Hardin v. PDX, Inc.
173 Cal. Rptr. 3d 397
Cal. Ct. App.2014Background
- Kathleen Hardin became blind and suffered severe scarring after taking lamotrigine (generic Lamictal); she alleged the drug can cause Stevens–Johnson syndrome (SJS) and related toxic epidermal necrolysis.
- Hardin and her husband sued multiple defendants, including Wolters Kluwer Health (WKH) (author of patient monographs), Safeway (pharmacy), and PDX, Inc./National Health Information Network (PDX/NHIN) (software distributor of monographs).
- WKH monographs summarize FDA materials but are voluntary, not FDA-reviewed; pharmacies print these monographs for patients when filling prescriptions.
- PDX provided software enabling pharmacies to print WKH monographs. In 2005 PDX eliminated an abbreviated print option systemwide; in 2006 it reprogrammed software to allow Safeway to print an abbreviated five‑section monograph that omitted the FDA “black box” rash warning.
- Hardin testified the WKH monograph she received omitted the black‑box rash warning, she relied on that monograph alone, and would not have taken the drug if she had received the omitted warning.
- The trial court denied PDX’s anti‑SLAPP motion, finding PDX had gone beyond mere distribution by reprogramming software to permit omission of warnings; the Court of Appeal affirmed (assuming arguendo the activity was protected speech, Hardin demonstrated a probability of prevailing).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether PDX’s conduct is protected activity under California’s anti‑SLAPP statute | Hardin argued the reprogramming to enable omission was not protected petition/speech because it altered content and increased risk to patients | PDX argued distribution of monographs is protected speech and thus subject to anti‑SLAPP dismissal | Court avoided deciding protection of conduct; assumed it might be protected but proceeded to second prong and found plaintiff showed probability of success |
| Whether Rivera v. First DataBank controls and bars liability | Hardin argued Rivera is distinguishable: here there is evidence the black‑box warning was actually omitted and applied to adults | PDX asserted Rivera holds as a matter of law that distributors of monographs owe no duty to consumers | Court held Rivera inapposite: factual differences and Rivera did not address negligent‑undertaking theory |
| Whether PDX assumed a duty under the negligent‑undertaking doctrine (Rest.2d Torts § 324A) | Hardin argued PDX undertook to provide patient monographs and knew omission risk, so it assumed duty to third parties | PDX contended no duty existed (pure distributor) and CDA / First Amendment / Civil Code § 47 immunities apply | Court held plaintiff presented sufficient evidence that PDX assumed a duty (e.g., internal acknowledgement and affirmative reprogramming) to survive anti‑SLAPP challenge |
| Whether federal immunity (CDA § 230) or privileges bar liability | PDX claimed CDA shields it as an interactive computer service; also invoked First Amendment and § 47(d) report privilege | Hardin argued PDX participated in creating/altering content (not merely third‑party publisher) so CDA does not apply; privilege not established on record | Court rejected CDA and privilege defenses as insufficiently shown at this stage; PDX’s evidence did not defeat plaintiff’s showing |
Key Cases Cited
- Rivera v. First DataBank, Inc., 187 Cal.App.4th 709 (distinguishable; court reversed where plaintiffs lacked evidence of omitted warning and warning did not apply)
- Equilon Enterprises v. Consumer Cause, Inc., 29 Cal.4th 53 (describes two‑step anti‑SLAPP analysis)
- Artiglio v. Corning Inc., 18 Cal.4th 604 (explains negligent‑undertaking duty principles and Restatement § 324A)
- FNS Mortgage Service Corp. v. Pacific General Group, Inc., 24 Cal.App.4th 1564 (assumption of duty where entity voluntarily undertook consumer‑protective enterprise)
- Taus v. Loftus, 40 Cal.4th 683 (plaintiff’s burden to state and substantiate legally sufficient claim opposing anti‑SLAPP)