United States District Court, D. Massachusetts
MEMORANDUM AND ORDER ON PLAINTIFFS' MOTION TO
Dennis Saylor IV United States District Judge.
case is part of a multi-district litigation proceeding
arising out of claims that the use of the drug Zofran
(ondansetron) by pregnant women caused birth defects.
Plaintiffs Thomas Brown and Maria Del Carmen Espindola Gomez
originally filed suit in Oregon state court against
defendants GlaxoSmithKline, LLC (“GSK”) and
Providence Health System-Oregon d/b/a Providence Newberg
Medical Center f/k/a Providence Newberg Hospital
(“Providence”) alleging that Espindola
Gomez's use of Zofran during pregnancy caused congenital
heart defects in her child.
case is before the Court for a second time, having been
removed, transferred to this MDL proceeding, and then
remanded three years ago. See Brown, et al. v.
GlaxoSmithKline, LLC, et al., 16-cv-10215-FDS. Upon
remand, and after two more years of litigation in Oregon
state court, the claims against Providence were dismissed
following a successful motion for summary judgment. That
prompted GSK to remove the case to federal court for a second
time. Plaintiffs have again moved to remand, contending that
the removal was untimely and barred by the
“voluntary-involuntary” doctrine. With
plaintiffs' motion to remand pending, the Judicial Panel
for Multidistrict Litigation (“MDL Panel”) once
again transferred the case to this district.
following reasons, and having considered the issue with the
benefit of the state court's summary-judgment record,
plaintiffs' motion to remand will be granted.
GSK distributed and sold the drug ondansetron under the brand
name Zofran. Zofran was first approved in 1991 for the
prevention of post-operative nausea and vomiting associated
with anesthesia and for nausea and vomiting caused by
radiotherapy and chemotherapy. In addition to those approved
uses, GSK is alleged to have marketed Zofran
“off-label” for pregnancy-related nausea and
vomiting, commonly known as “morning sickness.”
Plaintiffs in this multidistrict litigation allege that
Zofran was in fact unsafe for use in pregnant women, and that
in utero exposure to Zofran caused birth defects in
children born to mothers who took the drug. This particular
action involves the claims of two plaintiffs: Thomas Brown
and Maria Del Carmen Espindola Gomez, who are the parents of
M.B. Plaintiffs sued both GSK, the manufacturer of Zofran,
and Providence, a hospital located in Oregon that dispensed
Zofran to Espindola Gomez.
August 28, 2015, plaintiffs filed a complaint in Oregon state
court. The complaint named GSK and Providence as defendants,
and alleged seven counts arising out of congenital heart
defects suffered by M.B. and allegedly caused by Espindola
Gomez's use of name-brand Zofran during pregnancy. Three
of those claims were brought against Providence: strict
liability (Count Three); negligent misrepresentation (Count
Five); and loss of consortium (Count Seven).
October 2015, GSK removed the action to the United States
District Court for the District of Oregon based on a facial
challenge to the complaint, contending that Providence's
citizenship should be ignored for diversity jurisdiction
purposes because it was fraudulently joined. Plaintiffs moved
to remand the case for lack of subject-matter jurisdiction
due to a lack of complete diversity of citizenship among the
parties. On January 5, 2016, the district court stayed the
case pending its transfer to this district by the MDL Panel
for consolidation pursuant to 28 U.S.C. § 1407.
case was transferred by the MDL Panel to this district in
February 2016. On April 21, 2016, plaintiffs renewed their
motion to remand. GSK opposed remand on the ground that
complete diversity existed based on the doctrine of
Court granted the motion to remand on June 16, 2016. It
observed that under Oregon law, strict liability may attach
to a “seller” of a product in a defective
condition, unreasonably dangerous to the user or consumer, if
the seller “is engaged in the business of
selling” such a product. Or. Rev. Stat. Ann. §
30.920(1). At the time, the Oregon Supreme Court had not
decided the issue of whether a healthcare provider such as a
hospital may be held liable on a strict-liability claim as a
“seller” of a prescription drug. However, at
least two federal courts in the District of Oregon had held
that such a products-liability claim against a healthcare
provider may, in fact, be viable under Oregon law. Thus, and
in the absence of any controlling Oregon authority, the Court
concluded that there was at least a “reasonable
possibility” that the Oregon Supreme Court would
recognize a strict-liability claim against a healthcare
provider that dispensed a pharmaceutical product. See
Universal Truck & Equip. Co. v. Southworth-Milton,
Inc., 765 F.3d 103, 108 (1st Cir. 2014). The Court also
concluded that the allegations in the complaint, although
sparse, appeared sufficient to meet the statutory requirement
that Providence was in the “business of selling”
Zofran as required by the statute.
parties then litigated the case for two more years in Oregon
state court. Plaintiffs' claims against Providence
survived a motion to dismiss in December 2016, and the
parties proceeded to discovery. At the close of discovery,
Providence moved for summary judgment on the two remaining
claims against it: strict liability and negligent
the strict-liability claim, Providence contended that
plaintiffs had no basis for their claims that the hospital
“sold” Zofran to Espindola Gomez. It supported
that contention with, among other things, the following
• “[Providence] had an inpatient pharmacy located
within the hospital facility which stocked a wide range of
pharmaceuticals for administration to a patient upon the
order of a physician on its medical staff.”
(Providence's Mot. for Partial Summary Judgment at 9).
• “[Providence] dispensed pharmaceuticals as part
of its provision of medical services to patients at the
hospital only and was not in the business of selling Zofran
injectable or other medications to the public.”
• “[Providence] [did not] market or advertise
Zofran injectable or any other medications for sale.”
• “[Providence] was prohibited by state and
federal law from selling medications to patients after
discharge from the hospital.” (Id.).
• “A person such as plaintiff [Espindola] Gomez
could not just come in to [Providence] and purchase Zofran
opposed the motion as to the strict-liability claim,
contending that “Providence was engaged in the business
of selling Zofran and that defendant sold, distributed,
vended, administered and/or supplied the Zofran which caused
the injuries at issue in this case.” (Pls.' Resp.
at 7). They supported that contention with, among other
things, the following undisputed facts:
• “[Providence's] in-house pharmacy vended
[Zofran].” (Id. at 2).
• “[Providence] billed both Ms. Espindola
Gomez's insurer and Ms. Espindola Gomez herself for the
drug.” (Id. at 3).
• “Ms. Espindola Gomez signed a document . . .
entitled, ‘Condiciones de Servicio'
(‘Conditions of Service'), ” wherein she
“agree[d] to pay for the services or products
provided by Providence Health System.” (Id.)
(emphasis added). That agreement specified that
“Providence Health System includes hospitals, clinics,
ambulatory services, home and community services, retail
pharmacies and convalescent centers.”
(Id. at 4) (emphasis added).
voluntarily dismissed their negligent-misrepresentation claim
during oral argument on October 29, 2018. Ruling from the
bench on the strict-liability claim, Judge Silver concluded
that “in this particular case, under these facts,
” Providence was not in the business of selling Zofran.
Judge Silver specifically observed:
. . . I can't find, under the specific facts of this
case, that the hospital was engaged in the business of
selling Zofran. There certainly could be scenarios in which a
hospital could be found to be engaged in the business of
selling a particular drug. But under the facts of this case,
. . . I don't believe that the . . . intent of the