Inc., Teva Pharmaceuticals USA, Inc., and Barr Laboratories,
Inc. (collectively Generic Defendants) appeal the trial
court's denial of their summary judgment motion in a
products liability lawsuit filed by Diana Sherman.
Generic Defendants are manufacturers of metoclopramide, the
generic version of the prescription drug Reglan. Sherman
developed a movement disorder called tardive dyskinesia after
taking metoclopramide for six years as prescribed by Dr.
Bruce Silverman. She filed a lawsuit against the Generic
Defendants, alleging that they had violated the Washington
Product Liability Act (WPLA), chapter 7.72 RCW, by failing to
provide adequate warnings about the risk of developing
tardive dyskinesia associated with using metoclopramide.
duty to warn claim against the Generic Defendants derives
from federally approved changes to the Reglan label, also
known as the "package insert," that in 2004 and
2009 strengthened the warnings about using metoclopramide.
Sherman claims that the Generic Defendants violated their
duty to warn in two ways. First, they failed to update their
package inserts for generic metoclopramide to reflect the
strengthened warnings on the revised Reglan labels. Second,
they failed to communicate the strengthened warnings to Dr.
Silverman and the physician community in general in other
ways besides in their package inserts.
that the trial court erred in denying the Generic
Defendants' summary judgment motion regarding (1)
Sherman's "failure to update" claim because Dr.
Silverman's testimony that he did not read any package
inserts precluded any genuine issue of fact as to whether the
Generic Defendants' failure to update their
metoclopramide warnings proximately caused her tardive
dyskinesia; and (2) Sherman's "failure to
communicate" claim because, under the facts of this
case, the Generic Defendants had no duty under the WPLA to
communicate warnings by means other than the package
we reverse the trial court's order denying the Generic
Defendants' summary judgment motion and remand for the
trial court to dismiss Sherman's claims against the
is a prescription medication that is used for the treatment
of gastroesophageal reflux. A known risk of using
metoclopramide includes the development of tardive
dyskinesia, a neurological disorder characterized by abnormal
first saw Dr. Silverman in 2003 for severe digestive issues.
After other treatments failed to relieve Sherman's
symptoms, Dr. Silverman prescribed metoclopramide. While on
metoclopramide, Sherman's digestive symptoms improved
significantly. She stayed on metoclopramide from September
2004 to December 2010.
Silverman evaluated Sherman regularly while she was on
metoclopramide and before 2010 did not see any indication
that she was experiencing involuntary movements. However, in
June 2010, Sherman began experiencing involuntary movements.
In August 2011, she was diagnosed with tardive dyskinesia.
in 1985, the package insert for Reglan contained a warning
stating that tardive dyskinesia may develop in patients
treated with metoclopramide. The warning stated that the risk
of developing the syndrome was "believed to increase
with the duration of treatment and the total cumulative
dose." Clerk's Papers (CP) at 715. The warning also
stated that "[e]xtrapyramidal symptoms, manifested
primarily as acute dystonic reactions, occur in approximately
1 in 500 patients" treated with metoclopramide. CP at
715. Under the dosage and administration section, the package
insert stated that "[t]herapy longer than 12 weeks has
not been evaluated and cannot be recommended." CP at
2004, the brand-name manufacturer revised the Reglan package
insert. Both the indications and usage section and the dosage
and administration section of the revised package insert
contained a statement that therapy with metoclopramide
"should not exceed 12 weeks in duration." CP at
766. There was no change to the reference to tardive
dyskinesia in the warnings section.
2009, the Food and Drug Administration (FDA) required the
brand-name manufacturer to add a "black box
warning" to the Reglan package insert. CP at 84. The
warning was placed at the top of the package insert and
Treatment with metoclopramide can cause tardive dyskinesia, a
serious movement disorder that is often irreversible. The
risk of developing tardive dyskinesia increases with duration
of treatment and total cumulative dose. Metoclopramide
therapy should be discontinued in patients who develop signs
or symptoms of tardive dyskinesia. There is no known
treatment for tardive dyskinesia. In some patients, symptoms
may lessen or resolve after metoclopramide treatment is
stopped. Treatment with metoclopramide for longer than 12
weeks should be avoided in all but rare cases where
therapeutic benefit is thought to outweigh the risk of
developing tardive dyskinesia.
warnings section of the revised package insert contained
additional information about tardive dyskinesia, including
that "one published study reported a TD [tardive
dyskinesia] prevalence of 20% among patients treated for at
least 12 weeks." CP at 507. The warning concluded,
"Treatment with metoclopramide for longer than 12 weeks
should be avoided in all but rare cases where therapeutic
benefit is thought to outweigh the risk of developing
TD." CP at 507.
2013, Sherman filed a complaint against the Generic
Defendants and others. In her amended complaint, she asserted a
WPLA claim against the Generic Defendants for failing to
provide adequate warnings to doctors regarding the use of
metoclopramide. Specifically, Sherman alleged that the
Generic Defendants had breached their duty to provide
adequate warnings by failing (1) to update their package
inserts for metoclopramide to match the strengthened warnings
added to the Reglan label in 2004 and 2009, and (2) to
communicate the new warning information in the revised Reglan
labels to doctors through other means.
deposition, Dr. Silverman stated that he was aware when he
prescribed metoclopramide for Sherman that one of the
potential risks was development of some sort of movement
disorder. For any patient on metoclopramide, including
Sherman, he would always watch for movement disorders. Dr.
Silverman stated that he was not aware of any clinician who
had actually observed tardive dyskinesia associated with
using metoclopramide, but that at some point "word got
around" that tardive dyskinesia was something for which
doctors should be looking. CP at 192.
Dr. Silverman testified that he did not read package inserts
and did not recall ever reading a package insert. He did not
use package inserts to learn about medications. Specifically,
Dr. Silverman testified that he had never read a package
insert for Reglan or metoclopramide. He also did not recall
ever seeing a "Dear Doctor" letter from a drug
manufacturer. CP at 178. He said that such letters might have
been in a stack of mail he received every day that he never
opened. But he generally did not learn new information about
medications through the mail.
his treatment of Sherman, Dr. Silverman testified that he did
not rely on any package insert for Reglan or for generic
metoclopramide when deciding whether to initially prescribe
metoclopramide and whether to continue prescribing
metoclopramide. Similarly, he stated that any changes to the
package inserts for metoclopramide did not impact his
prescription decision because he did not look at them.
Instead, he relied on his clinical training and experience,
the experience of his colleagues and associates, and his
mentors and people in the academic world who he respected.
Generic Defendants filed a motion for summary judgment. In
support, they relied on Dr. Silverman's deposition
testimony to argue that any failure to warn could not be the
proximate cause of Sherman's condition as a matter of
law. The trial court denied the summary judgment motion.
Generic Defendants filed a motion for discretionary review of
the trial court's ruling. A commissioner of this court
granted the motion. Ruling Granting Review, Sherman v.