510 F.Supp.3d 1141
S.D. Fla.2020Background
- MDL over ranitidine (Zantac) after discovery that ranitidine can form NDMA, a probable human carcinogen; FDA requested voluntary market withdrawal in April 2020.
- Plaintiffs filed three Master Complaints alleging design defects, failure to warn, misbranding, negligent testing, manufacturing defects, warranty and consumer-protection claims against generic manufacturers and repackagers.
- Defendants moved to dismiss under Rule 12(b)(6) based on federal preemption (impossibility/conflict preemption), relying primarily on PLIVA v. Mensing and Mutual Pharm. Co. v. Bartlett.
- Court held hearing Dec. 15, 2020, and granted defendants’ motion: dismissed with prejudice claims that rest on product or labeling changes the defendants could not lawfully make under federal law.
- The Court dismissed absolute-liability theories against repackagers with prejudice; granted leave to replead limited categories (expiration dates, testing, storage/transport, warning the FDA, manufacturing defects, MMWA and derivative counts) where such claims might avoid preemption or were inadequately pled.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Misbranding (claims that ranitidine was "misbranded") | Misbranding claims parallel federal statute (21 U.S.C. §352) and therefore are not preempted; plaintiffs allege ranitidine was misbranded for failing to disclose NDMA, proper storage, expiration. | Mensing/Bartlett preempt such state claims because generics cannot unilaterally change labeling or formulation; allowing misbranding theory would swallow preemption. | Dismissed as preempted where claim requires changes defendants could not lawfully make; misbranding allegations do not avoid Mensing/Bartlett. |
| Expiration dates & testing | Expiration dates can differ for generics and could be shortened via CBE; adequate testing would have revealed instability and NDMA increases. | Testing/shortened-dating theories are effectively attempts to change labeling/formulation and are preempted; pleadings are also deficient. | Dismissed without prejudice (leave to amend). Court: such claims may escape preemption if CBE/other mechanisms lawfully permit change, but plaintiffs failed to plead state-law duties or separate counts by jurisdiction. |
| Storage & transportation labeling and handling | Plaintiffs allege inadequate testing and false/misleading storage instructions; also allege improper storage by defendants in facilities. | Storage/transport labeling changes require FDA approval and are preempted; changes that impact identity/quality are major changes. | Claims alleging labeling/communication changes are preempted and dismissed with prejudice. Claims asserting defendants personally stored products improperly were not plausibly pled; court declined to rule on preemption and dismissed for pleading deficiencies (leave to amend where appropriate). |
| Warning the FDA (duty to report to regulator) | Many states allegedly impose a duty to notify regulator; notifying FDA is permitted/required by federal law, so state-law duty to warn FDA should not be preempted. | Mensing rejected ‘‘ask the FDA’’ as a defense to preemption; Buckman/Tsavaris bar state suits seeking to enforce federal reporting/regulatory duties. | Court did not decide preemption on this theory because plaintiffs did not plead a discrete failure-to-warn-the-FDA claim; leave to plead such claims consistent with guidance. |
| Manufacturing defect | Plaintiffs say manufacturing failures (e.g., CGMP breaches) caused NDMA in batches; some manufacturing claims alleged separately from design defects. | Defendants: claims actually challenge the molecule/design; many proposed changes are major manufacturing changes requiring FDA approval and thus preempted. | Manufacturing-defect counts dismissed without prejudice for failure to plead particularized departures from intended design; preemption not resolved because pleading was implausible. |
| Magnuson-Moss Warranty Act (MMWA) | Plaintiffs assert express and implied warranty claims as MMWA anchors; implied warranties may survive even if express warranty is FDA-regulated. | MMWA claims require a valid state-law warranty anchor; many warranty claims rooted in FDA-regulated labeling, making MMWA inapplicable or preempted. | MMWA counts dismissed without prejudice; court noted MMWA is inapplicable to written warranties whose making/content are governed by federal law and plaintiffs failed to identify non-FDA-governed written-warranty text. |
| Absolute liability for repackagers | Plaintiffs invoke an absolute-liability theory against repackagers (relabelers) who profited from marketing. | No state has adopted absolute-liability for repackagers in a way that avoids federal duties; such theories would conflict with federal law. | Claims relying on absolute liability against repackagers dismissed with prejudice. |
| Derivative claims (wrongful death, loss of consortium, survival) | Derivative on underlying torts; survive if underlying claims survive. | If underlying claims preempted/dismissed, derivative claims must fall. | Dismissed without prejudice because they derive from underlying claims that were dismissed. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand-name manufacturer could unilaterally strengthen warnings via CBE; state-law failure-to-warn not preempted where manufacturer could lawfully change label).
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic manufacturers’ duty-of-sameness prevents unilateral label changes; state failure-to-warn claims preempted because generics cannot independently satisfy state duties).
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (design-defect claims against generics preempted where federal law and chemistry prevent changing composition and labeling cannot be unilaterally changed).
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law fraud-on-the-FDA claims preempted because they interfere with federal regulatory scheme and enforcement vested in the FDA).
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (state requirements preempted only to the extent they are different from federal requirements where statute expressly preempts).
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (express preemption questions turn on whether state elements impose broader obligations than federal law).
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (interpretation of express preemption in medical-device context; additional state elements may not always be preempted).