A woman underwent back surgery at the defendant hospital. During the procedure, the surgeon used a combination of two medical products: a putty to promote bone growth and a bone void filler. After the surgery, the product migrated to other areas of her body and the woman experienced excessive bone growth which required additional surgery. During the second surgery the surgeon used a different bone graft product in a manner that was not approved. The woman never recovered from the surgeries and suffered from disabling pain.
The woman sued the surgeons and hospital for negligence. 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. The woman moved to amend her complaint against the hospital to allege three new causes of action: (1) violation of California’s Protection of Human Subjects in Medical Experimentation Act, (2) fraud, and (3) negligence per se. The plaintiff also moved for leave to amend to seek punitive damages against the hospital in accordance with California’s Code of Civil Procedure.
In support of her motions, the woman presented a declaration from plaintiff's counsel and three attached letters from the hospital's Institutional Review Board (IRB) to the surgeon. The plaintiff's counsel declared that a third defendant 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 putty to promote bone growth on patients at the hospital. Counsel asserted the letters demonstrated plaintiff was an unwitting participant in a secret research project conducted by the hospital.
Finding the declaration from counsel and three letters sufficient evidence to support a claim for punitive damages, the Superior Court of Los Angeles County granted the woman’s motion to amend her complaint. The hospital appealed.
On appeal, the Second District, Division 5, California Court of Appeal issued an alternative writ of mandate directing the Superior Court of Los Angeles County to reconsider and reverse its ruling, or show cause before the Court of Appeal why a peremptory writ should not issue directing it to do so. The Superior Court of Los Angeles County 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.
The Court of Appeal issued a writ directing the Superior Court of Los Angeles County to set aside its order and enter a new order denying the motion. The court held that the plaintiff's counsel's declaration and the three letters were insufficient as a matter of law to support the motion to amend the complaint to allege punitive damages. The court determined that California law 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. The court found that the woman's showing in support of the motion to amend the complaint contained no competent evidence to substantiate any of her claims.
The court found that the only sworn evidence before the Superior Court of Los Angeles County was the declaration by plaintiff's counsel. Counsel's declaration established personal knowledge of only one fact relevant to the issue of punitive damages—that the three letters on hospital letterhead were a part of the discovery received from a third-party defendant. Counsel set forth no personal knowledge of the existence of a secret research study conducted by the hospital, plaintiff's participation in the study, or her lack of consent.
The court found that the three letters relied upon by the plaintiff and the Superior Court of Los Angeles County did not establish that the hospital was conducting a secret research project, that plaintiff was a subject of such a project, or that if a project existed, she did not consent to participation. The letters only reflect that the surgeon conducted a protocol study of the putty to promote bone growth. Nothing in the letters showed that the hospital, as opposed to the surgeon, was conducting a study. The letters did not reflect the existence of a secret research project. Because the participants in the protocol are not identified in the letters, they provide no proof that the woman was part of a study, or that if she was, that she did not give informed consent to the surgeon.
See: Pomona Valley Hospital Medical Center v. Superior Court, 2013 WL 497929, 13 Cal. Daily Op. Serv. 1545 (Cal.App. 2 Dist., February 7, 2013) (not designated for publication).
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory