Articles Tagged with “product liability lawyers”

Zantac, a popular over-the-counter and prescription medication for heartburn, has been recalledIf you take Zantac or ranitidine, it is time to change your medication. On April 1st, the Food and Drug Administration (FDA) asked manufacturers to immediately withdraw all medication from the market. This is due to concerns it contains a chemical which could cause cancer.

You will no longer be able to purchase the medication over the counter or refill existing prescriptions, according to the FDA. The agency has recommended alternative medications which you can discuss with your physician. While this announcement may come as a surprise during the COVID 19 outbreak, many had anticipated this move after the FDA’s initial warning last September and the subsequent recall of Zantac, the popular brand name medication, in October. Many other manufacturers have also issued voluntary recalls over the past six months.

The FDA announced testing showed ranitidine contained the contaminant N-Nitrosodimethylamine, or NDMA, which is a probable human carcinogen. The agency said the decision was made on the “best available science.” NDMA is a known environmental containment which is already present in our surroundings. It is found in water, meat, dairy and vegetables, but at low levels is “not be expected to lead to an increase in the risk of cancer,” according to the FDA.

When testing ranitidine, the FDA said it did not observe unacceptable levels in many drug samples. But ultimately, the agency decided the drug should not be available to consumers unless the quality can be assured.

Specifically, testing found the NDMA levels in some products increased in rising temperatures, which may be involved in distribution and a patient’s handling of the drug. And as the ranitidine product aged, so did NDMA levels.

This new FDA announcement will impact many people and present challenges. Patients can usually remember their daily medications. But Zantac is typically a short-term medication which is available in many ways, over-the-counter, by prescription or in a hospital. Because of this, many people may recall suffering from heartburn or a stomach ulcer, but may not remember which medication they took. Another challenge is the medication was sold under many brand names.

If you used Zantac or ranitidine, then experienced cancer or other illness or symptoms, you may want to learn more to guide you in your future medical care. You may also have the right to seek financial compensation to pay for your medical bills and other losses. At Breakstone, White & Gluck, our Boston product liability lawyers are now reviewing cases for patients who may be affected by Zantac and ranitidine injuries. For a free no-obligation legal consultation, call (800) 379-1244 or (617) 723-7676.

Here are a few points to remember:

Look for product names of ranitidine medications

Zantac was widely used. According to USA Today, before recall, there were 15 million prescriptions of Zantac annually. The manufacturer was Sanofi.

However, ranitidine was also sold under other names. It was manufactured by Dr. Reddy’s Laboratories Ltd., which manufactured ranitidine products sold by Dr. Reddy, Kroger and Walgreens. Brand names included American Health Packaging, Glenmark Pharmaceuticals, Precision Dose, Appco Pharma, Sandoz Inc. (a division of Novartis) and Northwind Pharmaceuticals.

Talk to your doctor about your ranitidine use

If you are taking a medication for heartburn or ulcers, carefully read the product labeling to see if it contains ranitidine.

If you are taking a ranitidine medication, stop and contact your primary care physician. The FDA recommends patients take an alternative heartburn medication, such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) or Prilosec (omeprazole). Discuss these with your physician. There have been no NDMA impurities found with these products, according to the April 1st announcement.

You may be thinking you don’t want to reach out to your doctor during the COVID-19 emergency, but this type of preventative step is important. You may have other medical conditions or other medications which you need to consider. Your doctor can advise you on how to take your medications safely.

Take care to safely dispose the medication

Due to the COVID 19 outbreak, the FDA is advising consumers to follow the disposal directions on packaging and dispose of medications at home, rather than a drug take-back location in your community.

Zantac lawsuits have already been  filed, with more expected

Patients have already filed Zantac lawsuits, alleging Sanofi, the manufacturer, failed to warn consumers that the medication contained NDMA and of potential risks. Our lawyers are advising and representing Massachusetts residents who may have been affected.

Free Legal Consultation – Breakstone, White & Gluck

With more than 100 years combined experience, Breakstone, White & Gluck represents those injured by defective products, including unsafe medication and defective medical devices in Massachusetts. If you have taken Zantac or another ranitidine medication subject to FDA action, you may have suffered illness and want to learn more about your legal rights.  You can find more information on Breakstone, White & Gluck’s web page on Zantac and ranitidine or contact our attorneys.

For a free legal consultation, call our Boston product liability lawyers at (800) 379-1244 or (617) 723-7676. You can also send a message through our contact form.

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Desktop magnet sets
There is a disturbing new report out about children ingesting rare-earth magnet sets at an accelerated rate since 2016, when the industry overturned a federal sales ban in court. The magnet industry now markets these powerful cluster sets to adults, but children continue to swallow them. Parents can take precautions by double checking holiday gifts and discarding any of these products.

The Consumer Product Safety Commission (CPSC) issued a rule banning the small rare-earth magnet sets in 2014 after hundreds of children reportedly ingested the magnets. The rare-earth magnets were (and still are) about 10 times as strong as other magnets. The CPSC’s ban required magnetic parts to have a lower force of attraction of 50 kG² mm² or less.

According to The Washington Post, child ingestions had dropped after the ban was implemented. Injuries dramatically rose between 2017 and 2019, with an estimated 1,580 ingestions this year.

Buckyballs We have written in the past about Buckyballs, a dangerous magnetic desk toy which has injured too many children. Last week came another development, which we hope finally removes this unsafe product from circulation.

On May 12, the U.S. Consumer Product Safety Commission (CPSC) announced a voluntary recall for all Buckyballs and Buckycubes. The recall settles an administrative case filed by the CPSC in July 2012. As part of this, Craig Zucker, the former chief executive officer of Maxfield & Oberton Holdings, agreed to establish a Recall Trust. Consumers will be able to request a refund from this fund, which will be controlled by the CPSC. The agency also urges the public to stop using these defective products immediately and look for loose pieces.

Maxfield & Oberton Holdings began selling Buckyballs in 2009. The company said the magnetic desk toy was intended for adults. The problem is if a child starts playing with the tiny magnets, they can swallow them. The magnets can attract inside a child and cause painful intestinal injuries. Surgery is often required and there can be serious longstanding health consequences, such as children having to consume food through a feeding tube.

The CPSC first worked with the company to improve warning labels. The products were marketed for children “Ages 13+” and the CPSC said they should have been marketed for age 14 and up. The company agreed to recall 175,000 magnetic toys and made the change. But the injuries continued. In July 2012, the CPSC filed a lawsuit asking the company to stop sales altogether, a rare legal action the agency has only taken four times in 11 years. The agency alleged that Buckyballs and Buckycubes contained, “a defect in the design, packaging, warnings and instructions, which pose a substantial risk of injury to the public.”

Maxfield & Oberton refused to recall Buckyballs and Buckycubes and in December 2012, the company went out of business. But it was vocal about disagreeing with the CPSC and posted this message on its website:

“Due to baseless and relentless legal badgering by a certain four letter government agency, it’s time to bid a fond farewell to the world’s most popular adult desk toys, Buckyballs and Buckycubes. That’s right: We’re sad to say that Balls & Cubes have a one-way ticket to the Land-of-Awesome-Stuff-You-Should-Have-Bought-When-You-Had-the-Chance.”

In April 2013, six retailers voluntarily recalled Buckyballs and Buckycubes while the CPSC kept trying to raise awareness about the dangers of Buckyballs and other magnetic toys. It established the Magnet Information Center as a consumer resource. Between 2009 and 2011, the CPSC estimates there were 1,700 ER-treated magnet ingestion cases related to high-powered magnet sets.

Zucker will have to eventually fund a website, where consumers can apply for a refund.

Related:
Buckyballs and Buckycubes High-Powered Magnet Sets Recalled Due to Ingestion Hazard; Craig Zucker To Fund A Recall Trust, Settles With CPSC, Consumer Product Safety Commission.
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carseat-010314.jpgCombi USA announced a recall of over 33,000 car seats last week and said parents should expect repair kits starting in February.

Combi USA recalled its Coccorro, Zeus, Turn and Zeus 360 models made through January 2013. The National Highway Traffic Safety Administration (NHTSA) reports the seat straps do not meet minimum requirements. Children may not be properly secured in case of a car accident.

The Charlotte, N.C. company said one part of the harness failed strength tests, but the harness as a whole meets safety standards. Seats made after January 2013 do not have this defect.

Combi USA will notify owners who have registered their products and mail out free harness replacement kits starting in February.

What to Know About Child Safety Seats
Choosing a safe car seat and learning how to properly install it is a struggle for many parents. There are a number of resources to help make the process easier.

Product Recalls.The Consumer Product Safety Commission (CPSC) website provides updates on product recalls. This recall was reported in the media and not listed on the website, but most recalls can be found there.

NHTSA. The National Highway Traffic Safety Administration provides online resources about child seat safety ratings.

State of Massachusetts. In Massachusetts, children must use some type of child passenger safety seat until they are 8 years old or weigh 57 pounds. All seats must meet federal standards. Read what types are appropriate for each age.

Local Police Departments and Organizations. Your local police may have an officer who has been specially trained to fit car seats. This is a free service.

Related:
Combi USA Recalls More than 33,000 Child Seats, ABC News.
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december-2014-recalls-3.jpgThe Consumer Product Safety Commission (CPSC) announced several recalls last week, including a popular holiday decoration and two children’s products. The commission also announced its annual list of winter-related products which were recalled during other seasons.

Yankee Candle Ring
The Yankee Candle Company recalled about 15,000 pine berry candle rings in the U.S. and 2,000 in Canada. They pose a fire risk because of the synthetic foliage, berries and cones ornamentation. No injuries have been reported. The recalled rings were sold in Yankee Candle and Hallmark stores nationwide from September 2013 through October 2013. They were sold for between $8 and $10 at these stores, as well as through Yankee Candle catalogs and Yankeecandle.com. Consumers are asked to return candles to the nearest Yankee Candle store for a full refund. See the CPSC recall notice.

Playtex Hip Hammock Infant Carriers
Playtex is offering parents a full refund after recalling a baby hammock-style carrier. Playtex Hip Hammock infant carriers were recalled because they pose a fall hazard to children. About 305,000 baby carriers were recalled in the U.S. and 36,000 in Canada.

The company received 87 reports of the product’s buckles cracking or breaking. Two reports involved injuries, including one infant who required care at a hospital emergency room.

Consumers are instructed to stop using the carrier and contact Playtex for a full refund. These carriers were sold from June 2004 to December 2008 in the U.S. and through January 2010 in Canada. Purchase price was about $40 for the basic model and about $60 for the deluxe model.

In the U.S., the baby carrier was sold at Burlington Coat Factory, Target, Amazon.com and other baby and discount stores.

The carriers are designed for children 15 to 35 pounds and are made of a suede fabric in black and navy. They have black, black and white check and burgundy lining on the inside. Read the CPSC recall notice for model numbers.

Cubetensils Children’s Eating Utensils
Edoche Inc. recalled about 1,100 children’s spoon and fork sets because the handle can detach, posing a choking hazard for infants. The Seattle, Wash. company received one report of a handle detaching and a baby putting it in their mouth. No injuries were reported.

The utensils were sold in seven different designs and patterns from May 2012 through November 2013 for about $8 per set. They were sold at retailers and specialty stores nationwide, along with Amazon.com and ebay.com. Consumers can contact Edoche for a full refund. Read the CPSC recall notice for more information.

Consumer Product Safety Commission Website
If you have never used this website, it is a great tool to become familiar with in the New Year. You can find the latest product recalls and more information about ones you learn about in the news. But often, product recalls are not picked up by the news media so it is important to seek out the information yourself periodically. If you use Facebook, you can also stay up-to-date by following our page, where we often report on recalls.

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Here is one page from the CPSC website which may help you now: “Check for These Winter Products Recalled Last Summer.”
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Toys recalled in summer of 2013
If you have young children, you have probably logged a few hours watching them play this summer. This joy of parenthood comes with an important responsibility: to make sure their toys are safe.

In the United States, the Consumer Product Safety Commission (CPSC) regulates the toy industry. Toys for children 12 and under are required to pass third-party testing and certification, but each year, defective toys still make it to store shelves and cause serious injuries and deaths. In 2011, more than 260,000 children were treated for toy-related injuries in the hospital emergency room and 13 were killed, according to the CPSC.

If you are a parent, be vigilant. Start by inspecting your children’s toys every time they play. Check the age labeling. Make sure they are no small parts that pose a choking hazard. When in doubt, set the toy aside and have your children play with something else.

Another way to protect your children is to stay informed. You may not see every toy recall on the TV news, but can visit the CPSC website and social media sites for news on toy recalls. A few recalls from this summer include:

Baby Einstein Musical Motion Activity Jumpers
Kids II voluntarily recalled about 400,000 Baby Einstein Musical Motion Activity Jumpers earlier this month. Another 8,500 activity seats have been recalled in Canada. The toy is linked to 61 injuries.

The hazard is when infants reach out and play with one of the attached toys (the toy with the smiley face), it rebounds back.

Kids II received 100 incident reports, including the 61 injuries. Injuries included bruises, facial lacerations and a 7-month-old boy who sustained a lineal skull fracture. In one case, an adult suffered a chipped tooth.

Kids II, which is based in Atlanta, Georgia, is the product importer. The toy was manufactured in China prior to November 2011. Kids II will replace the defective part for consumers for free. Many models were sold at Target, Toys R Us and Amazon.com between May 2010 and May 2013. Recall notice.


Kolcraft Jeep Liberty Strollers Kolcraft recalled 96,000 strollers in the United States after 39 reports of defective wheels. The inner tube can rupture, causing the wheel rim to fracture and fly off as a projectile. The reports included 18 injuries, most of which occurred when an adult attempted to fill a tire with air. Children and adults reported suffering lacerations, abrasions and contusions.

The stroller was manufactured in China. Kolcraft Enterprises, Inc. of Chicago, Illinois was the product importer. It was sold at Burlington Coat Factory, Sears and Toys R Us and other retailers from June 2010 to June 2013 for between $150 and $180.

Consumers are advised to stop using the defective stroller and contact Kolcraft for free replacement wheels. Recall notice.


“Buff Baby” Baby Rattles
In June, Fred & Friends announced the voluntary recall of 47,500 “Buff Baby” baby rattles in the United States. The rattles, which are designed to look like a dumbbell weight, are designed for children 3 months and older. The rattles were recalled because they pose a choking hazard to young users. The cap can separate and expose the plastic pellets inside to infants. Fred & Friends received two reports of this happening, but no injuries.

The rattles were sold in specialty toy and baby stores nationwide and in Canada, as well as online through Amazon.com and other websites from October 2011 through June 2013.

Consumers are advised to stop using the rattles and contact Fred & Friends for a full refund. Fred & Friends, which is located in Cumberland, Rhode Island, is the distributor. The toy was manufactured in China. Recall notice.


Thermobaby Bath Seats Recalled Due to Drowning Hazard
The Aquababy Bath Ring was recalled after the CPSC determined it does not meet federal safety standards. The product is supposed to hold children secure in the bath, but the design poses a risk for tipping over.

SCS Direct Inc. of Milford, Conn. voluntarily recalled 7,500 of the bath seats. There were no injuries involved in this recall. The seats were designed for children five months to ten months old. It was sold through Amazon.com. Consumers are advised to stop using the product and contact SCS Direct for a $35 refund. Recall notice.
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State officials have announced they will seek permanent surrender of New England Compounding Center’s (NECC) pharmacy license in the wake of a fungal meningitis outbreak which has infected more than 300 people and left 23 dead.

At a Tuesday press conference, state officials announced they will seek the pharmacy’s license and permanent license revocation for NECC’s three pharmacists. Recent state inspections of the closed-down Framingham facility found dirty and defective equipment and showed the company had failed to follow its own safety tests and properly sterilize tools.

Governor Deval Patrick said a federal criminal investigation has been launched, while Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said the company had been violating its state compounding license. The facility was licensed to produce medicine with a patient-specific prescription in hand, not manufacture large shipments.

As of this week, 304 people had contracted fungal meningitis or joint infections linked to the injectable steroid produced by NECC, reported The Boston Globe. Testing has found the fungus matches a type found in unopened vials of the steroid shipped from NECC, though they are still investigating how the fungus got into the vials. The injectable steroid is methylprednisolone acetate.

The 23 deaths linked to the defective steroid come from seven states. No one has been reported ill in Massachusetts. But federal officials say as many as 14,000 people may have been exposed to the contaminated drug between May 21 and Sept. 26, when it was recalled. The company went onto recall all its drugs.

The Food and Drug Administration released a list this week of more than 3,000 NECC customers who received products other than the injectable steroid blamed for the meningitis outbreak. They included 215 Massachusetts doctors, health centers and hospitals. The shipments fell within the time frame of when the defective steroids were produced at the facility.

Ameridose, a Westborough pharmacy with the same owners as NECC, has also been closed down since Oct. 10 in an agreement with state officials. It is scheduled to remain closed until Nov. 5 for state inspections.

Related:

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The DePuy Orthopaedics unit of Johnson & Johnson has recalled two types of hip implants that have failed one in eight patients and required a second surgery within five years. The standard hip implant lasts for 15 years.

DePuy recalled its ASR XL Acetabular System, a traditional hip implant procedure, and the ASR Hip Resurfacing System last week. Only the traditional hip implant procedure is available in the United States. About 93,000 DePuy devices have been implanted worldwide.

The recall was issued because of friction between the implant’s metal components. The friction generates metal ions which affect the healing of the joint in some people. The device is also difficult for surgeons to properly implant in the precise location.

In the past two years, the Food and Drug Administration has received about 400 complaints about DePuy hip implants.

The product recall is the latest in a series for Johnson & Johnson, which has pulled Tylenol and Acuvue contact lenses from shelves in recent months. The Tylenol recall is the subject of a federal inquiry over the company’s handling of over-the-counter product recalls.

If you have a DePuy hip implant, it is important you consult your surgeon. To find out what to expect, visit the Breakstone, White & Gluck website.

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