Fact Sheet - Paxil Withdrawal Reactions Class Action
Posted on: Saturday, August 25, 2001 at 16:40:33 (EDT)
http://www.stuartshipko.com/FAQ//paxilclass.html
Paxil is being touted as the "nonaddicting" treatment for panic disorder with a "more favorable side effect profile". It may be that it is highly addicting and loaded with side effects.
Fact Sheet - Paxil Withdrawal Reactions Class Action
The 35 plaintiffs named in the lawsuit are from AZ, CA, CO, FL, IN,KY, LA, MN, MO, NC,
NE, NJ, NV, OK, OR, TN, TX, UT, WI, and WY. Several of them are willing to talk to the
media. If you wish to speak with a victim please call
Robin McCall listed in the contact information.
Plaintiffs' lawyers have argued for years that antidepressants, such as Prozac, Paxil and
Zoloft, can induce some to experience adverse reactions which can result in suicide and
violence.
This summer, the New South Wales Supreme Court ruled that had it not been for David
John Hawkins' ingestion of Zoloft, he would not have strangled his wife of 50 years.
Last month GlaxoSmithKline was ordered by a federal jury in Cheyenne,Wyoming to pay
$6.4 million to relatives of Donald Schell, age 60, who had been taking Paxil for just 48
hours when he experienced hallucinations and shot and killed his wife, his daughter, his
granddaughter and then himself.
In the Spring of 2000, a Connecticut man, Christopher DeAngelo, was acquitted of armed
bank robbery based on his suffering from a manic reaction to Prozac at the time of his
crime.
This Paxil Class Action is the first of its kind against an SSRI maker, i.e.,in connection
with the drug's withdrawal reactions.
The first SSRI to reach the U.S. market was Prozac. The second was Zoloft, then came
Paxil. Collectively, the SSRI's (selective serotonin reuptake inhibitors) have been
approved for marketing in the U.S. for such conditions as depression, obsessive
compulsive disorder, post traumatic stress syndrome, and "premenstrual dysphoric
disorder."
SSRI's effect the brain's ability to reabsorb serotonin, a neurotransmitter in the brain,
which is supposed to affect mood, sleep and appetite.
Complaint allegations re victims:
An exemplar of the plaintiffs in this Class Action are briefly described below as well as
what they have suffered, according to the complaint:
Plaintiff #1 of North Hollywood, California was originally prescribed Paxil in September
1999, by her OB GYN. In the year 2000, she attempted to discontinue use of the drug
with her doctor's approval. Upon initial discontinuation of dosage and continuing
thereafter until February 2001, she experienced severe withdrawal reactions including,
but not limited to, restlessness and pain which severely impaired her ability to perform
activities of daily living. She did not know she was experiencing Paxil withdrawal.
Plaintiff #2 of Hollywood, California is a website designer who was prescribed Paxil by her
doctor for "panic attacks." Soon after taking the drug, her ability to eat and sleep were
severely impaired, and she was "nerved out all the time." When she decided to stop
taking the drug, her physician instructed her to lower her dose to 10mg. After about a
month and shortly after her last pill was consumed, she experienced frightening physical
sensations, including the sensation of being shocked with electrical charges,
uncontrollable shaking and unwanted intrusive thoughts. She did not know this was
caused by Paxil.
Plaintiff #3 of San Diego, California, first took Paxil in July 2000 which was prescribed by
her internist and allergist. When she tried to discontinue use of Paxil, she experienced
unwanted sensations of sharp,
intermittent stabbing pain in her head, severe headaches, dizziness,nausea, weakness in
her body and legs, shakiness, and severely impaired ability to perform mental functions.
As time passed, the reactions got worse and she became bedridden. She thought she
was losing her mind and that she had a brain tumor. She was hospitalized and had a CT
scan. It was not until later that she discovered her reactions were caused by
Paxil withdrawal. As of April 2001, she continues to suffer the injurious effects of Paxil
withdrawal.
Plaintiff #4 of El Cajon was prescribed Paxil in June 2000. Because she quickly gained 25
pounds on the drug, she was prescribed to discontinue the use of Paxil. She was
prescribed a tapering regime which was extremely painful and she suffered painful
reactions. At the time, she did not know these reactions were due to Paxil. From October
2000 to January 2001, she kept taking Paxil to combat her withdrawal reactions.
As of February 2001, she was still suffering shocks from Paxil withdrawal.
Plaintiff #5 of San Diego, California a Texas Tech University graduate, an ex Marine, and
a veteran of Desert Storm. In the spring of 1995, he was first prescribed Paxil. Initially
his physician told him that Paxil's side effects were mild, and specifically that there were
no problems stopping the drug if it was done gradually over a few weeks. After 5 years
on the drug, while discontinuing use of Paxil, he suffered debilitating physical and
psychological reactions, and became at times disabled. Unbeknownst to him, the
reactions were Paxil withdrawal. In August 2000, still suffering as he tried to reduce his
Paxil usage, he saw the television program "20/20" regarding Paxil withdrawal. It was at
that time he became determined to
wean himself off of Paxil once and for all. He continues to suffer Paxil withdrawal until the
end of the year 2000.
None of the named plaintiffs were ever informed before starting Paxil that it was
addictive, induced dependency, or created withdrawal problems when dosage was
reduced or terminated.
The claims of Plaintiffs are typical of the class and of other Paxil withdrawal victims. Each
of the Plaintiffs and class members were
uninformed of the hazards in reducing or terminating their Paxil dosage.
Each of them did, in fact, reduce or terminate their daily Paxil intake. Within one or two
days thereafter, severe withdrawal reactions appeared.
Complaint Allegations:
1) The lawsuit further alleges that Paxil is a short "half life" drug which means it leaves
the body at a relatively fast rate. GSK uses this feature to distinguish it from its
competitors alleging that, as a result, it has a shorter
duration of adverse events, decreased drug accumulation over time, better management
of sexual dysfunction, and reduction of time to establish steady state drug regimen. The
great disadvantage of a short half life
substance, however, is that it is more addictive, has a greater tendency to induce
physical and psychological dependency, and causes withdrawal reactions. While these
characteristics of "half life" substances have been well known among Defendant and
psychopharmacologists, such information is not generally known by general practice
physicians or even psychiatrists.
2) The habit-forming nature of Paxil has not been fully divulged to physicians in the
United States, hence neither physician nor patient has had sufficient information to
weigh the benefits/risks associated with Paxil. Serious habit forming characteristics
affect the patient, and he/she is
unable to wean himself/herself off of the drug after therapeutic use is no longer needed.
Physical and psychological dependency on Paxil is the result. When withdrawal problems
arise, the patient often feels entrapped, in despair, and desolate.
3) From 1992 to the present, patients attempting to taper down or discontinue use of
Paxil have suffered withdrawal reactions and dependency/withdrawal syndrome, as noted
above. In addition to the physical reactions mentioned above, patients can also
experience
psychiatric reactions such as anxiety, agitation, lability of mood, nervousness,
hypersexuality, crying spells, irritability and despair. The result of these combined
reactions is that many patients continue to take Paxil because they are unable to endure
the withdrawal reactions.
4) "Relapse" is not "withdrawal." Relapse occurs when a patient who has improved his/her
depressive state, then reverts back to a more seriously depressed state. Symptoms
exhibited during relapse are frequently
comparable to reactions exhibited during withdrawal. As indicated elsewhere in this
complaint, it is alleged on information and belief that GSK, over the years, categorized
numerous patients' withdrawal reactions as relapse symptoms. GSK did this in order to
gain FDA approval for Paxil and avoid revealing the drug's withdrawal problems.
5) After representing to the FDA that Paxil had been systematically tested for withdrawal
and that the tests were successful, Paxil was approved for marketing in the United
States. However, at that time and prior thereto, GSK knew of the withdrawal problems
with Paxil (particularly from its clinical trials, including those held in Yugoslavia). Contrary
to obtaining its marketing approval from the FDA based on its "systematic testing," GSK's
label for Paxil stated:
DRUG ABUSE AND DEPENDENCE. Physical and Psychologic Dependence: "Paxil has not
been systematically studied in animals or human for its potential for abuse, tolerance, or
physical dependence. While the clinical trials did not reveal any tendency for any drug
seeking behavior, these observations were not systematic and it is not possible to
predict on the basis of this limited experience the extent to which a . . . (central nervous
system) . . . active drug will be misused, diverted and/or abused once
marketed. Consequently, patients should be evaluated carefully for history of drug abuse,
and such patients should be observed closely for signs of Paxil misuse or abuse (e.g.,
development of tolerance, incrementations of dose, drug seeking behavior).
The above prescribing information and labeling is false and misleading on its face.
6) Evidence of GSK's knowledge of the withdrawal reactions its drug causes can also be
found in a report to Dr. Martin Brecher of the FDA which disclosed subjective reporting
gathered from patients by cinical investigators who told GSK management that Paxil was
dangerously addictive. A group of 108 patients ending their participation in a trial told
GSK that Paxil had caused them to suffer "withdrawal" reactions ("Group
of 108 Complaining Patients' Study"). Out of the 1293 patients in that trial, the 108
complaining patients constituted 8.3% of the participants. GSK improperly reclassified
these patients' withdrawal reactions as
"relapse" symptoms.
Complaint Allegation Claims:
First Claim for Relief for Fraud and Deceit
Since December 29, 1992, when Paxil was first approved by the FDA, GSK has defrauded
the medical profession in general, Plaintiffs' and their physicians in particular, and the
Paxil patient population in general, in that
it, among other acts:
(a) Knowingly mischaracterized and miscoded withdrawal syndrome occurring during the
clinical trials so as to reduce the number of recorded occurrences of withdrawal
reactions;
(b) Failed to inform the medical community that a significant number of individuals taking
Paxil during foreign clinical trials experienced withdrawal reactions and
dependency/withdrawal syndrome;
(c) Knowingly misrepresented and continues to misrepresent that its clinical trials and
investigations adequately tested for dependency withdrawal syndrome;
(d) Knowingly claimed that Paxil's withdrawal problems were a relapse, when in fact they
were not;
(e) Actively deceived Plaintiffs and class members by representations in written labeling
and oral communications suggesting that Paxil is not addictive, that it does not cause
physical or psychologic dependency, and
that it would not cause withdrawal reactions if dosage were reduced or terminated.
(f) Answering the question: "Is Paxil addictive?" with the response: "Paxil has been
studied both in short- and long-term use and is not associated with dependence or
addiction."
(g) Implementing false and misleading techniques to hide the linkage between
dependency/withdrawal syndrome on one hand, and Paxil on the other. After censoring
the word "withdrawal" from company files and
instructing its agents similarly, defendant GSK, began to dilute the medical vocabulary by
using misleading medical terms to substitute for withdrawal such as "discontinuation
syndrome."
(h) Over-promoting Paxil in order to increase its sale at the expense of revealing the
truth about the addictive/dependency nature of Paxil.
(i) Fraudulently conveyed to all health care providers in the U.S. that Paxil's side effects
were only "mild," when in fact GSK knew many of the drug's withdrawal side effects were
severe.
(j) Fraudulently conveyed to all health care providers in the U.S. that a British study
involving 13,741 patients illustrated that all of the SSRI's exhibited a similar rate of
withdrawal, when in fact GSK knew that study
illustrated Paxil to have the highest rate of withdrawal among SSRI's as recorded and
reported by the authors.
1. As a result of GSK's fraudulent acts and omissions as set forth herein, GSK has
deceived the medical community, including Plaintiffs' physicians, into believing Paxil does
not have the addictive qualities and does not cause dependency/withdrawal syndrome
which defendant GSK knows it in fact does.
2. When said representations were made by defendant GSK, it knew those
representations to be false, or in the alternative, willfully and wantonly and recklessly
disregarded whether the representations were true. These representations were made by
GSK, with the intent of defrauding and deceiving the public in general and the medical
community and to induce the medical community to recommend, prescribe, and dispense
Paxil and for the public to take it.
3. At the time the aforesaid representations were made by the defendant GSK, and at
the time that Plaintiffs ingested Paxil, both Plaintiffs and their prescribing physicians were
unaware of the falsity of said representations and reasonably relied on GSK's assertions,
promulgated through its
aggressive sales force to Plaintiffs' physicians as set forth herein, that the
drug was safe. In reliance upon said representations, Plaintiffs' physicians
did prescribe Paxil and Plaintiffs were induced to and did take Paxil. Had
Plaintiffs known of the actual dangers of Paxil, through their physicians or otherwise,
they would not have ingested Paxil.
4. GSK's motive of deliberately failing to advise physicians and the public of the adverse
effects that can lead to withdrawal problems (and that it knew a percentage of users of
the drug inevitably would experience) was for financial gain and its fear that, if properly
labeled, GSK would lose its share of the SSRI market through the efforts of competing
manufacturers who would adversely compare Paxil's half-life to their own. GSK's goal, at
the expense of those who took its antidepressant, was for Paxil to
become the dominant SSRI on the market.
5. At all times relevant herein, the conduct of defendant GSK, as set forth herein above,
was malicious, fraudulent and oppressive toward Plaintiffs and the public generally. GSK
conducted itself in a willful, wanton and
reckless manner as set forth herein above. Despite its specific knowledge as set forth
above, defendant GSK deliberately recommended, manufactured, produced, marketed,
sold, distributed, merchandized,
packaged, promoted and advertised the dangerous and defective drug Paxil. All of the
foregoing constitute an utter, wanton and conscious disregard of the rights and safety of
a large segment of the public, and by
reason thereof, defendant GSK, is guilty of reckless, willful and wanton acts and
omissions which evidence a total and conscious disregard for the safety of Plaintiffs and
class members.
6. As a proximate cause of defendant GSK's fraudulent and deceitful conduct and
representations and due to Paxil's addictive qualities, inducement of physical and
psychological dependency, and inducement of
dependency/withdrawal syndrome, all Plaintiffs and class members unexpectedly suffered
prolonged physical and mental anguish, harm, and suffering and have sustained damages
and other losses in an amount to be proven at trial.
Second Claim for Relief for Negligence
7. GSK owed Plaintiffs and class members a standard of care to ensure that they and
their physicians were adequately warned of Paxil's addictive qualities and
dependency/withdrawal characteristics before any were prescribed the drug. GSK
violated that standard of care through active
misrepresentations and failure to warn when it was GSK's duty to do so.
See complaint for more.
Third Claim for Relief for Strict Liability per § 402 Restatement (Torts)
8. At all times herein mentioned, defendants knew or should have known that Paxil was
and is addictive and causes withdrawal syndrome.
9. At all times hereinafter mentioned, neither members of the general medical community
nor members of the general public knew of the withdrawal dangers existing with respect
to the administration of Paxil.
10. Paxil was used by Plaintiffs and class members in the manner and amounts in which
the defendants intended it to be used.
11. At all times material hereto, in the United States, Paxil was not properly labeled by
defendants; in fact it was mislabeled and was not accompanied by proper warnings that
Paxil can cause withdrawal reactions and dependency/withdrawal syndrome.
12. Defendants promoted and maintained Paxil on the market both to physicians and
directly to patients/consumers with the knowledge of
Paxil's unreasonable risk to the public in general, and specifically to Plaintiffs and class
members.
13. Paxil, as used by Plaintiffs and class members, was defective and unreasonably
dangerous when sold by defendants, and defendants are strictly liable for the injuries
arising from its manufacture and Plaintiffs and class members' use.
14. As a direct and proximate result of the foregoing, Plaintiffs and class members
sustained damages and other losses according to proof.
Fourth Claim for Relief for Breach of Express Warranty - see complaint for information.
Fifth Claim for Relief for Breach of Implied Warranty - see complaint for information.
Posted on: Saturday, August 25, 2001 at 16:40:33 (EDT)
http://www.stuartshipko.com/FAQ//paxilclass.html
Paxil is being touted as the "nonaddicting" treatment for panic disorder with a "more favorable side effect profile". It may be that it is highly addicting and loaded with side effects.
Fact Sheet - Paxil Withdrawal Reactions Class Action
The 35 plaintiffs named in the lawsuit are from AZ, CA, CO, FL, IN,KY, LA, MN, MO, NC,
NE, NJ, NV, OK, OR, TN, TX, UT, WI, and WY. Several of them are willing to talk to the
Robin McCall listed in the contact information.
Plaintiffs' lawyers have argued for years that antidepressants, such as Prozac, Paxil and
Zoloft, can induce some to experience adverse reactions which can result in suicide and
violence.
This summer, the New South Wales Supreme Court ruled that had it not been for David
John Hawkins' ingestion of Zoloft, he would not have strangled his wife of 50 years.
Last month GlaxoSmithKline was ordered by a federal jury in Cheyenne,Wyoming to pay
$6.4 million to relatives of Donald Schell, age 60, who had been taking Paxil for just 48
hours when he experienced hallucinations and shot and killed his wife, his daughter, his
granddaughter and then himself.
In the Spring of 2000, a Connecticut man, Christopher DeAngelo, was acquitted of armed
bank robbery based on his suffering from a manic reaction to Prozac at the time of his
crime.
This Paxil Class Action is the first of its kind against an SSRI maker, i.e.,in connection
with the drug's withdrawal reactions.
The first SSRI to reach the U.S. market was Prozac. The second was Zoloft, then came
Paxil. Collectively, the SSRI's (selective serotonin reuptake inhibitors) have been
approved for marketing in the U.S. for such conditions as depression, obsessive
compulsive disorder, post traumatic stress syndrome, and "premenstrual dysphoric
disorder."
SSRI's effect the brain's ability to reabsorb serotonin, a neurotransmitter in the brain,
which is supposed to affect mood, sleep and appetite.
Complaint allegations re victims:
An exemplar of the plaintiffs in this Class Action are briefly described below as well as
what they have suffered, according to the complaint:
Plaintiff #1 of North Hollywood, California was originally prescribed Paxil in September
1999, by her OB GYN. In the year 2000, she attempted to discontinue use of the drug
with her doctor's approval. Upon initial discontinuation of dosage and continuing
thereafter until February 2001, she experienced severe withdrawal reactions including,
but not limited to, restlessness and pain which severely impaired her ability to perform
activities of daily living. She did not know she was experiencing Paxil withdrawal.
Plaintiff #2 of Hollywood, California is a website designer who was prescribed Paxil by her
doctor for "panic attacks." Soon after taking the drug, her ability to eat and sleep were
severely impaired, and she was "nerved out all the time." When she decided to stop
taking the drug, her physician instructed her to lower her dose to 10mg. After about a
month and shortly after her last pill was consumed, she experienced frightening physical
sensations, including the sensation of being shocked with electrical charges,
uncontrollable shaking and unwanted intrusive thoughts. She did not know this was
caused by Paxil.
Plaintiff #3 of San Diego, California, first took Paxil in July 2000 which was prescribed by
her internist and allergist. When she tried to discontinue use of Paxil, she experienced
unwanted sensations of sharp,
intermittent stabbing pain in her head, severe headaches, dizziness,nausea, weakness in
her body and legs, shakiness, and severely impaired ability to perform mental functions.
As time passed, the reactions got worse and she became bedridden. She thought she
was losing her mind and that she had a brain tumor. She was hospitalized and had a CT
scan. It was not until later that she discovered her reactions were caused by
Paxil withdrawal. As of April 2001, she continues to suffer the injurious effects of Paxil
withdrawal.
Plaintiff #4 of El Cajon was prescribed Paxil in June 2000. Because she quickly gained 25
pounds on the drug, she was prescribed to discontinue the use of Paxil. She was
prescribed a tapering regime which was extremely painful and she suffered painful
reactions. At the time, she did not know these reactions were due to Paxil. From October
2000 to January 2001, she kept taking Paxil to combat her withdrawal reactions.
As of February 2001, she was still suffering shocks from Paxil withdrawal.
Plaintiff #5 of San Diego, California a Texas Tech University graduate, an ex Marine, and
a veteran of Desert Storm. In the spring of 1995, he was first prescribed Paxil. Initially
his physician told him that Paxil's side effects were mild, and specifically that there were
no problems stopping the drug if it was done gradually over a few weeks. After 5 years
on the drug, while discontinuing use of Paxil, he suffered debilitating physical and
psychological reactions, and became at times disabled. Unbeknownst to him, the
reactions were Paxil withdrawal. In August 2000, still suffering as he tried to reduce his
Paxil usage, he saw the television program "20/20" regarding Paxil withdrawal. It was at
that time he became determined to
wean himself off of Paxil once and for all. He continues to suffer Paxil withdrawal until the
end of the year 2000.
None of the named plaintiffs were ever informed before starting Paxil that it was
addictive, induced dependency, or created withdrawal problems when dosage was
reduced or terminated.
The claims of Plaintiffs are typical of the class and of other Paxil withdrawal victims. Each
of the Plaintiffs and class members were
uninformed of the hazards in reducing or terminating their Paxil dosage.
Each of them did, in fact, reduce or terminate their daily Paxil intake. Within one or two
days thereafter, severe withdrawal reactions appeared.
Complaint Allegations:
1) The lawsuit further alleges that Paxil is a short "half life" drug which means it leaves
the body at a relatively fast rate. GSK uses this feature to distinguish it from its
competitors alleging that, as a result, it has a shorter
duration of adverse events, decreased drug accumulation over time, better management
of sexual dysfunction, and reduction of time to establish steady state drug regimen. The
great disadvantage of a short half life
substance, however, is that it is more addictive, has a greater tendency to induce
physical and psychological dependency, and causes withdrawal reactions. While these
characteristics of "half life" substances have been well known among Defendant and
psychopharmacologists, such information is not generally known by general practice
physicians or even psychiatrists.
2) The habit-forming nature of Paxil has not been fully divulged to physicians in the
United States, hence neither physician nor patient has had sufficient information to
weigh the benefits/risks associated with Paxil. Serious habit forming characteristics
affect the patient, and he/she is
unable to wean himself/herself off of the drug after therapeutic use is no longer needed.
Physical and psychological dependency on Paxil is the result. When withdrawal problems
arise, the patient often feels entrapped, in despair, and desolate.
3) From 1992 to the present, patients attempting to taper down or discontinue use of
Paxil have suffered withdrawal reactions and dependency/withdrawal syndrome, as noted
above. In addition to the physical reactions mentioned above, patients can also
experience
psychiatric reactions such as anxiety, agitation, lability of mood, nervousness,
hypersexuality, crying spells, irritability and despair. The result of these combined
reactions is that many patients continue to take Paxil because they are unable to endure
the withdrawal reactions.
4) "Relapse" is not "withdrawal." Relapse occurs when a patient who has improved his/her
depressive state, then reverts back to a more seriously depressed state. Symptoms
exhibited during relapse are frequently
comparable to reactions exhibited during withdrawal. As indicated elsewhere in this
complaint, it is alleged on information and belief that GSK, over the years, categorized
numerous patients' withdrawal reactions as relapse symptoms. GSK did this in order to
gain FDA approval for Paxil and avoid revealing the drug's withdrawal problems.
5) After representing to the FDA that Paxil had been systematically tested for withdrawal
and that the tests were successful, Paxil was approved for marketing in the United
States. However, at that time and prior thereto, GSK knew of the withdrawal problems
with Paxil (particularly from its clinical trials, including those held in Yugoslavia). Contrary
to obtaining its marketing approval from the FDA based on its "systematic testing," GSK's
label for Paxil stated:
DRUG ABUSE AND DEPENDENCE. Physical and Psychologic Dependence: "Paxil has not
been systematically studied in animals or human for its potential for abuse, tolerance, or
physical dependence. While the clinical trials did not reveal any tendency for any drug
seeking behavior, these observations were not systematic and it is not possible to
predict on the basis of this limited experience the extent to which a . . . (central nervous
system) . . . active drug will be misused, diverted and/or abused once
marketed. Consequently, patients should be evaluated carefully for history of drug abuse,
and such patients should be observed closely for signs of Paxil misuse or abuse (e.g.,
development of tolerance, incrementations of dose, drug seeking behavior).
The above prescribing information and labeling is false and misleading on its face.
6) Evidence of GSK's knowledge of the withdrawal reactions its drug causes can also be
found in a report to Dr. Martin Brecher of the FDA which disclosed subjective reporting
gathered from patients by cinical investigators who told GSK management that Paxil was
dangerously addictive. A group of 108 patients ending their participation in a trial told
GSK that Paxil had caused them to suffer "withdrawal" reactions ("Group
of 108 Complaining Patients' Study"). Out of the 1293 patients in that trial, the 108
complaining patients constituted 8.3% of the participants. GSK improperly reclassified
these patients' withdrawal reactions as
"relapse" symptoms.
Complaint Allegation Claims:
First Claim for Relief for Fraud and Deceit
Since December 29, 1992, when Paxil was first approved by the FDA, GSK has defrauded
the medical profession in general, Plaintiffs' and their physicians in particular, and the
Paxil patient population in general, in that
it, among other acts:
(a) Knowingly mischaracterized and miscoded withdrawal syndrome occurring during the
clinical trials so as to reduce the number of recorded occurrences of withdrawal
reactions;
(b) Failed to inform the medical community that a significant number of individuals taking
Paxil during foreign clinical trials experienced withdrawal reactions and
dependency/withdrawal syndrome;
(c) Knowingly misrepresented and continues to misrepresent that its clinical trials and
investigations adequately tested for dependency withdrawal syndrome;
(d) Knowingly claimed that Paxil's withdrawal problems were a relapse, when in fact they
were not;
(e) Actively deceived Plaintiffs and class members by representations in written labeling
and oral communications suggesting that Paxil is not addictive, that it does not cause
physical or psychologic dependency, and
that it would not cause withdrawal reactions if dosage were reduced or terminated.
(f) Answering the question: "Is Paxil addictive?" with the response: "Paxil has been
studied both in short- and long-term use and is not associated with dependence or
addiction."
(g) Implementing false and misleading techniques to hide the linkage between
dependency/withdrawal syndrome on one hand, and Paxil on the other. After censoring
the word "withdrawal" from company files and
instructing its agents similarly, defendant GSK, began to dilute the medical vocabulary by
using misleading medical terms to substitute for withdrawal such as "discontinuation
syndrome."
(h) Over-promoting Paxil in order to increase its sale at the expense of revealing the
truth about the addictive/dependency nature of Paxil.
(i) Fraudulently conveyed to all health care providers in the U.S. that Paxil's side effects
were only "mild," when in fact GSK knew many of the drug's withdrawal side effects were
severe.
(j) Fraudulently conveyed to all health care providers in the U.S. that a British study
involving 13,741 patients illustrated that all of the SSRI's exhibited a similar rate of
withdrawal, when in fact GSK knew that study
illustrated Paxil to have the highest rate of withdrawal among SSRI's as recorded and
reported by the authors.
1. As a result of GSK's fraudulent acts and omissions as set forth herein, GSK has
deceived the medical community, including Plaintiffs' physicians, into believing Paxil does
not have the addictive qualities and does not cause dependency/withdrawal syndrome
which defendant GSK knows it in fact does.
2. When said representations were made by defendant GSK, it knew those
representations to be false, or in the alternative, willfully and wantonly and recklessly
disregarded whether the representations were true. These representations were made by
GSK, with the intent of defrauding and deceiving the public in general and the medical
community and to induce the medical community to recommend, prescribe, and dispense
Paxil and for the public to take it.
3. At the time the aforesaid representations were made by the defendant GSK, and at
the time that Plaintiffs ingested Paxil, both Plaintiffs and their prescribing physicians were
unaware of the falsity of said representations and reasonably relied on GSK's assertions,
promulgated through its
aggressive sales force to Plaintiffs' physicians as set forth herein, that the
drug was safe. In reliance upon said representations, Plaintiffs' physicians
did prescribe Paxil and Plaintiffs were induced to and did take Paxil. Had
Plaintiffs known of the actual dangers of Paxil, through their physicians or otherwise,
they would not have ingested Paxil.
4. GSK's motive of deliberately failing to advise physicians and the public of the adverse
effects that can lead to withdrawal problems (and that it knew a percentage of users of
the drug inevitably would experience) was for financial gain and its fear that, if properly
labeled, GSK would lose its share of the SSRI market through the efforts of competing
manufacturers who would adversely compare Paxil's half-life to their own. GSK's goal, at
the expense of those who took its antidepressant, was for Paxil to
become the dominant SSRI on the market.
5. At all times relevant herein, the conduct of defendant GSK, as set forth herein above,
was malicious, fraudulent and oppressive toward Plaintiffs and the public generally. GSK
conducted itself in a willful, wanton and
reckless manner as set forth herein above. Despite its specific knowledge as set forth
above, defendant GSK deliberately recommended, manufactured, produced, marketed,
sold, distributed, merchandized,
packaged, promoted and advertised the dangerous and defective drug Paxil. All of the
foregoing constitute an utter, wanton and conscious disregard of the rights and safety of
a large segment of the public, and by
reason thereof, defendant GSK, is guilty of reckless, willful and wanton acts and
omissions which evidence a total and conscious disregard for the safety of Plaintiffs and
class members.
6. As a proximate cause of defendant GSK's fraudulent and deceitful conduct and
representations and due to Paxil's addictive qualities, inducement of physical and
psychological dependency, and inducement of
dependency/withdrawal syndrome, all Plaintiffs and class members unexpectedly suffered
prolonged physical and mental anguish, harm, and suffering and have sustained damages
and other losses in an amount to be proven at trial.
Second Claim for Relief for Negligence
7. GSK owed Plaintiffs and class members a standard of care to ensure that they and
their physicians were adequately warned of Paxil's addictive qualities and
dependency/withdrawal characteristics before any were prescribed the drug. GSK
violated that standard of care through active
misrepresentations and failure to warn when it was GSK's duty to do so.
See complaint for more.
Third Claim for Relief for Strict Liability per § 402 Restatement (Torts)
8. At all times herein mentioned, defendants knew or should have known that Paxil was
and is addictive and causes withdrawal syndrome.
9. At all times hereinafter mentioned, neither members of the general medical community
nor members of the general public knew of the withdrawal dangers existing with respect
to the administration of Paxil.
10. Paxil was used by Plaintiffs and class members in the manner and amounts in which
the defendants intended it to be used.
11. At all times material hereto, in the United States, Paxil was not properly labeled by
defendants; in fact it was mislabeled and was not accompanied by proper warnings that
Paxil can cause withdrawal reactions and dependency/withdrawal syndrome.
12. Defendants promoted and maintained Paxil on the market both to physicians and
directly to patients/consumers with the knowledge of
Paxil's unreasonable risk to the public in general, and specifically to Plaintiffs and class
members.
13. Paxil, as used by Plaintiffs and class members, was defective and unreasonably
dangerous when sold by defendants, and defendants are strictly liable for the injuries
arising from its manufacture and Plaintiffs and class members' use.
14. As a direct and proximate result of the foregoing, Plaintiffs and class members
sustained damages and other losses according to proof.
Fourth Claim for Relief for Breach of Express Warranty - see complaint for information.
Fifth Claim for Relief for Breach of Implied Warranty - see complaint for information.
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