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Posts Tagged ‘Defective Drugs’

Cholesterol Drug Crestor Linked to Kidney Disease

Crestor Injury Lawyer, Crestor Side Effects, Crestor Side Effects Attorney, Defective Drug Lawsuits, Defective Drugs

August 27th, 2010: Law Blogger

Crestor Side Effects and Injury Attorney

Crestor has been one of the leading cholesterol medications on the market since AstraZeneca, Crestor’s manufacturer, obtained approval for its sale and distribution in the United States in 2003. Overall, it’s estimated that as many as 4.5 million people have used Crestor to help manage and lower their high cholesterol levels, but unfortunately it wasn’t long before problems arose and calls to Washington Crestor side effects lawyers began to rise in number. Below is an overview of this issue.

If you experienced any harmful side effects of Crestor outlined below, do not hesitate in seeking medical attention and contacting our defective drug lawyers in Seattle to discuss your options.

Defective Drug Attorneys in WA Helping Victims of Crestor

Crestor is a drug that helps deal with LDL, which is sometimes referred to as ‘bad’ cholesterol that builds inside of many people. Crestor works by penetrating the patient’s liver and lowering the levels of LDL, thereby lowering the patient’s overall cholesterol reading. This is a benefit to patients because high amounts of cholesterol in the system can lead to serious health problems including heart attacks, strokes and the blockage of the arteries that lead to and from the heart.

Harmful Crestor Side Effects and Lawsuits

Unfortunately, Crestor was only on the market for a few months before reports of Crestor side effects began to arise and gain attention from defective drug attorneys around the country. These Crestor side effects included:

  • Chronic bleeding – Bleeding constantly was one of the stranger and more dangerous Crestor side effects to develop, and those who suffered from this Crestor side effect needed immediate medical attention to put a stop to this problem.
  • Acute kidney failure – When the kidneys fail, it creates instant and grave danger for the patient, and many people who used Crestor developed this condition. Medical steps required to help curb the dangers encountered included the removal of a kidney and a schedule of kidney dialysis.
  • Rhabdomyolysis – Rhabdomyolysis is a condition where the fibers of a patient’s muscle tissues deteriorate. When this occurs, myoglobin, which is the substance that forms these fibers, is released into the bloodstream, ultimately stopping in the kidneys. The presence of myoglobin in the kidneys can lead to kidney failure.

How Washington Crestor Side Effects Lawyers Can Help

Ultimately, the FDA issued a public warning regarding the dangers of Crestor side effects. While it remains on the market, those who have been harmed have outlets for help. If this includes you or someone you love has suffered as a result of trusting this medication, contact the Washington State Crestor side effects lawyers at Phillips Webster today to schedule a free initial consultation.

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Avandia Lawyers: Study Finds Actos Poses Same Heart Attack Threat as Avandia

Avandia, Avandia Attorneys, Avandia Lawsuits, Avandia Lawyers, defective drug lawyers, Defective Drugs

August 25th, 2010: Law Blogger

AvandiaNot all diabetes drugs are created equal, or are they? The controversy around the heart attack risk of the diabetes drug Avandia has led to sharp declines in sales and a surge in sales of the competing drug Actos, in part because perception, much of it fueled by the US Food and Drug Administration (FDA), that Actos was in some way safer and carried fewer harmful side effects.

Perhaps the reason for this is the fact that Avandia has been under fire from the Senate, Congress, and the medical community after a study revealed a 28% increased risk of heart attack in patients taking Avandia. This spurred the FDA to order the SCOUT study, which concluded in May of this year.

The Senate Finance Committee did its own inquiry and estimated that Avandia had caused 88,000 heart attacks in the decade it has been on the market. The FDA SCOUT study has since upped that number to an estimated 139,000 heart attacks in a decade. Heart attacks have a 37% chance of death according to the American Heart Association, so that equates to thousands of deaths.

The SCOUT study compared Actos and Avandia head to head. Actos came out the winner of not only the number of heart attacks, but also profit share. Sales of Avandia, as high as $3.4 billion in 2006, have fallen to about $1.1 billion this year, while sales of Actos have climbed to about $4.6 billion.

The Scout study of more than 200,000 Medicare patients suggested that Avandia, known generically as rosiglitazone, increased the risk of heart attack, cardiovascular disease, stroke and death by 30% to 40% compared with metformin and other, older diabetes drugs.

Armed with the knowledge of the serious dangers of Avandia the FDA held hearings in July to determine the fate GlaxoSmithKline’s defective drug. In a bold move the FDA decided to put a warning on the label, thus saving millions of dollars of profit for Glaxo and the government agency’s reputation for approving the drug in the first place. Of course patients still die, but the FDA has its priorities.

The SCOUT study also suggested that the increased risk was not observed with Actos, known generically as pioglitazone. But now a new study suggests otherwise, which exposes the FDA to further scrutiny.

Actos and Avandia Heart Attack Risk Study

actosThe new study was reported by HealthCore Inc., the research subsidiary of the health insurance company WellPoint Inc, on Monday. The research team studied the records of 28,938 patients who took either Actos or Avandia from 2001 to 2005. They obtained information about health outcomes from the company’s own records and about deaths from the National Death Index, a database administered by the government’s National Center for Health Statistics.

They reported in the journal Circulation: Cardiovascular Quality and Outcomes that, when they accounted for potential confounding effects, including age, gender and prior heart disease, about 4% of each group had a heart attack, heart failure or died.

Specifically:

  • 96 patients on Avandia suffered a heart attack, compared with 121 on Actos.
  • 265 on Avandia suffered heart failure, compared with 243 on Actos.
  • 24 on Avandia suffered both heart attack and heart failure, compared with 18 on Actos.
  • 217 on Avandia and 217 on Actos died.

“What distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths,” Debra Wertz, outcomes research manager and lead on the study, said in a statement.

“The study also followed patients for a longer period of time than earlier studies and the patients were younger,” she added. Unlike the earlier studies, however, it did not include strokes in the data, which may account for part of the difference in outcomes.

Avandia Lawsuits

The British drug maker and manufacturer of Avandia, GlaxoSmithKline, was facing as many as 13,000 lawsuits from victims around the country prior to the FDA hearing, but only days prior it was been revealed that Glaxo had settled about 10,000 of the defective drug lawsuits for an average of $46,000 each.

The $460 million settlement closed the vast majority of the patient’s lawsuits without admittance of fault. Many in the legal and scientific community view this settlement as not only low, but a mere slap on the wrist for a company that clearly displayed a profit-over-patient policy for more than a decade.

This is an injustice, but that doesn’t mean that future Avandia patients and their families aren’t able to seek compensation from the company that knowingly keep on selling a drug that seriously raises people’s chance of death above the risks posed by diabetes alone.

Takeda Pharmaceuticals, the maker of Actos, should certainly be seriously concerned about the outcome of this study because their label does not have the FDA heart attack risk verbiage on it like Avandia. Thus, unless explicitly told by a physician or pharmacist, the patient may not know that they are at a considerably higher risk of death taking Actos.

Phillips Webster is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. If you or a loved one have experienced a cardio-event while taking Avandia or Actos, call them today for a free consultation and to find out your legal rights as a patient.

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Meridia Lawyers: FDA Finally Agrees to Review Meridia Heart Attack Risk in September

defective drug lawyers, Defective Drugs, Meridia, Meridia Attorneys, Meridia Lawyers, Meridia side effects, Meridia side effects lawyers

August 17th, 2010: Law Blogger

Meridia LawyersHave you ever heard of the painkiller Vicodin? Well, you were probably given a few at the last painful hospital visit, they might have even had a jar full at the reception desk, that’s how popular it is. It’s one of the most profitable painkillers in the world just as Meridia (sibutramine) is one of the most popular weight loss drugs. Both of these drugs have propelled Abbott laboratories, one of the oldest pharmaceutical companies in the Untied States, to the upper echelon of drug manufacturers.

But this year just might turn out to be a tough year for their weight loss drug and its bloated profit (no pun intended). The US Food and Drug Administration (FDA), known for doing everything they possibly can to avoid conflict or admit their mistakes, has finally agreed to look at the evidence. Then, after review, they will politely ask Abbott officials about it in a courtroom setting on September 15th of this year.

This action is long overdue since the European Medicines Agency (EMA) banned the use of Meridia in 2002 and ordered the drug maker Abbott to conduct a study as to the drug’s link to cardiovascular events (heart attacks, stroke, etc).

The study, called the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) concluded in November of 2009. It was submitted to the FDA for clinical trail to test the data. Those tests have been concluded and now the FDA is prepared to discuss the results.

Do you see an ethical difference in ethical behavior between the EMA and the FDA? As the FDA slowly sets up the water glasses and microphones in preparation for the hearing, the drug remains on the market, whereas the EMA pulled the drug from the market nearly a decade ago while the risk was fully tested.

Meridia Risk of Heart Attack and Stroke

Meridia is specifically for people who are considered obese. Obesity is defined by the National Institutes of Health (NIH) as a Body Mass Index (BMI) of 30 and above. A BMI of 30 is about 30 pounds overweight. Since the BMI describes the body weight relative to height, it correlates strongly (in adults) with the total body fat content.

Patients who are considered obese are already at higher risk of heart attack and stroke due to a series of factors related to obesity such as high fat, high cholesterol, lack of exercise, and lowered immune system.

bmi chart

Though there is no denying that Meridia works as a fat blocker and helps people lose weight, the benefit of weight loss as related to heart attacks and strokes are not decreased, but slightly increased as the SCOUT study found.

The FDA, on its Adverse Event Reactions (AERS) database, indicates that at least 84 Meridia deaths from cardiovascular causes directly related to the use of Meridia have been reported. But these are the only ones reported, there could be many that may have been attributed to obesity, when in fact they were caused by the use of Meridia.

The SCOUT study tested 9000 obese patients against placebo (sugar pill) and found that patients taking Meridia were at a 1.4% higher risk of heart attack than patients taking placebo. That 1.4% difference may not seem significant on the surface, but spread over the thousands of people that take the drug it is significant. The reason for this is that according to statistics 37% of people actually die from heart attacks and that percentage goes up if it’s not their first.

To put it in perspective for you, there were still 294,000 prescriptions of Meridia filled in 2009 according to an IMS health report. If patients are filling their prescriptions on a monthly basis then that means 343 people are at risk of heart attacks and 127 of them will die as a direct result of taking Meridia.

Meridia Side Effects

Meridia doesn’t only raise the risk of heart attacks and strokes, but also has many serious rules that come along with it. It is not your everyday over-the-counter weight loss drug, even though sibutramine has been found in small doses in “herbal” supplements made all over the world. The risk remains, but the inscrutable manufacturers of these supplements don’t print the serious side effects, and more importantly, the serious drug reactions that can come with these supplements.

People should not take Meridia if:

  • Other Drugs – If you take drugs called monoamine oxidase inhibitors (MAOIs), for depression, Parkinsons Disease, and other disorders then you should never take sibutramine in any form or in any dose. This is extremely important because serious (even fatal) reactions can occur.
  • Other Weight Loss Suppliments or Medications- Weight loss medicines that act on the brain, such as phentermine could react with sibutramine. This includes prescription drugs, over-the-counter medicines, and herbal products.
  • Allergies – Have your doctor test if you are allergic to sibutramine.
  • Heart Problems – If you have coronary heart disease, angina (heart related chest pain), arrythmias, prior heart attack or congestive heart failure.
  • Other Diseases – If you currently have severe kidney or liver disease, refrain from taking Meridia.
  • Stroke – If you have had a stroke or symptoms of a stroke, that means you have cardiovascular and circulatory problems and should not take Meridia.
  • Pregnancy – If you are pregnant, planning to become pregnant, or breast- feeding.
  • Anorexic – If you suffer from anorexia nervosa this drug could kill you.
  • Depression – If you take drugs for depression or have had seizures or take drugs for seizures.
  • Disorder – If you have an eye disorder called narrow angle glaucoma.
  • Age – If are under 16 years of age then Meridia has not been approved for you.
  • Take other drugs that regulate serotonin - Combining Meridia with other serotonin regulators can cause a rare, but serious condition called “serotonin syndrome”, which requires immediate medical attention. Some serotonin regulators include most anti- depressants, some migraine headache therapies, lithium, tryptophan, and dextromethorphan (cough suppressant).

Meridia Lawyers

This hearing that the FDA is going to conduct next month does not particularly mean that direct action will result. They have a history of buckling under pressure and only taking action against a drug and the drug company if hundreds of thousands of patients have been injured or killed by a drug such as Vioxx.

Just last month, after the FDA’s own internal audit found that the diabetes drug Avandia caused up to 149,000 patients to have heart attacks and strokes over a decade, they decided to keep it on the market. This is despite the fact that there is an equally effective competitor with far fewer side effects. The speculation is that they made this decision so that the market will force Avandia off of the market rather having to admit they were sloppy in approving it in the first place. By keeping it on the market, the price will lower so that it just kills poor people rather than the insured.

Meridia may get the same soft treatment with even less scrutiny or publicity attached to it. Many foreign countries follow the lead of the FDA when approving and pulling drugs from their shelves. This could mean that the millions of people around the world could be affected by the heightened heart attack risk of Meridia.

The difference is that Americans have legal recourse to seek justice regarding personal injury or wrongful death caused by Meridia.If you have found that you were prescribed the drug and later had a cardio-event or heart attack, you need experienced legal council to represent you to assure that you get the compensation you deserve. Call the Meridia Lawyers at Phillips Webster for a free consultation as to your legal options.

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Crestor Attorneys: Harvard Doctor Calls Statins “Conspiracy of False Hope”

Crestor, Crestor Attorneys, Crestor Lawsuits, Crestor Lawyers, defective drug lawyers, Defective Drugs

August 13th, 2010: Law Blogger

Crestor AttorneysCholesterol is a major problem in American society. You see news reports everyday about the epidemic of obesity, usually accompanied by video of people with giant bums walking down the street. But as the billion-dollar diet industry is concerned more with that part of the human anatomy, the far larger and more profitable pharmaceutical industry has concerned themselves with another issue connected to cholesterol, heart attacks and strokes.

Statins were initially approved by the Food and Drug Administration (FDA) for reducing high cholesterol levels in order to prevent repeated heart attacks and strokes in at-risk patients. When used for that purpose, the drugs drive down the risk of another heart attack or stroke by lowering levels of LDL (or “bad”) cholesterol.

But then the attitude of the medical community toward the use of statins changed with a little nudging of pharmaceutical manufacturers in order to increase sales and profits.

Physicians came to believe statins could also reduce the risk of at-risk patient’s first heart attack with such factors as high LDL cholesterol or diabetes. Since the change in perception, now instead of statins being a reactionary drug, most patients are prescribed them for “primary prevention” of heart attacks and strokes, a use that has become controversial.

Now, about 24 million Americans take statin drugs. These include drugs such as Pravachol, Mevacor, Lipitor, Zocor and Crestor. The majority of the patients take them regularly believing that the drugs are going to stave off a heart attack or stroke.

But you see, it’s a slippery slope because, though statins appear to drive down the risk of heart attack or stroke by lowering the levels of fatty deposits circulating in the bloodstream, research suggests that statins dampen the inflammatory processes. This can prompt deposits of plaque to break away from blood vessel walls and cause sudden blockages of arteries leading to the heart or brain.

Experts say that this leads to heart attacks and strokes anyway and that the practice is not only misleading, but may be unethical.

Side Effects of Statins

Harvard Medical School’s Dr. John Abramson, who has co-written several critiques of the rise in statin use, including one published in June in theArchives of Internal Medicine, is highly skeptical of the current trends in the use of statins.

“There’s a conspiracy of false hope,” Abramson says. “The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

This suggests that the loop of deception may be institutional. The drug manufacturers have always tried to promote off-label uses or benefits that have not been clinically tested or proven in order to sell more pills. The distributor and marketers from individual physicians and marketing to the general public use various methods to perpetuate these misguided and untested off-label uses.

All of these activities are illegal. Drugs are only allowed to be promoted based on the uses approved by the FDA. If a company is found to be engaging in these practices then they usually receive a stern warning letter from the FDA and in some very rare occasions a tiny fine, but usually the damage is already done.

Once the physicians have the perception of benefits then they generally begin prescribing the drug, in this case statins, with little to no actual research backing up the rational behind the treatment. It is only based on belief perpetuated my the drug manufacturer rather than empirical evidence.

The fact that the pills trip from manufacturing to the patient’s mouth is all a misguided campaign of deception makes it an institutional conspiracy just as Dr. Abramson suggests.

He has the research to back up his claims that the pharmaceutical companies don’t.

Crestor Lawyers

Cholesterol buildupIn the first of three studies published recently in the Archives of Internal Medicine, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.

A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation.

In the third article, it suggests potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study. A roundabout way of saying that those who benefit the most financially from the outcome may have seriously influenced the presentation of the data.

This too is somewhat common in the pharmaceutical industry. They fund research with a predetermined outcome, hide research that they don’t find beneficial and seal findings that may prevent the drug from being approved by the FDA. All of these actions are unethical and, in some cases, illegal.

Statins still have ardent admirers, including cardiologist & famed pharmaceutical skeptic Steven Nissen of the Cleveland Clinic, who notes that even if statins do not reduce heart attack deaths, lives are improved by pushing a heart attack further into the future. You may remember his work from earlier articles on this blog where he broke open the massive risk of heart attacks on the diabetes drug Avandia in the Journal of the American Medical Association.

Harvard’s Abramson, author of Overdosed America, opposed his view saying that the best way to drive down the risk is not pills, but healthy diet, exercise, no smoking and moderate drinking.

Sage advise that should be common sense, but unfortunately is only practiced by a small group of Americans.

If you or your loved one has suffered a heart attack or stroke while taking Crestor, it is very important that you find a skilled attorney that is experienced in defective drug litigation so that you can get the compensation you deserve. Call Phillips Webster for a free consultation.

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Seroquel Lawyers: AstraZeneca Pays $198 Mil. To Settle 17,500 Side Effect Lawsuits

Defective Drugs, defective products, Seroquel, Seroquel Attorneys, Seroquel Lawyers

August 9th, 2010: Law Blogger

Seroquel lawyersBritish pharmaceutical mega-corporation AstraZeneca, the 6th largest drug company in the world, has triumphed today. They paid $198 million to 17,500 cases involving individuals who contracted various diseases such as diabetes and heart disease from side effects of taking their antipsychotic pill Seroquel.

That’s two weeks revenue of the world-wide sales of the drug.

Seroquel was initially used to treat schizophrenia and bi-polar disorder. It was originally touted to have fewer side effects than that of its predecessors such as Lithium. Of course, this turned out to be veering from truth on a collision course with the reality; Seroquel has lots of side effects and some people are finding out that they have the possibility of being deadly.

One of those big side effects is weight gain. Not a little bit, but considerable to the point that the side effects of the weight gain become residual side effects of Seroquel. Studies have shown that the average weight gain is 27 lbs, considerably increasing someone’s body mass index (BMI) and raising the patient’s fat category from normal to fat, and from fat to obese.

Of course, AstraZeneca is going to tell you that the weight gain and diabetes and heart disease don’t have a causal link as related to Seroquel. Yet, weight gain is part of the side effects list and schizophrenic and depressed people are not known for their concerns over diet and exercise.

But, just in June, Europe expanded the uses of Seroquel to include treatment of general depression, which is such a wide-open category that essentially anybody could potentially get a prescription.

Seroquel Lawsuits

Regardless, the company has already settled more than 4,700 lawsuits and now has brushed the majority of the lawsuits under the carpet without having to actually reveal any internal research, which they claim shows nothing, but they have gone though great pains to keep from being revealed in a court of law.

There were over 26,000 lawsuits pending and now the majority of them have been settled for just over $11,000 per plaintiff. As we said above, that’s merely 2 weeks revenue and far less than investors anticipated, so even though they are writing a massive check with more circles than a polka dot hat, they’re popping the bubbly.

With only around 6,000 more lawsuits to go and another ten years of competition-free sales on the drug to people who are depressed, AstraZeneca is about to discover a whole new realm of profit. In the last decade they have been pounding physicians hard about “off-label” uses for things such as depression and insomnia.

The US Food and Drug Administration (FDA) has warned AstraZeneca about promotional letters that they have sent out to physicians and asked them that they add diabetes to the list of side effects.

The side effects include:

  • Neuroleptic malignant syndrome (NMS) – a serious and deadly drug reaction
  • High blood sugar (hyperglycemia)  – fat in the blood
  • Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol.
  • Increase in weight (weight gain) – in some instances severe obesity has occurred
  • Tardive dyskinesia - uncontrolled movement in face and other body parts
  • Orthostatic hypotension (decreased blood pressure)
  • Increases in blood pressure in children and teenagers.
  • Low white blood cell count – lowered immune system
  • Cataracts – eyesight diminishes
  • Seizures
  • Abnormal thyroid tests – also related to weight gain
  • Increases in prolactin levels
  • Increases in liver enzymes
  • Long lasting and painful erection
  • Difficulty swallowing

This is the short list of side effects that they mentioned and even though some of the occupants of this list are deadly in their own right they are direct reactions to the drug found in clinical trials and not residual effect of one of the side effects. Consumers are trying to change this through a court of law with little success.

Seroquel Lawyers

astrazeneca headquartersThe troubles for AstraZeneca aren’t over. They are also trying to expand the US market for Seroquel to treat depression. Depression treatment in the United States almost reached $30 billion last year, which is almost equal to the profit of all of the drugs AstraZeneca sells. The British company is salivating to get that new customer base and it looks as if the FDA is seriously considering it.

Yet, the diabetes side effect issue has not been resolved. Settlements generally do not come with an admission of guilt, in fact, they’re a great way for a company to deny guilt and make their legal woes and the press to go away.

By increasing their market they will increase the number of people who are susceptible to weight gain and diabetes. Just because thousands of lawsuits have settled doesn’t mean that they have learned their lesson or are exempt from being sued once again.

If you or a loved one finds that you have been victim of a defective drug by either misdiagnosis or failure to prescribe the correct combination of drugs, then you may be entitled to compensation. To begin the process you will need to find a law firm that is experienced with defective drug litigationand medical malpractice lawsuits. Call Phillips Webster for your free consultation.

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Defective Drug Lawyers: Study Finds Zinc-Based Nasal Cold Remedies to Cause Loss of Smell

defective drug attorneys, defective drug lawyers, Defective Drugs, Zicam

July 20th, 2010: Law Blogger

Defective Drug LawyerRegular visitors of this blog might remember the summer of 2009 when we reported on the detriments zinc-based nasal remedies, particularly Zicam, a nasal remedy for the common cold manufactured by Matrixx Initiatives. Zicam was heavily advertised and taken by millions of people.

Then the US Food and Drug Administration (FDA) sent out a bulletin in June of 2009 warning, “Consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.” It is a medical condition called Anosmia in which the patient loses the ability to perceive one or all scents depending on how serious it is. It has also known to be permanent in some cases.

In case you still have some of these products in your medicine cabinet, they were:

  • Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
  • Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
  • Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

Of course Matrixx took a stance of total denial saying that there has been no causal evidence connecting their product Zicam to anosmia and that it has only proven to be helpful to all that have taken it. Now a study has come out, published in the Archives of Otolaryngology, one of the journals of the American Medical Association, that not only shows a causal connection, but also warns against all zinc based nasal remedies.

The Study

Nasal passageStudy author Dr. Terence Davidson, director of the University of California at San Diego Nasal Dysfunction Clinic first made a connection on the clinic level treating patients.

“In my practice, we started seeing people using the zinc nasal gel. They squirted it in, took a deep sniff and then had an incredibly intense burning sensation that lasted for several hours. When these people recovered, they found they had no sense of smell,” he said.

This and the findings of the FDA inspired him to conduct the clinical study. The analysis included 25 patients treated at the University of California, San Diego Nasal Dysfunction Clinic, which Davidson directs, who experienced loss of smell after using zinc nasal sprays or swabs to prevent or treat colds.

Along with colleague Wendy M. Smith, MD, Davidson applied the nine-point Bradford Hill causation environmental exposure statistical measure to assess the probability that the cold-remedy use caused the loss of sense of smell.

A statistician developed The Bradford Hill Criteria in 1965 because they wanted to establish a causal link between tobacco smoking and lung cancer. The method involves finding 9 key criteria necessary to find a causal link. It is a specific procedure with criteria that include:

  • Strength of the association (Is there a direct plausible connection?)
  • Consistency (Does it happen every time with every patient?)
  • Specificity (Whom does it effect?)
  • Timing (When and how long?)
  • Dose-response (Does the ailment get worse/better with weaker/stronger doses?)
  • Biological plausibility (Are certain people biologically predisposed to the ailment?)
  • Biological coherence (Are there biological triggers? How does it manifest itself?)
  • Experimental evidence
  • Analogy

Since it would be impossible, as well as unethical, to try to conduct a study where people with similar ailments are split between placebo groups and control groups that actually took the substance, they relied on the Bradford Hill Criteria through analysis of records and interviews to come to their conclusions.

The findings came back very similar to the conclusions of the FDA.

“Dr. Smith and I applied the criteria to zinc-induced anosmia and conclusively show that nasal zinc was the cause of the subsequent loss of smell,” said Davidson.

The patients seen by the researchers had a permanent loss of smell, but Davidson said there are likely people who have had lesser degrees of damage from these products as well. The study also yielded other unexpected results showing the efficacy of these products in reducing cold symptoms was “questionable”.

Defective Drug Lawyers

Defective Drug LawyersDavidson said that some of the people affected by the zinc-induced anosmia filed lawsuits against the manufacturers of these products. But yet Matrixx is not the only manufacturer and Zicam is not the only nasal product containing zinc.

You see, homeopathic low-dose remedies like nasal zinc aren’t subject to the same rules and regulations that prescription and over-the-counter medications are. Even though the FDA recommended consumers stop using the products and requested that the manufacturers stop selling them, some have stayed on shelves in various holistic and homeopathic retailers.

Oral zinc products are not associated with this problem and remain on the market.

Experts agree with the study and warn against nasal zinc-based products.

“I think this study was well-done, and I think intranasal zinc can impair the sense of smell. Does it happen all the time? No. Is it a rare event? No,” said Dr. Marc Siegel, an associate professor of medicine at the New York University School of Medicine and the NYU Langone Medical Center in New York City told US News and World Report.

“The problem is that it’s not FDA-regulated. If this were a prescription drug, you probably would’ve seen this [side effect] in the trials needed for approval,” he said.

In light of these findings you may have found that you replaced Zicam with just a lower dose, but just as detrimental homeopathic remedy that results in the same effect over a longer period of time. This is not a reasonable expectation or answer to your ailment. If this remedy was recommended to you by a medical professional you may choose to consult the practitioner and seek a second opinion.

If you have found that you or someone you know has suffered a severe loss of smell using a nasal product containing zinc then it is important that you find skilled legal representation that can get you the compensation you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.

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Defective Product Lawyers: Johnson and Johnson Expands Tylenol Recall to Motrin & Benedryl

Defective Drugs, defective product attorneys, defective product Lawyers, defective products

July 8th, 2010: Law Blogger

Defective Product LawyerHow is Johnson and Johnson (J&J) like a pop rock radio station? Well, the hits keep on coming of course. J&J and their subsidiary McNeil Consumer Healthcare have initiated their 6th recall this year, further besmirching an already overly-smirched reputation.

Many don’t remember the 1982 debacle in which Tylenol users were literally getting poisoned. Seven unfortunate customers died from cyanide poisoning. The company had to recall all 31 million bottles of Tylenol in the first recall of its size ever in the country. That inspired legislators to change the rules and require all over the counter drugs have tamper proof packaging.

The crime was never solved.

But in this instance the culprit is fully known and that culprit would be McNeil, the manufacturer of many of the adult and children’s over the counter drugs J&J produces. Most of the recalls are due to the conditions of the plant in which the drugs are manufactured leading to the various complaints that spurred the recall, foreign particles floating in the products, inconsistent doses, antibiotic resistant bacteria, and the reason for today’s recall, a musty odor due to the wooden pallets the products are transported on.

Tylenol Recalls

J&J announced the recall of 21 more lots of Tylenol and other over-the-counter medicines. The giant pharmaceutical company said the action, like one announced three weeks ago involving Tylenol and Benadryl, is a follow-up to a recall on January 15 that involved 53 million bottles of various products including many of the children’s medicines they produce.

McNeil Consumer Healthcare said today that it was now recalling various brands of Tylenol for children and adults and several forms of its Benadryl allergy tablets and Motrin painkiller.

“These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots,” J&J said in a release. ” The lots were sold in the United States, Fiji, Guatemala, the Dominican Republic, Puerto Rico, Trinidad and Tobago and Jamaica,” they added.

TBA ( 2,4,6-tribromoanisole) is a chemical the company uses to treat the wooden pallets.

The Food and Drug Administration (FDA) has come down hard on the company. One of McNeil’s three main factories, located in Ft. Washington, Pennsylvania, has been shut down while the company tries to fix multiple deficiencies cited by the FDA. The factories in Puerto Rico have also been cited and are under investigation for serious sanitation violations.

Johnson & Johnson’s other recalls:

  • November 2009 - five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
  • December 2009 - the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
  • January 2010 - the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
  • May 2010 - 50 children’s versions of these nonprescription medicines were also recalled because of quality and safety concerns. Following the pediatric medicine recall, Johnson and Johnson suspended production at McNeil’s facility in Fort Washington, Pennsylvania, that manufactured the children’s drugs.
  • June 2010 - McNeil disclosed it was voluntarily recalling four lots of Benadryl Allergy Ultratab Tablets (100 count) and one lot of Extra Strength Tylenol Rapid Release Gels (50 count).

Defective Product Lawyers

house of congressJ&J had learned as early as November 2008 that certain Motrin pills wouldn’t dissolve appropriately, thus reducing or completely negating their effectiveness. The company put a hold on lots at its distribution center. Then, instead of issuing a recall, they hired a contractor to sample some of the eight-count packages on store shelves to see if a recall was necessary, according to an FDA document.

The contractor, according to documentation provided to the FDA as part of their investigation, was then ordered to buy the pills from the shelves rather than announcing their findings to the public or to the FDA. This may have put the public whom had already purchased the product in jeopardy.

Then, last year, J&J announced plans to cut 8,200 jobs, or 7% of its work force, as part of a broad restructuring that aims to achieve $1.7 billion in yearly savings by 2011. J&J executives also recently moved to standardize compensation across the company.

During a U.S. House Committee on Health, Education, Labor, and Pensions hearings into the recalls speculated that it was the cost cutting measures that led to the serious sanitation and quality control problems. J&J’s consumer business, which includes the McNeil unit and other companies, had $15.8 billion in sales and $2.48 billion in profit in 2009.

Phillips Webster represents consumers and their loved ones in personal injury and wrongful death lawsuits resulting fromdefective drugs. If you or someone you know has been affected by the serious problems surrounding Children’s Tylenol or PediaCare products it is important to have experienced representation on your side to assure that your voice will be heard and that you receive the compensation that you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.

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Wrongful Death Lawyer: Children’s Tylenol Named in $7.5 Mil. Infant Death Verdict

Defective Drugs, Medical Malpractice, Wrongful Death, wrongful death lawyer

July 2nd, 2010: Law Blogger

Infant TylenolJohnson & Johnson (J&J) and their subsidiary McNeil PPC (the manufacturer of numerous Tylenol products including children’s products) have been feeling the heat this year. They were forced to recall millions of units of their Tylenol, Benadryl, and Pediacare products due to foreign particles, bacteria contamination, and worst of all, inconsistent dosage.

The Food and Drug Administration (FDA) has since begun a thorough investigation that, in the end, may reveal severe sanitation problems, serious quality control issues, and there has already been speculation of a cover-up at the executive level regarding the reporting of problems to the federal health agencies.

All of this came months prior to yesterday’s verdict, perhaps the first in the nation, regarding serious problems with inconsistent dosage levels of over the counter Children’s Tylenol. Children’s medicine is very specific because a larger than prescribed dose of medicine can cause serious liver damage and death in small children who are already vulnerable to illness. This is the case with Louisiana couple regarding their infant daughter who lost her life through a series of hospital misdiagnosis and drug company negligence.

Wrongful Death Lawsuit

It was January 3, 2003 when the parents of Brianna Hutto took their infant to Opelousas General Health System’s (OGHS) emergency room. She was diagnosed with a fever and cold and her parents were instructed to give her “Infant’s Tylenol.” 5 days later, on January 8th, the 5 month old died of liver failure.

The lawsuit names OGHS and McNeil-PPC, the company that makes Infant’s Tylenol, as to blame for Brianna’s death. It says, the hospital and company misinformed the family on the proper dosage amount of the medicine.

An Opelousas jury agreed by awarding the parents $7.5 million.

“They were devastated, as you can imagine. I mean they were 18 at the time, they just lost their 5 month old baby,” Hutto’s attorney said. “Their whole life was taken from them. Words can’t describe… they have felt that way continuously, the pain has not gone away.”

The Hospital has released a statement voicing their regret over the situation and touting their dedication to quality care. Neither J&J nor McNeil have given a statement regarding the verdict, but their recall of their products says a lot about the danger of the products.

The Hutto’s lawyer said that he hopes it stays off of shelves for good. “I think the most important part of this story is not necessarily the amount of money that was awarded, but the fact that Infant’s Tylenol is a dangerous product.”

Wrongful Death Lawyer

The family was forced to endure seven years of pain to come to this verdict. Many times to find justice for the death of a loved one the companies involved do what they can to prey on the emotional volatility of the victim’s family by forcing long delays and frustrating negotiations. The family could easily settle to avoid these problems, but generally the settlements come with the defendant denying fault and shirking their responsibility to change the system and policies which brought the lawsuit in the first place.

Phillips Webster is experienced in bringing justice to families that have lost loved one’s due to Medical Malpractice and Defective Drugs. We are skilled in both settlement negotiation and courtroom trials. We make sure that justice is addressed and that you receive the compensation you deserve.

Call the Wrongful Death Attorneys at Phillips Webster for a free consultation.

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Avandia Lawyers: GlaxoSmithKline Reeling From German Rejection of Avandia

Avandia, Avandia Lawyers, Defective Drugs, defective drugs attorneys

June 22nd, 2010: Law Blogger

Avandia LawyersThe global pharmaceutical whale GlaxoSmithKline has been fighting tooth-and-nail since 2007 for its diabetes drug Avandia, but it is looking daily like they are fighting in a German trench…even against the Germans!

Avandia been rejected in the Netherlands because of its heart attack risk, the American medical community has all but turned their backs on the drug, and now an influential German drug watchdog has recommended to health insurers around the country to no longer cover the drug, which could speed up a decline in sales of the controversial diabetes pill. Sales have been declining sharply since controversy over the drug’s heart risks first emerged in 2007. Sales of Avandia products fell 16% to $1.14 billion last year. That’s enough to make a pharmaceutical representative cry into his lobster bisque and wipe his tears away on the sleeve of his tailored $10,000 suit. Poor guy.

Avandia Research

You see, what Glaxo is fighting against is the evidence presented by two powerhouses in the medical research field, the New England Journal of Medicine 2007 study and the American Medical Association 2008 study. They try to throw less legitimate studies at the wall and hope that the recent data by Glaxo-paid researchers is more substantial than long term studies conducted over an extended time period by unbiased academic sources.

It is almost unquestionable that the German agency at least looked at those studies in their determination. Not only has the drug been linked to 83,000 heart attacks since 1999 according to a Senate Finance Committee’s recent report, a whistleblower within the Food and Drug Administration (FDA) has revealed that the FDA has been sitting on an internal study that has found that the number of heart attacks are actually double that of the SEC report and could be much more. Since heart attacks and cardio-events generally have a 37% chance of being fatal, that translates to over 50,000 deaths that could be directly linked back to the patient’s use of Avandia over the last decade.

The German group also may have looked at the studies conducted in the US and Canada tying Avandia to another serious side effect; broken bones. The studies show that women in particular, because of their osteoporosis risk, their bones have been rendered so brittle that they become more prone to pelvic fractures and even leg fractures from simply walking.

Glaxo has of course patently refused the findings of the German committee saying in a statement, “The committee’s course of action is not justified neither from a medical, nor legal point of view.”

However, the chairman of the German committee Rainer Hess said:

“There are other pharmaceuticals that have no such side effects and long-term risks. We believe that patients should be protected against useless and, more importantly, harmful therapies.” [Referring to rival diabetes drug Actos.]

Avandia Lawsuits

Glaxo HeadquartersGlaxo has begun settling the estimated 13,000 Avandia lawsuits around the country have been consolidated in to class action suits in their respective states. Glaxo is scrambling to settle them prior to the FDA’s meeting next month because an FDA ban and the full weight of their findings can only be bad for Glaxo and good for those involved in the lawsuits.

Their first lawsuit settlement in Philadelphia covered nearly 700 lawsuits there and was confirmed to come to around $60 million. Legal experts have called the settlement a relatively small amount and that if other lawsuits choose to settle for such measly amounts that Glaxo could end up settling paying out to families only around what amounts to 9 months profit from the drug (about $1.1 billion).

That would be a tragic outcome for the families of those who have lost loved ones, fathers, grandfathers and husbands to a drug that Glaxo has know for years increases risk of heart attacks. But yet they keep it on the market until the very last second that they can no longer profit from it, thus essentially putting a price on the lives of their customers.

Avandia Lawyers

Since Avandia was approved by the FDA for sale in 1998, even though there have been recent declines in sales, Glaxo has shown a considerable profit with an annual average of $3 billion in annual sales and $2 billion in annual profit. This profit is the very motivation behind the company aggressively trying to deny Avandia’s connection to the deaths of thousands of diabetes sufferers.

As an Avandia user or the loved one of an Avandia user who has suffered a loss of a loved one or serious personal injury related to taking Avandia you may be entitled to compensation for your pain and suffering. It is not too late to file a lawsuit so that you get the justice you deserve.

Phillips Webster is an experienced Defective Drug Law Firm with a proven track record of successful defective drug litigation. Call them today for a free consultation and to find out your legal rights as a patient.

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Product Liability Attorneys: New Tylenol Recalls Further Expose Johnson & Johnson

Defective Drugs, defective products

June 21st, 2010: Law Blogger

Johnson & Johnson HeadquartersJohnson & Johnson and their subsidiary McNeil Consumer Healthcare announced another recall of their Tylenol and Benadryl products, this time for adults. This comes on the heels of multiple recalls this year involving their most popular over the counter cold and flu medication.

The reason they gave on their website was that the drugs were “inadvertently omitted from the initial recall action” of January 15. McNeil disclosed it was voluntarily recalling four lots of Benadryl Allergy Ultratab Tablets (100 count) and one lot of Extra Strength Tylenol Rapid Release Gels (50 count).

Consumers have complained that the drugs emit a moldy or musty smell. The company has said that it’s because of  the product’s contact with the chemical 2,4,6-tribromoanisole (TBA) that was applied to shipping pallets, the company said.

Tylenol Recall

The recall covers specifically the products with lot number (found on the bottle label) ASA202, AJA008, ADA194, ABA022 and ABA264. If you have these products in your medicine cabinet then the company recommends customers should call 1-888-222-6036 or use the website www.mcneilproductrecall.com for information on how to receive a refund or replacement product. The drugs were sold in the United States and in Bermuda, Puerto Rico, Trinidad and Tobago.

The recalls are bad news for what seems to be systemic problems with sanitation throughout the McNeil Corporation where multiple manufacturing facilities that have been inspected by the Food and Drug Administration (FDA) in North America and Puerto Rico have been found to be in serious violation of material and bacterial contamination.

Many of these facilities produce a variety of children’s medicines and other products for Johnson & Johnson. The problems have had some serious problems such as traces of floating foreign materials, inconsistent dosage, and antibiotic resistant bacteria.

Johnson & Johnson’s other recalls:

  • November 2009 - five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
  • December 2009 - the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
  • January 2010 - the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
  • May 2010 - 50 children’s versions of these nonprescription medicines were also recalled because of quality and safety concerns. Following the pediatric medicine recall, Johnson and Johnson suspended production at McNeil’s facility in Fort Washington, Pennsylvania, that manufactured the children’s drugs.

Drug Recall Lawyers

These products can be highly detrimental to children and elderly people and are particularly dangerous for people with compromised immune systems or naturally low immune systems that have adverse reactions to pathogens and chemicals. It is very important that you are aware of these possible hazards and take extra precautions to minimize risk.

The manufacturing facilities are under a heated investigation by the FDA, but that should take time and doesn’t exonerate them from what has been revealed as less-than ethical behavior revealed recently involving the mass repurchasing of products rather than announcing a recall thus not informing the public whom had already purchased the products.

Phillips Webster represents consumers and their loved ones in personal injury and wrongful death lawsuits resulting from defective drugs. If you or someone you know has been affected by the serious problems surrounding Tylenol, Benedryl or PediaCare products it is important to have experienced representation on your side to assure that your voice will be heard and that you receive the compensation that you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.

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