Archive for May 2012

Toning Shoes Lawsuits Filed

May 31, 2012

(May 31, 2012) Toning shoes lawsuits have been filed against makers of various toning shoes, alleging that the wearers of these shoes suffered injuries as a result of wearing them. These toning shoes were advertised as helping people get into shape, however, some are arguing that those claims are baseless, and these shoes provide absolutely no health benefits whatsoever.

 

Those who argue that these shoes provide no health benefit also believe that there is no benefit in wearing these shoes over wearing regular athletic shoes while exercising. In fact, the American Council on Exercise, or ACE, conducted a study that showed that people who exercised in these shoes had no benefits in muscle activation.

 

These toning shoes, like the Reebok EasyTone and the Skechers Shape-ups, have a “rocker bottom,” which improves muscle tone by forcing the leg muscles to work harder during normal activities such as walking. They are advertised as toning the legs, promoting weight loss, improving posture, and reducing stress on the joints.

 

However, the Federal Trade Commission has filed a lawsuit against Reebok over its claims that its toning shoes would strengthen calf and hamstring muscles by 11 percent. Reebok settled for $25 million, using the settlement money to refund customers who have bought these shoes.

 

In addition, there has been at least one lawsuit filed over a women who wore the Skechers Shape-ups for five months while working and exercising, and has developed stress fractures in both her hips, despite a normal bone density level. Because the shoe forced her to change her gait, the stresses on the bones and connective tissue changed, thus increasing the risk of chronic injuries such as the stress fractures she suffered, as well as potential Achilles tendon ruptures and soft tissue damage.

 

In a world where everyone is on the go, running errands on working multiple jobs, nobody has time for the gym, or at least that is the image these product manufacturers portray, so that we will buy their products. But in reality, the products they are looking to profit off of are inherently dangerous. A toning shoe that is unstable will lead to a risk of injury from falling, and even broken bones. If you want toned legs, my suggestion is to go to the elliptical, or a machine in a gym that is manufactured specifically for toning.

 

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Legal Rights for Victims of Generic Drugs Gain Support of State Attorney Generals

May 29, 2012

(May 29, 2012) – A group representing state Attorneys General across the country has backed a proposed U.S. Senate bill, allowing the makers of generic prescription drugs to update safety labels on their products if they become aware of new dangers and side effects from taking them.

 

According to a statement from the National Association of Attorneys General, or NAAG, the bill proposed by Senators Patrick Leahy and Al Franken would give all users of prescription drugs the same legal rights if they suffer a side effect from taking it that’s not expressly noted on safety information included with the drug.

 

Under current federal law, makers of generic drugs are blocked from updating the safety labels and warnings on the copies of name-brand drugs they manufacture and distribute until the brand-name company makes changes. If a patient is prescribed or dispensed a generic drug and suffers a side effect, they are unable to file any legal actions against the makers of the generic drug, which is exempted from facing lawsuits for hiding side effects of that drug.

 

This law gained attention when the Supreme Court was presented with the case PLIVA Inc. vs. Mensing, in which the high court ruled that federal law only granting permission to makers of name-brand drugs to independently update the safety labels on drugs prevented those who suffered injuries caused by generic drugs from seeking any legal actions against the makers of it.

 

NAAG states that more than 70 percent of all prescriptions filled in the U.S. are for generic drugs, and that is likely to increase as patents for top-selling drugs expire, just like the cholesterol drug Lipitor has recently done.

 

If a patient receiving Lipitor in the name-brand form experienced side effects or adverse reactions to taking the drug not mentioned in the safety label or not explained by their physician, they had the right to take legal action against the makers of it for failing to disclose the dangers and side effects. A patient taking the generic form of the drug would not have the same legal rights under current federal laws, which the Supreme Court has determined supercede any state consumer protection laws.

 

“This preemption holding produces arbitrary and unfair results, as both the majority and dissenting opinions in PLIVA recognized. Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection,” the statement reads from NAAG. It was signed by 41 states and U.S. territory Attorneys General, and submitted to the Senators cosponsoring the new bill. “Congress can readily cure this problem by amending federal law.”

 

A group representing state Attorneys General across the country has backed a proposed Senate bill that would allow the makers of generic prescription drugs to update safety labels on their products if they become aware of new dangers and adverse side effects from taking these drugs.

 

It is about time that victims who used the generic versions of a drug have legal rights. We are no longer in an era where generics are the minority, as an alternative option. As mentioned above, 70% of all prescription drugs are generic. Therefore, these people should have the same rights as those who pay full price for the name-brands.

 

We look forward to receiving feedback. Comment on this blogpost. You may also follow us on Twitter, and become a fan of our Facebook page. If you have further questions, you may stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878).

Birth Defects Caused by Paxil During Pregnancy

May 27, 2012

(May 27, 2012) – In 2005, the U.S. Food and Drug Administration (FDA) issued a warning that anti-depressant drugs with a Selective Serotonin Reuptake Inhibitor (SSRI), such as Paxil, could put children at risk of birth defects if taken by pregnant mothers.  There are millions of at-risk children born to mothers who were prescribed such medications.

 

This warning came after the FDA reviewed a study conducted by Paxil manufacturer, GlaxoSmithKline. The FDA warned the medication could cause a range of birth defects. Data was collected from more than 3,500 women taking Paxil during the first three months of pregnancy. The medication has not been banned for pregnant women, though the warning has been upped from Class C to Class D, meaning that there is evidence that the drug poses a known risk to unborn children. Although it is not recommended for expectant mothers to take this medication, doctors may continue to prescribe it if the benefits for the mother outweigh the risk posed to the fetus. It is known that there is a common presence of depression in pregnant women.

 

Drugs like Paxil and Zoloft have been found to cause birth defects in children of pregnant mothers taking these drugs by experts with the National Birth Defect Prevention Study of Infants, the FDA, New England Journal of Medicine, University of Ulm and Aarhus University in Denmark, University of California at San Diego, and Boston University.

 

The birth defects, which were found directly related to mothers who took Paxil during pregnancy are:  skull defects, lung conditions, abdominal defects, club foot, brain deformities, heart defects, and spinal defects.

 

Paxil has been on the market in the U.S. since 1992, and is one of the most widely prescribed anti-depressants on the market. Ten years after it became available, the LA times published an article (December 15, 2002) estimating that in that year alone, 37 million prescriptions were filled. Just five years later, in 2007, the FDA calculated that 19.7 million prescriptions of Paxil were filled.

 

In 2010, annual reports showed that Paxil’s manufacturer, GlaxoSmithKline, earned more than $5 billion in profits. GlaxoSmithKline has spent approximately $1 billion to date to settle litigation claims regarding birth defects, according to an article published in Bloomberg News on July 20, 2010. On average, settlements amounted to $1.2 million in approximately 800 individual cases.

 

Even families that have yet to file a claim still retain their legal rights, despite the fact that hundreds of cases have already settled.

 

Paxil birth defects include:

–       Persistent Pulmonary Hypertension in the Newborn (PPHN)

–       Congenital (present at birth) heart defects

–       Neural tube defects (spina bifida)

–       Craniosynostosis

–       Infant omphacele

–       Club foot

–       Anal atresia

–       Lung defects

 

Persistent Pulmonary Hypertension in the Newborn (PPHN) is a life-threatening disorder in which a newborn’s arteries to the lungs remain constricted after birth, resulting in an abnormal blood flow through the heart and lungs, and insufficient oxygen delivery throughout the baby’s body. Surgery is required in serious cases.

 

Spina Bifida – During the first month of pregnancy, the two sides of the spine join together to cover the spinal cord, spinal nerves, and the tissues covering the spinal cord. Spina bifida refers to any birth defects involving incomplete closure of the spine. This requires major surgery, physical therapy for the child, and in some cases, special apparatus.

 

Craniosynostosis – A birth defect in which one or more of the joints between the bones of the infant’s skull close prematurely, before the infant’s brain is fully formed. When the baby has craniosynostosis, his or her brain cannot grow in its natural shape, and the head is misshapen. To treat this, the infant usually needs surgery to separate the fused bones. If there is no underlying brain abnormality, the surgery creates adequate space for the brain to grow and develop. Treatment must be done at birth while the baby’s head is still malleable in order to create proper room for the brain to grow and to relieve pressure and re-mold the skull’s shape.

 

Infant Omphacele – is an abdominal wall defect at the base of the umbilical cord; the infant is born with a sac protruding through the defect, which contains the small intestine, liver, and large intestine. Surgery is required; however, once the omphacele repair is completed, some infants have difficulty eating normally, and may require tube feeding. If the omphacele is large, a caesarean section is necessary.

 

Infant Omphalocele

 

Anal Atresia – is a congenital defect that affects the anus. In this condition, the opening of the anus is blocked or missing entirely. Surgery is the only treatment for anal atresia.

 

Lung Defects – Although there are many types of lung defects from blood flow to deformity to underdevelopment, these are addressed separately, with varying treatments that can be resolved through incubators or surgery. There is a possibility that the child will have breathing problems for their entire life.

 

These are very dangerous side effects, and many of these conditions are life long.  Although depression is a serious disease, is taking Paxil while pregnant worth passing such horrible side effects on to your unborn child?  The manufacturers of these anti-depressants, in this case, GlaxoSmithKline, manufacturer of Paxil, need to warn consumers about the increased risks they are facing when taking these drugs.  They are responsible for causing so much pain and sickness to millions of mothers and their babies. Now they really have something to be depressed about.

 

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Prozac’s Increased Risks of Birth Defects

May 25, 2012

(May 25, 2012) – Prozac (fluoxetine) is included in a group of medications called Selective Serotonin Reuptake Inhibitors (SSRIs) that work by boosting serotonin levels in the brain, resulting in the regulation of mood, sleep and appetite.  These SSRIs have been linked to serious side effects. Among the reported Prozac side effects are an increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), congenital heart defects and withdrawal symptoms. Prozac is an anti-depressant used to treat major depressive disorder, bulimia nervosa, obsessive-compulsive disorder, premenstrual dysphoric disorder (PMDD) and panic disorder.

 

According to researchers, pregnant women who take anti-depressants such as Prozac increase the risk of birth defects in their babies by more than half.  In addition, women using SSRIs in the first 12 weeks of pregnancy, when many women maybe unaware that they are pregnant, were at a 40 percent greater risk of their baby suffering malformation. The risk of heart defects was 60 percent higher. The study, conducted by researchers in the U.S. and Denmark, compared 1,054 women who took SSRIs during the first 3 months of pregnancy with 150,000 women who were not prescribed them.

 

The FDA approved Prozac in 1998 and it became the most widely prescribed drug for depression on the market. However, two years before the FDA’s approval, a 1996 study published in the New England Journal of Medicine found that women taking Prozac during pregnancy were twice as likely to deliver a baby with three or more “minor abnormalities” and poorer than average neonatal adaption.

 

Almost a decade later, in 2005, a Danish study indicated that pregnant women who take SSRI anti-depressant medication in early pregnancy may have an increased risk of giving birth to an infant with heart problems. In this study, infants exposed to SSRI anti-depressants during the first three months of pregnancy had a 60 percent higher chance of developing a heart problem compared with infants whose mothers did not take SSRI anti-depressants.

 

On July 19, 2006, the FDA released a warning that SSRI anti-depressants can cause serious or life-threatening lung problems in newborns whose mother took the medication while pregnant. The warning came after a study was published in New England Journal of Medicine that showed infants were six times more likely to suffer PPHN after being exposed to SSRIs such as Prozac. Babies whose mothers took Prozac while pregnant may also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia.

 

PPHN occurs when the blood vessels in the lungs constrict, causing increased pressure in the pulmonary artery, possibly resulting in death. Symptoms of PPHN include shortness of breath, chest pain, fatigue and fainting spells. Many patients with PPHN require a lung transplant. Even with treatment, 20 percent of newborns with PPHN die. Symptoms of PPHN include rapid breathing and heart rate, difficulty breathing, or bluish skin.

 

The FDA has placed Prozac in Pregnancy Category C. This means that animal studies have indicated that there is a risk to the fetus, but human studies do not show that the risk of birth defects is greater than the risks involved in discontinuing the medication. They also warn that Prozac can be transferred to an infant through breast milk.

 

Information released from National Birth Defects Prevention Study of Infants, SSRI anti-depressants like Prozac may cause two separate congenital abnormalities called omphalocele and craniosynostosis.

 

Omphalocele is a congenital (present at birth) abdominal wall defect at the base of the umbilical cord; the infant is born with a sac protruding through the defect, which contains small intestine, liver and large intestine.

 

Craniosynostosis is a congenital defect that causes one or more sutures on a baby’s head to close earlier than normal. The early closing of a suture leads to an abnormally shaped head.

 

Although depression is a serious condition, the proven birth defects caused from these SSRI medications are dangerous and should not be taken lightly. If these manufacturers are aware all the side effects these drugs cause, changes must be made.  Giving birth to a baby with such serious health problems is a major trade off to living without depression for nine months. Some women cannot live without these SSRIs and only the patient and their doctor know what is best for them, but for those that can manage without the drugs during pregnancy, it seems like the wise choice.

Lawsuits Filed Against Manufacturer of Dangerous Pradaxa

May 24, 2012

(May 24, 2012) – Pradaxa, a blood thinning drug which the U.S. Food and Drug Administration (FDA) is investigating for causing serious, possible fatal bleeding in patients. Doctors prescribe Pradaxa to help reduce strokes and prevent blood clots in patients diagnosed with atrial fibrillation (AFib), sometimes referred to as an irregular heart beat. This drug has been linked to bleeding so severe that it can cause heart attacks and possibly result in death. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceutical GmbH & Co. KG of Germany.

 

The FDA issued a safety alert regarding Pradaxa in December 2011. The FDA is conducting a safety review of reports of serious bleeding related to taking Pradaxa. Health agencies in Europe, Japan and New Zealand have also reported cases of severe and sometimes fatal bleeding, which may have been caused by Pradaxa. The drug was introduced as an alternative to warfarin, a commonly used anti-coagulant.  However, unlike warfarin, severe bleeding caused by Pradaxa cannot be stopped by injections of vitamin K.  In addition, there are no good antidotes for bleeding caused by Pradaxa. More than two million Americans have atrial fibrillation, which makes them prone to blood clots, which can cause strokes. Lawsuit claims against drug makers allege that the company failed to completely research its side effects and promoted it as a safe alternative to warfarin. Warfarin (Coumadin) is an established medication that has a reversal agent if bleeding problems occur. These lawsuits also allege that the manufacturer failed to adequately warn about Pradaxa’s lack of any reversal agent. In any case, Boehringer Ingelheim promoted its blood thinners as a more convenient alternative to warfarin because it requires less monitoring.

 

Pradaxa is relatively new to the market, being approved by the FDA in October 2010. Pradaxa is used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. From its approval until August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed to 371,000 patients.  There have been 250 deaths associated with Pradaxa as reported in the Bloomberg News.

 

Pradaxa has serious side effects to be concerned about. Serious bleeding incidents may occur in patients, even after minor injuries like a fall or bump to the head, which is a well-known complication of all anti-coagulant therapies.  In addition, a study done in January 2012 showed that Pradaxa patients had a 33 percent greater chance of heart attack or severe heart disease symptoms than those taking warfarin. Patients taking Pradaxa are also warned that bruising may occur more easily and take longer for the bleeding to stop. Patients are instructed to seek immediate care from a doctor if any signs or symptoms of bleeding are noticed:

 

–       unexplained bleeding from the gums

–       frequent nose bleeds

–       heavier than normal menstrual or vaginal bleeding

–       severe or uncontrollable bleeding

–       unexplained bruises that grow in size

–       coughing up blood or blood clots

–       vomiting blood or vomit that looks like coffee grounds

–       urine that is pink or brown

–       stools that are red or black and look like tar

 

The FDA is working with the manufacturer to analyze post market reports to identify possible evidence of inappropriate dosing, drug interactions or other clinical factors that might lead to uncontrollable bleeding.

 

Before patients discontinue use of Pradaxa they should discuss with their doctors. Stopping the use of blood thinning medications can increase the risk of stroke, leading to permanent disability or death.

 

Feel free to comment on this blogpost. Follow us on Twitter, and become a fan of our Facebook page. For more information, stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878).

Prevent Your Car From Breaking Down

May 24, 2012

(May 24, 2012) As summer is approaching, you should keep these tips in mind, so you can be assured that your car doesn’t break down.

 

The Automotive Research Center (ARC) at The Automobile Club of Southern California recently released a study for the most common reasons AAA members call for Roadside Assistance, which resulted in a two or repair. This study didn’t involve simple tire changes or jumping batteries, rather, 6,466 breakdowns that required bringing the stranded vehicle back to the shop. And avoiding your car becoming another statistic is really simple; in fact, you don’t need to know anything about cars to avoid calling for a tow.

 

The first step is to open up your owner’s manual to see the predetermined maintenance schedules of your vehicle. Change the oil and filter at the proper intervals, as well as following the lists that say “Inspect,” as in “Inspect and adjust all fluid levels” and “Inspect radiator and condenser.”

 

Monitor Your Fuel Levels:

Next, do not let your fuel level fall below one-eighth full. In fact, I was always taught that the tank should never be below a quarter full, just in case you get stuck in a major traffic delay from a serious accident or something of the sort. The fuel pump resides inside the tank and is cooled by surrounding fuel, so too little fuel can overheat the pump, causing it to fail. In addition, low fuel can lead to crud clogging your fuel filter and shutting your engine down.

 

Check Your Battery’s Charge:

Your battery should be tested once or twice a year if it is at least three years old. The AAA Mobile Battery Service technicians provide state-of-the-art assessments, and can replace a battery on the spot. Dying batteries aren’t always easy to detect, but if your engine is slow to turn over, or there is a clicking when you turn the key, it may be time to get a new battery.


However, before you run to replace your car battery, make sure it’s the battery that is the actual problem, and not something linked to the alternator. This is important because when the alternator fails, the battery gets discharged, making it seem like the battery is dead.

 

Coolant Leaking?:

If you see coolant on your driveway, or the “Temp” light is glowing on your dashboard, it may be too late, as the problem could be a leaking hose, corroded radiator, or something else.

 

Of the most common breakdowns in the AAA survey, this is how the results broke out:

543 Fuel Pump

347 Alternators

308 Battery

277 Starter

216 Radiator

194 Transmission

168 Hoses

 

Don’t become another statistic!

Bone Drugs Linked to Thigh Fractures

May 23, 2012

(May 22, 2012) – Bone strengthening drugs (bisphosphonates), more commonly known as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), and zoledronic acid (Reclast), were first introduced in the mid 1990s, and have become a popular treatment for osteoporosis.  Many women who suffer from osteoporosis following menopause take these bone strengthening drugs to reduce the risk of fractures.

 

A review conducted by the U.S. Food and Drug Administration (FDA) recently published in The New England Journal of Medicine questions whether or not there is any benefit to staying on these drugs long-term, in light of their potential for side effects.  A report in the Archives of Internal Medicine yesterday found that osteoporosis drugs significantly raise the risk of a rare, but serious, thigh fracture. Researchers noted that the longer the patient took the bisphosphonates, the greater the risk.  Although the researchers noted that studies generally support the benefits of osteoporosis medications to strengthen bones and prevent fractures, they suggested that patients re-evaluate whether or not to continue taking the drugs longer than 3-5 years.

 

Bisphosphonates have raised safety concerns in the past, including heart risks. In 2008, the FDA said it found no link between the drug and heart problems. In 2010, the FDA ordered drug labels to include a warning about the possibility of thigh fractures. In 2011, an expert panel sanctioned by the FDA, expressed concern over the possibility of atypical fractures.

 

In a current study, Swiss researchers examined records of 477 patients treated for broken legs; 438 of them had typical fractures caused by falls and other accidents. However, 39 of them had broken femur bones, caused by minimal or no trauma; 32 of the 39 with atypical thigh breaks had taken bisphosphonates – 82 percent; and 7 of the 32 had atypical fractures in both thighbones.

 

Some experts believe bone-strengthening drugs are being over-prescribed for healthy people.  It has been shown that bisphosphonates can actually weaken bones by impairing their ability to heal, leading to fractures, in a study conducted by researchers from N.Y. Presbyterian Hospital/Weill Cornell Medical Center.

 

Here’s how bisphosphonates work:  Bones undergo a constant process of breakdown (called resorption) and rebuilding. When bones break down faster than they can rebuild, they become weak – the condition known as osteoporosis. Weakened bones make people more vulnerable to fractures if they fall. Bisphosphonates decrease bone resorption, which helps maintain bone density and keep the skeleton strong.

 

In addition to the increased risk of thigh fractures, a study conducted by researchers from the University of Washington and published in the Archives of Internal Medicine showed Fosamax appears to double women’s risk of developing a chronic irregular heartbeat known as atrial fibrillation. This can lead to dizziness, fatigue and momentary loss of consciousness.

 

There were studies reported in The New England Journal of Medicine in 2006, warning about the link between bisphosphonates and osteonecrosis of the jaw (ONJ), also referred to as “dead jaw”, where the jaw bone dies.  Doctors had thought this was triggered by having teeth pulled, and there were warnings to avoid pulling teeth whenever possible. It was thought to be a growing epidemic and was directly linked to these drugs for osteoporosis.

 

Most drugs have side effects.  But, you would not expect a drug marketed for strengthening of the bones to actually cause the bones to break.  It is bad enough that these osteoporosis drugs had a risk of “dead jaw”.  When the reports surfaced regarding atrial fibrillation, women had to weigh the risks and benefits of taking these drugs. But now, the newest studies found that these bone drugs are actually increasing the risk of bones fractures! It seems that with all the new side effects linked to these bone drugs, maybe sticking with plain old exercise may be the best way to go, as exercise is one of the most effective ways to keep bones strong.

 

What do you think about these findings? Would you still risk taking these bisphosphonates? Comment on this blogpost; we look forward to hearing your feedback.

 

Follow us on Twitter, and become a fan of our Facebook page. For more information, you may stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878).