Opinion
22-CV-5735 (PAE) (BCM)
09-08-2023
NIVEDITA T. KULKARNI, Plaintiff, v. ACTAVIS GENERICS, et al., Defendants.
TO THE HON. PAUL A. ENGELMAYER
REPORT AND RECOMMENDATION
BARBARA MOSES, UNITED STATES MAGISTRATE JUDGE.
Plaintiff Nivedita T. Kulkarni, proceeding pro se, filed this action against five affiliated pharmaceutical companies on July 5, 2022, alleging that after she took a course of generic prednisone, manufactured by defendant Actavis Generics, she developed functional myoclonus, and that the drug label failed to warn her "of the potential of developing this lifelong disorder." Compl. (Dkt. 1) at ECF pp. 12-13.Now before me for report and recommendation (see Dkt. 25) are (i) defendants' motions to dismiss the Complaint (Dkts. 21, 23); and (ii) plaintiff's motion for leave to file an amended complaint. (Dkt. 37.) The four U.S.-based defendants argue that plaintiff's failure-to-warn claim is preempted by federal law. Teva Israel argues that it was never served with process and that the Court lacks personal jurisdiction over it.
The defendants are Actavis Generics, Actavis Laboratories UT, Inc., Actavis Laboratories FL, Inc., Teva Pharmaceuticals USA, Inc. (Teva USA) (incorrectly identified in the Complaint as "Teva North America"), and Teva Pharmaceutical Industries Ltd. (Teva Israel). See Compl. at ECF pp. 1, 9. The first four (the Teva Defendants) are incorporated or have their principal places of business in the United States. See id. at ECF pp. 3-8. Teva Israel is incorporated and headquartered in Israel. See id. at ECF pp. 9, 12.
Because plaintiff's failure-to-warn claim is preempted by federal law, and because her proposed amended complaint (which drops Teva Israel) likewise fails to state any claim upon which relief can be granted, defendants' motions to dismiss should be granted, plaintiff's cross-motion to amend should be denied, and this action should be dismissed.
I. BACKGROUND
A. The Complaint
In her Complaint, which invokes the Court's diversity jurisdiction, see Compl. at ECF p. 2, plaintiff alleges that from April 25 to July 15, 2019, she was administered a course of prednisone - a corticosteroid medication - which she took under a doctor's supervision, "within a normal range," and "tapered off per the instructions." Id. at ECF p. 12. The drug she took was manufactured by Actavis Generics. Id. Within 24 hours of her final dose, plaintiff "experienced a severe shaking episode," causing her to have "uncontrollable muscle spasms and jerks from head to toe." Id.. Since then, she has "continued having these episodes to varying degrees of severity[.]" Id. They now occur, to a less severe extent, "every day." Id.
Three years later, plaintiff "was diagnosed by a neurologist with Functional Myoclonus," Compl. at ECF p. 12, which is a functional movement disorder characterized by "[s]udden, brief involuntary twitching or jerking of a muscle or group of muscles." See Functional Neurologic Disorder, https://www.ninds.nih.gov/health-information/disorders/functional-neurologic-disorder (last visited Sept. 8, 2023). The neurologist explained that "Functional Myoclonus is caused by an initial clonus," such as plaintiff's initial "severe shaking episode," and "agreed" with plaintiff that in her case the cause "could have been" the medication plaintiff was taking. Id. Plaintiff asserts that "[t]here was no warning on the drug of the potential of developing this lifelong disorder," and explains that she is "suing for failure to warn of dangerous side effects of Prednisone (generic manufactured by Actavis Generics)." Id. at ECF p. 13.
B. The Motions to Dismiss
On January 9, 2023, the Teva Defendants moved to dismiss the complaint on the ground that plaintiff's failure-to-warn claim, which seeks to hold them liable "under state tort law on the theory that the Teva Defendants' FDA-approved labeling for their generic drug product was inadequate," is preempted by federal law, "[b]ecause Teva could not change the content of its warning label for this generic product without violating federal law[.]" Def. Mem. (Dkt. 22) at 5-6. Defendants rely on PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), in which respondents, like Kulkarni, sought to sue the manufacturers of a generic drug for failing to provide an adequate warning label, notwithstanding that the content of the label was mandated by the Food and Drug Administration (FDA) under federal law. The Court explained: "The question presented is whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. We hold that they do." Mensing, 564 U.S. at 609.
Separately, Teva Israel moved to dismiss for lack of personal jurisdiction and insufficient service of process. See Teva Israel Mem. (Dkt. 24) at 1. Teva Israel argues that dismissal as to it is required because the "Complaint contains no allegations whatsoever concerning Teva [Israel's] contacts with Plaintiff or the forum state of New York," and argues that this Court has neither general nor specific jurisdiction over it. Id. at 3. Additionally, Teva Israel notes that plaintiff failed to serve it "pursuant to the Hague Convention." Id. at 1-2.
C. Request for Leave to Amend
On February 20, 2023 (the day after her opposition papers were due), plaintiff submitted a letter requesting leave to file an amended complaint, and four weeks within which to do so. (Dkt. 33.) On February 22, 2023, I instructed her that she would be required to file a motion for leave to amend, and directed her to do so by March 22, 2023. See Order dated Feb. 22, 2023 (Dkt. 35), at 1-2. Additionally, I extended plaintiff's time to oppose defendants' motions to dismiss to March 22, 2023. Id. at 2. For plaintiff's guidance, I explained that, in order to defeat the motions, "she must demonstrate either that her existing complaint states a claim that is plausible on its face and is not preempted by federal law or that her proposed amended complaint meets that standard." Id.
On March 23, 2023, plaintiff filed her proposed amended complaint (Prop. Am. Compl.) (Dkt. 37), which corrects the names of certain defendants, adds two new defendants - Allergan plc and Hikma Pharmaceuticals (Hikma) - and drops Teva Israel altogether. As against the resulting group of defendants, plaintiff proposes to bring claims for failure to warn, defective manufacture, and negligence. Prop. Am. Compl. at ECF p. 22. With regard to her repleaded failure-to-warn claim, plaintiff acknowledges that, "[a]s the Supreme Court has ruled, the generic drug manufacturer is not held responsible for a drug's adverse reactions because the generic is not allowed to amend the label," but states that she "would like to make the case, anyway, because," with respect to prednisone, "[o]nly generics exist today." Id.; see also id. at ECF p. 29 ("Today, the original manufacturer of Prednisone has gone out of business and there are only generic manufacturers left. There are no brand-name manufacturers to hold accountable, because they no longer exist.").She adds that her newly-pleaded claims for defective manufacture and negligence "are not pre-empted by federal law." Id.
In an accompanying letter, dated March 22, 2023, plaintiff explains that she is dropping Teva Israel as a defendant because she "already served their American subsidiary, Teva Pharmaceutical USA, Inc., and they seem to be branches of the same company." Pl. Ltr. dated March 22, 2023 (Dkt. 36), at 2-3.
Somewhat inconsistently, plaintiff proposes adding Hikma as a defendant because it "currently holds the brand-name label to which the Actavis Generics version of Prednisone is listed as bioequivalent[.]" Id. at ECF p. 16. Plaintiff bases this allegation on a "phone conversation with the FDA." Id. She also alleges that Hikma produces "the current A/B rated drug (which the generic is compared to)." Id. at 17. As for Allergan plc, plaintiff explains that she wishes to add it as a defendant because it "merged with Actavis in 2015 and began conducting business under the name Allergan" before Teva purchased Allergan's "generics business," including Actavis Generics. Id.
Plaintiff supports her defective manufacture claim with quotations from and links to news articles from various sources that, in her view, "lead to a conclusion of faulty manufacturing at Actavis Generics' plant in Florida (as well as a long-standing history of Actavis failing to meet FDA manufacturing standards)." Prop. Am. Compl. at ECF p. 22. She adds that "Actavis has a long history of recalls and failing to meet FDA manufacturing standards," and notes that "[i]n 2008, Actavis recalled all of its products after a failed FDA inspection at a New Jersey plant." Id. at ECF pp. 22-23. However, she does not allege that the prednisone tablets she took were defectively manufactured, nor that her injuries were caused by a variance between the product as designed and the product she ingested.
With respect to her proposed negligence claim, plaintiff's primary theory is that "all defendants are guilty of negligence because they did not participate in the U.S. government's program to bring outdated drugs up to current FDA efficacy standards" under the FDA's (optional) Unapproved Drugs Initiative. Prop. Am. Compl. at ECF p. 24. Plaintiff explains that prednisone was "approved for clinical use in 1955," before a 1962 amendment to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., required drug manufacturers to establish, for the first time, "not only proof of safety" but also "proof of efficacy," and thus that prednisone "was 'grandfathered' in to FDA approval." Id. at ECF pp. 28-31. Notwithstanding that the Unapproved Drugs Initiative was voluntary - and was "canceled entirely during the Trump Administration due to rising costs," id. at 31 - plaintiff asserts that it should be "considered negligent for [a] drug company (including all defendants listed) to avoid further clinical testing that would bring their very old drug formulas up to today's standards of safety and efficacy - especially when it was requested and encouraged by the FDA." Id. at ECF p. 32.
Plaintiff further contends that defendants' "lack of attention to the side effects of thousands of Americans can be considered negligence." Prop. Am. Compl. at ECF p. 35. She provides a link to the FDA Adverse Events Reporting System (FAERS), which includes 49 reports of myoclonus, 287 reports of movement disorders, and 1,055 reports of tremors experienced by consumers who took prednisone (among a total of 21,831 reports of "nervous system disorders"). Id. at ECF pp. 36-38. Plaintiff further notes that drug manufacturers are required to "report adverse side effects to the FDA," whether or not they believe that their drug was responsible for the symptoms. Id. at ECF p. 35 (providing a link to the text of 21 C.F.R. § 314.80). She then alleges that if defendants had "reported these side effects to the FDA, or if they had taken the FAERS (consumer side effect reporting database) seriously, they would have already been required to change the label to account for all of the unlisted side effects that are not currently listed on the Prednisone drug labels." Id.
In their reply memorandum in further support of their motion to dismiss, filed on April 4, 2023, defendants reiterate that state law failure-to-warn claims against generic manufacturers are preempted by federal law - even if the reference-listed drug (RLD) is withdrawn from the market - because a generic manufacturer "still cannot unilaterally change the label." Def. Reply Mem. (Dkt. 44) at 4. Defendants further argue that plaintiff has failed to state any alternative state law claim based on a manufacturing defect because she does not "allege facts indicating that a [manufacturing] defect purportedly existed at the time the prednisone she took left the control of Teva, nor does she plead a causal connection between any purported (unidentified) manufacturing defect and her alleged injuries" or "suggest that the prednisone . . . in any way deviated from its specifications or its design[.]" Id. at 5. Similarly, defendants argue, to the extent plaintiff's negligence claim is not simply a repackaged failure-to-warn claim, it fails because defendants neither owed nor breached any duty to participate in the FDA's Unapproved Drugs Initiative. Id. at 7-9. Defendants add that there is no private right of action to enforce the FDA's side effects reporting requirements. Id. at 9-10.
On April 13, 2023, in a letter-brief which functioned as her reply memorandum in further support of her motion to amend, plaintiff drew the Court's attention to All. for Hippocratic Med. v. U.S. Food & Drug Admin., 2023 WL 2825871 (N.D. Tex. Apr. 7, 2023) (staying the effective date of the FDA's 2000 approval of mifepristone), aff'd in part, vacated in part, No. 23-10362, 2023 WL 5266026 (5th Cir. Aug. 16, 2023), which she characterizes as demonstrating that "FDA approval is not a catchall and is not infallible." Pl. Reply Mem. (Dkt. 46) at ECP p. 2. In the remainder of her reply brief, plaintiff argues that "Mensing pre-emption" should not apply here because "Teva's label does not match the current reference-listed label, and is therefore not protected under the Mensing ruling." Id. at ECF p. 4. In support of this contention, plaintiff alleges (for the first time) that "Teva/Actavis's listed side effects for Prednisone . . . are NOT the same as those on the reference-listed drug (HIKMA)," id., and reproduces a list of warnings that, she says, appear on the current Hikma label but not on the "Tevas/Activis label." Id. at ECF p. 9.
According to plaintiff, Actavis Generics "has not updated their drug label in nearly 8 years," while Hikma's label "has been updated many, many times since 2015." Id. at ECF p. 5. Plaintiff then provides links to both the "HIKMA label" and the "Teva/Actavis label." Id. at ECF p. 9. The Hikma link, however, appears to display the current (2023) labelling information for its prednisone product. See https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3115aef0-fd50-4ec8-a064-3effb695f3f2 (last visited Sept. 8, 2023).
II. DISCUSSION
A. Legal Standards
Fed. R. Civ. P. 8(a)(2) requires that a pleading contain "a short and plain statement of the claim showing that the pleader is entitled to relief." If that "short and plain statement" fails to present "sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face," the deficient claims may be dismissed pursuant to Fed.R.Civ.P. 12(b)(6). Absolute Activist Value Master Fund Ltd. v. Ficeto, 677 F.3d 60, 65 (2d Cir. 2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678. If the plaintiff has not "nudged [her] claims across the line from conceivable to plausible, [the] complaint must be dismissed." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007).
When faced with a motion made pursuant to Rule 12(b)(6), the court must "accept as true all factual statements alleged" and "draw all reasonable inferences in favor of the non-moving party." McCarthy v. Dun & Bradstreet Corp., 482 F.3d 184, 191 (2d Cir. 2007). However, those factual allegations "must be enough to raise a right to relief above the speculative level." Twombly, 550 U.S. at 555. "A pleading that offers 'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action will not do.' Nor does a complaint suffice if it tenders 'naked assertion[s]' devoid of 'further factual enhancement.'" Iqbal, 556 U.S. at 678 (internal citations omitted) (quoting Twombly, 550 U.S. at 555, 557). The courts will not "unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Id. at 678-79. In addition to the facts alleged in the complaint itself, a court faced with a Rule 12(b)(6) motion may consider "any written instrument attached to it as an exhibit, materials incorporated in it by reference, and documents that, although not incorporated by reference, are 'integral' to the complaint." L-7 Designs, Inc. v. Old Navy, LLC, 647 F.3d 419, 422 (2d Cir. 2011) (quoting Sira v. Morton, 380 F.3d 57, 67 (2d Cir. 2004)).
The court must construe a pro se complaint "liberally and interpret it 'to raise the strongest arguments that [it] suggest[s].'" Chavis v. Chappius, 618 F.3d 162, 170 (2d Cir. 2010) (quoting Harris v. City of N.Y., 607 F.3d 18, 24 (2d Cir. 2010)). To that end, the court may, "in its discretion, consider factual allegations made in the plaintiff's opposition papers 'as supplementing the Complaint, at least to the extent they are consistent with the allegations in the Complaint.'" Forrest v. City of New York, 2023 WL 2432493, at *5 (S.D.N.Y. Feb. 1, 2023) (quoting George v. Pathways to Hous., Inc., 2012 WL 2512964, at *6 n.7 (S.D.N.Y. June 29, 2012)), report and recommendation adopted, 2023 WL 2433115 (S.D.N.Y. Mar. 9, 2023). Even in a pro se pleading, however, "threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Harris v. Mills, 572 F.3d 66, 72 (2d Cir. 2009). Although a court is "obligated to draw the most favorable inferences that [a pro se plaintiff's] complaint supports," it "cannot invent factual allegations that [s]he has not pled." Chavis, 618 F.3d at 170.
Fed. R. Civ. P.15(a)(2) instructs that courts "should freely give leave" to amend a complaint "when justice so requires." However, leave to amend is properly denied based on, among other things, "futility of amendment." Ruotolo v. City of New York, 514 F.3d 184, 191 (2d Cir. 2008) (quoting Foman v. Davis, 371 U.S. 178, 182 (1962)). "'Proposed amendments are futile,' and thus must be denied, 'if they would fail to cure prior deficiencies or to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure.'" Tannerite Sports, LLC v. NBCUniversal News Grp., a division of NBCUniversal Media, LLC, 864 F.3d 236, 252 (2d Cir. 2017) (quoting Thea v. Kleinhandler, 807 F.3d 492, 496-97 (2d Cir. 2015)).
B. Analysis
1. The Initial Complaint
Plaintiff's failure-to-warn claim - the only claim asserted in her initial complaint - is unquestionably preempted by federal law. It is "[a] fundamental principle of the Constitution" that "Congress has the power to preempt state law," and consequently that state law claims are "naturally preempted" if it is "impossible for a private party to comply with both state and federal law." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000). The Supreme Court's decision in Mensing, followed two years later by Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 487 (2013) (holding that "New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce"), makes clear that "state law products liability claims against the manufacturers of generic drugs based on failure to warn and design defect are preempted by the provisions of federal law that require the labeling and composition of generic drugs to be identical to those of their name-brand counterparts." Coleson v. Qualitest Pharm. Manf., 2018 WL 2108238, at *3 (S.D.N.Y. May 7, 2018) (emphasis added); see also In re Acetaminophen - ASD-ADHD Prod. Liab. Litig., 2023 WL 3026412, at *7 (S.D.N.Y. Apr. 20, 2023) (explaining that in Mensing, the Court held that the FDCA preempts state law failure to warn claims brought against generic drug manufacturers, and that in Bartlett, "the Court expanded Mensing and held that the FDCA also preempts state law design-defect claims brought against generic drug manufacturers"), motion to certify appeal denied, 2023 WL 4976589 (S.D.N.Y. Aug. 3, 2023).
Both Mensing and Bartlett turned on the Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585, commonly known as the Hatch-Waxman Act, which amended the FDCA with respect to the approval process for generic drugs. Under the Hatch-Waxman Act, generic drugs "may be approved without the same level of clinical testing required for approval of a new brand-name drug, provided the generic drug is identical to the already-approved brand-name drug in several key respects," namely chemical equivalence, bioequivalence, and, as is relevant in this case, labeling. Bartlett, 570 U.S. at 477. "[T]he generic drug manufacturer must show that 'the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.'" Id. (quoting 21 U.S.C. § 355(j)(2)(A)(v)). Once the drug is approved, generic manufacturers are "prohibited from making any unilateral changes to a drug's label," id., and the FDA may withdraw a generic drug's approval if its label "is no longer consistent with that for the listed drug referred to in the abbreviated new drug application" (that is, with that for the brand-name drug). 21 U.S.C. § 314.94(a)(8)(iii).
Because "the label and composition of a generic drug must always be the same as its namebrand equivalent," and because generic manufacturers cannot alter or even strengthen warnings "without violating federal law," any failure-to-warn claim that would require generic manufacturers to do so is preempted by federal law. Coleson, 2018 WL 2108238, at *3. Generic manufacturers are also prohibited from changing warnings through channels such as "communications with healthcare providers and advertisements to the public." Montero v. Teva Pharm. USA, 2020 WL 1862593, at *3 (S.D.N.Y. Apr. 14, 2020); see also In re Fosamax Prods. Liab. Litig., 965 F.Supp.2d 413, 419 (S.D.N.Y. 2013) ("[A]ny claims stemming from the generic defendants' alleged failure to communicate additional warnings through some method other than their package inserts are preempted.").
As the Supreme Court acknowledged in Bartlett, "Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings" can in some cases leave a plaintiff with no clear remedy despite "tragic circumstances." 570 U.S. at 493; see also Montero, 2020 WL 1862593, at *3 ("the preemption doctrine leaves Plaintiff with little recourse against the manufacturer whose drug allegedly injured her"). Until and unless Congress resolves the issue legislatively, however, "a straightforward application of pre-emption law," Bartlett, 570 U.S. at 493, requires that plaintiffs state law failure-to warn claim be dismissed as against each defendant subject to this Court's personal jurisdiction. Consequently, the Teva Defendants' motion to dismiss the Complaint pursuant to Rule 12(b)(6) should be granted.
As noted above, defendant Teva Israel moved to dismiss pursuant to Rules 12(b)(2) and 12(b)(5) rather than pursuant to Rule 12(b)(6). At the pleading stage, "the plaintiff bears the burden of establishing personal jurisdiction." BWP Media USA Inc. v. Hollywood Fan Sites, LLC, 69 F.Supp.3d 342, 349 (S.D.N.Y. 2014) (citing MacDermid, Inc. v. Deiter, 702 F.3d 725, 727 (2d Cir. 2012)). Teva Israel is correct that plaintiff has alleged no facts that could subject it to either general or specific jurisdiction here. Nor did she contest Teva Israel's motion to dismiss, choosing instead to drop Teva Israel as a defendant. See Pl. Ltr. dated March 22, 2023, at 2-3. Because personal jurisdiction is a "threshold question" that "must precede merits," In re Rationis Enterprises, Inc. of Panama, 261 F.3d 264, 268 (2d Cir. 2001) (citation omitted), the Complaint should be dismissed as against Teva Israel pursuant to Rule 12(b)(2), without prejudice. See Smith v. United States, 554 Fed.Appx. 30, 32 n.2 (2d Cir. 2013) ("[A] dismissal for want of personal jurisdiction is without prejudice.").
2. The Proposed Amended Complaint
In her proposed amended complaint, plaintiff repleads her preempted failure-to-warn claim and adds two new claims, for defective manufacture and negligence. None of these claims can survive.
a. Failure to Warn
The proposed amended pleading attempts to distinguish this case from Mensing and its progeny on the ground that "the original manufacturer of Prednisone has gone out of business and there are only generic manufacturers left." Prop. Amend. Compl. at ECF p. 29. Defendants are correct, however, that "numerous federal courts" have held that even when the original RLD (commonly known as the brand-name drug) is withdrawn from the market, "the generic manufacturer still cannot unilaterally change the label," and therefore that failure-to warn claims remain preempted. Def. Mem. at 3-4; see, e.g., In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917, 934 (6th Cir. 2014) ("[E]very federal court to consider this issue has held that FDA's designation of a generic manufacturer's drug as the RLD does not subject an ANDA [generic] product to NDA, or brand-name, status or requirements."); Hogue v. Pfizer, Inc., 2012 WL 11944897, at *4 (S.D. Ohio Sept. 27, 2012) ("[T]he RLD designation does nothing to alter an ANDA holder's duties concerning labeling changes."); accord Cooper v. Wyeth, Inc., 2012 WL 733846, at *9 (M.D. La. Mar. 6, 2012); Morris v. Wyeth, Inc., 2012 WL 601455, at *6 (W.D. La. Feb. 23, 2012)."), aff'd sub nom. Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013); Moore v. Mylan Inc., 840 F.Supp.2d 1337, 1348 (N.D.Ga. 2012).
In her reply brief, plaintiff adds another argument: that since defendants' prednisone label is not identical to Hikma's (which according to plaintiff is now the "RLD label"), defendants are "not protected under Mensing, which requires the warnings to be the same on the two corresponding labels." Pl. Reply Mem. at ECF p. 9. Plaintiff cites no authority for this proposition, and - unsurprisingly - this Court has found none. It is Congress and the FDA, not the Supreme Court, that "require[] the warnings to be the same on the two corresponding labels." See Bartlett, 570 U.S. at 477 (noting that pursuant to 21 C.F.R. §§ 314.94(a)(8)(iii) and 314.150(b)(10), "[g]eneric manufacturers are also prohibited from making any unilateral changes to a drug's label"). Thus, even assuming, arguendo, that defendants violated the applicable FDA regulations, that violation would not free them from future obligations under the same regulations, nor give them free rein to make additional, unilateral changes to their label "without violating federal law." Coleson, 2018 WL 2108238, at *3. Since it would still be "impossible for [defendants] to comply with both [their alleged] state-law duty to strengthen the warnings on [prednisone's] label and [their] federal-law duty not to alter [prednisone's] label," state law "is pre-empted." Bartlett, 570 U.S. at 480.
b. Defective Manufacture
To succeed on a manufacturing defect claim under New York law, the plaintiff must plead and prove "that the specific product that caused plaintiff's injury was not manufactured as designed," Tears v. Boston Sci. Corp., 344 F.Supp.3d 500, 510 (S.D.N.Y. 2018), that is, that "a specific product unit was defective as a result of 'some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction.'" Colon ex rel. Molina v. BIC USA, Inc., 199 F.Supp.2d 53, 85 (S.D.N.Y. Dec. 19, 2001) (quoting Caprara v. Chrysler Corp., 52 N.Y.2d 114, 129, 417 N.E.2d 545, 553 (1981)); see also Lewis v. Abbott Lab'ys, 2009 WL 2231701, at *6 (S.D.N.Y. July 24, 2009) (because plaintiff "does not allege that the particular Depakote administered to her had a defect as compared to other Depakote," she "does not assert a manufacturing defect claim"). Additionally, the plaintiff must show "that the defect was the cause of plaintiff's injury." Colon, 199 F.Supp.2d at 85 (citing Caprara, 417 N.E.2d at 553); accord Williamson v. Stryker Corp., 2013 WL 3833081, at *4 (S.D.N.Y. July 23, 2013).
Plaintiff does not begin to satisfy this standard. First, nothing in the proposed amended complaint suggests that the prednisone that she ingested deviated in any way from its specifications. Not only does plaintiff fail to identify "the specific manufacturing defect" that rendered the product she ingested "defective as compared to other products manufactured pursuant to the same design," Goldin v. Smith & Nephew, Inc., 2013 WL 1759575, at *3 (S.D.N.Y. Apr. 24, 2013); she does not even show that the tablets she took were produced in a plant at which unsafe or substandard practices were used. Instead, plaintiff alleges in general terms that "Actavis has a long history of recalls and failing to meet FDA manufacturing standards," Prop. Am. Compl. at ECF p. 24, and includes links to articles reporting that "Actavis Generics was issued a warning by the FDA for unsafe production practices" in a Florida facility in 2018, id. at ECF pp. 22-23, and that ten years earlier, in 2008, "Actavis recalled all of its products after a failed FDA inspection at a New Jersey plant." Id. at ECF p. 24. But there is no indication in the proposed amended complaint (or in any of the linked materials) that the prednisone that plaintiff took was manufactured in the Florida facility that was the subject of the 2018 letter, or in the New Jersey facility that was the subject of the 2008 recall. Her allegations concerning those facilities therefore do not support her allegations as to the existence of a manufacturing defect. See, e.g., Rodman v. Stryker Sales Corp., 2014 WL 5002095, at *2 (S.D.N.Y. Oct. 7, 2014) (dismissing manufacturing defect claim where "the recall occurred years before the incident at issue . . . with respect to different products").
The FDA's warning letter identified the Florida facility as belonging to Actavis Laboratories FL, Inc., not Actavis Generics, which according to plaintiff was the manufacturer of the prednisone she took. See Prop. Am. Comp. at ECF p. 23. Similarly, the articles to which plaintiff links concerning the 2008 recall identify the affected New Jersey plant as belonging to Actavis Totowa LLC. See https://www.drug-injury.com/druginjurycom/2008/08/august-2008-actavis-recall-of-all-drugs-manufactured-at-its-little-falls-nj-plant.html (last visited September 8, 2023).
Since plaintiff has failed to plead facts showing or suggesting that the prednisone she took differed in any way from its design, her manufacturing defect claim cannot survive. See Krulewich v. Covidien, LP, 498 F.Supp.3d 566, 574 (S.D.N.Y. 2020) (dismissing manufacturing defect claim because "plaintiff has not alleged that the specific product that allegedly caused the plaintiff's injuries was defective as compared to other products manufactured by the defendant"); Sullivan v. Aventis, Inc., 2015 WL 4879112, at *8 (S.D.N.Y. Aug. 13, 2015) (dismissing because plaintiff failed to allege that the doses of Clomid administered to her mother "deviated from other doses in any way"); Goldin, 2013 WL 1759575, at *3 (dismissing because plaintiff provided "no reason at all to believe that the particular R3 Constrained Liner used in her surgery was defective as compared to other products manufactured pursuant to the same design"); Reed v. Pfizer, Inc., 839 F.Supp.2d 571, 577 (E.D.N.Y. 2012) (dismissing because plaintiff failed to plead "facts indicating how or why the Lybrel ingested by Ms. Reed differed from its design").
Second, plaintiff does not allege that a manufacturing defect was "the cause of [her] injury." Colon, 199 F.Supp.2d at 85. To the contrary: the bulk of the proposed amended complaint is devoted to her claim that prednisone should carry an enhanced warning label because it is "a dangerous drug with damaging side effects," Prop. Am. Compl. at ECF p. 32; that is, that the drug is "defective, if at all, by design." Sullivan, 2015 WL 4879112, at *8. While a plaintiff "is permitted to plead in the alternative," each alternative claim "must find support in factual allegations." Id. Here, there are no allegations supporting the causation element of plaintiffs proposed manufacturing defect claim. For this reason as well, that claim cannot survive. See Franzese v. St. Jude Med., Inc., 2014 WL 2863087, at *5 (E.D.N.Y. June 23, 2014) (dismissing manufacturing defect claim where plaintiffs adequately alleged that defendants "adulterated" the defibrillator at issue but "have not sufficiently alleged how this violation caused Plaintiffs' injuries"); Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, 589 (E.D.N.Y. 2009) (dismissing where the plaintiff "could not show that any alleged manufacturing violation was linked to the injury alleged").
c. Negligence
A negligence claim against a manufacturer, under New York law, has three elements: (1) "that the manufacturer owed plaintiff a duty to exercise reasonable care"; (2) "a breach of that duty by failure to use reasonable care so that a product is rendered defective"; (3) "that the defect was the proximate cause of the plaintiff's injury"; and (4) "loss or damage." Colon, 199 F.Supp.2d at 82 (citing McCarthy v. Olin Corp., 119 F.3d 148, 156 (2d Cir. 1997)).
Although plaintiff's proposed negligence claim is somewhat difficult to parse, she appears to advance two different theories. She first claims that "all defendants are guilty of negligence because they did not participate in the U.S. government's program to bring outdated drugs up to current FDA efficacy standards," despite all having "the opportunity to hold themselves to today's standards of drug testing, either under the Unapproved Drugs Initiative or otherwise[.]" Prop. Am. Compl. at ECF p. 24. Additionally, she alleges that defendants' "lack of attention to the side effects of thousands of Americans can be considered negligence." Id. at ECF p. 35.
To the extent plaintiff's proposed negligence claim is based on defendants' non-participation in the FDA's voluntary Unapproved Drugs Initiative, it fails because she does not identify any duty, owed to her by any defendant, to voluntarily conduct more testing than federal law requires. See Prop. Am. Compl. at ECF p. 31 (alleging only that the FDA "encouraged and offered incentives for 'voluntary compliance'" in the Unapproved Drugs Initiative). Because plaintiff fails "to identify a source of some relevant duty owed," her "conclusory assertion as to a duty owed will not suffice to establish this first element of a negligence claim." Vaccaro v. Bank of America, N.A., 2016 WL 4926201, at *7 nn.13-14 (S.D.N.Y. Sept. 15, 2016).
To the extent the proposed negligence claim is based on defendants' regulatory obligation to report adverse side effects to the FDA, it fails because plaintiff does not allege that any defendant named in her pleading breached its obligations under 21 C.F.R. § 314.80. Rather, her theory seems to be that "the manufacturers, labelers, and suppliers of Prednisone," as a group, either collectively failed to report enough adverse events to the FDA or collectively failed to "take the FAERS (consumer side effect reporting) database seriously." Prop. Am. Compl. at ECF p. 35. Nowhere in her proposed pleading does plaintiff identify any adverse event - or group of adverse events - that any defendant improperly failed to report to the FDA.
As plaintiff acknowledges, the FAERS database includes reports made directly to the FDA (rather than to the manufacturer of the drug) by consumers, physicians, pharmacists, nurses, and other healthcare professionals. See https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers (last visited Sept. 8, 2023). A manufacturer is obligated to send a report to the FDA if it "receives a report from a healthcare professional or consumer," id., but is "not required to resubmit to FDA adverse drug experience reports forwarded to the applicant by FDA." 21 C.F.R. § 314.80(b).
Even if plaintiff had alleged a violation of § 314.80, any state law negligence claim premised on that violation would fail, because "implied preemption prohibits state-law claims that seek to privately enforce duties owed to the FDA," Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017), including state-law negligence claims "based on a duty to file a report with the FDA." Id. at 1330; see also Roncal v. Aurobindo Pharma USA, Inc., 2022 WL 1237888, at *8 (D.N.J. Apr. 27, 2022) (dismissing negligence claim predicated on defendant's alleged failure to report adverse events concerning the generic drug amiodarone to the FDA in accordance with § 314.80 as "impliedly preempted"); Bennett v. Teva Pharms. USA, Inc., 2021 WL 797834, at *4 (D. Del. Mar. 2, 2021) (same), aff'd, 2022 WL 4093739 (3d Cir. Sept. 7, 2022); In re Zantac (Ranitidine) Prod. Liab. Litig., 546 F.Supp.3d 1284, 1314 (S.D. Fla. 2021) (dismissing negligence claim based on "Defendants' alleged failure to submit adverse event reports as required under 21 C.F.R. § 314.80" as preempted).
Even if plaintiff had identified a privately-enforceable duty to conduct additional testing or report side effects to the FDA - and adequately alleged a breach of that duty by defendants - her negligence claim would fail because it ultimately resolves into a failure-to-warn claim:
Had they reported these side effects to the FDA, or if they had taken the FAERS (consumer reporting database) seriously, they would have already been required to change the label to account for all of the unlisted side effects that are not currently listed on the Prednisone drug labels. For this reason (as well as lack of up-to-date drug testing), I claim negligence on the part of all of the defendants. This also provides proof (under the failure to warn claim) that the manufacturers/labelers/distributors of the drug had a duty to warn its consumers of potential unlisted side effects.Prop. Am. Compl. at ECF pp. 35-36 (emphasis added). For the reasons discussed in Part II.B.1 of this Report, supra, any negligence claim bottomed on a generic drug manufacturer's alleged failure to provide warnings above and beyond those on the FDA-approved label are preempted.
Moreover, a plaintiff cannot avoid preclusion under Mensing and Bartlett by speculating that if defendants had conducted more testing or reported additional side effects, the FDA itself would have required them to alter a generic drug's warning label. Plaintiffs in Mensing pursued a similar claim, arguing that if the generic manufacturers "asked the FDA for help in changing the corresponding brand-name label," they "might eventually have been able to accomplish under federal law what state law requires," thereby eliminating any conflict between federal and state law. 564 U.S. at 619. The Court rejected that approach:
We do not think the Supremacy Clause contemplates that sort of contingent supremacy [P]re-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties. When the "ordinary meaning" of federal law blocks a private party from independently accomplishing what state law requires, that party has established pre-emption.564 U.S. at 623. The same result is required here.
III. CONCLUSION
Because plaintiff fails to state any facts showing that Teva Israel is subject to general or specific personal jurisdiction in this Court, I recommend, respectfully, that Teva Israel's unopposed motion to dismiss (Dkt. 23) be GRANTED, and that plaintiff's claims against Teva Israel be dismissed WITHOUT PREJUDICE.
Because plaintiff fails to state any cognizable claim against the Teva Defendants - either in her original complaint or in her proposed amended complaint - I further recommend, respectfully, that the Teva Defendants' motion to dismiss (Dkt. 21) be GRANTED; that plaintiff's cross-motion to amend her complaint (Dkt. 37) be DENIED as futile; and that this action be DISMISSED.
NOTICE OF PROCEDURE FOR FILING OF OBJECTIONS TO THIS REPORT AND RECOMMENDATION
The parties shall have 14 days from this date to file written objections to this Report and Recommendation pursuant to 28 U.S.C. § 636(b)(1) and Fed.R.Civ.P. 72(b). See also Fed.R.Civ.P. 6(a) and (d). A party may respond to another party's objections within fourteen days after being served with a copy. Fed.R.Civ.P. 72(b)(2). Any such objections shall be filed with the Clerk of the Court, with courtesy copies delivered to the Hon. Paul A. Engelmayer, United States District Judge, at 40 Foley Square, New York, New York 10007. Any request for an extension of time to file objections must be directed to Judge Engelmayer. Failure to file timely objections will result in a waiver of such objections and will preclude appellate review. See Thomas v. Arn, 474 U.S. 140, 155 (1985); Frydman v. Experian Info. Sols., Inc., 743 Fed.Appx. 486, 487 (2d Cir. 2018) (summary order); Wagner & Wagner, LLP v. Atkinson, Haskins, Nellis, Brittingham, Gladd & Carwile, P.C., 596 F.3d 84, 92 (2d Cir. 2010).