Articles Posted in Dangerous Products

Air bag recalls have risen exponentially in the last year due to increased oversight by the National Highway Traffic Safety Administration (NHTSA). 10 million of the 30 million vehicles recalled in 2014 have been as a result of air bag defects which cause the inflator canister to explode inside vehicles, leading to metal shards flying around inside the passenger compartment.

The defective air bags were manufactured by the Takata Corporation, who began manufacturing air bags in 1988. Takata is one of the three largest worldwide air bags producers, along with the Swedish company Autoliv, and an American supplier TRW Automotive. Seven automobile manufacturers have announced recalls of vehicles containing the Takata air bags, including Toyota, Honda, Nissan, Mazda, Ford, Chrysler and BMW. Honda acknowledged that it was aware of in excess of 30 injuries and two fatalities from defective air bags manufactured by Takata. Despite the fact that Takata had a questionable safety record, with defective seatbelts manufactured by the company leading to 9 million recalls in the 1990’s, automakers have continued to retain Takata for production of air bags.

One devastating example is that of Kristy Williams. In 2010, while waiting at a red light in Georgia, the Takata air bags in her 2001 Honda Civic spontaneously deployed. Ms. Williams was struck by metal shards from the canister that contained the air bag propellant. The sharp shards went through the air bag fabric and punctured her neck and carotid artery. She underwent numerous operations and had several seizures and strokes. Honda and Takata worked out a settlement with Ms. Williams attorneys, with the usual non-disclosed financial terms. There have also been two deaths reported from the defective air bags in Oklahoma and Virginia. Both of these fatal accidents occurred in 2009 and involved Honda vehicles. The cases were settled by Honda and Takata with undisclosed terms.

Takata believes that the defective air bags are due to excessive moisture and humidity seeping inside the inflators, which then destabilizes the propellant inside the air bag. The NHTSA has received 6 reports of air bag inflator ruptures which all occurred in Florida and Puerto Rico, which would be consistent with the theory that moisture and humidity plays a strong part in these incidents. The Administration noted in a statement that it “supports efforts by automakers to address the immediate risk in areas that have consistently hot, humid conditions over extended periods of time.” If the driver’s side air bag explodes, the metal shards are likely to strike the driver, as they did to Ms. Williams in 2010. However, because of its placement in the glove compartment, an exploding air bag on the passenger side will likely send the shards toward the roof of the car, and not toward the passenger.

Honda recently recalled approximately 2 million vehicles with the Takata air bags, Toyota recalled 2.3 million cars, Nissan recalled 755,000 cars, and Mazda recalled 160,000 vehicles.

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One of the “Big Three” Automakers, General Motors, has announced a massive recall of 1.6 million vehicles which apparently had defective ignition switches, causing the cars to turn off and disabling airbags in the process. As a result of the defective ignitions, the electrical systems in the vehicles would be inoperable, causing the airbags not to deploy, and many drivers and passengers of GM vehicles died as a result.

According to the Center for Auto Safety, federal data complied by the National Highway Traffic Safety Administration (NHTSA) revealed that 303 deaths were caused due to the failure of airbags to deploy. GM acknowledges 12 fatalities due to the defective ignition switches, but nonetheless, has instituted a massive recall of 1.6 million vehicles, comprised of 2005-07 Chevrolet Cobalts, 2003-2007 Saturn Ions, 2005-2007 Pontiac G5’s, 2006-07 Chevrolet HHRs, the 2006-07 Pontiac Solstice, and the 2007 Saturn Sky.

GM is now facing a congressional investigation and an inquiry by federal prosecutors in N.Y. into its response to the defective ignition switches, after it was widely reported that GM engineers knew in 2004, and possibly as early as 2001, about the ignition switch problem.

Recently, a slew of lawsuits by crash victims’ families and shareholders have been commenced, and some were settled in the last few months. One recent settlement involved the death of 29 year old Brooke Melton, who was killed after her 2006 Chevy Cobalt suddenly lost power and crashed into another car. Her attorney made demands for GM internal documents and information as to other similar claims, in response to which GM’s attorneys fought bitterly in attempting to resist providing the information and documentation. However, in a complete reversal of strategy, GM settled the case with the requisite confidentiality agreement demanded by corporations in all such cases. Part of GM’s motivation may have been the public relations nightmare that Toyota experienced back in 2010 when the company was hit with numerous “sudden acceleration” cases and blamed driver error rather than addressing the problem in a reasonable, prompt fashion.

Similarly, there was the fatal accident of Hasaya Chansuthus, a 25 year old woman killed when her 2006 Chevrolet Cobalt went out of control in the rain in Murfreesboro, Tennessee on December 31, 2009. Her car sideswiped another vehicle and crashed into a tree at 70 miles per hour, with no air bag deployment. Initially, GM fought the case based upon Ms. Chansuthus’ blood alcohol level of 0.19, more than twice the legal limit. However, after litigation was commenced, GM changed tactics and quietly settled the case with a confidentiality agreement.

It appears that the problem often occurs due to heavy key chains, which cause the ignition switches to move from the on position to “accessory” or “off.” This apparently resulted in cars stalling, losing power for the steering and brake systems, and disabling the airbags. One of the issues that GM will now have in announcing a recall at this late date is the fact that many of the vehicles are now with second or third owners, who may have no connection with GM and may not be notified of the recall.

GM is recommending that all owners of the affected vehicles, until they are modified, take all non essential items off of their key rings to prevent the movement of the switches from “on” to “accessory” or “off”.

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I read an interesting and eye-opening (no pun intended) article in the New York Times on November 14, 2012 by Barry Meier. The article, entitled “Caffeinated Drink Cited in Reports of 13 Deaths”, discusses the recent disclosure by the U.S Food and Drug Administration (FDA) that it has received numerous reports and filings over the last several weeks of fatalities which are potentially attributable to consumption of caffeinated drinks such as “Five-Hour Energy” and “Monster Energy.” I have seen with my own children (ages 12 and 17) how these so called energy drinks such as Red Bull, Monster Energy and 5 Hour Energy are so readily available to anyone regardless of age with no clear understanding of what is contained in these products. What makes this much more frightening is that according to Beverage Digest, caffeinated beverages are the fastest growing soft drink in the United States with a sales increase of 17% in 2011 to approximately 9 billion dollars!

Apparently, 5 Hour Energy (which is sold in 2 oz. shots) contains approximately 215 milligrams of caffeine, whereas an 8 oz. cup of regular coffee, depending on how it is brewed, can contain from 100 milligrams of caffeine to as much as 165 milligrams in a 8 oz. cup as reported by Consumer Reports.

To be very clear, since 2008 the manufacturers of these energy drinks are required by federal law to report the fatalities and serious injuries they become aware of from consumers, but there is no absolute scientific proof that the products have caused these deaths. What is known is that over the last four years, the FDA has received reports from the distributor of Five Hour Energy, Living Essentials, that 13 people have died and the filings claim that these deaths were caused in some way by the consumption of the product. The FDA has also reported that it is in possession of five fatality filings involving Monster Energy. In 2010, the FDA was notified of 17 fatalities involving some form of weight loss product or dietary supplement. According to the Meier article, since 2009, 5-Hour Energy has been named in approximately 90 filings with the FDA, with one third of those reports involving serious or life-threatening conditions, including heart attacks, convulsions and one spontaneous abortion. Further, the Substance Abuse and Mental Health Services Administration, also a federal agency, reported in 2011 that more than 13,000 emergency room visits in 2009 were related to the consumption of energy drinks.

The FDA regulates products such as Red Bull as beverages, whereas 5- Hour Energy and Monster Energy are regulated as dietary supplements, which complicates rules regarding ingredients and reporting of adverse events.

Living Essentials responded to the reports by indicating that their product is safe when used as intended and denied knowledge of any deaths caused by the use of 5-Hour Energy. Monster Beverage, the manufacturer of Monster Energy, has also denied that their product is responsible for any fatalities and has alleged its products are safe as well. The FDA’s Director of dietary supplement programs Daniel Fabricant, noted on November 14 that the agency was looking into the circumstances of the 13 fatality reports submitted by the distributor of 5-Hour Energy, but that some of the reports might not have sufficient information to determine whether the supplements did in fact contribute to the fatalities.

Manoj Bhargava, the CEO of Living Essentials refused to comment about the fatality filings involving 5-Hour Energy, believing that the New York Times article would leave a negative perception of his product.

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This past Saturday, six people were killed in a Church van fatal rollover accident on the New York State Thruway just north of Harriman. The accident happened when a rear tire blew out, causing the driver to over correct, the van to roll over several times, and nine passengers to be ejected from the vehicle. The church group was on their way from the Bronx to a banquet in Schenectady, New York.

Tragically, the Ford Econoline van that the 14 passengers were riding in is known, as other 15 passenger vans are, for being prone to rollovers, and particularly when the vans are at full capacity. According to the National Highway Traffic Safety Administration, tire failures are the most common cause of fatal rollovers in passenger vans. Apparently, the rear tires in the vans are placed under tremendous stress when large passenger loads shift the center of gravity to the rear. The vans have a tall center of gravity and poor rear suspension, so that when at full capacity, the center of gravity is increased upward and toward the rear axle. Then, when there is a tire failure, the van will fishtail and rotate, going into a sideways rollover.

Certainly, requiring van manufactures to install rear seat belts would lessen the severity of accidents, as all of the fatalities in this accident involved rear passengers who were not belted and were ejected through the windows and killed. According to the NHTSA, from 2003 through 2007, 473 occupants of vans died in crashes, and of these, 56% were rollovers. A full 80% of those killed were not wearing seatbelts. The NHTSA has issued safety recommendations for the operation of passenger vans, which include keeping tires properly inflated, requiring that drivers have commercial licenses, and seating passengers, to the extent possible, near the front of the van. in 2002, The National Transportation Safety Board reported that over a 20 year period, the rollover rate for fully loaded passenger vans was about three times the ratio of vans with fewer than 5 passengers.

The six people killed in the September 18 accident were Bishop Simon White, his wife, Zelda White, the Rev. Titus McGhie, Avril Murray, Evelyn Ferguson, and Elaine Reid. State Police investigators are still seeking a statement from the the driver of the van, Bernard Lallibeaudiere, who is undergoing treatment at St. Francis Hospital in Poughkeepsie.

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In follow up to our post on February 22, 2010 entitled Diabetes Drug Blamed For Heart Problems, there is new information which reveals that SmithKline Beecham actively attempted to cover up studies which showed that the diabetes drug Avandia was dangerous to the heart. In a July 12, 2010 article by Gardiner Harris in the New York Times, it was revealed that since Avandia’s success was so vital to SmithKline, company executives decided not to publicize results of studies on its website or, more importantly, to submit these negative results to drug regulators at the Food & Drug Administration.

One particular company executive, when he found out that data revealed that Avandia was riskier to the heart than a competing drug Actos, wrote in an e-mail: “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of the [company].” Apparently, according to the article, SmithKline knew as early as 1999 of extensive heart problems from the use of Avandia, but had determined that they would lose between “$600 million from 2002 to 2004 alone” if the risks became public. Even worse, an F.D.A. reviewer who reviewed an Avandia clinical trial named “Record” found that 12 patients who suffered severe heart problems from Avandia were not included in the trial’s listing of “adverse events.”

Surprisingly, the issue of whether to withdraw Avandia as a dangerous drug from the market has split the F.D.A., with some regulators arguing in favor of keeping the drug on the market despite the risks. Other diabetes drugs available include Actos and an older diabetes drug named glyburide, which is also less expensive.

In 2004, when GlaxoSmithKline was found to have hidden data regarding the suicidal thoughts teenagers and children were having from its antidepressant Paxil, the company settled a lawsuit by publicizing all data from its clinical trials. The posting of clinical trial data became federally mandated in 2007. It would appear that the Paxil experience has not changed Smith Kline’s procedures when it comes to disclosing the risks of its products.

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In a front page story in the February 20, 2010 edition of the New York Times, Gardiner Harris reported on confidential FDA reports which have recommended that the diabetes drug Avandia be removed from the market. Apparently, FDA studies have determined that if diabetes sufferers had taken another drug, Actos, approximately 500 heart attacks and 300 cases of heart failure could have been avoided. Avandia, also known by its clinical name Rosiglitazone, is prescribed to patients with Type 2 diabetes. This apparently dangerous drug was linked to a shocking 304 deaths worldwide in the third quarter of 2009, according to a study by the Institute for Safe Medication Practice, a drug safety group

Two FDA researchers, Dr. David Graham and Dr. Kate Gelperin, concluded that “Rosiglitazone should be removed from the market.” There is a significant conflict over what should be done with Avandia. Naturally, the manufacturer, GlaxoSmithKline, is claiming that the reports of cardiac problems as a result of Avandia use are not scientifically definitive and require further study. Senators Charles Grassley, an Iowa Republican, and Max Baucus, a Montana Democrat, who have overseen the FDA study, are sharply critical of GlaxoSmithKline, stating that the company should have alerted patients many years ago of the potential cardiovascular risks of Avandia, thus offering patients the opportunity to take a less dangerous drug for their diabetes. But as early as 2003, according to the Senate investigation, GlaxoSmithKline and the FDA were aware of a GlaxoSmithKline study in which diabetics who used Avandia had substantially more heart problems than those given placebos!

Several years back, Avandia was one of the top selling drugs in the world, but after a 2007 study by a Cleveland Clinic cardiologist suggested cardiac risks from Avandia, the FDA got involved, and sales of the drug took a dive. Mr. Harris also reports that GlaxoSmithKline executives attempted intimidation tactics to prevent independent physicians from notifying patients or other doctors that Avandia posed serious heart risks to diabetics, who die from heart problems 66% of the time. In one egregious example, in 1999, University of North Carolina professor John Buse gave presentations at scientific meetings suggesting that Avandia caused heart problems. As a result, GlaxoSmithKline executives complained to his supervisor and warned of potential legal action against Dr. Buse in an effort to keep him quiet. Dr. Buse ended up signing a document prepared by GlaxoSmithKline agreeing not to publicly discuss his concerns about Avandia. The report mentions another similar incident of intimidation of University of Pennsylvania investigators.

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At The Law Office Of Mark A. Siesel in White Plains, New York, we represent many clients who are seriously injured as the result of using a dangerous or defective product or machine. Frequently, by the time they come to our office, several days or weeks have passed since the accident occurred, and valuable evidence may no longer be available or has been discarded by the owner of the product.

Thus, if you have suffered injury due to a dangerous product or device, you should do the following whenever possible:

1. Take photographs of the machine, from several angles, and in good light if available;
2. Obtain the manufacturer’s name, address (and phone number if on the machine);
3. Write down the model number, serial number and any other information that is on the machine;
4. Get copies of any operating manuals, instructions or paperwork that accompanied the product upon purchase;
5. Attempt to obtain any service records for the machine, or the names and addresses of any companies that serviced the machine;

6. Obtain records of any modifications or changes that have been made to the device or product over the years.

6. Document your injuries by taking photographs immediately after the accident;
7. Secure the names, addresses, phone numbers and e-mail addresses of any witnesses to your accident;

Often, it will not be possible to obtain all of the above items when the machine is old and records are lost or discarded. However, it is vital to the success of a New York defective products case to have as much information as possible to identify potential defendants including manufacturers, distributors, retailers, repair or service companies and suppliers. The manufacturer or distributor can be responsible for many different dangers, including defective design of the product, negligent manufacture of the product, failure to properly maintain the device, improper or lack of safety labels or warnings, and failure to recall products which have a known defect or flaw.

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Pills%20Blog%20image.jpgLast week, a federal advisory panel of the Food & Drug Administration (FDA) voted 20-17 to recommend a ban of Percocet and Vicodin, two very popular painkillers, due to their damaging effects on the liver. Percocet, also known as Oxycodone, and Vicodin, another name for Hydrocodone, are controlled substances due to their addictive nature, and combine a narcotic with high dosages of acetaminophen, a painkiller found in such medications as Excedrin, Tylenol and Nyquil.

Acetaminophen is combined with different narcotics in at least 7 other prescription drugs, and each of these drugs would be banned if the FDA takes the advice of its panel. Vicodin is prescribed more than 100 million times per year in the United States, according to the study, and patients who take these potentially dangerous drugs often need progressively larger doses to obtain the same pain relief.

In 2005, Americans bought 28 billion doses of products containing acetaminophen. Although it is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage. More than 400 people die and 42,000 are hospitalized in the U.S. every year from overdoses according to the panel. One panel member, an associate professor of medicine from Duke University Medical Center, noted that: “We’re here because there are inadvertent overdoses [of acetaminophen] which are fatal, and this is our opportunity to have a big impact.”

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In a great decision for victims of dangerous drugs throughout the United States, on March 4, 2009 the Supreme Court upheld a Vermont state court decision awarding 6.7 million to a woman who suffered permanent injuries from an anti-nausea drug. The case involved a Vermont resident who developed gangrene after a botched injection of the drug, which tragically resulted in the amputation of her hand and lower arm. The tragedy was compounded by the fact that the plaintiff was a musician, and lost her livelihood due to her injuries.

The physician’s assistant who performed the injection used a highly risky intravenous push technique, which allowed the drug to enter an artery, rather than the intravenous drip technique, the much safer method in which the drug is injected into liquid already flowing into a vein. Allowing the drug to enter the artery causes immediate and irreversible gangrene. Wyeth’s lawyers requested that the Supreme Court set aside the verdict, attempting to rely on the fact that they had complied with FDA labeling requirements. (In a case last year against medical device manufacturers of heart defibrillators, stents, and artificial hips, the Court had ruled that federal law and FDA scrutiny prevented product liability lawsuits in state courts). However, in a decision written by Justice John Paul Stevens, the elder statesman and most liberal member of the Supreme Court, the justices determined that Wyeth’s warnings were insufficient and should have made abundantly clear the dangers of serious injury if the drug was injected improperly.

The decision to allow state damage suits will undoubtedly cause manufacturers to use greater care in the production and labeling of their products. We would also expect a revisiting of last year’s decision protecting device makers, which seems somewhat inconsistent with the Court’s welcome decision protecting the public this week.

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The tobacco giant Phillip Morris was ordered to pay 8 million dollars this week to Florida widow Elaine Hess, whose late husband Stuart Hess died of lung cancer at age 55 in 1997. A jury in Fort Lauderdale awarded compensatory damages of 3 dollars and a whopping 5 million dollars in punitive damages, obviously convinced that Philip Morris knew that the cigarettes they marketed and sold are a dangerous product but that the company was more concerned about profit than safety.

Philip Morris USA announced that they would appeal the verdict, certainly to be expected after a major verdict against the tobacco giant in the first of what will likely be thousands of cases in Florida. Back in 2006, the Florida Supreme Court threw out a 145 billion dollar jury award in a dangerous product class action suit filed in the early 1990’s on behalf of 8,000 sick smokers. Undoubtedly, the Hess verdict will encourage the families of those 8,000 smokers to pursue their cases as well.

Compensatory damages are awarded for injuries including pain and suffering, lost earnings, loss of enjoyment of life, and medical bills. These type of awards are more likely to be upheld by an appellate court. Conversely, punitive damages, which as the name suggests, are imposed to “punish” the defendant for intentional or malicious conduct, are frequently either reversed or substantially reduced by higher courts on appeal.

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