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GlaxoSmithKline statement - BBC Panorama - 29 January 2007

Filed under: GLAXO — at 9:37 am on Tuesday, January 30, 2007

This statement has been issued following the BBC Panorama programme, ‘Secrets of The Drugs Trials’ which was aired on Monday 29th January.

GlaxoSmithKline (GSK) provided a written response to the allegations made in the above programme. GSK strongly denies suggestions that it has acted in any way improperly and wishes to make the following points:

· We are extremely concerned that as a result of the programme patients will be anxious about using their anti-depressant medication.

· Patients concerned by issues raised in the programme should seek advice from their doctor.

· Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide. Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

· In developing Seroxat , GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty. GSK conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, as treatment options for these vulnerable patients are extremely limited.

· GSK utterly rejects any suggestion that it has improperly withheld drug trial information. Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK’s website.

· No suicides were reported in any of the nine paediatric trials conducted by GSK. When reviewed individually, none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide. Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat . GSK brought this analysis to the attention of the regulatory authorities, including in the UK.

· GSK does not promote its medicines for indications for which they are not approved.The company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation, whether through clinical experts (“Key Opinion Leaders”) or any other route.

· Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age. GSK’s UK product labelling has been entirely consistent with that position, and at the time of the events in question, this label stated: “the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.” Any decision to prescribe a medicine outside its authorised indications, in the EU or the US, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient.

· GSK, in 2004, further demonstrated its commitment to data transparency by creating an unsurpassed on-line database, called the Clinical Trial Register (CTR). This is a record of detailed summaries of more than 2,800 clinical trials conducted in 50 countries to study 52 GSK prescription medicines and vaccines which is available to the public at http://ctr.gsk.co.uk

Yes.. but you took your time didn’t you…. 

PAMELA BLAIN, et al. v SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE

Filed under: Seroxat Claims, GLAXO, Courts — at 11:00 pm on Monday, January 29, 2007

PAMELA BLAIN, et al.
v.
SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE
CIVIL ACTION No. 06-1247

United States District Court, E.D. Pennsylvania.

January 25, 2007

MEMORANDUM OPINION

Savage, J.

In moving to certify this product liability action against the manufacturer
of the antidepressant drug Paxil as a national class action, the plaintiffs
seek to represent all persons whose children under age eighteen committed or
attempted to commit suicide while using the drug. The gist of the plaintiffs’
claims is that despite its specific knowledge of Paxil’s association with the
increased risk of suicidality in pediatric patients, the defendant
GlaxoSmithKline (”GSK”) failed to warn doctors, the medical community and the
public of this danger. [FN1] The plaintiffs seek a class trial on three
issues relating to liability: (1) whether Paxil can cause suicidality in
pediatric patients; (2) whether GSK knew or should have known that it can;
and (3) whether GSK failed to adequately warn of the danger. Opposing
certification, GSK argues that the plaintiffs cannot satisfy the commonality,
typicality and adequacy requirements of a class action under Federal Rule of
Civil Procedure 23(a), nor can they establish the predominance and superiority
elements of Rule 23(b)(3).

FN1. They assert claims of wrongful death/negligence (count I);
negligent pharmaco vigilance (count II); strict liability (count III);
breach of express warranty (count IV); fraud (count V); survival
(count VI); negligent infliction of emotional distress (count VII);
loss of consortium and loss of income (count VIII).

A class action is not an appropriate vehicle for litigating the issues in
this case. The plaintiffs fail to meet the typicality and adequacy prongs of
Rule 23(a). Typicality is wanting because the individual circumstances of the
named plaintiffs are markedly different from those of the putative class
members and GSK can raise unique defenses to almost each class member’s claim.
These same differences result in interests so divergent that the named
plaintiffs are inadequate representatives of the absent class members.
Finally, the predominance and superiority requirements of Rule 23(b)(3) are
lacking–predominance because the proposed common issues are overwhelmed by
the differences among the factual and legal issues affecting individual
causation, damages and defenses; and, superiority because the proposed class
would be unmanageable in light of the choice-of-law conflicts that are
resolved in favor of each individual’s home state. In essence, the plaintiffs
have failed to define a class capable of ascertaining membership without
individualized fact-finding. Therefore, the motion for certification will be
denied.

I. Background
Paxil [FN2] was first approved for sale in the United States in December of
1992 for the safe and effective treatment of depression in adults. [FN3] By
the early 2000s, the FDA expanded approval to include treatment of obsessive
compulsive disorder, social anxiety disorder and generalized anxiety disorder
in adults; and, it approved a new controlled-release formulation, called
Paxil CR, to treat depression. [FN4] Paxil has never been approved for
treatment of any condition in children. [FN5] Nonetheless, physicians may
prescribe Paxil “off-label” [FN6] for an “unapproved” population, such as
children or adolescents, without FDA knowledge or approval. [FN7] Since 1997,
drug manufacturers have been permitted to disseminate information about
“off-label” uses for their drugs generated by independent sources, including
medical journal articles, textbooks and participation in medical conferences.
The manufacturer must disclose both its interest in the drug and the fact that
the use has not been approved by the FDA. The information must not be false or
misleading. See 21 U.S.C.

360aaa (2006); Wash. Legal
Found. v. Henney, 128 F.Supp.2d 11 (D.D.C.2000).

FN2. Paxil is a member of the class of drugs called Selective Serotonin
Re-uptake Inhibitors (”SSRIs”), which is a type of antidepressant.
Joint Stipulation of Uncontested Facts (”Jt.Stip.”)

1.
Zoloft and Prozac are examples of other SSRIs. Plaintiffs’ Memorandum
of Law in Support of Plaintiffs’ Motion for Class Certification (”Pls.’
Mem.”) at 3.

FN3. Jt. Stip.

1-2.

FN4. Id.

5-7.

FN5. Id.

11.

FN6. The term “off-label” refers to the use, prescription or marketing
of an FDA-approved drug for an unapproved use, such as, in an unapproved
population, or for a condition other than for what it has been approved.
Steven R. Salbu, Off-Label Use, Prescription and Marketing of
FDA-Approved Drugs: An Assessment of Legislative and Regulatory Policy,
51 Fla. L.Rev. 181, 188-89 (1999).

FN7. Jt. Stip.

12-13.

From 1992 through 2004, the “PRECAUTIONS” section in the Paxil prescribing
information, in relevant part, stated: “Safety and effectiveness in children
have not been established.” [FN8] On October 15, 2004, after the FDA
completed a review of pediatric clinical data for all SSRIs and other
antidepressants, it required all manufacturers of SSRIs to include on the drug
label the following “Black Box” warning:

FN8. Id.

3, 8, 9.

Antidepressants increased the risk of suicidal thinking and behavior
(suicidality) in short-term studies in children and adolescents with Major
Depressive Disorder (MDD) and other psychiatric disorders. Anyone
considering the use of PAXIL or any other antidepressant in a child or
adolescent must balance this risk with the clinical need. Patients who are
started on therapy should be observed closely for clinical worsening,
suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation
and communication with the prescriber. PAXIL is not approved for use in
pediatric patients. (See WARNINGS and PRECAUTIONS–Pediatric use.)
Pooled analysis of short-term (4 to 16 weeks) placebo-controlled trials of 9
antidepressant drugs (SSRIs and others) in children and adolescents with
major depressive disorder (MDD), obsessive compulsive disorder (OCD), or
other psychiatric disorders (a total of 24 trials involving over 4,400
patients) have revealed a greater risk of adverse events representing
suicidal thinking or behavior (suicidality) during the first few months of
treatment in those receiving antidepressants. The average risk of such
events in patients receiving antidepressants was 4%, twice the placebo risk
of 2%. No suicides occurred in these trials. [FN9]

FN9. Id.

10.

Beginning in January of 2005, defendant GSK complied with this FDA directive
and updated its label accordingly. [FN10]

FN10. Id.

The plaintiffs allege that between 1998 and 2001, GSK conducted at least
three placebo-controlled studies of Paxil for pediatric depression which
showed that the drug is ineffective in the treatment of pediatric depression
and is associated with a high increased risk of suicidal events. The
plaintiffs claim that “as [the results of] these studies became known to GSK,
the company reacted by seeking to hide the data from the public,” and failed
to “publish its analysis of the suicidality risk associated with the pediatric
use of Paxil until 2006.” [FN11] In addition, the plaintiffs assert that
despite these studies showing that Paxil was neither safe nor effective in the
treatment of pediatric depression, GSK began a marketing campaign to promote
Paxil as safe and effective for such treatment. [FN12] GSK’s promotion of
Paxil for an off-label use, according to the plaintiffs, was false, misleading
and not based upon independently developed data.

FN11. Pls.’ Mem. at 10, 13.

FN12. Id. at 14. The promotional methods GSK allegedly used include
physician education, ghost-writing a purportedly “independent” medical
journal article, and sponsoring lectures and posters. Id. at 15-19.

II. Proposed Class Definition
The plaintiffs are moving for certification of the following class:
All persons (or if such person is deceased or under the age of majority, that
person’s legal representative) in the United States who committed suicide,
attempted to commit suicide, or engaged in other self-injurious behavior
while under the influence of the prescription drug Paxil and who were under
the age of 18 at the time of the person’s suicide, attempted suicide, or
self-injurious act at any time after December 29, 1992. [FN13]

FN13. Compl.

33.

III. Legal Standards for Class Certification
To be certified, a class must satisfy all four requirements of Rule 23(a) and
must fit one of the provisions of Rule 23(b). The plaintiffs must demonstrate
that: (1) the size of the class is so numerous that joinder of all members is
impracticable; (2) there are questions of law and fact common to the class;
(3) the claims or defenses are typical of the class; and (4) the
representatives will fairly and adequately protect the interests of the class.
Fed.R.Civ.P. 23(a)(1)-(4). Additionally, the proposed class action must be
one of the types recognized by Rule 23(b). Here, plaintiffs have moved for
certification only under subsection (b)(3), which requires a finding that
common questions of law or fact predominate over questions affecting only
individual class members, and that a “class action is superior to other
available methods for the fair and efficient adjudication of the controversy.”
Fed.R.Civ.P. 23(b)(3).

The burden is on the plaintiffs to demonstrate that a class should be
certified. Johnston v. HBO Film Mgmt., Inc., 265 F.3d 178, 183 (3d Cir.2001);
Baby Neal v. Casey, 43 F.3d 48, 55 (3d Cir.1994). Though the plaintiffs need
not establish the merits of their case at the class certification stage and
the substantive allegations of the complaint must be taken as true, Chiang v.
Veneman, 385 F.3d 256, 262 (3d Cir.2004) (citing Eisen v. Carlisle &
Jacquelin, 417 U.S. 156, 177-78 (1974)), the court must conduct a rigorous
analysis to determine the suitability of resolving the issues in a class
action. Because certification and the merits are intertwined, this analysis
necessitates a factual inquiry. Beck v. Maximus, Inc., 457 F.3d 291, 297 (3d
Cir.2006) (citing Newton, Merrill Lynch, Fenner & Smith, Inc., 259 F.3d 154,
167 (3d Cir.2001)). As the United States Supreme Court recognized in Coopers
& Lybrand v. Livesay, 437 U.S. 463 (197:
Evaluation of many of the questions entering into determination of class
action questions is intimately involved with the merits of the claims. The
typicality of the representative’s claims or defenses, the adequacy of the
representative, and the presence of common questions of law or fact are
obvious examples. The more complex determinations required in Rule 23(b)(3)
class actions entail even greater entanglement with the merits.
Id. at 469 n.12 (quoting 15A Charles Alan Wright et al., Federal Practice &
Procedure

3911, at 485 n.45). Nonetheless, the court may not
determine the merits of the plaintiff’s case. Eisen, 417 U.S. at 177-78.
Thus, we must look beyond the complaint and consider the substantive elements
of the plaintiffs’ cases. See Newton, 259 F.3d at 166. [FN14]

FN14. The parties conducted limited factual discovery to develop a
context for evaluating their respective positions on certification. See
Order, Civ. A. No. 06-1247 (June 21, 2006) (Doc. No. 39).

IV. Sufficiency of the Class Definition
Some courts have focused on the sufficiency of the class definition itself
before embarking on an analysis of the Rule 23(a) requirements. They have
refused to certify classes where a determination of the merits of each
individual’s claims would have been necessary to determine class membership.
Kline v. Sec. Guards, Inc., 196 F.R.D. 261, 267-68 (E.D.Pa.2000); Forman v.
Data Transfer, Inc., 164 F.R.D. 400, 403 (E.D.Pa.1995); Black v. Premier Co.,
No. Civ. A. 01-4317, 2002 WL 32122658, at *5 (E.D.Pa. Sept. 13, 2002)
(Baylson, J.).

Because the same considerations in evaluating the sufficiency of the class
definition are implicated in the commonality, typicality and adequacy of
representation analyses, and courts are charged with analyzing all of the Rule
23(a) factors anyway, the sufficiency of the class definition can be assessed
in the context of the Rule 23(a) analysis without engaging in a redundant
exercise.

Suffice to say at this point that the proposed definition cannot work as a
vehicle for a class action. The reasons why the class definition in this case
does not pass the test are detailed in the following discussion of the Rule
23(a) requirements.

V. The Four Requirements of Rule 23(a)
A. Numerosity

GSK does not challenge numerosity. There are presently fifty-six people that
are potential members of the putative class. In addition, based on GSK’s own
clinical trial data and statistical analysis, [FN15] the plaintiffs estimate
that there are potentially 7,000 children who committed or attempted suicide
while taking Paxil each year during the class period. [FN16] Thus, the
numerosity requirement is satisfied.

FN15. GSK’s analysis of the Paxil clinical trial data found a 3.4% rate
of a “suicide event” for pediatric patients taking Paxil. Pls.’ Mem. at
27 (citing Alan Apter, M.D., et al., Evaluation of Suicidal Thoughts and
Behaviors in Children and Adolescents Taking Paroxetine, 16 J. Child &
Adolesc. Psychopharm. 77 (2006)).

FN16. Pls.’ Mem. at 27-28.

B. Commonality

Commonality requires that the plaintiffs share a question of law or fact with
the prospective class members. The commonality threshold is low. So long as
the named plaintiffs share at least one question of fact or law with the
grievances of the prospective class, the existence of individual facts and
circumstances will not defeat commonality. Baby Neal, 43 F.3d at 56.

The plaintiffs propose three questions they contend are common to all members
of the putative class:
1. Whether Paxil can cause a pediatric patient to develop suicidality
(”General Causation”);
2. Whether, and when, GSK knew or should have known that Paxil is associated
with suicidality in pediatric patients (GSK’s Knowledge”); and
3. Whether Paxil’s label, promotion, and advertising were adequate during the
class period to apprise the medical community of Paxil’s true risks (”Failure
to Warn Claim”). [FN17]

FN17. The plaintiffs have abandoned most of the common questions they
had proposed for certification in their complaint. See Compl.

37(a)–(m); Pls.’ Mem. at 1.

1. General causation

The plaintiffs contend that there are two separate causation inquiries: can
Paxil cause suicide or suicidality, and did Paxil cause the suicide or
suicidality in the particular plaintiff. [FN18] They propose that the first
issue, general causation, be decided on a class wide basis, leaving specific
causation to be determined at each individual’s trial.

FN18. Pls.’ Reply Mem. at 4.

The two parts of the causation issue cannot be separated. Answering the
question whether Paxil can cause suicidality in pediatric patients is only the
starting point in the causation inquiry. The answer to the first part reveals
only who are potential members of the class. It is the answer to the second
part, that is, who suffered harm as a result of the drug, that defines the
class. Thus, whether the drug did cause the individual plaintiff’s
suicidality is the determinative question for class membership.

The answer to the specific causation question depends upon a number of
individualistic factors, such as: the patient’s diagnosis; the dosage taken;
the duration of treatment; the patient’s age and physical characteristics;
the patient’s family, mental and medical histories; and whether the patient
previously suffered from suicidality. Such a plaintiff-specific analysis
dominates the causation inquiry. [FN19] Thus, causation does not provide a
common question.

FN19. In mass tort cases, courts have routinely refused to certify
common questions of general causation. See, e.g., In re “Agent Orange”
Prod. Liab. Litig., 818 F.2d 145, 164-65 (2d Cir.1987); Dalkon Shield
IUD Prods. Liab. Litig. v. A.H. Robins, Co., 693 F.2d 847, 853 (9th
Cir.1982); In re Prempro Prods. Liab. Litig., 230 F.R.D. 555, 570
(E.D.Ark.2005); In re Paxil Litig., 212 F.R.D. 539, 546-47
(C.D.Cal.2003); Neenan v. Carnival Corp., 199 F.R.D. 372, 376-77
(S.D.Fla.2001); Emig v. Am. Tobacco Co., 184 F.R.D. 379, 390
(D.Kan.199; Barnes v. Am. Tobacco Co., 176 F.R.D. 479, 500-01
(E.D.Pa.1997); Arch v. Am. Tobacco Co., 175 F.R.D. 469, 488
(E.D.Pa.1997); Kurczi v. Eli Lilly & Co., 160 F.R.D. 667, 677 (N.D.Ohio
1995).

2. GSK’s knowledge

Whether and when GSK knew or should have known that Paxil is associated with
suicidality in pediatric patients is common to the putative class. The
individual facts of each member’s case, no matter how different, do not affect
what and when GSK learned about the incidence of pediatric suicidality and
Paxil. [FN20] Therefore, because the determination of GSK’s knowledge
requires no individual proof and will apply to all members, it is a question
common to the class. [FN21]

FN20. Pls.’ Reply Mem. at 5.

FN21. Pls.’ Mem. at 29.

GSK argues that what GSK knew about Paxil and pediatric patients changed over
time because the science was evolving; and, as a result, what duty it had and
what was an adequate warning changed. [FN22] Consequently, according to GSK,
to determine the adequacy of a warning when each member’s cause of action
accrued would entail a varying inquiry. [FN23]

FN22. Tr. of oral argument on Pls.’ Mot. for Class Certification, Nov.
15, 2006 (”Hr’g Tr.”) at 48-49.

FN23. GSK’s Brief in Opposition to Plaintiffs’ Motion for Class
Certification (”GSK’s Mem.”) at 30-32.

The question of what knowledge GSK had regarding Paxil’s association with
suicidality in pediatric patients and when it had the knowledge are common
questions for the class. If the substance of the warning changed over the
years in response to changing knowledge, the differences could be accounted
for by defining subclasses corresponding to the relevant periods. Therefore,
contrary to GSK’s assertion, individual adjudications would not be necessary
to ascertain what GSK knew and when.

3. Failure to warn

Plaintiffs argue that the jury’s findings on the failure to warn issue will
be common to all members of the class because:
A jury can compare what GSK said regarding pediatric suicidality in Paxil’s
label, advertising and promotion with what GSK knew about pediatric
suicidality. A jury may find that GSK adequately warned of this risk at all
times through the class period or that at a certain time, Paxil’s warning
became adequate after previously being inadequate … The common finding may
effect [sic] class members in different ways depending on when a class member
may have been prescribed Paxil or whether a class member’s doctor was already
aware of the information. However, the fact that a common liability finding
may affect class members differently does not render the issue individual.
[FN24]

FN24. Pls.’ Reply Mem. at 5-6.

What GSK knew and what it warned are questions common to all. Who was to
receive the warnings and how the warnings were to be given, however, are not
common because they are informed by requirements that vary from state to
state. The adequacy of GSK’s warnings regarding the risk of suicidality in
pediatric patients is governed by different state laws. In jurisdictions
where the learned intermediary doctrine applies, GSK may have no duty to warn
individual users, depending on each individual plaintiff’s physician’s
knowledge of the risks of prescribing Paxil to pediatric patients. In several
jurisdictions, a physician’s decision to use a manufacturer’s device in an
off-label manner does not per se subject the manufacturer to liability, even
if it knows of the off-label use. Davenport v. Medtronic, Inc., 302 F.Supp.2d
419, 439 (E.D.Pa.2004) (dismissing negligence claim based on a manufacturer
“allowing” a physician to use a medical device in an off-label manner when it
knew the FDA had only approved it for a different use); Cox v. Depuy Motech,
Inc., No. 95-CV-3848-L, 2000 WL 1160486, at *8-9 (S.D.Cal. Mar. 29, 2000). In
at least one jurisdiction, the manufacturer has no duty to warn of risks
associated with off-label uses of its drug, making a finding on the adequacy
of a warning irrelevant. See Robak v. Abbott Labs., 797 F.Supp. 475, 476
(D.Md.1992). In other jurisdictions, a manufacturer can be liable for failure
to warn of risks of off-label use of its product if that use accounted for a
significant portion of the manufacturer’s sales of the drug. See, e.g., Miles
Labs., Inc. v. Superior Court, 184 Cal.Rptr. 98, 103 (Cal.Ct.App.1982). In
some jurisdictions, the intervening negligence of a physician precludes the
manufacturer’s liability for failure to warn. See Peterson v. Parke Davis &
Co., 705 P.2d 1001, 1003 (Colo.Ct.App.1985); Reeder v. Hammond, 336 N.W.2d 3,
5-6 (Mich.Ct.App.1983).

Seeking to answer the question of the “adequacy” of GSK’s warnings would
require the application of different legal principles to too many individual
claims. Thus, this issue fails to meet the Rule 23(a)(2) requirement of
commonality.

In sum, the only proposed common issue that meets the commonality prong is
the one regarding GSK’s general knowledge of the risk of suicidality in
pediatric patients. Because the plaintiffs are required to share only one
question of fact or law with the grievances of the prospective class, they
overcome the commonality hurdle of 23(a)(2).

C. Typicality

The typicality prong of Rule 23(a) requires that the claims or defenses of
the plaintiffs are typical of the class. Fed.R.Civ.P. 23(a)(3). Typicality
requires a strong similarity of legal theories to ensure that the class
representatives’ pursuit of their own goals will work to benefit the entire
class. Barnes v. Am. Tobacco Co., 161 F.3d 127, 141 (3d Cir.199; Jones v.
GPU, Inc., 234 F.R.D. 82, 97 (E.D.Pa.2005). It entails an inquiry as to
whether “the named plaintiff’s individual circumstances are markedly different
or the legal theory upon which the claims are based differs from that upon
which the claims of other class members will perforce be based.” Baby Neal,
43 F.3d at 57-58 (quoting Eisenberg v. Gagnon, 766 F.2d 770, 786 (3d Cir.1985)
). Moreover, “[w]here the defendant can raise unique defenses to each
plaintiff’s claim, typicality may not exist if the defenses could threaten to
become the focus of the litigation.” Jones, 234 F.R.D. at 98. At the same
time, “factual differences will not render a claim atypical if the claim
arises from the same event or practice or course of conduct that gives rise to
the claims of the class members, and if it is based on the same legal theory.”
Baby Neal, 43 F.3d at 58 (quoting Hoxworth v. Blinder, Robinson & Co., 980
F.2d 912, 923 (3d Cir.1992)). Unlike the commonality requirement, however,
typicality requires more than just “one unifying factual or legal question.”
In re Paxil, 212 F.R.D. at 550.

An examination of the numerous factual and legal differences between the two
representatives themselves, and among them and the class members reveals how
marked the differences are. These differences overwhelm any similarities,
defying typicality.

The plaintiffs present Pamela Blain as typical of the class of parents who
had a child commit suicide while under the influence of Paxil and who claim
that Paxil was the proximate cause of death. They proffer Tonya Brooks as
typical of the class of plaintiffs who attempted to commit suicide or engaged
in other self-injurious behavior while under the influence of Paxil, which
behavior was proximately caused by taking Paxil.

As alleged in the complaint and the motion for class certification, Pamela
Blain, a Kansas citizen, is the personal representative of the estate of her
son Trevor, who allegedly committed suicide at age eleven after taking Paxil
for thirty-three days. She purports to represent family members who have lost
a child due to a “Paxil-induced” suicide. Trevor, who was eleven years old,
died in December of 2000, two weeks after attempting suicide by hanging.
[FN25] His parents had divorced when he was young, and he had fears and
anxiety about attending school. [FN26] In early 2000, his pediatrician
diagnosed Trevor with separation anxiety and referred him to a psychiatrist.
The doctor’s diagnoses were separation anxiety and depression. [FN27] Several
months later, in October of 2000, the psychiatrist prescribed between 10 and
20 mg/daily of Paxil. [FN28] Soon after he began taking Paxil, Trevor
experienced angry outbursts, insomnia, increased fidgetiness, and a detached
appearance. Approximately one month later, he attempted suicide by hanging in
a laundry room in his home and died two weeks later. [FN29]

FN25. Compl.

42.

FN26. Pls.’ Mem. at 21.

FN27. Id.

FN28. Jt. Stip.

66, 71.

FN29. Pls.’ Mem. at 21-22.

According to GSK, prior to taking Paxil, Trevor was “terrified’ of attending
school, afraid of his father, and highly anxious and depressed. He also had
an extensive family history of mental health issues. Both his parents and his
sister had been prescribed antidepressants for anxiety and depression, and his
sister had attempted suicide. [FN30] GSK also suggests that based on the
police investigation into the cause of Trevor’s death, the episode may have
been an accident or prank, and not an attempted suicide. [FN31]

FN30. GSK’s Mem. at 18-19.

FN31. Id. at 21.

A nurse practitioner working under the supervision of a psychiatrist provided
Trevor with Paxil. The nurse and the doctor had received the Paxil warnings
that were in effect in 2000, and the nurse gave Trevor’s mother a copy of the
package insert. [FN32] Trevor’s mother testified that if she had known Paxil
had not been approved for pediatric patients (which the package label stated
at the time), she would not have allowed her son to take it. Neither the
nurse nor the psychiatrist recalls any GSK representative discussing or
otherwise promoting the use of Paxil in the pediatric population. [FN33]

FN32. Id. at 19-20.

FN33. Id.

Tonya Brooks is a Texas resident who, at age seventeen, attempted suicide
after taking Paxil for 144 days. She seeks to represent those children who
attempted suicide while “under the influence of Paxil.” Tonya was sixteen
years old when she saw a television commercial encouraging people who were
uncomfortable in social settings to talk to their doctor about getting Paxil.
[FN34] Because she felt uncomfortable in large crowds, she asked her family
doctor if Paxil would help. [FN35] After diagnosing her with social anxiety
disorder, her doctor prescribed between 12.5 and 25 mg/daily of Paxil CR.
[FN36] Soon after taking Paxil, Tonya cut her wrist and leg with a razor blade
multiple times, and covered the marks with clothing. She experienced
increased anxiety, anger, agitation, and hostility; and became emotionally
abusive to friends and family. [FN37] Five months later, in June of 2004,
plaintiffs allege that Tonya attempted to commit suicide by swallowing large
amounts of Paxil and Ambien, a prescription sleep aid. Although she survived,
she was in a serious car accident the next day while still “under the
influence of the medication she had taken.” Three days later, Tonya gouged a
three-inch deep hole in her leg. After she ceased taking Paxil, her suicidal
and self-mutilation desires quickly subsided. [FN38]

FN34. Pls.’ Mem. at 22.

FN35. Id.

FN36. Jt. Stip.

67, 72.

FN37. Pls.’ Mem. at 22.

FN38. Id. at 23.

According to GSK, when Tonya was hospitalized for her suicide attempt, she
tested positive for PCP and amphetamines. She told her doctor that she did
not really intend to kill herself but had mistakenly taken too many pills.
[FN39] GSK suggests multiple other possible causes for Tonya’s behavior. It
points to Tonya’s “tumultuous childhood,” her extensive family history of
anxiety, depression and alcohol abuse, and her fear of crowds and panic
attacks. She also may have bipolar disorder, which, GSK asserts, could be the
cause of her behavioral changes that occurred after she started taking Paxil.
[FN40]

FN39. GSK’s Mem. at 14, 18.

FN40. Id. at 15, 16.

Tonya is the only pediatric patient for whom Dr. Lin, her family physician,
ever prescribed Paxil. Before prescribing Paxil for Tonya, Dr. Lin had
received two “Dear Healthcare Provider” letters from GSK about the FDA’s
ongoing analysis of pediatric suicidality data. Accordingly, she was aware
that Paxil was not approved for pediatric use. [FN41]

FN41. Id. at 15-17.

Just as there are between the two plaintiffs, there are numerous critical
factual and legal differences among the putative class members that preclude
typicality. Each class member took varying doses of Paxil, for varying
indications, at various times, at different developmental stages and for
different durations. Each has different medical, psychosocial, and
pharmaceutical histories. The prescribing physicians for each had different
specialities, varying levels of knowledge about Paxil and other SSRIs,
different clinical experience with Paxil and similar medications for pediatric
patients, and varying levels of contact with the patient. Based on these
differences, GSK can potentially raise unique defenses to each plaintiff’s
claim.

Any similarity in legal theories among the named plaintiffs and the proposed
class of plaintiffs is eclipsed by the individualistic defenses GSK can raise
to each plaintiff’s claim. “Where the defendant can raise unique defenses to
each plaintiff’s claim, typicality may not exist if the defenses could
threaten to become the focus of the litigation.” Jones, 234 F.R.D. at 98.
The danger is that the class representatives will be preoccupied with meeting
and defeating those defenses unique to them at the expense of those issues
that they share with the class members, a problem also implicating adequacy.
Therefore, because the individual circumstances of each of the named
plaintiffs are so markedly different from each other and those of the absent
class members, the plaintiffs have failed to meet the typicality requirement.

D. Adequacy of Representation

Rule 23(a)(4) aims to protect the interests of the class. There are two
parts to this test. The first goes to the competency of counsel, and the
second to the plaintiffs’ motivation and ability to protect the interests of
the other class members.

The first part of the adequacy requirement is not at issue. GSK does not
contest counsel’s competency to prosecute a class action. Class counsel have
litigated other class actions, have over a decade of experience with cases
involving SSRIs, and are presently counsel of record in other class actions
involving Paxil. [FN42]

FN42. Pls.’ Mem. at 32-33.

The second prong of the adequacy of representation requirement, which GSK
does challenge, tends to merge with the commonality and typicality
requirements of Rule 23(a). Jones, 234 F.R.D. at 98. As previously
determined, the plaintiffs have failed to meet the typicality requirement.
The same factual and legal differences among the named plaintiffs and the
unnamed class members that defeat typicality render plaintiffs inadequate
representatives of the putative class. The divergent interests and
circumstances will impair the plaintiffs’ ability to adequately protect the
interests of the class members. Therefore, the plaintiffs have failed to
satisfy the second part of the adequacy requirement.

VI. Rule 23(b)(3)–Predominance and Superiority
Meeting the four requirements of 23(a) satisfies only part of the
certification test. The action must also qualify as one of the types of class
actions described in Rule 23(b). In this case, plaintiffs have moved for
certification under subsection (b)(3), which requires that common questions of
law or fact predominate over questions affecting only individual class
members, and that a “class action is superior to other available methods for
the fair and efficient adjudication of the controversy.” Fed.R.Civ.P.
23(b)(3). Thus, the plaintiffs must satisfy both the predominance and the
superiority aspects of Rule 23(b)(3).

In determining whether the action fits within Rule 23(b)(3), the Rule
specifically directs the court to consider the interest of class members in
individually controlling the litigation, the status of ongoing litigation
brought by members of the class, the desirability of concentrating the
litigation in the particular forum, and likely management difficulties.
Fed.R.Civ.P. 23(b)(3)(A)-(D). In the end, it is the interests of the
individual members in controlling their own litigation that drives the
certification decision on predominance. The superiority analysis focuses on
the advantages and disadvantages of using the class-action device in relation
to other litigation methods.

A. Predominance and Rule 23(c)(4)(A)

There are two views of the interplay between the predominance requirement and
subsection 23(c)(4), which provides that: “[w]hen appropriate, an action may
be brought or maintained as a class action with respect to particular issues.”
One is that Rule 23(c)(4)(A) may be used to certify a class regardless of
whether the claim as a whole satisfies Rule 23(b)(3)’s predominance
requirement. See Valentino v. Carter-Wallace, Inc., 97 F.3d 1227, 1234 (9th
Cir.1996). The other view is that only after the predominance requirement of
23(b)(3) is satisfied may common issues be certified pursuant to 23(c)(4).
The latter approach considers Rule 23(c)(4) as a procedural tool to sever
common issues for trial and not as a vehicle to reach certification. Arch v.
Am. Tobacco Co., 175 F.R.D. 469, 496 (E.D.Pa.1997) (quoting Castano v. Am.
Tobacco Co., 84 F.3d 734, 745 n.21 (5th Cir.1996)).

The plaintiffs urge adoption of the former position. They contend that even
if common questions do not predominate over individual questions, the court
may isolate the common issues and perform the predominance evaluation solely
with respect to their proposed common issues. [FN43] I disagree.

FN43. Pls.’ Mem. at 35-36.

The better view is that issue certification under 23(c)(4)(A) does not
obviate the need to evaluate predominance. In other words, a predominance
determination is a prerequisite to certification under Rule 23(b)(3). Indeed,
the 1966 Advisory Committee Notes so instruct, stating that only where
predominance exists can the class action device be used. Fed.R.Civ.P.
23(b)(3) Advisory Committee’s Note. Using subsection 23(c)(4) to certify a
putative class that is otherwise improper for certification would bypass the
23(b)(3) predominance requirement. Castano, 84 F.3d at 745 n.21; Arch, 175
F.R.D. at 496. While some courts have noted that the purpose of Rule 23(c)(4)
is to provide “some flexibility in separating the distinct issues and classes
within the case in order to fashion a case suitable for class action treatment
.. and give courts the discretion necessary to advance judicial economy,”
those concerns have always been trumped when “the common issues are
inextricably tied to the individual issues.” In re Paxil, 212 F.R.D. at 543.
Therefore, only after the court has found that the cause of action satisfies
the predominance requirements of Rule 23(b)(3) may it certify common issues
pursuant to Rule 23(c)(4)(A). See Arch, 175 F.R.D. at 496.

B. Predominance and Rule 23(b)(3)

In a class action brought under Rule 23(b)(3), common questions of law or
fact must predominate over questions affecting only individual members and
must be a significant part of the individual cases. The predominance inquiry
is “far more demanding” than the commonality requirement of Rule 23(a). Amchem
Prods., Inc. v. Windsor, 521 U.S. 591, 623-24 (1997).
Subdivision [23](b)(3) encompasses those cases in which a class action would
achieve economies of time, effort, and expense, and promote uniformity of
decision as to persons similarly situated, without sacrificing procedural
fairness or bringing about other undesirable results….
It is only wh[en] predominance exists that economies can be achieved by means
of the class-action device.
Fed.R.Civ.P. 23(b)(3) Advisory Committee’s Note.

Predominance poses a problem for certification in drug product liability
cases. See, e.g., In re Prempro Prods. Liab. Litig., 230 F.R.D. 555, 567
(E.D.Ark.2005); Zehel-Miller v. AstraZenaca Pharm., L.P., 223 F.R.D. 659, 663
(M.D.Fla.2004); In re Baycol Prods. Litig., 218 F.R.D. 197, 204
(D.Minn.2003); In re Paxil Litig., 212 F.R.D. 539, 551 (C.D.Cal.2003); In re
Rezulin Prods. Liab. Litig., 210 F.R.D. 61, 65-68 (S.D.N.Y.2002); In re
Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 144 (E.D.La.2002). Individual
issues in such cases invariably overwhelm common ones. This case is no
different.

As the court stated in In re Paxil in finding no Rule 23(b)(3) predominance:
[i]ndividual questions of fact regarding causation nevertheless subvert any
benefits to be gained through a class action proceeding. Whether, and to
what extent, Paxil causes discontinuation symptoms varies from patient to
patient. Not only do individual physiologies affect the causation issues, but
so too do the underlying illnesses and medical history of each individual
plaintiff.
212 F.R.D. at 551. See also Georgine v. Amchem Prods., Inc., 83 F.3d 610,
628-29 (3d Cir.1996) (finding no 23(b)(3) predominance where each plaintiff’s
exposure to product and lifestyle differed from one another in material
respects, and manufacturers could raise varying defenses to each individual
class member’s claim), aff’d sub nom., Amchem Prods. v. Windsor, 521 U.S. 591
(1997); In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, No.
Civ. A. 93-7074, 1995 WL 273597, at *10-11 (E.D.Pa. Feb. 22, 1995) (Bechtle,
J.) (finding lack of predominance where “there are simply too many individual
issues with respect to causation, liability and damages,” including different
defenses to be raised against different plaintiffs).

For the same reasons typicality and adequacy are lacking, so is predominance.
The number and complexity of the questions that must be resolved to determine
liability in each individual’s case predominate over any common questions.
For instance, the psychological and medical histories, the pharmacological
regimens, the roles of the physician and the physical characteristics in each
individual’s case vary. Depending on the individual’s home state, GSK’s
defenses may or may not be applicable, or may be applied differently. In
short, determining liability in each case will require an individual fact
intensive inquiry that will minimize any common questions.

C. Superiority

Not only do the plaintiffs fail to satisfy the predominance prerequisite,
they cannot meet 23(b)(3)’s superiority requirement which requires the
plaintiffs to prove that a “class action is superior to other available
methods for the fair and efficient adjudication of the controversy.”
Fed.R.Civ.P. 23(b)(3). The superiority analysis assesses the advantages and
disadvantages of using the class-action device in relation to other methods of
litigation. The Rule itself suggests various factors to consider in making
this assessment: the interest of class members in individually controlling
the litigation, the state of ongoing litigation brought by class members, the
desirability of concentrating the litigation in the particular forum, and
likely management difficulties. Id. [FN44]

FN44. Although the plain language of Rule 23(b)(3) directs the court to
consider these factors in evaluating both predominance and superiority,
in a majority of cases, the courts consider these factors solely with
respect to making a determination of superiority. Moore’s Federal
Practice,

23.44[1], 23.46[2][a] (3d ed.2006).

1. Material advancement of the litigation

Litigating the proposed common issues will involve scientific evidence,
voluminous documents, a multitude of witnesses and volumes of discovery.
According to the plaintiffs, many class members cannot individually afford the
expense of proving a prescription drug product liability case. This argument
overlooks the fact that most, if not all, cases of this type are litigated on
a contingency fee basis. Consequently, the individual plaintiff need not bear
the cost of proceeding during the pendency of the case.

In addition, given the multitude of different circumstances and defenses
among the class members, each individual trial will consume a significant
portion of each individual’s case. Hence, if costs were prohibitive, the
expense of litigating a case would impede each individual in any event.

As seen in considering typicality, the most significant portion of the
litigation parsing out causation will take place in the context of each
individual’s claim where liability will consume the fact-finding process.
Even though the issues proposed by the plaintiffs must be tried in each trial,
it may be more beneficial for a jury to assess the individual claims in the
context of these issues. Hence, although it may be more convenient for
counsel to pool resources, class treatment will not materially advance the
litigation.

2. Class members’ interest in individually controlling their lawsuit

Although it may be more efficient for counsel and the court to try the issue
of general causation in a class trial, it would sacrifice the individual
plaintiff’s interest in controlling the litigation. Any hope of efficiency
would be subverted by the individual and unique circumstances of each member’s
case which are inextricably intertwined with the general causation issue.

Whether putative class members have a significant interest in individually
prosecuting their own separate lawsuits is affected by the financial stakes
involved in each individual’s case. The greater the damages in one’s claim
vis-a-vis others’ claims, the greater the interest the individual has in
controlling the litigation. The lesser the potential damages, the less the
interest is because separate suits may be impracticable. See Fed.R.Civ.P.
23(b)(3) Advisory Committee’s Note.

Here, the individual claims are for wrongful death or serious personal
injuries. Consequently, because the potential value of each individual’s
claim is high, each has a compelling interest in controlling strategic
decisions throughout the litigation and having those decisions made by the
attorney of his or her choice. The highly personal and emotional implications
in each case militate against surrendering individual choices and decisions in
the litigation. Therefore, the strong interest class members have in
controlling their own lawsuits disfavors certification.

3. The extent of existing litigation

The existence of individual lawsuits filed in jurisdictions outside of the
forum generally weighs against certification. See Turner v. Murphy Oil USA,
Inc., 234 F.R.D. 597, 610 (E.D.La.2006); Cent. Wesleyan Coll. v. W.R. Grace &
Co., 143 F.R.D. 628, 640 (D.S.C.1992) (stating that the inquiry under this
portion of Rule 23(b)(3) is aimed at determining whether there is so much
preexisting litigation that a class would be unproductive), aff’d, 6 F.3d 177
(4th Cir.1993); Dirks v. Clayton Brokerage Co. of St. Louis, Inc., 105 F.R.D.
125, 137 (D.C.Minn.1985); In re Elec. Data Sys. Corp. Sec. Litig., 226 F.R.D.
559, 571 (E.D.Tex.), aff’d sub nom., Feder v. Elec. Data Sys. Corp., 429 F.3d
125 (5th Cir.2005); cf. In re Reliant Energy ERISA Litig., Civ. A.
H-02-2051, 2005 WL 2000707, at *4 (S.D.Tex. Aug. 18, 2005) (finding that the
absence of other litigation concerning the putative claims indicates that the
individual class members have little interest in pursuing independent
actions). To overcome this principle and the fact that there are many similar
suits pending elsewhere in various stages of litigation, the plaintiffs point
out that the plaintiffs in those other cases are represented by either
plaintiffs’ counsel or one other law firm–the Pogust firm. [FN45] The cases
being prosecuted by plaintiffs’ counsel are in the early stages. Those filed
by the Pogust firm have had general discovery. In those cases, little expert
discovery has been conducted and no dispositive motions have been decided.

FN45. The Pogust firm and its clients consent to the class action.
Pls.’ Mem. at 39.

On one hand, the state of the other litigation seems to favor certification
because the parties have not invested a substantial amount of litigation time
and class certification will not result in overlapping and redundant discovery
and motion practice. On the other hand, certification is not favored because
there are no dispositive rulings that will interfere with the presentation of
each individual’s case. Hence, the existing litigation factor is neutral.

4. Manageability of proposed class and choice-of-law impediments

In examining the manageability of the proposed class, two factors are
considered: the manageability of the plaintiffs’ proposed trial plan, and
whether there are choice-of-law conflicts in a putative nationwide class. In
re Prempro, 230 F.R.D. at 562. Choice-of-law principles present a significant
problem for class certification in this case. Conflicts among the laws of the
various jurisdictions render a class action as proposed by the plaintiffs
unmanageable.

A federal court sitting in diversity must apply the choice-of-law rules of
the forum state. Berg Chilling Sys., Inc. v. Hull Corp., 435 F.3d 455, 462
(3d Cir.2006). Accordingly, Pennsylvania law applies here.

Pennsylvania uses a two-step process to resolve choice-of-law questions.
First, the court must determine whether there is a real conflict. Second, if
there is an actual conflict, the court must then decide which state has the
greater interest in applying its law.

If after applying the respective law of each state to the same set of facts
the result is the same, there is no conflict. Phillips Petroleum Co. v.
Shutts, 472 U.S. 797, 839 n.20 (1985). In other words, there is no conflict
where the application of either state’s law renders the same result. Berg
Chilling, 435 F.3d at 462. A true conflict, on the other hand, exists when
the governmental interests of both jurisdictions would be impaired if their
law were not applied. Lacey v. Cessna Aircraft Co., 932 F.2d 170, 187 (3d
Cir.1991).

If there is a true conflict, the court proceeds to the second step and
decides which state has the greater interest in the application of its law.
LeJeune v. Bliss-Salem, Inc., 85 F.3d 1069, 1071 (3d Cir.1996) (citing Cipolla
v. Shaposka, 267 A.2d 854, 855 (Pa.1970)). This flexible inquiry uses the
Restatement (Second) of Conflict of Laws as a guide to evaluate the
significance of the contacts or relationship of the states to the parties and
the dispute. See Berg Chilling, 435 F.3d at 463; Garcia v. Plaza Oldsmobile
Ltd., 421 F.3d 216, 220 (3d Cir.2005). After characterizing the nature of the
issue as founded in contract, tort or a hybrid, the court uses the appropriate
Restatement section identifying the most relevant contacts for that type of
action to assess which state has the more significant relationship and
contacts to the issue. Berg Chilling, 435 F.3d at 463, 467; Garcia, 421 F.3d
at 220. The contacts are weighed qualitatively within the context of the
competing policies and interests of each state. Berg Chilling, 435 F.3d at
467-68; In re Estate of Agostini, 457 A.2d 861, 871 (Pa.Super.Ct.1983) (
citing Cipolla, 267 A.2d at 856). After balancing the respective governmental
policy interests of the affected states, the court applies the law of the
state having the greater interest in the determination of the issue. Garcia,
421 F.3d at 219-20.

The plaintiffs acknowledge that there are actual conflicts among the various
jurisdictions’ laws. Accordingly, I proceed directly to the greater interest
analysis.

Because this action sounds in tort, section 145 of the Restatement (Second)
of Conflict of Laws guides the analysis. That provision dictates that the law
of the state which has the most significant relationship with the occurrence
and the parties applies, and lists the following factors to consider: where
the injury occurred, where the injury-producing conduct occurred, the
domiciles of the parties, and the place where the parties’ relationship is
centered. Restatement (Second) of Conflict of Laws

145 (1971).

Turning to this case, in light of these factors, I now evaluate the contacts
and relationship to the issue of liability–the issue implicated by the
plaintiffs’ proposed common questions. Each putative class member suffered
the injury in his or her home state. The tortious conduct took place not only
in Pennsylvania but in every state, including each class member’s home state,
where Paxil was delivered, marketed and taken. Although GSK is a Pennsylvania
corporation headquartered here, each plaintiff is presumably domiciled in his
or her state. The parties’ relationship is not centered in Pennsylvania.
Most if not all contacts with the class members, such as marketing,
prescribing and taking the drug, were in the home states. Thus, the state
having the most significant contacts and relationship to the liability issue
is each class member’s home state.

There is no way to apply Pennsylvania law to part of the liability
determination, as proposed by the plaintiffs, without disregarding the comity
afforded the other states whose interests are in protecting their citizens
from tortious harm caused within their boundaries. A state’s interest in
fixing liability for tortious harm caused within its boundaries goes to its
interests in protecting its citizens and regulating conduct there. Of course,
Pennsylvania has an interest in regulating its citizens’ labeling practices.
[FN46] When that conduct reaches and has consequences beyond the state’s
borders, it affects citizens of other states. When it does, the foreign
state’s interest in protecting its citizens outweighs Pennsylvania’s
regulatory concerns.

FN46. Plaintiffs argue that Pennsylvania has the greater interest in
applying its laws to the general liability issues, such as “general
causation” and “labeling decisions,” because it has a strong interest in
regulating its corporate citizens, pointing out that GSK’s decisions
regarding warnings, marketing, testing and distribution of Paxil
occurred in Pennsylvania at its headquarters.

To circumvent the conflicts between the differing states’ product liability
and negligence laws, the plaintiffs urge the court to invoke depecage, a
principle that applies the laws of different states to different issues in the
same case. Berg Chilling, 435 F.3d at 462. Specifically, they contend that
the court should apply Pennsylvania law to their proposed common issues of
general causation, GSK’s knowledge and its failure to warn: and then the law
of each individual class member’s home state will be applied to specific
causation and damages. Thus, the plaintiffs are proposing to apply
Pennsylvania law to determine general causation, and each class member’s home
state’s law to determine specific causation and damages.

The Third Circuit has not applied depecage to multi-state class action
claims. Nor has it applied different states’ laws to less than a complete
element of the claim, as plaintiffs are proposing we do here. Depecage
applies one state law to one entire claim and a different state law to another
claim in the same case. See, e.g., Berg Chilling, 435 F.3d at 463, 468
(applying Pennsylvania law to successor liability claim and applying New
Jersey law to contract claim); Zavecz v. Yield Dynamics, 179 F. App’x 116 (3d
Cir.2006) (upholding district court’s finding that California law applied to
contractual attorneys’ fees award claim and Pennsylvania law applied to the
tort law conversion claim).

The plaintiffs are actually asking that Pennsylvania law be applied to only a
part of the liability equation. However, the issue of liability cannot be
determined piecemeal. It must be decided by taking into consideration all
parts of the question, including defenses.

Plaintiffs assert that because the proposed common questions are so narrow,
the differences in the state laws are “inconsequential.” On the contrary, as
an unexhaustive survey shows, the variances in the laws of the various
jurisdictions are hardly inconsequential. In some states, a plaintiff may
recover; and, in another state, depending on the applicability of certain
legal principles, she may not based upon the same or similar facts. For
example, some states, like California, apply a strict liability standard to
prescription drug manufacturers for failure to warn of known or reasonably
scientifically knowable risks; others, like Pennsylvania, recognize
negligence as the only basis of recovery in cases involving prescription drugs
where a failure to provide a sufficient warning is alleged; and some, for
instance, Florida and Nebraska, have treated comment k to section 402A of the
Restatement (Second) of Torts as an affirmative defense to a prescription drug
strict liability claim. See Carlin v. Superior Court, 920 P.2d 1347, 1350- 52
(Cal.1996); Hahn v. Richter, 673 A.2d 888, 890-91 (Pa.1996); Adams v. G.D.
Searle & Co., 576 So.2d 728, 731-33 (Fla.Dist.Ct.App.1991); Freeman v.
Hoffman-La Roche, Inc., 618 N.W.2d 827, 840 (Neb.2000).

Differences in affirmative defenses also exist. For example, in some states,
assumption of the risk is a complete defense to a products liability claim;
in others, it involves a comparative fault analysis; and, in yet others, pure
comparative fault is used. Castano, 84 F.3d at 742 n.15. The learned
intermediary doctrine applies in some and not in other states.

Similarly, state laws differ with respect to the duty to warn and the
adequacy of the warning. State laws vary in how much knowledge a manufacturer
must have before a duty to warn arises. There are differences with respect to
whether warnings are required for the off-label use of a drug. Some states
require no warning, see Robak v. Abbott Labs., 797 F.Supp. 475, 476
(D.Md.1992), while others have varying levels of requirements for adequate
warning of an off-label use. Miles Labs., Inc. v. Superior Court, 184
Cal.Rptr. 98, 100 (Cal.Ct.App.1982) (manufacturer liable for failure to warn
of risks of off-label uses of its product if the manufacturer knew or should
have known of the off-label use and that use accounted for a significant
portion of the manufacturer’s sales of the drug); Peterson v. Parke Davis &
Co., 705 P.2d 1001, 1003 (Colo.Ct.App.1985); Reeder v. Hammond, 336 N.W.2d 3,
5-6 (Mich.Ct.App.1983) (intervening negligence of a physician precludes the
manufacturer’s liability for failure to warn of risks of off-label use).
Negligent infliction of emotional distress claims vary greatly among the
states. Some states require a physical impact or physical contact (see, e.g.,
Hammond v. Cent. Lane Commc’ns Ctr., 816 P.2d 593, 596-97 (Or.1991); Deutsch
v. Shein, 597 S.W.2d 141, 145-46 (Ky.1980); and others do not recognize the
cause of action at all (see, e.g., Allen v. Walker, 569 So.2d 350, 352
(Ala.1990)). These differences among the states’ laws are illustrative and
not exhaustive.

Plaintiffs propose two trial plans. In one plan, they state that the court
can conduct a class trial as to only the common issues without including any
issues that overlap with a class member’s individual case. Each class member
will return to his or her home state for a trial on the remaining disputed
issues. [FN47] In a second plan, plaintiffs propose to try each of the two
named plaintiffs’ cases to verdict on liability and damages. Using jury
interrogatories, the three proposed common issues can be decided and bind all
other members of the class in their separate trials to be conducted in the
individual’s original forum. [FN48] The plaintiffs offer no suggestion as to
how the verdicts in the plaintiffs’ cases would not be infected by the
individual facts and issues that are unique to them to ensure that the absent
class members would not be affected.

FN47. Pls.’ Mem. at 2-3.

FN48. Id. at 49-50; Hr’g Tr. at 8-9.

The plaintiffs have not demonstrated that their proposed class action is
superior to other available methods. As a threshold matter, the plaintiffs
have failed to devise a method of determining class membership without
individualized fact finding. Because an overwhelming number of individual
issues would remain unresolved for each class member, adjudication of the
proposed common issues would not materially advance a disposition of the case
as a whole. Moreover, the proposed class will be unmanageable because there
is no way to apply the varied state laws and, at the same time, guarantee
procedural fairness.

5. Appropriateness of forum

The only factor favoring this forum is that GSK is headquartered here.
Because many defense witnesses and documents are in this forum, it may be more
convenient for GSK. Yet, the defendant opposes certification and has moved for
the transfer of the plaintiffs’ cases.

The law governing liability and damages will be controlled by the individual
member’s home state’s jurisprudence. Furthermore, although there are some
liability witnesses in Pennsylvania, witnesses essential to proving liability
and damages in each individual’s cases are located in those other
jurisdictions. Thus, the forum factor does not lend to certification.

Conclusion
The proposed class does not satisfy the typicality and adequacy requirements
of Rule 23(a), nor the predominance and superiority requirements of Rule
23(b)(3). Therefore, the motion for class certification will be denied.

— F.Supp.2d —-, 2007 WL 178564 (E.D.Pa.)

Drug company ‘hid’ suicide link

Filed under: GLAXO — at 9:08 pm on Monday, January 29, 2007

Secret emails reveal that the UK’s biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers. Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced ‘independent’ academics.

GSK told Panorama: “GSK utterly rejects any suggestion that it has improperly withheld drug trial information.”

GSK faces action in the US where bereaved families have joined together to sue the company.

As a result, GSK has been forced to open its confidential internal archive.

Karen Barth Menzies is a partner in one of the firms representing many of the families.

She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.

She said: “Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children.”

GSK’s biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.

She also found an email from a public relations executive working for GSK which said: “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.

“Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.”

But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world.

The editor in chief of the British Medical Journal, Fiona Godlee, said that what she calls the “blind-eye culture of medicine” should be exposed by professionals.

She has written in response to the Panorama film: “We shouldn’t have to rely on investigative journalists to ask the difficult questions.

“Reputations for sale are reputations at risk. We need to make that risk so high it’s not worth taking.”

The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet.

A spokesperson told Panorama that the investigation has been given substantial additional resources and remains a high priority.

Seroxat was banned for under 18s in 2003 after the MHRA, revealed that GSK’s own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.

  • Secrets of the Drug Trials will be broadcast on Monday 29 January at 2030 on BBC One and this site.

  • If you are affected by any of the issues in the programme and would like to talk to someone in confidence for further information and support, please call the BBC Action Line on 0800 077 077. Lines open at 2100 GMT on Monday 29 January for a week and may be busy but the Action Line will be open from 0730 GMT until 0000 GMT. All calls are free and confidential.

    • Seroxat: Statement from GlaxoSmithKline

    Filed under: GLAXO — at 9:06 pm on Monday, January 29, 2007

    “In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression and refutes any allegation that it has failed in this duty. GSK utterly rejects any suggestion that it has improperly withheld drug trial information.

    Depression is a severe and disabling condition and a well-recognised tragic outcome of the disease, particularly among young people, is suicide.

    Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.

    GSK conducted nine studies over eight years to examine the use of Seroxat in treating children, those under the age of 18, with depression and other psychiatric disorders as treatment options for these vulnerable patients are extremly limited.

    Results from these studies were documented and submitted to regulators in accordance with regulatory requirements.

    No suicides were reported in any of the nine paediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

    Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat.

    GSK brought this analysis to the attnetion of the regulatory authorities, including in the UK.

    Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age and GSK’s UK product labelling has been entirely consistent with that position stating: “The use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”