Posts Tagged ‘“product liability”’
Defective Space Heaters Recalled
As consumers look to space heaters to stave off the winter chill, a large manufacturer has recalled over 100,000 defective units from the shelves.
Lasko Products, Inc. of West Chester, Pennsylvania recalled 107,500 defective space heaters this week in cooperation with the U.S. Consumer Product Safety Commission. An electrical connection in the base of the unit can overheat, causing it to melt and expose the electrical connection.
Lasko received 36 reports of electrical connection overheating with no reports of injury. There were 18 reports of minor burn damage to floors or carpets.
Two defective space heater models were involved in the product recall. The Lasko Model 5540 was sold at Sam’s Club and other retailers from September 2002 through early 2004. The Air Kind Model 8540 was sold primarily through W.W. Granger Inc. from late 2002 to 2004.
Consumers are advised to stop using the defective space heaters immediately and contact Lasko for a free replacement.
If you are using another space heater, please visit the website of the Boston product liability lawyers at Breakstone, White & Gluck. Click here for our home heating safety tips.
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What Accutane Users Need to Know
Accutane is an acne medication that was once widely used, but withdrawn from the market in June 2009. The manufacturer, Hoffman-LaRoche, discontinued the drug as it faced Accutane lawsuits related to the drug’s powerful side effects.
Accutane is also known as isotretinoin. Approved for use in 1982, the medicine was originally manufactured to treat certain types of cancer. Later marketed as an acne medication, it proved effective at treating severe nodular acne, a chronic condition characterized by large, red, swollen lumps on the skin. Left untreated, severe nodular acne can cause permanent scarring.
Between 1982 and 2009, Accutane was used by more than 13 million patients, including those in Massachusetts. Additionally, many other individuals used generic equivalents, such as Amnesteem, Claravis and Sotret. The generic equivalents are still being prescribed.
The drug has long faced government scrutiny for its side effects, including birth defects, inflammatory bowel disease, ulcerative colitis, Crohn’s disease, liver damage, suicidal thoughts and depression. In many cases, patients have required extensive medical treatment and surgery to correct Accutane injuries.
The FDA has issued several warnings about Accutane over the years. In 2005, it warned users to watch out for symptoms of depression, suicidal thoughts and mood disturbance. The government agency has worked with Hoffman-LaRoche for many years on its iPledge program to reduce the risk of birth defects among female users. In 2007, the FDA warned consumers not to purchase Accutane or its generic equivalents over the Internet without consulting a doctor.
If you have taken Accutane, it is important to be informed of your rights. If you have taken the defective drug and suffered personal injuries as a result, you may be able to file a claim against the manufacturer.
Breakstone, White & Gluck of Boston, Massachusetts is skilled at handling product liability cases involving defective drugs such as Accutane.
Click to learn more about our Massachusetts Accutane lawyers. Or if you have a case, contact us today at 617.723.7676 or use our form.
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Fisher-Price Recall Hits Parents, Children Hard
In the year’s largest recall, Fisher-Price has pulled more than 11 million children’s bikes, high chairs and other toys from the shelves. The recall impacts consumers in the United States and Canada. Parents in the two countries are asked to check their homes and immediately stop using any products on the recall list.
The Fisher-Price recall included nearly 50 types of products, including over 7 million tricycles such as the Hot Wheels Trike and the Barbie Butterfly Trike. These toys have a protruding part that can cut children. The company received 10 reports of children being injured.
A million high chairs sold under 23 different names were recalled. The high chairs can cut children on the legs. Seven children required stitches.
The Fisher-Price recall also included 2.8 million infant toys with inflatable balls. The balls have a valve that easily comes off and poses a choking hazard. Also recalled for creating a choking hazard were 120,000 car toys with small plastic wheels that easily come off.
For a full list of recalled toys, click here. Consumers impacted can contact the company’s recall information web page.
Fisher-Price, based in East Aurora, New York, is owned by Mattel, of El Segundo, California. The company recalled the toys voluntarily in partnership with the Consumer Product Safety Commission and Health Canada.
The Fisher-Price recall is a reminder parents need to test toys themselves and watch their children while playing. For infants and younger children, one way to judge whether a toy is a choking hazard is to take a toilet paper roll. Hold the toy or toy piece up to the toilet paper roll. If it’s small enough to slide through, it poses a hazard for your young child.
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FDA Considers Banning Diet Pill Meridia
The Food and Drug Administration (FDA) is now weighing whether to ban the diet pill Meridia following a split vote by its advisory panel.
The panel voted 8-8 on Sept. 15. Half the members voted to continue marketing the drug, which a study has shown increases risk for heart attacks and strokes. Half the panel voted to remove it from the shelves. European regulators banned the drug in January, but the FDA had wanted input from its advisory panel before acting.
Meridia is produced by Abbott Laboratories and has been on the market since 1997. Data released in November 2009 shows that when patients with heart disease took Meridia, they had a more than 11 percent risk of cardiovascular risks, compared with 10 percent taking a placebo. The study included 10,000 patients.
Meridia is one of only three prescription pills currently approved for weight loss. Many say the marginal benefits are not worth the risk. Among study participants, the average patient lost five pounds and 30 percent kept the weight off.
“We do make the assumption that weight loss is beneficial and that translates into clinical benefits, but we’re not presented with those here,” said Dr. Katherine Flegal of the Centers for Disease Control and Prevention. “On the whole, there are not the benefits that justify the risks.”
Prescriptions of Meridia have declined in recent years. About 283,000 Meridia prescriptions were filled in the U.S. last year, just more than half the number in 2005.
To read more about the Meridia product ban discussion, click here.
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Product Safety Recall: Baby Tents Pose Strangulation Risk
Just weeks after a massive children’s crib recall, a portable playard tent linked to a young boy’s fatal strangulation has been pulled for safety.
The U.S. Consumer Product Safety Commission (CPSC) and Health Canada, in cooperation with Tots in Mind Inc. of Salem, New Hampshire, has announced the voluntary recall of 20,000 Cozy Indoor Outdoor Portable Playard Tents Plus Cabana Kits. An additional 85 tents were recalled in Canada.
The tent is a white dome-shaped covering designed to fit over playards that contain a child. In December 2008, a two-year-old boy from Vinalhaven, Maine died when he climbed out of the playard. He was found hanging with his neck entrapped between the playard frame and the metal base rod of the tent. In this case, the tent had been tied to the playard with pieces of nylon rope and partially attached with the tent’s clips because the child knew how to remove the clips.
In three other incidents, children removed the clips on the tent and were able to place their necks between the tent and the playard. The children were not injured.
The unsafe cribs were made in China and sold at Walmart, Amazon and various baby stores from January 2005 to February 2010.
Consumers should immediately stop using the playard tents. They can contact Tots in Mind to get free replacement clips. Replacement clips will be available in late August or early September.
This is the second major product safety recall affecting parents and children in recent weeks. In June, the CPSC recalled two million cribs because of an unsafe drop-side rail, which created a gap where a baby’s head could become trapped. Government officials say this could lead to suffocation or strangulation.
The companies involved in the recall include Evenflow, Delta Enterprises Corp., Child Craft, Jardine Enterprises, LaJobi, Million Dollar Baby and Simmons Juvenile Products Inc.
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FDA Issues Tylenol Safety Warning
The Food and Drug Administration is urging parents to choose generic children’s medications over Tylenol as it broadens its investigation into manufacturing facilities operated by Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare.
New product safety concerns have arisen in the weeks after an April 30 recall involving McNeil’s Fort Washington facility in Pennsylvania, prompting the FDA to start investigating other manufacturing sites. McNeil recalled 43 over-the-counter children’s medicines it manufactures for Johnson & Johnson, including various flavors of liquid Tylenol, Motrin, Benadryl and Zyrtec. The FDA has not said how many facilities are being investigated.
McNeil Consumer Healthcare issued the April 30 recall voluntarily in consultation with the FDA. In a visit to McNeil’s Fort Washington facility, FDA officials uncovered inconsistent active ingredient concentrations, extremely potent metal particles in some medicines, an inadequate testing facility, poorly trained employees and drums of raw materials contaminated with bacteria.The full inspection report is available here.
Meanwhile, the House Committee on Oversight and Government Reform is scheduled on Thursday, May 27, 2010 to hold a hearing on the recent Tylenol recalls and whether McNeil properly handled consumer complaints. In a recent Fortune Magazine interview, Johnson & Johnson Chief Executive William Weldon admitted that his company owed an apology. Mr. Weldon has been invited to testify at the May 27 hearing.
The Pennsylvania facility has since been shut down but may resume operation once, according to Johnson & Johnson spokesman James Freeman, “we have taken the necessary corrective actions and can assure the quality of products made there”.
Tylenol has been involved in other product safety recalls in recent years. In 2008, McNeil recalled 51 types of Tylenol after consumer complaints of diarrhea, vomiting and other illness. The company said the medications – mostly all for children and infants – had been contaminated by trace amounts of a chemical used in shipping.
In 2008, McNeil recalled 21 types of children’s and infants’ Tylenolbliquid products, saying an active ingredient did not meet all quality standards.
For additional information on the Johnson & Johnson recalls, see the FDA’s website.
FDA Taking a Closer Look at the Health Effects of a Widespread Household Chemical
The US Food and Drug Administration (FDA) is looking into the health effects of a common chemical called triclosan, which is found in certain soaps, toothpaste, shower curtains and gym socks. The FDA is investigating scientific data indicating that the chemical causes hormonal changes in lab animals. Triclosan is added to products to reduce or inhibit bacteria growth and was originally used as a surgical scrub. At this time, the FDA has not recommended that consumers change products but has said that consumers concerned about using soap with triclosan can use regular soap. Concerned consumers can check product labels for triclosan.
Scientific data has shown that triclosan acts as an endocrine disruptor in lab animals. In humans, endocrine disruptors can increase the risk of developmental problems in fetuses and young children. Bishpenol A, known commonly as BPA, another endocrine disruptor found in some plastics, is banned in some states and has been voluntarily removed from shelves by some retailers. Triclosan’s use has increased over the past decade, especially as consumers seek to prevent the cold and flu. Additionally, a report by the US Geological Society found that between 1999 and 2000, triclosan was found in 60% of streams.
The FDA is not the only entity taking action. Representative Edward J. Markey is calling on the federal government to ban triclosan in products used to wash hands, prepare food, or products marketed to children. Additionally, he is filing legislation to speed up the process of evaluating and regulating potentially harmful products.
For more information on triclosan, see this Boston Globe article and the FDA’s website.
After Three Infant Deaths, Company Recalls Baby Sling– Massachusetts Residents Should Take Warning
The US Consumer Product Safety Commission (CPSC), in cooperation with Infantino LLC of San Diego, have announced a free replacement program for two models of defective infant slings. One million of the defective products are being recalled after the three wrongful deaths of infants due to incidents of suffocation. CPSC is aware of the deaths of a seven week old in Philadelphia, a six day old in Salem, OR, and a three month old and Cincinatti, OH. CPSC advises consumers to immediately stop using these slings for infants younger than four months of age due to a risk of suffocation and contact Infantino for a free replacement product. 
The affected sling models are the “SlingRider” and the “Wendy Bellissimo.” Infantino LLC sold the slings in the United States from January 2003 through March 2010 at Walmart, Burlington Coat Factory, Target, Babies “R” Us, BJ’s Wholesale, various baby and children’s stores and other retailers nationwide, and on Amazon.com, for between $25 and $30. The slings were manufactured in China and Thailand. Consumers should contact Infantino to receive a free replacement product.
CPCS has also released a general warning about sling carriers for babies as they pose two risks of suffocation. The sling’s fabric can press against an infant’s nose and mouth, blocking the baby’s breathing. Additionally, where a sling keeps the infant in a curled position bending the chin toward the chest, the airways can be restricted. CPCS is working with concerned companies to develop safety standards for baby slings.
For information on obtaining a free replacement product, visit www.infantino.com.
To report an incident involving a recalled product, file an incident report at https://www.cpsc.gov/cgibin/incident.aspx.
For more information on the CPCS warning, see the CPCS website. For more information on this specific recall, see this press release. Read More
Children’s Sweatshirts and Jackets Recalled due to Strangulation Risk–Massachusetts Parents Take Warning
Four companies are voluntarily recalling children’s hooded sweatshirts and jackets due to the danger of children suffering personal injuries or death. The recalled garments all have drawstrings through the hoods that pose a strangulation hazard for children. All four companies are cooperating with the US Consumer Product Safety Commission (CPSC). Baycreek Inc. of New York, NY is recalling 1,900 hooded sweatshirts. Weeplay Kids LLC of New York, NY is recalling 11,800 hooded sweatshirts. Bobens Trading Co., Inc. of Hicksville, NY is recalling 3,900 hooded sweatshirts and Franshaw, Inc. of New York, NY is recalling 2,400 hooded jackets; both companies’ recalled garments are sold exclusively at Burlington Coat Factory. No injuries or incidents have yet been reported.
To eliminate the risk of danger, parents should either remove the drawstring from the hood, or return the garment to the place of purchase or the manufacturer for a full refund. The CPSC issued guidelines in 1996 for children’s upper outerwear and the industry voluntarily incorporated these standards in 1997. The guidelines provide additional information and advice on how to eliminate the risk of strangulation from hooded outerwear.
To report an incident involving one of these garments, or a similar garment, file a consumer product incident report with CPSC.
For more information on the Weeplay Kids recall, see http://www.cpsc.gov/cpscpub/prerel/prhtml10/10142.html
For more information on the Baycreek recall, see http://www.cpsc.gov/cpscpub/prerel/prhtml10/10144.html
For more information on the Bobens Trading Co recall, see http://www.cpsc.gov/cpscpub/prerel/prhtml10/10140.html
For more information on the Franshaw recall, see http://www.cpsc.gov/cpscpub/prerel/prhtml10/10143.html
AstraZeneca Facing Over 25,000 Lawsuits–Antipsychotic Drug Claimed to Cause Diabetes
AstraZeneca is preparing for a products liability trial next week over claims that their antipsychotic medication Seroquel causes diabetes. About 26,000 lawsuits have been filed against the drugmaker, with one of many trials set for February 16th in New Jersey. That trial will be the first of thousands filed in New Jersey alone. Seroquel is the UK-based drugmaker’s second most popular drug after Nexium, the well known heartburn relief medication, and is used to treat bipolar disorder and depression. AstraZeneca claims that the plaintiffs’ evidence is insufficient to show that the drug was responsible for their alleged personal injuries.
In January, U.S. District Judge Anne Conway, who is overseeing all federal Seroquel litigation, ordered the parties to attend mediation. The parties were unable to reach a settlement agreement after two days of talks. The mediator, George Washington University Law Professor Stephen Saltzberg, said he expects further settlement negotiations to occur. Judge Conway, who sits in Florida, has said that she will ask a panel of judges to return the 6,000 consolidated cases scheduled to come before her to their resident states, adding to the litigation headache.
Seroquel was introduced in 1997 and has long been linked to weight gain and diabetes. The plaintiffs are claiming that AstraZeneca downplayed the risk of diabetes, cherry-picked positive trial results, and buried negative results. Documents discovered in 2009 appear to substantiate the plaintiffs’ claims. As early as 1997, emails between AstraZeneca officials reveal that the drugmaker hid negative trial results from US and Canadian investigators. AstraZeneca is not the first antipsychotic drugmaker to be hit with claims that its medication causes diabetes. In 2009, Zyprexra-maker Eli Lilly agreed to pay at least $1.2 billion to similar settle lawsuits filed by about 31,000 patients.
For more information on Seroquel side effects, see the Seroquel website. The Alliance for Human Research Protection has a collection of articles on the Seroquel product liability litigation.
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