Stephen Wendell; Lisa Wendell, for themselves and as successors-in-interest to Maxx Wendell, deceased, Plaintiffs-Appellants,
GlaxoSmithKline LLC; Teva Pharmaceuticals USA, Inc., Defendants-Appellees.
and Submitted September 16, 2016 San Francisco, California
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
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.
Testimony / Duty to Warn
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.
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.
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.
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.
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.
the panel reversed the district court's denial of
plaintiffs' motion for reconsideration, and remanded.
Wendell 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
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.
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,
Purinethol has never received approval for this use.
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
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.
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.
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.
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.
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
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