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Wendell v. GlaxoSmithKline LLC

United States Court of Appeals, Ninth Circuit

June 2, 2017

Stephen Wendell; Lisa Wendell, for themselves and as successors-in-interest to Maxx Wendell, deceased, Plaintiffs-Appellants,
v.
GlaxoSmithKline LLC; Teva Pharmaceuticals USA, Inc., Defendants-Appellees.

          Argued and Submitted September 16, 2016 San Francisco, California

         Appeal from the United States District Court for the Northern District of California No. 4:09-cv-04124-CW, Claudia Wilken, District Judge, Presiding

          Michael J. Quirk (argued), Williams Cuker Berezofsky LLC, Philadelphia, Pennsylvania; Kevin Haverty, Williams Cuker Berezofsky LLC, Cherry Hill, New Jersey; for Plaintiffs-Appellants.

          Alan J. Lazarus (argued) and William A. Hanssen, Drinker Biddle & Reath LLP, San Francisco, California, for Defendant-Appellee GlaxoSmithKline, LLC.

          Jeffrey F. Peck (argued) and Prentiss W. Hallenback, Jr., Ulmer & Berne LLP, Cincinnati, Ohio, for Defendant-Appellee Teva Pharmaceuticals USA, Inc.

          Before: Ronald M. Gould and Marsha S. Berzon, Circuit Judges, and William K. Sessions III, [*] District Judge.

          SUMMARY [**]

         Expert Testimony / Duty to Warn

         The panel reversed the district court's summary judgment in favor of Teva Pharmaceuticals USA, Inc., and the dismissal, as moot, of plaintiffs' motion to reconsider, in an action alleging negligence and strict liability concerning the manufacture and distribution of drugs that were used to treat plaintiffs' deceased son, Maxx Wendell, for inflammatory bowel disease.

         Plaintiffs alleged that the drugs caused Maxx Wendell to develop Hepatosplenic T-cell lymphoma, and that the manufacturers and distributors did not give adequate warnings about the risks associated with the drugs. The district court granted summary judgment for Teva because the testimony of plaintiffs' causation experts was not reliable and not admissible under Fed.R.Evid. 702, and because plaintiffs did not present evidence that Maxx's prescribing physician relied on Teva's warning labels.

         The panel held that the district court erred by excluding the experts' testimony. The panel held that the district 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. Specifically, the panel held that the district court improperly ignored the experts' experience, reliance on a variety of literature and studies, and review of Maxx's medical records and history, as well as the fundamental importance of differential diagnosis by experienced doctors treating troubled patients. The panel further held that the district court overemphasized certain facts; and taken together, these mistakes warranted reversal. The panel concluded that the proposed testimony was sufficiently reliable, and plaintiffs' experts should have been allowed to testify under Daubert, and admitted as expert testimony under Fed.R.Evid. 702.

         The panel reversed the district court's summary judgment to Teva on the duty to warn claim. The panel held that under California law, viewing the evidence in the light most favorable to plaintiffs, 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 declined to affirm the district court's judgment on alternative grounds, and held that Teva may raise the issues with the district court on remand.

         Finally, the panel reversed the district court's denial of plaintiffs' motion for reconsideration, and remanded.

          OPINION

          GOULD, Circuit Judge:

         Maxx Wendell[1] tragically died at the age of 21 of Hepatosplenic T-cell lymphoma (HSTCL), an exceedingly rare and aggressive form of cancer. For many years before his development of HSTCL, Maxx was treated with a combination of drugs for inflammatory bowel disease. After his death, his parents, Stephen and Lisa Wendell (Plaintiffs), sued the manufacturers and distributors of these drugs, asserting claims under California law for negligence and strict liability. Plaintiffs alleged that the drugs caused Maxx to develop HSTCL and that the manufacturers and distributors did not give adequate warnings about the risks associated with the drugs.

         The district court granted summary judgment to Teva Pharmaceuticals USA, Inc. (Teva), concluding that the Plaintiffs did not present admissible expert testimony of causation and did not show that Maxx's prescribing physician relied on the warning labels. For the same reasons, the district court dismissed as moot Plaintiffs' motion for leave to file a motion for reconsideration of the district court's prior order granting summary judgment to GlaxoSmithKline LLC (GSK). We reverse and remand.

         I

         In 1998, at the age of twelve, Maxx was diagnosed with a form of inflammatory bowel disease (IBD) called ulcerative colitis. IBD is an autoimmune disease characterized by chronic inflammation. Maxx began treatment with Dr. Edward Rich, a pediatric gastroenterologist at Kaiser Permanente in San Francisco. Relevant here, in June 1999, Dr. Rich prescribed mercaptopurine (6-MP), an immunosuppressant, and one of a class of drugs known as thiopurines. At the time, 6-MP was manufactured by GSK and marketed as Purinethol. Although it has been widely used off-label since 1980 to treat IBD, [2] Purinethol has never received approval for this use.

         In July 2002, Dr. Rich prescribed an additional drug, the tumor necrosis factor alfa antagonist (anti-TNF) drug infliximab, marketed as Remicade. Anti-TNF drugs are approved to treat various autoimmune disorders, such as Crohn's disease and rheumatoid arthritis.

         Maxx received his last dose of Remicade in March 2006, after which his IBD went into remission. Two months later, the Food and Drug Administration approved a new label for the drug. The label included a warning reporting postmarketing cases of HSTCL in young male patients with Crohn's disease treated with both Remicade and a thiopurine such as 6-MP or azathioprine. Centocor, the maker of Remicade, also issued a "Dear Health Care Provider" letter alerting prescribers to the labeling change and giving more details on the cases of HSTCL. When Maxx's symptoms returned, Dr. Rich prescribed another anti-TNF drug, Humira, which Maxx took until June 2007. At the time Dr. Rich prescribed Humira, its label did not warn of the risk of HSTCL.

         Maxx remained continuously on 6-MP from June 1999 until about March or April 2007. GSK stopped marketing Purinethol on July 1, 2003, and transferred ownership rights for the drug to Teva. Maxx continued on Teva's Purinethol until July 2004, when Dr. Rich switched him to a generic 6-MP. According to Maxx's mother, Maxx decided to stop taking 6-MP in 2007 after reading in Men's Health that young men on a combination of Remicade and other immunosupressive medication had developed HSTCL.

         In July 2007, Maxx checked into the emergency room with fevers, fatigue, and malaise. Several days later he was diagnosed with HSTCL-a non-Hodgkin's lymphoma that is exceedingly rare and aggressive. It has "low responses to chemotherapy, frequent relapses after contemporary treatments and the inability of the majority of the patients to undergo bone marrow transplantation." Most patients die within the first year of diagnosis; only a very small fraction achieve long-term survival. Maxx died from HSTCL on December 6, 2007, at the age of 21.

         In July 2009, Plaintiffs, Maxx's parents, sued multiple drug companies in Superior Court in California. The case was removed to federal court in September 2009. Plaintiffs filed the operative fourth amended complaint in April 2011. Several defendants, including GSK and Teva, then moved for summary judgment. The district court granted the motion, but subsequently withdrew its summary judgment order in light of Plaintiffs' need for further discovery. In July 2012, after reviewing new evidence, the district court denied the motion for summary judgment as to Teva and two other drug companies, Par Pharmaceutical, Inc. and Abbott Laboratories. The court granted summary judgment to GSK because it determined that Plaintiffs had not presented sufficient evidence that a reasonable jury could find GSK had a duty to warn of the risk of HSTCL before July 1, 2003, when GSK stopped distributing Purinethol. A year later, the district court granted summary judgment to Par Pharmaceuticals.

         In January 2014, the remaining defendants-including Teva-filed another motion for summary judgment. Plaintiffs settled their claims against the remaining defendants, except for Teva, before the district court ruled on the motion for summary judgment.

         On June 30, 2014, the district court granted Teva's motion for summary judgment because the testimony of Plaintiffs' causation experts, Dr. Andrei Shustov and Dr. Dennis Weisenburger, was not reliable and therefore not admissible under Federal Rule of Evidence 702, and because Plaintiffs did not present evidence that Maxx's prescribing physician relied on Teva's warning labels. It also denied Plaintiffs' motion for leave to file a motion for reconsideration of the Court's July 2012 order granting summary judgment to GSK. Plaintiffs filed a timely notice of ...


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