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From Products Liability Law Daily, March 20, 2018

High Court rejects drug maker’s challenge to Ninth Circuit’s reversal of expert testimony exclusion

By Susan Engstrom and Susan Lasser, J.D.

The U.S. Supreme Court has denied a request by the manufacturer of an immunosuppressant drug to review a federal appellate panel’s ruling that the trial court erred in finding that the testimony of two causation experts for the parents of a deceased patient failed to meet the Daubert reliability standards. The drug maker had complained that the U.S. Court of Appeals for the Ninth Circuit used a two-part standard of review that did not afford deference to the trial court, improperly empowering the appellate court to reverse the lower court’s decision to exclude evidence without the appropriate deference under an abuse-of-discretion review (Teva Pharmaceuticals USA, Inc. v. Wendell, petition for cert. filed November 20, 2017; cert. denied March 19, 2018).

The decedent was diagnosed at age 12 in 1998 with ulcerative colitis, an inflammatory bowel disease. His pediatric gastroenterologist prescribed Purinethol®, an immunosuppressant manufactured by GlaxoSmithKline LLC. Three years later, the patient also was prescribed Remicade®, a tumor necrosis factor alfa antagonist. His last dose of Remicade was in March 2006, at which point his inflammatory bowel disease went into remission. Two months later, the Food and Drug Administration (FDA) approved a new label containing a warning which reported cases of Hepatosplenic T-cell lymphoma (HSTCL) in treatments in which patients took Remicade in combination with drugs such as Purinethol. Remicade’s manufacturer sent a letter alerting prescribers to the change. When the patient’s symptoms returned, his physician switched from Remicade to Humira®, which contained no such warning and which the patient continued taking until June 2007. During this time, the patient had continued taking Purinethol until 2004, at which point the physician switched him to a generic version of the drug. In 2003, GlaxoSmithKline stopped marketing Purinethol and transferred ownership rights to Teva Pharmaceuticals USA, Inc. In 2007, the patient asked to stop using any version of Purinethol after reading a magazine article about the dangers of getting HSTCL when combining Purinethol and Remicade. In July 2007, the patient was hospitalized and diagnosed with HSTCL. He died five months later at age 21.

Early proceedings. His parents sued multiple drug companies, including Teva, alleging that the companies failed to give adequate warnings about the drugs’ risks. The drug companies removed the case to federal court. Eventually, the only remaining defendant was Teva after the other companies either settled with the parents or were granted summary judgment. The trial court granted summary judgment to Teva on the duty to warn claim for two reasons: (1) the parents failed to establish evidence that the physician relied on Teva’s warning labels; and (2) the testimony of the parents’ causation experts was inadmissible as unreliable. The parents appealed the decision to the Ninth Circuit.

Ninth Circuit decision. A panel for the Ninth Circuit held that the district court erred by excluding the experts’ testimony, reasoning that the lower court looked too narrowly at each individual consideration under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993), without taking into account the broader picture of the experts’ overall methodology [see Products Liability Law Daily’s June 5, 2017 analysis]. Specifically, the panel held that the trial court improperly ignored the experts’ experience, reliance on a variety of literature and studies, and review of the patient’s medical records and history, as well as the fundamental importance of differential diagnosis by experienced doctors treating troubled patients. The panel additionally found that the lower court overemphasized certain facts. Taken together, the appellate court said, the mistakes warranted reversal. The court concluded that the proposed testimony was sufficiently reliable, and that the parents’ experts should have been permitted to testify under Daubert and admitted as expert testimony under Fed. R. Evid. 702. Thus, the panel reversed the district court’s summary judgment order in favor of the drug maker on the duty to warn claim. The panel held that under California law, viewing the evidence in the light most favorable to the parents, there was a genuine dispute of material fact as to whether the prescribing physician’s conduct would have changed with warnings from Teva, and its predecessor, GlaxoSmithKline LLC. The panel reversed the district court’s denial of the parents’ motion for reconsideration, and remanded.

Petition. In its petition, the manufacturer had asserted that the Ninth Circuit, as well as the Third and Seventh Circuits, "has reformulated the standard of review, identifying a legal component of reliability determinations that allows them to exercise plenary appellate review and to reverse Daubert decisions based on mere disagreement, not abuse of discretion." The maker argued that rather than the abuse of discretion standard under Rule 702, the appellate court exercised plenary review over the lower court’s findings, employing a two-part standard of review by which it first reviewed the trial court’s ruling on the admissibility of expert testimony for an abuse of discretion, and then qualified its abuse-of-discretion review by reviewing "de novo the construction or interpretation of … the Federal Rules of Evidence, including whether particular evidence falls within the scope of a given rule." This two-part standard of review enabled the appellate court to review the district court’s Rule 702 decision without deference, according to the drug maker.

The manufacturer presented the following questions to the High Court:

  1. Whether the two-part standard of reviewing expert-admissibility rulings employed by the Ninth Circuit, along with the Third and Seventh Circuits, improperly empowers these courts to reverse district court decisions to exclude evidence without "the deference that is the hallmark of abuse-of-discretion review."
  2. Whether an expert’s qualifications and mere invocation of a scientific methodology can be sufficient to require admission of his testimony, as the Ninth Circuit concluded, or whether Rule 702 requires that a witness, no matter how qualified, must also satisfy the court that his methodology was "reliably applied to the facts of the case," as several other circuits have held.

The Court, however, denied the petition.

The case is Docket No. 17-747.

Attorneys: Kevin Haverty (Williams Cuker Berezofsky, LLC) for Stephen Wendell. William Hanssen (Drinker Biddle & Reath, LLP) for GlaxoSmithKline LLC. Thomas Michael Frieder (Hassard Bonnington LLP) and Jeffrey Francis Peck (Ulmer & Berne LLP) for Teva Pharmaceuticals USA, Inc.

Companies: GlaxoSmithKline LLC; Teva Pharmaceuticals USA, Inc.

MainStory: TopStory SupremeCtNews DrugsNews CausationNews WarningsNews

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