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In Re Bayer Corp. Combination Aspirin Products Marketing & Sales Practices Litigation
Citations: 701 F. Supp. 2d 356; 2010 U.S. Dist. LEXIS 31021; 2010 WL 1268196Docket: 09 Md.2023(BMC)(JMA)
Court: District Court, E.D. New York; March 30, 2010; Federal District Court
Bayer Healthcare LLC faces a motion to dismiss the Master Complaint in a multidistrict litigation concerning claims that it misrepresented the benefits of its combination products: Bayer Women's Low Dose Aspirin with Calcium and Bayer Aspirin with Heart Advantage. Plaintiffs allege that Bayer falsely marketed these products as FDA-approved and suitable for long-term use, while in fact, they lacked FDA approval and could not deliver the advertised health benefits. Specifically, the plaintiffs argue that taking these products as part of a low-dose aspirin regimen would not provide the recommended daily doses of phytosterols or calcium. They contend that Bayer's labeling was misleading, merging claims about low-dose aspirin with the benefits of calcium and phytosterols, resulting in confusion. Bayer's defense includes the argument that the plaintiffs' claims essentially amount to a violation of the Food, Drug, and Cosmetic Act, which does not allow for a private cause of action. Defendant contends that plaintiffs' claims lack sufficient theories of injury and damages; however, the court denies the motion. Bayer, a leading pharmaceutical company with over a century of experience with aspirin, markets low-dose aspirin products and promotes their benefits for daily use. Low-dose aspirin is available over-the-counter under an FDA monograph, allowing manufacturers to sell it without undergoing the new drug approval process, provided they adhere to the specified claims and include standard warnings about long-term use. Bayer's products, including Bayer Calcium and Heart Advantage, utilize approved health claims related to osteoporosis and heart disease. Bayer Calcium contains 81 mg of aspirin and 300 mg of calcium per tablet, labeled as a "PAIN RELIEVER/CALCIUM SUPPLEMENT," and suggests benefits for bone strength. The labeling implies that Bayer Calcium is comparable to milk as a dietary calcium source, despite only providing a fraction of the recommended daily amount of calcium. The label also includes health claims for calcium, highlighting the risks of osteoporosis in certain groups and the importance of adequate calcium intake. Bayer Calcium's packaging promotes it as a source of aspirin, mirroring health claims associated with Bayer Low-Dose Aspirin regarding cardiovascular benefits, such as reducing the risk of stroke and heart attacks. Plaintiffs argue that the packaging fails to inform consumers that these benefits are FDA-approved only for low-dose aspirin, not for Bayer Calcium. The FDA issued a warning on October 27, 2008, stating that Bayer Calcium, due to its combined active ingredients, was classified as a new drug requiring a New Drug Application (NDA) and could not be sold over-the-counter (OTC). The FDA also noted that the product was misbranded as it lacked appropriate usage directions for consumers. In early 2008, Bayer introduced Heart Advantage, which contains 81 mg of aspirin and 400 mg of phytosterols. Plaintiffs claim the marketing misleads consumers into believing that Heart Advantage possesses all the benefits of its individual components. The product is marketed as Bayer Aspirin "Plus Cholesterol Lowering Phytosterols" and includes an FDA-approved health claim regarding phytosterols' role in reducing heart disease risk. Similar to Bayer Calcium, the FDA sent a warning letter to Bayer about Heart Advantage for misbranding. Five plaintiffs, including Robert Nosbich, who purchased Heart Advantage while seeking health benefits, allege misrepresentation regarding the product’s efficacy in lowering cholesterol and its FDA approval status. Nosbich, who relied on the product's claims and purchased it regularly, contends he would not have bought it had he known it provided insufficient phytosterols to lower cholesterol effectively. He also highlighted the cost disparity between Heart Advantage and other low-dose aspirin options. He argues that to achieve the recommended phytosterol intake, he would need to take two tablets daily, which would exceed the safe aspirin dosage. Overall, Nosbich claims that Heart Advantage cannot meet the combined recommended daily intake of low-dose aspirin and phytosterols. Named plaintiffs are suing on behalf of a proposed nationwide class of consumers who claim they were misled by the defendant's false representations regarding a product they purchased. Although no physical harm occurred, the plaintiffs argue they paid a premium for a product they believed to be superior to low-dose aspirins, based on the defendant's assertions. They contend that had they known the products were not FDA approved and lacked adequate amounts of claimed health-benefiting ingredients, they would not have purchased them, thus seeking full refunds. The lawsuit is based on consumer protection laws from several states, including New York, New Jersey, California, and Illinois, with an additional claim referencing similar statutes from 43 other states. The plaintiffs also allege violations of express and implied warranties. They propose a California subclass alleging violations of specific California laws. In response, Bayer has moved to dismiss the case for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6), which requires a complaint to provide a short and plain statement of the claim. The court must accept the plaintiffs' well-pleaded allegations as true and allow reasonable inferences in their favor. The complaint must contain enough factual content to make the plaintiffs' claims plausible. For allegations of fraud, a heightened pleading standard under Rule 9(b) is applied, requiring specificity regarding the circumstances of the alleged fraud, including details about the fraudulent statements. Although the plaintiffs did not specify the exact details of the alleged fraudulent communications, the court finds their allegations sufficiently informative to notify the defendants of the alleged fraud's context. Allegations of fraud must be sufficiently detailed to inform the defendant of the specific fraudulent conduct but do not require precise details like date, time, and place. Relevant case law indicates that while Rule 9(b) imposes a heightened pleading standard for fraud claims, some state consumer protection claims may only need to meet the more lenient Rule 8(a) standard. The defendant contends that the plaintiffs’ claims, which allege misleading labeling of combination products, effectively amount to an enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA) and thus are preempted, lacking a viable claim of fraud under state law. Additionally, the defendant argues that the plaintiffs have failed to demonstrate injury or a plausible theory of damages. Regarding judicial notice, the defendant has requested the court recognize certain FDA documents and facts about aspirin. Bayer seeks judicial notice of the documents' publication and content, while the plaintiffs argue that only the fact of publication should be acknowledged. The court can take judicial notice of facts that are not reasonably disputed and are generally known or easily verifiable without changing the nature of the motion from dismissal to summary judgment. Courts regularly acknowledge extrinsic facts that meet these criteria, as demonstrated in various precedents. Plaintiffs reference *Global Network Communications Inc. v. New York*, where the Second Circuit vacated a district court's dismissal due to improper reliance on judicially noticed public records regarding the plaintiff’s financial capability. The district court made factual determinations based on these records, which influenced its legal conclusions on other claims. In contrast, the current case lacks similar factual resolutions from the defendant, as the FDA publications serve merely to contextualize the defendant's conduct rather than to resolve crucial factual issues. Judicial notice has been taken of regulations to assess a defendant's standard of behavior, akin to the FDA materials in this case. The plaintiffs contest the assertion that aspirin has been sold in the U.S. for over a century, despite acknowledging Bayer's long-standing association with aspirin and its marketing claims regarding safety and efficacy. The court accepts six exhibits under Rule 201(b), determining that the facts from the FDA website and other marketing materials are reliable and easily verifiable. On the issue of preemption, the defendant argues that the plaintiffs' complaints regarding Heart Advantage and Bayer Calcium only reflect violations of the FDCA, which cannot be privately enforced. The defendant asserts that any state law claims would be preempted, as the core allegation is that Bayer sold products without obtaining FDA approval. While the components are FDA-approved, the plaintiffs claim the combinations constitute new drugs requiring approval. The plaintiffs assert they would not have purchased Bayer's products if they had known of the lack of FDA submission. The defendant dismisses claims regarding product defects as irrelevant without evidence of physical harm and contends that the plaintiffs’ damage theories regarding price impact are insufficient. Defendants assert that enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA) is exclusively the responsibility of the FDA, as established in 21 U.S.C. § 337(a) and reinforced by the Supreme Court in Buckman Co. v. Plaintiffs' Legal Comm. This case held that private plaintiffs cannot pursue fraud claims related to the FDA's approval process, as such claims conflict with federal law. The FDCA aims to ensure that drugs are safe, effective, and not misbranded, which is within the FDA's purview. For a state-law claim to be viable post-Buckman, it must be based on conduct that violates the FDCA but is not solely derived from FDCA violations; it should also be actionable under state law absent the FDCA. Courts have clarified that if a plaintiff's claim is entirely dependent on an FDCA violation, it is impliedly preempted. Examples include claims dismissed for being reliant on FDA violations rather than traditional state law torts. However, state law and the Lanham Act can still function alongside FDCA provisions as long as they serve to protect commercial interests without entirely depending on FDCA violations. To avoid preemption of state law claims under the Federal Food, Drug, and Cosmetic Act (FDCA), a plaintiff must demonstrate that the defendant violated the FDCA but that their claims are not solely based on that violation; instead, they must be rooted in traditional state law. The Supreme Court's decision in Wyeth v. Levine reaffirmed that while the FDA provides a baseline for drug safety and labeling, states can impose additional protections. The Court emphasized that Congressional silence on the issue suggests an intent to allow common law claims and that state law serves as a complementary regulatory framework alongside federal oversight. Subsequent cases have reinforced this view, indicating that state law failure-to-warn claims can proceed if they do not conflict with federal regulations. The FDCA's primary focus is ensuring drug safety rather than addressing deceptive advertising, which falls under state consumer protection laws. Such laws, including the New Jersey Consumer Fraud Act, aim to protect consumers from fraud and ensure truthful advertising, requiring plaintiffs to specify instances of alleged deceptive practices to succeed in their claims. Courts have interpreted legal standards regarding misleading advertisements broadly to protect the public, as established in *Furst v. Einstein Moomjy, Inc.* and supported by cases like *Cox v. Sears Roebuck & Co.* and *American Home Products Corp. v. Johnson & Johnson*. Claims of false advertising extend beyond outright falsehoods to include innuendo and ambiguous implications that could mislead consumers. This principle emphasizes the necessity of scrutiny against sophisticated deceptive practices. Although claims relating to FDA regulations may be preempted, false statements in prescription drug marketing can still be actionable under state or federal law, as illustrated in *In re: Epogen* where a claim about bioequivalence was upheld due to allegations of literal falsehood. The Fourth Circuit supported this view in *Mylan Laboratories*, allowing claims based on fraudulently obtained FDA approvals. Similarly, in *In re Bextra and Celebrex*, misleading marketing claims were deemed actionable despite FDA determinations. The case of *Grove Fresh Distrib. Inc. v. Flavor Fresh Foods, Inc.* further demonstrated that plaintiffs could use FDCA definitions to substantiate claims of misrepresentation. In *In re Epogen*, while some allegations concerning off-label promotions were dismissed, others were actionable when false statements about patient risks were made. The distinction between FDA jurisdiction and Lanham Act claims is highlighted, asserting that defendants cannot make false claims about their products, regardless of FDA requirements. In Mylan Laboratories, the Fourth Circuit differentiated between a valid claim of false bioequivalence representations and an inadequate claim regarding implied FDA approval through standard inserts. The plaintiffs' assertion that the defendant's actions falsely implied FDA approval lacked specificity; they failed to identify any clear representations in the defendant's advertising that indicated proper FDA approval. The court noted that merely placing drugs on the market with standard inserts does not imply FDA approval. Claims of false FDA approval must be supported by detailed allegations and specific instances of misleading representation. For example, in Mutual Pharmaceutical Co. v. Ivax Pharmaceuticals, the court found viable claims where marketing practices implied FDA approval despite the drugs being unapproved. Similarly, in Cottrell, Ltd. v. Biotrol Int'l, Inc., plaintiffs successfully argued false advertising based on misleading agency approval representations. In the current case against Bayer, plaintiffs allege that Bayer's marketing of the Heart Advantage and Bayer Calcium misled consumers into believing the products were FDA-approved. They argue that Bayer's reputable branding and use of FDA-approved statements about the individual components implied FDA approval for the combination products. Bayer does not contest the use of FDA-approved claims in its marketing but defends the legitimacy of this practice. Bayer asserts that the FDA's approval of claims regarding calcium, phytosterols, and low-dose aspirin allows them to utilize these claims for their combination products, regardless of the lack of separate FDA approval for the combination products themselves. Plaintiffs counter this by alleging that Bayer misrepresented the safety and effectiveness of these products. They argue that adequate intake of calcium or phytosterols alongside a daily aspirin regimen is impossible without consuming dangerous amounts of aspirin. Specifically, to achieve the purported benefits of phytosterols, a consumer would need to take two Bayer Heart Advantage tablets, while a typical aspirin regimen only includes one 81mg tablet. Consequently, achieving the recommended intake of calcium through Bayer Calcium products would similarly require excessive aspirin doses. The plaintiffs contend that this dosing conflict undermines Bayer's claims about the effectiveness and safety of the combination products. Furthermore, plaintiffs highlight instances where Bayer allegedly implied that the combination products were FDA-approved, drawing parallels to legal precedents such as Mutual Pharmaceutical and Cottrell, where misleading marketing practices regarding FDA approval were scrutinized. In Mutual Pharmaceutical, the court recognized that misleading placement on pricing lists could create false impressions of FDA approval, while in Cottrell, the Fourth Circuit acknowledged viable claims based on deception of consumers regarding product efficacy and regulatory approval, despite some claims being precluded due to statutory enforcement issues. The first claim against Birex was dismissed as it alleged violations of the statute, related regulations, and EPA enforcement actions, which the court interpreted as enforcing the statute's substantive provisions. Conversely, the second claim was upheld because it focused on Birex's misleading consumer representations, specifically claiming false representations of EPA approval. The plaintiffs' case was viewed favorably, as it indicated that Birex falsely implied that certain combination products had FDA approval. Moreover, the plaintiffs' second and third claims, centered on Bayer's misrepresentation of the safety and effectiveness of its products, were based on alleged dosing discrepancies. The claims asserted that Bayer's labeling misled consumers into believing the products provided adequate calcium or phytosterols in a low-dose aspirin regimen. This constituted a traditional consumer misrepresentation claim rather than an enforcement of FDCA labeling requirements. Although the misleading nature of Bayer's claims touched on FDA-regulated areas, such as calcium and phytosterol sources, the court determined these claims were not preempted, as verification did not require specialized FDA expertise. While the plaintiffs referenced FDCA regulations and 2008 warning letters for context, their claims fundamentally rested on state law principles, allowing for recovery independent of the FDCA. The defendant's argument that the FDA's lack of action since the letters implied approval was countered by prior judicial reasoning that dismissed such claims of tacit approval. Defendant's argument regarding federal labeling compliance does not negate the possibility of misleading claims actionable under state consumer protection laws. To successfully assert preemption, the defendant must demonstrate that compliance with both federal and state laws is impossible. Even if labeling meets FDA requirements, it can still be considered misleading under state statutes. The plaintiffs reference FTC actions to support their claim that the labeling was deceptive, emphasizing that consumer perceptions are key in determining whether misleading representations occurred. At this stage, plaintiffs have provided sufficient facts to suggest that their claims are plausible and not preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). Regarding Bayer's motion to dismiss claims under state laws not directly related to the named plaintiffs’ residences, the plaintiffs assert that New Jersey law governs but also cite 43 other state consumer protection acts and warranty laws. Bayer contends that the plaintiffs lack standing to pursue claims outside their states and that their pleadings are inadequate. However, the distinction between Article III standing and class action requirements is crucial; the standing of named plaintiffs to assert claims in other states is irrelevant since they represent a class of consumers in those states. The complaint clarifies that claims under "sister state" laws are intended for class members, not the named plaintiffs themselves. Named Plaintiffs' lack of individual standing to assert violations of consumer protection laws in states other than their purchase locations is deemed irrelevant. Standing is distinct from the ability to represent a class under Rule 23. The court, referencing previous cases, emphasizes that the pertinent issue is whether the named plaintiffs' injuries are sufficiently similar to those of the proposed class to warrant a nationwide class action, which should be assessed during class certification. Defendants cannot dismiss state law claims based on standing, as this conflates issues of standing with adequacy of representation and common legal questions, which are to be addressed at class certification. At this preliminary stage, only the standing of the named plaintiffs is relevant. The defendants contend that the plaintiffs lack standing due to failure to allege physical injury from specific products; however, the court notes that to establish standing, a plaintiff must demonstrate a concrete injury-in-fact. Economic injuries, including receiving less than promised, are sufficient for standing. Plaintiffs' claims of being misled into purchasing a product that did not meet expectations satisfy the requirements for Article III standing. The argument that claims under state laws, aside from those of New York, New Jersey, Illinois, and California, should be dismissed for failure to state a claim is rejected. Dismissing these claims would allow the defendant to achieve indirectly what it cannot do directly. It is established that choice of law issues are determined at the class certification stage to assess commonality among claims. In Whitson v. Bumbo, the court ruled that the defendant's claim that the plaintiff did not sufficiently state a claim due to discrepancies in state laws was premature. The court indicated that such issues should be dealt with during the class certification phase, after discovery. It emphasized that while class actions cannot circumvent pleading standards, the adequacy of pleadings is critical. The defendant argued that the plaintiffs inadequately pleaded various state statutes, merely listing them without detailing the necessary elements of their claims. The court referenced established case law, stating that a plaintiff must provide enough information to outline their claims, moving beyond mere labels or conclusions. However, the court found that the plaintiffs had sufficiently connected their claims to the defendant’s conduct, differentiating their case from others where plaintiffs only listed statutes. For instance, in Count II, the plaintiffs alleged that the defendant's misleading advertising practices violated consumer protection acts across 43 states. This level of pleading was deemed adequate to allow inferences about the existence of necessary legal elements, thus satisfying the court's requirements at this preliminary stage. The plaintiffs effectively linked the defendant's actions to the claims under state law, providing a sufficient outline of their causes of action. Allegations in the case are deemed sufficient to withstand the defendant's motion to dismiss, particularly when combined with a detailed choice of law analysis at class certification. In consumer fraud cases, the applicable law is typically that of the state where the consumer resides. Courts analyzing nationwide consumer-protection class actions have concluded that the law of each plaintiff's residence should apply. The arguments presented by both parties focus on the Consumer Fraud Act (CFA), referencing case law from California, New York, and Illinois. Under the CFA, any individual who incurs an ascertainable loss due to unlawful practices may file a claim (N.J. Stat. Ann. 56:8-19). To establish a cause of action, plaintiffs must demonstrate: 1) an unlawful act by the defendant, 2) an ascertainable loss suffered by the plaintiff, and 3) a causal link between the defendant's conduct and the plaintiff's loss. Unlawful acts include deception, fraud, and misrepresentation (N.J. Stat. Ann. 56:8-2). Ascertainable loss is broadly defined, encompassing more than just monetary loss; it occurs when a consumer receives less than what was promised. The Second Circuit noted that asserting economic injury is sufficient to meet the ascertainable loss requirement. In this case, plaintiffs allege that the defendants' misrepresentation of Rezulin's safety led to economic loss, as they would not have purchased the product had they known the truth. However, claims based solely on price inflation have been deemed insufficient to establish the necessary ascertainable loss or causation in New Jersey courts. CFA claims based on fraud must adhere to heightened pleading standards under Rule 9(b), but courts are advised to exercise caution before dismissing such claims. In this case, the allegations in the Complaint, when accepted as true and viewed favorably towards the plaintiffs, establish a viable CFA claim. The plaintiffs allege that the defendant falsely implied FDA approval for their combination products, claiming they were safe and effective. The defendant argues that the plaintiffs fail to demonstrate injury and causation, asserting that the plaintiffs suffered no physical harm and that their price inflation theory does not constitute sufficient injury. However, the plaintiffs contend that their inadequate dosing argument underpins their claims of substantive defect, countering the defendant's assertion that they received what they bargained for. The absence of physical injury is considered irrelevant; as established in Desiano, economic loss can be sufficient for a CFA claim irrespective of physical harm. The Second Circuit's reasoning indicates that a purchaser can claim economic injury if misrepresentations led them to choose a more expensive product over cheaper alternatives. The plaintiffs' position aligns with precedents where courts found adequate injury claims based on misleading advertisements, which influenced purchasing decisions. The defendant's reliance on cases where plaintiffs did not claim defects or harm is deemed inapplicable to the present case, as the plaintiffs have explicitly argued that the misrepresentations influenced their purchasing choices. Plaintiffs believed they were purchasing an FDA-approved product and provided detailed claims regarding inadequate levels of phytosterols or calcium in the products, which failed to deliver the advertised health benefits. Unlike the plaintiffs in cited cases, they asserted a defect in the product's performance. The defendant criticized the plaintiffs' damages theory, arguing it only suggested that misrepresentations caused a general price increase, which New Jersey courts have deemed insufficient for establishing causation under the Consumer Fraud Act (CFA). Previous cases, such as *In re Schering-Plough*, rejected price-impact theories as they do not demonstrate a direct causal link between defendant's conduct and plaintiffs' injuries. Plaintiffs clarified that they did not claim the product was merely more expensive than alternatives, but rather that the misrepresentations were the reason for their purchase. They argued that, absent these misrepresentations, they would have opted for a less expensive alternative. This aligns with precedents where plaintiffs successfully demonstrated that misrepresentations induced their purchases, such as in the *In re Ford Motor Co.* case, distinguishing it from the "fraud on the market" theory, which is inadequate in CFA claims. Plaintiffs in the case against Ford Motor allege damages from fraudulent acts and omissions that resulted in a decrease in value and loss of use of the vehicles, rather than price inflation due to misrepresentations. Unlike previous cases like Merck and Schering-Plough, plaintiffs do not claim that the prices of the unsafe vehicles were inflated by advertising. Instead, they assert that Ford's false promises induced their purchases, seeking a full refund or the "benefit of the bargain," which reflects the difference between the product's actual value and its misrepresented value. Additionally, they may pursue "out of pocket" losses, which are accepted in state consumer protection claims. Defendant contests the plaintiffs' breach of warranty and unjust enrichment claims, arguing they hinge on the lack of FDA approval for the products, which they claim renders the products defective. However, this argument overlooks plaintiffs' allegations of misrepresentation regarding FDA approval and substantive defects in the products. The cases cited by the defendant differ, as those plaintiffs did not assert that the products were ineffective, only that they lacked FDA approval and sufficient evidence for health benefit claims. A distinction exists between allegations that challenge the safety or effectiveness of the Subject Drugs and claims that merely cite violations of the FDCA, for which there is no private right of action. Plaintiffs allege that Bayer's combination products failed to meet the claims made on their labels and falsely suggested FDA approval. Specific assertions include that Bayer Calcium's combination of aspirin and calcium does not effectively "fight" osteoporosis as advertised. Plaintiffs argue that Bayer breached express warranties by not fulfilling these promises. Furthermore, plaintiffs contend that Bayer's misleading marketing led them to purchase the products, resulting in unjust enrichment for the defendant. Defendants' claim that the unjust enrichment allegations are solely based on FDCA violations mischaracterizes the complaint. The allegations state that Bayer profited from misleading statements, justifying a claim for unjust enrichment. Consequently, the court denied the defendant's motion to dismiss. Additional notes clarify that OTC aspirin labeling cannot include cardiovascular benefit claims without medical supervision and that specific regulations govern health claims related to calcium content. Statements on the Bayer product packaging suggest it is intended for long-term daily use to prevent or treat cardiovascular disease. Plaintiffs claim that Bayer has promoted its Low-Dose Aspirin for daily consumption to prevent heart attacks and leveraged this marketing for the introduction of Heart Advantage, advertising it for long-term use in preventing heart attacks and lowering cholesterol. Each plaintiff purchased either Heart Advantage or Bayer Calcium after seeing health benefit claims on the labels. The packaging includes phrases indicating benefits for lowering cholesterol and treating hypercholesterolemia, which plaintiffs argue require FDA approval and imply that the product, when taken with low-dose aspirin, offers sufficient phytosterols for these benefits. Additionally, long-term aspirin use is cautioned against without medical supervision due to potential serious side effects. The plaintiffs challenge Bayer's arguments against their claims, particularly regarding the lack of FDA approval for marketing the products for these uses. Bayer contends that no enforcement action was taken by the FDA following warning letters, suggesting tacit approval of its marketing practices. Plaintiffs assert that Bayer’s claims violate the FDCA, while Bayer argues that the plaintiffs’ claims are either preempted or constitute mere allegations of FDCA violations. Named plaintiffs have detailed their experiences with the misleading packaging of Heart Advantage and Bayer Calcium, including specifics on purchase locations, duration of purchases, and the nature of the deception. The Complaint elaborates on the misleading aspects of the labeling. The applicable state consumer protection statutes mirror the FTC Act; for instance, the Illinois Consumer Fraud Act prohibits unfair and deceptive practices in trade. To establish a claim, a consumer must demonstrate a deceptive act intended for reliance, which caused injury. New York's laws also prohibit deceptive acts in commerce, allowing any injured party to file a claim for false advertising. These statutes aim to foster an honest marketplace and are broader in scope than those in New Jersey, with plaintiffs only required to meet basic notice pleading standards. The excerpt references McLaughlin v. American Tobacco, emphasizing that the case does not weaken the relevance of Desiano. In McLaughlin, the plaintiffs failed to demonstrate that misrepresentations about light cigarettes resulted in a reduced value, as they would have purchased cigarettes regardless. The plaintiffs in In re Schering-Plough Corp. had a different claim, focusing on misrepresentations affecting physician prescriptions, thus lacking a direct consumer injury link. The Second Circuit has warned against applying stringent causation requirements from RICO claims to state consumer protection laws, which often demand less proof of causation. If their primary argument fails, plaintiffs intend to pursue damages based on "benefit of the bargain" or "out of pocket loss" methods. The relevance of Schering-Plough is limited as it pertained to RICO claims rather than warranty claims.