131 Conn. App. 760
Conn. App. Ct.2011Background
- In 1996 Biogen and the university entered a clinical trial agreement to conduct a phase III natalizumab study for multiple sclerosis under Biogen’s protocol.
- The study was randomized, double-blind, placebo-controlled; placebo contained excipients but no natalizumab.
- Milton participated in 2002 after informed consent and medical history; she later developed a severe itchy rash and was found to be likely allergic to polysorbate 80.
- Milton was unblinded in 2002 and learned she had received placebo; she later alleged polysorbate 80 allergy and inadequate warnings.
- Plaintiffs filed a multi-count complaint in 2008 against the university, hospital, and Biogen alleging negligence, informed consent failures, and related claims; expert disclosures followed (Santilli, Clive Milton).
- The trial court granted several motions in limine and, after Porter hearings, granted summary judgment to all defendants, leading to this appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the Porter hearing was correctly ordered for Santilli’s testimony | Milton argues the Porter hearing was improper given Santilli’s disclosure and expertise | Defendants contend a Porter reliability analysis was warranted for scientific evidence | Porter hearing proper; reliability assessment allowed |
| Whether the in limine rulings precluding Clive Milton and Santilli were an abuse of discretion | Milton asserts exclusion of expert testimony violated due process of proving standard of care | Court acted within wide discretion; Milton lacked admissible, relevant expertise | No abuse; exclusion upheld |
| Whether summary judgment was proper given the lack of admissible expert testimony | Without expert testimony, plaintiff cannot prove medical malpractice or related claims | Sullivan and related authorities permit summary judgment when expert proof is unavailable | Summary judgment upheld for university, hospital, and Biogen |
| Whether the university’s motion to strike count seven (emotional distress bystander claim) was correct | Count seven should stand as a valid emotional distress claim | Maloney bars bystander emotional distress claims in medical malpractice contexts | Count seven struck; Maloney controls |
| Whether the court properly construed the university/hospital claims as medical malpractice rather than product liability | Plaintiff contends claims encompass product liability under Pitt; hospital/university not purely medical malpractice | Plaintiff stated claims were grounded in malpractice and negligence, not product liability | Claims construed as medical malpractice; product liability not found |
Key Cases Cited
- State v. Sorabella, 277 Conn. 155 (2006) (abuse of discretion standard for Porter-type rulings; Daubert framework applied to scientific evidence)
- Porter v. State, 241 Conn. 57 (1997) (Daubert-based admissibility; two thresholds for scientific evidence; reliability and fit)
- Sullivan v. Yale-New Haven Hospital, 64 Conn.App. 750 (2001) (summary judgment in medical malpractice when no expert testimony on standard of care)
- Bourquin v. B. Braun Melsungen, 40 Conn.App. 302 (1996) (expert testimony essential in malpractice; threshold necessity)
- Guzze v. New Britain General Hospital, 16 Conn.App. 480 (1988) (expert proof required for malpractice claims)
- Maloney v. Conroy, 208 Conn. 392 (1988) (bystander emotional distress claims in medical malpractice context barred)
- Baranowski v. Safeco Ins. Co. of America, 119 Conn.App. 85 (2010) (expert qualification standard; relevance and help to jury)
- State v. Haughey, 124 Conn.App. 58 (2010) (Porter framework for scientific testimony; threshold reliability)