As many as 34 million cars and 10 automakers are affected by the massive recall of airbags manufactured by the Takata Corporation. Most of the airbags were installed in automobiles sold in 2002 through 2008; however, in some instances the recall has been expanded to include 2014 models. The problem is related to a chemical that causes the airbag to inflate with explosive force, sending shrapnel into the passenger compartment. The root cause of the defect is still not thoroughly understood and remains under investigation. The faulty airbags are linked to at least 6 deaths and over 100 injuries.
It may be several weeks before a complete list of vehicles affected by the recall is available. According to recent reports, this could be the largest auto recall in U.S. history. For more details about the recall and an up-to-date list of the autos covered go to safercar.gov. To determine if your car or truck is covered by the recall enter the vehicle Identification Number (VIN) at: https://vinrcl.safercar.gov/vin/
Assuming the FDA adopts the advice of the panel, the drug companies will be forced to severely alter marketing strategies and the number of men prescribed these drugs will be significantly reduced. The recommendations might also impact insurance coverage of testosterone prescriptions.
On June 19, 2014 the FDA announced that labels for these drugs are now required to include warnings pertaining to the risk of blood clots.
Questions remain concerning the long-term risks of testosterone and prior studies have linked the medication to increased rates of heart disease. The same panel voted 20 – 1 for the FDA to require further studies be conducted related to cardiovascular risk and testosterone use. On Thursday, September 18th, the panel voted 18 – 3 against the approval of the oral testosterone drug Rextoro; the panel concluded that the risk-benefit ratio fails to support FDA approval.
GM has establish a Voluntary Compensation Fund for victims of the defective ignition switch in GM vehicles. The program is intended to cover victims killed or seriously injured when the airbag failed to deploy because a defect in the ignition switch causes the vehicle to stall, disabling air bags.
The program was launched on August 5, 2014. According to a report from Kenneth Feinberg, the administrator of the fund, 21 deaths and 16 claims of serious injures have been determined eligible for compensation from the fund. As of Friday, September 19th, 143 death claims have been received. A recent article from Reuters disclosed that $400 million has been set aside by GM to cover compensation costs for the victims of the recalled ignition switch.
Based on Feinberg’s announcement outlining the details of the compensation fund, the deadline for submitting claims is December 31, 2014. The full text of the announcement is available at www.GMIgnitionCompensation.com
For more information about the ignition defect and the vehicles covered by the recall see the GM Ignition Recall Safety Information website and the NHTSA Consumer Alert.
On October 3, 2013, the U.S. Consumer Product Safety Commission (CPCS) announce the recall of Schneider Electric APC Surge Protectors stating that the product “can overheat, smoke and melt, posing fire hazard.” According to the recall notice, the company received 700 reports of the surge protectors overheating and melting and 55 claims of property damage caused by smoke and fire. One incident reported $916,000 in fire damage to a home; another report claimed there was $750,000 in fire damage to a medical facility. They received 13 reports of injuries, including smoke inhalation and burns.
The recall notice applies to APC 7 & 8 series SurgeArrest surge protectors manufactured before 2003. They were produced by American Power Conversion (APC), now Schneider Electric, of West Kingston, RI and sold at Best Buy, Circuit City, Comp USA and other stores nationwide from January 1993 through December 2002. See the CPSC website for a complete list of serial numbers included in the recall.
Consumers are advised to stop using the surge protectors immediately and contact Schneider Electric for a free replacement.
Consumer Contact: Schneider Electric IT Corp., 1-888-437-4007 or http://recall.apc.com
On September 23, 2013 the FDA published the W.S. Badger Company’s voluntary recall of all lots of 4-ounce SPF 30 baby sunscreen lotion and one lot of its 4-ounce SPF kids sunscreen lotion after tests revealed microbial contamination. The products were discovered to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungus. Badger is a New Hampshire based company that has been manufacturing natural and organic body care products since 1995. As many a 30,000 tubes of the recalled sunscreen has been sold in the U.S. and Canada. It is the Number one selling all natural sunscreen in the U.S.
Although there have been no reports of adverse reactions to the sunscreen, possible risks associated with the contaminants include the following:
Pseudomonas bacteria: can cause skin rash and ear infections and is especially threatening to people with weakened immune systems. Severe illness can develop if the bacteria enters the bloodstream.
Candida parapsilosis: a fungus that can cause mild skin infection and severe infection if it enters the bloodstream.
Acremonium fungican: can lead to infection if it enters the bloodstream through broken or injured skin.
The company founder and chief executive, Bill Whyte, stated that the sunscreens passed all pre-sale tests but routine re-testing revealed that “several lots had been compromised.” Consumers are being advised to return the products to the original place of purchase for complete refund or contact Badger directly at 1-800-603-6100 or email@example.com.
See the FDA website to view the recall announcement, the complete list of lot numbers affected by the recall, and information on where to report adverse events related to the sunscreen products.
Approved in 2005, Byetta is an injectable medication used to help lower blood sugar levels of people suffering from Type 2 Diabetes. In 2007 the FDA issued a public warning that there were concerns over a possible link between pancreatitis, a condition associated with the development of pancreatic cancer, and the use of Byetta and other incretin mimetic drugs. A 2011 study from UCLA suggested that Byetta might increase the risk of developing pancreatic cancer and thyroid cancer. According to a report published by The Institute for Safe Medication Practices, 612 of the 1,069 cases of pancreatitis, pancreatic cancer, thyroid cancer or hypersensitivity reaction reported to the FDA in 2012 were linked to Byetta.
These concerns escalated in March of 2013 when a study suggested a connection between the use of Byetta and the development of a precancerous condition called pancreatic duct metaplasia. Although the FDA as yet to confirm that patients taking incretin mimetics such as Byetta are in fact at risk of this disease, research on this concern is ongoing. Both the FDA and the American Diabetes Association have requested more testing of drugs like Byetta to determine additional risks. A recent report in the British Medical Journal suggests that risks associated with incretin memtics have been minimized by drug manufacturers.
Over 60 lawsuits involving the use of Byetta and other incretin mimetic drugs such as Januvia and Victoza are underway in U.S. District Court, Southern District of California. On August 26, 2013 the Judicial Panel on Multidistrict Litigation consolidated these cases (Incretins Products Liability, Sales and Marketing Litigation, MDL 252, United States Judicial Panel on Multidistrict Litigation). The first trial conference is scheduled for October 17, 2013.
Gree Electric Appliances of China issued a recall of 12 Brands of dehumidifiers after receiving 165 reports from consumers, including 46 reports of fires and over $2 million in property damage. According to the September 12, 2013 recall announcement, there is danger of the dehumidifiers overheating and catching on fire. The Consumer Product Safety Commission (CPSC) issued a warning advising consumers to stop using the products immediately.
The brand names covered by the recall include: Danby, De’Longhi, Fedders, Fellini, Frigidaire, Gree, Kenmore, Norpole, Premiere, Seabreeze, SoleusAir and SuperClima. The dehumidifiers sold for $110 – $400, and were available in stores from 2005 to 2013. They were purchased from Home Depot, Lowe’s, Sam’s Club, Kmart, Menards, Sears and other stores in the U.S. and Canada. They were also available online from Amazon.
The complete list of brand names and model numbers covered by the recall, as well refund information, is available on the CPCS website.
To receive a refund consumers should contact Gree Electric at 866-853-22802 or online at www.greeusa.com.
The Consumer Product Safety Commission (CPSC) has announced recalls of the following children’s products:
1. As of May 29, 2013, Children’s Water Bottles sold by H&M have been recalled due to the risk of the spout breaking off and posing a choking hazard. Although there have been no reports of injuries, H&M received one report from a consumer stating that the spout broke off in a child’s mouth.
Consumers should stop using the water bottles immediately and contact H&M (855-466-7467 or http://www.hm.com) to receive a postage paid return mailer along with a complete refund and $25 gift certificate. The water bottles were sold exclusively at H&M stores from July 2012 through March 2013.
2. Pottery Barn Sweet Lambie Crib Bumbers have been recalled due to reports of the decorative stitching becoming loose and children getting entangled in the threads. The company has received two reports of children getting entangled in the stitching, including one incident where the threads became wrapped around an infant’s neck. The recall covers bumpers manufactured from April 2009 to July 2012, model numbers 708859, 708917 0r 7988348.
Customers are advised to stop using crib bumpers with the above model numbers and dates and contact Pottery Barn Kids for instructions on how to receive a complete refund or a replacement crib bumper. Contact Information: toll-free at (855) 323-5138, or online at www.potterybarnkids.com, click on Safety Recalls.
Visit the CPSC webpage for more information pertaining to these and other consumer product recalls.
McNeil Consumer Healthcare, together with the U.S. Food & Drug Association, has implemented the voluntary recall of infant and children’s liquid Tylenol, Motrin, Zyrtec and Benadryl due to concerns over manufacturing deficiencies. According to the announcement published on the FDA website, some of the products might a have higher concentration of the active ingredient than is specified on the label; others might contain inactive ingredients that have not satisfied testing requirements; and others possibly contain small particles that could be harmful to infants and children.
Although the likelihood of serious medical problems is believed to be remote, the FDA is advising consumers to discontinue using the above products. Consumers are being asked to report any adverse reactions to these products to: FDA’s MedWatch Program by fax 1-800-FDA-0178, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
In 2008 a New Hampshire federal jury awarded Karen Bartlett $21 million for injuries she sustained after using a medication called sulindac. She was prescribed Clinoril for shoulder pain and received the generic version — sulindac. The drug was directly responsible for Bartlett developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), conditions that led to severe skin deterioration. Bartlett eventually suffered additional permanent injuries, including near-blindness, lung damage and burns in her esophagus.
The jury award relied on a New Hampshire products liability law allowing for damages based on defective design. The defendant in the case, Mutual Pharmaceutical Company, appealed to the U.S. Court of Appeals for the 1st Circuit arguing that the federal law regulating generic drugs preempts state design-defect laws. The 1st Circuit upheld the lower court decision and Mutual Pharmaceutical then appealed to the U.S. Supreme Court. The Supreme Court agreed to hear the case and oral arguments were held on March 19, 2013.
Mutual Pharmaceutical claims no liability since they are required, pursuant to the Food & Drug Cosmetic Act (FDCA) to use the same ingredients and warning labels as those used by the original manufacturer. In other words, they claim they are legally required to keep a generic drug identical to the brand name drug. Brand name manufactures maintain that they are not responsible for injuries caused by drugs that were not purchased from them.
Ultimately, this case well help clarify how federal law applies to generic pharmaceutical companies as well as determine the extent to which state product liability laws pertain to the generic drug industry.
For a thorough analysis of the legal issues involved in this case see Cornell’s Legal Information Institute.