Products Liability
Toyota Recalls Lexus Models: What to Do if You’re a Lexus Owner
Toyota recalled 270,000 Lexus and Crown vehicles sold around the world this week due to possible contamination during valve spring manufacturing. The company has now recalled more than 8.5 million vehicles for sticking gas pedals, anti-lock brake software glitches and a host of other safety problems.
Massachusetts Lexus owners impacted by the motor vehicle recall will receive official notice from Toyota by first-class mail. Owners will be asked to contact their local Lexus dealer to have the engine’s valve spring replaced at no charge.
Toyota said a foreign substance involved in manufacturing may have contaminated a small number of the valves. If a vehicle is defective, drivers may notice idling or abnormal engine noise. The engine could also stop while the vehicle is in operation.
Of the 270,000 recalled vehicles, 138,000 were sold in the United States, 91,903 in Japan, 15,000 in Europe, 10,000 in the Middle East, 6,000 in China and 4,000 in Canada.
The vehicles were sold between July 2005 and August 2008. They include Lexus models GS350, GS450h, GS460, IS350, LS460, LS600h, LS600hl and Crown models.
This Lexus recall comes just days after Toyota recalled another Lexus model – the Lexus HS250h – because it spilled too much gasoline during crash tests. The tests were part of yearly safety reviews by the National Highway Traffic Safety Administration (NHTSA).
In May, Toyota paid a record $16.4 million fine in the United States for responding too slowly when motor vehicle safety problems emerged. The fine was the largest civil penalty ever assessed against an auto maker by the NHTSA.
The NHTSA has linked 89 motor vehicle deaths and 57 injuries over the last decade to Toyota accelerator problems. Overall, it has received more than 6,200 complaints involving unintended acceleration in Toyota’s cars.
Toyota faces more than 200 lawsuits in the United States. The cases involve defective automobiles, lower resale value of Toyota vehicles and stock price declines. The lawsuits, including 130 class-action lawsuits, are being heard in Southern California, near Toyota’s Torrance headquarters.
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Product Safety Alert: Maytag Recalls 1.7 Million Dishwashers
Maytag Corp. has recalled 1.7 million dishwashers across the United States, citing an electrical failure.The company, which is owned by Whirlpool Corp., issued the recall last week after 12 reports of electrical problems which pose a fire hazard.
Maytag recalled its Maytag, Amana, Jenn-Air, Admiral, Magic Chef, Performa by Maytag and Crosley brand dishwashers with plastic tubs and certain serial numbers. The Consumer Product Safety Commission (CPSC) and Maytag officials say the electrical failures caused by the defective products have caused property damage.
“Product safety is a major concern here because we use our dishwashers daily,” said Boston product liability lawyer Marc L. Breakstone. “We advise consumers to immediately stop using the dishwashers and to have them repaired or to replace them as soon as possible.”
The 12 electrical failure reports included one case of extensive kitchen damage. No injuries have been reported in Massachusetts or other states.
The CPSC advised consumers to immediately stop using the recalled dishwashers and disconnect the electrical supply by shutting off the circuit breaker or pulling the fuse.
Consumers can obtain free in-home repair of the recalled Maytag dishwashers or a $150 to $250 rebate toward a new model. The Maytag dishwasher recall impacts models priced $250 to $900.
If you suspect your dishwasher’s involved in the product safety recall, click here for the full list of serial numbers and for how to obtain a refund or repair.
Parents Advised to Check Medicine After Children Tylenol Recall
Parents are advised to stop using 43 popular over-the-counter medications for children following a widespread product safety recall involving liquid Tylenol, Motrin and Benadryl.
McNeil Consumer Healthcare, a division of Johnson & Johnson, voluntarily recalled the medications last Friday after the Food & Drug Administration (FDA) uncovered manufacturing deficiencies at the company’s plant in Fort Washington, Pennsylvania.
The product safety recall impacts consumers in Massachusetts, the rest of the United States, U.S. territories and nine other countries.
“While Tylenol has historically been a safe and effective product for children, parents are urged to use particular caution in giving it to their children at this time based upon the information received from the FDA,” Boston attorney Ronald Gluck said.
McNeil said some of the recalled products may contain a higher concentration of the active ingredient than is specified while others may contain inactive ingredients that do not meet internal testing requirements. Other medications may contain tiny particles.
The FDA advised parents to discontinue use of the recalled medications, although said it was unaware of any reports of illness. A spokesman for McNeil told The New York Times this weekend the company had received consumer complaints involving some of the recalled medications, but the recall was not issued on “the basis of adverse medical events.”
McNeil has suspended production at the facility while the FDA investigates.
The recalled medicines include various flavors of liquid Tylenol, Motrin and Benadryl for children and infants. Several types of children’s Zyrtec were also recalled.
The FDA advised parents to ask their pharmacists for alternative medicine options and cautioned them against giving adult versions of medications to children. Consumers with the recalled medications can also obtain a refund or coupon from the McNeil Product Recall website.
Read the full McNeil Product Recall list here.
McNeil has been involved with three major Tylenol recalls since 2008. In January, the company removed 51 types of Tylenol from the shelves after consumer complaints about vomiting, diarrhea and other symptoms. All but two of the recalled medications were for adults.The company said some of the medications had been contaminated by trace amounts of a chemical sometimes used for shipping and storage.
In 2008, McNeil recalled 21 types of children’s and infants’ Tylenol liquid products, saying an active ingredient did not meet all quality standards.
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Defective Product Leads to Proposed Plea Deal in the Largest Criminal Penalty Ever Assessed Against a Medical Device Company
Guidant LLC, a division of Massachusetts’ company Boston Scientific, has plead guilty to two misdemeanor counts alleging the medical device maker failed to disclose product changes involving over 20,000 implantable heart monitor devices.
The medical device manufacturer plead guilty Monday, April 5 and will learn over the next few weeks whether U.S. District Judge Donovan Frank will accept a proposed $296 million plea deal – the largest criminal assessment ever proposed against a medical device company.
The Department of Justice accuses Guidant of changing the design of its implantable cardioverter defribrillators, or ICDs, and failing to notify the Food and Drug Administration (FDA) of subsequent problems that lead to a Class 1 medical recall – the most serious category which indicate a defective product has the potential to cause serious personal injury or wrongful death.
Guidant’s implantable cardioverter defribrillators, Ventak Prizm 2 DR and Contak Renewal 1 and 2, were designed to monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating properly. But Department of Justice officials say Guidant discovered as early as 2002 that Ventak had the potential to suffer an electric arc, which could short-circuit the device. Although problems continued with the defribrillator, Guidant didn’t issue a warning until 2005. In at least seven cases, the devices failed to issue a lifesaving shock and the patient died.
In 2005, Guidant sent a product update to doctors, advising that a yellow warning screen indicated a potentially serious problem. However, the FDA says the company should have sent a product correction, rather than a product update, since the change reduced the risk of serious injury, and should have notified the FDA of the change within 10 days. Guidant ultimately recalled its three devices in 2005.
Attorneys for the affected patients are now urging the court to reject the plea deal because it will not provide restitution payments to victims. The government prosecutor has argued that the victims have other remedies for compensation and that the applicable law does not require restitution. The prosecutor points to the fact that most of the victims have settled civil suits with the company and the company has paid out over $650 million in settlement and warranty payments. Additionally, $42 million of the plea amount is forfeited funds and victims can petition the Justice Department for their share.
For more information on the plea deal, see this Boston Globe article and this Star Tribune article.
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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Toyota’s Headaches Continue–Massachusetts Prius Owners Should Be Aware of Defective Brakes
Toyota faced another round of bad news this week with the announcement today of a probe by the National Highway Traffic Safety Administration (NHTSA) into braking problems in the popular Prius hybrid model. NHTSA has received at least 124 complaints about momentary braking problems in the defective vehicles. As least four car crashes have been reported. The problems are apparently associated with speed bumps, potholes, and icy roads–three things Massachusetts drivers see plenty of. The investigation concerns the 2010 Prius model year.
The Prius investigation is the third in a string of product defect recalls which are tarnishing Toyota’s reputation for safety and reliability. On top of that, it seems that Toyota has been less than forthright about the problems in its cars. According to CNN (February 4, 1010), “Toyota has known about brake problems in its popular Prius cars for some time, going so far as to fix it in new production vehicles, but has kept Prius drivers in the dark about the problem until the Japanese government called for an investigation.” And the sticking gas pedal was first blamed on floor mats, and then later extended to the mechanics of the pedal itself. The Federal government has now demanded that Toyota demonstrate that the problem isn’t more serious, and that it does not include other parts of the throttle control systems. Defects relating to the gas pedals have been linked to several wrongful deaths.
U.S. Transportation Secretary Roy LaHood set off a brief panic on February 3rd when he said owners of the defective Toyotas should “stop driving them.” He later clarified his statement, saying instead that owners should have them repaired as quickly as possible.
NHTSA itself has been criticized for its slow response to consumer complaints about Toyota acceleration problems, some of which date back to 2003. According to Joan Claybrook, a former head of NHTSA, several investigations were opened, then closed based upon information provided by Toyota. According to NPR, she said, “I think as a result, some people have been killed and injured that wouldn’t have otherwise.” (NPR, Feb 4, 2010.)
Consumer Alert
This week Toyota finally began shipping replacement parts to dealers for the gas pedal recall. Checks with some dealers in Massachusetts revealed that free rental vehicles are available. If the dealer does not have the part, it should still provide you with a free car should you choose to leave it at the dealer for repair. Many Massachusetts consumers are rightfully fearful that their car could be involved in a motor vehicle accident.
The same courtesy should apply to the defective Prius models, and consumers should feel free to demand that the dealer provide them with a safe, alternative vehicle until their cars are fixed.
Affected Vehicles
Models affected by the recall include:
- 2009-2010 RAV4
- 2009-2010 Corolla
- 2007-2010 Camry
- 2009-2010 Matrix
- 2005-2010 Avalon
- 2010 Highlander
- 2007-2010 Tundra
- 2008-2010 Sequoia
Please see our earlier blog on Toyota recalls for additional safety information.
More Information
Much additional information on the Toyota recall is available from the NHTSA website, www.nhtsa.gov.
Answers to Questions About Toyota Repair Plans, NY Times, Feb 1, 2010
US Launches Probe of Prius Brakes, Reuters, Feb 4, 2010
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Massachusetts Consumers: Take Care in the Deli Department–Rhode Island Company Recalls Salami Products Due to Salmonella Risk
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced that Daniele International, with operations in Rhode Island, has recalled 1,240,000 lbs of ready-to-eat Italian sausage products currently in commerce due to risk of salmonella contamination. The recalled products include salami coated with black pepper.
The recall is the result of a multi-agency investigation into a salmonella breakout in several states. While searching for the defective food agent causing the outbreak, FSIS discovered a strain of salmonella in a Daniele International sample product. The tested product is similar to what people reported eating prior to becoming ill, but a direct link has not been established.
The strain of salmonella found in the tested product does not match the strain being investigated. In addition to recalling the ready-to-eat products, Daniele International presented information to FSIS and voluntarily recalled all products in commerce associated with black pepper, which the company believes is a possible source of contamination.
Eating products contaminated with salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The symptoms of salmonellosis include diarrhea, abdominable cramps, and fever within 8 to 72 hours of comsumption. Additional symptoms may be chills, headache, nausea, and vomiting for up to a week. Salmonella infections can be life-threatening to those with weak immune systems, such as infants, the elderly, and persons with HIV infection or undergoing chemotherapy.
The specific products recalled all carry a USDA mark of inspection bearing establishment numbers “EST. 9992” or “EST. 54.”. The following products can be returned to the retailer for a full refund:
For more information on the on-going investigation into the multi-state salmonella investigation, see the Center for Disease Control’s website. For a list of retailers that sold recalled products, see the FSIS recall website. Consumers with questions about food safety can ask a virtual FSIS representative on the Ask Karen website. Live chat services are available Monday through Friday, 10:00 a.m. – 4:00 p.m. Eastern Time (except Federal Holidays).