Baycol
Lawsuit News
Baycol
Lawsuit News
The Baycol
recall of August 2001 affected the over 6 million people worldwide
that were taking the cholesterol-lowering drug. Bayer, Baycol’s
manufacturer was criticized for allowing patients to continue
using the cholesterol drug for such an extended amount of
time despite the increased risk of fatality due to the condition
rhabdomyolysis, a breakdown of muscle tissue causing renal
failure and liver damage. The company has claimed the Baycol
recall was issued because doctors were not using the drug
as directed by Baycol labeling.
Although
Baycol belonged to the most widely prescribed drug class called
statins, which was linked to instances of rhabdomyolysis,
Baycol was considered a significantly greater risk of death
occurring because of rhabdomyolysis. Bayer has since been
left defending itself since the 2001 Baycol recall but once
again can be found making Baycol lawsuit news. At the time
of the Baycol recall, Baycol was linked to over 50 Baycol
deaths worldwide, however since then the number has risen
to over 100 Baycol deaths, in addition to 1,600 injuries worldwide.
For more information on the Baycol lawsuit news, please contact
us to confer with a Baycol lawyer.
Internal
Bayer Baycol Documents Revealed at First
Baycol Lawsuit Trial
In the first of the 7,800 Baycol lawsuits waiting to go
to trial, the highly publicized and scrutinized Baycol
trial taking place in Texas has exposed evidence of internal
company documents showing top Bayer executives became
increasingly more alarmed at the occurrence of the deadly
Baycol side effect rhabdomyolysis that was found to occur
at a rate much higher than with other statin drugs. If
you have taken Baycol and are suffering or have suffered
Baycol side effects including rhabdomyolysis, please contact
us to confer with a Baycol lawyer. “We
need to do everything possible to maximize sales results
since Baycol must carry the company for the short and
long haul.”
-May 1998 email from Bayer executive
“The
steadily increasing numbers of spontaneous reports of
rhabdomyolysis associated with Baycol...has overwhelmed
the available safety resources.”
-December 1999 report
“Some
are scared to uncover such data (bad data) because of
launch of 0.8 mg. If FDA asks for bad news, we have
to give, but if we don’t have it, then we can’t
give it to them.”
-January 2000 meeting agenda, unidentified Bayer
executive wrote
“I
am concerned that there is widespread knowledge in the
field with both Bayer and SB representatives that there
have been some death related to Baycol.”
-February 2000 email from Bayer executive
“There
has been a substantial increase in calls from our sales
representatives and opinion leaders requesting that
scientific affairs liaisons talk to physicians who had
cases of rhabdomyolysis.”
-June 2000, Bayer executive
“There
will be much more tremendous trouble in the future.”
-Bayer marketing partner in Japan urging the company
halt clinical trials of higher doses of Baycol viewed
to help increase sales, in July 2000, Bayer received
approval to sell a higher dose of Baycol
“So
much for keeping this quiet.”
-February 2000, email from Patricia Stenger, manager
in Bayer’s scientific affairs unit to other executives
Allegedly
top Bayer executives told sales staff to “redouble
our efforts, we’re going to make this a billion-dollar
drug.”
-March 2000
Stenger
wrote a June 2000 email with an attached document saying
that doctors reporting Baycol side effects were hearing
of similar cases with other patients and stated they
“appear to be more angry and concerned and feel
that Bayer is hiding information.”
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April
10, 2003
Another Baycol lawsuit settled, according to Bayer. The Baycol
lawsuit was supposed to be heard in a Texas courtroom late
April however, settled for undisclosed reasons and an undisclosed
amount.
April
9, 2003
A Baycol class action lawsuit was announced in the U.S. District
Court for Southern District of New York. The Baycol lawsuit
has alleged that Baycol maker Bayer AG violated sections of
the Securities Exchange Act of 1934 when issuing false and
misleading statements to the marketing in order to boost sales.
In addition, the Baycol lawsuit alleges that Baycol side effects
were minimized despite the knowledge by top Bayer executives
that Baycol patients were suffering deadly Baycol side effects.
For more information on Baycol lawsuits contact us to confer
with a Baycol attorney.
April
4, 2003
Baycol maker, Bayer AG announced that the number of out of
court settlements for its recalled drug was on the rise. Bayer
has already settled around 500 Baycol cases out of court at
$150.1 million. The company said it would update the Baycol
settlement and Baycol lawsuit figures later in April 2003.
Bayer is still facing around 8,400 Baycol cases. There have
been over 100 deaths linked to the use of Baycol, many of
the Baycol deaths attributed to a rare condition called rhabdomyolysis.
March
17, 2003, Baycol settlements included Baycol deaths
Baycol manufacturer Bayer AG has stated that in the 500 Baycol
lawsuits the company has settled, 13 cases of Baycol deaths
were included.
March
17, 2003, Second Baycol lawsuit begins
The second Baycol lawsuit is now underway in Mississippi.
Linked to the muscle disease rhabdomyolysis, Baycol settlements
have so far cost Bayer about $140 million for 500 Baycol lawsuits.
There have been about 8,400 Baycol lawsuits filed worldwide.
March
14, 2003, Baycol verdict not reached after first day of deliberations
After the fist day of deliberations in the first Baycol lawsuit
of about 8,400 to go to trial, a decision has not been made.
Evidence during the trial has shown that Baycol manufacturer
had a growing sense of alarm within the company about the
Baycol side effects despite the company’s efforts to
increase sales with internal projections of sales reaching
$1 billion by 2005.
March
14, 2003, Baycol executives may not have enough money for
Baycol lawsuits
The growing number of Baycol lawsuits filed is now up around
8,400 worldwide and combined with Baycol manufacturer’s
financial results, reporting tumbling stock losses.
March
12, 2003, Bayer shares fall another 10%
Bayer shares fell 10% after the announcement that the company
was being sued in a New York district court for violations
of the Securities Exchange Act. The allegations are that Bayer
omitted and/or misrepresented factual information regarding
Baycol, the anti-cholesterol drug, in order to artificially
inflate the market price of the company’s shares.
March
11, 2003, A lot riding on Baycol lawsuit
In the civil trial for recalled cholesterol drug Baycol, so
far company emails and documents have shown top executives
were aware of serious Baycol side effects long before it was
ever recalled. The Baycol lawsuit has been even more damaging
to the company, resulting in the plunge of its stocks in addition
to allegations of jury tampering. Many people are watching
the Baycol lawsuit to determine how the first of over 7,800
Baycol lawsuits plays out.
March
7, 2003
Bayer executives claim the company acted responsibly by pulling
Baycol off the market as soon as finding out the cholesterol
drug was causing deadly and serious side effects, including
rhabdomyolysis. As the first Baycol trial underway has shown,
internal emails from Bayer indicate the company waited two
months before sending doctors a warning letter to not allow
patients to start using Baycol at the higher dosage but the
Baycol labeling was never updated.
March
6, 2003
The trial of an 82-year old man suffering from rhabdomyolysis
due to use of Baycol is underway. When cross-examined, head
of Bayer’s worldwide regulatory affairs stated that
reports of Baycol causing adverse effects helped Bayer improve
the drug. The problem was that according to the plaintiff’s
attorneys, Bayer tried to maximize profits by failing to submit
evidence of adverse Baycol effects in a timely manner until
receiving FDA approval for the higher dosage of Baycol. The
company has acknowledged the plaintiff’s case of rhabdomyolysis
was the result of using Baycol. The result of the Baycol lawsuit
is widely focused on and may dictate the way the rest of the
thousands of Baycol lawsuits will play out.
March
5, 2003
Documents that have been presented in court at Baycol trials
showing that Baycol executives became increasingly more alarmed
about the instances of Baycol side effect rhabdomyolysis that
was occurring at a much higher rate than competing statins.
Bayer has maintained the company acted responsibly with Baycol
and had to issue the Baycol recall because doctors were improperly
prescribing the cholesterol drug.
March
3, 2003
A German lawyer is hoping to settle about 100 Baycol cases
out of court in Germany. Of the 2,000 German Baycol patients
the lawyer is representing, he believes that 5% of the instances
involve serious Baycol side effects damage.
March
3, 2003
Bayer has taken out full page ads defending Baycol on February
28, 2003 entitled “Facts not Mood-stirring” in
order to reassure worried Bayer investors. Bayer stated it
was impossible to forecast the outcome of future Baycol lawsuits
despite predictions made by attorneys and analysts. The company
has already paid a total of $125 million to settle 450 Baycol
lawsuits but faces thousands more.
March
2, 2003
Bayer is trying to calm the speculation talk of the impact
Baycol lawsuits will have on the company following the statements
a lawyer made saying Bayer faced damages of up to $50 billion.
Bayer released a statement claiming the Baycol lawsuit predictions
have been wildly overestimated and were press efforts to affect
Bayer stock and help legal battles. Analysts have estimated
Bayer could suffer damages of over $5 billion to almost $10
billion if Baycol negligence is proved.
February
28, 2003
GlaxoSmithKline is worried as its shares have continued to
slip for the fifth day in a row. Glaxo and Bayer jointly marketed
Baycol and Glaxo has been named in some Baycol recall lawsuits
for the deaths and serious injuries, including rhabdomyolysis
that occurred while the cholesterol drug was on the market.
Most Baycol lawsuits have only named Bayer because it was
predominantly responsible for the marketing and selling of
Baycol. Glaxo is still not sure what type of liability the
company holds in the future Baycol lawsuits.
February
28, 2003
The high profile Baycol lawsuit in Texas has drawn in dozens
of spectators. The Baycol trial is proving to continue being
controversial. Already, allegations of attempted jury tampering
have been made. In addition, the county district attorney
is looking into matters in response to the trial judges request
after Bayer had sent thousands of letters to city residents
urging them to keep an open mind about the company just a
day before jury selections had begun. The company’s
response to the letters was that they were a mistake, however
the trial judge found the letters to be “outlandish”.
February
27, 2003
Lawyer for a plaintiff in Germany are seeking $500 million
in punitive damages for recalled cholesterol drug Baycol,
marketed as Libobay outside of the U.S. The Baycol lawsuit
is in addition to the already present Baycol case occurring
in Texas with demands for a $100 million payout.
February
27, 2003
Investors are quickly dropping Bayer’s stock fearful
that the company will be forced to pay large quantities of
money to settle even more Baycol lawsuits. The investors have
been unable to determine what type of loss Bayer will suffer
when all the Baycol lawsuits have come to a close. The 7,800
Baycol lawsuits in the U.S. that Bayer faces, in addition
to any claims that are filed from 700,000 Baycol patients
that live outside of the U.S., Bayer may end up making payment
of more than $5 billion. Bayer officials are still denying
its executives knew of the deadly and serious Baycol side
effects well before adequately responding.
February
25, 2003
Bayer announced the company has paid a total of $125 million
to settle 450 Baycol cases out of court. The company said
that it is in active discussions with plaintiff lawyer about
settling 500 more Baycol cases. Bayer’s worry about
its Baycol liabilities do not seem to be lessening, especially
following the publication of company documents that indicate
Bayer executives knew long before the Baycol recall that the
drug had deadly risks.
February
24, 2003
Bayer shares fell almost 10% after the New York Times reported
a senior company executive was aware of the deadly risks associated
to Baycol long before a Baycol recall was issued. Of the more
than 7,800 Baycol lawsuits filed against Bayer, around 450
of them have already been settled out of court for amounts
ranging between $200,000 and $1.2 million. The maximum estimated
cost the Baycol recall problems for Bayer could result in
is around $1.6 billion. Court papers show that in 1997 the
President of Bayer’s North American pharmaceutical operations
had received a letter from executive vice president of pharmaceuticals
at SmithKline Beecham that he had “serious concerns”
about using Baycol with some other medicines the day after
Baycol received FDA approval.
February
22, 2003
Internal Bayer emails and depositions indicate that Bayer
was promoting Baycol with the knowledge that it can cause
rhabdomyolysis-induced deaths. A February 2000 Bayer email
included an executive noting that the word was leaking about
deaths related to Baycol and issuing an official statement
before the situation worsened. When the vice president for
scientific affairs at Bayer was asked in a deposition if the
company had delayed any knowledge of the link between Baycol
and life-threatening instances of rhabdomyolysis, the employee
responded that no knowledge was known. Other internal Bayer
documents showed the officials were more concerned with Baycol
becoming financially successful enough to fuel company operations
and compete with other pharmaceutical companies.
February
21, 2003
A Baycol lawsuit opened, which marked the first lawsuit of
its kind in the U.S. Alleging that Bayer officials were aware
of the deadly side effects, the Baycol lawsuit is the first
of many awaiting trial. The plaintiff suffered rhabdomyolysis
after taking samples of Baycol for less than a month.
January
16, 2003
Bayer announced the number of Baycol lawsuits the company
is facing has increased to 7,400, up from 5,700 in November
2002.
June 2002
In the UK the British Baycol users are waiting to hear if they
have won legal aid to sue Bayer, the Baycol manufacturer. This
is the first attempt for a class action in the UK for the Baycol
side effects British patients claimed to have suffered.
August 20, 2001
Bayer published an open letter to deny that the Baycol recall
is threatening their existence. The CEO of Bayer did claim
that "the withdrawal of the medicine (Baycol) has shaken
our company- but not to its foundation." After the Baycol
recall due to the link to at least 30 deaths, the company's
shares had fallen about 27%. The Baycol recall prompted a
number of class actions suits to be filed in the U.S. for
the damages Baycol patients experienced.
August 13, 2001
Dateline questions and answers about the Baycol recall.
What is rhabdomyolysis?
Rhabdomyolysis occurs when a large number of skeletal
muscle cells die, thus releasing a massive amount of muscle
protein into the bloodstream. This muscle protein becomes
entrapped in the kidneys, essentially clogging up the
filtering process of the kidneys and leading to kidney
failure and other organ system disorders.
Rhabdomyolysis is extremely rare as a drug side effect.
It is most commonly seen after massive muscle trauma (after
an auto accident, for instance,) or as a chief component
of heat stroke - the condition that recently killed Minnesota
Vikings star Korey Stringer. While all statin drugs are
known to cause a low-grade muscle disorder in some patients
- a disorder similar to rhabdomyolysis but on a much smaller
scale - the report with Baycol was the first time a statin
had been implicated in actually causing death by producing
a severe muscle disorder.
Is the problem limited to Baycol, or do other statins
do the same thing?
As noted, all statins can and do cause problems with the
skeletal muscles in some patients, and muscular pain is
one of the more common reasons that statins must be discontinued
in some individuals.
However, it is now recognized that Baycol has a much greater
propensity for causing muscle problems than do the other
statins - in fact, it is not at all clear that other statins
can cause actual rhabdomyolysis. So while precautions
need to be taken when using any statin (see below,) at
this point the potentially fatal problem of rhabdomyolysis
seems to be limited to Baycol.
Is the Baycol problem due to the drug itself, or to
the doctors?
Of the 31 people who died from Baycol-induced rhabdomyolysis,
12 were also taking gemfibrozil, another lipid-lowering
agent. It has been known for some time that using statins
in combination with gemfibrozil can make muscle problems
more likely to occur, and the warning labeling for statin
drugs have reflected this fact.
In the remaining 19 patients who died taking Baycol, it
has been reported that the large majority were started
directly on the highest dose of the drug. (The usual starting
dose - and the recommended starting dose - was 0.4 mg.
Most of the cases of rhabdomyolysis occurred after a 0.8
mg tablet was introduced in August 2000, when, apparently,
many doctors took to prescribing the higher dose immediately.)
In other words, if the prescribing practices of doctors
had followed a more conservative (i.e., the recommended)
path, it seems likely that most of these fatal cases of
rhabdomyolysis might not have occurred. Indeed, Bayer
withdrew Baycol from every country in the world except
Japan - where gemfibrozil is not used, and where the 0.8
mg tablet is not available. The available data supports
this decision.
What are the recommendations for people taking statins?
Patients now taking Baycol need to see their doctors about
switching to a different drug. Baycol will simply be no
longer available.
For patients taking the more established statin drugs
(lovastatin, simvastatin, pravastatin, and atorvastatin)
the recent problems with Baycol should not create any
additional concern. These older drugs have been used in
hundreds of thousands of patients for more than a decade
without causing similar problems. Thus, for these drugs
the recommendations have not changed. Statins should generally
not be used in combination with gemfibrozil - for reasons
that are not at all clear, this combination of drugs greatly
increases the risk of muscular disorders. Additionally,
people taking statins who experience muscle aches and
pains should report this symptom to their doctors. A simple
blood test (the CPK level) should reveal whether the statin
drug is causing any degree of skeletal muscle destruction
- if so, the statin should be discontinued. |
Heart
Disease Information
August 8, 2001
Baycol Recall:
Read the FDA Talk Paper
Read the Bayer Important Drug Warning
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