## Facts

- Laura Tivoli was diagnosed with Cushing’s syndrome and was referred to the National Institutes of Health (NIH) Clinical Center for evaluation and treatment.
- At the NIH Clinical Center, patients are placed into one or more studies overseen by the NIH Institutional Review Board (IRB).
- Tivoli underwent an Inferior Petrosal Sinus Sampling (IPSS) procedure in connection with confirming her diagnosis and locating a suspected pituitary tumor.
- The IPSS was treated as an experimental procedure in the NIH research setting.
- The IPSS was performed without obtaining the informed consent required by NIH and the IRB for research procedures.
- Tivoli suffered a stroke that left her severely injured, described in secondary summaries as crippled and disfigured.
- Tivoli brought a Federal Tort Claims Act (FTCA) action against the United States based on the acts and omissions of NIH clinicians, alleging failure to obtain the required informed consent in connection with the IPSS.

## Issues

1. In an FTCA action, may the United States be held liable under applicable state tort law for NIH clinicians’ failure to obtain informed consent for an experimental, research-protocol procedure performed at the NIH Clinical Center?
2. Does a failure to obtain NIH/IRB-required research informed consent support an informed-consent claim (or otherwise supply evidence of breach) under the FTCA’s “law of the place” standard?
3. What causation must a plaintiff show to recover for lack of informed consent, including whether the undisclosed risk materialized and whether proper disclosure would have changed the patient’s decision?

## Decision

- The district court issued an unpublished decision resolving Tivoli’s FTCA claims arising from the IPSS procedure and the alleged failure to obtain the required informed consent. *Tivoli v. United States*, 1996 WL 1056005 (S.D.N.Y. 1996).
- The United States Court of Appeals for the Second Circuit affirmed the district court’s judgment. See *Tivoli v. United States*, 164 F.3d 619 (2d Cir. 1998) (affirming).

## Legal Principles

- The FTCA permits suit against the United States for torts committed by federal employees acting within the scope of employment, but liability depends on whether a private person would be liable under the applicable state law where the acts occurred.
- Informed-consent liability generally turns on whether the physician failed to disclose material information (such as material risks, alternatives, and the nature of the procedure) that a reasonable patient would consider significant in deciding whether to undergo the procedure.
- A plaintiff asserting lack of informed consent must also establish causation, commonly requiring proof that the procedure caused the injury and that adequate disclosure would have led the patient to decline the procedure.
- Research-setting requirements (such as IRB and protocol consent requirements) can be relevant evidence when evaluating what information should have been disclosed and whether the care fell below required standards, but the actionable duty in an FTCA case remains tied to state tort law.

## Conclusion

*Tivoli v. United States* arose from NIH’s performance of an experimental IPSS procedure on a patient with Cushing’s syndrome without obtaining the research informed consent required by NIH and its IRB, after which the patient suffered a disabling stroke. Tivoli sued the United States under the FTCA for failure to obtain the required informed consent in connection with the procedure, and the Southern District of New York’s judgment was later affirmed by the Second Circuit.


Tivoli v. United States, 1996 WL 1056005 (1996)