Blain v. Smithkline Beecham Corp.

240 F.R.D. 179, 2007 U.S. Dist. LEXIS 5460, 2007 WL 178564
CourtDistrict Court, E.D. Pennsylvania
DecidedJanuary 25, 2007
DocketCivil Action No. 06-1247
StatusPublished
Cited by9 cases

This text of 240 F.R.D. 179 (Blain v. Smithkline Beecham Corp.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 2007 U.S. Dist. LEXIS 5460, 2007 WL 178564 (E.D. Pa. 2007).

Opinion

MEMORANDUM OPINION

SAVAGE, District Judge.

In moving to certify this product liability action against the manufacturer of the antidepressant drug Paxil ás 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 [182]*182public of this danger.1 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).

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

Paxil2 was first approved for sale in the United States in December of 1992 for the safe and effective treatment of depression in adults.3 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.4 Paxil has never been approved for treatment of any condition in children.5 Nonetheless, physicians may prescribe Paxil “off-label”6 for an “unapproved” population, such as children or adolescents, without FDA knowledge or approval.7 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).

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.”8 On October 15, 2004, after the FDA completed a review of pediatric [183]*183clinical data for all SSRIs and other antidepressants, it required all manufacturers of SSRIs to include on the drug label the following “Black Box” warning:

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.9

Beginning in January of 2005, defendant GSK complied with this FDA directive and updated its label accordingly.10

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.”11 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.12 GSK’s promotion of Paxil for an off-label use, according to the plaintiffs, was false, misleading and not based upon independently developed data.

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 29,1992.13

III. Legal Standards for Class Certification

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Bluebook (online)
240 F.R.D. 179, 2007 U.S. Dist. LEXIS 5460, 2007 WL 178564, Counsel Stack Legal Research, https://law.counselstack.com/opinion/blain-v-smithkline-beecham-corp-paed-2007.