Boston Personal Injury Attorney Blog

When you hear the words “tire recall,” your mind likely goes to the major recalls that took place in 2000. These recalls were of Firestone tires on Ford vehicles including Ford Explorers and Mercury Mountaineers. The problems were occurring due to the tread of the tires peeling off in a process called tread separation. Once the tread peeled off, the tire began to disintegrate. When the vehicle was going at full speed with the failing tires, there was a significant risk of the vehicle rolling over. Several hundred deaths and injuries resulted from these roll-over accidents and a widespread and famous tire recall occurred that was widely reported.

While the Ford and Firestone tire recall was perhaps the most famous and well-known tire recall in recent years, the fact remains that there are also other dangerous tires out there. Our Boston defective tire attorneys have a list of a few other tire recalls that occurred during 2012 as well as some tips for staying safe and making sure you aren’t driving on defective tires.

Tire Recalls in 2012
As 2012 draws to a close, several tire recalls have occurred or are underway. For example:

• In July of 2012, CBS 6 reported that Michelin North America had instituted a voluntary recall of 841,000 BFGoodrich and Uniroyal Tires. The affected tires were produced between April 2010 and July 2012 and were mainly found on full-sized heavy duty vans and light commercial trucks. Some drivers, however, might have bought the tires and used them on their personal cars. The tires were being recalled due to a potential tread-belt separation issue. No injuries had been reported at the time of the recall, although there is an increased injury risk.
• In October of 2012, Consumer Reports indicated that Yokohama Tire was recalling almost 11,000 of its Avid Touring S Vehicle tires. The recall was apparently necessary because improper geometry created production flaws. The consequences of the flaws could include cracks in the sidewalls of the tires or a sudden decrease in air pressure in the tires, causing the risk of a crash to increase. Again, no injuries were reported at the time of the recall. The recall was limited to only one size of all season tires.

These recalls demonstrate that tire dangers are still present and that drivers of cars, trucks, motorcycles and other vehicles all could potentially be at risk.

Staying Safe From Tire Recalls
Since many tire recalls are not as well publicized as the Ford and Firestone tire disaster, it is important for every driver to stay aware about potential recalls that could affect him. Recalls.gov provides you with online resources where you can find out about any recalls related to consumer products and motor vehicles. Checking their website routinely can be a smart way to make sure you do not miss any news about tire defects.

If you do receive something from the manufacturer of your car or tires, then it is a good idea to open the correspondence immediately to make sure it is not a recall notice.

By keeping tabs on what tires are recalled, you can help to ensure that you and your loved ones avoid accidents due to tire defects.
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When a defective product or a defective medical device causes you harm, you can file a lawsuit against the manufacturer who produced that product. If a person is killed as a result of a defective medical product or device, his or her surviving family members can bring a wrongful death claim. Unfortunately, in some cases, it is very challenging to prove that the defective product was actually the cause of some type of compensable harm. For example, a drug may cause a bad side effect such as high blood pressure, but since lots of things cause high blood pressure it can be hard to link the use of the drug to the resulting medical problem.

In the case of GranuFlo, however, proving that the drug is dangerous may be a little bit easier. Our Boston dialysis malpractice attorneys explain why.

The FDA Recall of GranuFlo

In the United States, an estimated 400,000 people receive dialysis each year and approximately a third of those receiving dialysis use products from a company called Fresenius. One such product is called GranuFlo. GranuFlo is an alkaline intended to neutralize acids that build up in a patient’s body during dialysis. Unfortunately, GranuFlo contained a lot of a substance that converted to bicarbonate in the body. Clinicians weren’t aware of this and didn’t adjust their treatment accordingly, and many patients began to experience bicarbonate overdoses.

A bicarbonate overdose creates a risk of sudden cardiac arrest. Patients in Fresenius’ own dialysis clinics began experiencing serious complications and more than 900 suffered heart attacks by November of 2011 when Fresenius sent out an internal memo to care providers in their clinics warning them of the dangers. Despite the huge number of heart attacks, Fresenius did not warn the general public and many more patients at dialysis clinics throughout the U.S. continued to be given GranuFlo and continued to be at risk for cardiac problems.

The FDA, however, took action and a Class I recall was issued in March of 2012. Class I recalls are limited only to situations where there is a serious risk of injury or death.

What the Recall Means For Your Dialysis Malpractice Case
The FDA Class I recall is very important for patients who have already suffered a cardiac event as a result of a Fresenius product. It is also very important for family members who have lost loved ones due to the sudden development of cardiac arrest due to dialysis. The recall is important to these individuals not because it can stop a heart attack that has already happened, but because it provides evidence that the injured victims can use to get fair and just compensation from Fresenius.

The FDA warning helps patients to overcome the difficulties inherent in proving that a drug or device specifically caused harm. With the FDA’s class I recall, it is openly and clearly acknowledged that GranuFlo is dangerous and that it is linked to cardiac arrest. Patients, therefore, will be able to use this information in a personal injury action against the manufacturers for the defective dialysis drugs.
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The Food and Drug Administration (FDA) is responsible for regulating the drug and medical device industry in the United States. While the FDA has broad power when it comes to drugs and medical devices, many drug recalls are not done at the behest of the FDA but instead are voluntarily done by manufacturers who realize their products are dangerous. When the FDA recalls a drug product or medical device, it is because there are serious and proven complications associated with the drug or device.

In 2012, there were two products that the FDA recalled. One was called GranuFlo and one was called NaturaLyte. These products were dialysis products that were made by a company called Fresenius Medical Care. Our Boston dialysis malpractice attorneys want to make sure everyone is aware of the recall as well as of the impact that the recall has on the legal rights of patients who have experienced complications due to the defective dialysis products.

The Dangers of GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are both alkaline substances that are administered to patients undergoing dialysis in order to neutralize the acid that can build up in the patients’ blood streams. Unfortunately, they also contain more of a substance called acetate that converts to bicarbonate in the body.

Doctors and care providers in dialysis centers who are not aware of this may not adjust the amount of bicarbonate that they administer to patients. The acetate in the GranuFlo and NaturaLyte can, therefore, lead to an overabundance of bicarbonate in the body. This creates a serious cardiac risk. As a result, dialysis patients given GranuFlo or NaturaLyte had a higher rate of sudden cardiac arrest.

On November 4, 2011, Fresenius sent out an internal memo alerting its own clinics of the increased risk of cardiac arrest. The memo indicated that 941 patients undergoing dialysis had experienced cardiac arrest at a total of 557 different dialysis clinics run by Fresenius. When Fresenius compared the patients at their facilities experiencing heart problems to a group of 80,000 other dialysis patients, they found that there was a significant increase in the risk of heart problems in patients with excess bicarbonate. In other words, their GranuFlo and NaturaLyte were putting people at serious risk.

Fresenius unfortunately sent their memo only to their own clinics, not to the other dialysis patients throughout the country who were using their products. These patients were left facing a great risk of heart attack. The F.D. A., however, stepped in to issue a class I recall. The FDA initiated the Class I recall on March 29, 2012. The recall stated that the manufacturer cautioned clinicians to be aware of the bicarbonate problem.

Class I recalls are the most serious type of FDA recalls issued. They are issued in situations where there is a reasonable possibility that using the recalled product could cause serious adverse health consequences or could cause fatalities. The fact that the recall was issued is a strong condemnation of GranuFlo as a terribly dangerous product.

The FDA recall not only helps to prevent more people from being harmed by the dialysis defects but it also provides strong evidence of the link between the dangerous products and the resulting harm (in this case, the increased risk of heart attack). This makes it easier for patients who suffer harm, or for family members of those killed by sudden heart attacks, to take legal action since the FDA recall can be used as proof that the dialysis products were unreasonably dangerous.
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In the United States, there are approximately 400,000 Americans receiving dialysis. Unfortunately, those Americans were put at risk in 2012 because of a failure on the part of a company called Fresenius to warn doctors that its GranuFlo contained more of an ingredient that the body converts to bicarbonate. This was a problem because doctors failed to account for the extra bicarbonate, leading to a potential overdose.

Our Boston dialysis malpractice attorneys want to make sure patients and care providers are aware of the dangers of GranuFlo. We also want patients to understand that they may have legal rights due to the failure of Fresenius to act in making sure the risks of their products were properly disclosed.

FDA Investigation Into Fresenius After Reports of Trouble
In July of 2012, the New York Times published an article informing the public that Fresenius was under investigation as a result of their behavior surrounding GranuFlo. The New York Times succinctly summarized the problems that had arisen with GranuFlo and the failures of Fresenius to keep patients safe.

The Times article pointed out that in November, the medical office at Fresenius sent an internal memo to doctors practicing in the company’s own dialysis clinic. The memo contained a warning that the failure of doctors to use GranuFlo properly was leading to a sharp increase in the risk of patients suffering a sudden and fatal cardiac arrest. The memo urged doctors to address the issue “urgently.”

Despite the fact that the memo clearly acknowledged that GranuFlo could be extremely dangerous when doctors failed to account for the extra bicarbonates being produced, Fresenius did not issue a widespread warning to other dialysis centers. Fresenius Medical Care not only treats around a third of all U.S. dialysis patients, but it is also the leading supplier of dialysis products. Their failure to issue a warning on the GranuFlo risks, therefore, led to a serious and widespread risk for all dialysis patients throughout the country.

The New York Times explains that this failure on the part of Fresenius came to the attention of the Food and Drug Administration, who launched an investigation into whether the company violated federal operating regulations. Although the FDA is the regulatory agency in the United States responsible for overseeing the safety of drug and alcohol products, they do not have the resources to individually test for problems and monitor for every single potential complication for every drug on the marketplace. They rely, in large part, on data from manufacturers as well as reports from independent studies and details on consumer complaints in overseeing the drugs already for sale. Fresenius’ failure to alert the public, therefore, is a major problem since they may have failed to fulfill their obligations under federal law.

The New York Times indicates that a spokesperson for the company argued that they had no way of getting in touch with the dialysis centers using their product except by medical journal and that the findings were still too preliminary for publication. The problem, however, is that the company could have made the effort to communicate with customers and instead they failed to do so, putting patients at serious risk.
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The holiday season is a time when your kids probably got a lot of new toys. All of these new products coming into your home can provide your children with hours of fun over the holiday break and in the coming months. Unfortunately, they can also present a risk to your kids. The problem is that not every toy is safe and that parents often are unaware of recalls or dangers until it is too late and their kids have suffered an injury.

Every effort is made to try to stop defective and dangerous toys from coming into the country or being sold. Unfortunately, our Watertown personal injury attorneys know that bad toys still make it to the shelves and into people’s homes every day. As a parent, the best thing you can do is to become aware of toy recalls, to educate yourself about toy dangers and to supervise your kids as they play with new gifts.

The Latest Toy Recalls
On November 29, 2012, the U.S. Consumer Product Safety Commission (CPSC) released a news report on their joint efforts with U.S. Customs and Border Patrol (CBP). According to their report, they indicated that more than 2 million dangerous or defective items were kept out of the hands of kid this year as a result of CPSC and CBP efforts. Further, over the past four years, more than 8.5 million units of around 2,400 different toys and products have been seized at ports coming into the United States.

Despite the effectiveness of efforts to stop dangerous toys from coming into the U.S., kids still die each year as a result of incidents involving either imported or locally-made toys. The CPSC 2010 report on toy recalls indicated that there were 44 recalls in 2010 and that 15 kids died because of toys in 2009.

Avoiding injuries and deaths due to dangerous toys is a top priority in 2013 and in the future. To help ensure your child doesn’t become a statistic, keep up to date with the latest recalls on toys. Some of these recalls include:

• The Izoard XP Bicycles. These bicycles were recalled by Wilier Triestina due to a fall hazard. Information on refunds or replacements can be obtained at (888) 849-7779.
• Norco Havoc Bicycles from 2011. Norco is recalling the bikes as a result of the risk of cracking at the joint near the intersection of the down and top tube. For more information on the recall or a replacement, call (800) 227-5579
• Bath seats from Dream on Me. The recall in this case was prompted by a drowning hazard. The seats tip over too easily, putting kids at risk. Call (877) 201-4317 to get your free replacement.

These are just a brief sampling of some of the latest toy and kids products that could present a danger. To make sure that your child has a safe holiday season, Recalls.gov provides you with a detailed list of appropriate websites to visit to learn all about recalls on all different products. The U.S. Consumer Product Safety Commission also maintains a page on their site dedicated to Recalls and Product Safety News that you can visit to keep up-to-date.
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