Products Liability
Defective Blind Xpress Window Blinds Recalled
The case of a young Michigan girl strangled to death in a vertical blind has prompted the recall of about 139,000 custom-made vertical window blinds and 315,000 horizontal products.
The Consumer Product Safety Commission (CPSC), in cooperation with Blind Xpress of Livonia, Michigan, announced the recall on September 6. The two-year-old girl from Commerce Township was reportedly strangled in the hanging loop of a Blind Xpress vertical blind cord in 2009.
The CPSC is recalling the defective window blinds because the design makes it easy for children to become entangled in the cord loop. Part of the problem is the custom vertical blind cords do not have a cord-tensioning device that attaches to the wall or floor. The horizontal blinds do not have inner cord stop devices.
The recall involves Blind Xpress blinds sold in specialty stores in Michigan, Ohio and Indiana from January 1995 through December 2011. The defective blinds were manufactured in the United States.
The CPSC urges consumers to immediately stop using the window blinds and contact the Window Covering Safety Council for a free repair kit. The toll-free number is 800-506-4636.
According to CPSC data, were 147 incidents involving children being injured or killed from 2004 to 2010 – or 21 per year.
The CPSC, industry and safety groups have made several efforts over the past couple decades, including recall/retrofit programs. The major push came in 2009, when after the death of 16 children, the industry recalled 55 million Roman Shades with exposed inner cords on the back of the shades.
The Parents for Windows Blind Safety, a non-profit organization which advocates for more stringent regulations, says the hazard lies with cords which stretch more than 7 1/4 inches. It proposes the window blind industry sell cordless blinds or those with inaccessible cords.
Related:
- Death of Child Prompts Recall of Window Blinds by Blind Xpress, Consumer Product Safety Commission.
- The History of Corded Window Covering Recalls, Parents for Window Blind Safety.
DePuy Hip Implant Cases Settled for $600,000
Johnson & Johnson has agreed to pay about $600,000 to resolve three product liability cases involving its DePuy hip implants, which were recalled in 2010 after hundreds of patient complaints and a study emerged revealing a substantial device failure rate.
The New Jersey-based company settled the cases of three women who had filed claims in a Las Vegas court. All three women had required a second hip revision surgery to treat and correct their pain. Each will receive about $200,000. The cases had been scheduled for trial Dec. 3.
The next three lawsuits involving defective DePuy hip implants are set for January in a Maryland state court.
In August 2010, Johnson & Johnson’s DePuy unit recalled 93,000 of its ASR hip implants globally and 37,000 in the United States. The recall was announced alongside results of a study from a UK joint replacement registry, which showed 12 percent of patients required a second revision surgery within five years. The Food and Drug Administration (FDA) also reported it had received about 400 complaints from patients in the two years prior.
Since the DePuy hip recall, more than 8,000 patients across the country have filed lawsuits against the medical device maker, alleging the ASR hips are defective. About 6,000 of these have filed in federal court.
Patients claim the DePuy metal-on-metal hip implants are defective, saying they caused friction between the metallic ball and socket components. The recalled DePuy hip implant can wear down and produce metallic particles in patients’ bloodstreams, along with pain, joint dislocations, infections and bone fractures.
Johnson & Johnson said it has spent about $800 million on the hip implant recall.
Related:
- J&J said to pay $600,000 to settle first suits over hips, Bloomberg Business Week.
- DePuy hip implant recall leads insurers to seek recovery, Massachusetts Injury Lawyer Blog.
Defective Drug Warning: Reumofan Diet Supplements
Those who take so-called “natural dietary supplements” want to listen to the Food and Drug Administration’s (FDA) latest alert on Reumofan Plus and Reumofan Plus Premium, which have now been linked to cases of death and stroke.
“Consumers who are currently taking Reumofan Plus or Reumofan Plus Premium, or who have recently stopped taking it, should immediately consult a health care professional,” said Elizabeth Miller, Pharm.D., acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud.
The FDA issued its first alert on the dangers of Reumofan Plus on June 1, stating the drug had several active pharmaceutical ingredients not listed on the label. This week, the agency issued an updated alert for both the drug and Reumofan Plus Premium, saying it had since received reports of death, stroke and these symptoms:
- Severe bleeding in the gastrointestinal tract
- Dizziness
- Insomnia
- High blood sugar levels
- Problems with liver and kidney functions
- Corticosteroid withdrawal syndrome
These defective products are marketed as natural dietary supplements which treat arthritis, muscle pain, osteoporosis and bone cancer. If not properly supervised by a medical professional, those who stop taking the supplements can face serious withdrawal symptoms.
The defective drugs may contain corticosteroids and abrupt discontinuation can supress the adrenal glands, which regulate a number of hormone and body functions. Users could experience fatigue, low blood sugar levels, fainting and other symptoms.
The Reumofan products are manufactured in Mexico by Riger Naturals and sold on the Internet, flea markets and some retail outlets. The Mexican Ministry of Health has also issued a health warning to its citizens and ordered Riger Naturals to recall the products.
FDA testing of Reumofan Plus and Reumofan Plus Premium show they contain two ingredients which require prescriptions: diclofenac sodium and methocarbamol. Reumofan Plus also contained dexamethason, a type of corticosteroid.
The FDA offers consumers these tips for avoiding defective and dangerous drugs:
- Be wary of off-the-counter products which only have prescription counterparts.
- Be cautious when a label has a foreign language.
- Be aware that so-called “natural dietary supplements” are not subject to the same FDA pre-market review as prescription drugs and some over-the-counter drugs.
Related:
- Reumofan Products Pose Risk to Consumers, Food and Drug Administration.
- Dietary Supplements, Food and Drug Administration.
Recalled Heart Device and Similar Model Under FDA Watch
The Food and Drug Administration (FDA) has ordered St. Jude’s Medical to expand studies into Durata defibrillator leads, saying the heart devices are sufficiently similar to Riata leads, which were recalled last year. The agency is also seeking new data on Riata.
Defibrillators are implanted in patients with abnormal heart rhythms to regulate the heart beat. The medical devices are connected to the heart with leads. Riata was recalled because in some cases, wires were breaking through the insulation, which can potentially lead to a life-threatening abnormal heart rhythm.
A recent St. Jude study of 700 Riata patients found the defective wire broke through the insulation in about 19 percent of cases. A study led by a Minneapolis Heart Institute cardiologist has linked Riata leads to 20 deaths.
St. Jude, of St. Paul, Minnesota, pulled the defective Riata leads off the market in December 2010 and the FDA issued a medical device recall in late 2011. A 2011 count found 79,000 patients were still implanted with the Riata leads.
Responding to the FDA order, St. Jude said it is already collecting data on both Riata and Durata. The company stated the medical devices are different in design and a new coating meant to protect the insulation.
The FDA’s orders include routine X-rays for patients enrolled in post-market Durata studies to identify any insulation problems. St. Jude must also perform X-rays in a three-year post-market study on the defective Riata leads. The goal is to detect extruded leads which are floating loose in the heart.
Surgery to remove extruded leads can be dangerous. St. Jude says many patients live with the loose wires and continue to function normally. The FDA has advised doctors to closely monitor patients.
Related:
- FDA Orders Review of Heart Devices, The Wall Street Journal.
- Riata patients should get X-rays, FDA says, Star Tribune.
- Doctors grapple with FDA advice for troubled heart wire, Fox News.com.
Defective Dehumidifiers Recalled by Sears and Kmart
Sears, Roebuck and Co. and Kmart Corp. have issued a large product recall for dehumidifiers which can overheat, smoke, melt and catch on fire.
The voluntary recall, issued in cooperation with the Consumer Product Safety Commission (CPSC), is for 795,000 Kenmore Dehumidifiers. The devices were manufactured by LG Electronics (TIanjin) Appliance Co. Ltd., of Tianjin, China.
There have been 107 reports of incidents involving injury, including three cases of smoke inhalation. The humidifiers have caused more than $7 million in property damage.
The product recall covers 35-, 50- and 70-pint dehumidifiers which were manufactured between 2003 and 2005. They were sold at Sears and Kmart stores nationwide as well as the stores’ websites from 2003 to 2009 for between $140 and $220.
If you suspect you have a defective device, click the link below to see if your product model number is on the list and how to contact the store. Consumers who own a defective device are advised to immediately stop using it and unplug it. They will be compensated with a gift card which can be used at Sears or Kmart, as well as with a $25 coupon to purchase a new device at Sears.
LG Electronics Tianjin Appliance Co. issued another dehumidifier recall in 2009 and again in 2011 for 98,000 units. The Goldstar and Comfort-Aire dehumidifiers had a power connector which could short circuit, posing a fire risk. The company issued that recall after receiving 11 reports of property damage totaling more than $1 million. A Hudson, Mass. sustained $183,000 in damage from one of the defective dehumidifiers.
Those dehumidifiers were sold at The Home Depot, Walmart and Heat Controller Inc. nationwide from January 2007 and June 2008. In that case, consumers were advised to stop using the defective products and contact LG to arrange a free repair at an authorized service center.
Related:
Sears Recalls Kenmore Dehumidifiers Due to Fire and Burn Hazards, Consumer Product Safety Commission.
Dehumidifiers Recalled by LG Electronics Tianjin Appliance Due to Fire and Burn Hazards, Consumer Product Safety Commission.
Consumer Product Safety Commission.
Product Liability, Breakstone, White & Gluck.
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Product Liability: Magnet Desk Toy is Children’s Choking Hazard
The Consumer Product Safety Commission (CPSC) has taken a rare legal action seeking to stop sales of a magnet desk toy, alleging children are swallowing the pieces, then suffering serious injuries requiring surgery.
The CPSC filed an administrative complaint on July 25 against Maxfield & Oberton Holdings LLC, of New York, N.Y., the maker of Buckyballs and Buckycubes. The government agency and company failed to agree on the CPSC’s proposed voluntary recall plan for the magnet sets with 216 units.
The CPSC alleges the popular desk furnishing contains a defect in design, packaging, warnings and instructions. It wants the company to stop selling the defective product, notify the public about potential for injury and offer consumers a full refund. It is the CPSC’s second time taking this type of legal action in 11 years.
The CPSC is intervening after receiving more than two dozen of reports young children and teenagers have swallowed the magnets, requiring surgery. At least a dozen involved Buckyballs.
When two or more magnets are swallowed, they can move toward each other through the stomach and intestinal walls, resulting in serious injuries such as holes in the stomach, intestinal blockage, blood poisoning and possible wrongful death.
The CPSC reports young children are removing the magnets from the kits and placing them in their mouth. Meanwhile, older children and teenagers have unintentionally swallowed the magnets while placing them in their mouths to mimic having a tongue ring.
At least 10 retailers, including Amazon.com, have agreed to stop selling the defective product. EBay is also removing these listings from its online marketplace.
In May 2010, the CPSC and Max & Oberton conducted a cooperative recall of about 175,000 Buckyball magnet sets for mislabeling. The toys were labeled “Ages 13+” and did not meet the federal toy standard that loose magnets not be sold for children younger than 14. Injury reports preceded and followed the notice.
In November 2011, the CPSC and Max & Oberton worked cooperatively to warn about the dangers that could occur, but injuries continued, leading to the CPSC’s latest action. The CPSC now says a recall is necessary because all these prior steps have been ineffective.
Related:
- CPSC Sues Maxfield & Oberton Over Hazardous Buckyballs and Buckycube Desk Toys, Consumer Product Safety Commission.
- Feds file suit against Buckyballs, retailers ban product, USA Today.
Surgical Mesh Maker to Phase Out Defective Medical Device
Johnson & Johnson, one of the largest manufacturers of surgical mesh, has announced plans to stop selling the medical implants, as it faces hundreds of lawsuits from injured women and increasing oversight from the Food and Drug Administration (FDA).
Surgical mesh is used to strengthen the pelvic wall in cases of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Last year, approximately 75,000 women had a transvaginal procedure using surgical mesh.
Johnson & Johnson disclosed it will phase out surgical mesh in a recent letter sent to New Jersey and West Virginia judges overseeing patient lawsuits against them. The company said it plans to discontinue four mesh products over the next three to nine months.
On July 13, 2011, the FDA issued a public safety advisory stating traditional POP repair with mesh has no advantage over traditional non-mesh repair. Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.
Many more women have stepped forward since the FDA advisory, many of whom have suffered painful, long-term injuries. Some injuries cannot be corrected through surgery. Hundreds of women have filed lawsuits against the manufacturers, which include Johnson & Johnson and Boston Scientific.
In September 2011, an FDA panel heard arguments from advocacy groups, surgeons and consumer organizations. Many wanted to see a surgical mesh recall, others wanted the FDA to implement more oversight. Some sought a reclassification while others said the surgical mesh problem made another case for overhauling the 510(k) system, which allows manufacturers to sell new products without a new review so long as they are “substantially equivalent” to an already legally marketed device.
The FDA did not require a surgical mesh recall. But in January 2012, it ordered Johnson & Johnson and the other companies to conduct studies to track surgical mesh complication rates over time. Johnson & Johnson has been collecting data to comply, but said it expects the FDA will waive the requirement.
Complaints from transvaginal surgical included mesh erosion with in the body, bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. While corrective surgery is an option, it is not always successful.
Some surgeons are now recommending women consider whether they really need POP surgery and if they do, request a procedure without mesh, according to a Consumer Reports article. Click here for a recent article.
Related:
- FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011.
- What to Know If You Have Been Injured By Surgical Mesh or Transvaginal Mesh.
- Urogynecologic Surgical Mesh Implants, Food and Drug Administration
Defective Bikes and Equipment List for Cyclists
Each spring, cyclists throughout Massachusetts say goodbye to winter and put their bikes back on the road. But whether you cycle every day or just occasionally, now is the time to make sure your bike and equipment meets the latest safety regulations.
It is good practice to test and inspect key parts of your bike, such as the quick release wheels, brakes and pedals.Then check with the manufacturer of your bicycle. Look online and see if if offers an owners’ manual. If you have not done so, register your bike so you may receive recall notices.
You can also check the Consumer Product Safety Commission (CPSC) website for recent bicycle recalls. Each year, the CPSC recalls hundreds of thousands of bicycles and parts after receiving reports of defects and injuries.
Here are a few recent bicycle and equipment recalls from the CPSC:
Recalled Bicycles. Some 91,000 Bridgeway Bicycles were recalled in September 2011 because of a defective bicycle chain which can break, causing the rider to lose control and fall. The CPSC received 11 incident reports, including injuries, lacerations and contusions. Read more.
Children Bicycle Seats and Trailers. Two of the largest bicycle-related recalls involve defective children’s equipment. Topeak Babyseat II Bicycle Carrier Seats were recalled in April 2012 after two reports of near amputations and crushed fingers. When a child is lifted out of the seat, their fingers can get caught in a defective hinge mechanism. The product recall affected 30,400 consumers. Read more.
In January 2012, 44,000 Chariot bicycle trailers and 70,000 trailer conversion kits were recalled after 24 incident reports around the world, including three in the U.S. The trailer’s hitch mechanism can crack and break, causing the trailer to detach from the bicycle. Read more.
Helmets. Little Tricky Bicycle Helmets recalled 30,400 bicycle helmets in January 2012. Product testing demonstrated the helmets did not comply with CPSC safety standards for impact resistance. Read more.
Click for a full list of recent bicycle-related recalls from the CPSC.
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Defective Pool Slide Kills Woman in Andover, Mass.
About 21,000 inflatable swimming pool slides are being recalled after the death of a 29-year-old woman in Massachusetts and two other people sustained serious personal injuries.
The Consumer Product Safety Commission (CPSC), Walmart of Bentonville, Ark. and Toys R Us Inc., of Wayne, NJ announced the recall Thursday, May 10. The Banzai inflatable water slides are designed for use with in-ground pools, but the CPSC says they pose a risk for injury. They can deflate and a user can hit the cement ground underneath the slide. The slide is also unsecure and can fall over, in both windy and still conditions. Finally, it carries inadequate warnings and instructions for users.
The CPSC is aware of one death and two serious personal injuries. In one case, a 29-year-old Colorado mother died in Andover, to the north of Boston. The woman died after going down a Banzai inflatable slide and hitting her head on the pavement below. The slide had been partially deflated.
The two injuries occurred in a similar manner, one leaving a 24-year-old man from Springfield, Mo. a quadriplegic. In a third case, an Allentown, Pa. woman fractured her neck.
The recalled pool slides were manufactured in China by Manley Toys, Ltd. and sold at Walmart and Toys R Us stores nationwide from January 2005 through June 2009. The defective product was sold for about $250. The vinyl slides have a blue base, yellow sliding mat and an arch going over the slide. The words ‘Banzai Splash’ are printed on the side of the defective slide.
The CPSC urges consumers to immediately stop using the defective product and return it to a Walmart or Toys R Us for a full refund. Consumers can also cut out the two safety warnings on the slide and return those for a refund. For additional information, visit www.walmart.com and www.toysrus.com.
Consumers can determine whether they have the slide by clicking here to look at pictures posted by the CPSC. If you still have the box and packaging, look for barcode number 2675315734 and model number 15734.
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Defective Medical Devices Gain Criticism from Consumer Reports
Consumer Reports is stepping into the debate about the medical device approval process, recommending that the Food and Drug Administration require more rigorous testing to prevent defective medical devices from going to market.
The magazine and its advocacy arm Consumers Union wants the FDA to require implants and other medical devices undergo testing to prove they are safe and effective. The FDA began classifying medical devices into three categories in 1976 and stated manufacturers would be required to show clinical data before approval of Class III products, the most at-risk category.
But the FDA routinely clears new medical devices under a process known as 510, in which manufacturers are required to bypass clinical testing if they can show a device is “substantially equivalent” to another device already on the market.
Consumers Reports is calling on Congress to require testing as part of the FDA’s approval process for medical devices. Next, it wants the practice of “grandfathering” high-risk implants stopped. Finally, the organizations seek an improvement to the system for notifying patients of medical device failures.
Currently, the system largely relies on physicians who are supposed to notify patients, but this is a problem when doctors stop practicing.
Without changes to the system, Consumer Reports said patients cannot properly protect themselves.
The magazine highlighted three types of defective medical devices which have caused injuries in recent years:
Surgical Mesh: This device was approved several years ago based on its relationship to a product used in the 1950s, even though the two products were inserted differently and treated different areas of the body. The FDA refused calls to recall surgical mesh, but in January ordered 33 companies to conduct the first-ever post-market safety studies of the product. The FDA is also considering reclassifying surgical mesh into a Class III category.
The Consumer Reports article shares the story of a 54-year-old woman who has undergone eight surgeries to correct her transvaginal mesh complications.
Artificial All-Metal Hips: DePuy Orthopedics recalled its ASR XL all-metal hip implant in 2010 after the FDA received about 400 complaints in two years from patients. The two metal parts were rubbing against each other, breaking and spreading metal particles into the blood stream. Injury reports about all-metal hip implants grew after that, with the FDA receiving more than 5,000 reports about hip implants in the first six months of 2011, according to a New York Times article. DePuy hip implants was estimated to account for 75 percent of those injury reports.
Related:
- Consumer Reports Investigates: Dangerous Medical Devices
- Protect Yourself Against Medical Device Injuries