FDA Announces Effort To Reduce Radiation Overdose Medical Malpractice

In my January 25 blog post, I discussed a phenomenon that should be of concern to patients in Massachusetts and elsewhere – the prevalence of medical malpractice involving radiation overdose.
This week, the Food and Drug Administration announced its “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.” The initiative will focus on two goals: 1.) insuring the medical necessity of any imaging procedure and 2.) optimizing the amount of radiation necessary for each procedure.
Over the past two decades, Americans’ exposure to ionizing radiation has nearly doubled. This increase in radiation exposure is largely attributable to exposure from CT scans, fluoroscopy and nuclear medicine. According to one study, the CT scans performed in the United States in 2007 alone could lead to 29,000 additional cases of cancer down the road.
It will be interesting to see how successful the FDA is in persuading the medical profession to use medical imaging only when necessary, especially in light of how profitable such procedures are for hospitals.
The corporate defense blog Mass Tort Defense has more on this story.

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Toyota Recall II: Is Sudden Uncontrolled Acceleration Something To Be Worried About?

The pro-business blog Point of Law insists, citing to an article in Popular Mechanics, that the dangers posed by Toyota’s acceleration system are overblown. Meanwhile, Department of Transportation head Ray LaHood is telling Toyota owners to stop driving (at least until political concerns cause him to backtrack).
Who do you trust?
Someone should tell Popular Mechanics that forty-one percent of reports of sudden uncontrolled acceleration are about Toyotas. Meanwhile Toyota held about 16 percent of US market share in 2009. Sounds statistically significant to me.

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Consumer Product Safety Commission Tells Massachusetts Parents To Stop Using Cribs

Today the Consumer Product Safety Commission issued an immediate recall of “Generation 2 Worldwide” and “childESIGNS” drop side cribs because of the risk of death from suffocation or strangulation created by the cribs’ drop side design. The recall notice urges parents to stop using the cribs immediately and not to attempt to fix the cribs’ design flaws. Here is a copy of the notice in its entirety:
Generation 2 Worldwide and “ChildESIGNS” Drop Side Crib Brands Recalled; Three Infant Deaths Reported

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is announcing the recall of all Generation 2 Worldwide and “ChildESIGNS” drop side cribs. CPSC is warning parents and caregivers who own these drop side cribs that infants and toddlers are at risk of serious injury or death due to strangulation and suffocation hazards presented by the cribs. CPSC staff urges parents and caregivers to stop using these cribs immediately and find an alternative, safe sleeping environment for their baby. Do not attempt to fix these cribs.
The crib’s plastic hardware can break which can cause the drop side of the crib to detach from a corner of the crib. When the drop side detaches, it creates a space into which an infant or toddler can roll and become wedged or entrapped. When a child is entrapped between the drop side and the crib mattress, it creates a risk of suffocation or strangulation. In addition, the crib’s mattress support can detach from the crib frame, creating a hazardous space in which an infant or toddler could become entrapped and suffocate or strangle.
CPSC has received reports of three infants who suffocated when they became entrapped between the crib mattress and the drop side when the drop side detached. In July 2007, an eight month old child from Newark, Ohio suffocated when he became entrapped between the drop side and the crib mattress. The drop side of his crib had detached due to a broken plastic stop tab on the lower track. In October 2003, an eight month old child from Richmond, Ind. suffocated when he became entrapped between the drop side and the crib mattress. The plastic hardware on the drop side was broken and allowed the drop side to detach from the crib headboard in one corner. In September 2002, a six month old from Staunton, Va. suffocated when he became entrapped between the drop side and crib mattress. The lower drop side track was missing two screws which allowed it to pull away from the headboard post and detach.
CPSC has also received reports of 20 other drop side incidents, 12 of which involved the drop side detaching in a corner of the crib. In two of these incidents, a child became entrapped. One child suffered bruising from the entrapment. There are five reports of children falling out of the cribs due to drop side detachment. One child suffered a broken arm as a result of the fall.
In addition, CPSC has received 8 reports of mattress support detachment in these cribs. Due to the space created by the detachment, three children became entrapped between the crib frame and the sagging mattress and four children crawled out of the crib. There was one report of cuts and bruises.
Due to the fact that Generation 2 went out of business in 2005, CPSC has limited information about the cribs. Although CPSC does not know the total number of units distributed or the years of production, it is believed that there were more than 500,000 of these cribs sold to consumers. Some of the known model numbers are: 10-110X, 10-210X, 21-110X, 20-710X, 64-315X, 26-110X, 90-257X, 20-810X, 46-715X, 64-311X, 74-315X, 21-815X, 21-810X, 20815X, 308154 and 54915. (The “X” denotes where an additional and varying number may appear at the end of the model number.) However, all Generation 2 Worldwide and “ChildESIGNS” drop side cribs are included in this recall, including those with other model numbers.
The name “Generation 2 Worldwide” appears on a label affixed to the crib’s headboard or footboard. Some labels identify the place of manufacture as Dothan, Ala. Others identify China as the country of manufacture. The name “ChildESIGNS” appears on the teething rail of some of the cribs.
The recalled cribs were sold at numerous local furniture and retail stores including Buy Buy Baby, and Kmart and Walmart stores nationwide for between $60 and $160. Consumers should contact the store from which they purchased the crib for remedy information, which will vary between a refund, replacement crib or store credit, depending on the retailer. Consumers are urged to contact CPSC and report any difficulties in obtaining a remedy from their place of purchase.
Important Message from CPSC:
CPSC would like to remind parents not to use any crib with missing, broken, or loose parts. Make sure to tighten hardware from time to time to keep the crib sturdy. When using a drop-side crib, parents should check to make sure the drop-side or any other moving part operates smoothly. Always check all sides and corners of the crib for disengagement. Any disengagement can create a gap and entrap a child. In addition, do not try to repair any side of the crib, especially with tape, wire or rope.
For more information on Crib Safety, visit CPSC’s Crib Information Center.
Picture of Recalled Drop Side Crib Picture of name ‘ChildESIGNS’ on teething rail

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Massachusetts Women Should Be Aware Of The Risks of Yaz

According to this news article, fifty Indiana women have sued Bayer, the maker of the Yasmin (or “Yaz”) birth control pill, because their use of the pill caused serious health problems, such as stroke and heart attacks.
Yasmin or “Yaz,” has been sold since 2001. It contains a hormone known as drospirenone that can lead to high levels of blood potassium. High levels of potassium can, in turn, lead to a condition known as hyperkalemia, which can be responsible for heart attacks, blood clots and circulatory problems.
In the past few months, dozens of lawsuits have been filed against Bayer, claiming that Yaz is unsafe. The Food and Drug Administration has issued a warning letter concerning Yaz, however Bayer has not recalled the product.
To date, no Yaz lawsuits have been filed in Massachusetts. We will update you if Massachusetts women do become part of this litigation.

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Toyota Acceleration Problem Poses Dangers For Massachusetts Drivers

Earlier this week, a third wrongful death lawsuit was filed against Toyota relating to acceleration problems that have caused Toyota vehicles to accelerate suddenly and uncontrollably.
This third lawsuit was filed by lawyers for Trina Renee Harris, a 34-year old mother of two, who was killed when her 2009 Toyota Corolla slammed into a cement divider on a toll road. There were no skid marks or other evidence of an attempt to brake.
Harris’ apparent inability to stop the car is consistent with reports of other recent Toyota crashes. In August, an off-duty California state trooper and three of his family were killed after the Lexus they were driving accelerated to 120 m.p.h. In a telephone call to 911 that the family made while trapped in the speeding Lexus, the family explained to 911 dispatch that the car was accelerating without their being able to control it.
Another Toyota driver, Bulent Ezal, had his Camry suddenly accelerate in a restaurant parking lot and plunge 70 feet off a cliff, landing in the ocean. Ezal’s wife was killed in this accident.
Thankfully, not all of the accidents have been fatal. One driver, Joseph Hauter, survived a crash that occurred when his 2008 Toyota Camry suddenly accelerated at a gas station. Investigators are looking into several other non-fatal accidents in multiple states.
Thus far, there have not been any reports of Massachusetts Toyota drivers being involved in sudden acceleration crashes. However, Massachusetts drivers need to take precautions because Toyota cars seem especially prone to this problem. As the Consumerist blog reports, 41 percent of sudden acceleration complaints that were made in 2008 were for Toyota and Lexus models.
Lawyers for the car accident victims in these cases believe that the problem lies in an electronic throttle system that was installed in many Toyota models. The electronic throttle system does not have any mechanical link between the accelerator pedal and the engine. In addition, there is no override system for the electronic throttle, so that pressing the brake when the throttle is stuck will not cause the accelerator to shut off.
Toyota has instituted a nationwide recall to attempt to address the problem. The vehicles affected by the recall include:

  • 2009-2010 RAV4
  • 2009-2010 Corolla
  • 2007-2010 Camry
  • 2009-2010 Matrix
  • 2005-2010 Avalon
  • 2010 Highlander
  • 2007-2010 Tundra
  • 2008-2010 Sequoia

Lexus models were not included in this recall, although, as noted above, Lexuses have been the subject of complaints and at least one wrongful death suit. If you own a Toyota model listed in the recall, or one not listed that you are concerned about, you can call Toyota’s customer service department at 1-800-331-4331.

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First Denture Cream Wrongful Death Lawsuit Filed

A wrongful death lawsuit has been filed in Florida, alleging that a sixty-four year old man died from zinc poisoning resulting from his use, over fourteen years, of the denture cream Poligrip. This is widely believed to be the first such wrongful death lawsuit filed in the United States, although scientific research about the hazards of denture cream has been accumulating for several years and other lawsuits have been filed that have alleged non-fatal instances of zinc poisoning from denture creams.
In 2008, the scientific journal Neurology published a case study of four people suffering from zinc poisoning that was traced to their use of denture creams that contained zinc. Since that time, several lawsuits have been filed on behalf of denture cream users who suffered neuropathy (pain in their extremities) and other neurological disorders caused by zinc overdose.
The wrongful death lawsuit that has just been filed alleges that, over a fourteen month period, the denture user’s zinc poisoning caused a decline in health that led to paralysis and, ultimately, death. We will keep you updated on future developments in denture cream litigation and the underlying scientific research.

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Baby Stroller Recall: Important News for Massachusetts Parents

As this Times article details, Graco Children’s Product, Inc. has recalled 1.5 million of its baby strollers because defective hinges on the stroller can amputate children’s fingers.
The defective strollers were sold in Massachusetts stores including Walmart, Babies R Us, Toys R Us, and Target between 2004 and 2008. The strollers affected by the recall are strollers marketed as part of the Graco’s Passage, Alano, Spree Travelers and Travel Systems lines.
The official recall notice can be read by clicking here.
If it seems to you that between the Toyota recall, the Graco recall, the crib recall and others, there has been a wave of massive product recalls lately, you’re right. As the Pop Tort blog explains, this increase in product recalls is partly the result of stepped-up enforcement by the Consumer Products Safety Commission after years of neglect under the Bush administration.

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Medical Malpractice Involving Radiation Overdose: A Troubling Phenomenon

Yesterday’s New York Times carried an eight-page story entitled “Radiation Offers New Cures, and Ways to Do Harm,” dealing with a surprisingly prevalent form of medical malpractice: radiation overdose.
The story – detailing the progression of radiation poisoning – is as gruesome to read as John Hershey’s Hiroshima, but there are some important takeaways for medical malpractice attorneys.
First, radiation overdoses are disturbingly common – the story cites to one hospital that did not detect an error in its machine’s calibration for more than a year. Second, they are dramatically unreported. One doctor quoted in the story, Dr. Fred A. Mettler, Jr., estimates that only about half of radiation overdoses are ever discovered and reported.
The source of the problem seems twofold. First, doctors are transitioning from the old-fashioned way of administering radiation therapy – an unfocused beam of weak radiation – to the newer method of focused, high-energy radiation administered by linear accelerators. Second, the software that is used to operate these linear accelerators does not seem to have enough fail-safes to make sure that the so-called “multileaf collimators” – equipment that shields the patient – is deployed in the right position.
Radiation overdose is really the intersection of two personal injury fields: medical malpractice (committed by the doctors and other technicians who operate the linear accelerators) and products liability (for the dangerous designs of some of these machines and their software). Decades of products liability litigation has made the industrial workplace safer by sending engineers back to the drawing board to design newer and safer machines. A wave of safety innovation has been the result and today’s factory floor is no longer the same threat to life and limb that it once was.
Let’s hope that medical malpractice and product liability lawsuits against the doctors who operate these linear accelerators and the manufacturers who design them will lead to similar product re-designs, so that simple mindless errors in the radiation ward no longer cause unspeakable tragedies.

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Lawyers In Massachusetts And Elsewhere Ponder Whether Football Helmets Cause Head Injuries: Part II

Assuming that the modern-day football helmets effectively prevent against the most serious head injuries – such as fractured skulls – but are ineffective in preventing other sorts of head injuries would Massachusetts product liability law regard the typical football helmet as a dangerous or defective product?
That’s a good question and there’s really no clear cut answer under Massachusetts law right now since there are no cases directly on point. Despite the lack of case law to guide us, there are a few things that we can say for certain. Massachusetts law recognizes three main types of product liability claims:
1. Manufacture defects: These types of cases involve something that went awry in the factory – basically this is a case when the machine spits out an irregular product, but it gets packaged up and sold anyways and the manufacture defect causes injury.
2. Design defects: This type of case involves a product that was manufactured as intended but the design concept was unreasonably dangerous.
3. Failure to warn: This is a claim that the product did not provide an adequate warning about a danger involved in its use and this failure-to-warn caused an injury.
If the safety of football helmets were litigated in Massachusetts, a player’s claim would like be premised on both a failure to warn theory and a design defect theory.
It would most likely be up to a jury to consider whether modern day football helmet has any design defects and, in weighing that question, a Massachusetts jury would be asked to weigh several factors:
-the gravity of the danger posed by the current football helmet design
-the likelihood that head injury will result from the use of the helmet
-the technical feasibility of a safer alternative design
-the financial feasibility of that alternative design, and
-any other consequences likely to result from the alternative design
However, even if a jury were to conclude that there exists a cost-effective design that would be more effective in preventing head injuries than the current football helmet design, the manufacturer might still have a few defenses under Massachusetts law: the so-called Vassallo defense and Correia defense. (The defenses are named after the Massachusetts cases that bear their name).
The Vassallo and Correia defenses would exonerate a defendant if either: 1. the danger could not be detected by reasonable testing at the time the product was sold or 2. the consumer unreasonably continues to use the defective product after becoming aware of its dangers. The relevance, if any, of these defenses would really only come out through litigating the case.
As you can see, a design defect case can be difficult to prosecute and normally requires expert testimony from engineers or other design defects. Failure-to-warn cases tend to be the simpler variety of products liability litigation.
If a football player were successful in such a products liability case who would be held liable? The helmet manufacturer and merchant who sold the helmet would definitely be liable and, under Massachusetts law, the school or team supplying the defective helmet might also be held responsible.
Will football helmet litigation ever take off in Massachusetts? Who knows. But let’s hope that we do see safer helmets down the road, so fewer players meet the plight of former Patriots linebacker Ted Johnson and others like him.

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Lawyers In Massachusetts And Elsewhere Ponder Whether Football Helmets Cause Head Injuries: Part I

In November, a Wall Street Journal article asked, “Is It Time to Retire the Football Helmet?” At the beginning of this month, Representative John Conyers (D-MI), of the House Judiciary Committee, held the second part of a hearing on whether football gear is causing brain injuries.
As football fans in Massachusetts and throughout New England who are familiar with former Patriot Ted Johnson’s story know well, football players stand a great risk of brain injuries. What may be surprising to most fans however is the questions that are being raised about how effective football helmets are in preventing brain injuries.
Some speculate that the helmets might actually do more harm than good. The modern football helmet was designed to prevent catastrophic injuries like fractured skulls. It does a fairly good job at this. But the modern football helmet, and the ubiquitous football face mask, have also made some players feel invincible. By protecting the player’s skull from an open fracture, his face from broken bones and his teeth from getting knocked out, the modern helmet has encouraged players to collide more violently and more often without fear for their own safety. According to some, such as University of North Carolina professor Fred Mueller, this has led to more concussions and other head injuries not fewer.
All of this seems to pose an interesting question: Assuming that the modern football helmet leads players to play more violently, causing more head injuries overall, is the football helmet a defective product? Could a football player who suffers brain damage from repetitive concussions caused by a style of play that is encouraged and enabled by the modern helmet sue the helmet manufacturer and win under Massachusetts law?
These are interesting questions. And in our next post we’ll take a closer look at Massachusetts product liability law to try and come up with some answers.

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