379 F. Supp. 3d 809
N.D. Cal.2019Background
- Plaintiffs allege Gilead designed and marketed TDF-based HIV drugs (Viread, Truvada, Atripla, Stribild, Complera) when a safer prodrug (TAF) or lower TDF dose was available, causing kidney and bone injuries.
- Plaintiffs assert design-defect, failure-to-warn, fraud, and consumer-protection claims under various state laws; some TDF drugs were FDA-approved before 2008 and some after.
- Gilead moved to dismiss on multiple grounds: claim/issue preclusion (relying on AIDS Healthcare Foundation), federal preemption (impossibility and Buckman), failure to plead causation, and Rule 9(b) deficiencies for fraud/consumer claims.
- The court declined to treat AIDS Healthcare Foundation as dispositive for consumer tort claims (it was an antitrust case addressing duties to competitors, not consumers).
- The court applied Supreme Court precedent on preemption in the drug context: Wyeth v. Levine, PLIVA v. Mensing, and Bartlett to formulate a two-step impossibility analysis (whether manufacturer could act independently; if so, whether there is clear evidence FDA would have disapproved).
- Ruling: motion granted in part and denied in part—pre-2008 and pre-approval design and warning claims survive; post-2008 post-approval labeling claims are preempted as pleaded; misrepresentation-based fraud/consumer claims dismissed for Rule 9(b) failure (leave to amend); omission-based consumer claims survive. Plaintiffs given leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preclusion from AIDS Healthcare Foundation | That prior decision should bar claims that Gilead had a duty to release TAF earlier | That the prior antitrust decision precludes/plaints' theory that Gilead had duty to introduce TAF earlier | Court: AIDS Healthcare Foundation not dispositive; it addressed antitrust duties to competitors, not consumer tort duties, and preclusion not shown |
| Impossibility preemption of pre-approval design-defect claims | Gilead could have and should have designed TDF drugs as TAF or lower-dose TDF before FDA approval; state-law claims should stand | Federal law prevents altering approved drugs without FDA approval, so pre-approval design claims are preempted or too speculative | Court: Pre-approval design-defect claims against brand-name Gilead are not preempted as pleaded; Gilead has not shown it was impossible to comply with state law before submission or clear evidence FDA would have rejected safer designs |
| Preemption of failure-to-warn claims (post-approval) | Plaintiffs: some warnings could/should have been changed pre- and post-approval; earlier postmarket data supported stronger warnings/monitoring instructions | Gilead: post-2008 CBE rule requires "newly acquired information" not previously submitted to FDA; plaintiffs fail to allege such new information, so post-2008 post-approval claims are preempted | Court: Post-2008 post-approval failure-to-warn claims are preempted as pleaded because complaint fails to plausibly allege information not previously submitted to FDA; pre-2008 and pre-approval warning claims survive |
| Causation for failure-to-warn claims | Plaintiffs: physicians would have acted differently (e.g., more frequent monitoring) if adequately warned, preventing or lessening injury | Gilead: plaintiffs must allege physicians would not have prescribed drug at all | Court: Plaintiffs adequately allege causation by alleging physicians would have monitored and acted differently; not required to allege physicians would have declined to prescribe |
| Rule 9(b) for fraud/consumer-protection claims | Plaintiffs: many claims are omissions-based and pleaded with sufficient specificity | Gilead: plaintiffs plead a unified fraudulent course and must meet Rule 9(b) particularity for misrepresentations and omissions | Court: Misrepresentation-based fraud/consumer claims fail Rule 9(b) and are dismissed with leave to amend; omission-based claims are pleaded with adequate particularity and survive |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (brand-name manufacturer's post-approval failure-to-warn claims not preempted absent clear evidence FDA would have rejected labeling change)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (generic manufacturers cannot unilaterally change labels; state failure-to-warn claims impossibly conflict)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (state-law design-defect claims that would require a generic to change composition or labeling are preempted)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (state-law fraud-on-the-FDA claims are preempted where they depend on federal regulatory scheme)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (presumption against preemption in areas of traditional state police power)
- Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir.) (pre-approval design-defect claims against brand-name defendant viewed skeptically as speculative but court distinguished scope)