In re Zantac (Ranitidine) Prods. Liab. Litig.

Decision Date31 December 2020
Docket NumberMDL NO. 2924,20-MD-2924
Citation510 F.Supp.3d 1175
CourtU.S. District Court — Southern District of Florida



This matter is before the Court upon Brand-Name Manufacturer Defendants("Defendants") Rule 12 Motion to Dismiss Plaintiffs’ Innovator-Liability Claims ("Motion to Dismiss"). DE 1585. The Court held a hearing on the Motion to Dismiss on December 14, 2020 (the "Hearing"). DE 2498. The Court has carefully considered the Motion to Dismiss, Plaintiffs’ Opposition thereto [DE 1973], Defendants’ Reply [DE 2132], the parties’ supplemental briefing [DE 2307; DE 2335], 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 .

I. Factual Background1

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.

Zantac has been sold since the early 1980's, first by prescription and later as an over-the-counter 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 drug in history to reach $1 billion annually in sales. ¶ 231.

GSK entered into a joint venture with Warner-Lambert in 1993 to develop an over-the-counter ("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.

II. Procedural Background

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.

III. The Master Personal Injury Complaint

For the purposes of this Order, the Court's references to "Plaintiffs" are to only those Plaintiffs who allegedly were injured solely by generic ranitidine products, not by brand-name ranitidine products. While there are fifteen counts asserted against Defendants in the MPIC, Plaintiffs acknowledged at the Hearing that the only substantive counts they are pursuing against Defendants are Counts VII and VIII. DE 2498 at 209; MPIC ¶¶ 542–73. Count VII is a claim for general negligence. MPIC ¶¶ 542–61. Plaintiffs allege that Defendants "breached their duty of reasonable care and failed to exercise ordinary care in the design, manufacture, testing, marketing, labeling, packaging, handling, distribution, storage, and/or sale of ranitidine-containing products." Id. ¶ 551. Count VIII is a claim for negligent misrepresentation. Id. ¶¶ 561–73. Plaintiffs allege that Defendants "owed a duty to Plaintiffs to make accurate and truthful representations regarding ranitidine-containing products" and breached that duty. Id. ¶ 564. In this Order, the Court refers to Counts VII and VIII as Plaintiffs"negligence-based claims." Additionally, Counts XIII-XV are derivative claims and include: loss of consortium, survival actions, and wrongful death. Id. ¶¶ 637–56.

It is undisputed that all of Plaintiffs’ claims against Defendants are based on a theory of liability that is currently only recognized under California and Massachusetts law. DE 1585 at 6;2 DE 1973 at 15; see also Rafferty v. Merck & Co. , 479 Mass. 141, 92 N.E.3d 1205, 1219–20 (2018) (holding that, under Massachusetts law, brand-name manufacturers owe a duty to generic drug consumers not to act in reckless disregard of an unreasonable risk of death or grave bodily injury and allowing common law claims against brand-name manufacturers for recklessness but not for ordinary negligence); T.H. v. Novartis Pharm. Corp. , 4 Cal.5th 145, 226 Cal.Rptr.3d 336, 407 P.3d 18, 47–48 (2017) (holding that, under California law, brand-name manufacturers owe a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party consumed the brand or generic drug, and allowing claims of general negligence and negligent misrepresentation against brand-name manufacturers). This theory of liability has been referred to as "innovator liability." See Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand–Name and Generic Drug Manufacturers , 60 Duke L.J. 1123, 1176 (2011). Under this theory of liability, the consumers of a generic drug product may hold a brand-name drug manufacturer liable for failing to warn of a defect in the product—a product that the brand-name drug manufacturer did not itself make, sell, or distribute. See id. The theory is based on a principle articulated in Section 311 of the Restatement (Second) of Torts, which provides in relevant part:

One who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results... to such third persons as the actor should expect to be put in peril by the action taken.

Restatement (Second) of Torts § 311(1)(b) (Am. Law Inst. 1965).

Here, Plaintiffs have pled that Defendants are liable for their alleged misrepresentations concerning the safety of ingesting brand-name ranitidine products which, according to Plaintiffs, created the market for generic ranitidine products, foreseeably led to the ingestion of generic ranitidine products, and, in turn, foreseeably led to generic consumers’ injuries.

IV. Summary of the Parties’ Arguments

Defendants filed the instant Motion to Dismiss seeking the dismissal of all claims asserted against...

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3 cases
  • In re Zantac (Ranitidine) Prods. Liab. Litig.
    • United States
    • U.S. District Court — Southern District of Florida
    • 31 December 2020
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    • U.S. District Court — District of Minnesota
    • 4 February 2021
    ...analysis on the duty question because the preemption issue was decisive. Id.7 See also In re: Zantac (Ranitidine) Prods. Liab. Litig. , MDL No. 2924, 510 F.Supp.3d 1175, 1209–12 (S.D. Fla. Dec. 31, 2020) (finding that the Sixth Circuit's holding in In re Darvocet is "sound and more persuasi......
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    • U.S. District Court — District of Connecticut
    • 10 June 2022
    ...made by some party other than the named defendant. GSK cites two more federal cases. See In re Zantac (Ranitidine) Prod. Liab. Litig., 510 F.Supp.3d 1175, 1207 (S.D. Fla. 2020); In re Zofran (Ondansetron) Prod. Liab. Litig., 2018 WL 2317525, at *4-5 (D. Mass. 2018). But because these ruling......
1 firm's commentaries
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    • 30 December 2021 of the offending witnesses were excluded. We idolized Incretin here. In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1175 (S.D. Fla. Dec. 31, 2020). We bent the rules (by one day) for this one, which was decided on New Year’s Eve, 2020. We may be fast, but we’r......

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