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Birth Control Medication Lawsuits (Yaz, Yasmin,
and Ocella Birth Control Drug Lawsuits)
YAZ,
Ocella,
and Yasmin are oral contraceptives that produced over $1
Billion in sales in the United States and $1.8 Billion
worldwide in 2008. These birth control pills are oral
contraceptives that have been heavily marketed by Bayer
HealthCare Pharmaceuticals, Inc., however, the FDA has found
that past marketing campaigns were misleading as it minimized
the potential health risks that have been associated with
these oral contraceptives. These health risks include
sudden death, cardiovascular problems, blood clots, heart
attacks, stokes, and gallbladder disease.
If you believe that you or a loved one
has suffered serious medical problems related to the use of
YAZ, Yasmin, or Ocella, please contact a doctor immediately.
Additionally, if you have lost a loved one who was taking
one of these birth control medications from a sudden heart
attack, stroke, pulmonary embolism, or gallbladder disease,
please report the incident to the deceased's doctor and FDA.
For more information on YAZ, Yasmin, or Ocella lawsuits,
please feel free to
contact Texas YAZ,
Ocella, and Yasmin Lawyer Jason Coomer
or
use our online submission form.
Yaz, Yasmin, and Ocella Birth Control Medications Contain
Drospirenone (DRSP) that has been Associated with Serious
Health Risks
YAZ and Yasmin are combined oral
contraceptive (COC) pills that contain ethinylestradiol (EE)
and drospirenone (DRSP). These birth control
medications are manufactured by Bayer HealthCare
Pharmaceuticals, Inc., while Ocella is the generic
equivalent of Yasmin that is manufactured by Barr
Laboratories. Each of these birth control medications
contain ethinyl estradiol and the new "fourth generation"
progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia
and these DRSP oral contraceptives have been
associated with adverse health effects such as Death, Deep
Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes,
Heart Attacks, Gallbladder Disease, and other health
problems.
YAZ Marketing Campaign Created Annual Revenues of
over $600 Million, but Overstated Drug Benefits and
Understated Drug Dangers
The FDA has found that Bayer's marketing
campaign that was directed at young women for the birth
control drug, YAZ, was misleading. The misleading
marketing campaign allowed YAZ to become the best-selling
oral contraception pill in the United States with annual
sales revenue of over $600 million in 2008, but understated
the birth control medications' health risks.
Through the efforts of the FDA and
several states' Attorney Generals, the manufacturer and
marketer of the oral contraceptive YAZ was required to run a
$20 million advertising campaign for the purpose of
correcting previous YAZ marketing statements and will be
required to submit all future YAZ ads for the next six (6)
years to the FDA for screening.
The YAZ ads allegedly overstated the
pill's ability to improve women’s moods and clear up acne,
while not fully warning of the drug's potential serious side
effect health risks including Death, Deep Vein Thrombosis (DVT),
Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder
Disease, and other health problems.
Recent FDA and Attorney Generals Take Action to
Correct the YAZ Marketing Campaign Making Sure Bayer Does
Not Understate Drug Dangers and Risks
In October 2008, the FDA took action
against Bayer sending a warning letter to Bayer saying that
two television ads overstated the drug’s benefits while
understating its risks. The
FDA warning letter stated that two 60 second direct to
consumer broadcast television advertisements entitled "Not
Gonna Take it" and "Balloons" submitted by Bayer HealthCare
Pharmaceuticals, Inc. were "misleading because they broaden
the drug's indication, overstate the efficacy of YAZ, and
minimize serious risks associated with the use of the drug".
Further, that these televisions advertisements "misbrand the
drug in violation of the Federal Food, Drug, and Cosmetic
Act".
The FDA had approved YAZ as a birth
control pill that has a side benefit in treating a very
specific mood-related psychological problem called
"premenstrual dysphoric disorder" and improving moderate
acne, however, Bayer overstated the drug's efficacy and
minimized its potential dangers.
FDA Action against Yasmin for Minimizing Health Risks in
2003 Suggests Bayer May Have Had Prior Knowledge of
Misleading Marketing that Minimized YAZ Health Risks
The contraceptive medication, YAZ,
closely resembles another birth control medication, Yasmin.
Both drugs contain contain ethinyl estradiol and the "fourth
generation" progestin drospirenone (DRSP). Yasmin has
been the subject of a similar
FDA warning letter in 2003 that warned the manufacturer
and marketer that their marketing advertisements were
understating potential health risks and overstating the
benefits of the birth control medication. At that time
Yasmin was manufactured and marketed by Berlex Laboratories.
In 2006, Bayer HealthCare
Pharmaceuticals, Inc. acquired Berlex Laboratories.
Bayer now markets both oral contraceptives, YAZ and Yasmin
which had sales of about $1.8 Billion in 2008.
Health Risks Related to the Oral Birth Control Mediations
Yaz, Yasmin, and Ocella
YAZ, Yasmin, and Ocella contain
drospirenone (DRSP), a synthetic progestational compound
that can cause serious side effects and has been associated
with serious health problems including formation of
dangerous blood clots, strokes, pulmonary embolisms (PE),
gallbladder disease, deep vein thrombosis (DVT), heart
attacks, and sudden death. Yaz and Yasmin are combined
oral contraceptive (COC) pills that contain ethinylestradiol
(EE) and drospirenone (DRSP). Both have been linked to blood
clots and cardiovascular events as well as other serious
health risks.
While it has long been known that taking
a combined oral contraceptive (COC) pill with a combination
of estrogen and a progestin hormone can increase the risk of
stroke and blood clots in the legs and lungs, the health
risks of newer synthetic should have been deceptively
marketed as having less health risks with other benefits
that the contraceptives do not have.
In October 2008, the Food and Drug
Administration (FDA), concerned with the improper
advertising of the YAZ/Yasmin/Ocella birth control drugs,
issued a warning letter to the Bayer Corporation to cease
unlawful promotion. Also, women who have taken these popular
oral contraceptives reported serious side effects, including
blood clots, stroke, gallbladder complications and heart
attack as a result of taking the drugs.
It is thought that these birth control
medications contain hormones the effect cholesterol
metabolism and excretion into the gallbladder thereby
affecting the cholesterol concentration and crystallization
of bile acids in the secretions leading to gall stones and
its sequelae as well as can lead to clots, strokes, or heart
attacks.
Manufacturing Concerns for the Oral Birth Control Mediation,
Yaz
In September 2009, the
Food and Drug Administration issued another warning letter
that its inspectors had uncovered testing problems at
Bayer's plant in Berghamen, Germany. The 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.
In this August 5, 2009 FDA Warning Letter
to Bayer, the agency told the drug company that about eight
batches of ingredients used in the drugs Yaz, Yasmin, and
Angeliq "should not have been released for distribution".
Off Label Drug Marketing of
Yaz, Yasmin, and Ocella Birth Control
Off label
drug marketing occurs when a drug is marketed beyond its
approved FDA uses. When combined with false
certifications to the United States Government, off label
healthcare whistleblower fraud claims can arise. For
more information on
Off Qui Tam Fraud Claims.
Pharmaceutical Fraud, Bad Drug, and Product Liability
Lawsuits
Product Liability Lawsuits including YAZ
Lawsuits, Ocella Lawsuits, Yasmin Lawsuits, Drospirenone (DRSP)
Lawsuits, and other defective drug & false marketed drug
cases, can be complicated lawsuits. This is especially
true if a young woman is killed by a defective drug or
suffers catastrophic injuries from using a deceptively
marketed drug.
Because of the complexity of these
lawsuits, product liability claims including defective drug
claims are often consolidated into one federal court or
jurisdiction for resolution. This process typically
helps the court and the parties so that they do not have to
litigate the same issues multiple times.
As a Texas Pharmaceutical Fraud, Bad Drug
and Product Liability lawyer, Jason Coomer commonly works
with other Lawyers throughout the United States as
well as in Texas. In working with other YAZ, Yasmin,
and Ocella lawyers,
we seek compensation from negligent drug companies and other
companies that
have severely injured or killed young women
selling dangerous products, medications, and drugs that they
should have known were dangerous, but intentionally mislead
consumers and hid dangerous health risk in order to sell more product to make a profit.
If you have suffered a serious injury
that you believe is related to the use of YAZ, Yasmin, or
Ocella or a woman close to you has suffered serious health
problems or has died while using YAZ, Yasmin, or Ocella, it
is important to contact a doctor and the FDA to report the
incident. If you have any questions about a Yasmin,
Ocella, or YAZ lawsuit or this webpage, feel free to
contact Austin Texas
Ocella, Yasmin, YAZ Attorney, Jason S. Coomer.
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