IN THE SUPERIOR COURT OF WASHINGTON FOR KING COUNTY
ANSHITA THAKKAR as Personal Representative of the ESTATE OF PRAFULL ISHVARLAL THAKKAR, Plaintiff, v.
EZRICARE, LLC, a New Jersey limited liability company; GLOBAL PHARMA
HEALTHCARE PVT LIMITED, a foreign business entity; AMAZON.COM, INC. a domestic corporation.
Defendants.
COMPLAINT FOR DAMAGES
Plaintiff alleges:
INTRODUCTION
Generic over the counter (OTC) medical products are ubiquitous in drug stores, big box stores, and online retailers. For the most part, manufacturers and retailers of OTC products have sufficient self-interest to make sure generic products are safe. Large retailers that carry their own generic brands are generally liable for any harmful effects to consumers. Smaller brick-and-mortar retailers face financial peril if they sell unreliable medical brands They cannot simply vanish without obligation the day a business is no longer profitable.
Yet that is exactly what online-only sellers do. They can start a medical product company with little more than a laptop and no medical expertise, obtain foreign-made products without manufacturing oversight, and then sell products nationwide through Amazon’s mass distribution channels. They reap all the profits and evade any responsibility
Since the beginning, Amazon’s business model depends on more products for greater selection, to drive traffic to the site, for greater revenue. By developing and propping up unproven medical brands for its own profit, Amazon enables unaccountable companies to exist. It promotes them to the forefront of its online store, replacing safe and established brands with dangerous products consumers do not need. At the same time, Amazon systematically advertises the safety of its products and its internal regulatory policies, giving consumers a false sense of security
In this case, EzriCare boasted institutional knowledge and quality control it did not possess, and sold generic OTC medical products manufactured carelessly by an Indian company it did not oversee. EzriCare mass distributed medical products via Amazon, killed and blinded dozens of Americans, and then vanished.
I. PARTIES
1.1 At all times material hereto, Plaintiff Anshita Thakkar was a resident of King County, Washington Ms. Thakkar was appointed personal representative of the Estate of Prafull Thakkar (“Decedent”) by Spokane County Superior Court on March 27, 2023. She brings claims on behalf of the Estate of Decedent and all statutory beneficiaries under RCW 4.20.010-020, RCW 4.20.046, and RCW 4.20.060. Decedent’s statutory beneficiaries include Smita Thakkar (spouse), Anshita Thakkar (daughter), and Ankit Thakkar (son).
1.2 At all times material hereto, Defendant EzriCare LLC (“EzriCare”) was a limited liability company organized under the laws of the state of New Jersey, with its principal place of
business in New Jersey. The owners and operators of EzriCare are believed to be citizens of New Jersey or New York. EzriCare markets Artificial Tears Lubricant Eye Drops (“Eye Drops”) under its own brand name throughout the United States, including in the State of Washington.
1.3 At all times material hereto, Defendant Global Pharma Pvt Limited, a.k.a Global Pharma Private Limited, a.k.a. Global Pharma Healthcare, (“Global Pharma”), was a company formed and existing under the laws of India with its principal place of business at No. 2A, 3rd F, 4th Street, Ganga Nagar, Chennai - 600 024, Tamilnadu, India. Global Pharma manufacturers the Eye Drops for distribution and sale in the United States, including the State of Washington. Global Pharma’s manufactured Eye Drops for sale by and under the brand names EzriCare and Delsam Pharma, both based in the United States. Global Pharma uses Aru Pharma Inc. as a distributor, which is based in the United States.
1.4 Amazon.com, Inc. (“Amazon”) is incorporated under the laws of Delaware and maintains its principal place of business in King County, Washington. Amazon is a citizen of the State of Washington because its officers direct, control, and coordinate the corporation’s activities here. Amazon is a retailer and product seller that sold Eye Drops to Plaintiff.
II. JURISDICTION AND VENUE
2.1 Venue is proper in and for King County because the acts and omissions as alleged herein resulted in personal injury and death in King County, Washington, and because one or more Defendant resides in King County, Washington. RCW 4.12.020.
2.2 Personal Jurisdiction. Each Defendant has been served with process in a proper manner as provided by law.
2.2.1 This Court has personal jurisdiction over EzriCare because EzriCare sold Eye Drops under its brand name to and for use by Plaintiff/Decedent, and shipped or distributed
its product for delivery to consumers in the State of Washington, causing Decedent’s personal injury and death. EzriCare committed one or more tortious acts in the State of Washington, knew that any danger arising out of its product would cause harm in the State of Washington, and has otherwise purposefully availed itself of the benefits of transacting business in the State of Washington, giving rise to Plaintiff’s claim.
2.2.2 This Court has personal jurisdiction over Global Pharma because it designed, manufactured, distributed, and sold Eye Drops to companies in the United States with knowledge and intent that they be widely sold and distributed, including within the State of Washington. Global Pharma committed one or more tortious acts in the State of Washington, knew that any danger arising out of its product would cause harm in the State of Washington, and has otherwise purposefully availed itself of the benefits of transacting business in the State of Washington, giving rise to Plaintiff’s claim.
2.2.3 This Court has personal jurisdiction over Amazon because its “nerve center” is in Seattle, Washington. Amazon’s officers direct, control, and coordinate the corporation’s activities here. Further, Amazon is a product seller within the meaning of RCW 7.72.010 because it is engaged in the business of selling products for use or consumption. Amazon sold a product that caused personal injury and death in King County, Washington.
III. FACTS
Amazon, Inc.
3.1 Amazon was founded by Jeff Bezos on July 5, 1994, in Bellevue, King County, Washington as an online bookstore, initially relying on third-party distributors and wholesalers for
order fulfillment. At the time the only hazard faced by Amazon customers was the potential for a severe paper cut.
3.2 In 2000 Amazon launched its third-party marketplace, allowing small business owners to put their products on Amazon – for a fee.
3.3 In 2006 Amazon launched its fulfilled by Amazon program – where it took over the customer service, packaging, and distribution for third-party sellers on its platform – for a fee.
3.4 Since its inception Amazon has operated under the “Amazon Virtuous Cycle” (i.e. Flywheel). The model thrives on increased traffic to Amazon.com; which garners more sellers to the Amazon market place; which in turn increases selection, lower costs/prices, and lead s to a better overall customer experience; that will lead to more traffic – for the cycle to start again.
3.5
In other words, more selection, through third-party sellers, equals more profits.
3.6 Today Amazon is the world’s most valuable retail company by market capitalization. Amazon’s revenues in 2022 were $514 billion, and as of May 2023, its market
1 https://www.amazon.jobs/en/landingpages/about-amazon
capitalization is $1.19 trillion.
3.7 Despite being the largest retailer in the world, Amazon regularly claims it is not a product seller, or retailer, under state product liability laws. Amazon argues instead it is purely a marketplace, like a mall that merely houses retailers
Amazon is a “Product Seller” under RCW 7.72
3.8 In reality, Amazon is not only a product seller, but is far more involved in partnering with companies on its site than any traditional retailer.
3.9 To start, Amazon identifies the nature of its business with the Washington State Secretary of State as “retail.”
3.10 Amazon identifies itself with the Washington State Department of Revenue under NAICS Code 459999 – All Other Miscellaneous Retailers.
3.11 The Consumer Product Safety Commission held Amazon was a distributor as a matter of law under 15 U.S. Code § 2052 (8) of the Consumer Product Safety Act. 2
3.12 Amazon sells its own products and those of over one million other manufacturers and vendors through its online store and affiliated brick and mortar places of business. It offers over 350 million products sold to 310 million customers in more than 100 countries around the globe.
Amazon’s Business Model
3.13 Amazon has developed the status as the most valuable retailer by expanding the selection of its products at its stores and by creating services for affiliated retailers that control almost all aspects of how goods are bought and sold over the internet.
2 https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/027-Order-on-Motion-to-Dismiss-and-Motion-forSummary-Judgement.pdf?VersionId=fgW05hge.c7FvPZZOijVWVapvJBQKudZ
3.14 Amazon’s primary business model is to sell products for other Sellers and take a commission on those sales. The more services it offers to those sellers, the larger Amazon’s commission. Amazon calls these sellers, “selling partners,” “third-party sellers,” or “sellers of record.”
3.15 Sixty percent of the units sold on Amazon are from what Amazon terms “selling partners.” These parties in certain situations can pay over 50-60% of the proceeds of a sale to Amazon.
Amazon creates companies that otherwise would not exist
3.16 Amazon has created a world where anyone can sell a product with national distribution directly from their laptop. 3
3.17 Amazon advises its Selling Partners that “you don't have to solve every business problem. Use Amazon’s infrastructure, tools, and customer reach to grow your business.” 4
3.18 These amateur sellers are instructed on how to sell by Amazon training programs and apps created, hosted, serviced by Amazon.
3.18.1 Amazon’s Seller University is “free educational resources to help brands, businesses, and entrepreneurs learn how to succeed as Amazon selling partners.”
3.18.2 Amazon has a Selling Partner Appstore that provides “more than 6,200 Amazon-vetted service providers and apps which are used by more than 1 million sellers worldwide to help sellers build, manage, automate, and scale their business,” whereby Amazon turbo charges the reach of Selling Partners.
3 “Selling in Amazon stores enables you to build a worldwide company from your laptop. Advertising, promotions, and global selling are just a few ways to expand.” https://sell.amazon.com/sell
4 https://sell.amazon.com/learn/start-ecommerce-business
3.18.3 Amazon promises these Selling Partners, “unrivaled scale, no cap.” It offers Selling Partners the ability “build, grow and scale your brand with our innovative toolkit.”
3.19 Amazon manages all products sold on its website through Amazon’s Sellers Central. From this parallel site Amazon instructs Selling Partners how to maximize profits It instructs selling partners on what to sell, how to find manufacturers to keep costs low, and how to create separately branded products that give the appearance of safety.
3.19.1 Through Amazon’s product opportunity explorer Amazon feeds selling partners “ideas for new products or offers,” by “provid[ing] insight into Amazon customer search and purchase behavior.”5
3.19.2 On the Amazon Seller Central article 7 Ways to Make Money on Amazon, selling partners are instructed to “work with a wholesaler or a manufacturer to set up a supply chain and get products into the hands of as many customers as possible.” 6
3.19.3 In the Q&A portion of Making money with Amazon, Amazon states, “you can sell almost anything in Amazon stores.” 7
3.19.4 Amazon advises that, “selling restricted products on Amazon can be one of the pillars of your marketing strategy. This is because the competition in the restricted categories is way lower. Hence, higher potential profit margins.”8
5 https://sell.amazon.com/blog/product-opportunity-explorer
6 https://sell.amazon.com/blog/make-money-on-amazon
7 https://sell.amazon.com/blog/make-money-on-amazon
8 https://www.sellerassistant.app/blog/amazon-restricted-products-complete-guide-for-sellers
3.19.5 In the How to find wholesalers and suppliers for your business Amazon provides a list of instructions on how to locate, and work with manufacturers and wholesalers. 9
3.19.6 Amazon advises its selling partners that, “[w]holesale sourcing is where a business purchases products in bulk at a discount from a wholesale supplier. The seller can then repackage the products and sell them to customers for a profit.”10
3.20 Amazon instructs amateur sellers on how to create a brand sold on and off-Amazon and then how to manage it through Sellers Central.
3.20.1 Amazon pitches the service Brand Registry to its Selling Partners, which Amazon states, “can help you personalize your brand and product pages, protect your trademarks and intellectual property, and improve the brand experience for customers-along with unlocking additional advertising options and recommendations on improving traffic and conversion.”
3.20.2 When Selling Partners link with Brand Registry, Amazon states they “[t]ap directly into Amazon’s largest aggregated data reports, available exclusively to brand owners: Amazon search terms, repeat purchase behavior, market basket analysis, item comparison, alternate purchase behavior, and demographics.”
9 https://sell.amazon.com/blog/how-to-find-wholesalers
10 https://sell.amazon.com/blog/how-to-find-wholesalers
3.20.3 Additionally, Amazon offers Selling Partners that brand their products a service which is called Amazon Attribution that “measure how your off-Amazon advertising impacts your brand’s shopping activity and sales on Amazon.”
Amazon controls the products sold on its site and “Partner Sellers”
3.21 To use Amazon’s services to list products, Sellers must assent to Amazon’s standardized Services Business Solutions Agreement (“the Agreement”). This Agreement governs Amazon’s total control over the sales on its platform and the products it sells.
3.21.1 Through this agreement, Amazon reserves the right to, at any time, cease providing any or all of the services it offers Sellers at its sole discretion and without notice, including suspending, prohibiting, or removing any listing.
3.21.2 Amazon can require Sellers to stop or cancel orders of any product. If Amazon determines that a Seller’s actions or performance may result in risks or hazards, it may in its sole discretion withhold any payments to the Seller.
3.22 Amazon controls what products can be sold on its marketplace. It bans certain products and requires that others obtain approval.
3.22.1 Amazon requires sellers to obtain prior approval on controlled goods, medical devices, automotive products, films and DVD, and prepackaged/processed food containing meat.
3.22.2 Amazon bans the sale of drugs or drug paraphernalia.
3.22.3 Amazon allows the sale of many health and personal care items: including vitamins and diet supplements, cold and flu medicine, and OTC drugs.
3.22.4 Many of these products require approval from Amazon through its Seller Central.
3.22.5 To obtain approval Amazon proclaims that its “approval process may include document requests, performance checks, and other qualifications.” 11
3.22.6 Amazon explains that most of these documents can be obtained by a supplier. 12
3.22.7 By allowing manufacturers often foreign manufacturers with little or no oversight to provide all documentation of quality control there is no need for Selling Partners to directly engage in the quality control of their products.
3.23 Amazon controls how products are displayed on its website, stating “[w]hen multiple sellers offer the same product, Amazon combines data from those various offers on a single detail page. Sellers who offer the product can contribute detail page information or request detail page reviews if the information displayed is incorrect.”13
3.24 Amazon controls the price Partner Sellers can list items on its store for. Through its “Fair Pricing Policy,” Amazon monitors the prices Partner Sellers charge and may take action such as terminating selling privileges of Partner Sellers that are charging a lower rate on other websites, including their own website. 14
11 https://sellercentral.amazon.com/help/hub/reference/external/200333160
12 https://sellercentral.amazon.com/help/hub/reference/GKKYJ3C25DG334PW
13 https://sell.amazon.com/sell
14 https://fingfx.thomsonreuters.com/gfx/legaldocs/xmvjkbqxjpr/2022-04-11%20FrameWilson%20Second%20Amended.pdf ; https://fingfx.thomsonreuters.com/gfx/legaldocs/zjvqjndgnpx/Frame-Wilsonopinion-2023-03-24.pdf
3.25 Amazon offer’s Fulfilled by Amazon (FBA) where Amazon, for a fee, handles the following:
3.25.1 Storing FBA products at its Amazon fulfillment centers.
3.25.2 Stocking and maintaining an inventory of Seller’s products
3.25.3 The use of Amazon employees to interact with the product to categorize, label, and move it through the distribution process.
3.25.4 Amazon delivery drivers to deliver a Seller’s product directly to a customer’s door in an Amazon vehicle.
3.26 To manage customer concerns and complaints Amazon offers Amazon sponsored 24/7 customer service through Amazon’s Seller Messaging Assistant. 15
3.27 Amazon advises Partner Sellers to have manufacturers produce branded products in bulk, then use FBA for distribution.
3.28 Amazon is in charge of accepting payment and issuing refunds on the products sold in its Amazon Store. This is done through a “secure transaction” where your credit card information won’t be turned over to the Partner Seller.
3.29 In the event of a product recall, Amazon will send out a notice to the purchaser of a product, as Amazon is the only entity with knowledge of who bought and sold a product.
3.30 This level of control over products and Partner Sellers disproves Amazon’s specious assertion that it is not a product seller, where Amazon in fact has far greater control than any ordinary retailer.
3.31 This level of control over products and Partner Sellers, prominently displayed by Amazon to customers, also gives the public the impression that products sold on Amazon are safe. Amazon advertises its alleged product safety practices to drive sales not safety
3.32 “Customers trust that they can always buy with confidence on Amazon.”16
3.33 Amazon gives the appearance of product safety, claiming it is “constantly innovating on behalf of our customers and working with regulators, third party experts, vendors, and sellers to improve the ways we detect and prevent illegal and unsafe products from reaching our marketplace. Amazon encourages you to report listings that violate Amazon’s policies or applicable law by contacting us. We will investigate each report thoroughly and take appropriate action.”
16 https://sellercentral.amazon.com/help/hub/reference/external/200164330
3.34 Amazon claims that “our product safety team investigates and acts on reported safety complaints and incidents to protect customers from risks of injury related to products sold on Amazon.com. 17
3.35 Amazon claims it does “monitor the products sold on our website for product safety concerns,” and “In concerning situations it may do the following:
3.35.1 Remove the products from the website.
3.35.2 Contact sellers and manufacturers for more information.
3.35.3 Put warnings on the product detail page.
3.35.4 Take other actions depending on the situation.
3.35.5 Report product safety concerns to relevant government agencies. This will strengthen their safety data and help with any necessary recalls.” 18
3.36 Amazon knows that “compliance is critical to promoting safety for Amazon customers, employees, and partners, and ensuring that the products sold on Amazon meet regulatory requirements. It’s important that products sold on Amazon’s store are safe for customers to use, and that everyone who shops and sells in Amazon’s store must be able to trust that the products are held to the highest standards.”19
Amazon endorses products to drive sales—not safety
3.37 Although Amazon professes to value safety, the products recommended by and endorsed by Amazon has more to do with how much a Selling Partner spends with Amazon, or how likely a customer is to purchase a product, and not how safe a product is.
17 https://www.amazon.com/gp/help/customer/displayhtml?nodeId=GLD7VXFKV4AWU78X
18 https://www.amazon.com/gp/help/customer/displayhtml?nodeId=GLD7VXFKV4AWU78X
19 https://sell.amazon.com/blog/manage-your-compliance
3.38 In order to have a product show highly on search results, third-party Sellers can pay additional money to be a “sponsored products,” “sponsored brands,” “sponsored display.”
3.39 Between the data analytics collected about users and its state-of-the-art ways to market them, Amazon’s own design influences and predicts how people will shop and what they will buy. To increase sales Amazon affirmatively recommends products to buy
3.40 Amazon identifies products beyond just sponsored or recommended. They include:
3.40.1 “Best seller,” designee(s) which are given to the product with the most sales for a key word.
3.40.2 “Amazon’s Choice,” designee(s) which are given to the product based on a combination of factors that include, sales, keyword ranking, availability, pricing, product reviews, and other factors.
3.40.3 “Highly Rated,” designee(s) which are based on customer ratings.
3.41 A study by fraudulent-review-detection service Fakespot found that around 42 percent of the 720 million Amazon reviews assessed in 2020 were fraudulent. 20
3.42 Despite the prevalence of fraudulent reviews, Amazon continues to base these designations and recommend products to customers in part based on fraudulent (fake) customer reviews
Amazon primes the distribution of dangerous products with no accountability
3.43 Amazon creates businesses that otherwise would not exist and opens channels for mass distribution of questionable products – that appear safe.
3.44 Amazon warrants safety of products, portends to regulate and oversee, but fails to.
3.45 For example, in response to consumer concerns regarding the safety of products sold, on August 23, 2019, Amazon post an article entitled, “Product safety and compliance in our store.” 21
3.45.1 Amazon proclaims, “Safety is a top priority at Amazon. Products in our store must comply with relevant laws and regulations and our sophisticated tools prevent non-compliant products from being listed.” The retailer boasts an “industry-leading safety and compliance program.”
3.45.2 Amazon claims, “In 2018 alone, we invested over $400 million to protect our store and our customers and built robust programs to ensure products offered are safe, compliant, and authentic.” Further, “Amazon offers customers hundreds of millions of items, and we have developed, and
20 https://www.blumenthal.senate.gov/newsroom/press/release/blumenthal-cals-on-amazon-to-curb-rampantfraudulent-reviews
21 https://www.aboutamazon.com/news/company-news/product-safety-and-compliance-in-our-store
continuously refine and improve, our tools that prevent suspicious, unsafe, or non-compliant products from being listed in our store.”
3.45.3 Amazon cites, “For example, we require toys to be tested to relevant safety standards set by the Consumer Product Safety Commission. We have a dedicated global team of compliance specialists that review submitted safety documentation, and we have additional qualification requirements that sellers must meet to offer products.”
3.45.4 “Once a product is available in our store, we continuously scan our product listings and updates to find products that might present a concern. Every few minutes, our tools review the hundreds of millions of products, scan the more than five billion attempted daily changes to product detail pages, and analyze the tens of millions of customer reviews that are submitted weekly for signs of a concern and investigate accordingly. Our tools use natural language processing and machine learning, which means new information is fed into our tools daily so they can learn and constantly get better at proactively blocking suspicious products.”
3.45.5 “We also regularly work with agencies including the Food and Drug Administration and Consumer Product Safety Commission, and the information we share helps them identify trends and develop regulations.”
3.46 Amazon tells customers it “monitor[s] the products sold on [its] website for product safety concerns.” 22
22 https://www.amazon.com/gp/help/customer/displayhtml?ref=helpsearch18&nodeId=GLD7VXFKV4AWU78X&qid=1685985303648&sr=1-8
3.47 On its site aimed at third-party sellers, it says “Amazon’s A-to-z Guarantee you’re your customers at ease. They know and trust us, and that trust extends to you.”23
3.48 Amazon advertises these safety assurances to “earn and maintain your trust,” in order to attain and retain a larger and more active customer base.
3.49 From the very beginning with the Bezos flywheel, much of Amazon’s business depends on the creation and success of an ever-growing population of otherwise unknown brands and partner sellers, using Amazon’s credibility and mass distribution channels to drive revenue In other words, Amazon makes businesses that would not otherwise exist to support its business.
3.50 In doing so, Amazon injects into society the mass distribution of products, including medical products required to be sterile, that can injure or kill hundreds or thousands of people.
3.51 Thus, Amazon creates an unreasonable risk of harm to the American public. When Amazon fails to live up to its safety and reliability promises and the reasonable expectations of consumers, it fails to take reasonable steps to prevent foreseeable harm.
23 https://sell.amazon.com/fulfillment-by-amazon/fba-small-and-light
3.52 Even more, Amazon affirmatively selects products to highlight to customers, using labels like “Amazon’s Choice” and “Highly Rated,” based on sales and profits, and not the safety or reliability of the products for consumers.
3.53 Then, when someone is injured or killed by a dangerous product sold on its platform, Amazon claims to not be a product seller at all and directs victims to small business Partner Sellers and often-foreign manufacturers. 24
Global Pharma
3.54 Global Pharma was first incorporated in 1986. The company manufactures dozens of prescription and over-the-counter (“OTC”) medical products, including ointments and creams, oral medications, and eye products. According to its website, Global Pharma has over 30 “countries of operation,” including many countries in Africa, Asia, and South America, as well as the United States.
3.55 Global Pharma operates out of a residential neighborhood in southern India.
3.56 A 2023 inspection of Global Pharma by the FDA would reveal “deficient manufacturing process,” deficient quality control procedures, and deficient recordkeeping, dating back to 2019. For example, between 2019 and 2022, Global Pharma ordered bottles and caps from a vendor, but did not test them for sterility before using in manufacturing. 25
EzriCare
3.57 EzriCare was established in 2020 by Ezriel Green. The company brands and sells OTC products manufactured by Global Pharma.
24 https://www.cpsc.gov/s3fs-public/pdfs/recall/lawsuits/abc/002-In-the-Matter-of-Amazon-com-Inc-Answer-8-31.pdf
25
https://wwwfda.gov/media/166739/download
3.58 Ezriel Green has no medical education or training. He holds a Master’s degree in Talmudic Studies. He describes himself on his LinkedIn page: “Self-starter that drives growth and success. Primarily focused in the pharmaceutical & medical devices industry, I've founded two companies in the last 8 years that have grown to 7-figure operations, constantly looking to improve processes, disrupt industries and create value for my customers.”
3.59 EzriCare sells the products on Amazon’s platform, and distributes them nationwide to consumers using Fulfillment by Amazon or other Amazon distribution channels.
3.60 According to its website, “EzriCare leverages technology & science to develop quality generics that always exceed expectations,” and “We use data to streamline the core behind our products and make generics that are effective, safe and transparent.” 26
3.61 EzriCare boasted institutional quality assurance on its website:
3.62 Yet after the recall of the product in this lawsuit, EzriCare’s recall notice states, “EzriCare, LLC's only role in introducing the product to the market was to design an exterior label
https://web.archive.org/web/20230123012832/https://ezricare.com/
and to market it to our customers. EzriCare, LLC had no role in the formulation, packaging delivery system design or actual manufacturing of this product.”27
3.63 EzriCare’s website and online retail presence has vanished since the recall, and the company apparently is no longer operational.
3.64 EzriCare took all the profit, and disclaims all responsibility. The Death of Prafull Thakkar
3.65 Prafull Thakkar earned his Masters in Electrical Engineering in the early 1970s, and later earned his Masters in Business Administration. He worked for many years as a Project Manager at the Hanford nuclear power plant in Richland, Washington. Prafull and his wife of 52 years, Smita Thakkar, had two children together: Ankit and Anshita.
3.66 On or about April 9, 2022, Plaintiff Anshita Thakkar searched on her Amazon app for “dry eye relief” or “eye drops,” or a similar search. Based on this search, Amazon generated a list of products related to the search. That list included EzriCare Eye Drops.
3.67 Amazon labeled EzriCare Eye Drops as “Amazon’s Choice,” “Best Seller,” or “Highly Rated.” Amazon’s label of EzriCare Eye Drops led Plaintiff to believe the product was manufactured by a reputable, safe, and reliable company.
3.68 Plaintiff purchased EzriCare Artificial Tears Lubricant Eye Drops, NDC 79503 10115, Lot No. PCMI 004, with expiration date August-2024, for use by her father, Prafull. She purchased them through Amazon, and they were delivered to her home in King County, Washington.
3.69 On information and belief, the Eye Drops were stored at and shipped from an Amazon facility/warehouse. EzriCare used Fulfillment by Amazon, where “Amazon fulfillment
specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.”28
3.70 These Eye Drops are the “relevant product” within the meaning of RCW 7.72. et seq. Global Pharma designed, manufactured, and distributed the Eye Drops to the United States, and is a manufacturer within the meaning RCW 7.72. et seq
3.71 Defendant EzriCare sold the Eye Drops under its own brand name as depicted below.
3.72 The full product package is depicted below.
28 https://sell.amazon.com/fulfillment-by-amazon
3.73 Prafull used the Eye Drops product.
3.74 On or about September 8, 2022, Prafull underwent blood cultures that tested positive for pseudomonas aeruginosa with VIM gene.
3.75 Pseudomonas aeruginosa with VIM gene is a bacteria that is highly resistant to all first-line antibiotics. It can be difficult or impossible to treat.
3.76 As a result of the Pseudomonas aeruginosa infection in Prafull’s blood, he was admitted to the ICU at UW Medical Center to be treated for shock.
3.77 Prafull Thakkar died in King County, Washington on September 14, 2022 at age 74, as a result of septic shock from Pseudomonas bacteremia (bloodstream infection). At the time, the origin of the infection was unclear to Prafull’s family and his treaters.
3.78 Then, on or about February 2, 2023, Global Pharma issued a nationwide recall of the Eye Drops due to possible contamination with treatment resistant Pseudomonas aeruginosa bacteria.
3.79 The FDA had recommended the recall due to Global Pharma’s current good manufacturing practice (CGMP) violations, 29 including lack of appropriate microbial testing, formulation issues (lacking adequate preservative), and lack of proper controls concerning tamperevident packaging. 30
3.80 The Centers for Disease Control and Prevention (CDC) had alerted the Food and Drug Administration (FDA) to an investigation of a multi-state cluster of Pseudomonas infections, with 55 reported adverse events including eye infections, permanent vision loss, and a death with a bloodstream infection. 31 Prafull Thakkar was the death with a bloodstream infection.
3.81 The FDA continues to collaborate with the CDC and state and local health departments to investigate what it calls a “multistate outbreak involving a rare, extensively drugresistant strain of Pseudomonas aeruginosa bacteria.” 32
3.82 On March 2, 2023, the FDA issued a citation to Global Pharma after an inspection of the manufacturing practices and facilities, which is incorporated herein by reference. 33
29 https://wwwfda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmpregulations
30 https://wwwfda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricareartificial-tears-due-potential-contamination
31 https://wwwfda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntarynationwide-recall-artificial-tears-lubricant-eye-drops-due
32 https://wwwfda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricareartificial-tears-due-potential-contamination
33 https://wwwfda.gov/media/166739/download
3.83 The FDA’s report details a “deficient manufacturing process,” deficient quality control procedures, and deficient recordkeeping in 2019, 2020, 2021, and 2022.
3.84 Subsequent testing of the Eye Drops bottle Prafull used confirmed contamination with pseudomonas aeruginosa
3.85 As a direct and proximate result of the acts and omissions by Defendants, Prafull Thakkar died, and his Estate and statutory beneficiaries suffered damages.
IV. LIABILITY
4.1 Global Pharma is strictly liable under the Products Liability Act, RCW 7.72 et seq., because the Eye Drops were not reasonably safe in construction and/or not reasonably safe because it did not conform to the manufacturer’s express or implied warranties.
4.2 The Eye Drops were not reasonably safe in construction because, when the product left the control of the manufacturer, the product deviated in some material way from the design specifications or performance standards of the manufacturer, or deviated in some material way from otherwise identical units of the same product line.
4.3 The Eye Drops were unsafe to an extent beyond that which would be contemplated by the ordinary user. Given the seriousness of potential harm from drug-resistant Pseudomonas infection, the feasibility of eliminating or minimizing the risk by complying with basic manufacturing safety practices such as CGMP, and the widespread use of a generally safe product, no ordinary user would expect to be poisoned with a rare infection by eye drops.
4.4 EzriCare is strictly liable as a manufacturer within the meaning RCW 7.72.010(2) because it is a product seller “that holds itself out as a manufacturer.”
4.5 EzriCare has the same strict liability as a manufacturer because the Eye Drops were marketed under EzriCare’s trade name or brand name. RCW 7.72.040(e).
4.6 EzriCare was a “product seller” within the meaning of RCW 7.72.010(1). EzriCare was negligent in many respects, including but not limited to its failure to inspect the manufacturing facilities, manufacturing practices, packaging, or otherwise verify the safety of products it sold, prior to selling or otherwise distributing the Eye Drops for sale to consumers.
4.7 Amazon was a “product seller” within the meaning of RCW 7.72.010(1). Amazon has the liability of the product manufacturers under RCW 7.72.040(2) because (a) No solvent manufacturer who would be liable to the claimant is subject to service of process under the laws of the claimant's domicile or the state of Washington; or (b) it is highly probable that the claimant would be unable to enforce a judgment against any manufacturer.
a. EzriCare was established in 2020, and after the product recall has apparently ceased all operations, including closure of its website other than the recall notice. Numerous lawsuits have already been filed against EzriCare.
b. Global Pharma has no known assets or physical location in the United States, and may contest personal jurisdiction.
4.8 Amazon was negligent in many respects, including but not limited to its failure to verify the reliability of partner sellers and safety of products sold as Amazon advertises it does, prior to selling, continuing to sell, or otherwise distributing the Eye Drops for sale to consumers.
a. Through its own policies, regulations, and public assurances expressly intended to hold consumer trust and reliance, Amazon had the opportunity, duty to investigate, and actual or constructive knowledge that the Eye Drops were not manufactured in a reliably safe manner, and were not distributed by companies with proficiency or accountability in verifying the safety of consumable medical products. Amazon was negligent in selling a high-risk consumable medical product without verifying
the competence of any part of the chain of manufacture and distribution, in any manner consistent with its public assurances.
b. Amazon’s public assurances include its long-term, systematic, worldwide promotion of safety and reliability of its products and partner sellers; Amazon’s restriction and control over the labeling, sale, and transport of certain items; and Amazon’s labeling of products as “Amazon’s Choice,” “Best Seller,” and “Highly Rated,” creating and reinforcing consumer expectation in the safety and broad reliability of a product.
c. Amazon’s negligence includes its failure to live up to the reasonable expectations it creates in customers regarding the safety of products sold on its platform, and Amazon’s creation of an unreasonable risk of harm to consumers by enabling unproven and unreliable businesses to mass distribute consumable medical products without taking reasonable precautions to assure their safety and reliability.
d. Amazon’s negligence in providing mass distribution channels for incompetent and unsafe businesses is particularly dangerous for consumable medical products that must be sterile and apply directly to an unprotected bodily surface, such as eye drops.
4.9 Defendants are liable for negligent misrepresentation because they supplied information regarding the safety of the product that was false, they knew or should have known the information was false, they were negligent in obtaining or communicating false information, the Plaintiff reasonably relied on false information, and the false information proximately caused Plaintiff’s damages.
4.10 Defendants are liable under the Consumer Protection Act, RCW 19.86 et seq., pursuant to RCW 7.72.010(4). Defendants’ manufacture and sale of a dangerous product constitutes unfair and deceptive acts or practices in trade or commerce, affecting the public interest, and proximately causing injury to Plaintiff’s business or property.
4.11 Plaintiff reserves the right to add additional allegations of liability under RCW 7.72 et seq., negligence, and punitive damages under any Defendant’s home state, as may be warranted by discovery.
V. NO CONTRIBUTORY FAULT
5.1 Decedent was not at fault for causing or contributing to cause his injuries or death.
5.2 No individual or entity other than Defendants caused or contributed to cause the above-described Pseudomonas infection
5.3 Decedent is not at fault for failing to mitigate his injuries and damages
5.4 Decedent did not assume the risk of Pseudomonas infection by applying the product.
VI. DAMAGES
6.1 As a direct and proximate result of the aforesaid liability of Defendants, the Estate of Prafull Thakkar suffered economic and non-economic damages, including all damages allowed pursuant to RCW 4.20.010-20, RCW 4.20.046 and RCW 4.20.060, in amounts to be proven at the time of trial. These damages include, but are not limited to, health care and funeral expenses; net accumulations lost to the Estate; and the pain, suffering, anxiety, emotional distress, humiliation, and fear experienced by Prafull Thakkar prior to death.
6.2 As a direct and proximate result of the aforesaid liability of Defendants, Smita Thakkar (spouse), Anshita Thakkar (daughter), and Ankit Thakkar (son) have suffered economic and
non-economic damages, individually and as wrongful death statutory beneficiaries, in amounts to be proven at the time of trial. These damages include, but are not limited to, damages identified under paragraph 6.1; past and future benefits of value; and loss of emotional support, love, affection, care, services, companionship, and assistance.
6.3 Plaintiff and beneficiaries have incurred other damages to be proven at the time of trial.
VII. PRAYER FOR RELIEF
WHEREFORE, Plaintiff prays for judgment against the above-named defendants jointly and severally as follows:
A For special damages in an amount to be proven at the time of trial;
B. For general damages in an amount to be proven at the time of trial;
C. For costs and disbursements herein;
D. For pre- and post-judgment interest as allowed by law;
E. For attorney’s fees; and
F. For such other and further relief as this Court deems just and equitable.
DATED this 17th day of July, 2023.
STRITMATTER KESSLER
KOEHLER MOORE
/s/Andrew Ackley
Andrew Ackley, WSBA #41752
Gemma Zanowski, WSBA #43259
Furhad Sultani, WSBA #58778
Debora Silberman, WSBA #59302 Counsel for Plaintiff