In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings
142 F. Supp. 3d 747
N.D. Ill.2015Background
- MDL involving >2,500 plaintiffs alleging injuries from testosterone replacement therapy (TRT) drugs; consolidated for pretrial proceedings.
- Defendants include makers of TRT approved via ANDA (generic pathway); Pfizer's Depo-Testosterone and Auxilium's Testopel are ANDA products that FDA designated as reference listed drugs (RLDs).
- Plaintiffs allege defendants marketed TRT for "Low T" (not classical hypogonadism), failed to warn of cardiovascular risks, and assert multiple state-law claims (failure to warn, design defect, negligence, fraud, consumer protection, etc.).
- ANDA defendants moved to dismiss under impossibility preemption (Mensing/Bartlett): they argue federal law forbids unilateral label changes for ANDA products, so state-law duties are preempted.
- Plaintiffs argue RLD designation permits ANDA RLD holders to use the CBE process and unilaterally strengthen labels (invoking Wyeth), so state-law claims survive; they alternatively sought discovery to show unilateral label changes occurred.
- Court took judicial notice of FDA regulations and guidance, followed federal precedent holding ANDA (even RLD) holders cannot unilaterally change labels, and concluded plaintiffs’ state-law claims against ANDA defendants are preempted; discovery request denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal law permits ANDA RLD holders to unilaterally change their warnings (CBE process) | ANDA RLD status makes the ANDA itself the RLD; CBE applies to the holder of an approved application, so RLD holders can unilaterally strengthen labels (Wyeth path) | Federal statutes, regulations, and FDA guidance require label "sameness" and preclude ANDA holders (including RLD holders) from using CBE to change labels independently (Mensing/Bartlett) | Held: ANDA RLD holders cannot unilaterally change labels; Mensing/Bartlett preemption applies. |
| Whether plaintiffs’ failure-to-warn claims survive preemption because ANDA RLD holders could have strengthened warnings | Wyeth allows state-law claims where federal law permits unilateral label changes; therefore failure-to-warn claims survive | Because federal law forbids unilateral changes by ANDA holders, state-law failure-to-warn duties are impossible and preempted | Held: Failure-to-warn claims are preempted. |
| Whether design-defect and other state-law claims survive despite inability to redesign drug | Plaintiffs acknowledge drug redesign is barred but argue claims flow from failure to warn and could be saved if label-change path exists | If label-change path is barred, design-defect claims also effectively require label changes or market withdrawal and are preempted (Bartlett) | Held: Design-defect and all claims premised on failure-to-warn are preempted. |
| Whether plaintiffs are entitled to discovery on preemption (e.g., evidence of unilateral label changes or pre-1984 knowledge) | Seek discovery to identify any unilateral label changes by ANDA RLD holders or evidence defendants knew risks pre-Hatch-Waxman | Preemption is primarily a legal question; FDA interpretation and law resolve the issue; complaint lacks pre-1984 allegations | Held: Discovery denied as unnecessary to resolve the legal preemption question; plaintiffs may amend complaint if they can plead pre-1984 knowledge consistent with Rule 11. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state-law failure-to-warn claims not preempted where federal law permits unilateral label changes via CBE)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (state-law failure-to-warn claims preempted for generic manufacturers because federal law prohibits unilateral label changes)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (design-defect claims preempted where federal law and chemistry make redesign or relabeling impossible)
- In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 756 F.3d 917 (6th Cir. 2014) (ANDA RLD designation does not allow unilateral label changes; follows Mensing and rejects RLD exception)