On September 15, 2009, the FDA published a warning letter to Bayer Healthcare and Bayer Schering Pharma AG, listing significant deviations found by FDA inspectors during a routine inspection of Bayer's Bergkamen, Germany plant. The FDA cited Bayer, manufacturer of Yaz and Yasmin birth control pills, for conflicting with the standard United States current good manufacturing practices (CGMP). Specifically, inspectors considered Bayer's laboratory controls to be deficient. The letter also explained how Bayer's quality management system failed to ensure that the drugs Bayer manufactured and released met the FDA's specifications. The FDA's list of these failing drugs included Drospirenone and Ethinyl Estradiol, the two major components of both Yaz and Yasmin.

The Public Citizen, in its "Worst Pills, Best Pills" list, labeled the combination of drospirenone and ethinyl estradiolas a "Do Not Use" drug because "it can cause increased blood levels of potassium and is no more effective than other oral contraceptives in preventing pregnancy."

The FDA has asked Bayer to provide a full list of all shipments to the U.S. that may have been subject to deficient methods, and also to provide a plan to prevent this problem from recurring. Meanwhile, Bayer has not advised healthcare providers to stop prescribing Yaz and Yasmin, nor has it suggested that patients might consider ceasing the use of Yaz and Yasmin.

FDA warns Yaz, Yasmin manufacturer over testing problems
Bayer warned by FDA over German manufacturing plant testing practices
By MATTHEW PERRONE • AP Business Writer • September 15, 2009

WASHINGTON — U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs.
In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company's plant in Berghamen, Germany, during a March visit.
FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.
Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.
The drug ingredients included drospirenone, which is used in the popular birth control pills Yaz and Yasmin. Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion.
After reviewing all drug batches shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in an April 7 letter that concluded "the quality of these batches was not affected."
But the FDA responded in its own letter last month, disagreeing with Bayer's "rationale and conclusion."
The agency has not advised patients to stop using the drugs and a Bayer spokeswoman on Tuesday said there have been no quality issues uncovered by a company assessment.
"We have identified no safety and efficacy impact on our products in relation to the ... issues as cited by the FDA," Rose Talrico said in a company statement.
The FDA has asked Bayer to provide a full list of all shipments to the U.S. that may have used the averaging method and provide a plan to prevent the problem from recurring.
The FDA said it will consider delaying imports from the factory until Bayer addresses the warning letter.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.
Earlier this summer, new FDA Commissioner Margaret Hamburg announced several changes designed to speed the pace of warning letters. They included a streamlined review process for sending the letters and shorter deadlines for companies to respond.

The human immune system is complex and more is being learned about it all the time. A substance produced by some of the immune system cells is called Tumor Necrosis Factor (TNF). It is a molecule that helps to regulate immune cells by carrying messages between them.

If you have a chronic inflammatory disease, too much TNF can be produced and that causes even more inflammation. Examples of chronic inflammatory diseases are:

• Crohn's disease
• Juvenile idiopathic arthritis (JIA)
• Psoriatic arthritis
• Rheumatoid arthritis
• Plaque psoriasis

Drugs have been developed called TNF blockers to treat these conditions. The drug names are Simponi, Humira, Cimzia, Remicade, and Enbrel.

FDA Studies of TNF Blockers
From the U.S. and other countries, 48 reports were sent to the FDA of childhood cancer apparently connected to use of TNF blockers. Starting in 2001, the FDA did a study of these drugs and in 2008 they released their conclusions. TNF blockers increase the risk of lymphoma, leukemia, and "other malignancies" in children, teens, and adults.

Last week the FDA called for new warnings on TNF blocker labeling and information sheets. The Boxed Warning will now warn doctors about the increased risk of cancer. There will also be an updated Warnings section that will include leukemia information relevant to all ages; and the Adverse Events section will now include text about increased risk for psoriasis with use of TNF blockers.

If you have a child who is taking a TNF blocker, try to be alert for any symptoms of cancer, such as:

• Weight loss
• Fatigue
• Increased bleeding or bruising
• Swollen lymph nodes

You might also want to watch your child's skin for red patches and bumps which could indicate psoriasis. Please contact your child's doctor if you have any concerns.

If you have already noticed suspicious symptoms, either in your child or yourself, please contact our pharmaceutical litigation attorneys. We will be happy to schedule a free case evaluation for you.

Toxic torts are a specific kind of litigation dealing with injury caused by those who manufacture, use or distribute various kinds of toxic chemicals. A toxic tort can occur due to a chemical spill, hazardous waste accident, or other negligence that leads to dangerous exposure to hazardous materials or chemicals.

Whether the victims of this negligent exposure are a neighborhood, a group of workers, or users of a particular product, Schlichter, Bogard & Denton can help with a toxic tort consultation to determine liability and to build a case.

Examples of Toxic Tort Litigation
Some recent toxic tort litigation has involved toxic substances such as:

• Benzene
• Heavy metals
• Chlorine
• Toxic molds
• Asbestos

Substances like these can be found in fertilizers, water contamination, contamination by nuclear or chemical plants, or as the result of transportation accidents or other types of waste spills. Toxic tort litigation usually involves a large group of people who have been injured due to the negligence that led to their exposure to dangerous substances. Information gained through toxic tort litigation can also help determine the long-term effects and toxicity of various substances.

If you believe you have been exposed to dangerous substances due to the negligence of another party, the experienced toxic tort attorneys at Schlichter, Bogard & Denton can help. Please contact us to schedule a free initial consultation. We work with clients nationwide, and can help you build your case to get the compensation you deserve.

Once used extensively for a variety of applications, including building insulation, asbestos has been highly regulated since the 1980s. A fibrous substance, asbestos is strong, heat-resistant, and a highly effective insulator, but it presents a significant danger to those exposed to it.

Dangers of Asbestos Exposure
Asbestos is made up of microscopic fibers. When asbestos is installed or removed, these fibers escape into the air. If they are breathed into the lungs, they embed in the lung tissue. The effects of this exposure can eventually lead to:

• Inflammation
• Scarring
• Lung cancer
• Mesothelioma

The symptoms of asbestos exposure can take many years to appear. People who worked with asbestos thirty or more years ago can only now be starting to experience the side effects of exposure.

What is Mesothelioma?
Mesothelioma is a relatively rare cancer, but is the most common cancer to be found associated with asbestos exposure. It affects the mesothelium, membranes that line the chest, abdomen, and other organs and body cavities, including the linings of the lungs. If detected early, a number of treatment options can be used.

If you or a loved one has been exposed to asbestos, the attorneys at Schlichter, Bogard & Denton can help. Please contact us to schedule a free initial consultation. We work with clients nationwide, and will do everything we can to get you the compensation you deserve.

Obesity is literally an epidemic in America, leading to numerous long-term health problems such as high blood pressure, diabetes, and high cholesterol. In an attempt to help those suffering from obesity, drugs have been developed that can help accelerate weight loss.

Unfortunately one of these drugs, orlistat, the major ingredient in Xenical and Alli, is now under FDA investigation for possibly causing liver damage in some users.

What are Xenical and Alli?
Approved by the FDA in 1999, orlistat is marketed under two names. Xenical, marketed by Hoffmann La Roche Ltd., is a prescription drug. In 2007, orlistat was approved for over the counter use, and is marketed over the counter as Alli by GlaxoSmithKline.

Orlistat works in the digestive system, preventing the body from absorbing about one-quarter of the fat ingested. This can lead to uncomfortable GI issues in many users, but these side effects are considered by most to be acceptable.

Serious Side Effects of Xenical and Alli
Other side effects, however, are not considered acceptable. Between 1999 and 2008, over thirty orlistat users experienced liver injury. Six of these experienced liver failure, and most were hospitalized.

Symptoms of liver failure include:

• Jaundice (yellowing of the skin and the whites of the eyes)
• Brown urine
• Stomach pain
• Overall feeling of weakness

Any of these symptoms should be reported immediately to your doctor as well as to the FDA to help establish the connection between liver failure and orlistat.

If you have experienced symptoms of liver failure while using Xenical or Alli, please contact the pharmaceutical injury attorneys at Schlichter, Bogard & Denton for more information and to schedule a free consultation. Schlichter, Bogard & Denton serves pharmaceutical injury clients nationwide.

Accidents involving tractor-trailers can be some of the deadliest on our nation's highways. Too often, this kind of accident results in devastating injuries or death. In addition, many trucking accidents are caused by negligence on the part of the truck driver or even the trucking companies, who sometimes enforce policies that lead to dangerous conditions for their drivers.

Since these cases can be difficult to pursue, the attorneys at Schlichter, Bogard & Denton are ready to help with a free initial consultation.

Negligence by Trucking Companies
Unfortunately, trucking companies sometimes ignore safety regulations and bypass common sense in order to increase their profits. Some dangerous practices that can lead to serious accidents include:

• Overloading vehicles
• Pushing drivers too hard
• Inadequate vehicle maintenance
• Lack of driver supervision

Drivers suffering from lack of sleep due to unrealistic delivery schedules, or vehicles that have not been kept in optimal condition, can be a major factor leading to devastating accidents on the road.

Seeking Compensation for Trucking Accident Injuries
Because trucking companies are often large corporations, it can be difficult and intimidating to seek compensation for trucking accident injuries. The attorneys at Schlichter, Bogard & Denton can help you determine who is at fault for your accident and what kind of compensation you are entitled to.

If you or a loved one has been injured in a trucking accident, please contact Schlichter, Bogard & Denton, nationwide trucking accident attorneys, to schedule a free consultation.

Bronchiolitis Obliterans, also known as popcorn lung, is a rare condition that has been linked to exposure to Diacetyl. Diacetyl is a compound used to flavor popcorn and other butter-flavored snacks. A high percentage of the persons who suffer from symptoms of Bronchiolitis Obliterans, work in the popcorn industry, or in the manufacturing process of other snack foods that use Diacetyl in their flavoring.

If you are employed in this industry, a consultation with Schlichter, Bogard & Denton, pharmaceutical injury attorneys, can help you determine if you have a case.

Symptoms of Popcorn Lung
Symptoms of popcorn lung are very similar to those of other respiratory conditions, and the disease is often mistaken for asthma, pneumonia, or emphysema. Misdiagnosis can have serious consequences, as the results of popcorn lung are severe and irreversible.

Symptoms of popcorn lung include:

• Shortness of breath
• Wheezing
• Dry, persistent cough

These symptoms can arise over a period of time, or can come on suddenly. If you are regularly exposed to Diacetyl and develop respiratory symptoms, it is important to check into the possibility of popcorn lung to avoid possible misdiagnosis.

Treatment for Popcorn Lung
Popcorn lung is incurable. It causes irreversible damage and scarring to the small airways within the lungs. While ending repeated exposure to Diacetyl will slow or stop the progress of the disease, it will not produce any improvement. In severe cases, the only recourse is a lung transplant.

Nationwide pharmaceutical injury attorneys Schlichter, Bogard & Denton are experienced in dealing with injury suits involving Diacetyl and popcorn lung. If you need assistance assembling a pharmaceutical injury case, please contact Schlichter, Bogard & Denton to schedule a consultation.

Popcorn lung, or Bronchiolitis Obliterans, is a serious respiratory disorder seen more commonly among workers in the popcorn industry than among the general population. A cause of popcorn lung is exposure to Diacetyl, a compound used to provide butter flavoring to popcorn and other snacks.

If you believe you or a loved one has been exposed to Diacetyl, a consultation with the pharmaceutical injury attorneys at Schlichter, Bogard & Denton can help you determine if you might be eligible to collect damages.

Symptoms of Popcorn Lung
Symptoms of popcorn lung are often misdiagnosed as another respiratory disorder, mostly because the disease is so rare. Popcorn lung causes inflammation and scarring in the airways of the lungs, narrowing these airways permanently. There is no way to reverse this damage, and some people who suffer from popcorn lung require lung transplants due to the extent of the injury.

Symptoms of popcorn lung include:

• Shortness of breath
• Wheezing
• Dry cough

Since popcorn lung can be mistaken for bronchitis, asthma, pneumonia, or other respiratory issues, those who work in the popcorn industry, or who are exposed to Diacetyl in the course of their jobs, should be especially vigilant of these symptoms.

If you work in the popcorn industry, or work in the manufacture of snacks or certain dairy products that use Diacetyl, please contact the pharmaceutical injury attorneys at Schlichter, Bogard & Denton to schedule a consultation about possible financial compensation. Schlichter, Bogard & Denton serves the Madison, Wisconsin area, as well as working for clients nationwide.