ADAMS

v.

PFIZER INC.

In this MDL, the Plaintiffs filed two types of class action claims: medical monitoring class action claims and economic loss class action claims. To resolve these class action claims, the Court, through its case management plan, first addressed the issue of general causation—can ranitidine (the drug at issue in this MDL) cause cancer in humans? Were the Plaintiffs’ personal injury claims to survive the general causation challenges, the Plaintiffs then could file their motion for class certification pursuant to the Court’s case management plan. The Plaintiffs’ claims, however, did not survive the Daubert challenges. Before the Plaintiffs moved for class certification, the Court concluded that the Plaintiffs have no reliable evidence that ranitidine could cause certain cancers. In light of its Daubert ruling, the Court undertook to determine whether the Plaintiffs still could move for certification of their medical monitoring and economic loss class action claims. In this Order, the Court sets forth why the Plaintiffs cannot do so. As such, the Court enters final judgment in the medical monitoring class action cases and dismisses without prejudice all of the economic loss class action cases for lack of standing. To explain how the Court reaches this conclusion, first the Court outlines the procedural history of the class action claims in this MDL, focusing on the Plaintiffs’ contention that they had standing to bring their economic loss class action claims. Then the Court analyzes the impact of the Court’s Daubert ruling on the medical monitoring and economic loss class action claims.

I. Background on the Plaintiffs’ Standing Theory Throughout the course of this MDL, the Plaintiffs had a standing theory. The Plaintiffs’ standing theory was clearly pled; it was the centerpiece of all of the Plaintiffs’ standing arguments; and, this standing theory survived multiple rounds of motions to dismiss. In this section, the Court reviews those allegations in the Plaintiffs’ complaints relevant to standing, the Plaintiffs’ arguments opposing the Defendants’ motions to dismiss based on lack of standing, and the Court’s rulings on standing. In the Plaintiffs’ class action complaint first filed in the MDL, the Plaintiffs alleged that ranitidine was “inherently defective, unreasonably dangerous, [] not fit to be used for [its] intended purpose,” and, therefore, worthless. See DE 889 (referring to ranitidine as “dangerous”¹,656 times). The Plaintiffs did not allege in their complaint that ranitidine was otherwise ineffective or did not perform as advertised. The Defendants moved to dismiss the complaint in its entirety for lack of standing, arguing that the Plaintiffs failed to state an injury-in-fact fairly traceable to the Defendants. See, e.g., DE 1630 at 26-27. In opposition, the Plaintiffs argued that they had suffered an economic injury-in-fact when they purchased ranitidine since it was a “worthless, dangerous drug” that created NDMA. DE 1980 at 10-11, 25; see also DE 2515 at 13 (“[The Plaintiffs] state that they suffered an economic injury, (i.e., a ‘pocketbook injury’) by paying for misbranded

2 and/or adulterated ranitidine products that should not have been available for sale, and which were economically worthless.”). They suffered an economic injury-in-fact not simply because something that is illegal to sell is automatically worthless merely because of that fact. It is because Congress made a particular kind of judgment in the Food, Drug and Cosmetics Act about what types of things are safe for people to consume, and it judged that a misbranded or adulterated drug or supplement would be unsafe, and for that reason illegal, not for a different reason, and that is what makes it an injury in fact.

Dec.¹⁴, 2020, Hearing Tr. at 127-28. In this way, the Plaintiffs’ standing theory rested on four points: ranitidine causes cancer, was unsafe, should not have been sold, and, therefore, was worthless, or at least worth less. Id. at 129-31. In its Order on the first round of motions to dismiss, the Court determined that it could not “undertake a full Article III standing analysis” because the complaint under review was a shotgun pleading, but the Court did reach certain conclusions about standing. DE 2515 at 13-14. First, in line with the parties’ agreement, standing for the class action claims should be evaluated before the class certification stage of the proceedings. Id. at 25. Second, the Court would evaluate standing on a claim-by-claim basis. Id. at 28. Third, the juridical link doctrine did not apply in this MDL;¹ as a result, the doctrine did not permit the Plaintiffs to sue on behalf of others with the same injury. Id. at 33. Fourth, the named Plaintiffs lacked standing to assert claims on behalf of class members whose claims arise under other states’ laws. Id. at 36. Significantly, fifth, the Court determined that the Plaintiffs could not rely on Debernardis v. IQ Formulations, LLC, 942 F. 3d 1076 (11th Cir. 2019), to support their theory of standing. In

NDMA?). And, the Plaintiffs did not contend that ranitidine was illegal to sell for any reason other than its cancer-causing propensity or the presence of NDMA at levels above the FDA’s acceptable daily intake level (“ADI”). The Plaintiffs only raised and, thus, the Court’s early attention and rulings on standing were singularly focused on the Plaintiffs’ misbranding theory. Based on this theory, the Court determined that the Plaintiffs had standing to proceed through the motion to dismiss stage by alleging an economic injury-in-fact based on the purchase of a misbranded, unsafe, and worthless product (ranitidine) that they would not have purchased had its label disclosed its cancer-causing propensity. DE 3720 at 51-53. The Court reasoned that, if a product performs as advertised (and therefore is not deemed worthless under applicable caselaw) but also causes cancer, the product could have been misbranded and should not have been sold. Because the Plaintiffs pled that ranitidine could have been misbranded and should not have been sold, the Court determined, that pursuant to the reasoning in Debernardis3 and Aqua Dots, the Plaintiffs suffered an injury-in-fact when they purchased ranitidine. Therefore, ultimately, the Plaintiffs had standing to pursue their claims stated in the Second Amended Consolidated Economic Loss Class Action Complaint (“SAELC”).

3 The Court partially relied on Debernardis in its order on the second round of motions to dismiss, in contrast to its earlier order distinguishing Debernardis. This is because in the Court’s later discussion of Debernardis, the Court focused on the Plaintiffs’ allegations of a misbranded product that should not have been sold, while in its earlier discussion, it focused on the fact that at all points at time, and even to this very day, ranitidine remains legal to sell.⁶ Despite its ruling on standing at the motion to dismiss stage of the proceedings, the Court informed the parties that it would return to the issue of standing when the evidentiary record in this MDL was more developed. The Court explained that “[t]he Court is free, and in fact obligated, to consider the question of standing sua sponte at each stage of the litigation.” DE 3720 at 53.

“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.” Id.; cf. DE 1980 at 19-20 (“After discovery, the evidentiary demands on a plaintiff go up, and the Court may insist that a litigant train its sights on the discrete defendants responsible for her injuries.”). The Court indicated that it would consider the issue of standing again should the Plaintiffs’ misbranding theory prove inapplicable because the Plaintiffs could not prove that ranitidine was in fact misbranded. After the motion to dismiss stage, the parties and the Court proceeded to the Daubert stage of the MDL, at which time the Plaintiffs submitted their strongest evidence to prove that ranitidine could cause the Designated Cancers.4 The Court determined that the Plaintiffs’ scientific evidence was unreliable, see DE 6120, and as a result, the Plaintiffs lack reliable evidence that ranitidine causes Designated Cancers, as well as Non-Designated Cancers (since the Plaintiffs did not present any evidence of Non-Designated Cancers), see DE 6299. Given the Plaintiffs do not have any evidence of other cancers with which to support their class action claims—the Plaintiffs do not have any reliable evidence of cancer causation.⁵

4 The Designated Cancers are bladder, esophageal, gastric, liver, and pancreatic cancers.⁵ As explained in the Court’s First Order to Show Cause, the Court’s Daubert ruling applies to the class action claims, in addition to the personal injury claims, for all of the reasons outlined on pages 11-20 of the Court’s order at docket entry 6303. Also, the Plaintiffs concede that the Daubert ruling applies to their class action claims. DE 6484 at 1. For both of these reasons, the Daubert ruling applies to the class action claims.⁷ II. The Effect of the Court’s Daubert Ruling on the Plaintiffs’ Misbranding Theory

In light of the Daubert ruling, the parties agreed that the Court should not proceed with briefing on class certification. In the Class Plaintiffs’ Motion to Stay Class Proceedings Pending the Outcome of Appellate Proceedings on this Court’s Daubert and Summary Judgment Rulings [DE 6148], the Plaintiffs moved the Court to stay class proceedings until they completed their appeals of the Daubert ruling. DE 6148 at 7. The Defendants, in response, requested that the Court enter final judgment for them on the class action claims because both sets of the Plaintiffs’ class action claims, the medical monitoring and economic loss class action claims, are no longer viable as pled. DE 6227 at 26. The Plaintiffs concede that their medical monitoring class action claims are no longer viable, but they assert that they still can pursue their economic loss class action claims. In the following section, the Court briefly analyzes the medical monitoring class action claims, before turning to the Plaintiffs’ economic loss class action claims—recounting the Court’s order to show cause process, the responses elicited during this process, and the Court’s conclusion as to the viability of these claims.

A. Medical Monitoring Class Action Claims

The Plaintiffs concede that their medical monitoring class action claims are not viable. DE 6254. Generally, to prevail on a medical monitoring claim, a plaintiff must prove (1) the defendant’s negligence (2) caused (3) the plaintiff to become exposed to a hazardous substance that produced, at least, subcellular changes that substantially increased the risk of serious disease, illness, or injury (4) for which an effective medical test for reliable early detection exists, (5) and early detection, combined with prompt and effective treatment, will significantly decrease the risk of death or the severity of the disease, illness or injury, and (6) such diagnostic medical examinations are reasonably (and periodically) necessary, in conformance with the⁸ standard of care, and (7) the present value of the reasonable cost of such tests and care as of the date of the filing of the complaint must be established.

In re Nat’l Hockey League Players’ Concussion Inj. Litig., 327 F.R.D. 245, 261 (D. Minn. 2018) (emphasis added). A plaintiff must show an increased risk of disease to sustain a medical monitoring claim. Therefore, in this MDL, an “increased risk of cancer is a predicate of medical monitoring claims.” Dec.¹⁴, 2020, Hearing Tr. at 149; June 3, 2021, Hearing Tr. at 210-12; see also id. at 146 (“We plausibly allege that the increased risk of disease warrants diagnostic testing that is reasonably necessary and different from routine medical care.”). The Court’s Daubert ruling directly impacts the Plaintiffs’ ability to prove that they have an increased risk of cancer. In the Motion to Stay, the Plaintiffs acknowledge that the Court’s Daubert ruling applies to their class action claims and, consequently, “[a]bsent reversal of the general causation Daubert ruling, . . . the Court’s rulings likely undermine the availability of medical monitoring claims.” DE 6148 at 4. Further, in their Reply, the Plaintiffs acknowledge that affirmance of the Daubert ruling “would likely spell the death knell of the medical monitoring claims,” DE 6254 at 2, because the Plaintiffs lack reliable evidence with which to prove that the Plaintiffs have an increased risk of cancer and cannot prevail on their medical monitoring class action claims without such evidence. The Plaintiffs did not argue in their briefing that their medical monitoring class actions claims are viable, thus conceding that these claims are not viable. And, the Court agrees with the Plaintiffs that these claims are not viable for all of the reasons outlined in the Court’s First Order to Show Cause [6484].6 DE 6484 at 5-6. The significance of the Court’s Daubert ruling is that the Plaintiffs do not have proof that they have an increased risk

B. Economic Loss Class Action Claims

In contrast, the Plaintiffs do not concede that, in light of the Daubert ruling, their economic loss class action claims lack viability. They argue that neither safety nor cancer causation are elements of economic loss class action claims and therefore the Court’s Daubert ruling does not specifically foreclose the Plaintiffs’ ability to prove those claims. See DE 6148 at 4. Stated another way, whereas the Court’s Daubert ruling directly impacted an element of medical monitoring—a substantial increase in the risk of disease—the Court’s Daubert ruling does not directly impact any element of the economic loss class action claims. The Plaintiffs argue that they can proceed with their economic loss class action claims, based not on their previously articulated misbranding theory (relating to safety, cancer, and worthlessness) but on new⁷ arguments centered on an “adulteration” theory. Id. In this section, the Court reviews the viability of the Plaintiffs’ misbranding theory before turning to the Plaintiffs’ new adulteration theory.

1. The Plaintiffs Do Not Defend Their Misbranding Theory.

The Plaintiffs do not defend their previously held misbranding theory, even though the Defendants argue that this theory is no longer viable. The Defendants argue that every count in the SAELC relies on allegations that the NDMA in ranitidine could cause cancer consistent with the Plaintiffs’ misbranding theory, and, now that the Plaintiffs do not have evidence of cancer causation, the Plaintiffs cannot succeed in proving the claims stated in the SAELC. DE 6227 at 13.

2. Misbranding Requires Evidence that Ranitidine is Unsafe.

The Plaintiffs may have chosen not to defend their misbranding theory because the theory fails without proof that ranitidine is unsafe. The Plaintiffs pled that ranitidine was misbranded because its label failed to disclose that it could cause cancer; every claim pled in the SAELC rests on the allegation that the NDMA in ranitidine could cause cancer. See DE 3325 at 14-15. Without proof of cancer causation, the Plaintiffs cannot succeed in proving their claims as pled. In addition, to succeed on a misbranding claim in general, a plaintiff must prove that the product is unsafe under the FDCA. See Brief for the United States as Amicus Curiae Supporting Petitioner at 6, 23-25, Mutual Pharm. Co. Inc. v. Bartlett, 570 U.S. 472 (2013) (No. 12-142), 2013

WL 314460, at *6, *23-25 (“A drug is misbranded if, inter alia, it is ‘dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.’”); United States v. 62 Packages More or Less of Marmola Prescription Tablets, 48 F. Supp. 878, 887 (W.D. Wis. 1943), aff’d, 142 F. 2d 107 (7th Cir. 1944) (“The purpose of the [FDCA] is to protect the public . . . . It was enacted to make self-medication safer and more effective, and to require that drugs moving in interstate commerce be properly labeled so that their use as prescribed may not be dangerous to the health of the user.”); 21 U.S.C. § 352(a)(1), (j) (“If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.”); 21 U.S.C.

11 § 321 (“If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account . . . the extent to which the labeling or advertising fails to reveal facts . . . material with respect to consequences which may result from the use.”). After the Court’s Daubert ruling, the

Plaintiffs lack reliable evidence to prove that ranitidine is unsafe and, therefore, their misbranding claims cannot succeed. For these reasons, the Plaintiffs’ misbranding theory is not viable after the Court’s Daubert ruling. 3. The Plaintiffs Effectively Concede Misbranding Is No Longer Viable. The Plaintiffs also effectively concede that their misbranding theory is no longer viable when they concede that their medical monitoring class action claims are not viable because they do not have reliable evidence of cancer causation. The Plaintiffs cannot, on the one hand, acknowledge that are unable to prove they have a significantly increased risk of cancer, while on the other hand claim that they can prove that ranitidine is unsafe and dangerous. Thus, in conceding their medical monitoring class action claims, the Plaintiffs concede that the Court’s Daubert ruling precludes them from pursuing all claims based on the allegation that the NDMA in ranitidine can cause cancer. This includes the economic loss class action claims proceeding under a misbranding theory. The Court concludes that the Plaintiffs’ misbranding theory fails because, in addition to the Plaintiffs’ concessions, the Plaintiffs lack evidence to prove that the NDMA in ranitidine could cause cancer. Because the Plaintiffs’ theory of standing based on misbranding is the only theory that the Plaintiffs have relied on in over three years of litigation, the Plaintiffs’ economic loss class

12 action claims should be dismissed for lack of standing. In the alternative, the Court analyzes the viability of the Plaintiffs’ new adulteration theory of standing.

III. The Plaintiffs Pivot to an Adulteration Theory

Instead of defending their misbranding theory of standing, the Plaintiffs pivot to arguments based on a different theory, adulteration. As a threshold matter, the Plaintiffs’ new standing theory contradicts the Plaintiffs’ prior representations to this Court. See DE 3682 at 184 (“[I]f ultimately the proof showed that the drug was not dangerous, or did not create NDMA, absolutely, I think we lose.”⁸ (referring to standing)). Putting aside the Plaintiffs’ prior representations on standing during the motion to dismiss stage of the MDL, the Plaintiffs relied on their misbranding theory, arguing that ranitidine could cause cancer, was therefore unsafe and, since it was unsafe, it should not have been sold and was worthless. The Plaintiffs clearly pled and clearly argued each of these points. In contrast, the Plaintiffs neither clearly pled nor clearly argued an adulteration theory for standing. When the Defendants twice moved to dismiss the Plaintiffs’ economic loss class action claims for lack of standing, both times, it was incumbent on the Plaintiffs to raise their adulteration theory if that theory was an independent basis for the Court to deny the Defendants’ motions to dismiss, but they did not do so.9 In the absence of a clearly pled (and argued) adulteration standing theory, the Court afforded the Plaintiffs multiple opportunities to explain their new theory. In this section, the Court

14 Plaintiffs also claim that their adulteration theory is based on ranitidine’s label, meaning, in theory, the Defendants could cure their adulteration problem under federal law by changing ranitidine’s label. Id. at 11-12. Yet the Plaintiffs do not explain how the Defendants could cure ranitidine’s adulteration problem (i.e., ranitidine contained NDMA) with a label change, which would do nothing to correct the contamination. Due to inconsistencies like this one and the Court’s other remaining questions, the Court issued a Second Order to Show Cause, again under Rule 56(f), ordering the Plaintiffs to respond to the Court’s unanswered questions, to explain why ranitidine was worthless, and to come forward with citations to their pleading or evidence to support their position. In Class Plaintiffs’ Response to the Court’s Second Order to Show Cause [DE 6676], the Plaintiffs provided no additional citations to their pleadings or additional insight into their adulteration theory. DE 6676 at 2. Further, the Plaintiffs failed to present any evidence to support their adulteration theory. From these two rounds of responses, it was clear to the Court that, whatever the Plaintiffs’ adulteration theory is, it is not the theory that the Plaintiffs had advanced throughout the duration of this MDL (that ranitidine could cause cancer; it was therefore unsafe; and, since it was unsafe, it should not have been sold and was worthless).

B. Matters Resolved in the Order to Show Cause Process

Despite the Plaintiffs’ failure to clearly articulate their adulteration theory or support it with evidence from the record, the Plaintiffs’ briefing did provide the Court with sufficient information to resolve several legal issues that bear on the viability of Plaintiffs’ economic loss class action claims under an adulteration theory. In the following section, the Court analyzes these issues related to the Plaintiffs’ adulteration theory.

15 1. The Plaintiffs Have Not Pled and Also Have Abandoned the Position that Ranitidine Was Unsafe for Any Reason Other than Cancer.

First, the Plaintiffs have not pled that ranitidine is “unsafe” for reasons other than cancer causation. The word “cancer” appears in the SAELC¹,636 times. This entire MDL is about a carcinogen, NDMA, found in ranitidine. During the second round of motions to dismiss, the Plaintiffs argued that their claims relied solely on ranitidine’s propensity to form NDMA; their claims did not rest on other carcinogens; thus, the Court concluded that the Plaintiffs’ claims did not relate to harms other than cancer. See DE 3682 at 213-14. In both Orders to Show Cause, the Court ordered the Plaintiffs to “explain to the Court their theory of injury in fact, if their theory is an injury other than cancer, and inform the Court where in their pleadings they have pled such a theory and in what filings they have pursued such a theory.” DE 6639 at 4. The Plaintiffs did not respond; they did not claim that ranitidine was unsafe because it caused a harm other than cancer. Moreover, because the Plaintiffs have not pled that ranitidine is unsafe for a reason other than cancer, because the Plaintiffs confirmed to the Court at oral argument that their claims were focused on cancer as the only potential harm in this MDL, and because of the Plaintiffs’ concession on the viability of their medical monitoring claims (as discussed above in Section II(B)(3)), the Plaintiffs have not advanced, and they also have abandoned, the contention that ranitidine is unsafe on account of any harm apart from cancer.

2. The Plaintiffs Have Not Pled and Also Have Abandoned the Position that Ranitidine Was “Worth Less.”

Second, the Plaintiffs have not pled and also have abandoned the contention that ranitidine was “worth less” (two words), instead of “worthless” (one word). During the second round of motions to dismiss, the Plaintiffs made this point on the record, at the Defendants’ prompting: 16 MS. COHAN: I think both are being argued, the worthless and worth less, but I think Plaintiffs concede both are not pled. Here they have merely pled Plaintiffs would not have purchased the product if they had been aware of the alleged cancer risk. In addition, in their briefing throughout they have said that the product is worth zero dollars. So, I do think that, despite that argument, that is not something they have followed through on.

THE COURT: Well, I guess you do argue it at 3429 at page 36. Are you putting that forth as a theory, the worth less, two words? I know you are saying it is subsumed, but I think the Defense should know what you are arguing right now.

MS. FEGAN: Your Honor, when I think of worth less as two words, I think of drug price premium cases, and I will commit this is not a price premium case, this is not about a slight overcharge and what it would have cost versus a competitor. We are talking about a drug that was recalled because it causes cancer, and in that context we are saying it as one word, it is worthless.

DE 3682 at 190 (emphasis added). The Court relied on the Plaintiffs’ representations when it rendered its earlier decision on standing; the Court undertook no analysis of an argument that ranitidine could have some value greater than zero because the Plaintiffs did not advance such a proposition. In the order to show cause process, the Court presented the Plaintiffs with two opportunities to persuade the Court that they had not abandoned the contention that ranitidine was worth less. In response to the First Order to Show Cause, the Plaintiffs argued that they did not abandon this position because they had not yet submitted their class certification motion and expert reports. DE 6589 at 12. In the Second Order to Show Cause, the Court ordered the Plaintiffs to “explain, in light of their commitment on the record that this is not a drug price premium case and their subsequent briefing filed in this case, how they have not abandoned the contention that ranitidine was worth less.” DE 6639 at 3. In response, the Plaintiffs did not offer anything further. Based on this record, the Court concludes that (i) the Plaintiffs have not pled that ranitidine could have a value greater than zero; (ii) the Plaintiffs clarified their pleading and represented to the Court that 17 they had not pled that ranitidine could have a value greater than zero; and (iii) the Plaintiffs abandoned the contention that ranitidine is worth less (some value greater than zero) and failed to persuade the Court otherwise in their responses to the Orders to Show Cause. In summary, the Plaintiffs’ standing theory, a misbranding theory, rests on the contention that ranitidine could cause cancer, it was therefore unsafe, and, since it was unsafe, it should not have been sold as a misbranded product and was worthless with a value of zero. Based on these allegations, the Court found that the Plaintiffs had standing to pursue their economic loss class action claims. Now, after the Court’s Daubert ruling and the order to show cause process, the Plaintiffs’ misbranding theory is no longer viable. The Plaintiffs have no evidence of cancer causation; they have no allegation that ranitidine is unsafe for some other reason; they have produced no evidence that ranitidine is unsafe for some other reason; they have (through their clarifications and representations to the Court) not pled that ranitidine has some partial, non-zero value; and, the Plaintiffs’ lack any basis—through pleadings or evidence—to advance the proposition that ranitidine is worthless, with a value of zero, even though it performed as advertised and even though they have no evidence it causes harm. IV. Viability of the Plaintiffs’ Adulteration Theory Under the SAELC The only question remaining is whether the Plaintiffs can proceed with their new standing theory based on adulteration under the SAELC. The Court makes certain observations about the Plaintiffs’ adulteration theory. First, this theory does not rely on the allegation that ranitidine is unsafe for some reason other than cancer; and second, this theory does not rely on the allegation that ranitidine was worth less, instead of worthless.

18 The Plaintiffs’ adulteration theory is incompatible with the misbranding theory pled throughout the SAELC. For example, the Plaintiffs’ misbranding theory posited that even though ranitidine performed as advertised (e.g. it alleviated heartburn), it was still a worthless product because it caused cancer. Under the Plaintiffs’ new theory, if ranitidine performed as advertised,

how can it be worthless (with a value of zero), given that the Plaintiffs have no reliable evidence that the drug was unsafe? The Court attempted to elicit an answer from the Plaintiffs on this question in response to the First and Second Orders to Show Cause. In response, the Plaintiffs failed to explain why ranitidine is worthless, instead noting that they can introduce a variety of evidence, such as: (1) their deposition testimony regarding what they would pay for Zantac (nothing); (2) expert testimony regarding the safety, or perceived safety, of Zantac in general (as opposed to expert testimony regarding whether Zantac causes the five designated cancers); (3) expert testimony regarding the economic value of Zantac, including expert testimony regarding how consumers consider dangers that are less rigorously proven than what a court would accept for purposes of Daubert; (4) evidence regarding the FDA’s recall of Zantac (likewise applying precautionary standards lower than that which passes muster under Daubert); and (5) Defendants’ unwillingness to sell the product knowing it degrades into NDMA.

DE 6589 at 14 (emphasis added). The Plaintiffs’ position appears to be that instead of proving that ranitidine was objectively worthless, they could prove that a Plaintiff believed it was worthless. In other words, the Plaintiffs’ position is that they can establish economic injury not because of an objective criterion, but because of a consumer’s subjective belief. This position is contrary to well established caselaw. See, e.g., Koronthaly v. L’Oréal USA, Inc., 374 F. App’x 257, 259 (3d Cir. 2010); In re Johnson & Johnson Talcum Powder Prods. Mktg. Sales Pracs. & Liab. Litig., 903 F. 3d 278, 281 (3d Cir. 2018); Shaulis v. Nordstrom, Inc., 865 F. 3d 1, 12 (1st Cir. 2017) (concluding that the plaintiff lacked standing because the plaintiff failed to identify 19 “anything objective” for which she had bargained and did not receive from her purchase, instead identifying only her “subjective belief as to the nature of the value” of her purchase). Regardless of the basis for the Plaintiffs’ measurement of the value of ranitidine, the Plaintiffs have provided no citations to the SAELC for the proposition that they previously pled that ranitidine is worthless for some reason other than cancer causation and, as discussed above, they have abandoned (and have not pled) the proposition that ranitidine could be worth more than zero, worth less. The Plaintiffs also previously represented to the Court that they would lack standing if ranitidine did not cause cancer: THE COURT: For example, am I understanding what you just said to say that perhaps, once we get into individual Plaintiff discovery and we learn, let’s just say hypothetically, gee, the risk was not so great, it wasn’t so harmful, or it wasn’t as harmful as alleged, would that bear -- should that bear on the Court’s consideration of standing, and would that be the more -- if yes, would that be a reason why the Court would want to consider that at a later point, or does that have nothing to do with the analysis of standing?

MS. FEGAN: Your Honor, if ultimately the proof showed that the drug was not dangerous, or did not create NDMA, absolutely, I think we lose. . . .

DE 3682 at 184. Because neither the SAELC nor the Plaintiffs’ prior representations to the Court are compatible with an adulteration theory, the Plaintiffs’ pursuit of that theory may only be viable through amendment. Yet, the Plaintiffs cannot now amend their SAELC to restate their economic loss class action claims under a new adulteration standing theory for two reasons. First, the Plaintiffs committed to the position that, because the SAELC is compatible with their adulteration theory, they neither needed nor wanted an amended pleading. See DE 6484 at 18; DE 6639 at 5; DE 6676 at 10. 20 Second, and in the alternative, even if the Plaintiffs were to request leave to amend, the Court would deny the Plaintiffs leave to file a fourth economic loss complaint for all of the reasons set forth in Brand Defendants’ Reply to the Court’s Order to Show Cause Why the Economic Loss Complaint Is Not Subject to Dismissal or Summary Judgment [DE 6624]. This MDL began in

2020, discovery began shortly thereafter, the Plaintiffs first filed their economic loss class action claims in 2020, their second pleading in early 2021, and their third and operative pleading, the SAELC, in late 2021. The Plaintiffs have had years to plead a theory of recovery (or standing theory) that is not based on cancer or safety and have not done so. Therefore, permitting amendment at this time is unwarranted and would be unfairly prejudicial to the Defendants, who would be surprised to have to defend against an entirely new standing theory, premised on a new theory of recovery that does not rely on cancer, over three years into this MDL. The Court’s denial of leave to amend could end the Court’s inquiry into standing; the Plaintiffs’ prior misbranding theory of standing fails; the SAELC does not support the Plaintiffs’ new adulteration theory; and, the Court will not permit yet another amendment. Yet, in the alternative, even if the Court were to permit the Plaintiffs to amend the SAELC and file a fourth amended economic loss class action complaint, the Court concludes that the Plaintiffs still would lack standing to pursue their claims under their new theory for the reasons set forth below. A. The Plaintiffs Improperly Rely on the FDA’s ADI to Establish Adulteration The Plaintiffs’ adulteration theory of standing is not viable because it improperly relies on the FDA’s ADI. The FDA established the ADI for NDMA in ranitidine around 2019. The Plaintiffs claim that ranitidine was adulterated “as determined by Congress because it was sold with amounts of NDMA higher than level permitted by Congress or under its delegation of

21 authority to the FDA.” DE 6254 at 9 (emphasis added). In other words, ranitidine was adulterated because it contained NDMA at levels exceeding the FDA’s ADI; since it was adulterated, it was worthless; and since ranitidine was worthless, the Plaintiffs suffered an economic injury-in-fact when they purchased it for a value greater than zero, without knowing that it contained NDMA.

One of the problems with this argument, though, is that many of the named Plaintiffs (and quite possibly all of them) allege that they purchased ranitidine before 2019, the year the FDA established the ADI, and the Plaintiffs do not explain whether the ADI applies retroactively, rendering all ranitidine ever sold adulterated, or prospectively, rendering only ranitidine sold after the establishment of the ADI potentially adulterated. The Court asked the Plaintiffs in the First and Second Orders to Show Cause to address the retroactivity of the ADI. See DE 6484 at 20; DE 6639 at 7. In response, the Plaintiffs provided no argument or authority to support the contention that the ADI applies retroactively, despite the Court twice directly prompting them to do so.¹⁰ Without any argument or authority to the contrary, the Court cannot conclude that the ADI applies retroactively. Consequently, the Court is unpersuaded that the Plaintiffs can state a viable adulteration theory of standing based on the ADI for NDMA in the years before the FDA established the ADI. B. Ranitidine Adulterates Itself Through an Alleged Design Defect The Plaintiffs cannot state adulteration claims under the FDCA because they have proceeded in this MDL on the grounds that ranitidine self-adulterates. The Plaintiffs’ arguments and the record evidence in this MDL supports the position that ranitidine self-adulterates, meaning ranitidine, when manufactured, stored, and distributed in compliance with all FDA regulations,

23 the claims that the Plaintiffs bring solely based on the presence of NDMA in ranitidine are design defect claims, not adulteration claims.¹¹ Second, even if the Plaintiffs are able to state adulteration claims based on the presence of NDMA in ranitidine alone, the Court is unpersuaded that the Defendants could cure the adulteration with a label change, as the Plaintiffs implicitly contend. When a product is adulterated because it contains an impurity, the Court can understand how a defendant may be able to cure the adulteration problem by removing the impurity; but the Court cannot understand how a defendant could cure the problem under the FDCA—the contamination—by changing the product’s label. Yet one area in which the Plaintiffs are clear is that their adulteration theory is based on ranitidine’s label. DE 6589 at 12. The Plaintiffs’ adulteration theory contends that ranitidine’s labeling was deceptive, that the Defendants could have and should have changed ranitidine’s label, so, presumably, changing the label would have cured ranitidine’s adulteration problem. The Court asked the Plaintiffs in the First and Second Orders to Show Cause to “provide authority for the proposition that a Defendant manufacturer may comply with state law (as well as federal law) if the Defendant discloses the impurity on its label in lieu of removing the impurity” and “any instance in which the FDA classified a drug as adulterated but, because the adulteration was subsequently disclosed on a label, the drug ceased to be adulterated.” DE 6484 at 21-22; DE 6639 at 8. The Plaintiffs did not respond to these questions, though they twice had the opportunity

V. The Plaintiffs Did Not Meet Their Standing Burden

The party invoking federal jurisdiction has the burden of proving that he or she has standing to pursue his claims in federal court. See FW/PBS, Inc. v. Dallas, 493 U.S. 215, 231 (1990). To have standing, the party “must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Debernardis, 942 F. 3d at 1083 (quoting Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016), as revised (May 24, 2016)). Each standing 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.” See Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992). Therefore, the party invoking federal jurisdiction “must ‘set forth’ by affidavit or other evidence ‘specific facts’” to support their claim of standing at the summary judgment stage of the litigation. Id. In this MDL, the Plaintiffs have the burden to prove that they have standing to pursue their economic loss class action claims, which they have not met. The Court issued two Orders to Show Cause under Rule 56(f), requiring the Plaintiffs to point to where in the SAELC they had pled their adulteration theory, to put forward evidence to prove injury-in-fact, and to explain their position on standing. The Plaintiffs either could have identified paragraphs in the SAELC to show how they had pled an adulteration theory that could succeed in light of the record evidence in this MDL,

25 or requested to amend the SAELC to establish standing based on an adulteration theory. But the Plaintiffs did neither.¹² See DE 6589 at 11-13 (failing to cite to any paragraphs in the SAELC when arguing that they have standing in response to the First Order to Show Cause); DE 6676 at 7-9 (citing to paragraphs in the SAELC, without explaining how these claims can succeed based on the record evidence, their abandonment of the position that ranitidine is unsafe for some reason other than cancer, and their abandonment of the position that the value of ranitidine was ever greater than zero, when arguing that they have standing in response to the Second Order to Show Cause). The Plaintiffs also failed to present any evidence in response to the Orders to Show Cause, as the Court ordered. Lastly, the Plaintiffs did not answer the Court’s specific questions about their standing theory, including why ranitidine was worthless without evidence of harm. For these reasons, the Plaintiffs did not meet their burden of persuasion, and the Court concludes that the Plaintiffs’ adulteration theory does not confer standing on the Plaintiffs. In the next section, the Court analyzes whether the Plaintiffs have standing for any reason other than an adulteration theory of standing.

VI. Application of Standing Caselaw to the Plaintiffs’ Adulteration Theory

The injury-in-fact analysis in this MDL begins with Debernardis. In Debernardis, plaintiffs who had purchased presumptively adulterated dietary supplements filed state-law claims and claims for common law fraud and unjust enrichment against the manufacturer and the exclusive distributor of the supplements. 942 F. 3d at 1080-82. The Eleventh Circuit concluded

Dots, a plaintiff does not have standing to sue a defendant merely because of buyer’s remorse. The Third Circuit concluded that a plaintiff lacked standing to sue L’Oréal for its failure to disclose that there were trace amounts of lead found in its lipstick in part because the plaintiff’s “subjective allegation that the trace amounts of lead in the lipsticks are unacceptable to her” did not constitute injury-in-fact. L’Oréal USA, Inc., 374 F. App’x at 259.13 Without evidence that a product was illegal to sell, harmful, or overpriced, a plaintiff does not suffer injury from purchasing a product and later wishing that he or she had not done so. See Herrington v. Johnson & Johnson Consumer

Daubert ruling, though, the Plaintiffs can no longer claim that ranitidine is unsafe or should not have been sold because of its cancer-causing propensity. As a result, the standing analysis for the economic loss class action claims is more similar to the analyses in L’Oréal and In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Liability Litigation. 903 F. 3d 278 (3d Cir. 2018). In Talc, the Third Circuit determined that a purchaser of baby powder did not have standing to pursue a refund for the product because she did not allege that it was unsafe; because the product was safe and effective, the plaintiff did not suffer an injury when she purchased it. See id. at 288-90.

28 Moreover, given the Court’s Daubert ruling, the allegations in the SAELC, the Plaintiffs’ prior concessions on the record and in their briefing, what the Plaintiffs are left with is a buyer’s remorse case. The Plaintiffs purchased ranitidine. They do not allege that ranitidine did not perform as advertised; they do not allege that it caused them harm; and they cannot claim that ranitidine is unsafe or had only partial value (instead of no value).¹⁴ Instead, what the Plaintiffs complain of, in their adulteration theory, is the presence of trace amounts of NDMA unconnected to evidence of human harm. This is precisely the sort of buyer’s remorse case that federal courts dismiss for lack of standing. Therefore, for all of the reasons set forth in the caselaw cited above, the Plaintiffs have no viable economic injury-in-fact because, without evidence of harm, the Plaintiffs can only prove that they regret purchasing a product that performed as advertised. Because the Plaintiffs have not put forth any viable theory of injury-in-fact, the Plaintiffs do not have standing to pursue their economic loss class action claims.

VII. Conclusion

In summary, the Plaintiffs concede that their medical monitoring class action claims are no longer viable. Even if the Plaintiffs did not concede the viability of these claims, the Court concludes from its own analysis that the medical monitoring class action claims are no longer viable for all of the reasons stated in this Order. For this reason, the Court GRANTS summary judgment pursuant to Rule 56(f) and the Court’s prior orders to cause under Rule 56(f) for the

Fob Fear, ROBIN L. ROSENBERG (/ Copies furnished to counsel of record UNITED STATES DISTRICT JUDGE

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