## Facts

- Cynthia Richardson received prenatal care from Dr. James Miller and reported palpitations, rapid heartbeat, and shortness of breath; a cardiologist found no significant abnormality.
- At about 35 weeks’ gestation, Richardson was hospitalized for preterm labor; initial efforts to stop contractions failed.
- Miller prescribed terbutaline, FDA-approved for asthma but commonly used off-label as a tocolytic; Richardson reported chest pain and refused further oral doses.
- Miller recommended a subcutaneous terbutaline infusion pump despite having little experience with such pumps; Tokos Medical Corporation supplied the pump and provided a nurse who set it up and instructed Richardson and hospital staff.
- Richardson received repeated terbutaline doses via the pump over the next few days; after labor stopped, she developed tachycardia and suffered a myocardial infarction, later requiring bypass surgery; the baby was delivered healthy.
- Richardson and her husband sued Miller and Tokos for negligence, alleging continued terbutaline therapy despite warning signs caused the heart attack; the health insurer intervened to seek reimbursement of medical payments.
- Before trial, the court excluded terbutaline package-insert and Physician’s Desk Reference (PDR) materials offered to show the drug’s labeled indications and lack of FDA approval for tocolysis.
- Plaintiffs also sought a missing-evidence jury instruction regarding an absent Tokos nursing assessment form; the trial court refused.
- A jury returned a defense verdict for Miller and Tokos, and the trial court dismissed the insurer’s reimbursement claim.

## Issues

1. Whether drug package labeling and corresponding PDR materials were admissible, with expert testimony, as evidence bearing on the medical standard of care for off-label terbutaline tocolysis.
2. Whether plaintiffs were entitled to a missing-evidence instruction due to the unexplained absence of a Tokos nursing assessment form.
3. Whether defendants were entitled to directed verdicts for insufficient proof of breach and causation.
4. Whether dismissal of the insurer’s reimbursement/subrogation claim was proper in light of the merits disposition.

## Decision

- The appellate court vacated the defense judgment and remanded for a new trial.
- The court held the package insert and PDR entry were relevant and admissible as standard-of-care evidence when presented with expert testimony; exclusion was error that materially impaired plaintiffs’ case.
- The court held denial of a missing-evidence instruction was error where the absent nursing assessment form was within Tokos’s control, expected to be preserved, and not satisfactorily accounted for.
- The court rejected defendants’ directed-verdict arguments, finding the proof created jury questions on breach and causation when viewed favorably to plaintiffs.
- The court vacated dismissal of the insurer’s claim for reconsideration on remand.

## Legal Principles

- Drug package inserts and parallel PDR references are admissible, with expert testimony, as relevant evidence bearing on the standard of care for prescribing and administering a medication.
- Off-label use is not negligence per se, but labeling and warnings may be probative of what a reasonable physician knew or should have known regarding indications and risks.
- A missing-evidence instruction permitting an adverse inference may be warranted when (a) the evidence was under a party’s control, (b) it was expected to be preserved, and (c) it is not produced without satisfactory explanation.
- Directed verdicts are improper where competent proof permits reasonable jurors to find breach of the standard of care and causation.

## Conclusion

The appellate court ordered a new trial because the plaintiffs were wrongly barred from using drug-labeling/PDR evidence to support expert standard-of-care testimony and were improperly denied a missing-evidence instruction concerning absent nursing documentation; the insurer’s reimbursement claim was also reinstated for consideration on remand.


Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000)