March 2009 Archives

Harvard professor Dr. Joseph Biederman is under fire as documents he was ordered to turn over in litigation call into question how unbiased his studies were, as he was receiving huge payments from drug maker Johnson and Johnson, and promising positive results for the company even before his clinical trials were begun. Clearly, the receipt of huge cash payments by these physicians that are providing allegedly "independent evidence" supporting the effectiveness or use of drugs made by the very manufacturer providing payments, causes one to wonder how independent these tests are, yet this has been going on for years and the Congress and public is just now becoming concerned about it!

The case that brought the above facts to light concerns states' attorney generals who have filed suit against drug manufacturers of antipsychotic drugs that defrauded Medicaid due to improper marketing.

Clearly new rules, regulation, and enforcement are needed to avoid such potential problems. However, that must come from the FDA which is already overworked, understaffed and underfunded, in my opinion. Where does that leave you? With yet another reason not to restrict lawsuits. With a clearly inadequate regulation system, little is left for the public but to rely upon plaintiffs' lawyers policing and enforcing the conduct of these manufacturers. Without the threat of a lawsuit and being hauled into court and held accountable before a jury, does one really think we can count on these manufacturers and physicians to police themselves?

Did you know that drowning is the second largest killer of children under age 14? In response to this, but in reality likely due to the death of former Secretary of State James Baker's granddaughter, the Virginia Graeme Baker Pool and Spa Safety Act 15 U.S.C. 8001 et seq. was passed on December 20, 2007. The requirements of the Act come into force December 19, 2008. Baker's granddaughter died in 2002 when she became trapped by a spa drain cover. Most old drain covers are flat and allow the swimmers body to become trapped against the drain cover. Younger children are unable to break free of the suction. One of the things the new Act requires is a special dome shaped cover, that helps prevent this.

Surprisingly, many municipalities and other organizations with pools are claiming that they were unaware of the Act and/or the effective date of its requirements and many claim that they will be unable to comply with its requirements. The requirements range from public pool drain covers, to special drain systems for public pools. Further, all swimming pool or spa drain covers manufactured or distributed in the United States must comply with American National Standard Institute (ANSI)/ American Society of Mechanical Engineers (ASME) standard A112.19.8 - 2007 titled Suction Fittings for Use in Swimming Pools, Wading Pools, Spas, and Hot Tubs. A nice summary of the act, including an account of the complaints by pool owners can be seen here.

As these pool owners have known about the Act for over 1 year now, I have no sympathy for them. The problem of children dying from drowning and receiving other horrific injuries from being trapped is well documented.

Given the backlog of orders for the drain covers, and that many pool owners are claiming ignorance of the act, it is very likely that you or your children may be swimming in a pool that is not in compliance with the Act this summer, or presently, if you swim in a facility with an indoor pool. This summer make sure that the club or municipal pool that your children are swimming at has complied with the Pool and Spa safety act. Always supervise your children and attempt to locate the drain area of the pool or spa and insure that your child stays away from that area.

Sunoco chemical company announced that it would restrict sales of bisphenol-A, or BPA to manufacturers who were using the chemical in food and water containers for children under three. This move makes Sunoco the first major manufacturer to acknowledge safety concerns about BPA or bisphenol-A.

This is the most recent action regarding moves against BPA. Last week, six of the nation's largest bottle manufacturers announced they would no longer be using BPA in baby bottles. Most major retailers, including Wal-mart and Toys-R-us, have now removed products containing BPA from their store shelves.

BPA is said to mimic the effects of the hormone estrogen and cause breast, prostrate and uterine tumors, in some studies. However, the FDA concluded that there was no harm from BPA, but that opinion is considered flawed by many as the FDA relied upon many of the industries' own internal studies.

My wife and I have a 5-month-old at home and it took us some looking to find bottles and plastics that did not contain BPA. I don't think manufacturers are currently required to warn or label their products as containing BPA, so look for labels that verify that the products do not contain BPA. While studies may be at odds, I always advise better safe than sorry, and would advise against using BPA containing products for children under three years of age.

I was doing some research last night to help a lawyer up in West Virginia on a carbon monoxide (CO) poisoning case he had and was surprised to learn of the extreme danger of engine driven generators. From 1999 to 2007 the Consumer Product Safety Commission was aware of 404 fatalities involving generators and CO poisoning. We know that the CPSC cannot be aware of every incident out there, so in all likelihood the number of deaths is even greater! As most of you know, the coldest months of the year are typically November through February. Nearly half of the fatalities occurred in these months. One third of the deaths were associated with power outages, which is not surprising to me as I would figure that is typically when the generator would be in use. The report can be found here .

Unfortunately, the report is just an analysis of deaths associated with Carbon Monoxide poisoning from engine driven generators and tools, and does not advise what one must do to avoid a similar fate. I did some additional research and many of the deaths were because the generator was run while the basement or crawl space. The most common reason for this was fear that the expensive piece of equipment would be stolen or that running the electrical cord outside would prevent a door from closing. Further research indicated a general lack of warnings or sufficient warnings on these generators along with a general lack of awareness of carbon monoxide poisoning. Other deaths included operators attempting to ventilate the area but the ventilation was insufficient. This can be caused from variations in CO output from the different machines. Further one of the big problems with carbon monoxide exposure (other than death) is that the affected victim is unable to help him or herself due to their impaired cognitive functioning or in layman's terms, ability to think and act. The onset of these symptoms can be extremely rapid. Always operate engine driven generators outside of the home. Do not operate the generator in a crawl space, basement or garage or near open windows, doors or anything else that would allow the carbon monoxide to potentially enter your home or trailer. If theft is a concern, chain the generator and lock it up if possible. I know these generators are expensive but they certainly not worth more than your life or your child's.
 

To my knowledge there are no voluntary standards for portable generators, although the CPSC is supposed to be currently working with Underwriter's Laboratory to develop one.

The United States Supreme Court rejected arguments that federal regulation preempted state lawsuits against drug makers. In the case of Wyeth v. Levine, the injured plaintiff Diane Levine, had her arm amputated after she was injected with Phenergan, made by Wyeth. Wyeth argued that federal approval of the Phenergan and its warning label protected the company from lawsuits. The case is seen as a surprise given that the Bush administration had argued that once a drug's warning label is approved by the FDA, consumers cannot pursue state law claims if they are injured by the drug. Justice Stevens, who wrote the majority opinion, said that Wyeth could "unilaterally strengthen its warning", especially after if learned of at least 20 other incidents prior to Mrs. Levine's injury. The FDA is charged with monitoring 11,000 drugs!!!

This outcome was shocking to many given the fact that the Supreme Court had earlier held that suits against medical device makers were preempted, in the case of Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). In Riegel, the Supreme Court held that makers of medical devices were immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it met the agency's specifications.

I agree with the Wyeth decision. The FDA is overworked and underfunded. As recognized, in the opinion, state court lawsuits provide a valuable service of uncovering problems with drugs and a "complementary form of drug regulation". With over 11,000 drugs, the FDA simply cannot be expected to catch and/or solve all problems. Without the ability to file suit, the consumer is left unprotected.

Recently, the Virginia Supreme Court decided a case that will surely have an impact (no pun intended) on those with automobile accident cases, in the future. In the case of Hancock-Underwood, the Virginia Supreme Court was asked to consider whether the trial court erred in refusing to instruct the jury on "unavoidable accident" and "sudden emergency". In the past these jury instructions, in my opinion, were used by defense lawyers to unjustly escape liability for their clients. In this case the plaintiff/ injured party was traveling on Route 130 in Virginia, with his family, when he saw an oncoming van cross the center line and head straight towards him. The plaintiff who was driving a truck, with a trailer in tow, moved over to the should as far as he could but he was still struck. The van operator was killed in the crash and the plaintiff was severely injured.


The Estate of the defendant van operator alleged that he suffered an acute medical crisis when he was driving his van. The Estate sought jury instructions on both the "unavoidable accident" and "sudden emergency doctrines". The trial court refused to give these instructions. The majority of courts in the United States do not approve of the "unavoidable accident instruction" .The Virginia Supreme Court joined the majority of courts across the nation in holding that the "unavoidable accident instruction" should no longer be given. The Court stated among other things, that the instruction overemphasizes the defendant's case and is apt to confuse and mislead the jury. I could not agree more this opinion.
 

With respect to the "sudden emergency" instruction, the Court held that the trial court correctly denied this instruction as well. A "sudden emergency" instruction allows the jury to consider whether the person confronted with the sudden emergency "acted as an ordinarily prudent person would have done under the same or similar circumstances". The Court restated its prior position that the instruction should rarely be given, but it also did not outright refuse to uphold this instruction in future cases. The Court decided that the jury instruction, as drafted by the defendant, was no appropriate and was not supported by the evidence. The Court cited with approval the trial court's reasoning that the defendant driver did not take immediate action under the defendant's theory of the case, as he was unconscious. This case does a good job of illustrating how crucial it is to hire a good attorney. Many attorneys would have probably allowed these two jury instructions to be read to the jury. As noted by the Virginia Supreme Court, these instructions should rarely be given and can confuse a jury. Had theses instructions been allowed, the defendant driver, likely would have escaped liability.

A recent case of interest is Centra Health v. Mullins. This is a landmark decision by the Virginia Supreme Court, on a key area of the law that usually comes up in the context of nursing home cases. In this case, the 84 year old plaintiff was admitted to the hospital for a broken hip he sustained in a fall. Due to negligent insertion and maintenance of a catheter, the man developed a urinary tract infection. After surgery for the broken hip, hospital staff failed to treat and recognize the infection and discharged the man back to the nursing home. The man returned to the hospital for treatment of the infection, and stayed at the hospital until his ultimate death.

The man's Estate asserted a wrongful death claim, basing the claim on their assertion that his death was caused by sepsis which resulted from the defendant's failure to treat the urinary tract infection, and as an alternative claim, they filed a survivorship action, for injuries sustained by the plaintiff prior to his death, the infection and its accompanying complications.

As a side note, in Virginia, the injured party's Estate must typically choose whether they are presenting a claim for the party's death, or for the pain and suffering for the injury while the person was alive. The recovery available under each theory is dramatically different.

To make a long story short, the defendants wanted the Estate to elect which theory-wrongful death or survivorship- they were proceeding on before trial. The Estate asserted that it did not have to make that decision before trial, if the evidence would support both theories. The Virginia Supreme Court upheld the trial court's decision that held that decision by the plaintiff is not required before the jury decides the issue of whether the negligence of the hospital caused the death or the injury. The Court held that "the election is required only at a time when the record sufficiently establishes that the personal injuries and the death arose from the same cause." In this case the evidence was in dispute, and the defendant's theory of the case was that it was not negligent on either theory. Therefore, the trial court correctly submitted both theories for the jury to decide the issue. Again an important decision for those involved in cases of medical malpractice or nursing home and/or assisting living negligence cases.

CBB recalled the following toys Fishing Games, Rattles, Pull-A-Long Cars, Mini Pull Back Cars, and Cartoon Bubble Guns due to the toys containing small parts which can separate from the toy and become choking hazards for small children. The mini pull back cars and bubble guns have surface paints which contain excessive levels of lead, violating the federal lead paint standard.

These toys were sold at dollar stores and toy stores. A detailed chart and photographs of the toys and their product numbers can be found here.

As always, I recommend visiting the CPSC website as several toys were recalled in February for choking hazards, including toys sold by Old Navy and Disney.

I always recommend examining any small toy before giving it to a child. This is true whether the toy is purchased from a dollar store, EBay, Wal-Mart, or an expensive specialty toy store. You should be looking for small objects that could separate and be swallowed by a child, sharp objects or points, and toys that have long strings or lanyards that could become a strangulation hazard. Currently toys for children under 3 years of age are subject to small parts regulation under federal law. See 16 C.F.R. Part 1501 and 1500.50-53. A small part is any object that fits completely into a specially designed test cylinder 2.25 inches long by 1.25 inches wide that approximates the size of the fully expanded throat of a child under three years old. (See figure). See 16 C.F.R. 1501. Other toys or items for use by children under 3 are subject to additional federal regulation: Pacifiers - 16 C.F.R. 1511; Rattles - 16 C.F.R. 1510; Cribs - 16 C.F.R. 1508, 1509; Infant Pillows, Cushions - 16 C.F.R. 1500.18(a)(16); Baby Walkers, Bouncers, Jumpers - 16 C.F.R. 1500.18(a)(6); Electrically Operated Toys - 16 C.F.R. 1505; Dolls, Stuffed Toys and Other Products that may cause lacerations or punctures. 16 C.F.R. 1500.18(a)(1), (2),(3) and Small Balls 16 C.F.R. 1500.18(a)(17).

I read recently where the Consumer Product Safety Commission (CPSC) just recalled 200,000 children's play yards. These "Rainforest" model play yards were made by Simplicity Inc., which is now out of business, for Fisher Price. There is a danger of the side rails collapsing and potential injury or death to the children or infants. Apparently CPSC officials knew last year that these side rails were collapsing, but felt that it did not "rise to the level of a recall". 

This article just reinforces my thoughts that you cannot depend on the CPSC to timely act and protect your children. It is my opinion that this agency is underfunded and overworked and hope that the new administration will provide additional funding and manpower, so that the agency can see that dangerous and defective products are taken off the shelves. Consumers need to know that just because a product is in the marketplace, does not mean that it has been tested or evaluated by the manufacturer or a government agency. If consumers experience safety problems with a product, they need to contact the CPSC. Apparently, it was the over 1300 complaints to the CPSC that finally motivated this recall!

 

To the credit of the CPSC, they only have 420 employees to police over 15,000 kinds of consumer products. In my opinion, the agency is woefully understaffed. The CPSC does not test or certify products before they are sold. The sellers or importers of products are charged with insuring that their products comply with government standards or regulations. Unfortunately, that means that we consumers pay the price through serious injury or death when a negligent product manufacturer or importer sells a product that has not been adequately designed, tested or inspected. My experience with the CPSC over the last 11+ years has been that they typically do not become involved in the investigation of a product until they have received several consumer complaints, and there is the potential for serious injury or death. They just have too few staff to go out and start randomly testing or inspecting items to see if they comply with government regulations. Luckily, with the internet, consumers can research products before they purchase them. I always recommend "googling" an item on the internet before purchasing it, and checking the CPSC website to see if the item or its manufacturer have any recent recalls.

In what is becoming an all too common occurrence, the Consumer Product Safety Commission has announced another recall involving infant cribs. The manufacturer of the cribs is Jardine Cribs, and the first recall was in June of 2008, affecting 320,000 cribs. The CPSC has now added another 56,450 cribs. The cribs were sold at KidsWorld, Geoffrey Stores, Toys "R" Us, and Babies "R" Us stores nationwide, and at Babies "R" Us.com, from March 2004 through January 2009 for between $220 and $330. The problem with the cribs is that the side rails can break, creating a gap for the infant to potentially fall through or be strangled in. Consumers have reported that their infant or toddler has broken the slat while in the crib! These cribs were made in China.
 

Many of you will recall last year's crib recall involving over 600,000 Simplicity cribs. These cribs had a problem with the side rail coming off track, creating a gap that the infant or toddler could become trapped in. These cribs were made in China as well.

I was involved in suing one of the largest child product manufacturers in the United States several years ago, involving a crib. Problems with the crib developed as a result of efforts by the manufacturer to decrease costs in the manufacture of the crib, without analyzing the potential safety risks. The company ended up paying a large fine to the CPSC as a result of reporting violations with the CPSC. The case settled for a confidential amount. I have not handled cases involving these latest manufacturers but it would be interesting to find out what, if any, product testing and evaluation was done by the manufacturers or importers. An obvious motivation for having products made in China is their relative cost compared to products manufactured here the United States. Many have suggested that quality and durability are sacrificed with these low cost imports. From many of the Chinese made products I have seen, I have to agree.

What can you do to determine if a product is safe? The first thing I would recommend would be to get on the internet to see if the product has been reviewed by any type of consumer group. The second thing I would do is to visit the Consumer Product Safety Commission's website to research the product and the manufacturer, to see if there are any warnings or recalls out. Many people have complained that the CPSC has been slow to act or to expand recalls, so you may find the item you are checking on is nearly identical to an item currently being recalled. Be very careful when purchasing children's items from yard sales, Ebay or used children's items stores. I have personally seen many recalled items still for sale on these venues, and in fact bought two of the recalled cribs that I needed as exemplars for my crib case off of EBay, and after the highly publicized recall!!!! Lastly, if the item looks and feels cheap, it probably is. In years of doing this work, just because a manufacturer or retailer is selling the item, does not mean that anyone has done any type of testing or safety evaluation of the product!! Many people are surprised to learn that the CPSC does not evaluate all toys or children's product for sale in the United States. Currently, no organization in the United States does that. Essentially, manufacturers are charged with policing themselves. Only when the CPSC receives complaints about a product, do they become involved.