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Federal court grants summary judgment for Firm client Novartis Pharmaceuticals Corporation because plaintiffs’ experts’ causation opinions were not sufficiently reliable or relevant to be admissible under Daubert.

On July 9, 2008, Judge Stewart Dalzell of the United States District Court for the Eastern District of Pennsylvania granted complete summary judgment to Firm client, Novartis Pharmaceuticals Corporation (NPC), in a lawsuit alleging that the prescription cream Elidel® caused a minor’s non-Hodgkin’s lymphoma (NHL), specifically a T-cell lymphoblastic lymphoma (T-LBL).  Perry v. Novartis Pharmaceuticals Corporation, 564 F. Supp. 2d 452 (E.D. Pa. 2008).  Judge Dalzell granted summary judgment after ruling that the necessary causation opinions of plaintiffs’ two experts were unreliable, and hence inadmissible, under Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

In Perry, plaintiffs Andrea and George Perry, as representatives of their minor son, Andreas Perry, alleged that the application of Elidel® Cream (active ingredient, pimecrolimus) caused Andreas Perry’s T-LBL.  Drs. Martyn T. Smith (toxicology) and E. Anders Kolb (hematology and oncology) submitted expert reports in support of plaintiffs’ theory that Elidel® causes NHL in humans and that it specifically caused Andreas Perry’s NHL.

Some highlights of the court’s detailed opinion are reviewed below:

  • Court explains the importance of “fit” as the expert’s opinion progresses from general to specific causation. “[T]here is . . . no fit when there is too great an analytical gap between an expert’s general causation conclusion and the specific causation question the jury must ultimately answer.” Slip Op. 19-20. The expert must “draw a chain of scientifically-reliable causal links;” and correspondingly, “[w]here . . . the expert reports leave wide, unexplained gaps in the causal chain, the evidence is not helpful to the trier of fact and must be excluded.” Slip Op. 20.
  • Although epidemiology is not required to prove causation, an expert cannot ignore the existing epidemiology or selectively choose from it.  Although not necessarily required, epidemiology is the primary, generally accepted method for demonstrating a causal relationship between a substance and a disease.  Slip Op. 21.  Accordingly, “no reliable scientific approach can simply ignore the epidemiology that exists.”  Slip Op. 21-22.  The Perry court found “most disquieting” Dr. Smith’s failure to mention, in his initial report, the only published epidemiological study.  Slip Op. 22.  With respect to another, unpublished epidemiological study, the Perry court observed that it “appears that Dr. Smith’s analysis of the i3 report focused not on the findings that were most relevant to the hypothesis he sought to test but on the findings that were most helpful to his paying client.  While this approach is, sadly, not uncommon, it is incompatible with the reliable application of the scientific method.”  Slip Op. 23-24.
  • Causation opinion must be based on existing and adequate scientific data. “[T]he non-existence of good data does not allow expert witnesses to speculate or base their conclusions on inadequate supporting science. In cases where no adequate study shows the link between a substance and a disease, expert testimony will generally be inadmissible, even if there are hints in the data that some link might exist. This may mean that early victims of toxic torts are left without redress because they are unable to prove their cases with the scientific data that exists. While this is a regrettable result in those individual cases, it is an unavoidable reality of the structure of our legal system and is necessary to protect the interests of defendants who might otherwise be subject to crippling verdicts on the basis of slender scientific evidence.” Slip Op. 28.
  • Court rejects notion that the pharmaceutical defendant should have conducted more or different studies. “In particular, suggestions in the expert reports that Novartis should have conducted additional studies or designed their studies differently are irrelevant here . . . . It will not do for either plaintiffs’ experts or counsel to raise vague inferences that Novartis’s failure to conduct certain studies is somehow evidence of malfeasance or guilt.” Slip Op. 28-29.
  • Absence of a reliable scientific link between accumulation of pimecrolimus in lymphatic tissue and development of lymphoma. The Perry court rejected Dr. Kolb’s theory that pimecrolimus accumulates in human lymphatic tissue wherein it causes NHL. Judge Dalzell ruled that “[b]ased on the data that exist today . . . any link that plaintiffs’ experts draw between dermal application of pimecrolimus and increased risk of lymphoma is mere guesswork – educated guesswork, but guesswork nonetheless.” Slip Op. 30.
  • Differential diagnosis failed to exclude no known cause. Noting that Dr. Kolb conceded that most NHLs and T-LBLs are idiopathic, the court rejected plaintiffs’ experts’ differential diagnoses because they failed to exclude the likelihood that Andreas Perry’s lymphoma had no known cause.  Slip Op. 30-36.  Moreover, plaintiffs’ experts suggested that the methods by which Elidel® could have caused Andreas Perry’s lymphoma were related to systemic immunosuppression, but there was an absence of evidence of systemic immunosuppression in his medical history.  Slip Op. 35-36.
  • High dose animal studies did not fit the facts of the case. Noting the disparity between the dosages in animal studies, upon which plaintiffs’ experts relied, and the dosages applied to Andreas Perry, the Perry court ruled that plaintiffs’ experts failed to show that the amount of Elidel® applied to Andreas Perry’s skin was sufficient to cause NHL. Slip Op. 37-38. “Plaintiffs’ experts’ general causation conclusions are primarily based on the animal studies and so their failure to satisfactorily address this analytical gap related to dosage levels undermines the usefulness of those conclusions to a jury.”  Slip Op. 38.