Category: Consumer Safety

THE RESEARCH RECESSION: 12 years of Anesthesiology progress in question

Over the past 12 years, anesthesiologist Scott Reuben revolutionized the way physicians provide pain relief to patients undergoing orthopedic surgery for everything from torn ligaments to worn-out hips. (Brendan Borrell, Scientific American)

Rueben’s drug studies were responsible for convincing orthopedic surgeons to move away from the first generation of non-steroid anti-inflammatory drugs to a new method, known as COX2 inhibitors. He claimed that these new drugs, made popular under the names Vioxx, Celebrex, and Bextra, in combination with anticonvulsants could be effective in decreasing postoperative pain and reduce the use of addictive pain killers, such as morphine, after surgery. What seemed to be a break through, Reuben’s findings were hailed as a great step forward in redesigning anesthesiology.

12 years later however, the profession is in a state of crisis after an investigation by the Baystate Medical Center revealed that at least 21 of Reuben’s papers were entirely made up, faking the beneficial results and in some cases, masking possible dangers. The investigation found that the data in these 21 studies had been partially doctored, and in some cases, entirely fabricated by Dr. Rueben.

Although this most recent investigation has brought the wall tumbling down for Dr. Rueben, signs of cracks had leaks had begun to rear their ugly head over the past five years. In the early part of the decade, orthopedic surgeons began to distrust Rueben’s COX2 inhibitors, when animal testing found that the drugs might actually hinder bone healing. Soon there after, in 2004, Vioxx and Bextra, and Celebrex were pulled from the market because of their link to an increased risk of heart attacks and strokes. All the mean time, Dr. Rueben continued to present positive “findings” for the use of these COX2 inhibitors in his research.

So, even with the public at risk, what motivated Dr. Rueben continue his campaign for these drugs? Simple. Money. It was discovered during the course of the Baystate investigation that Dr. Rueben’s research was entirely funded by Pfizer; the maker of both Celebrex, and the anticonvulsants lauded by Dr. Rueben’s study to be used in conjunction with the COX2 inhibitors. Baystate however could not find any records of the payments, suggesting that the payments were made not to Dr. Rueben’s research group, but instead directly to Dr. Rueben.

Although we may think of doctor’s as always having the best intentions, one must always remember the power of money. Pharmaceutical corporations are some of the richest and most powerful companies in the world, and they need doctors on their side. It is much easier today for these drug companies to pay off a doctor to get the results they need rather than go back to the drawing table and leave behind an unsuccessful product. Because of this, remember to always remain informed when consulting with your doctor about possible medication options. An informed patient is always the safest patient.

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AIG – Arrogant, Ignorant, and Grossly Immoral

We have all read the headlines over the past months worthy of making an individual sick. Constantly we are told of how drastically irresponsible some insurance and financial institutions have been with the bailout money they have received from the Federal Government. At the top of that list sits AIG.

You may remember this, from an article in the Washington Post, dated October 8th, 2008:

Only one day after it was revealed that AIG had sprung for a $440,000 spa vacation shortly after getting an $84 billion government-loan bailout comes this report: The government is loaning AIG another $38 billion.

If that wasn’t enough to make you gag, wait until you hear this. While spending exorbitant amounts of taxpayer dollars on pedicures and vacations, AIG has been simultaneously dragging a suffering family through the mud for over a decade. After a fatal fire killed two Brooklyn firefighters in a, “fireproof,” building insured by AIG, the families of Lt. Joseph Cavalieri and Christopher Bopp were awarded several million dollars in damages by a unanimous jury decision.

AIG however, has continued to refuse to pay. By exploiting the appeals system of the courts, AIG has dodged payment for over 10 years.

“How do you possibly appeal something like this?” Mother of Christopher Bopp, Deloris Bopp recalled saying when she first heard of the appeal. Indeed, it seems hard to find grounds on which to appeal when the jury only needed an hour to award the families with $10 million dollars.

As the appeal was moving forward, the wheels began to fall off the oversized AIG corporate machine. When Ms. Bopp found out that AIG would be receiving $85 billion in bailout money, she became furious, and rightfully so.

How can a company pay millions of dollars in bonuses and all expenses paid vacations for its employees, while denying payment of the $10 million dollars that is rightfully owed to the victims under their policy? Easy: by taking massive amounts of taxpayer’s dollars and ignoring all moral responsibility to the public.

Supreme Court Overrules Public Safety

A Supreme Court ruling last year has begun to show its true colors, as many federal cases against Medical Technology Corporations will go unheard. In February of 2008, the high court decided to restrict the legal options for patients who claim they have been injured by a defective device. If the Food and Drug Administration has approved the device after, “rigorous review,” than a suit cannot be filed under state laws.

This unjust ruling will prevent many individuals who have been subject to hard due to faulty design from collecting the compensation they need to maintain a reasonable quality of life.

Devices that are not properly engineered can have catastrophic effects when implanted in a patient. Janet Moore, of the Star Tribune, provides us with an example:

“Make it stop,” Liz Fossum remembers thinking.

For about an hour early that November morning two years ago, Fossum’s implanted defibrillator repeatedly shocked her heart — 54 times all told. It felt like a horse was kicking her in the chest.

The 68-year-old grandmother from Golden Valley now knows that part of her heart device, an insulated wire made by Medtronic Inc., had been recalled by federal regulators because a small number had malfunctioned, occasionally causing unnecessary shocks.

Unfortunately for people like Ms. Fossum, there is little she can now do under the new law. Several Hundred cases had been filed against Sprint Fidelis, all of which were subsequently dismissed as a result of the Supreme Court decision. Obviously, all those affected by the faulty product were outraged by the Supreme Court’s decision to protect corporate interests over the interests of the public.

This new decision has left consumers without any means to remedy the harmful situation they were put in by a lack of vigilance on the part of the FDA. Henry Waxman, a Representative from California, believes that the Supreme Court puts too much faith in the FDA testing process. He stated that, “The Supreme Court assumed that FDA approval ensures medical devices are safe, but many recent stories of patients harmed by faulty devices have proven those assumptions false.”

Waxman along with New Jersey Representative Frank Pallone plan to introduce legislation that would circumvent the Supreme Court ruling and protect Americans from dangerous medical devices. Until that time however, citizens must remain vigilant. If you are in need of or considering the possible use of a medical device, please research all companies and available options fully. Until the government decides to protect consumers again, self-education is the best defense.

If you have been subject to a faulty medical device, please contact an attorney immediately. There are several possible options, which may allow you the compensation you deserve.

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Chamber of Commerce Torches the Economy and Asks for Refund

Like the child who kills his parents and then begs for mercy because he is an orphan, the U.S. Chamber of Commerce now is begging President-elect Barack Obama to protect corporate interests in the nation’s civil litigation system as a way of restoring jobs and bolstering an economy shattered largely (as we now know) by corporate greed and misfeasance. – Andrew Cohen, CBS
Unbelievable.  After decades of corruption, greed, and lack of responsibility to the public, the corporate machine has been exposed as the true cause of the economic plunge we are currently facing.  And what do they want in return?  For the government to shield them from the system put in place for the very purpose of enforcing that responsibility. 

 

Here is what the president of the Chamber of Commerce’s legal arm wrote in an open letter to Obama: “We understand the critical necessity of revitalizing the economy by restoring American jobs, encouraging the growth of U.S. businesses, and protecting the savings and investments of millions of Americans. However, we are concerned that the potential expansion of legal liability significantly impairs these much needed steps toward a national recovery.”

In a desperate attempt to plead for mercy to the new President-Elect, The chamber of commerce is merely renewing an argument that has failed for decades.  The Chamber has been pushing tirelessly for almost half a century now to rein in plaintiffs’ attorneys (who look to punish corporate negligence or fraud with civil lawsuits), deregulate industry and commerce (we all know how well Wall Street did with its freedom), and nullify important consumer protection laws (like the one in Maine which is allowing smokers to go after tobacco companies for false advertising).History has shown us how devastatingly successful the Corporate interest machine can be.  Because of the Chamber’s organization, innocently named The Institute for Legal Reform, the Securities and Exchange Commission backed off its scrutiny of screwy deals and schemes, the Congress was lax in its oversight of the mortgage industry, litigators were thwarted or punished, and the White House and Justice Department pushed a legal doctrine (“preemption”) that almost always helped employers over employees. 

Results such as this put public interest on the loosing side.  The American legal system over the past 20 years has been a victim of unremitting advances for the Chamber and its fellow travelers in law, politics and governance. The Chamber has labeled “abusive litigation” as the cause of almost every economic problem to face the modern United States.  Could the lawyers who enforce corporate responsibility truly is the cause every economic disaster of our modern economy? 

 

 CBS Correspondent and Attorney Andrew Cohen thinks not:

Plaintiffs’ attorneys aren’t responsible for the mortgage-fueled economic meltdown. Class-action litigation isn’t, either. And don’t blame overzealous regulators or greedy employees who want better pay or conditions in their own factories. The people with whom the Chamber and the Institute do battle are not the people who invented or allowed the great pyramid schemes, which brought down Freddie Mac and Fannie Mae. They did not force consumers to spend more than they earned or save less than they should. Corporate America is directly responsible for what has just happened to corporate America, and if you don’t believe me, ask the folks at Ford, GM and Chrysler.The economic meltdown came about because business interests were able to greatly decrease the vital tensions between industry and regulation, between oversell and oversight. And it will take the restoration of those tensions by government leaders not just to help bring us out of our slump but to help ensure that the next downturn doesn’t come again for a long time.
The more the chamber of commerce attempts to deregulate the market and further bolster its litigation shield, the farther away we get from turning around the current economic crisis. 

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Child Accidents Raise Concern Over Automobile Safety

According to a global study performed by the World Health Organization and Unicef, it has been found that around the globe, accidents kill 830,000 children each year.  Over all, although 95 percent of all injuries to children occur in poor and middle-income countries, injuries account for 40 percent of all child deaths in rich ones – Including the United States.

Dr. Étienne Krug, director of injuries and violence prevention at the World Health Organization, believes this is because wealthier nations tend to not have much better child health care, but do not attempt to remedy the causes of childhood accidents.  In a recent article in the New York Times, Dr. Krug was quoted saying, “This is a huge public health problem, and it’s been ignored for a long time.  It’s a combination of ignorance about how big it is, and because of fatalism, of thinking, ‘Oh, it’s an accident, we can’t do anything about it.’ ”

The Center for Disease control reports that in the United States, accidents kill 12,175 children a year.   That is more than all diseases combined.  At the center of this statistic lies a fact, which many American law makers already know, but choose to ignore.  Automobile accidents claim the lives of many infants and toddlers, however by the time children reach their teenage years, automobile accidents instantaneously become the leading cause of death. 

In a New York Times article, Ileana Arias, The Center for Disease control’s chief of injury prevention, reports that the three changes that would save the most lives of American children would be for more states to pass “graduated driver’s license” laws, which forbid teenagers to drive at night or with teenage passengers, to enforce seat-belt laws on teenagers and to make all children younger than 8 ride in booster seats.

Currently however, these suggestions do not carry the power of the law.  They are however the best solution to an epidemic problem.  As Ms. Arias recommends, please keep your child in a booster seat until they reach the age of eight.  If you have a teenage driver, remember that they more than likely don’t share your priorities and equal judgment when it comes to driving.  Please talk to your teenagers often enough about the importance of the seatbelt, and the effects of distracted driving. 

If you or someone you know has been seriously hurt in an accident, please contact an attorney immediately. 

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Morphine, Dextroamphetamine, and Isosorbide added to the Ethex Recall

The Ethex Corporation has added three new drugs to its list of recently recalled products.  After Ethex discovered that their propafenone tablets were over-sized, it became evident that many other drugs being manufactured by the company were also over-sized. 

Isosorbide

Isosorbide is a drug used principally in the treatment of angina. It works by dilating the blood vessels in order to reduce blood pressure. All of the recalled Isosorbide Mononitrate tablets said they were 60mg on the bottle and were made by the ETHEX Corporation with expiration dates ranging from 12/2008 and 11/2009.

Recalled lot numbers: 63466, 66034, 67351, and 67354

Dextroamphetamine

Dextroamphetamine is a stimulant used to increase energy and decrease appetite.  The recalled Dextroamphetamine Sulfate came in 10mg pills with expiration dates ranging from 6/2009 to 5/2007. All were made by the ETHEX Corporation.

Recalled lot numbers: 73934, 75892, 77945, 81137, 86320.

Amphetamines are very dangerous drugs, especially when taken in excessive doses. If the batch number on your pill bottle matches any of the above recalled Dextroamphetamine batch numbers you should contact your doctor and/or pharmacists immediately.

Morphine

Two strengths of immediate release Morphine Sulfate and one strength of extended release Morphine Sulfate were recalled, all of them tablets made by the ETHEX Corporation. The two recalled Morphine immediate release pills were 15mg and 30mg. The recalled Morphine extended release pills were 15mg.  The recalled tablets come from any of the following lots with expiration dates ranging from 8/2009 to 3/2011.

Recalled Lot Numbers:

15mg Extended Release Morphine – 81175, 82514-16, 89660, 89664, 89667, 90249-51, 91687
15mg Immediate Release Morphine – 77852-54, 81746, 82519-20, 84113, 90276-78
30mg Immediate Release Morphine – 75093, 77855-57, 82297, 82521-22, 87239, 88925, 90288-98

Morphine is a highly potent and addictive drug in the opiate family. Like other opioids, such as heroin, morphine acts on the central nervous system to relieve pain. Morphine is highly addictive. Tolerance, physical and psychological dependence develops very rapidly. Overdosing on Morphine is very dangerous and can result in severe side effects, including death.

 If you or anyone you know is prescribed any of these drugs, please immediately check the manufacturer and lot number on your pill bottle.  Contact your physician immediately.  Even in the case that you don’t think you have a recalled prescription; call your pharmacy and physician to confirm. 

 If you or a family member has been hurt by any of the Ethex Corporation recalled drugs, please contact an attorney immediately.  You may be entitled to compensation. 

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DRUG ALERT : Ethex Corporation Recalls Overdosed Propafenone Tablets

As first reported on November 11th, there has been a Propafenone recall by the ETHEX Corporation because the pills may have been oversized, which could result in overdose of the drug Propafenone.

Three different strengths were recalled, all of them Propafenone HCI tablets made by the ETHEX Corporation. They were 150mg, 225mg and 300mg pills from any of the following lots with expiration dates ranging from 6/2009 to 3/2011.

Below are the recalled lot numbers:

150 mg – 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, 90526
225 mg – 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, 90657
300mg – 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42

The 150 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “331? with a bisect on the reverse. The 225 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “332? with a bisect on the reverse. The 300 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “333? with a bisect on the reverse. Life threatening consequences of overdosing on Propafenone Hydrochloride includes heart arrhythmias (irregular heartbeat) and dangerously low blood pressure.

If you or someone you know is prescribed Propafenone, please call your physician immediately.An overdose of this substance is very serious, and can cause severe harm.

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YAMAHA RHINO AT CENTER OF FEDERAL REGULATION CRITICISM

“The U.S. Consumer Product Safety Commission is probing the design of so-called recreational off- highway vehicles after reports of fatal accidents involving the new, unregulated products.” – Alan Ohnsman

The CPSC review, although covering many brands, focuses primarily on the Yamaha Rhino.The Rhino has caught the attention of the CPSC after over 30 fatalities and many more injuries were reported.

The probe spotlights gaps in oversight of the vehicles, which have been produced for about five years.For the past five years, these vehicles have been categorized as All-Terrain Vehicles, or ATV’s.There are several key differences between vehicles such as the Rhino and conventional ATV’s. The Rhino is larger than conventional all-terrain vehicles, it has two side-by-side seats as opposed to a centered seat, and utilizes a steering wheel and protective roll cage.

Despite mounting evidence, The Yamaha Corporation insists that the Rhino is, “…one of the safest, most-reliable vehicles in the category.”Putting profit before customer safety, the Yamaha Corporation is attempting to protect its interests by defining the vehicle as an ATV as opposed to re-designing a safe product.Yamaha also claimed that unsafe use of the vehicles lies at the center of the problem, and that proper use will result in a drastically safer product.

Don’t be fooled.There are inherent design problems in the Rhino which have resulted in serious injuries.The center of gravity on the Rhino is significantly higher than the average ATV, making it prone to tipping.The lack of doors to keep limbs inside the vehicle also contributes to many crippling injuries and possible fatalities.These two factors highlight the danger of driving one of these vehicles through rough terrain.If the Rhino is truly an ATV, why is it so dangerous to drive it in rough terrain?

If you, your family, or anyone you know owns a vehicle such as the Rhino, please inform them immediately of the CSPC study and the potential hazard of driving it.Other vehicles with similar designs include Polaris’s Razor, Honda Motor Co.’s Big Red, Kawasaki Heavy Industries Ltd.’s Mule and Arctic Cat Inc.’s Prowler.

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Window blinds and shades recalled after 1 child strangled, another nearly killed

By NATASHA T. METZLER, Associated Press Writer
7:04 AM PST, November 20, 2008

WASHINGTON (AP) _ About 677,300 IKEA and Green Mountain Vista window blinds and shades were recalled in the United States on Thursday after a young child choked to death.The Consumer Product Safety Commission said a 1-year-old girl from Greenwich, Conn., died in April when she got caught in the inner cord of a set of IKEA Roman blinds over her playpen.

The agency also received a report of a 2-year-old girl from Bristol, Conn., who nearly died in June on the beaded-chain loop hanging from a set of Green Mountain Vista shades. The girl’s neck was deeply bruised, but she was saved by her older brother.The recall includes about 670,000 IRIS and ALVINE Roman blinds, manufactured in India and distributed by IKEA Home Furnishings. They were sold at IKEA stores nationwide between July 2005 and June 2008. Another 4.8 million blinds were sold outside the country.

The blinds can be returned to any IKEA store for a full refund and its better to ask for help www.longmontwindowcompany.com.

Also recalled are about 7,300 insulated blackout roller shades and insulated Roman shades manufactured in China by Green Mountain Vista Inc. The shades were sold around the country by Country Curtains, Plow & Hearth, The Linen Source, Sturbridge Yankee Workshop, Ann & Hope, The Sportsman’s Guide, Target.com, The Curtain Shop of Maine, and the Solutions catalog. They were available between June 2005 and September 2008.

Green Mountain Vista shade owners should check to see if the tension device is attached. If not, contact the company for a free repair kit and installation instructions.

For more information on the Green Mountain Vista shades, call (800) 639-1728.

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Parents Beware- Toys With Hazardous Chemical to Remain on Market this Holiday Season

So much for the Holiday Spirit. As you shop for your kid’s holiday presents this season, you risk buying a toy that contains an already banned plastic linked to children’s illnesses.That’s because “a new federal ban on the use of the controversial chemical phthalate in teethers, pacifiers and other children’s products won’t apply to goods already in warehouses or on store shelves, federal safety regulators said yesterday.” – Annys Shin, The Washington Post

Unfortunately the Consumer Product and Safety Commision has decided to allow the makers of child toys and products containing a banned plastic to remain on the shelves.This means that, various companies, including manufacturers in China and other third will countries, will be allowed to sell their products containing the controversial chemical as long as they are manufactured before the date the ban takes place (February 10th, 2009).Most of these products are already on shelves for the holidays.

The ban, which was passed in August as part of a landmark product safety law, is supposed to remain in effect until a panel finishes a scientific review of phthalates.Although testing is still taking place, a scientific consensus has already formed that demonstrates this plastic’s hazard.Studies have shown that phthalates, “…have been shown to change hormone levels and cause birth defects.” Phthalates have negative effects on individuals of all age, however, in particular, “Young infants are more vulnerable to the potential adverse effects of phthalates given their increased dosage per unit body surface area, metabolic capabilities, and developing endocrine and reproductive systems.” – Sathyanarayana

The ban is supposed to remain in effect until a panel finishes a scientific review of phthalates.With studies showing the adverse effects of phthalate on the body, it is clear that this decision violates the direct purpose of the law.If consumers will not be able to tell what products were made when, and which products contain phthalates, than the ban will have little to no effect in helping consumers protect themselves.As Rachel Weintraub of the Consumer Federation of America puts it, “How will parents know whether the rubber ducky they’re buying was made today and not in March?'”

Here are some tips to parents prevent your child from exposure to phthalates.First, look for the common names of phthalates on ingredient lists, which is usually an abbreviation with a “P” on the end, such as DEHP, DINP, DBP, DEP, and DIP.Second, when purchasing toys for your child after this holiday season check to see that it is manufactured after the date of February 20th, 2009.This assures that the ban has taken effect, and that the toy is phthalate free.For more information on phthalates and how to recognize which products contain them, please visit the Children’s Health Environmental Coalition profile page on phthalates.

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