Case 1:21-cv-08244 Document 1 Filed 10/06/21 Page 1 of 55
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`Case No. ______________
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`CLASS ACTION COMPLAINT
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`JURY DEMAND
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`SHANNON WEBB, individually, and on behalf of
`all others similarly situated,
` Plaintiff,
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`v.
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`PFIZER, INC.,
` Defendant
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`Plaintiff Shannon Webb (“Plaintiff”), by and through their undersigned counsel, brings this
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`action individually and on behalf of all others similarly situated, to seek economic damages for
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`those who paid for or made reimbursements for generic varenicline-containing drugs (“VCDs”)
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`that were illegally and willfully manufactured, distributed, and/or introduced into the market by
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`Defendant Pfizer, Inc. (“Pfizer”).
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`INTRODUCTION
`This case arises from adulterated, misbranded, and unapproved varenicline-
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`1.
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`containing drugs (“VCDs”) that were designed, manufactured, marketed, distributed, packaged,
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`and/or ultimately sold by Defendant Pfizer, Inc., in the United States under the brand name
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`Chantix®. These VCDs are non-merchantable, and are not of the quality represented by Defendant.
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`2.
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`The brand name drug Chantix is known generically as varenicline (as the tartrate
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`salt), and is a partial nicotine agonist. It is a first-line therapy in the treatment to aid in smoking
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`cessation. Unlike many other smoking cessation aids, Chantix does not contain nicotine.
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`3.
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`Pfizer obtained approval from the United States Food and Drug Administration
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`Case 1:21-cv-08244 Document 1 Filed 10/06/21 Page 2 of 55
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`(“FDA”) to sell Chantix as a first of its kind treatment in May 2006.
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`4.
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`Chantix quickly became one of Pfizer’s fastest growing products. Major media
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`spending on Chantix totaled $55 million in 2007 (the year after its approval). In the year Chantix
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`was launched, Pfizer spent $4.3 million in medical journal advertisements alone.
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`5.
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`The market rapidly embraced Chantix, and continues to do so to this day. For
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`example, from launch through 2015, the number of Chantix prescriptions amongst Medicaid
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`beneficiaries increased 13,277% (thirteen-thousand, two-hundred seventy-seven percent).1
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`6.
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` The price for Chantix has steadily climbed since its launch. Price estimates at
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`launch were approximately $113.98, which climbed to $254.50 as of 2015. In 2018, the price
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`nearly doubled to $485 for a 30-day supply, bringing in $997 million in sales that year.2
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`7.
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`The market for smoking cessation treatments remains robust and continues to grow.
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`Pfizer’s Chantix sales remain strong, with sales of at least $919 million last year. Indeed, Chantix
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`was Pfizer’s eight-best-selling product in 2020. To this day, Chantix remains one of the few, and
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`most prevalent, smoking cessation drug treatments, and one of Pfizer’s top drug products. Pfizer
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`extended patent protection on Chantix to ensure exclusivity through at least August 2022, thus
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`ensuring Pfizer’s Chantix is the exclusive varenicline product without generic competition
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`currently.
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`8.
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`At all pertinent times for this action, Defendant represented and warranted to
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`consumers that its VCDs were therapeutically equivalent to and otherwise the same as the FDA-
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`approved brand name drug Chantix. Specifically, Defendant represented and warranted that the
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`1 Xiaomeng Yue, et al., TRENDS IN UTILIZATION, SPENDING, AND PRICES OF SMOKING-CESSATION MEDICATIONS IN
`MEDICAID PROGRAMS: 25 YEARS EMPIRICAL DATA ANALYSIS, 1991-2015, Am. Health Drug Benefits 2018 Sep;
`11(6):275-285, at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207314/ (last accessed Sept. 27, 2021).
`2 Price of Pfizer’s smoking-cessation drug Chantix doubles in just 5 years: report, Fierce Pharma (June 26, 2018) at
`https://www.fiercepharma.com/pfizer-hikes-price-smoking-cessation-drug-chantix-106-5-years-report (last accessed
`Sept. 27, 2021).
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`VCDs were fit for their ordinary uses, met the specifications of Defendant’s FDA-approved
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`labeling materials, and were manufactured and distributed in accordance with all applicable laws
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`and regulations.
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`9.
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`However, Defendant willfully ignored warnings about the operating standards, and
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`knowingly and fraudulently manufactured, sold, labeled, marketed, and/or distributed adulterated
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`and/or misbranded VCDs for purchase in the United States by consumers.
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`10.
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`Defendant VCDs were adulterated and/or misbranded (and thereby rendered
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`worthless) through contamination with a probable human carcinogen known as n-nitroso-
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`varenicline. Additionally, Defendant was on notice of other potential nitrosamines as well, such
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`as n-nitrosdimethylamine (“NDMA”) and n-nitrosodiethlamine (“NDEA”).
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`11.
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`According to the FDA and other global health authorities, nitrosamines are
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`dangerous probable human carcinogens.
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`12.
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`According to FDA testing, VCDs subject to this action contained NDMA
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`contamination levels many times higher than the FDA’s updated interim limits for NDMA and
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`other nitrosamine impurities.
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`13.
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`On July 2, 2021, and July 19, 2021, Pfizer initiated recalls of VCDs “because [the
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`product] may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s
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`acceptable intake limit.”3 The FDA has yet to release full testing results for other nitrosamine
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`impurities. On September 16, 2021, Pfizer extended its recall to all Chantix.4
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`14.
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`-Upon information and belief, N-nitroso-varenicline contamination of Defendant’s
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`3 FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix) at
`https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-
`varenicline-chantix (last accessed Sept. 27, 2021).
`4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-
`include-all-lots-chantixr-varenicline-tablets-due-n (last accessed Sept. 27, 2021).
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`VCDs dates back many years, at which point Defendant had actual and/or constructive notice of
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`the contamination.
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`15.
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`Ironically, the Defendant’s wrongful acts resulted in persons who sought to use
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`smoking products less end up with a Chantix pill that contained a carcinogen.
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`16.
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`The Class Plaintiffs paid for VCDs that were illegally and willfully introduced into
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`the market by Defendants, which caused them and the millions of other VCD consumers, to sustain
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`economic damages. Defendant’s VCDs were not fit for their ordinary use and Defendant has been
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`unjustly enriched through the sale of these knowingly adulterated and/or misbranded drugs.
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`Defendant’s conduct, as detailed in this Complaint, also constitutes actionable common law fraud,
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`consumer fraud, and other violations of state and federal law.
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`PARTIES
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`A. Plaintiff
`Plaintiff Shannon Webb is a citizen and resident of Schenectady, New York.
`17.
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`During the class period, Plaintiff Webb paid money for one or more of Defendant’s VCDs. The
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`product purchased bore a unique National Drug Code (“NDC”) which denoted that it was indeed
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`sold, manufactured, and/or distributed into the United States supply chain by Defendant.
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`Defendant in this paragraph expressly and impliedly warranted to Plaintiff Webb (either directly
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`or indirectly by adopting warranties that were passed along to and incorporated by another
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`Defendant further downstream and as mentioned in this paragraph) that their respective VCDs
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`were the same as the branded Chantix. But in fact, Plaintiff Webb bought a product that was not
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`the same as Chantix. Had Plaintiff Webb known the product was not the same, Plaintiff Webb
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`would not have paid for these Defendant’s VCDs. Likewise, had Defendant’s deception about the
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`impurities within their products been made known earlier, Plaintiff Webb would not have paid for
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`Defendant’s VCDs.
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`B. Defendant
`Defendant Pfizer, Inc. (“Pfizer”) is a Delaware corporation with its principal place
`18.
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`of business at 235 East 42nd Street, New York, NY 10017. Pfizer on its own and/or through its
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`subsidiaries regularly conducts business throughout the United States and its territories and
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`possessions. At all times material to this case, Pfizer has been engaged in the manufacturing, sale,
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`and distribution of adulterated and/or misbranded generic VCDs in the United States.
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`FACTUAL ALLEGATIONS
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`I. Background
`A. Prescription Drug Reimbursement
`The pharmaceutical supply chain in the United States consists of four major actors:
`19.
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`pharmaceutical manufacturers, wholesale distributors, pharmacies, and Pharmacy Benefit
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`Managers (“PBMs”).
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`20.
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`Pharmaceutical manufacturers produce drugs that they distribute to wholesale
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`distributors, who further distribute to retail or mail-order pharmacies. Pharmacies dispense the
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`prescription drugs to beneficiaries for consumption. Prescription drugs are processed through
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`quality and utilization management screens by PBMs.
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`21.
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`Third-party payors (“TPPs”) contract with and pay PBMs to administer their drug
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`programs. PBMs, acting as agents for the TPPs, are tasked with developing drug formularies (the
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`list of drugs included in coverage at various pricing “tiers”), processing claims, creating a network
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`of retail pharmacies, and negotiating with pharmaceutical manufacturers. TPPs pay PBMs to
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`control prescription drug costs. In some instances, PBMs are responsible for placing generic drugs,
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`such as VCDs, on the TPPs’ formularies.
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`22.
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`In conducting formulary management, TPPs and their PBMs reasonably expect that
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`generic prescription drugs reimbursable on their formularies are bioequivalent or otherwise the
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`same as their RLD counterparts. TPPs seek to include the lowest cost generic drugs possible in
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`their formularies. This is only made possible because of the manufacturers’ and distributors’
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`representations that these generic drugs, such as the Defendant’s VCDs, comply with their
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`respective ANDAs, which state that the generic drugs are bioequivalent to their respective branded
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`drug. Thus, the TPPs permitted the VCDs to be included on their formularies based on the
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`Defendant’s misrepresentations that their VCDs were bioequivalent to Chantix, complied with all
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`current Good Manufacturing Practices (“cGMPs”), and were safe for consumption.
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`23.
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`The formulary placement corresponds with the amount that a plan participant must
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`contribute as a co-payment when purchasing a drug — the higher the placement, the lower the co-
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`payment, and the higher likelihood that plan beneficiaries will purchase the drug instead of a more
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`expensive alternative. As a result, higher formulary placement increases the likelihood that a
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`doctor will prescribe the drug. TPPs provide copies of their PBMs’ formularies to providers,
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`pharmacists, and patients in their network to aid prescribers’ adherence to the formulary.
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`24.
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`The following chart, published by the Wall Street Journal, broadly illustrates the
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`pharmaceutical supply chain:5
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`5 Joseph Walker, Drugmakers Point Finger at Middlemen for Rising Drug Prices, WALL ST. J. (Oct. 3, 2016), available
`(last
`at https://www.wsj.com/articles/drugmakers-point-finger-at-middlemen-for-rising-drug-prices-1475443336
`accessed June 11, 2019).
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`25. When a patient presents his/her prescription at a pharmacy, the drug’s placement
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`on the TPP’s formulary will determine the amount of the patient’s co-payment. Once the patient’s
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`prescription is filled, the pharmacy submits a claim to the PBM for reimbursement. PBMs then
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`accumulate those individual reimbursements and present them to TPPs for payment.
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`B. Prescription Drug Product Identification and Tracing
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`26.
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`For each approved product (whether brand or generic) the FDA issues a unique 10-
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`digit code (the National Drug Code, or NDC) that follows the product from manufacturing through
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`retail dispensing. The NDC embeds details about the specific product, including the identity of the
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`manufacturer (or labeler), the strength, dosage form, and formulation of the drug, and the package
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`size and type.6
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`27.
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`The NDC is a critical component of each and every transfer of a prescription drug
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`(from the manufacturer to the wholesaler; from the wholesaler to the retailer; and from the retailer
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`to the consumer) and therefore every transaction is accompanied by and labeled with the NDC.
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`This same code is used by TPPs in the real-time claims adjudication process to identify the precise
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`dollar amount they will reimburse the pharmacy for a particular prescription drug purchase.
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`28.
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`Retail prescription labels display the NDC of the dispensed product, which is part
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`of the electronic dispensing record. In many cases, the “lot” number will also appear on the
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`prescription bottle provided to the consumer and, thus, specifically indicate whether the recall
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`applies to the particular pills in the bottle.7
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`29.
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`The lot number is also used to report issues arising around a particular drug. For
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`example, lot numbers are used by pharmacists to report Adverse Events (“AE”) (i.e., patient-
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`6 United States Food and Drug Administration, “National Drug Code Directory,” accessed June 9, 2021 at
`https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm; FDA, “National Drug Codes Explained,”
`accessed June 9, 2021 at https://www.drugs.com/ndc.html.
`7 A lot number is an identification number tied to a particular lot of pills from a single manufacturer.
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`specific side effects or complications associated with the use of a prescription drug). This is an
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`important part of drug safety monitoring in the United States and has led to recalls or relabeling of
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`numerous drugs. Pharmacists make such reports using the FDA’s MedWatch system using Form
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`3500.8
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`C. The Drug Supply Chain Security Act Requires Tracing of Product
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`30.
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`The Drug Supply Chain Security Act (“DSCSA”)9 was enacted in 2013, and
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`requires prescription drug manufacturers, wholesalers, repackagers, and pharmacies to
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`“[e]xchange information about a drug and who handled it each time it is sold in the U.S. market.”
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`31.
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`The DSCSA was implemented as one part of the Drug Quality and Security Act
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`(“DQSA”), aimed at addressing vulnerabilities in the drug supply chain, and facilitating tracing of
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`certain prescription drugs in finished dosage form through the supply chain. 10
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`32. While the DSCSA was enacted in 2013, participants in the pharmaceutical supply
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`chain (including various Defendant here) maintained similar information as a part of their ordinary
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`course of business prior to the enactment of the DSCSA.
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`33.
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`The DSCSA generally requires participants in the drug supply manufacturing chain
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`(starting from the manufacturer, through the wholesaler, to the retail pharmacy) to retain, for every
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`pharmaceutical drug transaction, the following information about that transaction: product name;
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`National Drug Code; container size; number of containers; lot number; date of transaction; date of
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`shipment; and name and address of the entity transferring ownership and taking ownership of the
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`June
`accessed
`3500,”
`FDA
`Form
`for Completing
`“Instructions
`FDA,
`8
`https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-
`3500#Section%20B:%20Adverse%20Event%20or%20Product%20Problem.
`9 21 U.S. Code § 360eee.
`10 U.S. Department of Health and Human Services, Drug Supply Chain Security: Dispensers Received Most Tracing
`Information, March 2018, accessed March 11, 2020 at https://oig.hhs.gov/oei/reports/oei-05-16-00550.pdf, at p. 2.
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`2021
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`at
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`9,
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`product.
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`34.
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`The DSCSA requires that this data be kept in a manner to allow these authorized
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`participants to respond within 48 hours to requests from appropriate federal or state officials — in
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`the event of a recall or for the purpose of investigating suspect product or an illegitimate product
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`— for the transaction history of the pharmaceutical product. 11
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`35.
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`The supply chain for distribution of prescription drugs in the U.S. is highly
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`concentrated. This means that data obtained from a relatively small number of market participants
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`can provide detailed information about the large majority of VCD sales, transfers and prescription
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`fills.
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`36.
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`The entire process of reimbursing pharmacies and consumers for end-purchases
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`depends upon the ability to know the precise drug and packaging that was dispensed, as well as
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`the manufacturer of that drug. This system has necessarily resulted in very high levels of data
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`standardization in this industry. Although pharmacies maintain their own “pharmacy log” data
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`reflecting dispensing, sales and return activity, the key elements are fundamentally similar.
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`37.
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`Because pharmacies require similar information for their own tracking and
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`inventory systems, and wholesalers sell to multiple pharmacy chains, the key elements are
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`fundamentally the same.
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`38.
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`Further, all pharmacies must use the basic data fields, definitions and formats
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`provided in the Telecommunications Guidelines developed by the National Council for
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`Prescription Drug Programs, the use of which was made mandatory in 2003 under regulations
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`implementing the Health Insurance Portability and Accountability Act (HIPAA).12 Because of
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`11 FDA, Title II of the Drug Quality and Security Act, December 16, 2014, accessed March 11, 2020 at
`https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act.
`12 Federal Register, August 17, 2000 (Volume 65, Number 160), at pp. 50311-50372; NCPDP, Pharmacy: A
`Prescription for Improving the Healthcare System, October 2009, accessed January 30, 2019 at
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`9
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`these HIPAA requirements, all of these inter-related systems (Manufacturers, Wholesalers,
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`Retailers, and TPPs) use a common language to identify products.
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`39.
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`As a general matter, for Medicare and Medicaid compliance, pharmacies typically
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`keep prescription records for ten years.13
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`40.
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`A key part of the DSCSA is the requirement that “product tracing information
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`should be exchanged” for each transaction and retained for at least six years,14 including the
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`following transaction information (“TI”):15
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`• Proprietary or established name or names of the product
`• Strength and dosage form of the product
`• National Drug Code (NDC) number of the product
`• Container size
`• Number of containers
`• Lot number of the product
`• Date of the transaction
`• Date of the shipment, if more than 24 hours after the date of the
`transaction
`• Business name and address of the person from whom and to whom
`ownership is being transferred
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`For example, the DSCSA also mandates use of a composite “product identifier”
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`41.
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`that Manufacturer Defendant were required to begin applying to prescription drug packages and
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`cases.16
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`42.
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`The term “product identifier” “means a standardized graphic that includes, in both
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`human-readable form and on a machine-readable data carrier … the standardized numerical
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`https://www.ncpdp.org/NCPDP/media/pdf/wp/RxforImprovingHealthcare.pdf, at p. 14.
`13 CFR § 423.505(d)
`14 FDA, Protect Your Patients, accessed June 9, 2021 at https://www.fda.gov/media/113114/download; DSCSA,
`Sections 582 (b)(1)(A)(ii), 582 (c)(bb)(BB)(II)(v)(I), 582 (d)(1)(A)(iii).
`15 FDA, Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview of Product Tracing
`Requirements, September 2015, accessed June 9, 2021 at https://www.fda.gov/media/93779/download, at pp. 8-9.
`16 Enforcement of this rule was delayed by the FDA until November 2018. DA, Product Identifier Requirements Under
`the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry, September 2018, accessed June 9,
`https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifier-
`2021
`at
`requirements-under-drug-supply-chain-security-act-compliance-policy-guidance.
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`identifier, lot number, and expiration date of the product.”17
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`43.
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`Publicly available Guidelines published by AmerisourceBergen require that “each
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`Prescription Drug lowest saleable unit” it receives from a manufacturer must have the clearly
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`indicated product identifier on the unit label.18 In addition, case labels, and partial case labels must
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`list the lot number and expiration date.19 The Guidelines illustrate these requirements as
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`reproduced below.
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`AmerisourceBergen Manufacturer Labeling Requirements20
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`
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`17 21 U.S. Code § 360eee.(14).
`18 AmerisourceBergen, AmerisourceBergen Manufacturer Packaging and Logistics Requirements Guide, accessed
`June 9, 2021 at https://www.amerisourcebergen.com/-/media/assets/amerisourcebergen/manufacturer/manufacturer-
`logistics-guideline-final-v14.pdf?la=en&hash=5297B4C716DBBE9A956F31CD2B194BD165F97465, at p. 14.
`19 AmerisourceBergen, AmerisourceBergen Manufacturer Packaging and Logistics Requirements Guide, accessed
`https://www.amerisourcebergen.com/-
`February
`25,
`2020
`at
`/media/assets/amerisourcebergen/manufacturer/manufacturer-logistics-guideline-final-
`v14.pdf?la=en&hash=5297B4C716DBBE9A956F31CD2B194BD165F97465, at pp. 15-16.
`20 AmerisourceBergen, AmerisourceBergen Manufacturer Packaging and Logistics Requirements Guide, accessed
`June 9, 2021 at https://www.amerisourcebergen.com/-/media/assets/amerisourcebergen/manufacturer/manufacturer-
`logistics-guideline-final-v14.pdf?la=en&hash=5297B4C716DBBE9A956F31CD2B194BD165F97465, at pp. 14, 15,
`16.
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`D. The Drug Approval Framework
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`44.
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`Brand drug companies submitting a New Drug Application (“NDA”) must
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`demonstrate clinical safety and efficacy through well-designed clinical trials. 21 U.S.C. § 355 et
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`seq.
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`45.
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`The NDA is the vehicle through which drug sponsors formally propose that the
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`FDA approve a new drug for sale and marketing in the United States.
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`46.
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`An NDA is supposed to provide enough information to permit the FDA to decide
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`(i) whether the drug is safe and effective for its proposed use(s) and whether the benefits of the
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`drug outweigh the risks; (ii) whether the drug’s proposed labeling is appropriate and what it should
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`contain; and (iii) whether the methods used in manufacturing the drug and the controls used to
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`maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and
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`purity.21
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`47.
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`As the FDA puts it, the submitted NDA documentation “is supposed to tell the
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`drug’s whole story,” including “what the ingredients of the drug are.”22
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`48.
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`If a branded drug manufacturer ceases to manufacture a drug that meets all terms
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`of its NDA approval, or in other words, when the drug is not the same as its corresponding brand-
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`name drug, then the manufacturer has created an entirely new and unapproved drug.
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`49.
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`If a branded drug manufacturer ceases to manufacture a drug that meets all terms
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`of its NDA approval, or in other words, when the drug is not the same as its corresponding brand-
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`name drug, the generic manufacturer may no longer rely on the brand-name drug’s labeling.
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`E. Approval of the NDA for Chantix
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`50.
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`Chantix is known generically as varenicline (as the tartrate salt), and is a partial
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`nicotine agonist. It is a first-line therapy in the treatment to aid in smoking cessation. At a very
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`high level,. The drug works by interfering with the nicotine receptors in the human brain. This has
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`the effect of lessening the pleasure a person gets from smoking, or lessening the craving to smoke.
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`51.
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`The FDA approved Chantix in May 2006. Pfizer later succeeded in extending its
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`patent exclusivity for Chantix through August 2022, meaning Chantix has not faced generic drug
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`competition since its launch.
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`52.
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`Chantix’s FDA-approved labeling specifies the active and inactive ingredients.
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`Neither N-nitroso-varenicline nor NDMA nor any other nitrosamine is listed among the FDA-
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`approved ingredients nor are any of these contaminants FDA-approved ingredients of any
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`varenicline-containing product.
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`21 See, e.g., https://www.fda.gov/drugs/types-applications/new-drug-application-nda (last accessed Sept. 27, 2021).
`22 Id.
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`F. Drugs Must Be Manufactured in Compliance with Good Manufacturing Practices
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`53.
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`Under federal law, pharmaceutical drugs must be manufactured in accordance with
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`“current Good Manufacturing Practices” (“cGMPs”) to ensure they meet safety, quality, purity,
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`identity, and strength standards. See 21 U.S.C. § 351(a)(2)(B).
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`54.
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`21 C.F.R. § 210.1(a) states that the cGMPs establish “minimum current good
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`manufacturing practice for methods to be used in, and the facilities or controls to be used for, the
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`manufacture, processing, packing, or holding of a drug to assure that such drug meets the
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`requirements of the act as to safety, and has the identity and strength and meets the quality and
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`purity characteristics that it purports or is represented to possess.” In other words, entities at all
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`phases of the design, manufacture, and distribution chain are bound by these requirements.
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`55.
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`The FDA’s cGMP regulations are found in 21 C.F.R. Parts 210 and 211. These
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`detailed regulations set forth minimum standards for: organization and personnel (Subpart B);
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`buildings and facilities (Subpart C); equipment (Subpart D); control of components and drug
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`product containers and closures (Subpart E); production and process controls (Subpart F);
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`packaging and label controls (Subpart G); holding and distribution (Subpart H); laboratory controls
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`(Subpart I); records and reports (Subpart J); and returned and salvaged drug products (Subpart K).
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`The FDA has worldwide jurisdiction to enforce these regulations if the facility is making drugs
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`intended to be distributed in the United States.
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`56.
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`Under federal law, cGMPs include “the implementation of oversight and controls
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`over the manufacture of drugs to ensure quality, including managing the risk of and establishing
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`the safety of raw materials, materials used in the manufacturing of drugs, and finished drug
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`products.” 21 U.S.C. § 351(j). Accordingly, it is a cGMP violation for a manufacturer to contract
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`out prescription drug manufacturing without sufficiently ensuring the continuing quality of the
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`subcontractors’ operations.
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`57.
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`FDA regulations require a “quality control unit” to independently test drug product
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`manufactured by another company on contract:
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`There shall be a quality control unit that shall have the responsibility
`and authority to approve or reject all components, drug product
`containers, closures, in-process materials, packaging material,
`labeling, and drug products, and the authority to review production
`records to assure that no errors have occurred or, if errors have
`occurred, that they have been fully investigated. The quality control
`unit shall be responsible for approving or rejecting drug products
`manufactured, processed, packed, or held under contract by another
`company. 21 C.F.R. § 211.22(a).
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`
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`58.
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`Indeed, FDA regulations require a drug manufacturer to have “written procedures
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`for production and process control designed to assure that the drug products have the identity,
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`strength, quality, and purity they purport or are represented to possess.” 21 C.F.R. § 211.100.
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`59.
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`A drug manufacturer’s “[l]aboratory controls shall include the establishment of
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`scientifically sound and appropriate specifications, standards, sampling plans, and test procedures
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`designed to assure that components, drug product containers, closures, in-process materials,
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`labeling, and drug products conform to appropriate standards of identity, strength, quality, and
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`purity.” 21 C.F.R. § 211.160.
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`60.
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`“Laboratory records shall include complete data derived from all tests necessary to
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`assure compliance with established specifications and standards, including examinations and
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`assays” and a “statement of the results of tests and how the results compare with established
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`standards of identity, strength, quality, and purity for the component, drug product container,
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`closure, in-process material, or drug product tested.” 21 C.F.R. § 211.194.
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`G. Adulterated or Misbranded Drugs Are Illegal to Sell
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`61.
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`Any drug not manufactured in accordance with cGMPs is deemed “adulterated” or
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`Case 1:21-cv-08244 Document 1 Filed 10/06/21 Page 16 of 55
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`“misbranded” and may not be distributed or sold in the United States. See 21 U.S.C. §§ 331(a),
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`351(a)(2)(B). States have enacted laws adopting or mirroring these federal standards.
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`62.
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`Among the ways a drug may be adulterated and/or misbranded are:
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`a.
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`“if it has been prepared, packed, or held under unsanitary conditions
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`whereby it may have been contaminated with filth, or whereby it may have
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`been rendered injurious to health”23 ;
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`b.
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`“if … the methods used in, or the facilities or controls used for, its
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`manufacture, processing, packing, or holding do not conform to or are not
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`operated or administered in conformity with current good manufacturing
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`practice to assure that such drug meets the requirements … as to safety and
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`has
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`the
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`identity
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`and
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`strength,
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`and meets
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`the quality
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`and
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`purity characteristics, which it purports or is represented to possess”24;
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`c.
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`“If it purports to be or is represented as a drug the name of which is
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`recognized in an official compendium, and … its quality or purity falls
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`below, the standard set forth in such compendium”25; and/or
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`d.
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`“If … any substance has been (1) mixed or packed therewith so as to reduce
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`its quality or strength or (2) substituted wholly or in part therefor.”26
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`63.
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`A drug is misbranded:
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`a.
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`“If its labeling is false or misleading in any particular”27;
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`
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`23 21 U.S.C. § 351(a)(2)(A).
`24 21 U.S.C. § 351(a)(2)(B).
`25 21 U.S.C. § 351(b).
`26 21 U.S.C. § 351(d).
`27 21 U.S.C. § 352(a)(1).
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`b.
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`“If any word, statement, or other information required … to appear on
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`the label or labeling is not prominently placed thereon…in such terms as to
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`render it likely to be read and understood by the ordinary individual under
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`customary conditions of purchase and use”28;
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`c.
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`If the labeling does not contain, among other things, “the proportion of each
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`active ingredient”29;
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`d.
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`“Unless its labeling bears (1) adequate directions for use; and (2) such
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`adequate warnings … against unsafe dosage or methods or duration of
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`administration or application, in such manner and form, as are necessary for
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`the protection of users”30;
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`e.
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`“If it purports to be a drug the name of which is recognized in an official
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`compendium, unless it is packaged and labeled as prescribed therein”31
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`f.
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`g.
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`h.
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`“if it is an imitation of another drug”32;
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`“if it is offered for sale under the name of another drug”33;
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`“If it is dangerous to health when used in the dosage or manner, or with the
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`frequency or duration prescribed, recommended, or suggested
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`in
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`the labeling thereof”34;
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`i.
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`If the drug is advertised incorrectly in any manner35; and/or
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`
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`28 21 U.S.C. § 352(c).
`29 21 U.S.C. § 352(e)(1)(A)(ii)
`30 21 U.S.C. § 352(f).
`31 21 U.S.C. § 352(g).
`32 21 U.S.C. § 352(i)(2).
`33 21 U.S.C. § 352(i)(3).
`34 21 U.S.C. § 352(j).
`35 21 U.S.C. § 352(n).
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`j.
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`If the drug’s “packaging or labeling is in violation of an applicable
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`regulatio