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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. |
