Consumer Protection
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.
Consumer Safety Alert: 1.8 Million Plastic Toys Recalled from Family Dollar Stores
The U.S. Consumer Product Safety Commission (CPSC) has announced the voluntary recall of 1.8 million toy dart gun sets sold at Family Dollar Stores after they were involved in the asphyxiation deaths of two young boys.
The CPSC issued the recall in cooperation with the Charlotte, North Carolina discount store. The importer, Henry Gordy International, Inc., of Plainfield, N.J. refused to recall the soft, plastic toy, which poses a risk if a child places it in his mouth. The defective toy can be inhaled into the throat and prevent a child from breathing. The toy was sold exclusively through Family Dollar Stores from September 2005 through January 2009 for about $1.50.
“Parents should take these toys out of their child’s hands immediately,” said Massachusetts personal injury attorney David W. White of Breakstone, White & Gluck in Boston. “Given the size of this recall, you really want to take a minute to look through your toy bin if you do any shopping at the Family Dollar Stores.”
A 9-year-old boy in Chicago, Illinois and a 10-year-old boy in Milwaukee, Wisconsin suffered asphyxiation deaths while playing with the toy, which was manufactured in China. No Massachusetts consumer safety problems have been announced.
Consumers should discard the toys or return them to a Family Dollar store for a full refund. For additional information, contact Family Dollar at (800) 547-0359 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s website at www.familydollar.com.
For more information, read the U.S. Consumer Product Safety Commission’s recall. announcement.
Lettuce Recall Affects 23 States, Including Massachusetts
Another recent recall of fresh produce highlights the importance of safe food handling and rinsing even pre-washed produce. Freshway Foods of Ohio has announced a voluntary recall of romaine lettuce after reports of food borne illnesses from possible E.coli contamination. The New York State Public Health Laboratory found E.coli 0145 in an unopened recalled bag of shredded romaine. Products affected include bags of shredded romaine lettuce with “best if used by” dates prior to May 12; bags with “best if used by” dates of after May 12 are not affected. Freshway Foods sold the recalled products to wholesalers, food service outlets and some in-store deli and salad bars in Alabama, Connecticut, Washington DC, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia, and Wisconsin. Although these products are now off the shelves, consumers should make sure they throw away any remaining products in their homes.
Nineteen cases of illness resulting from E.coli 0145 have been reported from Michigan, New York, and Ohio; twelve of these cases required hospitalization. Symptoms of foodborne illness caused by E.coli can range from nothing to acute stomach cramps and diarrhea to kidney damage. Three of the reported cases involved a life threatening complication called hemolytic uremic syndrome which causes blocked circulation or bleeding in the brain or kidneys. People experiencing a diarrheal illness with high fever, bloody stool, prolonged vomiting that could cause dehydration, symptoms of dehydration, or if the diarrheal illness lasts longer than three days should seek medical attention.
How to Protect Yourself
Consumers can protect themselves from foodborne illness by taking simple precautions. Cook meat and eggs thoroughly, using an internal thermometer. Avoid cross contamination by keeping raw meat and eggs away from vegetables and cooked foods and washing all surfaces that come into contact with raw products thoroughly. Chill leftovers promptly if they are not going to be eaten within four hours. Handle produce with clean hands and always rinse produce, even produce that has been pre-washed, and remove the outer leaves of lettuce and cabbage. Finally, report incidents of foodborne illness to your local health department.
For more information on this specific recall, read this article on Time.com. For more information about foodborne illnesses in general, see the CDC web pages on food safety. For more information on E.coli specifically, see the CDC’s web page on E.coli.
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
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
Read More
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).
Huge Toyota Recall Affects Thousands of Massachusetts Drivers–Defective Gas Pedals May Cause Runaway Acceleration
Toyota has issued another recall affecting millions of its popular vehicles due to acceleration problems caused by sticking gas pedals which are known to have caused serious personal injury and several deaths. In addition, Toyota has halted sales and will halt production of several product lines until it designs a fix for the product defect. This recall seriously affects Toyota’s reputation for safety and reliability. It also affects tens of thousands of Massachusetts drivers who own the defective Toyotas. It also affects others on the highway who may be struck by a runaway vehicle.
Toyota announced the voluntary recall last Thursday, which includes about 2.3 million vehicles, “to correct sticking accelerator pedals on specific Toyota Division models.” The sticking pedals may fail to return, or return slowly, to the idle position, causing the cars to accelerate or maintain a high speed unexpectedly.
The recall comes after a recall on floor mats in September 2009 affecting 3.8 million vehicles. That recall was found to be insufficient to solve the accelerator problems. Investigators realized the product defect included more than just the floor mats after a family of four suffered wrongful deaths when their Avalon crashed into a lake. The floor mats were discovered in the trunk of that car.
In November 2009, the National Highway Traffic Safety Administration (NHTSA) called the removal of the offending floor mats an interim measure only, and said, “This remedy does not correct the underlying defect in the vehicles involving the potential for entrapment of the accelerator by floor mats, which is related to accelerator and floor pan design.”
Unfortunately, Toyota has not yet proposed a plan to fix its millions of defective vehicles.
Massachusetts consumers who experience gas pedal problems are advised to apply firm pressure to the brake, and to pull off the road as soon as that can be done safely. The car should not be driven. In an emergency, the car can be put into neutral or the key turned to off. Push-button start controls can be turned off if the button is depressed for several seconds.
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.
Toyota customers affected by this recall should call the Toyota “Customer Experience Center” at 1-800-331-4331 with questions or concerns.