Archive for the ‘Product Safety’ Category

Yamaha Rhino goes to court in Georgia – not happy with verdict!

June 3, 2010

When the weather is warm, outdoor activities are the amusement. Expecting them to end in injury usually isn’t the case!

In Gwinnett County, GA, Roger McTaggart was injured in 2007 while riding his Yamaha Rhino recreational utility vehicle. Mr. McTaggart and his wife, Glenda, sued Yamaha Motor Corporation USA, which happens coincidentally to be located in Gwinnett County.

The McTaggart’s case is just one of over 100 cases that allege the Rhino recreational vehicles are unsafe. The Rhino vehicles are alleged to have latent stability defects which cause the vehicles to unexpectedly roll over.

Similarly, the McTaggart’s claimed early in their case that the stability defect caused Mr. McTaggart to unexpectedly roll his vehicle at a low speed and on relatively flat ground.

McTaggart was driving his Rhino and stopped the vehicle. He then starting going forward again and turned the steering wheel to the right, “and the Rhino tipped onto the driver’s side, trapping his leg under the vehicle,” according to McTaggart’s complaint.

McTaggart sustained a “crush” injury in which the “skin exploded” and bone was exposed, Childers said.

Mr. and Mrs. McTaggart also argued that the recreational vehicle should include a barrier which would keep the rider’s legs inside the vehicle. Yamaha rebutted the argument, claiming that doors for the vehicle were produced and added three the four months after Mr. McTaggart’s leg injury.

During the two week trial, all experts, including plaintiffs, concluded that the accident could only have happened while Mr. McTaggart was riding on a side incline, not on an relatively flat and uneven surface. Counsel for the McTaggart’s focused arguments on the fact that had the vehicle contained doors,  Mr. McTaggart’s legs would not have been injured when the unexpectedly vehicle rolled over.

After 10 hours of deliberation, a Gwinnett County jury awarded $317,002 to the plaintiffs. Compensation included pain and suffering, medical expenses, lost wages, future lost wages and loss of consortium for Mrs. McTaggart. The plaintiffs’ attroney, Andrew Childres, claimed that the jury was swayed by Yamaha’s lack of performance testing on the Rhino recreational vehicle, with particular focus on “occupant containment”.

Yamaha claims that the company is upset by the verdict and there is a chance for appeal in the Gwinnett County case. The well known motor-sport company further states:

[We are]…saddened whenever anyone is injured in a Yamaha product-related accident, and we urge all our customers to follow the safety recommendations on our products and, as importantly, to always operate the products in a safe and responsible manner.

As we enter the summer months, it is important to remember that safety is the number one key to outdoor activities. When operating motor vehicles, of any kind, be sure to heed all safety precautions to ensure safe amusement.

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Connecticut Jury Awards Smoker $8 Million Against Tobacco Co.

June 3, 2010

Despite the national headlines over the past decade or more regarding tobacco litigation, the state of Connecticut had never before seen a successful product liability action against a tobacco company. That is, until Barbara Izzarelli recently prevailed in her case against tobacco giant R.J. Reynolds. Law.com recently reported that a federal jury awarded Ms. Izzarelli $8 million as compensation for larynx cancer that she developed at age 36 and which she contended was caused by smoking R.J. Reynolds cigarettes for more than twenty years.

The case focused on R.J. Reynolds’ marketing strategy, primarily the company’s alleged efforts to specifically target the teen market back in the 1970’s when Ms. Izzarelli was a teenager and first began to smoke. Her attorneys, led by David Golub of the law firm of Silver, Golub & Teitell, alleged that R.J. Reynolds conducted marketing research on the smoking habits of youths as young as twelve and implemented various business practices directed at luring young people to cigarettes.

[Golub] contended that in the 1970s, after young smokers were attracted to flip-top boxes in which Philip Morris’ Marlboro cigarettes were sold, R.J. Reynolds developed new products to appeal to 14- to 20-year-olds. Golub further argued that those cigarettes were sold in popular teen hang-outs and at reduced prices.

While the jury found in Ms. Izzarelli’s favor, it did not absolve her completely of her own conduct in choosing to smoke for more than twenty years. The original verdict had been $13.6 million, but the jury found that Ms. Izzarelli was 42% at fault so the verdict was reduced to $8 million (Connecticut recognizes the doctrine of comparative negligence, meaning that a jury award can be reduced depending on whether, and to what extent, the plaintiff was negligent.). Still to be decided is the issue of whether R.J. Reynolds should be subjected to punitive damages, i.e., a monetary award intended to punish the company and deter others from engaging in similar conduct. Should punitive damages be assessed, the total award could potentially be as high as $24 million.

For Ms. Izzarelli, who will soon turn 50, this verdict was a long time coming. She was originally diagnosed with larynx cancer in 1996. She filed suit eleven years ago in 1999. According to her attorneys, she is currently “very disabled” and is unable to breathe through her nose or mouth. She instead uses a tube inserted in her throat. Because of her injuries, her diet is restricted to soft foods. Despite these limitations, Mr. Golub calls her “a remarkable woman to overcome these health problems and lead a normal life as much as she can.”

Despite the decade-long efforts to seek redress for her injuries, the verdict and the jury award are still not final. According to David Howard, a spokesperson for R.J. Reynolds, the company has promised to appeal the verdict.

“We’re disappointed in the decision in this matter,” said Howard. “We have several grounds for appeal and we are confident in our defenses going forward.”

Early comments by the defense indicate that R.J. Reynolds will challenge the trial court allegedly denying it the right to put on a ‘full medical defense’ in which Reynold intended to show that it was improbable that the plaintiff’s injuries were related to her smoking. The second issue mentioned post-verdict was the perceived error by the trial judge allowing “all youth marketing evidence despite the fact that, before trial, one of the plaintiff’s claims was dismissed because there was no evidence that the plaintiff was affected by any quote, unquote youth marketing.”

We will keep you posted on any developments in this case.

Child Safety Tips: As mercury goes up, so do safety risks for kids!

June 2, 2010

By picpoke.com

Yes, it is really getting hot out there this week!!!  Coming from Florida to DC last year, I thought “OK, so it will not get nearly as hot up here, or at least not as early in the summer.”  Yes, I was wrong.  This thought brought me to thinking about some of the fun things to do in the summer, but also the dangers for our little ones during this time if we are not extra careful.  Lo and behold, I found this article today, courtesy of the Dallas Morning News and reprinted by the Kansas City Star:

Emergency-room professionals have their own name for the long, lovely, lazy days that kids look forward to in summer: trauma season. Because that’s when hospitals see a spike in drownings and heat-related accidents.

The article discusses several myths and related facts associated with those myths.  Here are a few samples from the article:

MYTH: Pool parties are safe as long as adults are around.

FACT: Many drownings happen when adults are close by. The problem is too much commotion. The key is to have a designated adult watching the water because that is where the danger is. The pool should be free of excess toys that can block the view of the water.

MYTH: Floaties keep little ones safe in the water.

FACT: Floaties are designed for fun, not safety. They give a false sense of security, can deflate and can slip off.

MYTH: The kids will be fine in the pool for the short time it takes to answer the phone or get a cold drink.

FACT: In a minute, a child can go under water. In two or three minutes, the child can lose consciousness. In four or five, the child could suffer irreversible brain damage or die. According to the Centers for Disease Control and Prevention, drowning is the second-leading cause of unintentional, injury-related death for children 1 to 14 years old, second only to car and transportation-related accidents.

The article states several other myths and facts, which include the hazards of leaving children unattended in cars and car seats, as well as sun exposure and dehydration.  We encourage you to read the article in its entirety.  Let’s all have a safe summer out there, please!!

Child Health: Labels Urged for Food That Can Choke

May 27, 2010

Earlier this year, we posted a blog on our website in regard to the American Academy of Pediatrics (AAP) policy statement in regard to the prevention of choking among children.  Earlier this week, the New York Times featured an in-depth story on an issue that is very much a part of this policy statement:  food choking hazards among small children.  The article discusses the advocacy efforts to place warning labels on foods, which pose a choking hazard to small children, as well as the proposition that small children should not be allowed to eat certain foods at all.  The article starts with an all too familiar setting that ended in tragedy:

On a July afternoon in 2006, Patrick Hale microwaved a bag of popcorn for his two young children and sat down with them to watch television. When he got up to change the channel, he heard a strange noise behind him, and turned to see his 23-month-old daughter, Allison, turning purple and unable to breathe.

As a Marine, he was certified in CPR, but he could not dislodge the popcorn with blows to her back and finger swipes down her throat. He called 911, but it was too late: by the time Allison arrived at the hospital, her heart had stopped beating. An autopsy found that she had inhaled pieces of popcorn into her vocal cords, her bronchial tubes and a lung.

Does this story make you think twice before giving your little ones popcorn?  On a personal note, I called my wife immediately after reading this story, and we discussed the fact that we should no longer allow our son, who is now two and a half, to have any popcorn. Ironically, she was on her way to take him to a movie that was going to be serving….you guessed it, popcorn.

Now, some of you may say “Well, little kids can choke on anything.”  Well, that is true.  However, there are some foods that pose an increased risk of choking.  Consider the dynamics of how a small child eats, as well as the size of their airway:

Children under 4 are at the highest risk, not only because their airways are small (the back of a toddler’s throat narrows to the diameter of a straw) but also because of the way their eating abilities develop. Front teeth usually come in at 6 or 7 months — so babies can bite off a piece of food — but the first molars, which grind food down, do not arrive until about 15 months, and second molars around 26 months.

“Between the ages of 3 and 4, they’re developing their ability to chew adequately and prepare for swallowing,” said Dr. Nisha Kapadia, a pediatric resident at Johns Hopkins Children’s Center.

When young children chew foods like peanuts, raw carrots and popcorn, some is ground down and some is not, and they tend to swallow unchewed bits of food that can block the airway or be inhaled into the bronchial tubes and lungs.

This concern and the tragic deaths associated with this concern have prompted several organizations to propose various options to attempt to prevent these injuries and deaths.  One such organization is the Center for Science in the Public Interest:

Some advocates say the government should put hazardous foods off limits to young children.

“The F.D.A. needs to set a uniform standard for cautionary information on food that should not be consumed by children under 5,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest, an advocacy group that lobbied unsuccessfully in 2003 for a bill to require the Food and Drug Administration to develop food labeling regulations.

Where this debate will end up, we don’t know.  However, to think that in 2001 there were 17,500 children 14 years old and younger treated in emergency rooms for choking, with 60% of those events caused by food, there must be a way to create a safer environment for our children when they are eating.  Any suggestions?

Product Safety Alert: Children’s Giraffe Blanket Recalled Due to Choking Hazard

May 21, 2010

Approximately 44,000 giraffe blankets have been recalled by the Consumer Product Safety Commission (CPSC), due to the balls on the top of the horns detaching, and posing a choking hazard to small children.  The giraffe blankets are sold exclusively at Target Stores.  The full details on the recall can be found by clicking here.  

The recall states that, thankfully, no injuries have been reported, as of this publication.  The product is imported by Rashti and Rashti out of New York, and details on the recall can be found on their website, as well.  As the CPSC recall notice states “Consumers should immediately take the recalled blankets away from children and contact Rashti & Rashti for a full refund.”

Even though no injuries have been reported, let’s keep it that way! Follow the recommendations even if your child may cry for a bit when you take away their ‘security blanket.’ A sad but safe child sure beats the alternative.

Allergic to Dairy? Read Before Eating Those Sunflower Seeds!

May 19, 2010

Ryt-Way Industries, LLC, a food packaging company, is immediately recalling some of the sunflower seed products that they have packaged, as they contain undeclared dairy ingredients.  The recall, which includes products that have been distributed nationwide, is a voluntary recall, and is being done in conjunction with the FDA:

Ryt-way Industries LLC of Lakeville, MN is voluntarily recalling select BIGS ® Original Salted & Roasted Sunflower Seeds because they may contain dairy ingredients that were not declared on the packaging.  The product is packaged in 5.35oz plastic bags with BEST BY Dates of 30MAY2011 and 31MAY2011 with an individual bag UPC code 896887002196.  People who have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume these products.

It was discovered that the sunflower seed packages at issue, as manufactured by BiGS, do not disclose the presence of dairy within them.  Ryt-Way goes on in their announcement to instruct consumers that are allergic to dairy how to handle this situation, should they be in possession of these recalled items:

Consumers who are allergic to dairy and who have purchased the recalled products are advised not to consume the product and are urged to return it to the place of purchase for a full refund.  Consumers with questions may contact 1-877-722-7556

So, if you are allergic to dairy and/or have a sensitivity to dairy products, and love those sunflower seeds, please check your home for these recalled products.  As the weather gets warmer and we try to snack on “healthier” items to get that “younger figure back for summer”, don’t let this recall pass you by!

Hot Air Balloon Goes Up in Flames – Canada

May 14, 2010

A pleasant hot air balloon ride in Vancouver proved deadly for some.

Twelve passengers gathered aboard the balloon and prepared for takeoff, when suddenly flames erupted from above. It was discovered that the tubing of the balloon providing the propane to the burners which heat the  air came loose. When the tube broke loose, fire began spraying wildly into the basket where  passengers had been patiently awaiting lift-off.

MSNBC News reported that Canadian authorities confirmed two of the twelve passengers aboard did not make it out. As the balloon began to rise and the fire spread, there was no chance for escape.

Of the survivors, Jack Ziyone and his family escaped with relatively minor injuries; while others suffered burns and other injuries. The two passengers that did not escape had been the wife and daughter of a survivor.

“When I was on the ground, he was crying and pointing up,” Jack said. “‘My wife and daughter are up there!’ He was crying. He couldn’t do a thing about it.”

The veteran pilot, whose name was not released, had taken 10,000 passengers aloft throughout his career. He escaped with severe burns and was also hospitalized.

Nigel Vonas, an onlooker, who caught the sight on video stated:

It was just excitement to see something very strange going on in the sky. Those thoughts quickly turned to morbid thoughts that perhaps there was something very wrong going on up there.

All I can come up with is just a very simple message: Life is precious… We need to stop for a second. Put down the iPhones, put down the guns and just realize that life is beautiful. You never know when it’s going to be your last chance to say ‘I love you’ to the person beside you.

He’s right – you never know. Tragedy strikes so quickly. The common and expected things in life we take for granted so often. Sometimes, the unexpected happens and our lives are never the same again. But you know that – just keep remembering it.

Infant Safety – drop-down crib hazard; CPSC issues recall

May 11, 2010

In February of this year, we reported on the Consumer Product Safety Commission’s (CPSC) commitment to crack-down on the defective crib issues that have resulted in multiple deaths of infants on our blog site.  A report just released by the CPSC, which involves a comprehensive review of crib-related fatalities since January 2000 revealed the tragic statistics:  32 deaths since January 2000 and hundreds of related instances related to drop-side detachments in cribs:

In addition to the 32 deaths the CPSC staff associated with the drop-side detachments, CPSC has received an additional 14 reports of infant fatalities due to entrapment in cribs that could be related to a drop side. The information obtained was insufficient for staff to conclusively determine whether or not the drop side was involved. Of the 32 deaths that were analyzed, some occurred in cribs where the drop side detached without caregivers noticing the detachment, while some other deaths occurred after a consumer tried to repair the detached drop side, but the repair ultimately failed.

As a result, the CSPC is issuing a voluntary recall of ALL drop-side cribs, effective June 1, 2010. There will be new improved mandatory standards for cribs as well.  The CPSC announcement also provides cautions regarding older cribs and reminds parents to not use cribs with broken, missing of loose parts.

Let’s hope these new standards save infants from injuries and death!

Guidant’s Guilty Plea for Failure to Notify FDA of Defective Defibrillators Takes New Twist – Will Plea Agreement be Accepted by the Court?

April 24, 2010

Just over two weeks ago, the newswires were advising the public that Guidant LLC, a unit of Boston Scientific Corp, had been implicated in short circuiting failures of three models of their implantable cardioverter defibrillators (ICD’s). At issue in the charges brought last November by the Department of Justice were 20,146 devices identified as the Ventak Prizm 2 and Contak Renewal 1 and 2 defibrillators. It was also reported that Guidant pleaded guilty to the criminal charges. Guidant’s defibrillators became available to the public in 2005.

Dr. Ananya Mandal, the author of one of the lead articles relating to the case at that time, provided the following information about the devices:

The implantable cardioverter defibrillator (ICD) is a life saving battery operated device much like a pacemaker that is placed near the heart in a minor surgical procedure. This device detects abnormal heart rates and rhythms in the patient and delivers an electric shock to make the heart beat normally again. These save millions of people in the US and all over the world from sudden death.

As a result of the proposed plea agreement, Guidant has agreed to pay a combined criminal penalty of more than $296 million, which, according to a report in Reuters, is “the largest criminal penalty against a medical device company.”  In essence, the charges stemmed from Guidant’s withholding information from the U.S. Food and Drug Administration regarding catastrophic failures in some of the devices. According to this same Reuters report, “Boston Scientific reached a settlement with defibrillator patients in 2007 covering the 2005 product issues and additional issues the following year. It agreed to pay up to $240 million to cover up to 8,550 claims, including ones collected in a multi-district litigation case.”

This plea agreement is currently being considered by U.S. District Court Judge Donovan Frank, who announced at a hearing on April 5, 2010, that he would make his decision as to whether or not to approve the plea agreement within three weeks of that last hearing.  If he stays within the self-imposed time limit, his decision should be announced this coming week.

Photo of Ventak Prizm 2 by mindfully.org

Last week, however, a new twist to the case was reported by several news sources, including one posted by Reuters this past Thursday, April 22, 2010 – “two cardiologists who cared for a 21-year-old college student who died when his implantable defibrillator made by Guidant failed to deliver a life-saving shock are urging a federal judge to reject a plea agreement with the company.” These physicians are identified as Dr. Robert Hauser and Dr. Barry Maron.

The doctors’ comments in a letter to Judge Frank bear quoting:

“We are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act.

“On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.

“To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.”

Whether the judge heeds the words of these physicians or not remains to be seen. What is absolutely laudatory is the fact that these physicians have expressed their outrage as to this manufacturer’s conduct.  Are they not correct – the money paid both through civil settlements and, if approved, by virtue of the criminal charges will be “entirely borne” by the company’s shareholders? Where is the personal accountability for this outrageous conduct?  Our system of justice is one not only of compensation to the victims of such heinous conduct but also should serve to deter other individuals from taking the same life-threatening conduct in the future.  There is nothing like a good long jail sentence for those involved in this horrible scheme to deter other corporate executives from going down the same path of profit at all costs – even to human life.

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

April 12, 2010

The FDA has recently launched a comprehensive new study regarding ways to reduce radiation exposure as a result of medical imaging.  The on-line article sets the background for the study, then provides comprehensive scientific and medical information for support:

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks.  These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions.  At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer.  As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of these medical imaging exams while minimizing the risks.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.  Each patient should get the right imaging exam, at the right time, with the right radiation dose.

The related White Paper discusses types of medical imaging procedures,  factors causing the unnecessary exposure, and proposes possible solutions.  The factors include: Issues relating to Device Use, as well as Issues Relating to Clinical Decision Making.  Solutions include: Promoting Safe Use of Medical Imaging Devices, supporting informed clinical decision making, as well as increasing patient awareness.