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DIANA MICHELE MILTON ET AL. v. DOROTHY ROBINSON ET AL.* (AC 32150)
Beach, Espinosa and Pellegrino, Js. Argued May 25--officially released October 4, 2011

(Appeal from Superior Court, judicial district of Waterbury, Complex Litigation Docket, Stevens, J.) Diana Michele Milton, pro se, and Clive Milton, pro se, the appellants (plaintiffs). Joseph G. Blute, pro hac vice, with whom were Yalonda T. Howze, pro hac vice, and, on the brief, Charlsa D. Broadus, James H. Rotondo and James E. Hennessey, for the appellee (defendant Biogen Idec, Inc.). Kevin M. Smith, with whom, on the brief, was Robert J. Klee, for the appellee (defendant Yale University School of Medicine et al.).

Opinion

BEACH, J. The plaintiffs, Diana Michele Milton and her husband, Clive Milton,1 appeal from the summary judgment rendered by the trial court in favor of the defendants, Biogen Idec, Inc. (Biogen), Yale University School of Medicine (university) and Yale-New Haven Hospital (hospital).2 On appeal, the plaintiff claims that the court (1) erroneously ordered a Porter3 hearing regarding one of her expert witnesses, (2) abused its discretion by granting certain motions in limine in favor of the defendants, (3) erred by granting summary judgment in favor of the defendants and by denying her motion for summary judgment, (4) erroneously granted the university's motion to strike a count of her substitute complaint and (5) erroneously construed the counts of her complaint pertaining to the hospital and the university as sounding in medical malpractice rather than product liability.4 We disagree and affirm the judgment of the trial court. The following factual and procedural history is relevant to our resolution of the plaintiffs' appeal. In 1996, Biogen and the university entered into a clinical trial agreement in which the university agreed to conduct a phase III clinical study (study) investigating the efficacy of natalizumab, a Biogen product, for the treatment of relapsing-remitting multiple sclerosis. The agreement provided that the university was to conduct the study pursuant to a lengthy protocol developed by Biogen.5 The protocol dictated that the study was to be randomized, double-blind and placebo-controlled. As such, the participants randomly were assigned to either a group receiving natalizumab or a group receiving a placebo. The placebo consisted of the excipients used in the study drug: saline solution, polysorbate 80 and water, but did not contain natalizumab, the active ingredient in the study drug. The study was double-blind in that neither the participants nor the personnel administering the study were informed of which participants were receiving natalizumab and which participants were receiving the placebo. According to the plaintiff's deposition, she was diagnosed in 1997 with relapsing-remitting multiple sclerosis. Following her diagnosis, the plaintiff began consulting with Joseph Guarnaccia, a neurologist. Guarnaccia treated the plaintiff with various therapies that ultimately were unsuccessful and, as a result, she opted to cease all treatment. The plaintiff subsequently experienced trouble with her eyesight, which was caused by her multiple sclerosis. Having already attempted unsuccessful treatment regimens, Guarnaccia recommended to the plaintiff that she participate in the study at issue in this case. In June, 2002, pursuant to Guarnaccia's recommendation, the plaintiff and Clive Milton consulted with Silva

Markovic, a physician at the university who was an investigator for the study. Markovic explained to the plaintiff the purpose and procedure of the study. Markovic also provided to the plaintiff an informed consent form, which described the study in detail, including its potential benefits and risks associated with the study.6 After reading the informed consent form, the plaintiff and Clive Milton also discussed with Markovic the risks. In particular, they discussed the possibility that the plaintiff could suffer from rashes and allergic reactions. The plaintiff conceded that although she understood the disclosed risks associated with the study and was satisfied that such risks adequately were explained to her, she nonetheless voluntarily chose to participate in the study. She signed the informed consent form on June 11, 2002.7 As part of the screening process, the plaintiff also was required to complete a detailed medical history to determine whether she qualified to participate in the study. In her medical history, the plaintiff indicated that she suffered from various allergies but at the time was unaware of any allergy or sensitivity to polysorbate 80. Upon completing the medical history, the plaintiff was deemed qualified to participate in the study. On July 9, 2002, the university administered to the plaintiff her first intravenous infusion pursuant to the study protocol.8 The plaintiff claimed that following the infusion she experienced nausea and heart palpitations for approximately two or three hours. Clive Milton later telephoned the university to report the side effects from which the plaintiff suffered. On August 6, 2002, the plaintiff received her second intravenous infusion. The plaintiff claimed that immediately after the infusion, she suffered from nausea and heart palpitations that lasted for a brief period of time. The plaintiff could not recall whether she formally reported these side effects; she, however, did discuss the side effects with the physician who had administered the infusion. The plaintiff conceded that she was not aware of any rashes or skin problems at this point in her treatment. On September 9, 2002, the plaintiff received her third infusion. The plaintiff again claimed to have suffered from nausea and heart palpitations immediately following the infusion. Within twenty-four hours of the infusion, the plaintiff also began to experience a severe itching in her scalp. The itching extended down to the plaintiff's torso, at which time she noticed that her back was covered with ``a big red rash . . . like I had a million mosquito bites.'' The plaintiff contacted the university and left a message informing it of the side effects from which she suffered. The university contacted the plaintiff approximately two days later and referred her to Julie Schaeffer, a dermatologist employed by the university. After conducting a biopsy, Schaeffer

informed the plaintiff that she likely was suffering from a drug related reaction. Thereafter, because the plaintiff's rash persisted, she decided, after consulting with university physicians, to withdraw from the study. The plaintiff subsequently was ``unblinded,'' and it was revealed that she had been receiving infusions of the placebo rather than the study drug, natalizumab. The plaintiff contends that subsequent testing revealed that she was allergic to polysorbate 80. The plaintiffs filed the operative complaint on January 29, 2008.9 Counts one through six10 of the complaint were directed against the university and the hospital and alleged, inter alia, that they (1) negligently conducted the study, (2) negligently failed to respond properly to the plaintiff's adverse reaction to the placebo and negligently failed to remove her from the study, (3) failed adequately to obtain her informed consent to participate in the study and (4) failed to provide medical treatment to the plaintiff. Counts seven through ten were directed against Biogen and alleged, inter alia, that Biogen (1) negligently failed to respond properly to her adverse reaction to the placebo and negligently failed to remove her from the study, (2) was negligent in using polysorbate 80 as a compound in the placebo, (3) negligently failed to conduct preliminary allergy testing as to the components contained in the study drug and the placebo, (4) breached its fiduciary relationship to the plaintiff and (5) deviated from its standard of care in developing the study protocol. The complaint also alleged that Clive Milton suffered both a loss of consortium and emotional distress as a result of the defendants' negligence. On November 6, 2008, the plaintiff disclosed John Santilli, Jr., an allergist, as an expert witness concerning, inter alia, standard of care and causation. On May 1, 2009, the plaintiff disclosed Clive Milton as an expert witness concerning standard of care and causation. On May 13, 2009, the university and the hospital filed a joint motion for summary judgment, which the court denied on August 31, 2009. On May 15, 2009, Biogen filed a motion for summary judgment, which the court on September 2, 2009, granted only as to count seven of the complaint. On August 5, 2009, the university and the hospital filed a motion in limine seeking to preclude Clive Milton from testifying as an expert, which the court granted. Also on August 5, 2009, the defendants filed several motions in limine seeking to preclude or to limit the testimony of Santilli. The court granted these motions in part and precluded Santilli from testifying as to some of the subject matters listed in the disclosure. The court also ordered a Porter hearing regarding some of the issues raised in the multiple motions in limine. On November 20, 2009, following the hearing, the court denied as moot the Porter motion but precluded Santilli

from testifying as an expert witness as to standard of care. Upon the court's ruling regarding the preclusion of Santilli's expert testimony, the defendants filed renewed motions for summary judgment, which the court granted. This appeal followed. Additional facts will be set forth as necessary. I The plaintiffs first claim that the court erroneously ordered a Porter hearing in order to determine the admissibility of Santilli's testimony. We disagree. The following additional facts are relevant to our resolution of the plaintiffs' claim. On August 5, 2009, Biogen filed a motion in limine seeking to preclude Santilli from offering testimony pertaining to, inter alia, ``any opinions on the adequacy of the clinical trial design,'' ``the use of polysorbate 80 . . . in the . . . [s]tudy [d]rug placebo'' and any opinions regarding any causal connection between polysorbate 80 and the plaintiff's skin rashes. Also on August 5, 2009, the university and the hospital filed three motions in limine seeking to preclude Santilli from offering testimony regarding causation and standard of care and to limit his testimony to the opinions he expressed during his deposition. The court held a hearing on these motions on September 8, 2009. During the hearing, the court stated that it was ``not confident that [it] could make the ruling on the basis of [Santilli's] deposition.'' The court ruled on parts of the motion but as to the other parts said that it was ``inclined to hear . . . evidence [regarding Santilli's testimony] on the record . . . [a]nd evaluate the arguments and the motions which have been made in that context.'' The court scheduled a Porter hearing; the plaintiffs claim that the court erred in scheduling a hearing.11 The plaintiff's disclosure of Santilli as an expert witness stated that Santilli planned to offer, inter alia, the following opinions: (1) the study protocol developed by Biogen was defective because of the lack of allergen testing of the study drug components, (2) the plaintiff was allergic to polysorbate 80 prior to the study, (3) the infusion of the placebo caused the plaintiff's hypersensitivity to polysorbate 80, (4) the plaintiff should have been removed from the study after both the first and second placebo infusions, (5) the informed consent forms signed by the plaintiff were insufficient such that her consent was not fully informed, (6) the placebo contained a substance not intended for injectable use, (7) the university and the hospital breached their duty properly to review the study protocol and (8) the university improperly supervised the study. We first set forth our relevant standard of review and legal principles that govern our analysis of the plaintiffs' claim. ``[T]he trial court is vested with wide discretion

in determining the admissibility of evidence. . . . Because a trial court's ruling under Porter involves the admissibility of evidence, we review that ruling on appeal for an abuse of discretion.'' (Citation omitted; internal quotation marks omitted.) State v. Sorabella, 277 Conn. 155, 214, 891 A.2d 897, cert. denied, 549 U.S. 821, 127 S. Ct. 131, 166 L. Ed. 2d 36 (2006). ``In State v. Porter, [241 Conn. 57, 698 A.2d 739 (1997) (en banc), cert. denied, 523 U.S. 1058, 118 S. Ct. 1384, 140 L. Ed. 2d 645 (1998)], our Supreme Court adopted the test for determining the admissibility of scientific evidence set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). In so doing, the court noted two threshold requirements to the admissibility of scientific evidence. First, that the subject of the testimony must be scientifically valid, meaning that it is scientific knowledge rooted in the methods and procedures of science . . . and is more than subjective belief or unsupported speculation. . . . This requirement establishes a standard of evidentiary reliability . . . as, [i]n a case involving scientific evidence, evidentiary reliability will be based upon scientific validity. . . . Second, the scientific evidence must fit the case in which it is presented. . . . In other words, proposed scientific testimony must be demonstrably relevant to the facts of the particular case in which it is offered, and not simply be valid in the abstract.'' (Citation omitted; internal quotation marks omitted.) State v. Haughey, 124 Conn. App. 58, 71, 3 A.3d 980, cert. denied, 299 Conn. 912, 10 A.3d 529 (2010). Although the Supreme Court in Porter established the requirements for the admissibility of scientific evidence, it ``did not define what constituted `scientific evidence,' thereby allowing the courts to maintain some flexibility in applying the test. As a result, a court's initial inquiry should be whether the [evidence] at issue . . . is the type of evidence contemplated by Porter. . . . In Porter, our Supreme Court noted that `some scientific principles have become so well established that an explicit . . . analysis [under Daubert v. Merrell Dow Pharmaceuticals, Inc., supra, 509 U.S. 579] is not necessary for admission of evidence thereunder. . . . Evidence derived from such principles would clearly withstand a Daubert analysis, and thus may be admitted simply on a showing of relevance.' '' (Citations omitted; internal quotation marks omitted.) State v. Legnani, 109 Conn. App. 399, 419, 951 A.2d 674, cert. denied, 289 Conn. 940, 959 A.2d 1007 (2008). The plaintiffs argue that because Santilli was disclosed properly and because he is a board certified allergist, it ``was a manifest error [for] the . . . court to hold a Porter [hearing] for . . . Santilli when it was not expressly required as a matter of law.'' We disagree. Even if Santilli was properly disclosed and was a board certified allergist, his proposed testimony was

not necessarily admissible simply upon a showing of relevance. The scientific principles informing his proposed testimony, which pertained to study protocols and allergic reactions to polysorbate 80, were not so obviously well established or universally recognized as reliable as to render erroneous the ordering of a reliability assessment pursuant to Porter. See Maher v. Quest Diagnostics, Inc., 269 Conn. 154, 168 n.19, 847 A.2d 978 (2004) (``the standard articulated in Porter applies generally to scientific evidence, unless that scientific evidence is so well established that a threshold admissibility analysis is rendered unnecessary''); compare State v. Hasan, 205 Conn. 485, 534 A.2d 877 (1987) (podiatrist's testimony concerning probability that pair of sneakers would fit defendant's feet not scientific evidence because jury could employ common sense and independent judgment to view and evaluate evidence). In order to conduct the reliability assessment under Porter, the court determined that a hearing was necessary and that it could not rule on the motions in limine based solely on Santilli's deposition. In doing so, the court acted within its discretion. Accordingly, we cannot say that the court erred by holding a Porter hearing to determine the admissibility of Santilli's testimony.12 II The plaintiffs claim that the court abused its discretion by granting various motions in limine in favor of the defendants and thus precluding their disclosed expert witnesses from offering expert testimony. We are not persuaded. We first set forth our relevant standard of review and legal principles that govern our analysis of the plaintiffs' claim. ``The trial court's ruling on evidentiary matters will be overturned only upon a showing of a clear abuse of the court's discretion. . . . The trial court has wide discretion in ruling on the qualification of expert witnesses and the admissibility of their opinions. . . . The court's decision is not to be disturbed unless [its] discretion has been abused, or the error is clear and involves a misconception of the law. . . . Expert testimony should be admitted when: (1) the witness has a special skill or knowledge directly applicable to a matter in issue, (2) that skill or knowledge is not common to the average person, and (3) the testimony would be helpful to the court or jury in considering the issues. . . . It is well settled that [t]he true test of the admissibility of [expert] testimony is not whether the subject matter is common or uncommon, or whether many persons or few have some knowledge of the matter; but it is whether the witnesses offered as experts have any peculiar knowledge or experience, not common to the world, which renders their opinions founded on such knowledge or experience any aid to the court or the jury in determining the questions at issue. . . . Implicit in this standard is the requirement . . . that the expert's

knowledge or experience must be directly applicable to the matter specifically in issue.'' (Internal quotation marks omitted.) Baranowski v. Safeco Ins. Co. of America, 119 Conn. App. 85, 94

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