ORDER GRANTING IN PART AND DENYING IN PART THE DEFENDANTS' OMNIBUS MOTION TO DISMISS AND/OR STRIKE CONSOLIDATED MEDICAL MONITORING CLASS ACTION COMPLAINT AND CONSOLIDATED AMENDED CONSUMER ECONOMIC LOSS CLASS ACTION COMPLAINT
ROBIN L. ROSENBERG, UNITED STATES DISTRICT JUDGE.
This matter is before the Court on the Defendants' Omnibus Motion to Dismiss and/or Strike Consolidated Medical Monitoring Class Action Complaint and Consolidated Amended Consumer Class Action Complaint [DE 3116] (the "Motion"). The Court held a hearing on the Motion to Dismiss on June 3, 2021 (the "Hearing"). The Court has carefully considered the Motion, the Response [DE 3429], the Reply [DE 3508], 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 Defendants' Motion to Dismiss is
I. Factual Background
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 1980s, 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. AMPIC ¶ 240. GlaxoSmithKline ("GSK") first developed and patented Zantac. Id. ¶ 239. Zantac was a blockbuster—the first prescription drug in history to reach $1 billion in sales. Id. ¶ 240.
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. ¶ 243. Pfizer acquired Warner-Lambert in 2000 and took control of the sale of OTC Zantac in the United States. Id. ¶ 245. The right to sell OTC Zantac in the United States later passed to Boehringer Ingelheim Pharmaceuticals and then to Sanofi. Id. ¶¶ 249-50, 253-55. 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. ¶¶ 260-62.
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. ¶ 322. The FDA issued a statement on September 13 warning that some ranitidine products may contain NDMA. Id. ¶ 323. On November 1, the FDA announced that testing had revealed the presence of NDMA in ranitidine products. Id. ¶ 333. The FDA recommended that drug manufacturers recall ranitidine products with NDMA levels above the acceptable daily intake level. Id. Five months later, on April 1, 2020, the FDA requested the voluntary withdrawal of all ranitidine products from the market. Id. ¶ 338.
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, approximately 1,400 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 tens of thousands of claimants who have not filed lawsuits have registered their claims. See DE 547.
Plaintiffs filed their first Master Complaints on June 22, 2020. DE 887, 888, 889. In those Master Complaints, Plaintiffs contended 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. DE 887 ¶¶ 1, 6, 19. They alleged 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. The Plaintiffs pursued federal claims and state claims under the laws of all 50 U.S. states, Puerto Rico, and the District of Columbia. See generally DE 889.
The Court has entered numerous Pretrial Orders to assist in the management of this MDL. In Pretrial Order # 36, the Court set a schedule for the filing and briefing of the first round of motions to dismiss under Rule 12 directed to the Master Complaints. DE 1346. The various defendants filed motions to dismiss.
On December 31, 2020, the Court granted the Defendants' Motions to Dismiss and dismissed the Master Complaints without prejudice and with leave to amend. DE 2515. The Court also struck all allegations of physical injury and medical monitoring from the Consolidated Consumer Class Action Complaint, while permitting the plaintiffs to seek leave of Court for an alternative pleading to allege their class physical injury and/or medical monitoring claims.
Following an amendment to Pretrial Order # 36, Plaintiffs filed the AMPIC on
III. The Master Complaints
A. The Consolidated Medical Monitoring Class Action Complaint
Fifty-two named Plaintiffs bring the MMC on behalf of themselves and the various classes established in the MMC. MMC ¶¶ 93-144. The Plaintiffs purchased and used ranitidine products in fourteen jurisdictions.
There are five categories of classes: (1) Brand Manufacturer Prescription Medical Monitoring Classes; (2) Brand Manufacturer OTC Medical Monitoring Classes; (3) Generic Prescription Medical Monitoring Classes; (4) Store-Brand Medical Monitoring Classes; and (5) Store-Brand Manufacturer Medical Monitoring Classes. Within each category, there are state- and Defendant-specific classes. For example, within the third category (Generic Prescription Medical Monitoring Classes), several named Plaintiffs bring claims against Defendant Amneal on behalf of themselves and eleven state-specific "Amneal Prescription Medical Monitoring Classes." Id. ¶ 998. Within the fourth category (Store-Brand Medical Monitoring Classes), five named Plaintiffs bring claims against Defendant CVS on behalf of themselves and four state-specific "CVS Medical Monitoring Classes." Id. ¶ 1004. The various classes are comprised of individuals who purchased and used one of the Defendants' ranitidine products while residing in a particular state, and who have not been diagnosed with a Subject Cancer.
The Defendants named in the MMC are "entities that designed, manufactured, marketed, distributed, labeled, packaged, handled, stored, and/or sold Zantac or generic Ranitidine-Containing Products." Id. ¶ 6. The Plaintiffs categorized the Defendants into three groups: (1) Brand Manufacturer Defendants (Prescription and OTC); (2) Generic Prescription Manufacturer Defendants and/or Store-Brand Manufacturer Defendants; and (3) Store-Brand Defendants. The MMC alleges 638 counts against the various Defendants.
B. The Consolidated Amended Consumer Economic Loss Class Action Complaint
One hundred and eighty named Plaintiffs bring the ELC on behalf of themselves and all others similarly situated. Each Plaintiff asserts that he or she purchased
The Plaintiffs bring the action in their individual capacities and on behalf of numerous classes pursuant to Rule 23. The Plaintiffs bring state class actions under various state laws stemming from the Defendants' sale of prescription-strength ranitidine for approximately forty states.
The Defendants named in the ELC are entities that "designed, manufactured, marketed, distributed, labeled, packaged, handled, stored and/or sold Zantac or generic Ranitidine-Containing Products." ELC ¶ 1. The Defendants are categorized into three groups: (1) Brand Manufacturer Defendants (Prescription and OTC); (2) Generic Prescription Manufacturer and/or Store-Brand Manufacturer Defendants; and (3) Store-Brand Defendants. The ELC alleges 1,675 counts against the Defendants. The Plaintiffs bring claims for violation of various state consumer protection statutes, common-law unjust enrichment, common-law breach of quasi-contract, and breach of implied warranty.
IV. Summary of the Parties' Arguments and the Court's Rulings
A. The Consolidated Medical Monitoring Class Action Complaint
The Defendants move to dismiss and/or strike the MMC. They contend that Indiana and Montana do not recognize medical monitoring claims, and additionally, that the Plaintiffs fail to plausibly plead several required elements for medical monitoring that are common across jurisdictions. The Defendants also contend that the Plaintiffs fail to plead their claims of negligence and strict liability. Finally, the Defendants argue that the MMC violates the Eleventh Circuit's rule against claim splitting.
The Plaintiffs respond that medical monitoring is an available remedy in Indiana and a cause of action in Montana. Additionally, the Plaintiffs cite allegations in the MMC that, in their view, plausibly demonstrate each medical monitoring element that the Defendants challenge. The Plaintiffs also cite allegations in the MMC to demonstrate that they plausibly plead their negligence and strict liability claims. Lastly, the Plaintiffs respond that the MMC does not constitute claim splitting, since the Plaintiffs complied with the Court's order (and the Defendants' request) that they allege their class physical injury and/or medical monitoring claims in an alternative pleading.
The Court concludes that the Indiana Supreme Court would recognize medical monitoring as an available remedy, but that the Montana Supreme Court would not recognize medical monitoring as a cause of action. Separately, the Plaintiffs have failed to plausibly plead required elements for medical monitoring. The Plaintiffs have plausibly pled some of their negligence and strict liability claims, but the Court need not address every claim, as certain claims are dismissed with prejudice on grounds of pre-emption through other orders. Finally, the Defendants' claim splitting argument is premature. Given the foregoing, the Court dismisses Plaintiffs' Montana medical monitoring claims (Counts 134-137) with prejudice, and dismisses all remaining Counts in the MMC without prejudice and with leave to amend consistent with this Order.
B. The Consolidated Amended Consumer Economic Loss Class Action Complaint
The Defendants argue that the ELC remains a shotgun pleading, and that the Plaintiffs still lack Article III standing because they have not alleged an injury-in-fact. Additionally, the Plaintiffs' claims related to prescription ranitidine should be dismissed under the learned intermediary doctrine. Furthermore, many of the ELC's state-law claims are barred pursuant to state consumer protection safe harbors, or relatedly, because the Defendants' FDA-approved labels were presumptively valid. Finally, the Plaintiffs fail to state claims for unjust enrichment.
The Plaintiffs respond that the ELC is not a shotgun pleading because the Plaintiffs addressed the shotgun deficiencies that the Court identified in the prior version of the ELC. The Plaintiffs also have Article III standing because they suffered economic injury-in-fact. The Court should not dismiss the Plaintiffs' prescription-based claims pursuant to the learned intermediary doctrine, in part because it is premature to determine the doctrine's applicability. Further, the Defendants' safe-harbor and FDA labeling arguments lack specificity and are inapplicable because the Plaintiffs allege that the Defendants' product labels violated both state and federal law. Finally, the Plaintiffs have stated a claim for unjust enrichment, since they allege that they conferred a benefit on the Defendants due to misrepresentations.
The Court concludes that the ELC is not a shotgun pleading, and the Plaintiffs have Article III standing because they allege that they suffered economic injury. The Plaintiffs' prescription-based claims lack allegations that are relevant to the learned intermediary doctrine. The Defendants' arguments related to state safe harbors, FDA labeling, and unjust enrichment are inadequately briefed for the Court to reach a conclusion at this juncture. Given the foregoing, the Court dismisses the Plaintiffs' prescription-based claims (Counts 2-71 and 409-1062) without prejudice and with leave to amend consistent with this Order.
V. Standard of Review
A. Rule 12(b)(1)
Federal courts are courts of limited jurisdiction. "[B]ecause a federal court is powerless to act beyond its statutory grant of subject matter jurisdiction, a court must zealously insure that jurisdiction exists over a case, and should itself raise the question of subject matter jurisdiction at any point in the litigation where a doubt about jurisdiction arises." Smith v. GTE Corp., 236 F.3d 1292, 1299 (11th Cir. 2001).
B. Rule 12(b)(6)
A court may grant a motion to dismiss a pleading if the pleading fails to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). A Rule 12(b)(6) motion to dismiss should be granted only when the pleading fails to contain "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The pleading must contain more than labels, conclusions, a formulaic recitation of the elements of a cause of action, and naked assertions devoid of further factual enhancement. Id. The "[f]actual allegations must be enough to raise a right to relief above the speculative level." Twombly, 550 U.S. at 555, 127 S.Ct. 1955; see also Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (explaining
A court ruling on a motion to dismiss accepts the well-pled factual allegations as true and views the facts in the light most favorable to the plaintiff. Jones v. Fransen, 857 F.3d 843, 850 (11th Cir. 2017). But the court need not accept as true allegations upon information and belief that lack sufficient facts to make the allegations plausible. Mann v. Palmer, 713 F.3d 1306, 1315 (11th Cir. 2013) (citing Twombly, 550 U.S. at 551, 557, 127 S.Ct. 1955); see also In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 756 F.3d 917, 931 (6th Cir. 2014) ("The mere fact that someone believes something to be true does not create a plausible inference that it is true."). The court also need not accept legal conclusions couched as factual allegations. Diverse Power, Inc. v. City of LaGrange, Ga., 934 F.3d 1270, 1273 (11th Cir. 2019). "Under Rule 12(b)(6), dismissal is proper when, on the basis of a dispositive issue of law, no construction of the factual allegations will support the cause of action." Allen v. USAA Cas. Ins. Co., 790 F.3d 1274, 1278 (11th Cir. 2015) (quotation marks omitted).
VI. Analysis of the Defendants' Motion to Dismiss
The Motion raises several separate legal issues. For each issue, the Court reviews the parties' arguments, the relevant allegations, and the relevant law before providing its analysis and conclusion.
A. Issues Raised in the MMC
1. Medical Monitoring Claims in Montana and Indiana
a. Arguments and Allegations
The Defendants argue that the Plaintiffs' Indiana medical monitoring claims should be dismissed. Indiana state and federal courts have held that medical monitoring is not a cognizable claim. DE 3116 at 20 (citing Hunt v. Am. Wood Preservers Inst., No. IP 02-0389-C-M/S, 2002 WL 34447541, at *1 (S.D. Ind. July 31, 2002), and Johnson v. Abbott Labs., Nos. 06C01-0203-PL-89, 06C01-0206-CT-243, 2004 WL 3245947, at *6 (Ind. Cir. Ct. Dec. 31, 2004)). Although an Indiana federal court recognized medical monitoring damages in Allgood v. General Motors Corp., No. 102CV1077DFHTAB, 2005 WL 2218371 (S.D. Ind. Sept. 12, 2005), it did so only for nuisance claims, which are not alleged in this case. DE 3116 at 20. Nuisance claims are fundamentally different than the negligence and strict liability claims alleged in the MMC. DE 3508 at 10.
The Defendants also argue that the Plaintiffs' Montana medical monitoring claims should be dismissed. Only one Montana trial court case, Lamping v. American Home Products., Inc., No. DV-97-85786, 2000 WL 35751402, 2000 Mont. Dist. LEXIS 2580 (Mont. Dist. Feb. 02, 2000), has recognized medical monitoring. DE 3116 at 20. Lamping is more than twenty years old, is unpublished, has not been acknowledged by other Montana courts, and only recognized medical monitoring on that case's specific facts. Id. The Eleventh Circuit has said that state trial court opinions are not authoritative for purposes of an Erie analysis, and that is particularly true here, where no Montana case post-Lamping has acknowledged medical monitoring as a cause of action under Montana law. DE 3508 at 11 (citing Mesa Air Grp., Inc. v. Delta Air Lines, Inc., 573 F.3d 1124, 1131 n.8 (11th Cir. 2009)).
The Plaintiffs first argue that Indiana recognizes medical monitoring damages. DE 3429 at 29. In Gray v. Westinghouse Electric. Corp., 624 N.E.2d 49 (Ind. Ct. App. 1993), the Indiana Court of Appeals recognized that a plaintiff could obtain medical monitoring despite the absence of
The Plaintiffs also argue that Montana recognizes medical monitoring as a cause of action. Lamping is well reasoned, has never been rejected through another Montana case, and has been recognized by other courts as reflecting Montana's medical monitoring law. Id. at 31. The case warrants even greater weight because Montana does not have an intermediate appellate court. Id. Moreover, Lamping is like the instant case, for it involved drugs that caused a high risk of serious heart valve disease. Id. Similarly, the Plaintiffs here allege that because of their exposure to dangerous levels of NDMA, they have a significantly increased risk of developing serious and potentially fatal cancers. Id.
b. Law on
A federal court sitting in diversity must apply state substantive law. Erie R. Co. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). Where the highest state court has spoken on a topic, the federal court must follow its rule. Molinos Valle Del Cibao, C. por A. v. Lama, 633 F.3d 1330, 1348 (11th Cir. 2011). Where the highest state court has not spoken on the topic, the federal court must follow the decisions of intermediate appellate courts unless persuasive evidence demonstrates that the highest court would conclude otherwise. Id. If there is no explicit state law on an issue, "a federal court attempting to forecast state law must consider whatever might lend it insight, including `relevant state precedents, analogous decisions, considered dicta, scholarly works, and any other reliable data tending convincingly to show how the highest court in the state would decide the issue at hand.'" Guideone Elite Ins. Co. v. Old Cutler Presbyterian Church, Inc., 420 F.3d 1317, 1326 n.5 (11th Cir. 2005) (quoting McKenna v. Ortho Pharm. Corp., 622 F.2d 657, 663 (3d Cir. 1980)). "It is not the function of federal courts to expand state tort doctrine in novel directions absent state authority suggesting the propriety of doing so." Douglas Asphalt Co. v. QORE, Inc., 657 F.3d 1146, 1154 (11th Cir. 2011).
c. Analysis and Conclusion
The Plaintiffs seek medical monitoring damages for their Indiana negligence claims. DE 3429 at 30. They allege medical monitoring as an independent cause of action in Montana. Id. at 31. The highest courts in Indiana and Montana have not addressed whether medical monitoring is a form of damages or an independent cause of action, respectively. The Court must
By reversing the dismissal of the owners' claim for medical monitoring damages, the Court of Appeals implicitly recognized the availability of such damages in Indiana. The Southern District of Indiana acknowledged that point in Allgood, stating: "If medical monitoring were not an available remedy under these circumstances... the Gray court could have affirmed the trial court to the extent it had dismissed that request for relief." 2005 WL 2218371, at *7. The court in Allgood also clarified that "[t]he Gray court did not treat medical monitoring as a cause of action, but simply as one form of relief that could be available under the traditional common law tort of nuisance." Id. Based on its review of Gray, the Allgood court predicted that Indiana courts would recognize a claim for medical monitoring damages for nuisance claims. The court, however, declined to articulate the precise elements necessary to obtain medical monitoring damages.
This Court predicts that the Indiana Supreme Court would recognize medical monitoring as a form of damages for negligence claims. Since Gray is an Indiana appellate court decision, the Court must follow its recognition of medical monitoring damages absent persuasive evidence that the Indiana Supreme Court would conclude otherwise. The Defendants have not presented such evidence.
While the Defendants argue that Gray and Allgood only recognize medical monitoring damages for nuisance claims, the Court does not construe those cases so narrowly. In Allgood, the court stated that that "[i]f plaintiffs are able to prove the elements of a recognized tort such as nuisance, then the court will need to craft jury instructions to provide more specific guidance as to available remedies." Id. (emphasis added). Allgood thus contemplated medical monitoring damages for torts beyond just nuisance, and negligence certainly qualifies as a recognized tort. This reading is consistent with other jurisdictions which have acknowledged that medical monitoring relief can be sought for both nuisance and negligence claims or
Hunt and Johnson do not persuade the Court. Unlike Gray, neither is an Indiana appellate court decision. Moreover, whereas Gray and Allgood contain detailed analyses of the plaintiffs' medical monitoring claims, Hunt and Johnson do not. In Hunt, the Southern District of Indiana granted a motion to dismiss the plaintiffs' medical monitoring claim and stated, without explanation or citations, that "such a claim is not cognizable in the State of Indiana." 2002 WL 34447541, at *1. In Johnson, the Indiana Circuit Court denied plaintiffs' motion for class certification, in part because the plaintiffs' request for a medical monitoring class did not satisfy the predominance requirement for class certification. 2004 WL 3245947, at *6. The court merely cited Hunt and stated that "Indiana does not recognize medical monitoring as a cause of action." Id. The lack of analysis in these cases is inadequate to overcome the Indiana Court of Appeals' decision in Gray. This is especially true of Johnson, which addresses whether Indiana recognizes medical monitoring as a cause of action, rather than whether medical monitoring is an available remedy.
It is not this Court's role to expand state tort law absent the propriety of doing so. Douglas Asphalt, 657 F.3d at 1154; see Guarino v. Wyeth, LLC, 719 F.3d 1245, 1251 (11th Cir. 2013) ("[C]onsiderations of comity and federalism counsel that [federal courts] proceed gingerly when venturing into unchartered waters of state substantive law."). Notwithstanding the Plaintiffs' reliance on Lamping, the Court does not believe that the opinion supports expanding Montana law in the manner that the Plaintiffs suggest; to conclude otherwise would run counter to Eleventh Circuit guidance. See Mesa Air Grp., 573 F.3d at 1131 n.8 (11th Cir. 2009) ("On no interpretation of Erie of which we are aware may a decision by a state trial court be credited as determining the law of the state."). The Defendants' reasoning is more persuasive, including that the Court lacks any relevant guidance from the Montana Supreme Court, and that no Montana trial court has cited Lamping since it was issued more than twenty years ago.
2. Plausibility as to Medical Monitoring Claims
a. Arguments and Allegations
The Defendants argue that the Plaintiffs fail to plausibly allege facts supporting several elements of medical monitoring claims that are common across multiple jurisdictions. DE 3116 at 21.
First, the Plaintiffs fail to allege any exposure to a hazardous substance, since no Plaintiff plausibly alleges that the ranitidine he or she took actually contained NDMA. Id. at 21-23. The Plaintiffs instead allege that because they consumed ranitidine, and the testing of some ranitidine products at various times revealed NDMA, the Plaintiffs must have been exposed to NDMA. DE 3508 at 11. That chain of inferences is inadequate to plausibly plead exposure to NDMA. Id. Further, the mere risk that ranitidine products might have contained NDMA is insufficient. DE 3116 at 23. Even if the Plaintiffs did plausibly allege some exposure, they neither allege a threshold level of exposure that places them at an increased risk of developing a Subject Cancer, nor that any Plaintiff's exposure exceeded that threshold. DE 3116 at 23. By failing to allege a threshold level of exposure, the Plaintiffs essentially argue that any level of exposure to NDMA is sufficient to obtain medical monitoring. DE 3508 at 12. And to the extent that the Plaintiffs rely on the FDA's daily allowable limit of 96 nanograms of NDMA, that regulatory threshold is too low and would lead to a monitoring program of unlimited scale. Id. (citing Riva v. Pepsico, Inc., 82 F.Supp.3d 1045 (N.D. Cal. 2015)).
Second, the Plaintiffs fail to plead that diagnostic testing exists that would make the early detection of any Subject Cancer possible, since they merely allege that their proposed medical monitoring regime would include "baseline tests and diagnostic examinations that will assist in early detection." Id. at 24 (quoting MMC ¶ 1043).
Third, the Plaintiffs fail to plead that their proposed medical monitoring regime differs from routine examinations that they would normally undergo as members of the public. Id. at 25-26. The Plaintiffs' allegation that their proposed regime "is not generally given to the public at large" is insufficient, and courts in multiple jurisdictions have dismissed medical monitoring claims containing such a formulaic recitation of this required element. Id. at 26.
The Plaintiffs argue that whether medical monitoring is an appropriate remedy is a fact-intensive question requiring expert testimony, and one that should not be decided on a Rule 12 motion. DE 3429 at 24. Moreover, the Plaintiffs plausibly allege exposure to NDMA through years of ingesting ranitidine, which contained levels of NDMA many multiples beyond the FDA's allowable limit. Id. at 25, 27. Regarding diagnostic testing, the Plaintiffs satisfy the element by alleging that they require monitoring that includes "baseline tests and periodic diagnostic examinations." Id. at 26 (citing MMC ¶¶ 978, 980). The Court must accept this allegation as true. Id. The Plaintiffs also plausibly allege a monitoring regime that is different from routine examinations, since they allege that their injuries "require specialized testing ... that is not generally given to the public at large," and which is "different from that normally recommended in the absence of exposure to this risk of harm." Id. (citing MMC ¶ 979). The Court must also accept those allegations as true. Id. Rule 8 does not require the detail that the Defendants suggest is necessary to
b. Law on Medical Monitoring
Medical monitoring claims are non-traditional torts, through which individuals "seek to recover the anticipated costs of long-term diagnostic testing necessary to detect latent diseases that may develop as a result of tortious exposure." In re Nat'l Hockey League Players' Concussion Inj. Litig., 327 F.R.D. 245, 259-60 (D. Minn. 2018) (quotation marks omitted). Medical monitoring claims "evolved from the realization that widely recognized tort law concepts premised upon a present physical injury are ill-equipped to deal with cases involving latent injury." Id. at 260 (quotation marks omitted). "[A]n action for monitoring seeks to recover only the quantifiable costs of periodic medical examinations necessary to detect the onset of physical harm ...." In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 850 (3d Cir. 1990).
The law of medical monitoring varies across jurisdictions, with some requiring a showing of manifest physical injury, some requiring subcellular or subclinical injury, and others not requiring any present physical injury. Nat'l Hockey League, 327 F.R.D. at 260. The Plaintiffs here seek medical monitoring in states where they allege that proof of present physical injury is not required: Arizona, California, Colorado, Florida, District of Columbia, Indiana, Maryland, Missouri, Montana,
Petito v. A.H. Robins Co., Inc., 750 So.2d 103, 106-07 (Fla.App. 3 Dist. 1999).
Yet among these states, the elements differ in nuanced ways. For example, some states require that testing procedures exist to detect diseases early, while others do not. Compare id. at 106 (requiring that "a monitoring procedure exists that makes the early detection of the disease possible"), with Nat'l Hockey League, 327 F.R.D. at 263 (citing Meyer, 220 S.W.3d at 712, and Burns v. Jaquays Min. Corp., 156 Ariz. 375, 752 P.2d 28 (1987), to note that Missouri and Arizona do not require that procedures exist).
c. Analysis and Conclusion
The Court concludes that the Plaintiffs have plausibly alleged at least some exposure to NDMA. Each paragraph identifying the named Plaintiffs alleges the timeframes during which they used ranitidine. MMC ¶¶ 93-144. Next, the Plaintiffs allege that NDMA is a known carcinogen, as determined by several agencies and health authorities and supported by various studies. Id. ¶¶ 185-229. The Plaintiffs then allege that testing revealed the presence of NDMA in ranitidine products, which in turn led to voluntary recalls. Id. ¶¶ 230-49. The Plaintiffs further allege that ranitidine degrades to form excessive levels of NDMA by breaking down in the human body and upon exposure to heat, moisture, and/or time. Id. ¶¶ 250-304. The Plaintiffs later allege that they "ingested Ranitidine-Containing Products at various times," and that "unbeknownst to the Plaintiffs, [the Ranitidine-Containing Products] transformed into dangerous levels of NDMA." Id. ¶¶ 975-76. Collectively, the Plaintiffs' allegations create a reasonable inference that they were exposed to NDMA.
The Defendants' plausibility challenge— that the Plaintiffs have failed to allege a significant increase in their risk of cancer —raises two distinct questions. First, pursuant to the Plaintiffs' allegations, how much NDMA
In Riva, the trial court concluded that the plaintiffs had adequately alleged that a
The Plaintiffs distinguish Riva by arguing that, unlike the plaintiff in Riva, their complaint is specific. DE 3429 at 28. To demonstrate the specificity of their allegations, the Plaintiffs aver:
Id. The Court analyzes this response phrase-by-phrase. First, the Court construes the Plaintiffs' position to be that the level of exposure to NDMA needed to warrant the remedy of medical monitoring could be as low as 96 ng of NDMA but is, in any event, no greater than 3,000 ng. Second, the Court construes the Plaintiffs' position to be that each ranitidine dose gives the consumer at least 3,000 ng of NDMA. Third and finally, the Plaintiffs describe the frequency of doses by each Plaintiff as "therapeutic doses." The Court addresses each of these topics in turn before turning to the level of specificity the Court requires in any amended MMC.
The Amount of NDMA Needed to Significantly Increase the Risk of Cancer
If the Plaintiffs' position is that 3,000 ng of NDMA is the amount necessary to significantly increase a Plaintiff's risk of cancer, the Plaintiffs should clearly allege this. The Plaintiffs' response quoted above contains no citation to the MMC for this proposition. True, the Plaintiffs have clearly alleged that the consumption of 96 ng each day, for seventy years, will result in a .001% increase in the risk of cancer. MMC ¶ 210. But by the Court's math, that would mean a Plaintiff consumed not 96 ng, but 2,452,800 ng of NDMA, albeit over the course of an entire lifetime. Relatedly, if the Plaintiffs equate a .001% increased risk with a significantly increased risk, then the Plaintiffs should clearly make that argument. The Court is unable, however, to find any allegation in the MMC from which the Court could infer that a single dose of NDMA, be it 96 ng or 3,000 ng, is equated to a substantial increase in the risk of cancer. Instead, the scientific studies that the Plaintiffs rely upon study lifetime diet habits and then conclude, based upon a lifetime of eating or not eating NDMA-rich foods, the relative risk of a consumer's cancer. If the Plaintiffs' position is that the Court may infer, from those studies, that a single exposure to 3,000 ng results in a significantly increased risk of cancer, the Plaintiffs should make
Based upon the Court's review of the MMC, the Court believes that the more likely basis for the Plaintiffs' position is that a 3,000 ng exposure to NDMA, frequently administered, would result in a significant increase in the risk of cancer. The Court is unable to analyze that position, however, without more information.
To explain, the Plaintiffs allege that every human being consumes NDMA through eating, drinking, and even breathing. E.g., MMC ¶ 252 (NDMA in drinking water); ¶ 185 n.35
Suppose, for the sake of illustration, that the Plaintiffs allege that a typical Plaintiff consumes 50 ng of NDMA per day from food and water. Further suppose that the Plaintiffs rely upon the study at footnote 71 which found that there was a statistically significant increase in the rate of cancer for persons who consumed 510 ng per day. This would mean that, if the Plaintiffs allege that every ranitidine pill contained 360 ng (discussed below), then, according to the Plaintiffs' allegations the total daily NDMA consumption would be 50 + 360 = 410 ng. This number would fall short of the daily 510 ng cited in the study as showing a statistically significant increase in the rate of cancer.
The Court is also unable to apply the Plaintiffs' allegations to the NDMA studies of lifetime eating habits because the Court does not know the frequency of the Plaintiffs' ranitidine dosages (also discussed below). By way of example, if a typical Plaintiff consumed 50 ng of NDMA per day, and received 3,000 ng of NDMA from one ranitidine pill, but only consumed one pill per week, the Plaintiffs' weekly consumption of NDMA would still fall short of the daily 510 ng threshold discussed at footnote 71.
The Amount of NDMA in Each Ranitidine Dose
To the extent the Plaintiffs rely upon the 3,000 ng of NDMA per-dose referenced in their response, the Court has been unable to locate that number anywhere in the 2,192-page MMC, and the Plaintiffs provide no citation. Because the Plaintiffs argue in their response that the amount of NDMA per ranitidine pill is over 3,000 ng, the Court has conducted an extensive review of the MMC in an effort to determine the amount of NDMA each ranitidine dose is alleged to contain. The Court has been able to locate four different sets of numbers, and each set has been referenced by the Plaintiffs in their various responses throughout the entirety of this MDL; the Court addresses each set of numbers below.
First, the Court has been able to locate an allegation that each ranitidine dose contained 47,000 ng of NDMA. MMC ¶ 274. This number is sourced from a Stanford University study where researchers measured levels of NDMA in urine samples after a subject consumed a ranitidine pill. Id. The citation to the study is provided in footnote 126, however, when the Court utilized the citation to read the study, a red retraction notice appears on the top of the study:
If the Plaintiffs' position is that the Court may conclude that the Plaintiffs have plausibly alleged a claim for medical monitoring based upon a retracted study, the Plaintiffs should clearly argue and explain that position.
Second, the Court has been able to locate an allegation that each ranitidine dose contained over 2,000,000 ng of NDMA. MMC ¶ 276. That number is sourced in the laboratory tests of a private company, Valisure. Id. Valisure arrived at that number by heating ranitidine to 266 degrees Fahrenheit. Id. Pursuant to the Plaintiffs' allegations, however, the temperature of the human body is 98.6 degrees, not 266 degrees. MMC ¶ 278. If the Plaintiffs' position is that the Court may conclude that the Plaintiffs have plausibly alleged a claim for medical monitoring based upon a study utilizing 266-degree temperatures, the Plaintiffs should clearly allege and explain that position. In the absence of such allegation, the Court does not conclude that a test utilizing 266 degrees of heat plausibly establishes a significantly increased risk of cancer, particularly given the additional findings of Valisure discussed below.
Valisure did not end its testing after the 266-degree test. Instead, Valisure conducted
Postulating that ranitidine degrades into NDMA when combined in the human stomach with foods rich in nitrites (such as tacos or pizza), Valisure conducted additional tests in an artificial human stomach where, using 98.6 degrees of heat, ranitidine was mixed with sodium nitrite. Id. Valisure's sodium nitrite findings are the third set of numbers that the Court has been able to locate in the MMC. Using "25 mM" of sodium nitrite in an artificial stomach, Valisure detected 23,600 ng of NDMA per ranitidine pill. Id. Using "50 mM" of sodium nitrite, Valisure detected 304,500 ng of NDMA per pill. Id. The Plaintiffs have repeatedly relied upon this 304,500 ng of NDMA number in their various filings in this Court.
At the Court's initial conference on law and science, the Defendants gave their own opinion on what 50 mM of sodium nitrite means and whether such an allegation renders the Plaintiffs' claims plausible. According to the Defendants, for a human stomach to contain the 50 mM of sodium nitrite necessary to produce 304,500 ng of NDMA, the consumer would first have to eat "33 pounds of bacon" before consuming ranitidine. DE 960 at 38. Because this statement was made to the Court outside of the briefing on the current Motion to Dismiss, the Court assigns no weight to the Defendants' position. The Plaintiffs did not offer their own explanation or context as to what 50 mM of sodium nitrite means, either in the MMC or in their response to the Motion to Dismiss. The Court gave the Plaintiffs the opportunity at the Hearing to explain the significance and context for 50 mM of sodium nitrite, but the Plaintiffs did not do so: "I don't have an opinion.... I would need to refresh my recollection from an expert." Hearing Tr. at 218.
In the absence of an explanation or context from the Plaintiffs, the Court endeavored to understand what, mathematically and scientifically, 50mM of sodium nitrite means. The Court attempted to perform its own mathematical calculations to discern the amount of bacon
Just as the Court assigns no weight to the Defendants' representations about the significance of 50 mM, the Court similarly assigns no weight to its own calculations. The Court merely explains why the Plaintiffs must provide context and explanation if the Plaintiffs are to rely upon the 50mM number. Furthermore, the Plaintiffs' need to explain is directly traceable to the Plaintiffs' related allegations; Valisure concluded that 10 mM of sodium nitrite in the human stomach produced no NDMA. MMC ¶ 281. As a result, the difference between these two amounts of sodium nitrite matters pursuant to the Plaintiffs' own pleading—according to Valisure, 10 mM results in no NDMA, while 50 mM results in a large amount of NDMA. The Court therefore requires additional and sufficient allegations to determine that 50 mM represents an amount of sodium nitrite
Fourth and finally, the Court has been able to locate allegations about the amount of NDMA in ranitidine from tests performed by the FDA. At footnote 90, the Plaintiffs incorporate a laboratory study by the FDA. In that study, the FDA tested a large number of ranitidine batches— batches from many different manufacturers. Id. The amount of NDMA found in the ranitidine was not equal across the Manufacturing Defendants.
The Court addresses one final point about the FDA's findings. In the FDA's own words, the "NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats." MMC ¶ 237 n.87. For this reason, the FDA characterized the amount of NDMA in a ranitidine dose as "low levels." Id. The European Medicine Agency's findings (incorporated into the MMC) are similar: "Available safety data do not show that ranitidine increases the risk of cancer, and any possible risk is likely to be considered very low." MMC ¶ 249 n.102. If the Plaintiffs ultimately rely upon the FDA's findings to plausibly establish the amount of NDMA per ranitidine pill is around 360 ng, then the Plaintiffs should also explain why the statements of the FDA about the low levels of danger of ranitidine (also incorporated into the MMC) should be disregarded or otherwise not impact the Court's decision on plausibility.
In summary, with the possible exception of the FDA's findings, the Court is unclear on just how much NDMA exposure the Plaintiffs have alleged is caused through ranitidine ingestion. And, even if the Court were to base its plausibility determination on the FDA's findings, the Court is still unable to conclude that the Plaintiffs have plausibly alleged a significant increase in the risk of cancer because of the Plaintiffs' lack of allegations about the frequency of ranitidine consumption, discussed below.
The Frequency of the Plaintiffs' Dosages
The Plaintiffs contend in their response that the MMC is specific about the number of doses that each Plaintiff received because each Plaintiff is alleged to have received "therapeutic dosages." On page 8 of the Plaintiffs' response, footnote 3, the Plaintiffs contend that "All MM Plaintiffs took therapeutic doses of ranitidine." For support, the Plaintiffs cite to paragraph 975 of the MMC. Paragraph 975 contains no information on the frequency of the Plaintiffs' dosages, only stating that the Plaintiffs "ingested [ranitidine] at various times as part of their treatment." That allegation says nothing about "therapeutic dosages." The Plaintiffs
The Level of Specificity Required in any Amended MMC
The Plaintiffs rely upon three cases to argue that they do not need to plead any additional facts in the MMC. First, the Plaintiffs cite to Trujillo v. Ametek, Inc., but in that case the plaintiffs were specific —the plaintiffs went so far as to allege with precision that their risk of cancer had increased from 5.6 chances in a million to 42 chances in a million. No. 15-CV-1394, 2015 WL 7313408, at *6 (S.D. Cal. Nov. 18, 2015). Second, the Plaintiffs cite to Allgood v. General Motors Corp., but in that case the trial court was not presented with a plausibility challenge on the "substantial increase" element; the trial court was even uncertain what, under Indiana law, the remedy of medical monitoring required. 2005 WL 2218371, at *7-8. Third and finally, the Plaintiffs spent most of their argument at the Hearing and in their response in reliance upon In re Paulsboro Derailment Cases, and it is true that the Paulsboro court was presented with a plausibility challenge. No. 13-784, 2013 WL 5530050 (D.N.J. Oct. 4, 2013). It is equally true that the Paulsboro court was satisfied with the allegations in the complaint and required no further level of detail from the plaintiffs, however the Court sets forth below some of the allegations that the Court was able to locate in the Paulsboro complaint at docket entry 29 in the court file.
A train carrying vinyl chloride, a carcinogen, crashed, leaking the carcinogen into the water supply of a town and the air as well. Id. at p. 16. The leakage into the air created a poison mist, a fog. Id. The townspeople began to walk through the fog with small children, for example to get to school, and they were completely exposed. Id. The fog could be tasted in the mouths of those who walked through it. Id. at p. 17. Townspeople immediately received pain in their chests and eyes while inside the fog. Id. The pain lasted a long time. Id. Many townspeople developed debilitating coughs from walking through the fog, and the coughs lasted for several weeks. Id. Townspeople went to the hospital and were diagnosed as having been chemically exposed to a dangerous carcinogen. Id.
In conclusion, the Court cannot clearly ascertain from the MMC: (i) the number of doses of ranitidine the Plaintiffs consumed, (ii) the amount of NDMA each Plaintiff received per dose, and (iii) how much NDMA is necessary to cause a significantly increased risk of cancer for each of the Subject Cancers alleged in the MMC. The Court does not mean to suggest that the only way that the Plaintiffs may plausibly plead a substantial increase in the risk of cancer is by answering in detail, through their allegations, the questions the Court has posed or by dispelling all of the uncertainty that the Court has highlighted in this Order. The Plaintiffs may, of course, plead a substantial increase in the risk of cancer in whatever way they deem best, including through avenues other than NDMA exposure and NDMA frequency. The Court's ruling is merely that, as pled, the Court cannot conclude that the Plaintiffs have plausibly alleged a substantial increase in the risk of cancer. The Plaintiffs must replead their medical monitoring claims, and the MMC is dismissed without prejudice and with leave to amend.
The Court concludes that the Plaintiffs have failed to plausibly allege that diagnostic tests exist for early detection of the Subject Cancers. The Plaintiffs' allegation amounts to a "naked assertion devoid of further factual enhancement." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. The Plaintiffs do not expressly allege that any tests and exams exist, much less specify what they are.
The Defendants' caselaw is persuasive. In Slemmer v. McGlaughlin Spray Form Insulation, Inc., the plaintiffs proposed a monitoring regime of "diagnostic tests and pharmaceutical interventions." No. 12-6542, 2013 WL 5655480, at *3 (E.D. Pa. Oct. 17, 2013). Their class action complaint was dismissed for "fail[ure] to identify specific medical monitoring procedures as required," and for "fail[ure] to aver that a monitoring program procedure exists that makes early detection of a specific disease possible." Id.; see also In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., MDL Nos. 1871, 07-MD-01871, 2011 WL 4006639, at *3 (E.D. Pa. Sept. 7, 2011) (granting a motion to dismiss where "[t]he claim for medical monitoring essentially tracks the elements of the claim, but without any specific facts alleged (e.g., as to what medical monitoring procedure exists and how it differs from the monitoring for all patients with Type 2 diabetes)"). Additionally, the Defendants cite Bell v. 3M Co., where medical monitoring claims were dismissed for, among other deficiencies, the plaintiffs' failure to allege that there were any diagnostic tests that could detect the plaintiffs' diseases early. 344 F.Supp.3d 1207,
Courts overseeing large cases—including those involving medical monitoring claims—have demanded specificity in pleadings before permitting the case to advance further. See, e.g., Cook v. Rockwell Intern. Corp., 755 F.Supp. 1468, 1475 (D. Colo. 1991) ("In a case of this magnitude, a district court must retain the power to insist upon some specificity in pleading before allowing a potentially massive factual controversy to proceed.") (quotation marks omitted). As to this element, the Plaintiffs' current allegations lack the specificity present in the Third Amended Complaint in Bell. They likewise suffer from deficiencies similar to those in the complaints that were dismissed in Slemmer, Avandia, and Bell. The Court will not permit those deficiencies, and thus dismisses the Plaintiffs' medical monitoring claims in all jurisdictions requiring a diagnostic testing element.
Hearing Tr. at 198-99. The Plaintiffs' claims are thus dismissed without prejudice on this basis, and with leave to replead as to this specific element.
The Court concludes that the Plaintiffs' allegations are merely a recitation of the required element. Indeed, the Plaintiffs' allegations are like those in cases that Defendants cite, where medical monitoring claims were dismissed. See Coffie v. Fla. Crystals Corp., 460 F.Supp.3d 1297, 1314 (S.D. Fla. 2020) (dismissing a medical monitoring count where plaintiffs "merely pled a formulaic recitation
Although Rule 8 does not require that a pleading contain an extraordinary level of detail, the Court will not accept a pleading that merely recites a necessary element and does not provide any factual support. The Court thus dismisses the Plaintiffs' medical monitoring claims in all jurisdictions requiring that a proposed monitoring regime differ from what is recommended to the public at large. At the Hearing, counsel for the Plaintiffs stated that they may be able to allege more regarding this element. Hearing Tr. at 203 ("[T]here may be a bit measure more of explanation that we could plead ...."). The Plaintiffs' claims are therefore dismissed without prejudice, and with leave to replead as to this specific element.
3. Failure to Plead the Claims Based on Expiration Dates and Product Containers
a. Arguments and Allegations
The Defendants contend that the Plaintiffs have failed to plausibly plead the claims based on improper expiration dates and product containers, and the Defendants therefore seek dismissal of all of these claims in the MMC.
The Plaintiffs allege that ranitidine internally degrades to form NDMA, that the level of NDMA in a ranitidine product increases over time, and that this higher level of NDMA increases the risk of cancer. See, e.g., MMC ¶¶ 880-81, 883. The cancer risk is lower if the product is consumed shortly after it is manufactured. Id. ¶¶ 882-83. Therefore, had ranitidine products had shorter expiration dates, the ranitidine that consumers ingested would have had lower levels of NDMA, and their cancer risks would have been lower. Id. ¶ 883. Pill bottles with a large number of pills are likely to be stored for long periods of time. Id. ¶ 941. Selling ranitidine products with
The Plaintiffs also allege that the Defendants knew or should have known about all of the risks associated with ranitidine. Id. ¶ 183. They "knew or should have known that ranitidine had an inherent risk of degrading into NDMA because it has both a nitroso (N) and dimethylamine (DMA), which are all the ingredients needed to form NDMA." Id. ¶ 939. Federal law requires drug manufacturers to conduct stability testing on their products to assess drug stability and to determine appropriate storage conditions and expiration dates. Id. ¶¶ 885-86; see 21 C.F.R. § 211.166(a) ("There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates."). "Simple, widely available and cost-effective tests" would have reveled degradation and NDMA accumulation in ranitidine products. MMC ¶¶ 882-84. Furthermore, research conducted and published before Zantac entered the market revealed elevated levels of NDMA in ranitidine when it was properly tested. Id. ¶ 312. For example, a doctor published a note in a popular scientific journal in 1981 that discussed "the results of his experiments showing that ranitidine was turning into mutagenic N-nitroso compounds, of which NDMA is one, in human gastric fluid when accompanied by nitrites—a substance commonly found in food and in the body." Id. ¶ 314.
b. Analysis and Conclusion
The parties utilize a "known or should have known" standard in making their respective arguments about the sufficiency of the pleading. The parties have not briefed whether any state's law would use a different standard to meet the element of notice for any of the claims at issue. For purposes of analyzing the adequacy of the Plaintiffs' pleading, the Court utilizes a "known or should have known" standard. Should any party contend that the standard is different under a particular state's law, that party may raise the issue at the appropriate time in connection with state-specific arguments. See Pretrial Order # 61 ("To the extent that other state-specific issues become relevant at a later stage of the litigation, such as at the bellwether trial stage, the parties agree that they may seek leave of the Court to raise the issues at that time.").
The Plaintiffs have plausibly pled that the Defendants should have known, through stability testing of their ranitidine products, that ranitidine can degrade to form NDMA over time and due to exposure to moisture. The Plaintiffs allege that federal law requires all drug manufacturers to conduct stability testing on their products to assess drug stability and to determine appropriate storage conditions and expiration dates. MMC ¶ 886 (citing 21 C.F.R. § 211.166). The Plaintiffs further allege that testing would have revealed degradation and NDMA accumulation in ranitidine products. Id. ¶ 884.
The Defendants argue that the Plaintiffs' allegations about stability testing are insufficient because they do not identify which tests the Defendants should have conducted that would have revealed ranitidine degradation or when such tests became available. DE 3116 at 28. The Defendants assert that some of them
But the Plaintiffs have identified one test that they maintain could have detected NDMA and that was available at all times that ranitidine products were manufactured. That is, the Plaintiffs have alleged that "mass spectrometry" was a "gold-standard" test that was available by at least 1982, around the same time that the FDA approved the first ranitidine product for sale. MMC ¶ 264 (faulting a 1982 GSK study for failure to use "gold-standard mass spectrometry"), ¶ 151 (alleging that the FDA approved the sale of Zantac in 1983). And the Plaintiffs have alleged that "gas chromatography-mass spectrometry" testing in 2019 revealed high levels of NDMA in ranitidine pills. Id. ¶ 230. These allegations, in conjunction with the allegations about federal requirements for stability testing and the availability of testing that would have revealed degradation, plausibly plead that the Defendants should have known that ranitidine can degrade to form NDMA with time and with exposure to moisture.
4. Viability and Pleading of the Claims for Failure to Warn Consumers Through the FDA
The Plaintiffs bring claims against the Manufacturer Defendants in the MMC for failure to warn consumers through the FDA. These claims are raised under the laws of California, the District of Columbia, Indiana, Maryland, Missouri, Nevada, and Pennsylvania. The Plaintiffs allege that the Manufacturer Defendants breached their duties, under the laws of these jurisdictions, to convey warnings to the FDA of the dangers of ranitidine products when those warnings could have reached consumers. See, e.g., MMC ¶¶ 1068-69.
The Manufacturer Defendants argue that the claims must be dismissed because they are not viable under the laws of the seven jurisdictions and because the claims are not plausibly pled. DE 3116 at 29-33. The Plaintiffs' response incorporates by reference their opposition to the dismissal of Count V of the AMPIC, another claim for failure to warn consumers through the FDA. DE 3429 at 34; see DE 3424. The Plaintiffs argue that their claims are plausibly pled and that the Manufacturer Defendants incorrectly interpret state law in reaching their conclusion that jurisdictions would not recognize the claims. DE 3424 at 35-44. The Plaintiffs concede that the District of Columbia and Indiana would not recognize the claims, and they seek leave to amend their pleading to raise the claims under the laws of Idaho and Wisconsin. Id. at 45.
In the Court's Order Granting in Part and Denying in Part the Branded Defendants' Rule 12 Partial Motion to Dismiss Plaintiffs' Three Master Complaints as Preempted by Federal Law, the Court concluded that the Plaintiffs' claims for failure to warn consumers through the FDA are pre-empted under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), for the reasons that the Eleventh Circuit Court of Appeals outlined in Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017). The Court dismisses the claims with prejudice for that reason. In light of this ruling, the Court need not address arguments directed to the viability of the claims under state law and pleading deficiencies or the Plaintiffs' request to add sub-counts under the laws of Idaho and Wisconsin.
5. Claim Splitting
The Defendants argue that the Plaintiffs have impermissibly split their claims between the MMC and the ELC. This is impermissible, the Defendants argue, because in the Eleventh Circuit all of a plaintiff's related claims must be brought in one pleading. As explained by the Eleventh Circuit: "The rule against claim-splitting requires a plaintiff to assert all of its causes of action arising from a common set of facts in one lawsuit." Vanover v. NCO Fin. Servs., Inc., 857 F.3d 833, 841 (11th Cir. 2017). The rule exists "to allow district courts to manage their docket and dispense with duplicative litigation." Id. The Defendants' claim-splitting argument is premature for several reasons.
First, there is no "duplicative litigation," because there is but one case pending before the Court—this MDL— and all other cases have been administratively closed pending remand. Second, the reason the Plaintiffs have arguably split their claims between two master pleadings is because the Court expressly granted the Plaintiffs permission to do so at docket entry 2720. Third, the reason the Court granted the Plaintiffs permission to file an additional master complaint was because the Court was exercising its authority to "manage [its] docket."
6. Factual Inconsistencies
The Defendants argue that certain counts in the class complaints are factually inconsistent because, within the allegations incorporated into the counts, the Plaintiffs advance multiple theories as to how ranitidine injured the Plaintiffs. E.g., MMC ¶¶ 185-304. The Defendants contend that these different theories of injury are inconsistent. In response, the Plaintiffs argue that their theories are not inconsistent— they simply postulate different explanations for the Plaintiffs' injuries, not inconsistent explanations. The Court concludes that Plaintiffs' claims need not be dismissed or amended based on these alleged inconsistencies. To the extent the Plaintiffs' various theories for recovery implicate pre-emption concerns, that is a matter that will be addressed in the Court's Order on the Generic Defendants' Rule 12 Motion to Dismiss on the Ground of Preemption.
B. Issues Raised in the ELC
1. Shotgun Pleading
a. Arguments and Allegations
The Defendants argue that the ELC is still a shotgun pleading that violates Rule 8, despite the Court's Order at docket entry 2515 ("Shotgun Order") noting that the ELC impermissibly incorporated hundreds of allegations into every count and lumped the Defendants together. DE 3116 at 35. Rather than cure those deficiencies, the Plaintiffs merely re-organized their claims. Id. In turn, each of the ELC's 1,675 counts still incorporate hundreds of paragraphs of allegations, and many of the same paragraphs are alleged against all
The Plaintiffs argue that the ELC neither impermissibly incorporates paragraphs nor lumps the Defendants together. DE 3429 at 40-41. The Plaintiffs incorporate only relevant factual allegations into each count, and it is of no consequence that there may be hundreds of relevant paragraphs. Id. at 40. The Plaintiffs also separately set forth each Defendant and each claim in the ELC. Id. at 41.
b. Law on Shotgun Pleading
Rule 8(a) requires that any claim for relief contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). A shotgun pleading fails "to one degree or another, and in one way or another, to give the defendants adequate notice of the claims against them and the grounds upon which each claims rests." Weiland v. Palm Beach Cnty. Sheriff's Office, 792 F.3d 1313, 1323 (11th Cir. 2015). There are roughly four types of shotgun pleadings:
Id. at 1321-23 (footnotes omitted).
Rule 9(b) states that "[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake." Fed. R. Civ. P. 9(b). To satisfy Rule 9(b), a complaint must set forth:
Ziemba v. Cascade Int'l, Inc., 256 F.3d 1194, 1202 (11th Cir. 2001).
c. Analysis and Conclusion
In the Shotgun Order, the Court concluded that the Plaintiffs (1) impermissibly incorporated hundreds of allegations into every count, and (2) impermissibly lumped related and unrelated Defendants together. DE 2515 at 22. The Defendants argue that the ELC still commits both sins. The Court disagrees.
As noted in the Shotgun Order, the original ELC indiscriminately incorporated
Separately, the Defendants argue that the Plaintiffs "still lump groups of Defendants together and allege in undifferentiated fashion the purported conduct supposedly underlying the subsequent, separated claims." DE 3508 at 19. Contrary to the Defendants' argument, the Plaintiffs appear to have eliminated the lumping that the Court found problematic in the original ELC. While many counts in the original ELC were alleged against multiple groups of Defendants, or all Defendants, each count in the amended ELC appears to be alleged against one specific Defendant (or related Defendants). Compare DE 889 at 354 (Count 9, violation of the Alabama Deceptive Trade Practices Act, alleged "Against Brand-Name Manufacturer Defendants and Generic Manufacturer Defendants"), with ELC at 1554 (Count 409, violation of the Alabama Deceptive Trade Practices Act, alleged "Against Amneal").
Finally, the Defendants' argument that the Plaintiffs' "fraud-based claims" fail under Rule 9(b) is unpersuasive. DE 3116 at 38. The Defendants appear to devote just one sentence in their Motion to this argument, and do not specify which of Plaintiffs' ELC counts are "fraud-based claims." Absent adequate briefing on the issue, the Court declines to consider the matter.
Even if the Defendants view the ELC as imperfect, the Court is satisfied that the Plaintiffs have adequately addressed the shotgun pleading sins that were previously present. The ELC need not be perfect; it need only provide the Defendants with fair notice of the allegations. Twombly, 550 U.S. at 554-56. If the Court ordered the Plaintiffs to replead with the detail that the Defendants demand, the ELC would likely balloon to thousands of more pages and make an already massive pleading even larger. That would in turn jeopardize one major purpose of multidistrict litigation, namely to "promote the just and efficient conduct" of "actions involving one or more common questions of fact pending in different districts." 28 U.S.C. § 1407(a) (emphasis added).
Particularly in an MDL of this size, a district court retains wide discretion to ensure that the litigation progresses efficiently and without undue delay. This Court has exercised that discretion at various stages of the litigation in order to efficiently administer this MDL, including through the issuance of more than 60 Pretrial Orders. Its conclusion on this issue is consistent with fulfilling the Court's obligation to properly manage the MDL.
2. Article III Standing: Injury-in-Fact
a. Arguments and Allegations
Renewing an argument raised in a prior
The Plaintiffs respond that they plausibly plead an economic injury, since they purchased ranitidine products that they would not have bought had they known that the products cause cancer. DE 3429 at 35. Their financial injury is equal to the price that they paid for the products, which is adequate for Article III standing. Id. at 36. The Plaintiffs' case is exactly like In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, MDL No. 2875, 2021 WL 100204 (D.N.J. Jan. 12, 2021). Valsartan also involved allegations that the defendants' products contained NDMA, and the district court found that the plaintiffs pled an injury-in-fact by alleging that they did not receive the benefit of their bargain when purchasing the defendants' products. Id. at 37.
While the Plaintiffs do not rely exclusively on Debernardis to establish injury-in-fact, the case's principles apply here, including that under a benefit-of-the-bargain theory, a purchaser who buys a product with significant defects may receive nothing of value. Id. The Plaintiffs' case is stronger than Debernardis, for the Plaintiffs here allege a substantive safety defect—that the Defendants' products contained NDMA—while the plaintiffs in Debernardis alleged a procedural defect, namely that the defendants sold a presumptively adulterated dietary supplement containing an ingredient that the FDA had not approved. Id. at 37-38. In this regard, the Plaintiffs' case is more like In re Aqua Dots Products Liability Litigation, 654 F.3d 748 (7th Cir. 2011), wherein the plaintiffs alleged that they would not have purchased the defendants' products had they known of their real-world defects. Id. at 38. Further, the Defendants' argument that the Plaintiffs allege neither physical injury, nor that the ranitidine products were ineffective, is unpersuasive, as the Plaintiffs' theory of economic injury is not premised on those
b. Law on Article III Injury-In-Fact
"Article III, § 2, of the Constitution extends the `judicial Power' of the United States only to `Cases' and `Controversies.'" Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 102 (1998). That a case or controversy exists is a bedrock requirement, and courts cannot exercise judicial power without it. Muransky v. Godiva Chocolatier, Inc., 979 F.3d 917, 924 (11th Cir. 2020) (en banc). "Standing, ripeness and mootness are three traditional doctrines governing whether a case or controversy exists." Id. Standing is "perhaps the most important of the jurisdictional doctrines." Id. (quotation marks omitted).
The "irreducible constitutional minimum of standing" entails three elements: injury-in-fact, causation, and redressability. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). The party invoking federal jurisdiction bears the burden of establishing each element. Id. at 561, 112 S.Ct. 2130. The Lujan elements are "an indispensable part of the plaintiff's case, [and] each element must be supported in the same way as any other matter on which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required at the successive stages of the litigation." Id.
The Defendants only challenge the injury-in-fact element. To show an injury-in-fact, a plaintiff must demonstrate "an invasion of a legally protected interest" that is "concrete and particularized" and "actual or imminent, not conjectural or hypothetical." Id. at 560, 112 S.Ct. 2130 (quotation marks omitted). A particularized injury is one that "affect[s] the plaintiff in a personal and individual way." Spokeo, Inc. v. Robins, 136 S.Ct. 1540, 1548 (2016). A concrete injury is one that is "real" and not "abstract." Id. A plaintiff can allege concrete harm in three ways:
Hunstein v. Preferred Collection and Mgmt. Servs., Inc., 994 F.3d 1341, 1346 (11th Cir. 2021) (quotation marks and citations omitted).
"At the pleading stage, general factual allegations of injury resulting from the defendant's conduct may suffice, for on a motion to dismiss we presume that general allegations embrace those specific facts that are necessary to support a claim." Lujan, 504 U.S. at 561, 112 S.Ct. 2130. "But that is not a free pass—these general factual allegations must plausibly and clearly allege a concrete injury," and mere conclusory allegations are insufficient. Godiva, 979 F.3d at 924 (quotation marks omitted). Courts "will not imagine or piece together an injury sufficient to give a plaintiff standing when it has demonstrated none," and "are powerless to create jurisdiction by embellishing a deficient allegation of injury." Id. at 925 (quotation marks omitted).
Economic harm is the epitome of a concrete injury. MSPA Claims 1, LLC v. Tenet Fla., Inc., 918 F.3d 1312, 1318 (11th Cir. 2019). A person experiences economic
c. Analysis and Conclusion
Relying on a benefit-of-the-bargain theory, the Plaintiffs allege that they have suffered tangible harm through financial loss. E.g., ELC ¶¶ 92-272 (The Plaintiffs have "suffered concrete injury in the form of economic damages," since due to the Defendants' conduct, the ranitidine products they purchased "were unsafe for human ingestion and, therefore, were worthless at the time of purchase"); id. ¶ 1319 ("Had Defendant not engaged in the deceptive acts and practices alleged herein, Plaintiff and the Class members would not have purchased the drug, and, thus, they did not receive the benefit of the bargain and/or suffered out-of-pocket loss."). The Plaintiffs' theory for injury-in-fact is not premised on present physical injury, an increased risk of some future injury, or "statutory violation that gives rise to an intangible-but-nonetheless-concrete injury." Hunstein, 994 F.3d at 1346.
The Court concludes that at this procedural juncture, the Plaintiffs have plausibly alleged economic injury-in-fact through purchasing worthless drugs that contained NDMA and were misbranded, and which the Plaintiffs would not have purchased but for the Defendants' conduct. This conclusion is supported by allegations throughout the ELC, including those discussed below.
The Plaintiffs allege that NDMA has been a known human carcinogen since the 1970s. ELC ¶ 443. Two years before Zantac entered the market, Dr. Silvio de Flora published research warning of "toxic and mutagenic effects" when ranitidine interacted with human gastric fluid and nitrites. Id. ¶¶ 373, 388. Dr. de Flora's research
The Plaintiffs later allege that pursuant to federal regulations, the Defendants were required to inform the FDA annually about new information affecting ranitidine's safety, effectiveness, or labeling. Id. ¶¶ 464-65. Despite publicly available science demonstrating that ranitidine products contained and exposed users to NDMA, the Defendants allegedly disregarded that science and never disclosed those risks to the FDA, in violation of their reporting obligations. Id. ¶¶ 462, 466-68. "Because Manufacturer Defendants never properly disclosed the risks to the FDA, they never proposed any labeling or storage/transportation guidelines that would have addressed this risk." Id. ¶ 468. Yet once the FDA learned about the NDMA risks associated with ranitidine products, it ordered voluntary recalls of the products. Id. ¶¶ 372, 469. Had any Manufacturer Defendant notified the FDA about the risks sooner, the FDA would have ordered the ranitidine products removed from the market. Id. ¶ 469. And by failing to include warnings on labels that consumers were at elevated risks of cancer, the Defendants made false statements in the labeling of their products. E.g., id. ¶ 844.
In sum, the Plaintiffs allege that based on research pre-dating the FDA's approval of ranitidine, the Defendants knew or should have known that ranitidine transformed into NDMA. Notwithstanding that research, the Defendants withheld the information from the FDA and consumers, including through product labeling that did not warn about NDMA exposure or an increased risk of cancer. In turn, the Plaintiffs purchased products that contained NDMA, were mislabeled, and were worthless. The Plaintiffs were thus denied the benefit of their bargain, and had they been properly warned of the risks associated with the Defendants' ranitidine products, they would not have purchased them. Those allegations suffice at this stage of the litigation. While the Defendants argue that, because the Plaintiffs do not allege physical injury or product inefficacy, they cannot say that the ranitidine products were worthless, courts inside and outside this circuit have rejected that argument. See, e.g., Valsartan, 2021 WL 100204, at *10-11 ("Defendants argue [that] unless Plaintiffs allege they were physically harmed by a product or that it failed to perform its anticipated benefit, there is no economic injury in fact. This is just not true."); see also Aqua Dots, 654 F.3d at 750-51 (rejecting argument that absent physical injury, plaintiffs lacked standing, since "[t]he plaintiffs' loss is financial: they paid more for the toys than they would have, had they known of the risks the beads posed to children. A financial injury creates standing."); Yachera v. Westminster Pharms., LLC, 477 F.Supp.3d 1251, 1263 (M.D. Fla. 2020) ("Such allegations may be `sufficient to establish standing,' but they are not `necessary to establish
The Court's decision does not settle the issue of standing for the remainder of the case. The Court is free, and in fact obligated, to consider the question of standing sua sponte at each stage of the litigation:
Hallandale Prof. Fire Fighters Local 2238 v. City of Hallandale, 922 F.2d 756, 759 (11th Cir. 1991). Discovery may reveal additional facts bearing on the Plaintiffs' standing (or lack thereof), and the Plaintiffs must back up the allegations that they rely on for standing with evidentiary support in the record. Debernardis, 942 F.3d at 1090 (Sutton, J., concurring) ("At summary judgment, each claimant will need evidence to back the point up. Why was the product worthless as to each of them? How did it deliver less than expected? Did each of them use the product even after they knew of the labeling deficiency? The answers to these questions and others will determine whether the case may proceed further....").
The legal landscape as to standing in general, and standing based on economic injury, is less than clear. See Sierra v. City of Hallandale Beach, Fla., 996 F.3d 1110, 1116 (11th Cir. 2021) (Newsom, J., concurring) ("Despite nearly universal consensus about standing doctrine's elements and sub-elements, applying the rules has proven far more difficult than reciting them."); id. at 1117 ("[O]ur Article III standing jurisprudence has jumped the tracks."). Indeed, caselaw cited by the parties reveals a range of approaches to analyzing economic injury as a basis for Article III injury-in-fact, with many cases emphasizing different factual aspects to justify their conclusions. Compare, e.g., Debernardis, 942 F.3d at 1088 (standing where "the plaintiffs purchased adulterated dietary supplements that they would not have purchased had they known that sale of the supplements was banned"), with Doss v. Gen. Mills, Inc., No. 18-61924, 2019 WL 7946028, at *2 (S.D. Fla. June 14, 2019) (no standing where plaintiff did not allege health effects from eating Cheerios, or that "the Cheerios she herself bought actually contain[ed] any glyphosate"), with Aqua Dots, 654 F.3d at 751 (plaintiffs suffered economic injury, despite their children
While this Court is bound by Debernardis, the Eleventh Circuit stated that its opinion was intended to be read narrowly. See 942 F.3d at 1088 ("We caution that our decision is limited to the specific facts alleged in this case—that the plaintiffs purchased dietary supplements that Congress, through the FDCA and the [Dietary Supplement Health and Education Act], had banned from sale with the purpose of preventing consumers from ingesting an unsafe product."). Debernardis thus left open meaningful questions as to whether the factual allegations in the instant case should result in the same outcome, or whether the Plaintiffs' allegations, without more, will open the floodgates to future litigation—a concern expressed at the oral argument in Debernardis. Id. Because the Court has the duty to re-examine standing at every juncture of the case, it is reasonable, and arguably consistent with the reasoning in Debernardis, to allow the case to proceed at this time. With a more fully developed factual record, the Court will be better positioned to discern whether this case leans toward or away from Debernardis, and if the latter, whether the rationale for finding standing in Debernardis nevertheless supports standing in this case.
3. Learned Intermediary Doctrine
The Defendants argue that the Plaintiffs' failure-to-warn claims concerning prescription ranitidine fail as a matter of law under the learned intermediary doctrine. DE 3116 at 42. This is so because "Plaintiffs do not allege that their physicians were inadequately warned about the alleged cancer risk associated with ranitidine, or that their physicians would have made different prescribing decisions if they had been warned." Id.
At the Hearing, the Court noted that the Defendants did not challenge the MMC or the AMPIC on the basis of the doctrine; it also observed that, unlike the ELC, those complaints contain allegations about the Defendants' failure to warn the Plaintiffs' prescribing physicians. Hearing Tr. at 191-92.
Hearing Tr. at 194-95. While the Defendants did not commit to the position that the relevant allegations in the AMPIC and MMC were sufficient to overcome the learned intermediary doctrine, they did suggest that at this stage, such allegations would be sufficient if made in the ELC, subject to the Defendants' ability to re-raise the issue later in the litigation:
Id. at 196:15-23.
Given the foregoing, the Court dismisses the Plaintiffs' prescription-based claims— namely, Counts 2-71 and 409-1062—without prejudice, and with leave to plead allegations that are specifically relevant to the learned intermediary doctrine. This scope of leave is not broad, but rather extremely narrow and specific as to this discrete issue. Following the Plaintiffs' replead as to this issue, the Court will not entertain further motions to dismiss on this issue. Consistent with Pretrial Order #61, however, the Defendants may seek leave of Court to re-raise this issue as it becomes relevant at a later stage of the litigation.
4. Consumer Protection Safe Harbors; FDA Labeling Presumed Valid; Unjust Enrichment
The Defendants argue that for 24 states,
Notwithstanding the Defendants' ability to move for dismissal on the issues summarized above, their briefing of each is inadequate. Due to each issue's complexity, the number of jurisdictions involved, and the number of claims that the Defendants seek to dismiss through each issue, the Court would need far more extensive briefing to reach fully informed conclusions. The Defendants' Motion is therefore denied without prejudice as to these issues. Consistent with Pretrial Order # 61, the Defendants may seek leave of Court to raise these state-law issues at a later stage of the litigation.
For the foregoing reasons, it is
The Plaintiffs subsequently moved to certify a question for interlocutory appeal. DE 2693. In that motion, the Plaintiffs argued that because of the Court's Order on preemption for Brand-Name Manufacturer Defendants [DE 2532], they could no longer allege economic loss claims premised on personal injury. The Court denied the motion without prejudice, and re-clarified that its prior Order did not preclude the Plaintiffs from pleading as they described. DE 2716 at 2. The Plaintiffs' decision to premise their economic loss purely on purchasing an allegedly unsafe and worthless product—rather than on personal injuries— was not because they were prohibited from doing so. At the Hearing, the Plaintiffs confirmed that they were aware of their right to seek leave to file a class personal/physical injury complaint, but did not exercise it. Hearing Tr. at 167-68.
Hearing Tr. at 183-84.