Triad Group and H&P Industries of Hartland, Wisconsin, are accused of violiating good manufacturing standards and failing to heed FDA inspections and warnings about problems with contamination and sterility.  Today’s actions mean that these groups cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess.  Additionally, about $6 million worth of products were seized by federal health officials over public safety fears.

Triad Group and H&P Industries have been sued by a Houston couple who blame the tainted pads for the death of their two-year-old son.  The boy, who recently underwent surgery, was treated at the hospital with alcohol that were later recalled.  The boy developed an infection with Bacillus cereus, and later died.

A veteran of class action and complex litigation, Arsenault’s firm is actively involved in the pending lawsuits against the makers of the recalled painkillers, and continues to investigate additional claims.

Darvon, Darvocet and other forms of propoxyphene where pulled from the U.S. market by the FDA in November 2010 because of serious, potentially fatal heart-related problems and overdose risks, which were determined to outweighed the drugs’ benefit.

Earlier this year, DePuy Orthpaedics, a division of Johnson & Johnson, initiated a worldwide recall of its ASR hip replacement products because of higher-than-expected failure rates.

It has been reported that 1 in 8 patients implanted with the recalled hip systems will have to undergo revision surgery within 5 years.

Neblett, Beard & Arsenault has filed litigation against Johnson & Johnson DePuy and continues to investigate other claims against the makers of the recalled ASR hip replacement systems.

Earlier this year, DePuy Orthpaedics, a division of Johnson & Johnson, initiated a worldwide recall of its ASR hip replacement products because of higher-than-expected failure rates. It has been reported that 1 in 8 patients implanted with the recalled hip systems will have to undergo revision surgery within 5 years. A veteran of complex and class action litigation, Arsenault is a frequent speaker and chair of legal conferences. Arsenault’s firm has filed a lawsuit against Johnson & Johnson DePuy and continues to investigate other claims against the makers of the recalled ASR hip replacement systems.

Entrapment and strangulation can occur, especially to infants younger than 12 months of age, when a child is not harnessed. An infant can pass through the opening between the stroller tray and seat bottom, but his/her head and neck can become entrapped by the tray. Infants who become entrapped at the neck are at risk of strangulation.

The recall involves older versions of the Graco Quattro Tour™ and MetroLite™ strollers and travel systems manufactured prior to the existence of the January 2008 voluntary industry standard which addresses the height of the opening between the stroller’s tray and the seat bottom. This voluntary standard requires larger stroller openings that prevent infant entrapment and strangulation hazards.

This recall involves Graco Quattro Tour™ strollers and travel systems manufactured prior to November 2006 and MetroLite™ strollers and travel systems manufactured prior to July 2007. The strollers and travel systems were distributed between November 2000 and December 2007. The model numbers are printed on a label at the lower portion of the rear frame, just above the rear wheels or underneath the stroller. The name “Graco” appears on a label on the stroller tray and the headrest. Models included in the recall are:

Quattro Stroller
$100-$190
Distributed Between
Nov 2002 – Dec 2007

Model Numbers: 35735, 35759, 7111ASB, 7111BKW, 7111CLN, 7111CUN, 7111DIA, 7111HEA, 7111HIG, 7111LAG, 7111KSH, 7112CNP, 7112MTR, 7113CJR, 7113CMR, 7113COT, 7119GGG, 7119WSR, 7121MAY, 7125QST, 7126RNS, 7127LEG, 7132RXY, 7134SMB, 7138RNS

Quattro Stroller Travel System
$200-$250
Distributed Between
Oct 2002 – Oct 2007

Model Numbers: 35760, 7411ATR, 7411BGN, 7411BGN2, 7411BLB, 7411KBK, 7411KBK2, 7411LV, 7411MCH, 7411MCH2, 7411MLY, 7411MLY2, 7419LIM, 7419LIM2, 7419OWD2, 7B00BDA, 7B00DRB, 7B00KAS, 7B01MNS, 7B03CST2, 7B03LTC2, 7B03TFE2

MetroLite Stroller
$90-$190
Distributed Between
Nov 2000 – Dec 2007

Model Numbers:1104, 1240, 6110DW, 6110F3, 6110S7, 6110TS7, 6111FKB, 6111VIN, 6113SCR, 6114HAV, 6114JAM, 6114LAG, 6114NGS, 6116NRF, 6120SHL, 6121CJG, 6121CNP, 6121GGG, 6121MTR, 6123EME, 6124LRD, 6125SMB, 6J01DAI, 6J01HRL, 6J03RIT, 6J04JEN, 6J05MIN

MetroLite Travel System
$190-$250
Distributed Between
Dec 2000 – June 2005

Model Numbers: 1070, 7000KSB, 7308DEL, 7308DEL2, 7308DEL4, 7308TYR, 7308TYR2, 7406PLT, 7408MRT, 7409GRG, 7410CON, 7413CML, 7413MRN, C7413CML

Quattro and MetroLite strollers ending with the number 3 are NOT affected by this recall.

The strollers were sold at AAFES, Babies R Us, Burlington Coat Factory, Fred Meyer, Kmart, Meijers, Navy Exchange, Sears, Target, Walmart and other stores nationwide between November 2000 and December 2007 for between $90 and $190 for the strollers, and between $190 and $250 for travel systems.

The 2002 recall, which was expanded in 2006, was announced after Black & Decker and the CPSC received numerous reports of the cordless lawn mowers’ engine overheating and causing a fire hazard. This time, 160,000 Black & Decker and Craftsman brand cordless lawnmowers are being recalled because the mower’s motor and blade can unexpectedly turn on after the mower’s safety key is removed, posing a laceration hazard to consumers. Black & Decker has received 34 reports of the motor operating after removal of the safety key, including two incidents that resulted in finger lacerations.

The recalled cordless electric mowers were sold in home centers, hardware and discount stores under both the Black & Decker and Craftsman brand names. The recalled Black & Decker mowers have model number CMM1000 or CMM1000R. All date codes and types are included in the recall. The date code and type information are both located on a silver and black label affixed to the rear door of the mower.

The Black & Decker mowers have either an orange or green deck with a black motor cover. The Craftsman-brand mowers have model number 900.370520 and the recall include all date codes and types. The model number is located on the silver and black label affixed to the rear door of the mower. The Craftsman-brand mowers have a dark green deck with a black motor cover.

The CPSC is urging customers to stop using the recalled lawnmowers immediately.

Over 2.8 million Baby Playzone™ Crawl & Cruise Playground™, Baby Playzone™ Crawl & Slide Arcade™, Baby Gymtastics™ Play Wall, Ocean Wonders™ Kick & Crawl™ Aquarium (C3068 and H8094), 1-2-3 Tetherball™ and Bat & Score Goal™ have been recalled due to choking hazards. The plastic valve of the inflatable ball on these toys can come off and pose a choking hazard to young children.The CPSC and Fisher Price have received 54 reports of the valve detaching from the toys, including 14 reports of the valve being found in children’s mouth and 3 reports of children choking on the plastic valve.

About 950,000 high chairs are being recalled due to risk of injury and laceration. The recalled products include Healthy Care, Easy Clean and Close to Me High Chairs. According to the CPSC, the problem with the recalled Fisher Price high chairs is that children can fall on or against the pegs on the rear legs of the high chair, which are used for high chair tray storage. This could result in a child sustaining cuts, scrapes and other injuries from the protruding object. Fisher Price and the CPSC have recieved 14 reports of injuries, including 7 that required stitches and 1 reported injury to a child’s mouth. Recalled models include Healthy Care 79638, 79639, 79640, 79641, B0326, B2105, B2875, C4630, C4632, C5936, G4406, G8659, H0796, H1152, H4864, H7241, K2927 and L1912; Close to Me H8906; and Easy Clean H9178, J4011, J6292 and J8229.

120,000 Fisher-Price Little People Wheelies Stand ‘n Play Rampway products are being recalled in the US and Canada. Fisher Price has received several reports of the wheels detaching from the green and purple cars, which poses a serious choking hazard to small children.The recall involves Little People Wheelies Stand ‘n Play Rampway with model numbers T4261 and V6378.

Over 7 million Fisher Price Trikes and Tough Trikes toddler tricycles are being recalled because of a protruding plastic ignition key, which if a child sits or falls on, can result in serious injuries. Fisher Price has recieved 10 reports of injuries resulting from the protruding key, including 6 reports of little girls needing medical attention for genital bleeding. Recalled models include J72633 Hot Wheels Trike, 72642 Lil’ Kawasaki Trike, 72639 Barbie Free Spirit Trike, 72643 Boys Tough Trike, 72644 Girls Tough Trike, 72792 Kawasaki Trike, B8775 Kawasaki Tough Trike, B8776 Barbie Tough Trike, K6672 Dora the Explorer Tough Trike, K6673 Diego Tough Trike, M5727 Barbie Tough Trike Princess Ride-On, N6021 Kawasaki Tough Trike, T6209 Thomas Tough Trike and V4270 Diego Tough Trike.

The CPSC is urging parents to immediately stop using these products, as they can result in serious injuries to young children. Recalls that affect children’s products are always unsettling.  Parents expect trusted brands to produce and market products that are safe for children and babies.  According to the CPSC, manufacturers should be working harder to build safety into their products, rather than intiaing recalls after injuries are reported.

At Neblett, Beard & Arsenault, our injury attorneys  have represented families whose children and infants have been seriously injured or killed by products that were supposed to be safe.  We  know first hand the sadness and trauma that defective childrens products inflict on a family.  We will continue to monitor this recall closely and post additional updates.

Name of Product: Siemens and Murray Circuit Breakers, Load Centers and Meter Combos

Units: About 2.2 million

Importer: Siemens Industry Inc., of Alpharetta, Ga.

Hazard: The recalled circuit breakers have a spring clip that can break during normal use, leading to a loss of force to maintain a proper electrical connection in the panelboard. This can lead to excessive temperature, arcing or thermal damage at the connection point, and damage to the panelboard’s electrical insulation and can result in a fire, property damage, or personal injury.

Incidents/Injuries: Siemens has received one report of a circuit breaker spring clip that broke during installation. No injuries have been reported.

Description: This recall involves Siemens and Murray 15 through 50 AMP single and double pole circuit breakers, load centers (circuit breakers that come with an electrical panel), and meter combos (contain a load center and a meter socket). “Siemens” or “Murray,” date codes 0610 or 0710 and the catalog number are printed on a label on the side of the circuit breakers. Date codes between June 2010 through August 2010 are stamped on the inside of the metal box of the load centers and meter combos. The catalog number for the load centers and meter combos is printed on a label inside the metal box door and on the packaging.

Recalled Product: Circuit Breakers
Date Codes: 0610, 0710
Catalog Numbers: Q115, Q120, Q130, Q215, Q230, Q250, MP115, MP115U, MP120, MP130, MP215, MP230, MP230U, MP250

Recalled Product: Load Centers
Date Codes: Jun 23 2010 – Aug 25 2010
Catalog Numbers: G2020B1100CP, G3030B1100CP, G4040B1200CUSGP, LC4040B1200P, G3040B1200CP, G3040L1200CP, G4040B1200CP, G3030B1150CP, W3040B1200CP, G1624L1125CP, W4040B1200CP

Recalled Product: Meter Combo
Date Codes: Jun 23 2010 – Aug 25 2010
Catalog Numbers: JA2040B1200SP

Sold at: The Home Depot, Lowes, other hardware and building supply stores and numerous electrical distributors nationwide from June 2010 through August 2010 for between $2.50 to $235.

Manufactured in: Mexico

“For many seniors, what should have been newfound mobility has instead become less mobility because their hip replacements systems are defective,” says Attorney Richard J. Arsenault, senior partner at Neblett, Beard & Arsenault.

DePuy Orthopaedics, a division of Johnson and Johnson, announced a worldwide recall of its ASR XL Acetabular System and ASR Hip Resurfacing System after reports indicated the systems were failing at a higher than expected rate.  According to a study published by the National Joint Registry of England and Wales, 1 out of every 8 patients (12%-13%) who had been implanted with a recalled device had to undergo revision surgery within five years.

The recalled ASR hip systems may loosen or dislocate after implantation, resulting in pain, fracture, swelling and less mobility in the patient.  The ASR hip system utilizes a ball and socket component that moves against one another.  Over time, the metal on metal contact may create metal debris, which could result in damage to the bone, soft tissue and nerves.

“It is troubling to think that over 90,000 people may have been implanted with defective, perhaps dangerous hip replacement systems.   It raises the question whether these devices were properly vetted before they were put on the market.  Further, did DePuy work fast enough to recall these products after knowing that they were resulting in revision surgeries, complications and pain?” questioned Arsenault.

The recalled toy is a seven piece set which includes a pink plastic tent with carrying handle, a plastic rabbit, a pink plastic chair with a floral seat design, plastic marshmallows on a stick, a plastic campfire ring, and a small plastic doll.

The doll, known as Sonya Lee, can come apart at the waist. When this happens, small parts of the dollar are easily accessible. These parts constitute a possible choking hazard for young children.

The toy’s product number is R6935 and was manufactured in China. This particular Fisher Price toy was sold nationwide for approximately $15.00. No other Sonya Lee plastic dolls have been recalled.

In all, 96,000 U.S. units are involved in the recall. 14,000 Canadian units have also been implicated. With the exception of the Sonya Lee doll, all other pieces of the playset are not recalled. Sonya Lee’s name is imprinted on the figure itself.

CPSC and Baby Matters are aware of one other incident in which an infant became entrapped when the Nap Nanny was used in a crib, contrary to the product instructions. In that incident, the infant fell over the side of the Nap Nanny®, despite being harnessed in, and was caught between the baby recliner and the side of the crib. The infant sustained a cut to the forehead.

CPSC and the firm have received 22 reports of infants, primarily younger than 5-months-old, hanging or falling out over the side of the Nap Nanny® despite most of the infants being placed in the harness. One infant received a bruise as a result of hanging over the side of the product.

Infants can partially fall or hang over the side of the Nap Nanny® even while the harness is in use. This situation can be worse if the Velcro™ straps, located inside the Nap Nanny® cover are not properly attached to the “D”-rings located on the foam, or if consumers are using the first generation model Nap Nanny® that was sold without “D”-rings.

In addition, if the Nap Nanny® is placed inside a crib, play yard or other confined area, which is not a recommended use, the infant can fall or hang over of the side of the Nap Nanny® and become entrapped between the crib side and the Nap Nanny® and suffocate.

Likewise, if the Nap Nanny® is placed on a table, countertop, or other elevated surface and a child falls over the side, it poses a risk of serious head injury. Consumers should always use the Nap Nanny® on the floor away from any other products.

The Nap Nanny® is a portable recliner designed for sleeping, resting and playing. The recliner includes a foam base with an inclined indentation for the infant to sit in and a fitted fabric cover and a three point harness. The first generation model of the Nap Nanny® can be identified by the absence of “D”-rings in the foam base. In second generation models, the harness system has “D”-rings in the foam base and Velcro™ straps inside the fitted fabric cover.

The recalled Nap Nannys® were sold at toy and children’s retail stores nationwide and online, from January 2009 through July 2010 for about $130.

The recalled product was manufactured in the United States and China.

Consumers with a first generation Nap Nanny® models, without “D”-rings, should stop using the recalled baby recliners immediately and contact the firm to receive an $80 coupon towards the purchase of a new Nap Nanny® with free shipping. Consumers with a second generation Nap Nanny® model, with “D”-rings, should immediately stop using the product until they are able to visit the firm’s website to obtain new product instructions and warnings. Consumers will also view an important instructional video to help consumers ensure the harness is properly fastened. Consumers who are unable to view the video or new instructions online, should contact the firm to receive free copies by mail. For more information, contact Baby Matters toll-free at (888) 240-4282 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s website.

Alexandria, LA (PRWEB) July 1, 2010 — The U.S. Food and Drug Administration should adopt a proactive approach to food safety such as the one outlined in a new report by the Institute of Medicine and National Research Council, says Louisiana food safety advocate Richard J. Arsenault.

The 500-page report, requested by Congress 18 months ago after a rash of foodborne illness outbreaks, states that the FDA’s current “reactive” model makes inefficient use of its limited resources and relies on a case-by-case approach to gathering and using information on risks.

By switching to a “risk-based” approach outlined in the report, the FDA could better identify problems in the food supply and distribution chain, efficiently direct resources to high-risk areas and catch problems before they turn into widespread outbreaks, the report says.

“More than 300,000 people need to be hospitalized and over 5,000 people die from foodborne illness in America every year, and that number of victims is unacceptable when many of these illnesses could have been prevented,” says Arsenault, whose firm, Alexandria-based Neblett, Beard & Arsenault, has represented hundreds of foodborne illness victims throughout Louisiana and across the country.

“The IOM report, for the most part, sets out a vision for how local, state and federal officials can work together to catch problems before they spread and harm innocent consumers, and I think Congress and the FDA should give serious consideration to its recommendations,” Arsenault says. “It’s not a perfect plan, but it serves as a good blueprint.”

The FDA is charged with ensuring the safety of approximately 80 percent of the nation’s food supply, including seafood, fruits, vegetables and dairy products. The federal agency shares food safety responsibility with the U.S. Department of Agriculture, which oversees meat, poultry and egg products, as well as state and local agencies, which inspect food production facilities.

According to the IOM report, the FDA needs to adopt a system that would increase coordination with those other agencies, and it needs more authority to carry out its mission through amendments to the federal Food, Drug and Cosmetic Act – much of which is currently contained in proposed legislation before the Senate.

The report calls for establishing a centralized food safety data center that would collect information, quickly assess risks and take steps to address food safety problems without competing with other agencies for resources.

To enhance its efficiency, the FDA could also delegate food facility inspections to states and establish national standards for the intensity and frequency of those reviews, the report says.

According to the report, this change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors, and it would increase the quality of inspections and avoid duplication of efforts.

The report also asks Congress to consider legislation that would specify the FDA’s authority in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration and banning of certain food imports if the public’s health is at risk.

“What is significant to me about this report is that a committee of experts has clearly stated that our current food safety system is inadequate and in dire need of change,” Arsenault says. “Improvements need to be made.”

The retailer is cooperating with the recall although the importer maintains the toy meets federal safety rules. Their attorney insists the toy is not unreasonably dangerous because “there really isn’t any reason for a child to put this plastic dart in their mouth” even though the company has known the toy was deadly for more than three years. The first child death occurred in late 2006 and Gordy was notified in January of 2007.

The CPSC sent a draft recall alert letter to Gordy’s attorney last September, but the company declined to recall the $1.50 toy. Because nearly all recalls are voluntary, the safety commission negotiates the wording of recall alerts with the manufacturers or importers to avoid forcing mandatory recalls which can result in lengthy court battles. Despite lengthy negotiations with Gordy, the importer continued to refuse to recall the toy so the CPSC turned to the retailer Family Dollar who voluntarily stopped selling it in January 2009.

This recall and one involving a different suction cup dart toy imported by OKK Trading Inc. which was linked to the 2007 death of a child in Texas has caused consumer advocates and toy industry officials to rethink their position regarding choking hazards in children older than three years of age. Rules generally are written with the idea that children over the age of 3 don’t put toys in their mouths.The committee that sets toy safety standards will now study which toys older kids put in their mouths. In the meantime, parents should immediately discard the Auto Fire toy gun dart sets and make sure their children stay away from any short, pliable toy darts with a suction cup end.

Federal safety officials have said that in the Nissan situation, the wiring that holds the airbags in place may wear down enough to interrupt the signal to deploy the airbags. It appears from this preemptive action, Nissan has learned from the mistakes Toyota made and is erring on the side of caution and consumer safety.

The recall litigation conference, a follow-up to the widely publicized Toyota Litigation Conference held in San Diego this March, is scheduled on the eve of the inaugural Toyota Multidistrict Litigation Status Conference before the newly appointed Judge James V. Selna.

Richard J. Arsenault, a veteran of complex and class action litigation, has filed multiple lawsuits against Toyota as a result of the automaker’s on-going problems with sudden unintended acceleration in its vehicles. Under his leadership as co-chair, March’s Toyota Recall Litigation Conference was well-attended by over 100 plaintiff and defense attorneys. The event was profiled by the Wall Street Journal, Associated Press, National Public Radio, Bloomberg News, CBS, TV Tokyo, Nippon TV and other members national and international media.

Today’s conference boasts an impressive line-up of speakers, including some of nation’s most preeminent attorneys, many with decades of experience handling large, complex national cases. The curriculum will cover a number of issues pertaining to the unique circumstances of the Toyota recall and resulting litigation.