Heard: May 5, 2016.
action commenced in the Superior Court Department on
September 21, 2010.
case was heard by Heidi E. Brieger, J., on a motion for
P. Luhana, of New York, for the plaintiff.
M. Sharko, of New Jersey, for Ortho-McNeil Pharmaceutical,
Inc., and others.
Present: Cypher, Blake, & Henry, JJ.
Duffy was a seventeen year old college student when she
collapsed in her dormitory room and died of a pulmonary
embolism. Duffy's mother, Leslie Niedner, as
administratrix of Duffy's estate, filed a complaint
against the defendants, Ortho-McNeil Pharmaceutical, Inc.;
Johnson & Johnson; and Johnson & Johnson
Pharmaceutical Research and Development, LLC (collectively, J
& J), alleging multiple causes of action relating to J
& J's birth control product, Ortho
Evra.Following a hearing on J & J's
motion for summary judgment, a judge of the Superior Court
allowed the motion and ordered the dismissal of the complaint
in its entirety. We affirm.
following undisputed facts are taken from the summary
judgment record. Sara M. Nelson of the Massachusetts General
Hospital Chelsea Healthcare Clinic was Duffy's
pediatrician from about October of 2004, until her death in
2009. In July, 2008, Duffy, accompanied by Niedner, met with
Nelson to discuss birth control options. Nelson recommended
and prescribed an oral birth control pill. The prescription
was filled in July, August, and September of 2008. Duffy also
used condoms when she was sexually active. At some point
thereafter, Duffy discontinued her use of oral birth control
June, 2009, Duffy decided that she needed a backup birth
control method, again, in addition to condoms. She and
Niedner met with Nelson on June 23, 2009, to discuss
Duffy's options. Duffy asked Nelson about the Ortho Evra
patch (patch), as she wanted an easy and simple method of
birth control. The patch prevents pregnancy by transferring
synthetic forms of the hormones estrogen and progestin
through the skin. Unlike oral birth control pills, which must
be taken at the same time each day, the patch is applied to
the skin once per week for three weeks, followed by a fourth
prescribed the patch for Duffy at that meeting. As she had
when she prescribed oral birth control pills, Nelson informed
Duffy and Niedner of the risks associated with using the
patch, including that all hormonal contraceptives come with a
risk of suffering blood clots. When the prescription was filled
by Walgreens pharmacy (pharmacy), the package included an
insert prepared by J & J (the manufacturer), as well as a
leaflet from the pharmacy, both of which set forth the risks
associated with use of the patch, including the risks of
stroke, heart attack, and blood clots. Approximately three
months after Duffy began using the patch, she died from a
massive bilateral pulmonary embolus.
October 29, 2010, Niedner filed her first amended complaint
alleging that Duffy's use of the patch had caused her
death, and that J & J was liable for breach of warranty
(under theories of design defect, failure to warn, and
manufacturing defect), breach of express warranty,
negligence, fraudulent concealment, conscious pain and
suffering, and violating the consumer protection act, G. L.
c. 93A. The complaint centers on Niedner's
failure to warn claim, which is based on her allegation that
she and Duffy were not told that the risk of suffering a
blood clot is significantly increased with use of the patch
as compared to an oral contraceptive. Put another way,
Niedner's complaint is focused on the comparative risk of
developing blood clots, not the risk of developing blood
clots in and of itself. J & J moved for summary judgment,
arguing that the risks of using the patch, including the
increased risk of blood clots, were adequately disclosed, and
that Niedner's remaining causes of action fail as a
matter of law for lack of evidence. The judge agreed and
allowed the motion. After judgment entered, this appeal
followed. Additional facts will be set forth as necessary.
Standard of review.
review a grant of summary judgment de novo to determine
'whether, viewing the evidence in the light most
favorable to the nonmoving party, all material facts have
been established and the moving party is entitled to a
judgment as a matter of law.'" Julianov.Simpson, 461 Mass. 527, 529-530 (2012),
quoting from Augat, Inc. v.Liberty
Mut. Ins. Co., 410 Mass. 117, 120 (1991). See
Mass.R.Civ.P. 56(c), as amended, 436 Mass. 1404 (2002).
"The moving party bears the burden of affirmatively
demonstrating the absence of a triable issue."
Inc., 457 Mass. 234, 237 (2010). "Conclusory
statements, general denials, and factual allegations not
based on personal knowledge [are] insufficient to avoid