Summary:



http://justiceseekers.com/html/Complaint.121604.pdf

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF OKLAHOMA
ANNABEL DOBBS, §
Individually and as §
Personal Representative of the §
Estate of TERRY DOBBS, Deceased, §
Plaintiff, §
§
vs. § CIVIL ACTION NO. ________
§
FOREST LABORATORIES, §
WYETH PHARMACEUTICALS, §
Defendants. § JURY TRIAL DEMANDED
COMPLAINT
Now comes Annabel Dobbs, individually and as personal representative of the
Estate of Terry Dobbs, deceased, and files this suit against Defendants Forest
Laboratories and Wyeth Pharmaceuticals, complaining about the personal injuries to,
and wrongful death of, Plaintiff’s husband Terry Dobbs.
Nature of the Case
1. This is an Oklahoma diversity, products liability, personal injury and
wrongful death case arising out of the tragic death of Terry Dobbs on or about
December 30, 2002, in Mustang, Oklahoma. At the time of his death Mr. Dobbs was
under the influence of two powerful, serotonergic, psychotropic drugs, Lexapro and
Effexor, produced and manufactured by Forest Laboratories and Wyeth
Pharmaceuticals, respectively.
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Parties
2. Plaintiff Annabel Dobbs is the widow of Terry Dobbs and personal
representative of his estate. She is a citizen and resident of the State of Oklahoma and
a proper party to assert this claim under the Oklahoma survivor’s statutes and
Wrongful Death Act.
3. Defendant Forest Laboratories is a pharmaceutical company. It is
headquartered in New York, New York. Forest conducts business throughout the
State of Oklahoma and is, thus, amenable to jurisdiction in this state. It designed,
manufactures, and/or markets two forms of the generic compound CITALOPRAM,
both of which are marketed in this country as antidepressants. Forest markets the
stereo-isomer version of this drug under its trade name Celexa and a single isomer
version as LEXAPRO.
4. Defendant Wyeth Pharmaceuticals is a foreign corporation headquartered
in New Jersey. It designed, manufactures and markets a serotonergic, psychoactive
medication called Effexor. Wyeth conducts business throughout the State of
Oklahoma and is, thus, amenable to jurisdiction in this state.
Jurisdiction and Venue
5. Jurisdiction is based on diversity of citizenship. 28 U.S.C. §1332. The
amount in controversy is substantially in excess of Seventy-Five Thousand Dollars
($75,000), exclusive of interest and costs. The actions giving rise to this cause of
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action happened within this District, and both Defendants, Forest and Wyeth,
transacted business and are “found” throughout the State of Oklahoma. Therefore,
venue is permissible in this District pursuant to 28 U.S.C. §1391.
Facts
It has become necessary to file this suit as a result of the following facts.
Serotonin, Suicide and Depression
6. Serotonin, which is commonly identified in scientific literature as “5HT,”
is an important and naturally occurring chemical which is found in the brain and
throughout other parts of the human body. It is one of a number of informational
chemicals in brain called “neurotransmitters.” Among other things, it is widely
believed in the scientific community that this brain chemical is some how and in some
way related to mood. However, it also affects inhibition, self-control, impulse, and
aggressiveness.
7. Some years ago, it was reported from a series of autopsies that people
who had committed suicide seemed to have lower levels of the serotonin metabolite,
5HIAA, in the cerebra spinal fluid than people who had died of other causes. From
this somewhat facile observation, researchers postulated that, if a drug could be
devised which would increase the serotonergic levels in the brain, that it might
enhance mood, and, thereby, reduce depression.
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8. This hypothesis lead to the development of an entire class of drugs called
“selective serotonin reuptake inhibitors” the “SSRI’s” have been marketed in this
country with extraordinary commercial success. The first such drug licensed by the
FDA as an antidepressant was Prozac. It has become a virtual household word in
America.
9. Eli Lilly, the manufacturer of Prozac, and its sister pharmaceutical
companies like Forest Laboratories and Wyeth Pharmaceuticals have marketed the
SSRI drugs as if they were highly selective medicines with rifle-like precision and the
ability to treat a host of maladies with one simple pill. The marketing of these drugs
has capitalized on a popular notion that some undesirable human behavior is caused
by a “chemical imbalance.” However, none of the SSRI manufacturers can tell us
what constitutes a proper chemical
balance of serotonin in the brain. Thus, the truth
is that Lexapro and Effexor and their serotonergic cousins lie somewhere on the
continuum between “magic bullets and snake oil.” Healy,
THE A NTIDEPRESSANT E RA
(Harvard Press, 1998) at p.4.
10. Put another way, Defendants simply do not know exactly how or why its
medications elevate the mood of some individuals, and they have no way to predict
how any given individual will respond -- physically or emotionally -- to these
powerful psychotropic agents. They just know that the drugs work well to a
“statistically significant” degree in a population of depressed patients.
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11. Lilly secured FDA approval to market Prozac as an antidepressant in the
Fall of 1987, and launched the drug into the US market in early 1988. By early 1990,
the potential for Prozac-induced suicidality was raised in the public forum via the
publication of an article by two highly respected Harvard psychiatrists, one of whom
had been a clinical investigator for Prozac. The article, entitled “
Emergence of Intense
Suicidal Preoccupation During Fluoxetine Treatment
,” was coauthored by Drs.
Martin Teicher and Jonathan Cole, along with Nurse Carol Glod, and was published
in volume 147:2 of the American Journal of Psychiatry.
12. In the decade plus since the Teicher & Cole article, the debate about
SSRI-induced suicidality has raged in the scientific literature, the popular media, and
in the courts. For a long time prior to Terry Dobbs’s death it has been evident that
there is a clear association between SSRI drugs and suicidality, and the antecedent
conditions that trigger it. For example, one such antecedent condition is a pernicious
neurological condition called “akathisia.” The association between SSRI drugs and
akathisia, and, thence, from akathisia to suicidality, is so “generally accepted” that it
is even incorporated into the “Bible” of psychiatric diagnoses in this country,
i.e. ,
DSM-IV-TR, §333.99.
13. The watershed moment in the civil justice system came on June 6, 2001,
when an eight-person jury rendered its verdict in the case of
Tobin v. SmithKline
Beecham
, Civil Action No. 00-CV-0025-Bea, in the United States District Court for
1 On August 22, 2003, Wyeth did issue a sua sponte “Dear Doctor” letter, without prior
FDA approval, in which it warned about the association between Effexor and pediatric
suicidality. It did so on the authority of a separate FDA regulation that permits a drug maker to
“add or strengthen” a warning without prior FDA approval.
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the District of Wyoming. The jury found that “Paxil can cause some individuals to
commit suicide and/or homicide.” [Question 1]. It also found SKB at “fault” for
failing to test and to warn. [Question 3]. The
Tobin court found that there was
scientifically reliable, legally admissible evidence linking SSRI drugs to
homicide/suicide and thereby supporting the jury’s verdict, entered judgment, and
then denied SKB’s motion for new trial.
Tobin v. SmithKline Beecham
Pharmaceuticals
, 164 F.Supp.2d 1278 (D.Wy. 2001).
14. These and many other developments occurred before Terry Dobbs’s
death. In light of them, and especially considering the fact that the FDA regulations
(which establish only the “minimum safety standards”) do not require proof of
causality for a warning, but rather, mandate a warning whenever there is an
“association” between a drug and a potentially lethal condition, 21 C.F.R. §201.57(e),
Forest and Wyeth could and should have issued warnings about Lexapro and Effexor.
15. However, neither Forest nor Wyeth ever did so. On information and
belief it is alleged that neither Forest nor Wyeth
1 ever warned on their own about the
association between their drugs and adult suicidality or its antecedent conditions, and
neither ever asked the FDA for permission to warn. Pleading further, on information
and belief, it is alleged that the FDA never told Forest or Wyeth that it could not warn
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about Lexapro or Effexor-induced suicidality, or about any precursor side effect,
including akathisia, disinhibition or emotional lability, sleep disturbances, mania,
hypomania or psychosis or threatened it with any legal proceedings if it did so warn.
16. Lexapro is a powerful psychoactive drug in the same “SSRI” class as
Prozac, Paxil, and Zoloft. Effexor is also a powerful, mind-altering drug which is
specifically designed and marketed to alter a person’s serotonin system. Although
some industry standard sources, e.g., Goodman & Gilman, T
HE P HARMACOLOGICAL
B ASIS OF T HERAPEUTICS (10 Ed., 2001, Table 19-1) th treat Effexor as a member of the
class of drugs commonly called Selective Serotonin Reuptake Inhibitors [SSRI’s],
Wyeth itself attempts to differentiate Effexor, calling it an “SNRI,” which stands for
Serotonin & Norepinephrine Reuptake Inhibitor. In any event, however, the principal
mode of action for Effexor is inhibition of the reuptake of serotonin. For years it has
been known that serotonin functioning is directly related to aggression and violence,
both directed at oneself and at others.
17. Lexapro and Effexor may help some of the patients who take them.
Unfortunately, however, there is a “small vulnerable subpopulation” of patients who
are at an increased risk of violence and suicide as a result of taking Effexor, Lexapro,
and other SSRI drugs.
18. Forest and Wyeth have known about this small vulnerable subpopulation
for years. And, yet, they have failed to conduct any prospective tests to determine the
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frequency of this phenomenon or to develop means of identifying, screening, and
protecting those patients who are in this risk group. One or both of them have also
utilized material misrepresentations to promote and market their drugs,
inter alia via
the practice of “ghost writing” scientific articles for publication under the names of
prominent academic “authors.” And, perhaps most importantly, both Forest and
Wyeth have also failed to warn prescribing physicians, pharmacists, and patients
about this risk or to instruct them on the known ways to reduce or ameliorate the risk.
19. To be more precise, Wyeth failed to warn totally until August 22, 2003,
when it invoked the authority of 21 C.F.R. §314.70 to promulgate, without FDA prior
approval, a warning about Effexor induced suicidality for children and adolescents.
It did so because of the increased risk of violence and suicide. However, even on
August 22 , the “warning” did not encompass
nd adults, who, like children and
adolescents, are also at an increased risk of these lethal side effects.
20. On March 22, 2004, the FDA itself finally realized that the association
between these serotonergic medications and suicidality was important enough to merit
a warning. It issued a “Public Health Advisory” in which it “recommended,” among
other things, that Forest issue a warning about this association viz. a viz. both of its
CITALOPRAM drugs, i.e., Celexa and Lexapro, and that Wyeth issue a similar
warning about the association between Effexor and adult suicidality. Both Forest and
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Wyeth have now complied with this recommendation. Unfortunately, however, this
warning was “too little/too late” for the Dobbs family.
21. Subsequently, on October 15, 2004, based on its finding that “causality
has been established” between SSRI drugs and pediatric suicidality, the FDA has
ordered Forest and Wyeth to put
BLACK BOX WARNINGS
about Lexapro and Effexor-induced suicidality in the pediatric and adolescent
population on the Lexapro and Effexor labels.
22. Separate and apart from the minimum standards of the FDA regulations,
Oklahoma law requires drug makers like Forest and Wyeth to act reasonably and
responsibly, and holds them legally accountable if they fail to do so. Both Forest and
Wyeth could, and should, have taken affirmative steps to warn doctors, pharmacists,
and patients about the association between suicidality and its precursor conditions
long, long before the FDA made it do so. There are many means that they could have
employed to educate people about this risk. One, of course, is via a formal change in
the label or “prescribing information.” As noted above, the FDA regulations
specifically permit a company to “add or strengthen” a warning without waiting for
FDA approval. Another would have been to do what Wyeth did on August 22, 2003,
when it issued a “Dear Doctor” letter to physicians in this country about the increased
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risk of suicidality for children and adolescents on the serotonergic drug Effexor. Yet
another would be via personal advice from its sales staff.
23. There are undoubtedly many other ways that Forest and Wyeth could
have “gotten the word out.” That would have been the reasonable and responsible
thing to do. That, with respect, is what the Oklahoma law requires.
24. But that course of action would have been bad for business. Prozac has
now gone generic, and both Paxil and Zoloft are facing “generic intrusion” in the near
future. That has created a market opportunity for Forest and for Wyeth. In order to
penetrate this lucrative market, Forest has promoted and over-promoted both Celexa
and Lexapro, and Wyeth has done the same with Effexor. They have made material
misrepresentations about the safety of these drugs, and have totally failed to warn
about the increased risk of suicide. On information and belief, its overpromotion
activities include massive “direct-to-consumer” advertising. Legally, its duty to warn
is commensurate with such advertising.
25. In addition to misrepresentations and failure to warn, Forest and Wyeth
have also failed to test or investigate. Neither of them have conducted any
prospective, double-blind studies designed to determine causation (one way or the
other) or to measure the incidence rate of this phenomenon, and neither has
adequately investigated the instance of suicidality of patients taking Celexa or
Lexapro or Effexor.
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26. It is against this backdrop of events that the Court and Jury must consider
the untimely death of Terry Dobbs.
A Word about FDA Regulatory Requirements
27. Forest and Wyeth have failed to comply with the FDA’s warning
requirements. Specifically, they failed to issue a warning about the increased risk of
suicidality and its precursor conditions, as required by 21 C.R.R. §201.57. This
violation of FDA regulations constitutes negligence
per se under Oklahoma law.
28. Additionally, on information and belief, it is alleged that both Forest and
Wyeth, before and after it manufactured the particular batch of Lexapro and Effexor
that killed Terry Dobbs, withheld from or misrepresented to the FDA required
information that was material and relevant to the performance of the drug and was
causally related to Terry Dobbs’s injuries and death.
29. Under these circumstances, neither Forest nor Wyeth may hide behind
FDA regulation, and the FDA’s belated actions or earlier inactions with regard to
Lexapro and Effexor and suicidality, even with regard to the failure to warn theory.
The Wrongful Death of Terry Dobbs
30. “I’d never do that to you. I can’t think of a worse thing to do to your
family.” These were the words spoken by 53-year-old Terry Dobbs when his wife
Annabel discussed suicide with him two days before his death. Less than forty-eight
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hours later, Terry got out of bed at four o’clock in the morning, got his shotgun, put
the barrel in his mouth and pulled the trigger.
31. Early in December of 2002, Terry had been anxious about the specter of
being laid off from his job at Lucent Technologies. Even though he had already
received an offer from another company, Terry was concerned about the financial
impact of the impending layoff.
32. Because of his job situation, Terry Dobbs was having difficulty
concentrating and decided to see his doctor. His regular physician’s partner, a family
practice physician, prescribed the anti-depressant Lexapro for Terry’s anxiety. It
didn’t help. Actually, it made things worse.
Much worse. He could barely function
at work and couldn’t sleep at home. After taking the Lexapro for eighteen days, Terry
went back to the prescribing doctor and reported that he was now having more
problems on the drug than he’d ever experienced without it. His doctor stopped his
Lexapro, made him take a one day break from any medication, and then started him
on Effexor, another serotonergic anti-depressant.
33. Six days later, Annabel noticed that Terry was uneasy, restless, fidgeting
and shaking. She made him a bowl of soup, but had to feed it to him as his hands
were shaking so badly. Concerned about what seemed to be a deteriorating condition,
Annabel questioned her husband about his nervousness and anxiety. Terry tried to
reassure her, stating that he was fine and would be all right.
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34. Less than five hours later, Terry Dobbs was laying dead on his bedroom
floor, the victim of a violent, impulsive suicide.
35. Terry Dobbs did to his family what he promised he’d never do: he broke
their hearts. His death was sudden, violent and totally out of character for a man who
had been a rock of stability.
36. After eighteen days of Lexapro and six days of Effexor, just two weeks
before his twenty-sixth wedding anniversary, this husband, father of three and
grandfather could no longer keep his promise. His death by violent means fits the
pattern of suicidality which Teicher & Cole had described years earlier.
Legal Theories and Causes of Action
All of these facts are cognizable under several well-recognized theories of law
in Oklahoma as follows:
37. FIRST: Defendants Forest Laboratories and Wyeth Pharmaceuticals are
strictly liable for designing and manufacturing a defective product and for marketing
it with inadequate and/or legally defective labeling and via material
misrepresentations. Restatement (Second) of Torts, §§402A and 402B, and the new
Restatement (Third).
38. SECOND: Defendants are liable because Lexapro and Effexor were
defective and potentially harmful to its consumers/users, including Plaintiff’s
husband, and because adequate warnings were not provided with the product or after
2 Moreover, she notes that “[t]he reviewing court has no right to place limitations on
amounts of damages returned by the jury unless it is convinced an amount of recovery bears no
relation whatever to evidence, or that it was induced by bias or prejudiced on part of the jury.”
Cartwright v. Atlas Chemical Industries, Inc., 593 P.2d 104 (Okla. Ct. App. 1978).
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manufacture, and as such was unsafe to an extent beyond that contemplated by an
ordinary user and consumer.
39. THIRD: Defendants’ conduct is unreasonable, or negligent, and was a
proximate cause of Plaintiff’s decedent’s injuries and death. The manufacturer was
negligent for failing to warn, failing to test or otherwise to investigate the association
between both Lexapro and Effexor and suicidality and their precursor conditions,
including akathisia, and for misrepresenting and over-promoting both drugs.
40. Under the Oklahoma “heeding presumption” case law, there is a
rebuttable presumption that Terry’s doctor would have heeded a legally adequate
warning from the drug manufacturers. Consequently, in law and in fact, Forest’s and
Wyeth’s tortious conduct was a legal cause of Terry’s injuries and death.
Damages and Remedies
41. This suit is brought, inter alia, pursuant to the Oklahoma Wrongful Death
Act, Okla. Stat. Ann. tit. 12. §1053, for the exclusive benefit of Terry’s widow and his
child. Plaintiff seeks all damages permitted under this statute and the case law
construing it.
2
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42. Additionally, suit is brought under the Oklahoma Survival Statute, Okla.
Stat. Ann. tit. 12 § 1051, to recover damages for the enormous pain and anguish
which Terry himself must have endured prior to his death.
43. The amount of damages is alleged to be in the millions of dollars, and
will be particularized upon request.
44. Plaintiff is also entitled to recover prejudgment interest and costs of
court.
Jury Demand
45. Plaintiff hereby invokes her constitutional right to trial by jury.
WHEREFORE, Plaintiff prays that Defendants, Forest Laboratories and Wyeth
Pharmaceuticals, be cited to appear and answer herein, and that, after a trial, she
receives such monetary damages and other relief, including all other general and
special damages allowable by law, as are appropriate under the law and the facts.
DATED this _____ day of December 2004.
Respectfully submitted,
U B R TON & GOODMAN
_______________________
Ms. Tia Goodman
Okla Bar Number 19664
500 North Walker
Suite B
Oklahoma City, Oklahoma 73102
(405) 236-2221
Email:
tg@burtongoodmanlaw.com
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OF COUNSEL:
V
ICKERY & WALDNER , LLP
Paul Waldner
Texas State Bar No. 20679800
One Riverway Drive, Suite 1150
Houston, TX 77056-1920
Telephone: 713-526-1100
Facsimile: 713-523-5939
Email:
paul@justiceseekers.com
(Admission pro hac to be sought)