553 P.3d 867
Ariz.2024Background
- David Francisco was prescribed Cipro (an antibiotic with an FDA black box warning) by Dr. Kevin Art after a urological procedure, without counsel about its risks, despite Francisco’s medical history.
- Francisco experienced severe adverse effects associated with Cipro, including ruptured tendons and neuropathy, which expert witnesses attributed to Cipro toxicity.
- The Franciscos sued, alleging Dr. Art’s failure to warn constituted negligence and claimed they would have refused the drug or procedure if properly informed.
- Plaintiffs did not file an expert affidavit initially, arguing the FDA black box warning established the standard of care and that no expert testimony was necessary under Arizona law.
- The trial court dismissed the case for failure to provide the required expert affidavit; the Court of Appeals reversed, but the Arizona Supreme Court granted review.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Can FDA black box warnings replace expert testimony in establishing standard of care in medical malpractice? | FDA warning alone lets a jury discern the standard of care—no expert needed in this case. | Standard of care must be shown through expert testimony when medical judgment is involved; FDA warnings cannot substitute. | No, FDA warnings may be evidence but cannot establish the standard of care without expert testimony in Arizona. |
| Do the expert affidavit requirements (A.R.S. §§ 12-2603, 12-2604) apply to lack of informed consent/ negligent disclosure claims? | This is not true medical malpractice but only negligent disclosure, so expert affidavit should not be required. | Claims about negligent disclosure or lack of informed consent are medical malpractice claims, requiring compliance with statutory expert testimony rules. | Yes, the statutory requirements apply because such claims constitute medical malpractice under Arizona law. |
| Is this one of the rare cases where expert testimony is not needed (res ipsa loquitur)? | Lay jurors can understand the negligence from the warning alone; this should be a res ipsa case. | A warning’s omission here involves medical judgment requiring expert guidance, beyond lay knowledge. | No, determining the duty to warn involved medical judgment; the res ipsa exception does not apply. |
| Do expert witness requirements here violate the Arizona Constitution’s anti-abrogation clause? | If no urologist will testify due to professional standards, the right to sue is denied in violation of the Constitution. | The requirements regulate, but do not abrogate, the right to sue; difficulty finding an expert does not make the law unconstitutional. | No, the requirements are permissible regulations and do not violate the anti-abrogation clause as applied. |
Key Cases Cited
- Duncan v. Scottsdale Med. Imaging, Ltd., 205 Ariz. 306 (expert testimony required to establish disclosure parameters in informed consent cases)
- Seisinger v. Siebel, 220 Ariz. 85 (Arizona courts generally require expert testimony to establish standard of care in medical malpractice)
- Riedisser v. Nelson, 111 Ariz. 542 (custom to warn must be established by expert testimony, unless obvious negligence)
- Baker v. Univ. Physicians Healthcare, 231 Ariz. 379 (statutory regulation of expert witness requirements permissible if reasonable alternatives to bring actions remain)
- Faris v. Drs. Hosp., Inc., 18 Ariz. App. 264 (no expert needed when lack of care is within lay comprehension)