FREQUENTLY
ASKED QUESTIONS ABOUT
PRODUCT LIABILITY REGARDING LOTRONEX
What is product liability?
What is Lotronex?
What is IBS?
When and Why was Lotronex withdrawn from the market?
What are some of the early signs of the adverse effects associated
with the use of Lotronex?
What are some of the other side effects associated with Lotronex?
Do Lotronex users have a right to be compensated for any health
problems caused by Lotronex?
What should I do if I am currently taking Lotronex?
Will Lotronex be recalled from the pharmacy?
What is a “failure to warn” claim?
What kind of claims can be brought for product liability?
What is strict liability?
What is negligence?
What is breach of warranty?
What damages does the law allow in product liability cases?
What are economic damages?
What are noneconomic damages?
What are punitive damages, and may they be recovered in product
liability cases?
If I bring my case to you, what will you do?
How do I know that you will do a good job on my case?
What are your fees?
Q. What is product liability?
A. Product liability is the body of law that provides for
compensation for physical injuries resulting from defective and unreasonably
dangerous products and from the failure of a manufacturer or seller to warn
the consumer of product dangers.
Q. What is Lotronex?
A. Lotronex is a prescription medicine used to treat women
with irritable bowel syndrome (IBS) who have diarrhea as their main symptom
(diarrhea-predominant IBS). Lotronex has not been shown to help men with IBS.
Q. What is IBS?
A. IBS is also called irritable colon and spastic colon.
IBS causes lower abdominal pain and discomfort, urgency (a sudden need to have
a bowel movement), and irregular bowel habits, such as diarrhea or constipation.
In some people IBS causes mostly constipation; in others mostly diarrhea; some
people have alternating periods of diarrhea and constipation. Lotronex was
approved only for women with diarrhea-predominant IBS. Lotronex should not
have been used by women who have constipation as their main IBS symptom. IBS
is a symptomatic disease that can cause significant discomfort but which does
not result in complications that need bowel surgery (an operation).
Q. When and Why
was Lotronex withdrawn from the market?
A. On November 28, 2000, Glaxo Wellcome, the manufacturer
of Lotronex (alosetron) tablets-a drug used to treat irritable bowel syndrome
in women-withdrew Lotronex from the market. This action was taken because the
drug had been associated with reports of serious side effects such as intestinal
damage as a result of reduced blood flow to the intestine (ischemic colitis),
severely obstructed or ruptured bowels (complications of severe constipation),
and death. As of November 10, 2000, the FDA had reviewed a total of 70 cases
of serious adverse events, including 49 cases of ischemic colitis and 21 cases
of severe constipation. Of these 70 cases, 34 resulted in hospitalizations
without surgery, 10 resulted in surgical procedures (some of which involved
the removal of parts of patients' intestines), and three resulted in death.
Q. What are some
of the early signs of the adverse effects associated with the use of Lotronex?
A. One of the possible serious side effects of Lotronex is
severe constipation, which may be serious enough to completely block movement
of stools through the intestines. Another is development of ischemic colitis,
a serious condition caused by reduced blood flow to the intestines. Early signs
of this condition include new or worsening abdominal (lower stomach area) pain,
bloody diarrhea or blood in your bowel movements. Either of these side effects
could lead to hospitalization and possibly surgery.
Q. What are some
of the other side effects associated with Lotronex?
A. Some of the other reported side effects include: hypertension,
gastrointestinal or abdominal discomfort and pain, gastrointestinal gaseous
symptoms, viral gastrointestinal infections, heartburn, nausea and vomiting,
abdominal distension (bloating) and hemorrhoids.
Q. Do Lotronex
users have a right to be compensated for any health problems caused by
Lotronex?
A. If Lotronex has caused you or a loved one significant
physical damage, you may be entitled to a large compensatory award. You must
protect those legal rights before they lapse by passage of time and are barred
by various states' statutes of limitations. You should contact us to evaluate
your rights. Many valuable legal rights are lost everyday because of peoples'
failure to take legal precautions. Call us now at 1-800-DRUG
LINE to protect your rights. Or E-Mail us
for more information.
Q. What should
I do if I am currently taking Lotronex?
A. We encourage those people who have taken Lotronex to contact
their doctor and discuss the appropriate follow-up, and alternative treatments.
Any decision about which drug product to take to treat your symptoms should
be made in consultation with your doctor based on an assessment of your specific
treatment needs, specific risk profile, and other factors. We are not health
care professionals and cannot comment on, or recommend a course of treatment
for any individual.
Q. Will Lotronex
be recalled from the pharmacy?
A. The FDA has not yet recalled Lotronex. However, the company
has indicated that they are planning to recall the product from pharmacies.
Q. What is a “failure to warn” claim?
A. Failure to warn is the claim that a manufacturer failed to provide directions for the safe use of a product.
Q. What kind of
claims can be brought for product liability?
A. The alternative theories of liability in a product liability
case are (1) strict liability; (2) negligence and (3) breach of warranty. Sometimes
all three theories are pursued in one case.
Q. What is strict liability?
A. Strict liability is the legal principle that a person
or company which sells a product in a “defective condition” that is
unreasonably dangerous to the ordinary user may be liable for any physical
injuries. The defect may be in the product’s design or manufacturing, in
the product’s container or packaging, or in the instructions or warning
necessary for the product’s safe use. In a strict liability case, the injured
person is not required to prove the manufacturer or seller was negligent.
Q. What is negligence?
A. Negligence is a breach of a duty owed by the manufacturer
to the user in light of the reasonably anticipated harm arising from all reasonably
foreseeable uses of the product. The duty includes design, manufacturing, instructing
and warning. In a negligence case the injured party must prove a violation
of a standard of reasonable care by the manufacturer in the manufacture of
the product.
Q. What is breach
of warranty?
A. A warranty is an expressed or implied representation
about the product to the consumer. Common warranties are that the product is
fit for the ordinary purpose for which it is used or that the product is fit
for a particular specific purpose. Breach of warranty generally means that
the product did not perform as represented or expected.
Q. What damages
does the law allow in product liability cases?
A. Generally, the plaintiff is to be reasonably compensated
for all injuries and losses resulting from the occurrence in question. Damages
are split into two general categories: economic (past and future), and noneconomic
(past and future).
Q. What are economic
damages?
A. Economic damages include almost everything that can be
replaced with a checkbook. This category of damages is very broad and will
vary from case to case. Economic damages can include the reasonable expenses
of necessary medical care; hospitalization and treatment; loss of income or
earning capacity; the reasonable value of services provided by family members
for free; the cost of hiring others to perform normal household duties; and
the loss of the injured person's services to his or her spouse. These losses
are projected into the future based, among other factors, on medical testimony
regarding continuing disability and future needs.
Q. What are noneconomic
damages?
A. Noneconomic damages are those losses which cannot be
quantified in a dollar amount. The most prominent examples are pain and suffering,
mental anguish, inconvenience, physical impairment or disability, disfigurement,
and loss of enjoyment of life. The importance of categorizing damages as economic
or noneconomic lies in the fact that noneconomic damages are sometimes limited
under some state laws. We often see cases where people's lives are devastated
by catastrophic injuries, but if they are children or elderly, economic losses
are limited and the capped amount of noneconomic damages is unfairly inadequate.
Q. What are punitive damages, and may they be recovered in product liability cases?
A. Punitive damages are not based upon the severity of the injury to the plaintiff, but rather upon the need to punish the defendant and deter others from engaging in like conduct. Before punitive damages may be awarded, the plaintiff must prove that the defendant acted in a “wanton or intentional” way, which includes the “reckless disregard” of a known danger to the plaintiff’s health and safety. This must be proven by clear and convincing evidence. Punitive damages are extremely rare, but available in appropriate circumstances.
Q. If I bring
my case to you, what will you do and how much will it cost?
A. First of all, we will not charge you for any of the time
we spend visiting with you or for the cost of investigating your case. We start
with an interview to determine the facts as you know them, and make a judgment
about whether the case is one which falls within our expertise and interests.
The ensuing investigation begins with the collection of all pertinent records,
including accident reports, product literature, company brochures, and medical
records. We ask you to sign releases authorizing us to obtain these records.
We then review and analyze the records. If we believe there is a strong possibility
that a product was defective, we will submit it to the appropriate experts
for review, asking them for their opinions on the issues of the defective nature
of the product, damages and causation. If, after consultation with experts,
we believe that we can satisfy our burden of proof, we recommend that the case
be filed.
to the top
Q. How do I know
that you will do a good job on my case?
A. We believe that our experience and results in product
liability cases count. We have a commitment to getting an excellent result
in every case we decide to pursue, and our track record and credibility are
extremely important to us. Please keep in mind, however, that every case is
different and no result is guaranteed. All we can promise is our best effort
on each and every case.
A. Balkin & Eisbrouch handle
all cases on what is called a contingency fee. This means that no fees or
costs are charged unless we collect money damages for you. We advance all
costs for investigators, court reporters, expert witness testimony, accident
reconstructionists, filing fees and any other expenses related to your case.
All of the consultations with our office are absolutely free. When you recieve
compensation, meaning we have successfully concluded your case, either by
settlement or litigation, our fees are a percentage of the gross settlement.
This percentage is agreed upon before we begin work on your case and is generally
between 20% and 40%. The percentage depends on the complexity and type of
case.
to the top
No Recovery, No Fee!
We know most people can't afford high, hourly legal fees. That's why we work on a contingency basis. This means you won't pay anything, unless we recover money for you.
If you or someone you love has been injured in a car accident anywhere in the United States, Canada, Puerto Rico and all American possessions, let our experienced auto accident lawyers help you receive the compensation you deserve.
Email us or call us today at 1-800-RESULTS.
"THE RESPECT YOU DEMAND. THE RESULTS YOU DESERVE."®
Balkin & Eisbrouch, LLC
A National Law Firm
"Making Things Right For Over 35 Years"
