## Facts

- Angela Morlino, approximately eight and one-half months pregnant, went to a hospital emergency room with a sore throat.
- Two weeks earlier, she had been treated at the same facility and prescribed amoxicillin; her symptoms persisted.
- Emergency physician Dr. J. Dugenio examined Morlino, ordered tests including a throat culture, and diagnosed acute pharyngitis.
- Before the culture results returned, Dr. Dugenio prescribed and administered ciprofloxacin (Cipro) after consulting the Physicians’ Desk Reference (PDR).
- The PDR entry warned against use of Cipro in children and pregnant women based on animal studies, stated fetal risk could not be ruled out, and noted benefits might justify risks; it did not state Cipro was absolutely contraindicated in pregnancy.
- The throat culture later showed bacteria resistant to several antibiotics including penicillin.
- A sonogram the next day revealed fetal death.
- Morlino sued the hospital and physicians, alleging Cipro caused fetal death and that prescribing it violated the standard of care, asserting the PDR/package-insert warning reflected that standard.

## Issues

1. Whether pharmaceutical package inserts and PDR entries are admissible evidence of a physician’s standard of care in a medical malpractice action, and what evidentiary weight they carry.
2. Whether a jury instruction stating a physician is not liable for a mistake in diagnosis or treatment if the physician exercised medical judgment consistent with accepted practice improperly insulates negligent conduct.

## Decision

- The New Jersey Supreme Court affirmed the defense verdict.
- PDR entries and package inserts are admissible and may be considered with expert testimony, but they do not, by themselves, establish the standard of care or constitute prima facie evidence of negligence.
- The “exercise of judgment” jury instruction, read as part of the full charge, did not mislead the jury and was not reversible error, though the Court cautioned that “mistake” wording can be misunderstood and may warrant refinement in model instructions.

## Legal Principles

- The medical standard of care is ordinarily established through qualified expert testimony regarding what reasonably prudent practitioners do under similar circumstances.
- Manufacturer warnings (including package inserts and PDR compilations) may support or impeach expert opinions, but cannot substitute for expert proof or set the legal standard of medical care.
- A physician is not an insurer of results and is not liable merely because a reasonable choice among accepted diagnostic or treatment alternatives proves unsuccessful, so long as the physician exercised reasonable care and skill consistent with accepted standards.
- Alleged evidentiary or instructional errors warrant reversal only if they likely affected the verdict; otherwise, any error is harmless.

## Conclusion

The court held that drug-label materials may be used as evidence only in conjunction with expert testimony and do not independently define malpractice, and it upheld a medical-judgment jury instruction as nonprejudicial when the overall charge correctly required proof of deviation from accepted professional standards.


Morlino v. Med. Ctr. of Ocean Cnty., 152 N.J. 563, 706 A.2d 721 (N.J. 1998)