Baycol

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Frequently Asked Baycol Questions and Answers (Baycol FAQs)


  What are the grounds for Baycol litigation?

  What has been done so far with regard to Baycol litigation?

  What options do I have if I have been affected By Baycol?

  Is the legal problem of Baycol being addressed around the      world?


  What are the treatments for the disorders caused bby Baycol?

  What are the symptoms of a serious reaction to the effects of      Baycol?

  What are the dangers of Baycol?

  Are there any drugs closely linked or related To Baycol?

  Are there any safer alternatives to Baycol?

  What could have been done to avoid the current situation?

  What are the conditions caused by Baycol?

  What is Baycol and what is it used for?

 

What are the grounds for Baycol litigation?

This is the most frequently asked Baycol question that we are asked. The answer depends on you individual circumstances. If you have developed either Rhabdomyolysis or kidney failure since
beginning to use Baycol it is likely that the conditions were related to the drug. As with all cases of negligence with regard to firms, you are at liberty to incite legal proceedings in order to obtain compensation. The grounds for this are assistance with treatment costs, and financial compensation to attempt to offset the pain caused by the muscle cells released into the bloodstream by the drug.

There are various lawyers devoted to such cases and most offer services on a no-win no-fee basis. The likelihood of successful litigation can be ascertained from the sheer number of different legal firms offering their services specifically on this subject, but will depend on the specific factors of each case. The circumstances of each person's use of the drug will differ and may determine the outcome of any legal action brought by them. There are also local issues, involving specific State laws, which may alter the treatment of each case.

Grounds for legal proceedings lie almost solely with the Bayer Pharmaceutical Division and so this is most likely where the proceedings would be directed..

 



What has been done so far with regard to Baycol litigation?




Proceedings against the Bayer Pharmaceutical Division began in earnest in March 2002, when four people filed lawsuits against the company having allegedly suffered serious injury as a result of their usage of Baycol. The lawsuits, filed in Portland, Oregon, amounted to a total of $15 million. The basis for these claims were that the Bayer Pharmaceutical Division had failed to correctly raise awareness about the possible effects of Baycol, and had not warned either the government or the FDA to a sufficient extent.


Of the four lawsuits, three were filed in Multnomah County Circuit Court, while the fourth lawsuit was filed in U.S. District Court for Oregon. This is the seminal case of Baycol litigation since its withdrawal, although there are several others around the country. Defendant corporations are Bayer A.G., Bayer Corporation, GlaxoSmithKline
plc, and SmithKline Beecham Corporation.

The United States District Court for Minnesota, based in Minneapolis, approved a Case Management Order to set an early deadline for moving the case to trial. This court presides over the National Baycol Products Liability Litigation, and so its orders affect the entire nation with regard to Baycol litigation. The effects of the order included a schedule for production of relevant documentation by the prosecution, and 250,000 such documents have already been produced. 

 

There are various events along the timeline, but the projected date for the official trial is some time early in 2003. An official website for the case has been established by the court, noting important updates to the trial. It can be found here.
 



What options do I have if I have been affected by Baycol?

Obviously, the first thing to do if affected by the Baycol problem is to cease consumption of the drug, although this is likely to have already occurred since its withdrawal. There are two further options of action: treatment and legal proceedings, both which may be carried out concurrently and interlinked. 

 

The basis for legal proceedings will often be to ease the financial burden brought about by Baycol and the treatment of its side-effects. A simple search for "Baycol lawyers" on any search engine will result in several options, and a multitude of qualified lawyers who specialize in your case. Similarly, a look in any local business directory for lawyers specializing in personal accidents and damages will result in someone equally eager to take your case. With regard to treatment, your local doctor will be able to offer advice and a realistic diagnosis of any effects from the drug.



Is the legal problem of Baycol being addressed around the world?

There is no doubt that the main focus of Baycol was in the United States, where over 700,000 people regularly consumed the drug. However, the drug was also sold in other markets, as would be expected from a German company boasting one of the largest global market shares. The drug was withdrawn from sale concurrently, apart from Japan where it remained on shelves for two weeks longer than other markets. 

 

No other nation has yet incited legal proceedings against the Bayer Pharmaceutical Division concerning the product, but the lead taken by the United States is almost certain to influence similar activity around the world.

$568 million of Baycol was sold during the year it was on sale. Although this accounted for only 3.5 percent of the total statin
market, it still meant that 700,000 people in the USA used the drug, and thousands of others around the world.
 



What are the treatments for the disorders caused By Baycol?

The primary advice offered my medical personnel regarding Baycol is to cease consumption of the drug immediately. If the muscle pains have not already been diagnosed, then canceling usage of the drug should eliminate possibilities of such problems arising in the future. The problems were caused as a direct result of the actions of the drug, and if the drug is no longer present then the release of muscle cells into the blood stream will no longer take place.

There are a variety of treatments for Rhabdomyolysis
, the main and most dangerous side effect of the drug. A physician decides the treatment itself on an individual basis, as Rhabdomyolysis can be of various severities. As it is a muscle disorder, the treatments revolve around those traditional in this area.

The two specific treatments for Rhabdomyolysis are classified as pre-hospital and emergency ward care. The major procedure for the former is vigorous hydration with an isotonic crystalloid. This also forms a major aspect of the emergency ward care. A full description of the different treatments and medication can be found in an article by Sandy Craig, located here.
 






What are the symptoms of a serious reaction to the effects of Baycol?

The major side-effect of using Baycol is Rhabdomyolysis. Any of the following could be signs that the condition has manifested itself:

         Muscle tenderness due to affliction by the disease

         General weakness in the muscles

         Stiffness in the body

         Unexplainable fatigue

         Abnormal urine color

         Unintentional gain of weight

         Joint pain

         Trauma from loss of fluid

         Chills and shakes

Other alleged conditions caused through the use of Baycol include peripheral neuropathy, gastrointestinal side effects, and unexplained allergic reactions. Peripheral neuropathy can be recognized from the loss of feeling in the hands or feet. Gastrointestinal problems are easy to spot and will result in a general feeling of poor health that would encourage a diagnosis from a doctor. Finally, allergic reactions can be discovered if objects that were previously harmless now result in an allergic reaction.
 



What are the dangers of Baycol?

The actual problem with Baycol is that in addition to performing its
prescribed task of blocking a specific enzyme, it also affected other parts of the body in a harmful capacity. The main location of bodily problems related to Baycol was the muscle tissue. Something that escaped the research capacity of Bayer was the discovery that Baycol forced parts of the muscle tissue to break away from their normal location in the body and become a part of the bloodstream. 

 

The main problem is myglobin, a pigment found in this muscle. The body knows that it is harmful, and in the same way as it attempts to remove other harmful substances, the kidneys try to filter it. However, myglobin can effectively block the kidney, causing damage. This is where the disease Rhabdomyolysis becomes relevant, as it is defined as a disorder involving injury to the kidney caused by toxic effects of the contents of muscle cells.
 



Are there any drugs closely linked or related to Baycol?

Baycol is one of a family of drugs known as statins. All statins work on the same principal: the blockage of an enzyme that features heavily in the synthesis of cholesterol. Their practical purpose is to lower cholesterol levels for patients in danger of heart disease. With all working in a similar way, they carry a risk of causing the conditions made so widespread by Baycol. However, this is to a much lesser extent. Baycol had only a 2 percent market share, but was responsible for over 45 percent of statin-related illnesses. Therefore, what made Baycol unique was also what made it so dangerous. There are five other FDA approved drugs that are classed as statins:

         Lovastatin = Mevacor

         Pravastatin = Pravachol

         Simvastatin = Zocor

         Fluvastatin = Lescol

         Atorvastatin = Lipitor

 

 


 

Are there any safer alternatives to Baycol?

Baycol is one of a number of statins, all of which are used to reduce
cholesterol and therefore lower the chance of heart disease. The major alternatives to Baycol are each of the five other FDA approved statins. However, there are a number of different methods of cholesterol control that may be utilized. These alternatives are generally prescribed by a doctor based on any changes in the condition, as each is focused largely on cholesterol control for a different reason. Nicotinic acid, for example, is a water-soluble B vitamin and largely inexpensive, plus is available over the counter. It reduces 'bad' cholesterol that causes disease, while
increasing the levels of 'good' cholesterol, such as HDL-cholesterol.

 

Other possibilities include fibric acids and bile acid resins. However, a doctor should be consulted prior to the use of any of these as an alternative to statins, as they are not all aimed at the same condition.



What could have been done to avoid the current situation?

The Food and Drug Administration (FDA) approved Baycol in 1997 following the testing of the drug on approximately 3,000 people by Bayer. Prior to its release, related drugs known as statins had already been seen to cause problems such as those endured by Rhabdomyolysis sufferers, but on a hugely inferior scale. 

 

The main method of prevention would have required more extensive research. The base of people on whom the drug was tested was very clustered and so the effects on a wider range of people were merely estimated. Had further tests been done, it would have been discovered that the elderly were much more at risk from the drug than younger people, and that a combination of Baycol and gemfibrozil was particularly dangerous.



Many problems would have also been averted had the FDA made more of an effort to clarify the dangers it was concerned about. The screening process at the time was less stringent as the FDA was under pressure to approve more products from the pharmaceutical industry, at the time, worth more than $100 billion to the economy.

Gemfibrozil was taken by 12 of the patients who died as a result of their usage of Baycol. This drug is another agent that performs a similar task to Baycol, limiting the usefulness of lipids. The danger of using Gemfibrozil in conjunction with statins was well documented prior to Baycol ever being released. However, it was seen as sufficient to label bottles of statins with relevant warnings, as opposed to banning their concurrent supply to the same patient. The enthusiasm of doctors to provide a high a dosage of the drug as possible also may have contributed to a large part in the deaths. Many of the cases became widespread following the introduction of the 0.8 mg tablet, as doctors were keen to move patients straight to this increased dosage from the previous, safer 0.4 mg tablets.
 



What are the conditions caused by Baycol?

The name for the condition caused by Baycol is Rhabdomyolysis. It is a condition where injury is caused to the kidney by the toxic effects of the content of muscle cells. The condition affects one in 10,000 people, and Baycol is not the only cause of the disorder. Any problems that may cause damage to skeletal muscle tissue, particularly trauma, may possibly affect the kidney as it attempts to remove the toxic content from the blood. The muscle tissue blocking the kidney, preventing it from functioning correctly, causes the damage. The kidney itself is effectively a filter, and so other harmful substances are able to remain in the bloodstream, and the kidney becomes less efficient as it suffers damage from the obstructing
tissue. Thus far, 50 deaths have been attributed to Rhabdomyolysis allegedly cause by the use of Baycol.



What Is Baycol And What Is It Used For?

The FDA passed Baycol in 1997 as a drug that would form part of the family of statins. These drugs were used to lower cholesterol levels in the body, thus preventing heart disease. It does this by blocking an enzyme responsible for the synthesis of cholesterol in the body. It was passed at a time when the FDA was being pressured to pay more attention to the pharmaceuticals industry. It was a very valuable market sector but was not having as many new products accepted as some felt it deserved. Therefore, concerns over the safety of the drug were pushed into the background and the German firm Bayer released the drug.

Baycol was withdrawn from sale on August 8, 2001, following its alleged part in the death of 52 patients. It was claimed that Baycol caused the possibly fatal disease Rhabdomyolysis. Bayer recognized the concerns and withdrew the drug voluntarily.
 


If you have any additional Baycol questions, or if the answers provided in this Baycol questions and answers page does not provide you with the specifc information you are seeking, please email:Frequently Asked Questions about Baycol and we will add your Baycol question and the answer to this page.

 

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Philadelphia Lawyers - Pennsylvania Lawsuits at Monheit Law

Law Offices of Michael Monheit 1368 Barrowdale Road  Rydal, PA  19046
Call Us Toll Free: 866-761-1385  P: 215-840-6573  E: Michael@Monheit.com


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Philadelphia Lawyers - Pennsylvania Lawsuits at Monheit Law

Law Offices of Michael Monheit 1368 Barrowdale Road  Rydal, PA  19046
Call Us Toll Free: 866-761-1385  P: 215-840-6573  E: Michael@Monheit.com