Defective Products

Advanced Bionics Hearing Aids: FDA Seeking Penalty

2008-04-01T09:33:00.000-07:00

The U.S. Food and Drug Administration (FDA) has announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.

The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant hearing aid surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices.

The complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.

Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used.

The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

FDA's complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.

Advanced Bionics, LLC, is located in Sylmar, Calif.

CPSC Announces Creation of New Import Surveillance Division

2008-03-10T10:34:00.000-07:00

U.S. Consumer Product Safety Commission (CPSC) has announce the creation of the new Import Surveillance Division at the CPSC. This team, in coordination with the CBP, is tasked with inspecting, detecting and stopping hazardous products from entering into the United States.

“With new strategies and growing resources, I am confident that we can prevent the entry of unsafe products into our country, remove those that do find a way in and punish those who willfully disregard the safety of our consumers,” said Acting Chairman Nancy Nord.

The Port of Long Beach in California is the first port that will have a permanent CPSC presence and additional staff will be assigned to other busy ports as the division is expanded. Carol Cave, formerly director of Field Operations, is the head of the new office.

In announcing the creation of the new division Acting Chairman Nord also announced that CBP is strengthening its cooperative relationship with CPSC; for those ports of entry where there are permanent CPSC staff assigned, the agency this year will have the ability to identify, stop, examine and either hold or release shipments coming into the United States.

The agency, she said, will test more samples and conduct more port-of-entry surveillance blitzes with assistance from CBP. CBP has already been assisting the agency in doing some product testing at its labs, and CPSC will continue to use this resource to leverage the agency’s ability to identify product hazards and violations of the agency’s standards.

Working with Customs, CPSC is utilizing the CBP’s import tracking system known as ACE. ACE will expose CPSC to many potential problems sooner, and give the agency more time and information to respond before the dangerous product reaches U.S. shores.

Posted March 2008.

Baby Safety and Crib Recalls

2008-02-28T07:04:00.000-08:00

The Consumer Product Safety Commission (CPSC) is urging parents and other caregivers to provide infants in their care with a safe sleep environment.

A CPSC analysis of crib-related deaths found that crib deaths have been caused by:

suffocation when infants ended up face down on pillows or face down in a crib with pillows, quilts or other bedding
entrapment between components of old cribs that were in bad condition, with broken or missing parts or loose hardware
entrapment in spaces generated between the sides of a crib and an ill fitted mattress
accessories situated in/around the crib (such as window cords or curtain tie backs)
falls out of cribs
alterations made to cribs
entrapment when the child became wedged between the crib and other furniture or a wall

CPSC also issued a recent press release warning parents and other caregivers of baby deaths associated with air mattresses.

The CPSC is urging parents:

To reduce the risk of SIDS and suffocation, place baby to sleep on his or her back in a crib that meets current safety standards
To prevent suffocation never use a pillow as a mattress for baby to sleep on or to prop baby’s head or neck
Infants can strangle to death if their bodies pass through gaps generated between loose components, broken slats and other parts of the crib and their head and neck become entrapped in the space.
*Do not use old, broken or modified cribs
*Regularly tighten hardware to keep sides firm
Infants can suffocate in spaces generated between the sides of the crib and an ill fitted mattress; never allow a gap larger than two fingers at any point between the sides of the crib and the mattress.
Never place a crib near a window with blind or curtain cords; infants can strangle on curtain or blind cords.
Properly set up play yards according to manufacturers’ directions. Only use the mattress provided with the play yard. Do not add extra mattresses, pillows or cushions to the play yard, which can cause a suffocation hazard for infants.
Routinely check nursery products against CPSC recall lists and remove recalled products from your home.
Sign-up for automatic e-mail recall notifications at www.cpsc.gov.

The CPSC has been working since 1973 to improve crib safety with the publication of mandatory standards for full-size cribs and non-full size cribs. CPSC staff has also been involved in the development of voluntary standards for cribs addressing issues such as corner posts and structural and mechanical failures. The work of the CPSC has contributed to an 86% decrease in crib related deaths.

Recent crib recalls:

Please send this information to parents of infants and others who take care of babies.

Glue Gun Burns and Dollar Tree Store Glue Gun Recall

2008-02-05T12:16:00.001-08:00

Glue gun burns due to a defective glue gun may give rise to a lawsuit against the manufacturer, distributor, importer, retailer and others. Dollar Tree Stores Inc. has recently recalled a potentially defective glue gun, Crafters Square Hot Melt Mini Glue Guns. Below is information on the glue gun recall from the U.S. Consumer Product Safety Commission. We are providing it here as a public service.

Glue Guns Recalled by Dollar Tree Stores Due to Fire, Burn and Shock Hazards

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, has announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Crafters Square Hot Melt Mini Glue GunsUnits: About 253,000Retailer: Dollar Tree Stores Inc., of Chesapeake, Va.

Importer: Greenbrier International Inc., of Chesapeake, Va.

Hazard: The recalled glue guns can short circuit, causing the gun to smoke and catch fire. This poses fire, burn and shock hazards to consumers.

Incidents/Injuries: Dollar Tree is aware of seven incidents in which these glue guns short circuited resulting in two injuries, including electrical shock and burns.

Description: The glue guns dispense hot glue and are intended for craft projects. The recalled glue gun is black with a yellow trigger and is approximately 4 1/2 inches from the back of the gun to the tip. Attached is a 44-inch electrical cord. "Crafters Square" and product number 818261-72 or 818261-75 are located on the guns' packaging.

Manufactured in: China

Sold at: Dollar Tree, Dollar Bill$, Dollar Express, Greenbacks, Only One $1, and Deal$ stores nationwide from February 2007 through August 2007 for about $1.

Remedy: Consumers should immediately stop using the recalled glue guns and return them to the store where purchased for a full refund. [Note from Pritzker Ruohonen: If someone has been injured by a recalled glue gun, contact a lawyer at our law firm. It is important not to return the glue gun because it could be used as evidence in a lawsuit seeking compensation for damages related to injuries caused by the glue gun.]

Home Shopping Network HSN LP Fined $875,000

2008-01-02T06:32:00.000-08:00

The U.S. Consumer Product Safety Commission (CPSC) recently announced that HSN LP (previously known as Home Shopping Network), of St. Petersburg, Fla., has agreed to pay a civil penalty of $875,000. The civil penalty settles allegations that HSN LP failed to report in a timely manner, as required by federal law, serious injuries and hazards with the Welbilt Electronic Pressure Cookers.

CPSC alleged that from September 2001 through about October 2004, HSN received at least 25 reports from consumers indicating that the pressure cookers contained a defect that could create a substantial product hazard or that the pressure cookers created an unreasonable risk of serious injury. CPSC alleged that HSN failed to immediately report this information as required by the Consumer Product Safety Act, 15 U.S.C. Sec. 2064(b), which requires manufacturers, distributors and retailers to immediately report to CPSC information about products that could create a substantial risk of injury to the public or that create an unreasonable risk of serious injury or death. Failure to provide the information immediately is a prohibited act under the Consumer Product Safety Act, 15 U.S.C. Sec 2068(a)(4).

In agreeing to settle this matter, HSN denied CPSC’s allegations that it violated the Consumer Product Safety Act.

The Welbilt Electronic Pressure Cookers were recalled in June of 2005, four years after HSN received the first report from consumers indicating that the pressure cookers contained a defect that could create a substantial product hazard or that the pressure cookers created an unreasonable risk of serious injury.

Posted January 2008.

Air Mattresses and Infant Deaths

2007-12-20T07:50:00.001-08:00

The following is from a CPSC news release. 16 babies have died when placed to sleep on air mattresses. Please email this to everyone you know who takes care of an infant.

Deadly Danger: CPSC Urges Parents To Not Place Infants on Air Mattresses

WASHINGTON, D.C. - This is the season when homes fill up with gifts and guests. When traveling, parents may choose alternative sleeping environments for babies. The U. S. Consumer Product Safety Commission (CPSC) is warning families nationwide that air mattresses are too soft for use with sleeping infants. Never place infants to sleep on air mattresses or other soft surfaces (such as water beds and adult beds), which are not specifically designed or safe for infant use.

Since 2002, CPSC has received reports of 16 tragic deaths, mostly infants younger than 8 months of age who were placed to sleep on air mattresses: 11 suffocated in a face down position on an air mattress and 5 died due to suffocation after falling into gaps between the mattress and bed frame and mattress and adjacent furniture or wall.

Generic twin-, full-, or queen-sized inflatable mattresses are usually intended for adults and older children. Even properly inflated air mattresses are usually too soft for infants to maintain a clear airway. Air leaks and under-inflation also contribute to incidents.

Wherever your baby sleeps should be as safe as possible. CPSC recommends these safe sleeping tips:

Always place your baby to sleep on his or her back to reduce the risk of SIDS.
Never place baby to sleep on an adult bed. Infants can suffocate on bedding or can become entrapped between the mattress and bed frame or mattress and wall.
When using a crib, make sure it meets current safety standards, has a firm, tight-fitting mattress and tight-fitting bottom sheet.
When using a portable crib or play yard, be sure to use only the mattress or pad provided by the manufacturer.

Posted December 2007.

Age Intervention Eyelash, Bimatoprost and Vision Problelms

2007-11-16T21:20:00.000-08:00

If you have been using Age Intervention Eyelash and now have vision problems, you may have a claim against Jan Marini Skin Research, Inc., the the seller and distributor of Age Intervention Eyelash.

Today, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized 12,682 applicator tubes of Age Intervention Eyelash for the following reasons:

FDA considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness. In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.
FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.

If you have been using Age Intervention Eyelash and now have vision problems, you need to consult your health care provider regarding the effect bimatoprost may have had on your vision. If you are diagnosed with macular edema, uveitis or any damage to the optic nerve, contact one of out product liability lawyers as soon as possible regarding a possible lawsuit against Jan Marini Skin Research and any other parties that may be responsible for your injuries. To contact us, please call toll-free at 1-888-377-8900 or submit the online consultation form on the upper-right-hand corner of this page.

Aqua Dots Recall Prompted by Injuries to Children

2007-11-08T10:55:00.000-08:00

A chemical coating on Aqua Dots converts to a powerful “date rape” drug when ingested. Two children in the United States slipped into a coma after swallowing some of the Aqua Dots. As a result Spin Master, manufacturer of Aqua Dots, has recalled 4.2 million Aqua Dot products, which were manufactured in (you guessed it) China.

Millions of toys sold in the U.S. and manufactured in China have been recalled due to high lead content (usually in the paint). Now Chinese manufacturers are coating products meant for children with a “date rape” drug. What will be next?

Legally, Spin Master is liable for any injuries to children that are caused by Aqua Dots. We are using “caused” in the legal sense, which means it has to be more probable than not that Aqua Dots caused a specific injury. We are accepting Aqua Dots lawsuit cases. If your child has been seriously injured by Aqua Dots, please contact us toll-free at 1-888-377-8900 or submit the online consultation form for review by one of our nationally-recognized product liability lawyers.

Wendy Bellissimo Collection Convertible Cribs Recalled

2007-11-08T09:54:00.000-08:00

Wendy Bellissimo Collection convertible cribs have been recalled due to possible entrapment and strangulation of infants. The cribs were made in China and sold by Bassettbaby, a Bassett, Virginia company.

The bolts connecting the top corners of the recalled cribs can come loose, creating a gap and posing a serious entrapment and strangulation hazard. Bassettbaby has 85 reports of bolts loosening, including one report of a 13 month-old child’s hand becoming entrapped between the railings.

The crib recall involves about 8,900 Wendy Bellissimo Collection convertible cribs, model numbers 5945-0521 and 5545-0521, sold in honey and cherry finishes. The full size cribs have a sleigh design and one of the following purchase order numbers at the bottom rail of the headboard: 272903, 272904, 273904, 276728, 276729, 291081, 323975, 324472, 320318, 323976, 332883 365620, 368466 in honey, and 338535, 338537 and 332884 in cherry. All other Wendy Bellissimo Collection cribs are not involved in this recall.

The recalled cribs were sold at Babies R Us stores nationwide from July 2005 through October 2007 for about $500. Consumers should stop using these cribs immediately and contact Bassettbaby for a free repair kit. If your infant has been injured by a recalled crib, contact an attorney immediately. We are accepting cases of serious injury associated with cribs, including Wendy Bellissimo Collection convertible cribs and Simplicity cribs.

Lead Poisoning Recalls

2007-10-11T12:43:00.001-07:00

Manufacturers, distributors, and sellers of children’s products—including jewelry, toys and candy—are making, distributing and selling products with lead. They are putting our children at risk for lead poisoning. The devastating effects of lead poisoning to children are well documented:

Young children under the age of six are especially vulnerable to lead's harmful health effects, because their brains and central nervous system are still being formed. For them, even very low levels of exposure can result in reduced IQ, learning disabilities, attention deficit disorders, behavioral problems, stunted growth, impaired hearing, and kidney damage. (National Safety Council)
At high levels of exposure, a child may become mentally retarded, fall into a coma, and even die from lead poisoning. (National Safety Council)
Lead exposure has been tied to ADHD, a neurological condition that affects a child’s ability to focus on tasks and complete them (MedlinePlus)

Learn More