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And so the Avandia saga continues. A recent analysis of articles and reviews about the type 2 diabetes drug manufactured by drug giant, GlaxoSmithKline, indicates that experts who were paid by Glaxo consistently gave more positive reviews concerning the drug’s efficacy and safety than those not paid by Glaxo. Hundreds of studies have been performed in the last three years, many arriving at very different conclusions regarding this very popular drug.

The New England Journal of Medicine, in 2007, published an article indicating that the use of Avandia was "associated with a significant increase in the risk of heart attack." Shortly after the publication of this article, the FDA issued a black box warning and recommended that Glaxo take the dangerous drug off the market.

In response to the allegation that Avandia is receiving positive reviews based on money being paid to those reviewing the drug, Mary Anne Rhyne, Glaxo spokeswoman, said GSK "will disclose research payments made to health care professionals and their institutions" beginning next year; the disclosures will cover all research studies that began on January 1, 2010.

If you or a loved one has taken Avandia and has suffered adverse cardiac events because of it, please contact the defective drug attorneys at Schlichter, Bogard & Denton, serving Little Rock, Arkansas and all of the U.S., today to schedule a confidential consultation.

The United States Food and Drug Administration (FDA) is charged with ensuring the efficacy and safety of many different products, many of which are drugs and medical devices. Once a drug is approved by the FDA, consumers like to believe the drug is safe. Unfortunately, however, that is not always the case. You will often hear news reports about drugs being recalled or being issued a "black box warning," (the most serious warning a drug can be given by the FDA before being recalled) even after receiving FDA approval. What many people may not realize is that the FDA is not responsible for conducting its own trials of the drugs it approves for sale.

In legal speak, the FDA was given legal authority by the Federal Food and Drug Act of 1938 to "review and approve new drugs for sale in the United States based on scientific support provided by the drug manufacturer as to the safety and efficacy of the drug or medical device."

After testing a drug, the drug manufacturer sends the FDA an application known as a "New Drug Application." If a review by the FDA's physicians indicates the drug’s benefits outweigh the known risks, the drug is approved and marketed. When the FDA discovers that a drug maker has violated FDA regulations, the FDA will send a warning letter to the drug company identifying the violation(s) and orders the company to correct the problems. The FDA then follows up to make sure the corrections were made. If they were not, the drug could be recalled or be issued a black box warning.

The FDA is not responsible for creating the warning labels on medications; the pharmaceutical companies have this responsibility. The problem lies in the fact that sometimes, drug manufacturers do not fully comply with their obligations to ensure the products they put on shelves are safe and effective. When this responsibility is shirked, people can get very sick and die due to adverse effects from the drugs they were prescribed. When lives are lost or people are made seriously ill from dangerous drugs, lawsuits can be filed against the drug manufacturer and other parties involved in providing the drug to the victim.

Many claim there are problems with the FDA-approval process of drugs and medical devices. One major claim against the approval process is that drugs are often approved after only short clinical trials, which means that long-term effects of the drug cannot be detected. Drug companies are supposed to perform studies after the drug hits the market, but many of these companies simply do not follow through with these studies because the FDA has little power after a drug is approved.

The FDA approval process for drugs and medical devices is a complicated one that cannot possibly be explained fully here. To learn more about this process, please read our page FDA Approval Process & the Pharmaceutical Manufacturers.

If you or a loved one has been harmed by a dangerous drug, an experienced defective drug attorney can review your case and advise you of how to proceed. Please contact Schlichter, Bogard & Denton today to schedule a confidential consultation.

A "recalled drug" is any prescription or over-the-counter medication that has been removed from the market. The recall may be voluntarily issued by the drug manufacturing company, or required by the Food and Drug Administration (FDA).

The FDA is responsible for making sure that foods, drugs and medical devices are safe for public use. When it has been proven that a medication has severe adverse side effects and the drug has not been recalled by the drug manufacturer, the FDA will issue a massive recall.

The caring and aggressive defective drug lawyers at Schlichter, Bogard & Denton know how difficult it is to deal with the adverse side effects of a dangerous drug. Our aggressive attorneys can get you the money you deserve.

Categories of Drug Recalls

A drug recall may fall into one of several categories:

• Class I Recall: These are issued when there is a reasonable probability that the use or exposure to a given product will cause severe adverse health consequences or death.

• Class II Recall: This recall is issued when the use or exposure to a product or drug can cause temporary or medically-reversible adverse health consequences. This is also issued when there is a moderate probability of serious adverse health effects.

• Class III Recall: This recall is issued when a product violates FDA labeling or manufacturing regulations but is not likely to cause adverse health consequences.

If you your or a loved one has suffered because of a dangerous drug or is taking a medication that has been recalled, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. Our firm serves clients nationwide.

Multidistrict litigation (MDL) is a way for the courts to collectively handle multiple lawsuits involving the same plaintiff, such as a drug manufacturer. MDL cases are civil cases that involve the same questions of fact, such as whether a drug manufacturer was negligent in manufacturing dangerous pharmaceuticals.

The experienced attorneys at Schlichter, Bogard & Denton understand the frustration of a large civil case and will fight to get you the compensation you deserve for your pain and suffering.

Multidistrict Litigation vs. Class Action

MDL is not a type of class action. Class action suits are large-scale proceedings, usually brought about in product liability cases, on the behalf of multiple clients who have a shared interest in the case. Class actions, however, may be transferred to an MDL consolidation in the same way single-plaintiff cases are.

The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL, based on one or more questions of fact. Since commonality is also a requirement for class action suits, these cases are often litigated in MDL proceedings.

Common MDL Cases

The most common types of MDL cases are:

• Torts involving disaster (most often airplane crashes)
• Complex product liability cases
• Trademark and patent infringement
• Securities violations
• Antitrust issues

If you would like more information on multidistrict litigation, please contact the experienced pharmaceutical litigation attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Produced by GlaxoSmithKline, Avandia is an oral medication prescribed for type-2 (adult onset) diabetes. It works by improving your blood sugar levels by making your cells more receptive to insulin.

But despite its effectiveness at regulating type-2 diabetes, studies have revealed that this medication can lead to serious and potentially deadly side effects.

The dangerous drug lawyers at Schlichter, Bogard & Denton know the difficulty of dealing with a dangerous, recalled medication. We will help your family get the money you deserve during this trying time.

Santa Clara, California

The county of Santa Clara, California has filed a lawsuit against Avandia’s manufacturer on behalf of both diabetes patients and health care providers. The county claims that GlaxoSmithKline falsely advertised this diabetes drug and concealed the increased risk of heart attacks and other dangerous side effects. Filed in the U.S. District Court in San Jose, this case is believed to be the first government lawsuit against the company over the drug Avandia.

Santa Clara County has been especially affected by Avandia problems. Their county-run hospital spent $2 million on Avandia between 1999 and 2007 for its patients. It also treated numerous patients who suffered heart attacks and other side effects as a result of Avandia use.

If you your or a loved one has been injured by Avandia, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. Our firm represents clients nationwide.

The birth control pills Yaz® and Yasmin® contain a new kind of progestin hormone known as drsp or drospirenone. But this hormone has been shown to increase the user’s potassium levels, which can lead to adverse health problems such as:

• Blood clots
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Stroke and heart attack
• Gallbladder disease and removal
• Kidney and renal failure
• Pancreatitis
• Death

The defective drug attorneys at Schlichter, Bogard & Denton empathize with patients who are suffering the adverse health effects of Yaz® and Yasmin®. With experience and perseverance, our lawyers will win you the money you deserve for your suffering.

A Growing Concern

More than 30 lawsuits have been recently filed in states throughout the U.S. against Bayer Pharmaceuticals Corporation and other Bayer-related companies. The allegations include the accusation that Bayer did not provide sufficient warnings against the dangerous side effects of Yasmin®/Yaz®, potentially increasing the risk of serious health complications for users.

Schlichter, Bogard & Denton are investigating these cases, and are working to get injured women the compensation they deserve for their injuries. Our attorneys are also investigating cases involving the generic drug Ocella that is manufactured by Barr Laboratories.

If you your or a loved one has been injured by Yaz®/Yasmin®/Ocella, please contact the effective dangerous drug attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

A black box warning is the strongest warning that a medication can carry and still remain on the market. Certain medications are safe for some patients and severely dangerous for others. When a given drug has been shown to cause harmful side effects, the Food and Drug Administration (FDA) will issue a "black box warning" for the product.

The defective drug attorneys at Schlichter, Bogard & Denton are caring and determined lawyers who will fight to get you the money you deserve for your injuries and emotional anguish.

The Black Box

This warning is named after the bold black border drawn around the text. The border is created to draw attention to the warning, and to differentiate it from other labeling information. A black box warning must be printed on all materials, both inside the packaging and on the documents received by doctors who will prescribe the medication.

A black box warning must include any important information about:

• Safety concerns
• Serious side effects
• Life-threatening risks

How a Drug Receives This Warning

A drug is issued a black box warning when studies performed on the drug suggest that it may cause dangerous side effects. Unfortunately, many of these warnings are issued after the drug has been on the market and used by countless consumers.

If your medication has received a black box warning, you should discuss with your doctor the potential side effects and any alternatives. Then decide whether the benefit of the drug is worth the potentially harmful consequences.

If you or someone you love has suffered adverse side effects from a defective drug, or your medication has been recalled, please contact the knowledgeable defective drug attorneys at Schlichter, Bogard & Denton. We serve clients nationwide.

If you watch TV, surf the Internet or browse through magazines, you have seen ads for medications that depict healthy, active people. Prescription and over-the-counter medications are used by millions of people each day for a variety of ailments, diseases, and medical conditions.

Overall, medications provide relief and health benefits. But sometimes a serious side effect or adverse health consequence is revealed after a drug is introduced into the marketplace. When these undesired results are extreme, the Food and Drug Administration (FDA) or drug manufacturer will issue a drug recall.

The compassionate defective drug attorneys at Schlichter, Bogard & Denton understand the difficulty of dealing with a drug recall and any adverse side effects you have experienced as a result of a dangerous drug.

Sometimes a defective or dangerous prescription drug is voluntarily recalled by the drug manufacturer. If the FDA becomes involved, it can request a recall, which is the fastest way to remove a harmful drug from the market.

The FDA’s Jurisdiction

The FDA has jurisdiction over recalls involving the following:

• Drugs
• Vaccines
• Medical devices
• Blood and plasma products
• Veterinary products
• Other biologics

Once the FDA requests a drug recall, the manufacturing company is responsible for making sure that the recall is successful. Companies must tell the FDA when the prescription recall has begun, and file progress reports. When the recall is completed, the FDA oversees the destruction of the dangerous prescription drug, and then investigates what made the drug harmful.

If you your or a loved one has been injured by a dangerous drug or is taking a medication that has been recalled, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

On December 17, 2009 a recall of all shelled hazelnuts processed by Willamette Shelling from October 12, 2009 through November 25, 2009 was announced. The recall is due to possible contamination with Salmonella. Hazelnuts still in their shells are not affected by the recall.

The nuts listed in the Willamette Shelling recall were labeled under the following brand names:

• Kunze Farms
• Evonuk Oregon Hazelnuts
• Canadian Hazelnuts
• Firestone Farms

Willamette Shelling, located in Newberg, Oregon, shells hazelnuts for other hazelnut processors. The recall has trickled down, producing recalls of several brands of packaged hazelnuts, recalls of products containing the shelled hazelnuts, and recalls by several retailers of shelled hazelnuts sold in bulk. The recall affects organic and non-organic, raw and roasted nuts.

In addition to the Willamette Shelling announcement, recalls have been issued by Whole Foods Market, Mountain Man Fruit & Nut Company, Market of Choice, Janzen Farms, and others.

Consumers seeking a refund or replacement should contact the retailers from which they purchased the nuts, rather than Willamette Shelling.

The recall was launched as a precautionary measure after one production lot of the shelled hazelnuts tested positive for Salmonella contamination. Willamette Shelling processed over 600,000 pounds of shelled hazelnuts during the affected time period, but only about 114,350 pounds of the of the nuts left the facility.

Salmonella infection can be fatal in young children, the elderly, and people with weakened immune systems. Even those who are not at high risk can experience sever symptoms including nausea, vomiting, diarrhea, abdominal pains, and fever. Although rare, there is always the chance of salmonella entering the bloodstream and leading to more serious health problems.

If you believe that you have become ill from eating recalled hazelnuts or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

On December 18, 2009 McNeil consumer Healthcare announced an expansion of its recall of Tylenol Arthritis Pain Caplets 100 count bottles with EZ-OPEN CAP to include all available lots. It had previously recalled only five lots of the defective drug. The recalled bottles have a red cap.

The recall was issued due to complaints from consumers of an unpleasant odor and gastrointestinal symptoms. The odor is described as musty, mildew-like, or moldy. Symptoms associated with taking the recalled drug include:

• Nausea
• Vomiting
• Diarrhea
• Stomach pain

Contamination by a chemical called 2,4,6-tribromoanisole (TBA) causes the odor. TBA is also one of the substances responsible for cork taint, a common problem in the wine industry.

TBA is byproduct of interaction between fungi or bacteria with a substance called 2,4,6- tribromophenol (TBP). TBP is used as a fungicide, antiseptic, wood preservative, and fire retardant. Materials used to package the recalled Tylenol are stored and transported on wooden pallets. These wooden pallets and the substance they were treated with are believed to be the source of the problem.

The health effects of TBA are not well-known. McNeil says reports it has received of illness caused by the recalled medication have not been serious and the effects were temporary.

If you have Tylenol Arthritis Pain Caplets affected by the recall, please do not use them even if they do not seem to have a strange odor. Individuals’ sense of smell is not a reliable indicator of contamination with TBA.

If you have taken the recalled Tylenol or any other product that was later discovered to be defective or dangerous in any way, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. We have offices in Missouri, Arkansas, Illinois, Indiana, Kansas, Wisconsin and Iowa.

Parker Farms, Inc. has recalled several of its products which are sold under various brand names. The recall was announced on January 8, 2010, after sampling by the states of Wisconsin and Minnesota detected Listeria monocytogenes in some of its finished product. Listeriosis is a potentially serious and even fatal infection. No illnesses have been reported in connection with the recall.

Recalled Parkers Farm Products

The recall includes several varieties of peanut butter, cold pack cheeses, salsa, dips, and spreads. They were sold under the brand names:

• Parkers Farm
• Parkers
• Happy Farms
• Kroger
• Central Markets
• Dutch Farms

The recalled foods were sold in 15 different retail chains across the U.S. Stores where the recalled products were sold include, but are not limited to:

• Sam’s Club
• Costco
• Jewel
• Target
• Whole Foods

What You Should Do

If you have any of the recalled products in your possession, do not eat them. Listeriosis does not usually pose a serious threat to healthy adults with normal immune systems, but it can be very dangerous or fatal to the elderly, children, and people with weakened immune systems. Additionally, pregnant women are at an elevated risk for becoming infected if they eat food contaminated with listeria and it can cause miscarriage, stillbirth, or newborn death.

You can return the recalled product to the place from which you purchased it for a full refund.

If you believe that you have become infected with listeriosis from eating recalled Parkers Farm Products or any other product that was discovered to be contaminated, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

The Senate Finance Committee conducted an investigation of the diabetes drug, Avandia which links the drug to an increased risk of heart attacks. It is estimated that by July 2007, Avandia was associated with approximately 83,000 heart attacks since the drug came to market. The Senate's Committee reports that GlaxoSmithKline, the manufacturer of Avandia, knew of the risks for years.

The report states: "Had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 some of these heart attacks may have been avoided."

GlaxoSmithKline counters that the Senate report relies on outdated information.

Click this LINK for the report.