Baycol Lawsuit
The FDA has been heavily criticized for allowing an increasingly
larger number of drugs become approved in a shorter amount
of time. The result has been a higher number of recalled drugs
and more drugs approved that are simply modified versions
of already available drugs. The Baycol
recall on August 8, 2001 due to the 100 plus deaths worldwide
has been attributed to the FDA becoming more cautious in recent
years.
Drug companies do agree that the FDA has become more stringent
recently and that the Baycol deaths probably influenced this
safety action. Currently, adverse drug reactions cause so
many deaths in the U.S. it is number four on the leading causes
of death. Baycol was linked to the very rare condition rhabdomyolysis
that can lead to a life-threatening kidney failure. Most recently,
in April 2002, it was reported that over 300 lawsuits were
filed in Pennsylvania alone against Bayer Corporation, Baycol
manufacturer due to the dangerous Baycol side effects that
have resulted from its use.
Baycol's legal battles began days after the Baycol recall
was announced. Bayer has claimed they tried to pull Baycol
from the market before as early as possible, but despite their
claims the health minister of Germany criticized the company
for waiting too long before telling patients of the dangers
of Baycol. On May 21, 2001, Bayer revised the Baycol prescribing
information to read, "the combined use of cerivastatin
(Baycol) and gemfibrozil is contraindicated due to a risk
for rhabdomyolysis and concurrent use should not occur under
any circumstances.
Label changes have been shown to have little impact on healthcare
professionals and patients that rarely even read the labeling.
The withdrawal prompted numerous law firms to file Baycol
class actions, as well as individual lawsuits as a result
of the deadly Baycol side effects. Initial symptoms of rhabdomyolysis
were sometimes mistaken for signs of flue instead of being
associated to Baycol.
Thus, the Baycol patients were not able to receive the proper
treatment for the potentially deadly disease. When treating
rhabdomyolysis, early,
proactive treatment can prevent future complication. By administering
high volumes of intravenous fluids the rhabdomyolysis can
be kept from progressing to kidney failure if the urine flow
is kept high enough to flush the pigments through the kidney.
Baycol patients were not warned about the deadly Baycol side
effects until at least 40 deaths reported worldwide resulted
in the Baycol recall. Over
a hundred people have since died from Baycol, and the number
of other serious injuries and deaths not reported must also
be considered.
If you have taken Baycol and
would like to speak with a Baycol lawyer please contact us.
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