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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.
Do I have a case?
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