose concerns.

Earlier this month in Chicago, a woman sued Walgreen Co. and McNeil for the wrongful death of her 4-month-old son who died after taking Infant Tylenol Cold Decongestant Plus Cough and Pediatric Drops-Cough Plus Cold, which are two over-the-counter medications.

FDA panel to review Tamiflu’s effect on brain, USA Today, November 26, 2007
Lawsuit alleges Illinois infant died from cold medicine ingredient; mother suing 2 companies, International Herald Tribune/AP, November 14, 2007
Makers Pull Cold Medicines for Infants, CNN.com, October 11, 2007

Tamiflu

Related Web Resources:

FDA Questions the Safety Of Asthma Drugs for Kids, The Wall Street Journal, November 24,2007

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Merck & Company says it will pay $4.85 billion to settle thousands of lawsuits related to injuries sustained by people who use Vioxx, a popular painkiller that was pulled from the market three years ago because studies revealed that it increased the risk of stroke and heart attack.

There have been thousands of personal injury lawsuits filed in federal and state courts over the past few years. The settlement agreement is intended to resolve these disputes. The $4.85 billion will be placed in a fund for the tens of thousands of Vioxx victims who suffered heart attacks and strokes because they once used the prescription drug. The fund will only be established, however, if 85% of the plaintiffs agree with the way the claims will be resolved.

The agreement consolidates the claims but is not a class-action settlement.

Merck had said initially that it would fight every claim based on whether or not the plaintiff had used Vioxx for an extended period of time or whether other factors could have led to the stroke or heart attack. Of the different products liability and wrongful death lawsuits that have already gone to trial, some of them resulted in verdicts in favor of the plaintiffs while other juries rule din favor of Merck.

Vioxx is believed to have doubled the risks of cardiovascular problems in people who had used the drug for more than 18 months. Nearly 20 million people in the United States are estimated to have used Vioxx.

Vioxx

Vioxx belongs to a category of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Vioxx was used to decrease stiffness, pain, and inflammation in patients with osteoarthritis, rheumatoid arthritis, and certain forms of juvenile rheumatoid arthritis. It was also used to alleviate migraines, acute pain in adults, and menstrual pain. Vioxx was been known to cause heart attacks, stroke, death, and other serious and not so serious side effects.

Merck to Pay $4.85B Vioxx Settlement, Washington D.C., November 9, 2007
Vioxx, Drugs.com

Related Web Resources:

Vioxx Information Center, Merck.com
Merck yanks arthritis drug Vioxx, CNN Money, October 6, 2004

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Two children in the United States and three children in Australia were hospitalized after swallowing beads from a popular toy product that contain a chemical that metabolizes into a potent date rape drug when absorbed into the body.

The two children who became sick in the United States went into nonsresponsive comas. One of the children, a 20-month-old toddler, has recovered completely. The other child is recovering.

The toy, called Aqua Dots in the United States, has been recalled. 4.2 million Aqua Dots toys have been pulled off toy shelves throughout Canada, the United States, and Australia. Spin Master Toys, a Toronto-based company, distributes the product in North America. The toy is called Bindeez in Australia.

Aqua Dots toys are very popular in the United States and have been sold at major retail stores since April 2007. Aqua Dots were on Wal-Mart Stores’ list of top 12 Christmas toys for this year.

The toys are manufactured in China. The toy’s beads can be arranged into designs when sprayed with water. According to scientists, a chemical that coats the beads, when swallowed, turns into gamma hydroxy butyrate, the date rape drug, which can cause unconsciousness, drowsiness, seizures, coma, and death.

If your child was injured by a defective toy, you may be able to sue the manufacturer or distributor by filing a products liability lawsuit. An experienced products liability attorney can let you know whether you have grounds for a claim or lawsuit.

In other toy recent recall-related news, 405,700 toys said to be contaminated with lead where also pulled off shelves in the United States on Wednesday. Toys recalled include Pull-Back Action toy cars, “Big Red” wagons, Dragster and Funny Car toys, Duck Family wind up toys, Dizzy Ducks music boxes, and Winnie-the-Pooh spinning top products.

Toy contaminated with ‘date rape’ drug pulled, CNN.com, November 8, 2007
List of Lead-Contaminated Toys Recalled, AP, November 7, 2007

Related Web Resources:

GHB Drug Fact Sheet

Gamma-Hydroxybutyrate (GHB): A Newer Drug of Abuse, American Family Physician, December 1, 2000

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Payless Shoesource Inc. is voluntarily recalling some 90,000 Girls’ Boots that were manufactured in China because the guitar-shaped zipper pull on each boot can interlock and cause a girl to trip and fall while walking.

The shoes are sold were sold at Payless ShoeSource stores across the U.S. and Payless.com from August 2007 to September 2007. There have been five reports of the zipper pulls interlocking and one incident of a four-year-old girl who skinned her knee because she fell.

If a person is injured because of a defective product, he or she may have grounds to file a products liability claim or lawsuit against the manufacturer and/or the store where the product was brought.

The recalled boots have “Hannah Montana” engraved on their outsoles and were sold in girls’ sizes 4 ½ to 10.

Jewelry, jackets, shoes, belts, hooded sweatshirts, bathrobes, pants, and sweaters are just some of the clothing items that can be recalled if any of them prove to be flammability hazards, strangulation hazards, choking hazards, toxic hazards, or slip and fall hazards.

Product recalls are authorized because a particular product item has proved to be dangerous to users. The recall warns users of the hazard and pulls the product off store shelves.

Recent Recalls involving Children’s Clothing (Healthnews.com):

• Children’s Necklaces Recalled by GeoCentral Due to Lead Poisoning Hazard (June 19, 2007)

• Choking Hazard Prompts Nordstrom Recall of Children’s Jackets (June 14, 2007)

• Children’s Jeweled Sandals Sold by Nordstrom Recalled Due to Choking Hazard (June 14, 2007)

• Silver Stud Earrings Sold Exclusively at Kmart Recalled by Crimzon Rose Accessories Due to Lead Poisoning Hazard (June 12, 2007)

• Personalized Infant Long Johns Recalled by Personal Creations Due to Choking Hazard (June 7, 2007)

• Lead Poisoning Hazard Prompts Cardinal Distributing to Again Recall Children’s Rings (May 2, 2007)

• Oriental Trading Company Inc. Recalls Children’s Necklaces Due to Lead Hazard (May 2, 2007)

• Payless ShoeSource Recalls Children’s Clog Shoes Due to Choking Hazard (May 2, 2007)

If you or someone you love was injured by any kind of defective product in Maryland or Washington D.C., do not hesitate to contact an experienced products liability attorney right away. You may be eligible to receive compensation for injuries, pain, and suffering.

Payless ShoeSource Recalls Girls’ Boots Due to Fall Hazard, CPSC.gov, October 18, 2007
Clothing Recalls, Product Recalls, Health News

Related Web Resource:

Payless Shoesource

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Dr. Joshua M. Sharfstein, a pediatrician and the Baltimore Health Commissioner told a Food and Drug Administration (FDA) advisory panel that cough and cold medicines don’t work and are dangerous for children under six years of age. He attributed lax FDA regulations as the reason that pharmaceutical companies are allowed to market drugs to the parents of young children—even though there is no proof that the drugs are effective and there is growing evidence of related illnesses and deaths.

Sharfstein is part of a group of pediatricians trying to convince the FDA to stop drug manufacturers from marketing cough and cold medicines to the parents of young children.

Last week, drug manufacturers voluntarily pulled cold and cough medicines by Tylenol, Little Colds, Triaminic, Pediacare, and Robitussin for infants, toddlers, and young children. Manufacturers cited concerns that parents might give too big a dose to their children who are younger than six years of age. Labels provided on the medicines withdrawn suggest that parents ask a doctor for advice regarding dosage.

The CDC says that since 2005, some 1500 toddlers and infants have been taken to hospital emergency rooms because of an adverse reaction to taking cold medication.

The FDA says that there have been 54 reported infant fatalities attributed to decongestants. Antihistamines reportedly caused 69 child deaths.

Two months ago, federal health officials recommended that the “ask the doctor” directive be replaced with a warning not to give the medication to children younger than 2 unless specifically instructed on how to do so by a pediatrician.

If you suspect that your child may have gotten sick or died because of a dangerous drug or because a drug manufacturer did not provide the correct instructions on the dosage to give your child, you should speak to an experienced products liability attorney in Maryland or Washington D.C.

The drug manufacturer is legally obligated to reasonably protect all consumers and must include safety warnings of any potential side effects. A drug manufacturer can also be held liable for personal injury if it markets the drug in a way that misrepresents it.

Sharfstein makes case to ban cold remedies, Baltimore Sun, October 18, 2007
Child deaths lead to FDA hearing on cough, cold meds, CNN, October 17, 2007

Related Web Resources:

What Parents and Caregivers Need to Know: OTC Cough and Cold Medicines and Children, Consumer Healthcare Products Association
Drug Facts Label

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Kraft Foods announced a U.S. recall of its Baker’s Premium White Chocolate Baking Squares. The packaged foods maker cited concerns of possible Salmonella bacteria contamination.

The products affected include the UPC Code 0043000252200 and the best-when-used by dates of:

• 31 MAR 2008 XCZ
• 01 APR 2008 XCZ
• 02 APR 2008 XCZ
• 03 APR 2008 XCZ

The products were distributed across the U.S. The possibility of Salmonella contamination was discovered after the Food and Drug Administration conducted tests and noticed that some of the chocolate packages had Salmonella. Kraft says it is taking aggressive action to discover the source o the problem.

Salmonella

Salmonella is a bacteria that causes infections. Salmonella usually leads to diarrhea, fever, abdominal cramps—and in people with a weakened immune system—death. Salmonella is foodborne, and can be spread via people eating contaminated food products.

Beef, milk, poultry, and eggs have been known to contain salmonella. Raw foods can contain salmonella, but cooking a contaminated food properly can kill the salmonella. A food item can also be contaminated with salmonella if the person that prepared their food did not wash their hands after going to the bathroom or already has salmonella and touches the food with their hands.

Nearly 40,000 salmonellosis cases are reported in the U.S. annually. Some 600 people die from salmonella every year. The elderly, young children, and those with weaker immune systems are most likely to contract salmonellosis.

The CDC offers consumers what they can do to avoid salmonella contamination:

• Cook poultry, ground beef, and eggs thoroughly before eating. Do not eat or drink foods containing raw eggs, or raw unpasteurized milk.
• If you are served undercooked meat, poultry or eggs in a restaurant, don’t hesitate to send it back to the kitchen for further cooking.
• Wash hands, kitchen work surfaces, and utensils with soap and water immediately after they have been in contact with raw meat or poultry.
• Be particularly careful with foods prepared for infants, the elderly, and the immunocompromised.
• Wash hands with soap after handling reptiles or birds, or after contact with pet feces.
• Avoid direct or even indirect contact between reptiles (turtles, iguanas, other lizards, snakes) and infants or immunocompromised persons.
• Don’t work with raw poultry or meat, and an infant (e.g., feed, change diaper) at the same time.

• Mother’s milk is the safest food for young infants. Breast-feeding prevents salmonellosis and many other health problems.

Food distributors, producers, and workers are legally obligated to ensure that their food products are not a health threat to consumers. When this obligation is not met, a person who becomes sick, injured, or dies because of the contaminated food product may have grounds to file a products liability claim or lawsuit.

Other common foodborne illnesses that can lead to a products liability case if the contamination is caused by negligence:

• E.coli
• Food poisoning
Kraft recalls white chocolate, CNN.com, October 4, 2007
Kraft Foods Recals Baker’s Premium White Chocolate Baking Squares Because of Possible Health Risk, Kraft.com, October 3, 2007
Salmonellosis, CDC.gov

Related Web Resources:

What are Salmonella?, Salmonella.org

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A couple with two children is suing McDonald’s and two Missouri operators for personal injury. They say that they were mislead about the ingredients used to make hash browns and French fries, which resulted in their two children—who have food allergies—from becoming injured.

Mekenzie Miller, 7, and Macauley Miller, 4, experienced stomach problems and other emotional and physical illnesses because they ate McDonald’s French fries, which contains casein and wheat.

Their parents, Frank and Beth Miller, say that they checked the list of ingredients that McDonald’s uses to make French fries prior to letting their children eat them. Neither casein or wheat were on the list. Mekenzie has celiac disease, which is an allergy to wheat and gluten products. Macauley is autistic. Milk, gluten, and wheat can exacerbate his behavioral issues. His parents say that eating the fries set back Macauley’s behavioral therapy.

The lawsuits are being filed against McDonald’s along with 16 other injury cases in Florida. Another federal class action suit has also been filed.

Restaurants, food manufacturers, and food retailers have a responsibility to ensure that the food that they offer consumers will not cause them to become ill or die. A food provider also must ensure that consumers are warned of any potential causes of injury or illness. Failure to do so can be grounds for a products liability claim or lawsuit against any negligent parties.

The FDA mandates that all food producers have to make sure that the food they produce and/or sell is correctly labeled and includes a proper list of nutritional content and ingredients. Any expiration date must be properly listed. All food must not contain any harmful bacteria, toxic substances, or foreign objects inside them.

If you or someone you love has become ill or sustained injuries because of a harmful ingredient in a food item or because the food item was improperly processed, improperly prepared, incorrectly labeled, or contained a harmful substance in it, you should speak with a personal injury lawyer who is experienced in handling products liability cases.

O’Fallon, Mo., couple sue McDonald’s over ingredients in fries, STltoday.com, September 25, 2007

Related Web Resources:

McDonald’s Lawsuit Timeline, Compassionate Spirit

McDonald’s

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The MRL/Welch Allyn AED 20 Automatic External Defibrillators are being recalled. The medical devices are used by medical and emergency personnel to treat pediatric and adult patients that have suffered heart attacks.

Welch Allyn Protocol, Inc. announced the recall. It said that the defibrillators might display a “Defib Comm” error message that would result in the device’s terminal failure to function properly and give an unconscious patient the proper electric shock needed to restore normal heart rhythm.

The FDA is calling this a Class I recall, which is the most serious level of recall and indicates that the product defect could cause wrongful death or serious injury. Medical and emergency personnel are being told to stop using the AED 20 Automatic External Defibrillators right away.

This is not the first recall initiated by Welch Allyn. In June, 580 medical devices were recalled because the internal electrical connection could potentially fail. 30 cases reported the malfunction, which delayed patients’ resuscitation.

If you or someone you love is seriously injured because of a defective medical device, you should speak with a products liability attorney right away.

The manufacturers of medical devices are legally responsible for making sure that their products are safe for use. They have to notify consumers of any possible risks that can result in injury or death. If the manufacturer fails to do so, they can be held liable for any injuries and wrongful deaths. The re-sellers and distributors of defective medical devices can also be held legally responsible.

Every year, thousands of people in the United States are affected by a defective medical device—either through injury, misdiagnosis, medical error, or wrongful death. Aside from this current recall, over 236,000 defective defibrillators have been recalled in the past two years.

Welch Allyn Defibrillators that are part of the recall:

RL/Welch Allyn AED 20 Automatic External Defibrillators, serial numbers between 205787 and 207509

Other defibrillators that have been recalled include defibrillators by Guidant, Medtronic, and St. Jude.

Class I Recall Issued for Welch Allyn Defibrillators, News Inferno, September 18, 2007

Related Web Resources:

Food and Drug Administration

Welch Allyn

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Toy company Toys ‘R’ Us and the U.S. Consumer Product Safety Commission (CPSC) say that they are recalling approximately 27,000 Imaginarium wooden coloring cases that were manufactured in China because the ink printed outside the cases have lead. Some of the black watercolor paint used is also said to have very high levels of lead and therefore violates the federal lead paint standards.

The product recall could lead to personal injury claims and products liability lawsuits across the country if anyone becomes seriously ill or dies because of exposure to the lead. So far, no injuries have been reported.

The CPSC says that all consumers should stop using the coloring cases right away. The 213-piece wood cases comes with pastels, crayons, fiber pens, colored pencils, a pencil, a paintbrush, water colors, white paint, a palette, a pencil sharpener, and a ruler.

Some 8,300 wooden art sets have already been sold to customers under the Imaginarium label. The sales occurred between October 2006 and August 2007 at Toys “R” us stores and on the Toys “R” Us Web site. Toys “R” Us said that it had purchased about 27,000 art sets from the company Funtastic.

The product recall comes on the heels of a series of recalls earlier this month by Mattel Inc., which recalled millions of toys made in China because they either contained powerful magnets that could be easily swallowed or were made with excessively high levels of lead paint.

Exposure to lead can be very dangerous for children, especially boys and girls six years of age and under. Results from studies show that lead exposure can result in hyperactivity, ADD, a lower IQ, kidney damage, hearing problems, learning disorders, stunted growth, and behavior problems in children.

Adults exposed to lead have been known to develop muscle and joint pain, fertility problems, higher blood pressure, memory loss, and nerve problems.

If you or someone you love has become injured or sick because of exposure to lead from a defective product, you could have grounds to file a products liability claim against the negligent party. There may even be more than one negligent party that can be held responsible for your personal injury, such as the product manufacturer, the product distributor, the company that marketed the product, and the store that sold the product to you.

CPSC and Toys ‘R’ Us recall wooden art cases, Marketwatch.com, August 30, 2007
Toys ‘R’ Us Recalls Chinese Art Sets, Forbes.com/AP, Auugust 30, 2007
Lead Poisoning, NSC.org
Toys “R” Us Recalls Wooden Coloring Cases Due To Violation of Lead Paint Standard, CPSC.gov, August 30, 2007
Corporate Page, Toys “R” Us

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Mattel, the maker of toys, such as Barbie and Dora, is voluntarily recalling nine million toys in the U.S. It is recalling 18.2 million magnetic toys around the world. Toys with magnets that can come off and are easily swallowed are among the toys being recalled.

Polly Pocket accessories and Polly Pocket Dolls make up 7 million of the toys being recalled. 680,000 Barbie and Tanner play sets, 1 million Doggie Daycare sets, and nearly 350,000 Batman and One Piece magnetic action figures are also being recalled.

The toys were manufactured between May 2003 and November 2006. Some accident reports name children who were seriously injured after they swallowed more than one magnet. Three children had to have surgery because they suffered internal perforations caused by the magnets sticking to each other.

Some 253,000 “Sarge” die-cast toys related to the movie “Cars” by Pixar were recalled because of dangerous levels of lead in the paint. Any “Sarge” toys that are recalled were sold between May 2007 and August 2007.

Mattel says it is going to review its testing procedures, which it claims are already very strict. It is the second recall for the toy company in two weeks.

Fisher-Price, another Mattel Company, recalled 1.5 million toys that had been manufactured in China because of lead paint concerns. Diego and Dora character, as well as Big Bird and Elmo characters were included in the recall.

The US Consumer Product Safety Commission (CPSC) and the National SAFE KIDS Campaign offer a number of 2003 statistics involving children and toy-related injuries, including:

Injury and death rates:
• Approximately 155,400 children, ages 14 and under, were treated at hospital emergency rooms for toy-related injuries in 2003. Nearly half of the children treated for these injuries were ages 4 and under.

• Most toy-related injuries do not require hospitalization (97 percent), however, in 2003, 11 children died due to toy-related injuries.

Causes:
• Injury from non-powered scooters is the leading cause of toy-related death.

• Sixty-four percent of toy-related deaths in 2003 were due to choking. About 71 percent of those deaths were attributed to toy balls.

Other causes of toy-related deaths include drowning, suffocation, and riding toy accidents (such as when a child is hit by a motor vehicle while riding a toy, or when the child rides a toy into a body of water).

A person who is injured because of a dangerous or defective toy or any other dangerous/defective product could have grounds to file a products liability claim or lawsuit against the negligent party.

Mattel recalls 9 million toys in U.S., CNN, August 14, 2007
Toy Safety – Injury Statistics and Incidence Rate, ChildrenSNYP.org

Related Web Resources:

List of Toys in Mattel Recall, Forbes.com, August 14, 2007
U.S. Consumer Product Safety Commission

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