Increased Federal Scrutiny Leads To Air Bag Recalls

June 25, 2014 by Mark Siesel

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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GM Recalling 1.6 Million Cars Due To Defective Ignition Switches

March 17, 2014 by Mark Siesel

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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“5- Hour Energy” and “Monster Energy”—Can They Be Fatal?

November 15, 2012 by Mark Siesel

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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Deadly Roll Over Accident on New York State Thruway

September 22, 2010 by Mark Siesel

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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Diabetes Drug Manufacturer Failed to Disclose Data On Risks

July 13, 2010 by Mark Siesel

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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Diabetes Drug Avandia Blamed For Heart Problems

February 22, 2010 by Mark Siesel

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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New York Dangerous Products--A Primer

December 29, 2009 by Mark Siesel

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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U.S. FDA Panel Recommending Ban Of Vicodin And Percocet

July 9, 2009 by Mark Siesel

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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U.S. Supreme Court Delivers Blow to Pharmaceutical Industry

March 11, 2009 by Mark Siesel

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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Philip Morris Hit With 8 Million Dollar Verdict

February 23, 2009 by Mark Siesel

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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U.S Supreme Court Deals Large Blow To Big Tobacco

December 18, 2008 by Mark Siesel

The United States Supreme Court ruled this past Monday that smokers may sue tobacco companies for fraud in the marketing of "light" cigarettes. In a surprising 5-4 decision considering the conservative, pro-business nature of the Court, the Supreme Court determined that several Maine residents had been deceived by Altria and Philip Morris USA into believing that light cigarettes deliver less tar and nicotine to smokers than regular cigarettes. Although it is true that the light cigarettes do have less tar and nicotine than regular cigarettes, smokers apparently compensate for the difference by taking larger puffs, smoking more cigarettes or inhaling more deeply.

The plaintiffs sued Philip Morris under the Maine Unfair Trade Practices Act, claiming that they had been injured by the deceptive advertising and marketing of cigarettes such as Marlboro Lights. The Supreme Court had to decide whether the plaintiffs had the right to sue at all considering the Federal Cigarette Labeling and Advertising Act, which was enacted in 1965 and required tobacco companies to place warnings on their packaging and advertising. The federal law had prohibited the states from making their own similar laws as to smoking and health based on the United States Constitution's Supremacy Clause, which states that when there are conflicts between federal and state laws, federal laws must prevail. The majority opinion, written by Justice Anthony Kennedy, determined that the Cigarette Labeling and Advertising Act was intended to prevent states from making their own laws about health problems from smoking, not to pre-empt laws such as Maine's which establish a general responsibility not to deceive consumers.

Naturally, the four judges in the minority, Scalia, Roberts, Alito and Thomas, sided with big business in claiming that that the Maine statute was essentially an attempt to get around the federal statute, and was instituted only to regulate smoking and health, not the deceptive business practices of Philip Morris. In a major victory for plaintiffs around the country, the decision will allow dozens of similar lawsuits to proceed in other states. Hopefully, the case will also start a trend by which ordinary Americans will be successful in holding corporations accountable for their dangerous practices.

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Heath Ledger's Accidental Drug Overdose Part Of Growing Trend

August 5, 2008 by Mark Siesel

Deaths such as actor Heath Ledger's drug overdose from a mixture of medications have soared since the 1980's according to a study published in The Archives of Internal Medicine yesterday. The authors studied 50 million death certificates since 1983, and found that there were more than 224,000 fatal medication errors, including mixing prescription drugs with alcohol and street drugs. Astonishingly, deaths from medication mistakes at home have risen 700 percent from 1983 to 2004, with 1,132 deaths in 1983 and 12,246 in 2004.

This huge increase in fatalities is attributable to several factors, including the widespread home use of prescription medications like Oxycodone, (which 25 years ago was much more likely to be prescribed in hospitals than for home use), people sharing prescriptions, patients ignoring the risk of mixing alcohol with prescriptions, and as in the case of Heath Ledger, the mixing of medications which are contraindicated. The huge increase in deaths is highest among people in their 40's and 50's.

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Expired Tires Causing Needless Deaths And Serious Injuries

July 22, 2008 by Mark Siesel

There was a shocking and sobering story on the ABC's 20-20 program several weeks ago. Tires sold throughout this country in stores such as Sears, Wal-Mart, and Goodyear have expiration dates, and become dangerous after 6 years regardless of whether they have ever been placed on a vehicle and put in use. Despite this fact, and the tire manufacturers and retailers' knowledge that unused tires are dangerous after several years, they are routinely sold as new to unsuspecting consumers, often with tragic results.

The headline story was that of 19 year old Andy Moore, who was driving his family's van on a graduation trip to Canada with a friend. Although the tires on the van had been purchased 4 years earlier and appeared to be in good shape, they were in fact 9 years old, and very dangerous. The accident was caused when the tread on one of the tires literally peeled off, Andy lost control of the vehicle, and Andy and his friend were killed in the accident. Apparently, as in numerous cases across the country, the tires on the Miller van had been sitting on the retailer's shelves for years, looking new, but drying up and becoming increasingly dangerous.

The 20-20 story was very informative in showing consumers how to tell the expiration date on these dangerous tires. At the very end of the series of numbers along the side of the tires, are numbers such as "414" or "4202", for example. The first number, "414", means that the tire was manufactured in the 41st week of 1994! The second number, "4202", signifies that the tire was made in the 42nd week of 2002. One commentator noted that the tires are "like ticking time bombs on people's cars", and in England, unlike the United States, dealers are now warned to stop selling any tires that are six years old or older. 20-20 found 12 year old tires being sold as new in a New Jersey Sears, a 7 year old tire sold as new in an Indianapolis Wal-Mart, and 9 year old tires sold in a San Francisco Goodyear store. In one instance, the salesperson acknowledged that the tires were old to the 20-20 narrator, and suggested that the tire should be used as a spare tire only!

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Dennis Quaid's Twins Almost Die From Massive Overdose Of Heparin

March 28, 2008 by Mark Siesel

Supplementing our February 29, 2008 post "Blood Thinner Heparin Tied To Several Deaths", the actor Dennis Quaid appeared on "60 Minutes" last Sunday to reveal every parent's nightmare: He and his wife almost lost their newborn twins last year at Cedar's Sinai Hospital in Los Angeles due to a massive overdose of the blood thinner Heparin, manufactured by Baxter International.

The nurses were supposed to give the twins a dosage of "Hep-Lock", a weak form of Heparin to keep IV lines open. Instead, they gave the twins Heparin in a dosage which Quaid described as "10,000 times the normal dosage", causing a drug overdose which could have been fatal. Apparently the almost tragic mistake was caused by the very similar blue backgrounds on the vials of Hep-Lock and Heparin. Quaid said that "our kids were bleeding from everyplace they were was blood everywhere."

Shockingly, this same event occurred in Indianapolis a year earlier, which resulted in the deaths of three infants. Despite this fact, Baxter International, being sued by the Quaids in a multi-million dollar defective product lawsuit, did not change the colors of the two vials until after the Quaid twins incident--now, one vial is red and the other is blue, making a mistake by nurses much less likely.

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Immigration Department Admits Wait For Green Card And Citizenship Now 18 Months

March 14, 2008 by Mark Siesel

The United States Citizenship and Immigration Services USCIS acknowledged that due to a huge increase in applications for green cards and citizenship in July of 2007, the average waiting time for legal residency and citizenship is now 18 months. The surge in applications in July of 2007 (7 times more than the average month), which resulted in the increased waiting time from approximately 7 months to 18 months, was due to applicants submitting their papers just before the almost 50% increase in fees on July 30, 2007.

The USCIS has been under fire for not anticipating and planning for the huge increase in applications last July, although they did hire 750 additional agents for the sole purpose of working on applications. Michael Aytes, the associate director of domestic operations of USCIS has pledged that the agency will keep its promise made at the time of the increase: that in return for the higher fees, by 2010, applications for U.S. citizenship will be processed within 5 months, and petitions for green cards will be handled within four months.

This writer is somewhat skeptical about these optimistic predictions from the USCIS, but we will give the agency the benefit of the doubt and hope that these 750 extra officers will make the difference once the July 2007 surge in applications is two years behind us.

U.S. Supreme Court Now Considering Protecting Drug Manufacturers From Lawsuits

March 10, 2008 by Mark Siesel

Following up on our blog "U.S. Supreme Court Deals Blow to Lawsuits Against Defective Products", the Court heard arguments on February 25 in Warner-Lambert v. Kent, to determine whether drug manufacturers should receive similar protection from lawsuits that the Court handed out to medical device makers earlier in February. Judge Breyer, normally one of the Court's most liberal justices, gave a strong indication that the Court is heading in the direction of protecting drug makers when he stated: "Who should make the decisions that will determine whether a drug is on balance, going to save people or, on balance, going to hurt people?... An expert agency, [The Food and Drug Administration] on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don't see those who need the drug to cure them."

Seemingly forgetting about the thousands of injured victims of Vioxx, for example, who used a dangerous drug which had been approved by the F.D.A. and nevertheless suffered numerous deaths, heart attacks, and other complications, and without question needed the courts to redress their grievances, it appears that the Supreme Court is now ready to bar lawsuits against drug makers.

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U.S. Supreme Court Deals Blow to Lawsuits Against Defective Products

March 4, 2008 by Mark Siesel

Last week, the U.S. Supreme Court ruled that private lawsuits against medical device manufacturers are not permitted when the device in question complies with federal requirements. Essentially, the Court's decision in Riegel v. Medtronic is another example of the U.S. Supreme Court's attack on consumer rights, and will have far reaching negative effects for those who are seriously injured by dangerous and defective products . Charles Riegel received a balloon catheter manufactured by Medtronic which ruptured due to over inflation. He developed a heart block and was forced to undergo emergency surgery to save his life.

The Riegels brought a claim in federal court in New York, which was dismissed by the court, and upheld by the U.S. Circuit Court as being preempted by the Medical Devices Amendments (MDA). The MDA precludes lawsuits against manufacturers where the device in question complied with federal requirements. The problem with the Court's decision, as noted by Justice Ginsberg in her dissenting opinion, is what if evidence of the product's defect becomes known after the product has received premarket approval?

The Court stated in no uncertain terms its belief that juries are not capable of evaluating the risks associated with dangerous devices, with such language by Judge Scalia as the following: "The Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices." And this quote from the opinion is even more frightening for those who believe in our civil justice system as a means to hold manufacturers of defective products accountable: "A jury on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."

The Riegel decision should send a chill down the spine of citizens in this country who believe that the civil justice system is vital in the effort to require manufacturers to ensure that their products are safe for the public before they are placed on the open market.

Blood Thinner Heparin Tied To Several Deaths

February 29, 2008 by Mark Siesel

The Food and Drug Administration announced on February 28 that "potential deficiencies" at a Chinese plant that produces the active ingredient in Heparin, a blood thinner used to treat blood clots during dialysis and after some surgery, is a possible cause of 21 deaths, as well as hundreds of allergic reactions including vomiting, nausea and difficulty breathing. Baxter International, the company which makes the brand of Heparin that is now considered a potentially dangerous product, has announced an immediate recall of virtually all of its Heparin products, which it buys from a Chinese plant known as Changzhou SPL.

Heparin is made from pig intestines. In China and other developing countries, tracing the source of the animals used to make the product can be very difficult. The FDA also acknowledged that other problems which could have led to the manufacture of the dangerous product include the lack of specific procedures outlining removal of impurities, and no records showing the suppliers' source of the products.

The Food and Drug Administration estimates that over one million multi-dose vials of Heparin are sold per month in the United States, and half of those are manufactured and distributed by Baxter. However, the FDA has provided assurances that there is an adequate supply in the market to meet the demand for Heparin, which clearly is a necessary and lifesaving drug.