Milton v. Robinson, AC 32150

CourtAppellate Court of Connecticut
Decision Date04 October 2011
Docket NumberAC 32150


AC 32150


Argued May 25
officially released October 4, 2011

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Beach, Espinosa and Pellegrino, Js.

(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.).

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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. Guar-naccia 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

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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. Mar-kovic 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

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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...

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