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 What
are Fen-Phen & Redux?
Fen-Phen and Redux were, up until September of 1997, two of the most
widely prescribed drugs or drug combinations for weight loss and
weight control. Fen-Phen is a combination of Fenfluramine (Fen) and
Phentermine (Phen), sold separately but prescribed in combination.
Redux is a newer version of Fenfluramine (dexfenfluramine) which was
prescribed by itself.
How did the drugs work?
Serotonin is a chemical within the brain that acts to give a person
a feeling of "well being" and "fullness". Fenfluramine and
dexfenfluramine cause the brain to release an excessive amount of
Serotonin, and, at the same time, block the body's ability to
reabsorb Serotonin. The excess Serotonin in the system makes you
feel full and reduces hunger. Phentermine is an amphetamine or
stimulant and has the ability to counteract the drowsiness of
Fenfluramine. In 1992, a University of Rochester professor first
promoted the drug combination, Fen-Phen, as a weight loss magic
pill. Mass marketing of this combination followed, and in 1996 alone
an estimated 18 million prescriptions were filled for Fen-Phen and
Redux. These diet drugs were sold under a variety of trade and
generic names including:
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Pondimin (Fenfluramine)
|
. |
Zantryl (Phentermine) |
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Fastin (Phentermine) |
. |
lonamin (Phentermine) |
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Redux (DexfenfluraiTiine) |
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Adipex-P (Phentermine) |
Were These Drugs Approved By The FDA?
Fenfluramine and Phentermine have each been individually approved by
the FDA, however, the combination of Fen-Phen was never submitted to
the FDA, nor was it ever approved as a combination medication. Redux
was approved by the FDA. In September 1997, at the FD/fe request,
Pondimin and Redux were pulled from the market and are no longer
available.
Who Manufactured These Drugs?
Several companies manufactured and distributed these drugs. American
Home Products, and Interneuron Pharmaceuticals made Pondimin and
Redux. In 1996 the sales of Redux accounted for approximately $132
million in revenue and the sales of Pondimin accounted for
approximately $173 million in revenue for these manufacturers.
Several manufacturers made Phentermine, which has been marketed
under a number of brand names.
What are the health problems associated with these weight loss
drugs?
Some of the side effects that have been reported and which maybe
linked lo these drugs are as follows:
A. Primary Pulmonary Hypertension or PPH is a serious lung
disease where the blood vessels constrict and create abnormally high
blood pressure. Patients experience shortness of breath and fatigue.
Unfortunately, PPH is usually a permanent condition and in many
instances can lead to death.
B. Heart Valve Damage In July of 1997, the Mayo Clinic
released the results of study which demonstrated that a large number
of persons who had taken Fen-Phen or Redux had developed heart valve
leakage. Heart valve damage in Fen-Phen users was 500% higher than
in non users. A buildup occurs on the valves of the heart which
prevents them from sealing properly as the heart chambers pump
blood. This makes the heart pump much harder, and the valve
deterioration can become life threatening, requiring surgical
repair. Valve damage is generally a silent condition, causing no
symptoms to the patient, until the condition becomes severe.
C. Other symptoms from the diet pills are:
- chest pain
- loss of energy
- fatigue
- swelling of extremities
- shortness of breath
D. Psychological or neurological problems such as short
term memory loss, headaches, irritability, personality changes and
depression. These symptoms are currently under investigation in
relation to the taking of Fen-Phen and Redux.
What Does The Government Recommend?
Shortly after the PDA action and the withdrawal of the drugs from
the market, a conference was held among the Food and Drug
Administration, Department of Health and Human Services, Center For
Disease Control and The National Institute For Health, with the
assistance of numerous medical professionals. The conclusion was the
issuance of a position paper which essentially recommended the
following, at a minimum:
- Every person who has taken Fen-Phen or Redux should see a
physician to have a complete medical history taken and a physical
examination performed.
- If there is a suspicion of heart or lung disease, the patient
should have an echocardiogram to determine the existence of heart
valve damage.
- Even if there is no evidence of heart or lung disease, any
Fen-Phen user that is about to undergo a medical or dental
procedure, which is of a nature that an antibiotic would be
prescribed for a heart patient, should also have an echocardiogram
performed.
What
is an Echocardiogram?
This is a non-invasive ultrasonic test of the heart. It provides
the doctor with a "moving picture" of the heart and allows for a
comprehensive analysis of heart valve functions and pressure.
How Do I Know If My Problem Is Caused By Fen-Phen Or Redux?
The level of this medical science is new and constantly
developing. First, you should advise every treating physician of
your history with Fen-Phen or Redux. Second, you should ask the
physician directly, whether they are able to attribute your problem
to any cause other than Fen-Phen or Redux. If your condition
persists without any explanation, obtain a second opinion. Lastly,
if you have any doubts about the source of your symptoms, insist on
an echocardiogram. As a result of the FDA/DHHS position paper, the
failure to prescribe this test to a patient with specific complaints
could expose the physician to his or her own liability.
LEGAL ISSUES AND ANSWERS
What Are My Rights?
If you were a Fen-Phen or Redux user, and have suffered damages,
you may have any number of claims, depending on your medical
condition and the level of care you received. Some of the causes of
action
- Individual actions against the manufacturers for failing to
properly test the drugs and warn the public of known side effects
and possible harm
- Class actions against the manufacturers seeking specific
damage relief, or seeking long term medical monitoring of patients
that have taken the drugs
- Medical malpractice actions against the prescribing physician
for:
- failing to properly inform the patient of side effects before
prescribing
- failing to properly diagnose a problem
- failure to monitor a patient under a drug regimen
- prescribing the drugs for an excessive period of time
- prescribing these drugs to persons who should not have taken
them at all due to other prior health problems
What Should I Do Now?
1. Our first instruction to clients who have taken Fen-Phen
or Redux, is to seek medical treatment, including an echocardiogram.
2. Complete the medical questionnaire from our firm and
return it promptly.
3. Save all remaining pill bottles, prescription receipts or
other evidence of the name, dosage, refill orders and the date of
each prescription.
4. Save all medical bills
and the literature that you received from the doctor or pharmacy
about the drugs. If you were taking the drugs through a weight loss
center, save all the forms and information that you were provided.
5. Write out a history of your involvement with the drugs,
including start and end dates from when you took the drugs. Document
all symptoms, your recollection of statements that the physician
made, dates of visits, etc.
6. Do not discuss you involvement with the litigation with
anyone.
7. Contact any of the attorneys listed in this brochure to
discuss your case and to arrange for a free consultation.
8. Contact us immediately if your medical condition changes,
or if you receive results from any testing.
What is the history or
chronology of the diet drug settlement?
- September 15, 1997 - Diet drugs Pondimin� and Redux™ withdrawn
from market
Early winter 1997 - Lawsuits and class actions filed
December 10, 1997 - Cases transferred to federal district
court
Early 1998 to Late 1999 � Negotiations between plaintiffs and
drug manufacturers
November 23, 1999 - Preliminary approval for the settlement
class.
May 2, 2000 � Hearings held to determine whether the proposed
Settlement Agreement was fair, adequate, and reasonable.
August 10, 2000 � Additional Hearings on the fairness of
changes contained in the 4th Amendment to the Settlement
Agreement.
August 28, 2000 - Approval of settlement
September 1, 2000 - AHP Settlement Trust established. The
Trust is a special purpose entity established solely to administer
the provisions of the Settlement Agreement, and to process the
claims of Class Members who file claims with the Trust in
connection with their use of Pondimin�and/or Redux™
August 15, 2001 through October 3 2001 - Appeals
January 3, 2002 - Final Judicial Approval occurred
The Law
Offices of Nadrich & Associates is a fifteen person law firm which
does commit the necessary resources to fight any pharmaceutical
corporation including the manufacturers of Redux and Pondimen and
all other diet drugs.
We work on a contingency fee basis. A contingency fee means we only
obtain a fee if we make a recovery. If we do not win the case
or make a recovery our clients owe us nothing for our time, costs or
expenses.
With many decades
of combined experience, the Law Offices of Nadrich & Associates, and
our highly experienced staff of trial attorneys, paralegals,
investigators and law clerks have the expertise and ample resources
to successfully research, investigate and litigate all of our
clients Primary Pulmonary Hypertension
claims. We
promise every client that their claim will be reviewed diligently
and carefully. If we take a case, we will work extremely hard to
obtain the best possible result. We can help you
immediately. All
e-mail and
form
submissions will be responded to by a qualified member of our
firm within 24 hours.
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