In re Zantac (Ranitidine) Prods. Liab. Litig.
| Citation | 510 F.Supp.3d 1141 |
| Decision Date | 31 December 2020 |
| Docket Number | MDL NO. 2924,20-MD-2924 |
| Parties | IN RE: ZANTAC (RANITIDINE) PRODUCTS LIABILITY LITIGATION |
| Court | U.S. District Court — Southern District of Florida |
ORDER GRANTING GENERIC MANUFACTUERS’ AND REPACKAGERS’ RULE 12 MOTION TO DISMISS ON THE GROUND OF PREEMPTION
This matter is before the Court on Defendants Generic Manufacturers’ ("Generic Manufacturer Defendants") and Repackagers’ ("Repackager Defendants") (collectively "Defendants") Rule 12 Motion to Dismiss on the Ground of Preemption ("Motion to Dismiss"). DE 1582. The Court held a hearing on the Motion to Dismiss on December 15, 2020 ("the Hearing"). The Court has carefully considered the Motion to Dismiss, Plaintiffs’ Opposition thereto [DE 1978; DE 2010-1],1 Defendants’ Reply [DE 2133], Plaintiffs’ Notice of Supplemental Authority [DE 2488], the arguments that the parties made during the Hearing, and the record and is otherwise fully advised in the premises. For the reasons set forth below, the Motion to Dismiss is GRANTED .
This case concerns the pharmaceutical product Zantac
and its generic forms, which are widely sold as heartburn and gastric treatments. The molecule in question—ranitidine—is the active ingredient in both Zantac and its generic forms.
has been sold since the early 1980's, first by prescription and later as an over-the-counter ("OTC") medication. In 1983, the U.S. Food and Drug Administration ("FDA") approved the sale of prescription Zantac. MPIC ¶¶ 226, 231, 432. GlaxoSmithKline ("GSK") first developed and patented Zantac. Id. ¶ 230. Zantac was a blockbuster – the first prescription drug in history to reach $1 billion in sales. Id. ¶ 231.
GSK entered into a joint venture with Warner-Lambert in 1993 to develop an OTC form of Zantac
. Id. ¶ 233. Beginning in 1995, the FDA approved the sale of various forms of OTC Zantac. Id. ¶¶ 233, 237. The joint venture between GSK and Warner-Lambert ended in 1998, with Warner-Lambert retaining control over the sale of OTC Zantac in the United States and GSK retaining control over the sale of prescription Zantac in the United States. Id. ¶ 234. Pfizer acquired Warner-Lambert in 2000 and took control of the sale of OTC Zantac in the United States. Id. ¶ 235. The right to sell OTC Zantac in the United States later passed to Boehringer Ingelheim Pharmaceuticals and then to Sanofi. Id. ¶¶ 239-40, 242-44. When the patents on prescription and OTC Zantac expired, numerous generic drug manufacturers began to produce generic ranitidine products in prescription and OTC forms. Id. ¶¶ 249-51.
Scientific studies have demonstrated that ranitidine
can transform into a cancer-causing molecule called N-nitrosodimethylamine ("NDMA"), which is part of a carcinogenic group of compounds called N-nitrosamines. Id. ¶¶ 253, 321, 324, 331. Studies have shown that these compounds increase the risk of cancer in humans and animals. Id. ¶¶ 253, 264-72. The FDA, the Environmental Protection Agency, and the International Agency for Research on Cancer consider NDMA to be a probable human carcinogen. Id. ¶¶ 254, 258. The FDA has set the acceptable daily intake level for NDMA at 96 nanograms. Id. ¶¶ 4, 263.
Valisure LLC and ValisureRX LLC, a pharmacy and testing laboratory, filed a Citizen Petition on September 9, 2019, calling for the recall of all ranitidine products due to high levels of NDMA in the products. Id. ¶ 285. The FDA issued a statement on September 13 warning that some ranitidine
products may contain NDMA. Id. ¶ 286. On November 1, the FDA announced that testing had revealed the presence of NDMA in ranitidine products. Id. ¶ 296. The FDA recommended that drug manufacturers recall ranitidine
products with NDMA levels above the acceptable daily intake level. Id. Six months later, on April 1, 2020, the FDA requested the voluntary withdrawal of all ranitidine products from the market. Id. ¶ 301.
After the discovery that ranitidine products may contain NDMA, Plaintiffs across the country began initiating lawsuits related to their purchase and/or use of the products. On February 6, 2020, the United States Judicial Panel on Multidistrict Litigation created this multi-district litigation ("MDL") pursuant to 28 U.S.C. § 1407 for all pretrial purposes and ordered federal lawsuits for personal injury and economic damages from the purchase and/or use of ranitidine products to be transferred to the undersigned. DE 1. Since that time, hundreds of Plaintiffs have filed lawsuits in, or had their lawsuits transferred to, the United States District Court for the Southern District of Florida. In addition, this Court has created a Census Registry where thousands of claimants who have not filed lawsuits have registered their claims. See DE 547.
Plaintiffs filed three Master Complaints on June 22, 2020. DE 887, 888, 889. Plaintiffs contend that the ranitidine
molecule is unstable, breaks down into NDMA, and has caused thousands of consumers of ranitidine products to develop various forms of cancer. MPIC ¶¶ 1, 6, 19. Plaintiffs allege that "a single pill of ranitidine can contain quantities of NDMA that are hundreds of times higher" than the FDA's allowable limit. Id. ¶ 4. Plaintiffs are pursuing federal claims and state claims under the laws of all 50 U.S. states, Puerto Rico, and the District of Columbia. See generally CCCAC. The entities named as defendants are alleged to have designed, manufactured, tested, marketed, distributed, labeled, packaged, handled, stored, and/or sold ranitidine products. MPIC ¶¶ 20, 225.
The Court has entered numerous Pretrial Orders to assist in the management of this MDL. In Pretrial Order # 30, the Court set a case management schedule that is intended to prepare the MDL for the filing of Daubert motions on general causation and class certification motions in December 2021. DE 875; see generally Daubert v. Merrell Dow Pharms., Inc. , 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). In Pretrial Order # 36, the Court set a schedule for the filing and briefing of motions to dismiss under Federal Rule of Civil Procedure 12 directed to the Master Complaints. DE 1346. Defendants filed the instant Motion to Dismiss pursuant to that schedule.
Plaintiffs filed three Master Complaints in this MDL: the MPIC, the CCCAC, and the CTPPCC. DE 887, 888, 889. The MPIC raises claims against parties referred to as Generic Manufacturer Defendants that allegedly manufactured generic ranitidine
products. MPIC ¶¶ 38-144. The MPIC further raises claims against parties referred to as Repackager Defendants that allegedly repackaged ranitidine products into different containers and changed "the content on an original manufacturer's label to note the drug [was] distributed or sold under the relabeler's own name," "without manipulating, changing, or affecting the composition or formulation of the drug." Id. ¶¶ 211-15. Some of the parties categorized as Generic Manufacturer Defendants are also categorized as Repackager Defendants. See, e.g. , id. ¶¶ 44, 52. The parties named as Generic Manufacturer Defendants and as Repackager Defendants are not identical among the Master Complaints.
The MPIC contains 15 counts: Strict Products Liability—Failure to Warn, Strict Products Liability—Design Defect, Strict Products Liability—Manufacturing Defect, Negligence—Failure to Warn, Negligence Product Design, Negligent Manufacturing, General Negligence, Negligent Misrepresentation, Breach of Express Warranties, Breach of Implied Warranties, Violation of Consumer Protection and Deceptive Trade Practices Laws, Unjust Enrichment, Loss of Consortium, Survival Actions, and Wrongful Death. Each count is brought against Generic Manufacturer Defendants. All of these counts, other than the Strict Products Liability—Manufacturing Defect and Negligent Manufacturing counts, are also brought against Repackager Defendants.
The CCCAC also raises claims against parties referred to as Generic Manufacturer Defendants and Repackager Defendants. CCCAC ¶¶ 277-357, 416-20. The CCCAC contains 314 counts on behalf of putative nationwide and state classes. The putative nationwide class alleges counts for unjust enrichment, violation of the Magnuson-Moss Warranty Act, 15 U.S.C. § 2301, et seq. ("MMWA"), and common law fraud. The putative state classes allege counts for negligence, battery, product-liability, breach-of-warranty, consumer-protection, and medical-monitoring causes of action.
The CTPPCC raises claims against parties referred to as Generic Manufacturer Defendants. CTPPCC ¶¶ 46-121. The CTPPCC contains nine counts on behalf of a putative nationwide class of Third Party Payors that allegedly paid for prescription medications for others or, alternatively, on behalf of putative state classes. Id. ¶¶ 124, 506, 508. The putative class alleges counts of Breach of Express Warranties, Breach of Implied Warranties, Violation of the MMWA, Fraud, Negligent Misrepresentation and Omission, Violations of State Consumer Protection Laws, Unjust Enrichment, and Negligence.3
Defendants argue in the Motion to Dismiss that all of Plaintiffs’ state-law claims against them, regardless of how labeled and pled, are claims for design defect or failure to warn. The Supreme Court has ruled in two significant opinions— PLIVA, Inc. v. Mensing , 564 U.S. 604, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) and Mutual Pharmaceutical Co. v. Bartlett , 570 U.S. 472, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013) —that such claims against generic drug manufacturers are pre-empted because they cannot remedy design defects or provide additional warnings while remaining in compliance with federal law. The Supreme Court's rulings apply with equal force to repackagers. Therefore, all of the state-law claims against Defendants must be dismissed. And because Plaintiffs’ only federal claims against Defendants, for violations of the MMWA, require a...
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