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Niedner v. Ortho-McNeil Pharmaceutical, Inc.

Appeals Court of Massachusetts, Suffolk

September 21, 2016

LESLIE NIEDNER, administratrix, [1]

          Heard: May 5, 2016.

         Civil action commenced in the Superior Court Department on September 21, 2010.

         The case was heard by Heidi E. Brieger, J., on a motion for summary judgment.

          Roopal P. Luhana, of New York, for the plaintiff.

          Susan M. Sharko, of New Jersey, for Ortho-McNeil Pharmaceutical, Inc., and others.

          Present: Cypher, Blake, & Henry, JJ.

          BLAKE, J.

         Adrianna 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.[3]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.


         The 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 pills.

         In 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 patch-free week.

         Nelson 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.[4] 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.

         On 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.[5] 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.


         1. Standard of review.

         "We 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." Levv.Beverly Enterprises-Mass., Inc., 457 Mass. 234, 237 (2010). "Conclusory statements, general denials, and factual allegations not based on personal knowledge [are] insufficient to avoid ...

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