DOBBS v. WYETH PHARMACEUTICALS — (UNITED STATES DISTRICT COURT)

To view complete transcript click here

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, §

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.

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.

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.

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 ERA, (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.

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 the District of Wyoming. 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. 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 Wyeth1 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
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, THE P HARMACOLOGICAL BASIS 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 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 Wyeth have now complied with this recommendation. Unfortunately, however, this arning 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 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 over-promotion 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.

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 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.

34. Less than five hours later, Terry Dobbs was lying 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.