ORIGINAL PROCEEDINGS; petition for writ of mandate. Michael P. Linfield, Judge. (L.A. Super. Ct. No. BC465313)
The opinion of the court was delivered by: Kriegler, J.
CERTIFIED FOR PUBLICATION
Code of Civil Procedure section 425.13, subdivision (a),*fn1 as interpreted in College Hospital Inc. v. Superior Court (1994) 8 Cal.4th 704 (College Hospital), precludes a plaintiff from alleging punitive damages against a health care provider unless the plaintiff demonstrates "a substantial probability" that she will "prevail on the claim." Based on a declaration from counsel for plaintiff and real party in interest April Christine Cabana and three letters obtained from a third party defendant, respondent court granted plaintiff's motion to amend her complaint to allege a claim for punitive damages against petitioner and defendant Pomona Valley Hospital and Medical Center (the Hospital).
We issued an alternative writ of mandate to respondent court, citing, inter alia, College Hospital, which rejected an attempt to amend a complaint to allege punitive damages based on a showing far stronger than plaintiff's. Our alternative writ directed respondent court to reconsider and reverse its ruling, or show cause before this court why a peremptory writ should not issue directing it to do so. Respondent court held a hearing in compliance with the alternative writ but concluded it had properly granted the motion to amend the complaint to allege punitive damages.
Because plaintiff's counsel's declaration and the three letters are insufficient as a matter of law to support the motion to amend the complaint to allege punitive damages, we direct respondent court to set aside its order and enter a new order denying the motion.
Plaintiff filed a complaint on July 13, 2011, against various defendants, including the Hospital*fn2 . Defendant Dr. Ali H. Mesiwala performed surgery at the Hospital on plaintiff for back pain on September 26, 2008, using two products manufactured by defendant Stryker Biotech, LLC--Calstrux and OP-1. Plaintiff alleged the mixture had not been approved by the Food and Drug Administration. Complications from use of the products in the surgery resulted in injury requiring a second surgery. The Hospital was named as a defendant only in the eleventh cause of action, which alleged negligence by the Hospital staff in connection with the two surgeries.
Plaintiff's Motion to Amend the Complaint and Seek Punitive Damages
On August 20, 2012, plaintiff filed a motion to amend her complaint against the Hospital to allege three new causes of action: (1) violation of Health and Safety Code section 24170 et seq. (the Protection of Human Subjects in Medical Experimentation Act); (2) fraud; and (3) negligence per se. In addition, plaintiff moved for leave to amend to seek punitive damages against the Hospital in the manner required by section 425.13.
The sworn evidence presented in support of the motion to amend
consisted of a declaration from plaintiff's counsel and three attached
letters from the Hospital's Institutional Review Board (IRB)*fn3
to Dr. Mesiwala. Plaintiff's counsel declared that
defendant Stryker Biotech had provided discovery of approximately
85,000 pages of documents, including the three letters. Counsel
described the three letters as showing the Hospital "was conducting a
secret 'research project' which included patient 'randomization' to
test the experimental/humanitarian device OP-1 Putty on patients at
the hospital." Counsel asserted the letters demonstrated plaintiff
was an unwitting participant in a secret research project conducted by
the Hospital. The balance of counsel's declaration consisted of
argument as to why the proposed amendments should be allowed.
The three letters relied upon by plaintiff were on the Hospital's letterhead, addressed to Dr. Mesiwala. Each letter pertained to "Protocol Study: OP-1 Putty: An FDA approved device under the Humanitarian Use Device (HUD) regulations." The letters were signed by either the chairperson or vice-chair of the Hospital's IRB.
The first letter, dated February 4, 2009, gave approval of "your request" for annual renewal by the IRB of the OP-1 Putty protocol study. The letter indicated that information submitted in connection with the annual renewal showed four subjects in the study, all of whom were "still alive" and "in follow-up." "While the PVHMC Board has approved the study, we are requesting the following information be submitted as soon as possible in order to better understand your study: 1. How many patients are enrolled nationally? 2. You mentioned that the material and procedure under study are very effective. If efficacy is obvious, should the research project and randomization be continued? Is there an ongoing statistical review process to make sure that the incoming study data do ...