Knipe v. SmithKline Beecham’s Empirical Analysis

Citation profile

1 federal appellate · 1 district ·

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 11 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “Prior to April of 2002, GSK had never submitted any pediatric clinical trial data to the FDA. 32 It remains undisputed, however, that, as of 1998, GSK had completed Studies 329 and 377, both of which were the first two placebo controlled clinical trials of Paxil in children and adolescents. (PSUF ¶ 5, Ex. 5; ¶ 8, Ex. 14; ¶ 12, Ex. 21.) On July 30, 2001, GSK also issued the Final Clinical Report on Study 701, which was designed to evaluate the efficacy of Paxil in pediatric patients with major depressive disorder. (Id. ¶ 18, Ex. 30.) The first time GSK sought approval for pediatric indication of Paxil was on April 11, 2002, at which time it first submitted the results of the three studies. (Id. ¶ 26, Exs. 36, 37.) This submission, by all accounts, was the catalyst for a series of events culminating in the FDA required “black box” warning. On October 7, 2002, Dr. Andrew Mos-holder, the FDA reviewer of the pediatric Supplemental NDA for Paxil completed his review and noted an increase in “behavioral effects” coded “with terms such as hostility and emotional lability” which was “potentially confusing.” (Id. ¶ 29, Ex. 39 at 6.) Accordingly, on October 21, 2002, the FDA requested from GSK clarification of the data regarding behavioral adverse events, as well as GSK’s “rationale for coding suicide attempts and other forms of self-injurious behavior under the ... term ‘emotional lability.’ ” (Id. ¶ 30, Ex. 40.) Seven months later, GSK responded to this request and submitted a report ”

   1 later decision quote this exact passage · from the concurrence
   e.g. Knipe v. Smithkline Beecham

2. “Suicidality in Children and Adolescents 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 [insert established name] 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 other unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Insert established name] is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses 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 4400 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 on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.”

   1 later decision quote this exact passage
   e.g. Knipe v. Smithkline Beecham

3. “During the relevant period in this case, Paxil was not — and to date has not been — approved for pediatric use. As of the original approval in 1992, no evidence exists that the FDA received any pediatric clinical studies from any of the major SSRI manufacturers. In late 2001, the FDA first began receiving controlled studies of the seven major SSRI’s in pediatric patients for the treatment of Major Depressive Disorder. Kallas Amicus Brief 13. On September 30, 2002, although the FDA had yet to affirmatively link increased suicid-ality in adolescents to Paxil, it declined to approve Zoloft, another SSRI, for treatment of pediatric Major Depressive Disorder, on the grounds that it could not prove efficacy.... At no point did the FDA deem the proposed pediatric warning scientifically unsubstantiated.”

   1 later decision quote this exact passage · from the concurrence
   e.g. Knipe v. Smithkline Beecham