Complaint Unlimited Fee Applies

Cal. Super. - 6th Dist.April 23, 2020

\OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O E-FILED 4/23/2020 11:15 AM BRIAN I. PANISH, California State Bar No. 116060 Clerk 0f Court PamSh@PSblaw-C0m , , Superior Court of CA, KEVIN R. BOYLE, Cahforma State Bar N0. 192718 County Of Santa Clara b0yle@psblaw.com ZOCV3661 96PETER L. KAUFMAN, California State Bar N0. 269297 . _ kaufimncgpsblawwm ReVIewed By. Y. Chavez PANISH SHEA 8: BOYLE LLP 11111 Santa Monica Boulevard, Suite 700 Los Angeles, California 90025 Telephone: (310) 477.1700 Facsimile: (310) 477.1699 GREGORY L. BENTLEY, California State Bar No. 151147 gbentley@bentleym0re.com KEITH P. MORE, California State Bar N0. 140679 kmore@bentleym0re.c0m BENTLEY &- MORE LLP 4931 Birch Street Newport Beach, CA 92660 Phone: (949) 870-3800 Facsimile: (949) 732-6291 Attorneys for Plaintifi‘ Wendy Fabe SUPERIOR COURT FOR THE STATE OF CALIFORNIA COUNTY OF SANTA CLARA WINDY FABE, individually, CASE N0. ZOCV3661 96 Plaintiff, V. COMPLAINT AND DEMAND FOR JURY ALLERGAN, INC. f/k/a INAMED TRIAL CORPORATION f/k/a MCGHAN MEDICAL CORPORATION' a 1. Strict Product Liability-Failure t0 Warn Delaware corporation with its r1nc1 a1 lace 0f busmess 1n alifomia; ALLERGAN HQLDCQ 2. Strict Product Liability-Manufacturing U.S., INC, a Delaware cor oration Defect with its princi a1 lace of usiness in Cahforma; AL E GAN HOLDINGS, 3. Negligence INC., a Delaware corporation with its rincipal place 0f business in , _ , gahfomia; ALLERGAN SALES, LLC 4. Intentlonal Mlsrepresentatlon/ a Delaware limited liabili company Concealment with its princi a1 lace 0f usiness in cahfomlar AL E CAN .USAI INC" a 5. Negligent Misrepresentation/ Delaware corporatlon w1th 1ts rincipal place of business in concealment alifornia; ALLERGAN PLC, a foreign corporation with its rinci a1 lace 0f business in Califorma; an OES 1 through 100, inclusive, Defendants -1- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O TABLE OF CONTENTS INTRODUCTION ......................................................................................................................... 5 PARTIES ......................................................................................................................................... 9 A. Plaintiff.................................................................................................................... 9 B. Defendants ........................................................................................................... 10 VENUE AND JURISDICTION .................................................................................................. 17 A. A11 Of The Named ALLERGAN Defendants Are ”At Home” In California .............................................................................................................. 17 1. ALLERGAN consistently identifies Irvine, California as the location of its primary worldwide business office ............................. 17 ALLERGAN’S Claims that its entities are located in New Jersey are disingenuous .......................................................................... 18 Defendant ALLERGAN PLC is merely the alter-ego of Defendants ALLERGAN, INC. and ALLERGAN SALES, LLC such that it too is at home in Irvine, California .................................. 20 B. Alternatively, This Court Has Specific Jurisdiction Over The Named ALLERGAN Defendants .................................................................................... 21 1. Pursuant to federal law, ALLERGAN identifies Irvine, California as the location 0f the entities ”directly responsible” the production and distribution of all BIOCELL Textured Breast Implants in the United States .................................................... 22 2. ALLERGAN’S additional California contacts regarding the development, production and distribution 0f all BIOCELL Textured Breast Implants across the United States run deep ........... 24 GENERAL ALLEGATIONS ...................................................................................................... 3O A. Federal Law and Requirements ........................................................................ 30 1. N0 express preemption of state-law claims paralleling MDA and federal regulatory requirements ................................................... 31 -2- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 2. No implied preemption of state-law claims premised on Violations of the MDA and federal regulatory requirements ........... 33 Statement of Facts Relating to Preemption Applicable t0 Plaintiff’s Failure t0 Warn and Negligence Claims .......................................................... 34 1. ALLERGAN violated 21 C.F.R. § 803.50 et seq by failing t0 file MDRs following receipt of both foreign and domestic complaints of BIA-ALCL ........................................................................ 36 ALLERGAN violated 21 C.F.R. §§ 803.50 and 803.52 by concealing pertinent adverse event reports by burying them in unscrutinized spreadsheets ............................................................... 38 ALLERGAN failed t0 investigate and evaluate complaints 0f BIA-ALCL per 21 C.F.R. §§ 820.198 and 803.18(e) and prepare corresponding medical device reports ................................................. 43 ALLERGAN failed t0 timely submit reports 0f BIA-ALCL per 21 C.F.R. § 803.50(a) and attempted to transmit such reports years after first receiving notice 0f the event ......................................45 ALLERGAN failed t0 provide all information reasonably known to it per 21 C.F.R. § 803.50(b) in its reports 0f BIA- ALCL but rather simply regurgitated its misleading and deficient labeling .....................................................................................48 ALLERGAN failed t0 use the appropriate device problem code for reports 0f BIA-ALCL instead representing that there was ”no apparent adverse event” ......................................................... 50 Statement 0f Facts Relating to Preemption Applicable to Plaintiff’s Manufacturing Defect and Negligence Claims ............................................... 52 Statement 0f Facts Applicable t0 Plaintiff’s Intentional and Negligent Misrepresentation Claims ............................................................... 57 -3- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 1. ALLERGAN spends years downplaying or dismissing the growing link between BIA-ALCL and the presence of an ALLERGAN BIOCELL Textured Breast Implant ............................... 57 2. As early as 2010, when ALLERGAN would publicly address BIA-ALCL in its adverse event reports, they were riddled with half-truths and misrepresentations ............................................. 64 E. Statement of Facts Relating to Causation Applicable to A11 Counts ........... 69 1. The connection between ALLERGAN’S failure t0 report and Plaintiff’s injuries ..................................................................................... 69 2. The connection between ALLERGAN’S failure t0 implement quality control systems and Plaintiff’s injuries ................................... 7O 3. The connection between ALLERGAN’S misrepresentations and Plaintiff’s injuries ............................................................................. 71 FIRST CAUSE OF ACTION ....................................................................................................... 73 SECOND CAUSE OF ACTION ................................................................................................. 77 THIRD CAUSE OF ACTION ..................................................................................................... 82 FOURTH CAUSE OF ACTION ................................................................................................. 86 FIFTH CAUSE OF ACTION ...................................................................................................... 90 PUNITIVE DAMAGE ALLEGATIONS ................................................................................... 93 PRAYER FOR RELIEF ................................................................................................................ 95 JURY DEMAND .......................................................................................................................... 96 -4- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Plaintiff WINDY FABE (”Plaintiff”) brings this action against Defendants ALLERGAN, INC., ALLERGAN HOLDCO U.S., INC, ALLERGAN HOLDINGS, INC, ALLERGAN SALES, LLC, ALLERGAN USA, INC, ALLERGAN PLC (all corporations headquartered in California With their principal place 0f business and key executives located in California; collectively referred t0 as ”Defendants” 0r ”ALLERGAN”), and DOES 1-100 seeking damages arising out 0f ALLERGAN’S negligence, deceit, concealment, and misrepresentations concerning the deadly and defective condition of its BIOCELL Textured Breast Implants. INTRODUCTION 1. ALLERGAN is a global company that has long pushed a portfolio 0f consumer products in the medical aesthetics, eye care, central nervous system, and gastroenterology fields. Among its portfolio of products is a specific type of breast implant and tissue expander for cosmetic and reconstructive surgery, referred t0 broadly herein as the BIOCELL Textured Breast Implant suite 0f products. ALLERGAN developed, sought regulatory approval for, marketed, advertised, manufactured, distributed, and sold those BIOCELL Textured Breast Implants through its primary office in the United States, located in Irvine, California. 2. Across multiple generations of the product, ALLERGAN has sold hundreds of thousands of textured breast implants and developed and marketed dozens of additional styles incorporating their BIOCELL technology. Those products have been sold worldwide, and have been implanted into tens, if not hundreds, 0f thousands 0f California and United States consumers. This was highly profitable for ALLERGAN, which received tens, if not hundreds, of millions 0f dollars’ worth 0f revenue through its sale and distribution of the BIOCELL Textured Breast Implants to consumers across the world. 3. ALLERGAN has longed claimed that these products are safe for consumer use, and based 0n those promises they have been widely used by women for both -5- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O reconstructive surgery-particularly after a breast cancer diagnosis, genetic testing, or other concern-as well as for cosmetic uses. 4. But those products pose a significant risk-a risk that was long hidden and buried by ALLERGAN in advertisements, flyers, reports, and other communications t0 both the marketplace and the FDA. ALLERGAN’S BIOCELL Textured Breast Implants have a surface roughness significantly higher than the industry standard and are capable 0f embedding silicone surface particles in the fibrous scar tissue that naturally forms around the implant, known as the ”capsule.” 5. In part because of that flaw, the medical and scientific consensus has determined that the extreme texturing 0f the implants, when combined with a bacterial accumulation or a genetic predisposition, form a perfect storm for the development 0f Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).1 BIA-ALCL is an uncommon but emerging subtype 0f non-Hodgkin's lymphoma-a cancer that originates from lymphatic cells, which are part 0f the immune system. BIA-ALCL is thus a cancer 0f the immune system, and not a type of breast cancer. 6. Because 0f the processes used in their manufacture, ALLERGAN’S BIOCELL Textured Breast Implants increase the likelihood 0f a woman developing BIA- ALCL dramatically from other textured breast implants on the market, with one study finding that the nexus jumps approximately 10 times from other products on the US marketplace. 7. Despite the grave risks posed by its BIOCELL Textured Breast Implants, and the ready possibility of a safer product, ALLERGAN has for decades orchestrated a disinformation campaign aimed at discrediting and concealing the Clearly established link between the occurrence 0f BIA-ALCL and the presence of an ALLERGAN BIOCELL Textured Breast Implant. This was done in the interest 0f placing ALLERGAN’S 1Allergan’s Vice President 0f Clinical Development, Stephanie Manson Brown, acknowledged -whi1e still downplaying-that “[h]igher implant surface area may be a risk factor” because ”[s]urface area contributes t0 bacterial accumulation” in her presentation at the FDA Medical Devices Advisory Committee General and Plastic Surgery Devices Panel on March 25, 2019. -6- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O pecuniary interest and profits over public safety, so that ALLERGAN could continue to sell and distribute a dangerous product into the marketplace at great financial gain to the company. 8. For example, Plaintiff is informed and believes and thereon alleges that between 2007 and 2010-f0110wing premarket approval for its first generation 0f silicone-filled breast implants-ALLERGAN received worldwide 22 complaints of BIA- ALCL in women implanted With the silicone brand of the BIOCELL Textured Breast Implants. Despite the public health crisis implicated by such statistics, ALLERGAN unlawfully failed to report these events 0f BIA-ALCL t0 the FDA at all. 9. Thereafter, as events of BIA-ALCL continued to surface, ALLERGAN doubled-down on its unlawful concealment efforts by abusing its unique adverse health event summary reporting privilege for its breast implants, known as Alternative Summary Reporting. This privilege was available only for specific adverse event types associated with breast implants where compliance with some 0f the reporting requirements was not necessary t0 protect the public health because such events were known and well-documented. Despite its ineligibility for summary reporting, from at least 2009 until 2019 When the Alternative Summary Reporting was discontinued due t0 misuse, ALLERGAN buried complaints 0f BIA-ALCL, and symptoms associated therewith, transmitted to the company from health care professionals, user facilities, and patients in the unscrutinized summary reporting spreadsheets which only recently became publicly available. 10. Because ALLERGAN failed to perform its duties under federal law to warn the FDA about BIA-ALCL, and because ALLERGAN failed t0 comply with its reporting duties under federal law With respect t0 BIA-ALCL, Plaintiff's claims set forth below are not subject to preemption. 11. Plaintiff is informed and believes and thereon alleges that at all times ALLERGAN allowed their BIOCELL Textured Breast Implants t0 remain in the market knowing they suffered from a serious safety defect/risk and failed t0 disclose, concealed, -7- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O and misrepresented the important safety risks associated with textured breast implants in representations made to Plaintiff and the FDA, specifically the clear links between ALLERGAN’S BIOCELL Textured Breast Implants and BIA-ALCL. ALLERGAN misrepresented the scope 0f the risk, failed t0 publicly report the cases of BIA-ALCL that had been caused by its products as it was obligated t0 d0 under federal law and regulations, and failed t0 remedy the danger t0 consumers around the world and across the country. 12. Had Plaintiff known the truth about ALLERGAN’S BIOCELL Textured Breast Implants, she would not have had them implanted into her body. Instead, she would have, among other things, forwent implantation, 0r Chosen smooth 0r microtextured implants, thereby avoiding the heightened risk 0f developing BIA-ALCL. 13. Finally, after decades of misrepresenting and hiding the scope of the problem-and the danger posed t0 women with these implanted products-the cancerous propensities 0f ALLERGAN’S product finally started coming t0 light. On December 18, 2018, ALLERGAN was banned from selling its BIOCELL textured implants in the European Union based on health and safety concerns. Five months later, Health Canada suspended ALLERGAN’S license t0 sell BIOCELL Textured Breast Implants in Canada following a safety review that brought t0 light the increased risk 0f BIA-ALCL amongst those implanted with BIOCELL Textured Breast Implants sold by the Defendants. Yet ALLERGAN continued to sell its textured implants in the United States. 14. On July 24, 2019, the FDA announced the world-Wide recall 0f ALLERGAN’S BIOCELL Textured Breast Implants in order t0 ”protect individuals from the increased risk 0f BIA-ALCL, associated with BIOCELL textured breast implants.” 2 The FDA’s analysis was attributed t0 a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases 0f BIA-ALCL, 481 are reported t0 have Allergan breast implants at the time 0f diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time 0f their BIA-ALCL diagnosis. -8- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 15. Following that recall, and with knowledge of the danger finally being provided t0 the public, numerous consumers across the country are left with fear, concern, and worry that their ALLERGAN BIOCELL Textured Breast Implants have now exposed them t0 the dangers 0f BIA-ALCL. As is only reasonable, people, like Plaintiff WINDY FABE, want these dangerous products out of their bodies-yet ALLERGAN has refused t0 assist in providing for the surgical, medical, hospital, facility, and many other expenses that will be incurred by thousands upon thousands of women across the country, not to mention the stress, fear, anxiety, and worry caused by the company’s dangerous products. This action is brought to remedy the dangerous, deceptive conduct 0f ALLERGAN resulting in the implantation of these dangerous, defective products in Plaintiff WINDY FABE. PARTIES A. Plaintiff 16. Plaintiff WINDY FABE, is a resident 0f the state 0f California, County of Santa Clara, and City 0f San Jose. In February 2015, WINDY FABE was tested and learned she was a carrier 0f the deadly BRCA2 gene, putting her at grave risk of developing breast cancer. Accordingly, WINDY FABE underwent a preventative bilateral mastectomy in May 2015 and was implanted with Tissue Expanders. In July 2015, the tissue expanders were removed and WINDY FABE was implanted with ALLERGAN silicone-filled BIOCELL Textured Breast Implants. 17. Thereafter, WINDY FABE did not receive any update or warning from ALLERGAN any time before or after her surgery in July 2015 about the clearly established link between ALLERGAN’S BIOCELL Textured Breast Implants and BIA- ALCL. 18. Following the worldwide recall and revelations about the dangers 0f ALLERGAN’S products, WINDY FABE underwent an explantation surgery on February 3, 2020 for the removal 0f the BIOCELL Textured Breast Implants. -9- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 19. Plaintiff had to pay out-of-pocket for the removal of the dangerous textured breast implants because ALLERGAN has refused to do 50.3 20. Plaintiff has worried about the risks she faces, has also been subject to out- of-pocket expenses in relation t0 seeking medical advice, evaluating the flawed product implanted into her body, and seeking recommendations for future care and treatment. Plaintiff also continues t0 suffer from mental stress, anxiety, worry, humiliation, fear, concern and other personal and financial hardship due to the continuous fear of BIA- ALCL. 21. Plaintiff has had to take time away from work in order to seek medical treatment, advice, and consultation, and due t0 the stress and anxiety related t0 her flawed ALLEGAN implants. 22. Plaintiff would not have had BIOCELL Textured Breast Implants implanted in her had the Defendants honestly, fully, and completely disclosed the risks. B. Defendants 23. ALLERGAN does not adhere to the formalities of corporate structure, but rather employs an extremely fluid corporate hierarchy through a series of largely employee-less holding companies whereby the various entities within the corporate structure serve as alter-egos of each other. 24. Defendant ALLERGAN PLC (formerly known as Actavis plc) is the principal entity for the ALLERGAN business and was incorporated in Ireland 0n May 16, 2013. 25. Defendant ALLERGAN PLC ordinary shares are traded 0n the NYSE under the ticker symbol ”AGN.” 3 On July 30, 2019, following the worldwide recall, Carrie Strom, Senior Vice President, U.S. Medical Aesthetics, Allergan plc, announced t0 customer that “Allergan will not provide surgical fee assistance t0 revision patients.” -10- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 26. Defendant ALLERGAN PLC represents itself to the public as a global specialty pharmaceutical company engaged in the development, manufacturing, marketing, and distribution of brand name pharmaceutical products, medical aesthetics, biosimilar, and over-the-Counter pharmaceutical products. Conversely, When convenient, Defendant ALLERGAN PLC represents that it is simply a holding company that exists for the purpose 0f holding shares 0f other companies that manufacture and distribute such products rather than producing or selling its own goods or services. 27. Although Defendant ALLERGAN PLC claims its only principal office is located at Clonshaugh Business and Technology Park Coolock, Dublin, D17 E400, Ireland, it maintains headquarters located at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054 and 2525 Dupont Drive, Irvine, California 92612. 28. As a result of its acquisition of Defendant ALLERGAN, INC. on March 17, 2015, Defendant ALLERGAN PLC expanded its franchises to include medical aesthetics/ dermatology/plastic surgery, which included the BIOCELL Textured Breast Implants. 29. Defendant ALLERGAN, INC. represents itself to the public as a multi- specialty health care company focused 0n developing and commercializing innovative pharmaceuticals, biologics, medical devices and over-the-Counter products ”that enable people to live life to its full potential - to see more Clearly, move more freely and express themselves more fully.” Conversely, when convenient, Defendant ALLERGAN, INC. represents that it is a holding company with n0 employees. 30. Defendant ALLERGAN, INC. was established pursuant t0 the laws 0f Delaware with its principal executive office located at 2525 Dupont Drive, Irvine, California 92612. Defendant ALLERGAN, INC. is headquartered in California, With both its principal place 0f business as well as its executive team located primarily, if not entirely, in California. 31. Defendant ALLERGAN PLC utilized Defendant ALLERGAN, INC. in California as its primary agent, appointed subsidiary, and designated entity for the -11- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O marketing, development, sales, research, distribution, approval, processing, and regulatory approval of products in the medical aesthetics, dermatology, and plastic surgery fields, including the BIOCELL Textured Breast Implants. Defendant ALLERGAN PLC was thus operating through Defendant ALLERGAN, INC. With respect t0 the BIOCELL Textured Breast Implants, and was doing so through Defendant ALLERGAN, INC.’s primary corporate offices in Irvine, California. 32. In fact, while Defendant ALLERGAN, INC. is a wholly owned subsidiary 0f Defendant ALLERGAN PLC, a Management Service Agreement between Defendant ALLERGAN PLC, 0n the one hand, and Defendants ALLERGAN, INC. and ALLERGAN SALES, LLC, 0n the other, puts these California entities in Charge 0f Defendant ALLERGAN PLC’s executive management; its strategic direction in terms 0f business operations, financial goals and long-term growth; and its general and administrative services. Thus, Defendant ALLERGAN PLC is the shareholder of the very entities that manage it from California. 33. On March 23, 2006, Defendant ALLERGAN, INC. completed the acquisition 0f INAMED CORPORATION, then a global healthcare company that developed, manufactured, and marketed breast implants, a range of facial aesthetics, and obesity intervention products. 34. INAMED CORPORATION was the corporate successor t0 MCGHAN MEDICAL CORPORATION-the original manufacturer of breast implants for plastic and reconstructive surgery-Which was incorporated in 1974. 35. INAMED CORPORATION and MCGHAN MEDICAL CORPORATION were the entities that sought and received PMAS for a majority 0f the recalled BIOCELL Textured Breast Implants, principally from their California headquarters located in Santa Barbara, California. 36. Defendant ALLERGAN SALES, LLC, a Delaware limited liability company formed on February 25, 2002, was engaged in the business 0f designing, manufacturing, developing, preparing, processing, inspecting, testing, packaging, promoting, -12- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O marketing, distributing, labelling, or selling for profit, either directly or indirectly, through an agent, affiliate, predecessor 0r subsidiary, BIOCELL Textured Breast Implants, and did so in part by extensively targeting, marketing to, packaging, distributing, manufacturing, advertising in, and selling to consumers in California. 37. Along With Defendant ALLERGAN, INC, Defendant ALLERGAN SALES, LLC manages Defendant ALLERGAN PLC’s business operations. 38. Defendant ALLERGAN SALES, LLC maintains its principle executive office at 2525 Dupont Drive, Irvine, California. Defendant ALLERGAN SALES, LLC's members are Defendant ALLERGAN HOLDCO U.S., INC. and Defendant ALLERGAN HOLDINGS, INC, both 0f which are domiciled in California. 39. Defendant ALLERGAN HOLDCO U.S., INC, is engaged in developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for consumers around the world, including ALLERGAN’S BIOCELL Textured Breast Implants. Defendant ALLERGAN HOLDCO U.S., INC. is principally engaged in being an intermediate holding company between Defendant ALLERGAN, INC. and Defendant ALLERGAN SALES, LLC. As recently as August 20, 2019, Defendant ALLERGAN HOLDCO U.S., INC. represented in its periodic 31-550 form to the California Secretary of State that its principle executive office is in Irvine, California. 40. Defendant ALLERGAN HOLDINGS, INC, is engaged in developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for consumers around the world, including ALLERGAN’S BIOCELL Textured Breast Implants. Defendant ALLERGAN HOLDINGS, INC. is principally engaged in being an intermediate holding company of between Defendant ALLERGAN, INC. and Defendant ALLERGAN SALES, LLC. Defendant ALLERGAN HOLDINGS, INC. maintains its principle executive office in Irvine, California. 41. Additionally, Defendant ALLERGAN HOLDINGS, INC. is the direct parent company 0f Allergan Pharmaceuticals Holdings Unlimited Company, which is the direct parent company 0f Allergan Costa Rica, S.R.L. -the entity responsible for -13- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O actually manufacturing ALLERGAN’S BIOCELL Textured Breast Implants at ALLERGAN’S plant in Heredia, Costa Rica. 42. Defendant ALLERGAN USA, INC. was and is a wholly owned subsidiary 0f Defendant ALLERGAN SALES, LLC and is a corporation established pursuant t0 the laws 0f Delaware. Defendant ALLERGAN USA, INC. maintains its principle offices at 5 Giralda Farms, Madison, New Jersey and at 2525 Dupont Drive, Irvine, California. 43. At all relevant times, Defendant ALLERGAN USA INC. was engaged in the business of designing, manufacturing, developing, preparing, processing, inspecting, testing, packaging, promoting, marketing, distributing, labelling, or selling for profit, either directly 0r indirectly, through an agent, affiliate, predecessor or subsidiary, BIOCELL Textured Breast Implants, and did so in part by extensively targeting, marketing t0, packaging, distributing, manufacturing, advertising in, and selling to consumers in California. 44. At all material times, ALLERGAN or its parents and subsidiaries were engaged in the business 0f designing, manufacturing, developing, preparing, processing, inspecting, testing, packaging, promoting, marketing, distributing, labelling, 0r selling for profit, either directly 0r indirectly, through an agent, affiliate, predecessor, 0r subsidiary, recalled BIOCELL Textured Breast Implants t0 patients for breast augmentation and reconstruction, in the United States including California, including the following recalled products: Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under PMA N0. P990074. The following are the textured styles: o Style 163 - BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants o Style 168 - BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred t0 as 168MP (168 Moderate Profile) o Style 363 - BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, 0r 363 Low Height Full Projection -14- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Style 468 - BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone- Filled Breast Implants) approved under PMA N0. P020056. The following are the textured styles: Style 110 - BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants Style 115 - BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants Style 120 - BIOCELL Textured Round High Projection Gel Filled Breast Implants Style TRL - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants Style TRLP - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants Style TRM - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants Style TRF - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants Style TRX - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants Style TCL - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants Style TCLP - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants Style TCM - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants Style TCF - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants Style TCX - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants Style TSL - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants Style TSLP - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants Style TSM - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants -15- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O o Style TSF - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants o Style TSX - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under PMA No. P040046. The following are the textured styles: o Style 410FM o Style 410FF . Style 410MM o Style 410MF o Style 410FL o Style 410ML . Style 410LL . Style 410LM o Style 410LF . Style 410FX . Style 410MX o Style 410LX Allergan Tissue Expanders for the breast that have BioCell texturing originally cleared for commercial distribution under Section 510(k): o Natrelle 133 Plus Tissue Expander (K143354) o Natrelle 133 Tissue Expander with Suture Tabs (K102806) (Collectively, "BIOCELL Textured Breast Implants") 45. Plaintiff is unaware of the true names and capacities of the remaining defendants sued in this action by the fictitious names DOES 1 through 100. Plaintiff will amend this complaint when those names and/or capacities become known t0 Plaintiff. Plaintiff is informed and believe that each of the fictitiously named defendants is in some manner responsible for the events and allegations set forth in this complaint. 46. At all relevant times, defendants, and each 0f them, were the agents and employees 0f each 0f the remaining defendants, and were at all times acting within the purpose and scope 0f said agency and employment, and each defendant has ratified and approved the acts of its agents. -16- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O VENUE AND IURISDICTION A. A11 Of The Named ALLERGAN Defendants Are "At Home” In California 47. Venue is proper in this county in accordance with Section 395 0f the California Code 0f Civil Procedure because Defendants reside in this county. 48. ALLERGAN has past, present, ongoing, and continuing contacts with the State of California and the County of Orange by designing, formulating, testing, packaging, labeling, producing, creating, constructing, making, assembling, advertising, clinical testing, marketing, promoting, distributing, manufacturing, importing, and selling consumer products, including the BIOCELL Textured Breast Implants, in this state and county with the reasonable expectation and knowledge that they will be thereafter be distributed across the state, across the country, and throughout the world. 49. Accordingly, ALLERGAN has past, present, ongoing, and continuing contacts With California by transacting substantial and regular business in this state and manufacturing, distributing, and/or selling goods with the reasonable expectation and knowledge that they Will be used in this state, across the country, and throughout the world. Such contacts are so continuous and systematic as t0 render ALLERGAN at home in California. 1. ALLERGAN consistently identifies Irvine, California as the location 0f its primary worldwide business office 50. California law requires all corporations, limited liability companies and common interest development associations t0 update the records 0f the California Secretary of State either every year 0r every two years based 0n year 0f registration by filing a Form 81-550, which amongst other items, requires entities to identify the location 0f its principal executive office, i.e. its primary worldwide business office, 0r the ”nerve center” 0f the corporation. ALLERGAN’S filings indicate the following: -17- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 51. Defendant ALLERGAN, INC.’s November 22, 2019 filing identifies its principal executive office as being located at 2525 Dupont Drive, Irvine, CA 92612; Defendant ALLERGAN HOLDCO US, INC.’s August 20, 2019 filing identifies its principal executive office as being located at 18581 Teller Avenue, Irvine, CA 92612; Defendant ALLERGAN HOLDINGS, INC.’s January 7, 2020 filing identifies its principal executive office as being located at 2525 Dupont Drive, Irvine, CA 92612; Until November 14, 2017, Defendant ALLERGAN USA, INC.’s principal executive office was located at 2525 Dupont Drive, Irvine, CA 92612 and had been such since 2007; and Until June 20, 2018, Defendant ALLERGAN SALES, LLC’s principal executive office was located at 2525 Dupont Drive, Irvine, CA 92612 and had been such since 2002. ALLERGAN’S claims that its entities are located in New Jersey are disingenuous On September 26, 2018, in the matter captioned Pamela Shelp et al. vs. Allergan, Inc. et al, 2:18-CV-1427 (WD. Wash.) the Assistant Secretary of Defendant ALLERGAN SALES, LLC, Judith W. Tomkins, submitted a declaration under the penalty of perjury in support 0f a notice 0f removal whereby she declared: a. ”Allergan USA, Inc. is a Delaware corporation with its principal place 0f business located in New Jersey; Allergan, Inc. is a Delaware corporation that is a holding company with n0 employees. T0 the extent Allergan, Inc. could be said to have a principal place of business, it would not be in Washington. Allergan Sales, LLC is a limited liability company formed in the state 0f Delaware. Allergan Sales, LLC'S members are Allergan Holdco U.S., Inc. -18- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O and Allergan Holdings, Inc, both of which were incorporated in Delaware and are domiciled in California. d. Allergan plc is a public limited company formed and organized outside of the United States with its principal place 0f business located in Dublin, Ireland and with its U.S. administrative offices in New Jersey.” 52. Ten months later, 0n July 30, 2019, in the matter captioned In re: National Prescription Opiate Litigation, N0. 1:2017-md-02804 (N.D.O.H) Defendants ALLERGAN PLC, ALLERGAN SALES, LLC, and ALLERGAN USA, INC. submit the expert report of Professor Jonathan R. Macey-the Sam Harris Professor of Corporate Law, Corporate Finance, and Securities Law at Yale Law School, and Professor in the Yale School 0f Management. Professor Macey reports having more than 3O years of experience in the area 0f corporate governance. Professor Macey further states that in the process 0f preparing his report he examined the relationships among the ALLERGAN entities from a corporate governance perspective. Importantly, he concludes: a. ”Allergan Sales, LLC. Defendant Allergan Sales, LLC was formed in Delaware and is headquartered in Irvine, California. b. Allergan USA, Inc. Defendant Allergan USA, Inc. is incorporated in Delaware and headquartered in Irvine, California.” 53. Three months later, on November 1, 2019, in the matter captioned In re: Allergan Biocell Textured Breast Implant Litigation, MDL N0. 2921, Defendants ALLERGAN, INC. and ALLERGAN USA, INC. file a response to a motion t0 transfer and centralization of the related proposed class actions. As part of their response, Defendants ALLERGAN, INC. and ALLERGAN USA, INC. make the dubious Claim: ”The District 0f New Jersey is where Allergan is located. Allergan USA, Inc. is headquartered and has its principal place 0f business in New Jersey.” 54. ALLERGAN has a pattern and practice of making conflicting representations 0f Where its entities are located for the purposes 0f evading litigation and escaping the jurisdiction 0f courts across the country. The equitable and just result -19- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O demands that the ALLERGAN entities be held to be at home in all of these locations, including Orange County, California. 3. 55. Defendant ALLERGAN PLC is merely the alter-ego of Defendants ALLERGAN, INC. and ALLERGAN SALES, LLC such that it too is at home in Irvine, California On September 7, 2017, in the matter captioned State 0f Ohio vs. Purdue Pharma L.P., et aL, No. CV-17 CI 000261 -one of the seminal prescription opioid cases where Defendant ALLERGAN PLC was accused of, amongst other things, deliberately maintaining deficient suspicious order monitoring system protocols that enabled the distribution of billions of opioid pills nationally-the Senior Vice President and Chief Accounting Officer at Defendant ALLERGAN PLC, James C. D’Arecca, submitted a declaration under the penalty of perjury in support of a motion to dismiss for lack of personal jurisdiction whereby he declared: a. ”Allergan plc f/k/a Actavis plc ("Allergan plc") is a corporation incorporated under the laws 0f the Republic 0f Ireland. Allergan plc's headquarters, and its only offices, are located in Ireland [. . .] Allergan plc is a holding company that exists for the purpose 0f holding shares of other companies that manufacture and distribute prescription drugs rather than producing its own goods or services [. . .] Allergan plc also does not manufacture any goods or sell any products (including Kadian® 0r other opioids) 0r services either in the United States 0r anywhere else in the world [. . .] Allergan plc is not registered t0 do business anywhere in the United States. Allergan plc does not now conduct and has never conducted any business operations in the United States. Allergan plc does not lease 0r own any offices 0r facilities in the United States, and it has no employees in the United States (other than certain corporate officers and members 0f its Board 0f Directors who reside in the United States). The administrative -20- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O offices in the United States referenced on Allergan.com are not owned or leased by Allergan plc [. . .] d. Allergan plc does not currently and has never manufactured, distributed, marketed, promoted, 0r sold any pharmaceutical products (including Kadian®) in the United States.” 56. However, it was later revealed in that action that Defendant ALLERGAN PLC’s top executives live in the United States and a vast majority of its profits are generated in the United States. In fact, Defendant ALLERGAN PLC does not maintain its own tax group separate from Defendant ALLERGAN SALES, LLC, and Defendant ALLERGAN SALES, LLC employs and pays Defendant ALLERGAN PLC’s executive officers. 57. Moreover, while Defendants ALLERGAN, INC. and ALLERGAN SALES, LLC are wholly owned subsidiaries of Defendant ALLERGAN PLC, a Management Service Agreement between Defendant ALLERGAN PLC, on the one hand, and Defendants ALLERGAN, INC. and ALLERGAN SALES, LLC, on the other, puts these California entities in Charge 0f Defendant ALLERGAN PLC’s executive management; its strategic direction in terms of business operations, financial goals and long-term growth; and its general and administrative services. Thus, Defendant ALLERGAN PLC is the shareholder of the very entities that manage it from California. 58. It is clear the ALLERGAN entities attempt to abuse the corporate form to obfuscate ALLERGAN’S corporate hierarchy for the purposes 0f insolating Defendant ALLERGAN PLC from jurisdictional reach 0f courts in the United States and thereby avoiding liability. Thus, again, the equitable and just result demands that Defendant ALLERGAN PLC be held to be at home in the location 0f the entities that control it- which is Irvine, California. B. Alternatively, This Court Has Specific Jurisdiction Over The Named ALLERGAN Defendants -21- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 59. This Court has specific personal jurisdiction over the parties to this civil action because BIOCELL Textured Breast Implants that were implanted in Plaintiff were researched, designed, tested, labeled, marketed, promoted, distributed, and sold from this forum, regulatory compliance and postmarket surveillance was orchestrated from this forum, and ALLERGAN has purposefully availed itself 0f the privileges and benefits of doing business in California. 1. Pursuant to federal law, ALLERGAN identifies Irvine, California as the location of the entities "directly responsible” the production and distribution of all BIOCELL Textured Breast Implants in the United States 60. Owners 0r operators 0f places 0f business (also called establishments or facilities) that are involved in the production and distribution 0f medical devices intended for use in the United States are required t0 register annually with the FDA. This process is known as establishment registration. Pursuant to 21 C.F.R. 807.20(a), the registration and listing requirements pertain t0 any entity engaged in the manufacture, preparation, propagation, compounding, assembly, or processing 0f a device intended for human use, including any person Who: a. initiates 0r develops specifications for a device that is t0 be manufactured by a second party; b. sterilizes or otherwise makes a device for or on behalf of a specifications developer 0r any other person; C. repackages 0r relabels a device; d. reprocesses a single use device that has previously been used 0n a patient; e. acts as an initial importer. 61. The FDA’s Establishment Registration & Device Listing for the BIOCELL Textured Breast Implants identifies the establishment specification developer for these implants as Defendant ALLERGAN SALES, LLC with a corresponding address 0f 2525 -22- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Dupont Drive, Irvine, California 92612 with a date of registration 0f 2020. 4 The listing further identifies ALLERGAN SALES, LLC as the initial distributor/importer of these implants. 62. Moreover, the identified owner/operator is Defendant ALLERGAN, INC. with a corresponding address 0f 2525 Dupont Drive, Irvine, California 92612.5 63. The listed official correspondent identifies ALLERGAN’S Director 0f Regulatory Information Management, David J. Fisher, with a corresponding address of 2525 Dupont Drive, Irvine, California 92612 and telephone number 714-246-38626 64. The FDA’s Establishment Registration & Device Listing for the BIOCELL Textured Breast Implants identifies the establishment manufacturer for these implants ambiguously as Allergan-presumably referring t0 Allergan Costa Rica, S.R.L., the subsidiary of the California entity Defendant ALLERGAN HOLDINGS, INC. -with a corresponding address 0f 900 Parkway Global Park, La Aurora De Heredia, Heredia, Costa Rica with a date of registration 0f 2020. 65. The manufacture listing further identifies the owner/operator as Defendant ALLERGAN, INC. with a corresponding address 0f 2525 Dupont Drive, Irvine, California 92612. 66. The listed official correspondent identifies ALLERGAN’S Director 0f Regulatory Information Management, David J. Fisher, with a corresponding address of 2525 Dupont Drive, Irvine, California 92612 and telephone number 714-246-3862. 4 Pursuant t0 21 C.F.R. 807.3(C), “[e]stab1ishment means a place 0f business under one management at one general physical location at which a device is manufactured, assembled, 0r otherwise processed.” 5 Pursuant t0 21 C.F.R. 807.3(f), ”[0]wner 0r operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.” 6 Pursuant t0 21 C.F.R. 807.3(e), ”[0]fficial correspondent means the person designated by the owner 0r operator of an establishment as responsible for the following: (1) The annual registration of the establishment; (2) Contact with the Food and Drug Administration for device listing; (3) Maintenance and submission 0f a current list 0f officers and directors t0 the Food and Drug Administration upon the request 0f the Commissioner; and (4) The receipt 0f pertinent correspondence from the Food and Drug Administration directed t0 and involving the owner 0r operator and/or any 0f the firm's establishments.” -23- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOUIr-POJNHOOOOVQU‘Ip-war-AO 67. The designated US Agent is ALLERGAN’S Executive Director for Regulatory Affairs for Devices and Combination Products, James Wabby, with a corresponding address of 2525 Dupont Drive, Irvine, California 92612 and telephone number 714-246-2259? 68. Further, the applicant addresses for each 0f the PMAs and the PMA supplements for the BIOCELL Textured Breast Implants lists ALLERGAN’S business office in Irvine, California.8 69. The FDA identifies the ”Recalling Firm/Manufacturer” for the BIOCELL Textured Breast Implants Class 1 Device Recall as Defendant ALLERGAN PLC with a corresponding address 0f 2525 Dupont Dr., Irvine, CA 92612.9 70. Thus, there is n0 disputing that the named ALLERGAN entities engaged in and were responsible for the importation, manufacture, preparation, propagation, compounding, assembly, 0r processing 0f the BIOCELL Textured Breast Implants are all basing their operation in Irvine, California. 2. ALLERGAN’S additional California contacts regarding the development, production and distribution of all BIOCELL Textured Breast Implants across the United States run deep 71. In addition to representing to the U.S. Government that all things related t0 the national production and distribution of the BIOCELL Textured Breast Implants are orchestrated from Irvine, California, ALLERGAN has additional California contacts related t0 the BIOCELL Textured Breast Implants such that it has purposefully availed 7 Pursuant to 21 C.F.R. 807.3(5), ”United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent.” 8 https://www.accessdata.fda.gov/scripts/Cdrh/Cfdocs/Cfpma/pma.cfm?ID=P990074; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020056; https://www.accessdata.fda.gov/scripts/Cdrh/Cfdocs/Cfpma/pma.Cfm?id=P040046; https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfpmn/pmn.cfm?ID=K143354; https://www.accessdata.fda.gov/scrlpts/Cdrh/cfdocs/Cfpmn/pmn.Cfm?id=K1 02806. 9 https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/chES/res.cfm?id=175502. -24- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O itself of the privileges and benefits of doing business in California. Those minimum contacts and purposeful availment consist, at least in part, of the following: a. ALLERGAN’S predecessor corporations, INAMED CORPORATION and MCGHAN MEDICAL CORPORATION conducted product development, executive functioning, and legal compliance for all 0f the recalled BIOCELL Textured Breast Implants in its California headquarters in Santa Barbara County. ALLERGAN, INAMED CORPORATION and MCGHAN MEDICAL CORPORATION organized Clinical studies concerning the BIOCELL Textured Breast Implants across the state, including in Santa Barbara, Goleta, Carpinteria, Irvine, and Campbell, California. On information and belief, ALLERGAN’S predecessor corporation, MCGHAN MEDICAL CORPORATION, purchased, license, or otherwise acquired the rights to use the BIOCELL texturization process from two residents of Santa Barbara, California. Until 2014, just prior t0 its acquisition by Activis plc, ALLERGAN maintained a facility in Santa Barbara, California that served as the center 0f its breast implant research and development. Thereafter, the breast implant research team was located t0 ALLERGAN’S facilities in Irvine, CA. Plaintiff’s Device Identification Card dated February 10, 2017 for her BIOCELL Textured Breast Implants ”given t0 patients if necessary t0 protect the public health” pursuant t0 21 C.F.R. § 814.82 identifies Defendant ALLERGAN, INC. With a corresponding address 0f 2525 Dupont Drive, Irvine, California 92612. The consignee identified on import bills 0f lading for ALLERGAN breast implant prostheses from ALLERGAN’S manufacturing plant in Heredia, Costa Rica is Defendant ALLERGAN USA, INC. 0r ambiguously Allergan, -25- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O with a corresponding address of 18655 Teller Avenue, Irvine, California, 92612. The United States Patent and Trademark Office identifies the registrant of the BIOCELL trademark as MCGHAN MEDICAL CORPORATION with a corresponding address 0f 700 Ward Drive, Santa Barbara, California 93111. The current listed owner identified is Defendant ALLERGAN, INC. with a corresponding address of 2525 Dupont Drive, Irvine, California 92612. ALLERGAN’S medical aesthetics division responsible for design/ development, clinical operation, data analysis and regulatory affairs for its breast implant products, including the BIOCELL Textured Breast Implants Class 1 Device Recall, is based in its Irvine, California headquarters. ALLERGAN has been repeatedly haled into court in California for issues related t0 its implantable breast protheses. In those matters, ALLERGAN voluntarily accepted service 0f summons, and voluntarily consented t0 the personal jurisdiction of California for the injuries resulting from the implantation of its products. It used some 0f the same counsel it has retained in this matter (Shook, Hardy 8t Bacon), and actively litigated those cases, serving and answering discovery, filing motions, attending mediations, and settling claims against it. The FDA’s November 17-20, 2003 establishment inspection concerning the BIOCELL Textured Breast Implants occurred at ALLERGAN’S, then INAMED CORPORATION’S, headquarters at 71 South Los Carneros Road, Goleta, CA 93117. That inspection focused 0n the monitoring activities for both the investigational device exemption study and adjunct clinical studies 0f ALLERGAN’S silicone gel-filled breast implants. A complaint regarding lack 0f monitoring and oversight 0f clinical investigators involved in the adjunct study was also investigated. -26- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O The FDA’s February 16-18, 2005 establishment inspection concerning the BIOCELL Textured Breast Implants occurred at INAMED CORPORATION’S headquarters at 71 South Los Carneros Road, Goleta, CA 93117. This inspection focused 0n the ALLERGAN’S Style 410 silicone gel-filled breast implants study, accountability practices for the adjunct study were also covered and resulted in the issuance 0f an FDA-483 for having 7,065 devices with unknown status. The FDA’s April 4-6, 2007 establishment inspection, the first inspection following ALLERGAN’S acquisition 0f INAMED CORPORATION, concerning the BIOCELL Textured Breast Implants occurred at ALLERGAN’S offices at 71 South Los Carneros Road, Goleta, CA 93117. The inspectors noted that while ”Allergan’s corporate offices are located at 2525 Dupont Drive, Irvine, California 92612 [. . . a]11 manufacturing operations for silicone and saline breast implants and tissue expanders are performed at Allergan’s facility in Ireland. Complaints and MDRS for this product are handled at the Goleta, California facility.” The FDA’s August 9-12, 2011 establishment inspection concerning the BIOCELL Textured Breast Implants occurred at ALLERGAN’S offices at 71 South Los Carneros Road, Goleta, CA 93117. Again, inspectors noted that while ”Allergan’s corporate offices are located at 2525 Dupont Drive, Irvine, California 92612 [. . . a]11 manufacturing operations for silicone and saline breast implants and tissue expanders are performed at Allergan’s facility in Ireland. Complaints and MDRS for this product are handled at the Goleta, California facility.” Moreover, ”[t]he Santa Barbara facility is a corporate office where specifications are developed and complaint & MDR activities are performed.” The FDA’s February 5-6, 2014 establishment inspection concerning the BIOCELL Textured Breast Implants occurred at ALLERGAN’S offices at 71 -27- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O South Los Carneros Road, Goleta, CA 93117. Inspectors noted that the upper managers for ALLERGAN ”are located at Allergan’s headquarters, 2525 Dupont Drive, Irvine, CA 92612.” The report further states: i. The inspected Goleta site does n0 manufacturing 0f any finished medical device or any components t0 a medical device. It is registered as a specification developer because it is responsible for design controls for most of the aesthetic devices, including the BIOCELL Textured Breast Implants. ii. It is registered as a manufacturer because it is responsible for determining if a complaint investigation is required, conducts the failure analysis of retuned breast implants, and reports MDRS and PSRs. iii. Goleta makes the decision whether a complaint needs t0 be investigated and if it needs to be reported as an MDR. iv. Returned breast implants and explants are analyzed at the Goleta facility. The most recent Establishment Inspection Report performed by FDA Supervisory Consumer Safety Officers 0n October 19, 2016 for the recalled BIOCELL Textured Breast Implants occurred at the 2525 Dupont Drive, Irvine, California headquarters. Importantly, the name and address 0f the appropriate ALLERGAN employee for all FDA official correspondence regarding BIOCELL Textured Breast Implants was Defendant ALLERGAN PLC’s CEO/President Mr. Brent Saunders with a corresponding address 0f 2525 Dupont Dr., Irvine, CA 92612. The report further states: i. This Irvine facility performs design/development, clinical operation, data analysis and regulatory affairs. ii. The firm is registered with the FDA as a specification developer and importer. -28- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O iii. That while the firm was acquired by Actavis PIC in 2015, the legal name of the facility remains unchanged as Allergan, Inc. 72. At all times material hereto, Defendants maintained systematic and continuous contacts in this judicial district, regularly transacted business within this judicial district, employed numerous individuals in this district and regularly availed themselves of the benefits 0f this judicial district. Defendants received substantial financial benefit and profits as a result of the designing, formulating, testing, packaging, labeling, producing, creating, constructing, making, assembling, advertising, clinical testing, marketing, promoting, distributing, manufacturing, and selling BIOCELL Textured Breast Implants in this state and county, and throughout the United States. Defendants promoted, sold, distributed, made, assembled, marketed, advertised, and promoted the BIOCELL Textured Breast Implants in California with those products ultimately causing harm across the United States. 73. At all times material hereto, the action arises from obligations that arise out 0f, 0r are connected with, Defendants’ activities within the State 0f California. 74. Plaintiff is informed and believes and, 0n that basis alleges that Defendants have purposefully directed their activities at this forum State and the exercise 0f jurisdiction is reasonable and would not offend the traditional notions 0f fair play and substantial justice. 75. Plaintiff is informed and believes and, on that basis, alleges that Defendants have purposefully availed themselves 0f the privileges and benefits 0f conducting activities and business Within the forum State, and have invoked the benefits and protections of its laws. 76. Accordingly, a substantial part 0f the events giving rise t0 Plaintiff’s Claims occurred in California, including federal and state regulatory compliance, the preparation and submission of the relevant product PMAs, and communication regarding the product, the design, formulation, testing, packaging, labeling, production, creation, construction, making, assembly, advertising, clinical testing, marketing, -29- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O promotion, distribution, manufacturing, and selling of the BIOCELL Textured Breast Implants. 77. Thus, none of the named ALLERGAN Defendants can deny this Court has specific personal jurisdiction over the parties t0 this civil action because ALLERGAN has purposefully availed itself 0f the privileges and benefits of doing business in California. GENERAL ALLEGATIONS A. Federal Law and Requirements 78. The Medical Device Amendments of 1976 (MDA), 21 U.S.C. 360C et seq., t0 the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., impose a regime 0f detailed federal oversight administered by the FDA for medical devices. Depending 0n the nature of the device and the risks it presents, that oversight ranges from general federal regulations governing the labeling and manufacture 0f all medical devices, to a rigorous regime of premarket approval for certain devices. 79. FDA may grant premarket approval (”PMA”) for a device only if it finds, among other things, that (a) there is ”reasonable assurance” 0f the device's ”safety and effectiveness” under the conditions 0f use included in the proposed labeling, and (b) the proposed labeling is neither false nor misleading. 21 U.S.C. 360e(d)(1)(A), (2)(A), (B) and (D). After premarket approval, a manufacturer generally must receive FDA's approval of a supplemental application before making any change to the device itself that would affect its safety 0r effectiveness. See 21 U.S.C. 360e(d)(6)(A)(i); 21 C.F.R. § 814.39(a). 80. PMA is specific t0 individual devices, but such devices are thereafter also subject to the more general provisions of the MDA and FDA's regulations. Of particular importance are the requirements that a medical device manufacturer: (a) Collect and report t0 the FDA within certain timeframes information on certain adverse events associated with its device. See 21 U.S.C. 360i(a); 21 C.F.R. Part 803. -30- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O (b) Implement quality systems and current good manufacturing practices with respect to the device. See 21 U.S.C. 351(h); 21 C.F.R. Part 820. 81. Additionally, within the MDA exists an express preemption provision applicable t0 PMA devices which states: [N]0 State 0r political subdivision of a State may establish 0r continue in effect with respect to a device intended for human use any requirement - (1) which is different from, or in addition to, any requirement applicable under [the FDCA] to the device, and (2) which relates to the safety 0r effectiveness of the device 0r t0 any other matter included in a requirement applicable to the device under [the FDCA]. 21 U.S.C. 360k(a). 1. No express preemption of state-law claims paralleling MDA and federal regulatory requirements 82. As set forth in the MDA’s express preemption provision, a state requirement is preempted only if it is ”different from, 0r in addition t0,” federal requirements. 21 U.S.C. 360k(a)(1). Through that qualification, Section 360k(a) permits a State to provide a traditional damages remedy for Violations of common-law duties when those duties parallel federal requirements. 10 83. For example, where both the FDCA (as implemented by FDA) and State law require a manufacture to deliver warnings regarding its device through an appropriate channel-such as the FDA-those duties are parallel such that preemption is inapplicable. That parallelism is reinforced by the FDCA'S command that either inadequate warnings (21 U.S.C. 352(f)(2)) 0r a failure t0 submit required adverse event reports t0 FDA (21 U.S.C. 352(r)(2), 360i(a)) will render a device misbranded, and 10 As the Supreme Court stated in Riegel v. Medtronic, Ina, ”§ 360k does not prevent a State from providing a damages remedy for claims premised 0n a violation of FDA regulations; the state duties in such a case ’parallel,’ rather than add t0, federal requirements.” (2008) 553 U.S. 312, 330 (Citing Medtronic, Inc. v. Lohr (1996)518[lS.470,495) -31- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O therefore ”prohibited [from] introduction 0r delivery for introduction into interstate commerce.” 21 U.S.C. 331(a). 84. As the Ninth Circuit reasoned in Stengel v. Medtronic Ina, such a ”claim rests 0n a state-law duty that parallels a federal-law duty under the MDA ....” 704 F.3d 1224, 1233 (2013) (en bane). Specifically, the plaintiff alleged that the manufacturer's failure to warn the FDA 0f adverse health consequences constituted a Violation 0f both the MDR requirements and the general duty of reasonable care under State law, Which includes a duty t0 warn. Ibid. 85. This is because the MDR regulations are related to the manufacturer's duty to provide the FDA with information regarding a device's safety and effectiveness, and this information is disseminated t0 the public. Manufacturers provide these reports t0 the FDA, the FDA then disseminates the reports to the public, and the reports are then relied upon by physicians and authors of medical journals in comparing the relative safety of medical devices. 86. Likewise, California imposes a duty 0n manufacturers to warn of potential risks or dangers 0f their products, which sounds in both negligence and strict liability. See Carlin v. Superior Court (1996) 13 Ca1.4th 1104, 1110-1112. This is a continuing duty that lasts as long as the product is in use. Valentine v. Baxter Healthcare Corp. (1999) 68 Ca1.App.4th 1467, 1482; see also CACI Nos. 1205, 1222. The state-law duty to warn may in some Circumstances be satisfied by giving the information to a third party who can reasonably be relied 0n t0 convey the danger. Persons v. Salomon North America, Inc. (1990) 217 Cal.App.3d 168, 175-178. California follows the Restatement Second 0f Torts standard for a manufacturer's reasonable reliance 0n an intermediary to convey warnings. Id. at 175 (adopting Restatement Second 0f Torts, § 388, com. n). The focus 0f this standard is whether, in light of all the circumstances, a manufacturer 0r supplier acted reasonably in relying 0n a third party to pass warnings on to the ultimate user. Id. at 175-178. -32- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 87. Thus, a factfinder could infer that a manufacturer's failure to provide information regarding a device's safety and effectiveness as required by FDA regulations is a parallel Violation of the state duty to provide reasonable and adequate information about a device's risks. 88. This parallelism is reinforced under California's doctrine 0f negligence per se where the failure t0 exercise due care is presumed from a Violation 0f a ”statute, ordinance, 0r regulation 0f a public entity.” Cal. Evid. Code, § 669(a)(1). By its terms, this doctrine applies to the law of any public entity, not just California public entities. See, e.g., DiRosa v. Showa Denko K.K. (1996) 44 Ca1.App.4th 799, 808. Thus, under California law, a money damages remedy exists for negligent Violation 0f the FDCA and regulations promulgated thereunder which proximately cause injuries, and there is n0 need for California’s Legislature t0 act in order t0 create such a remedy. 89. The foregoing principles refute any anticipated contention by ALLERGAN that Section 360k(a) expressly preempts Plaintiff’s state law claims set forth below. Under Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, the U.S. Supreme Court held the premarket approval 0f the plaintiff’s device established preemptive requirements with respect to the design and labeling of the device. Those would preempt any Claim alleging in substance that FDA should have conditioned its approval 0n adopting some other design or labeling. Such were the nature of the Claims at issue in Riegel, and those claims were therefore preempted. 90. But where, as here, a plaintiff’s Claims are based on conduct after a device received premarket approval, that conduct is governed not by the terms 0f the device’s premarket approval, but rather by FDA’s general regulations governing medical devices generally. Accordingly, state law claims-whether styled as arising from a failure to make adverse event reports to FDA or from a failure t0 maintain appropriate quality control systems- are not expressly preempted. 2. No implied preemption of state-law claims premised on Violations of the MDA and federal regulatory requirements -33- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 91. Where a plaintiff alleges that a defendant had made fraudulent misrepresentations to the FDA in the course of obtaining premarket approval for a medical device, such ”fraud on-the-FDA Claims” are impliedly preempted because they conflict With the FDA'S responsibility t0 police fraud 0n the agency and they seek t0 enforce an exclusively federal requirement not grounded in traditional tort law. Buckman C0. v. Plaintifls' Legal Comm. (2001) 531 U.S. 341, 348-353. 92. Central to the doctrine of implied preemption is that a state law Claim cannot exist solely by Virtue 0f the federal enactments-State law has no role to play in policing the relationship between a federal agency and the entity it regulates. Conversely, Claims relying 0n traditional State tort law which had predated the federal enactments in question are unaffected. Therefore, a Claim against a device manufacturer is viable if the plaintiff is suing for conduct that violates the FDCA (0r else her claim is expressly preempted by Section 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). 93. Thus, as recognized in Stengel, a manufacturer's failure to report, for example, is more than a mere misrepresentation to the FDA because it simultaneously misled the device's current and potential users, t0 whom the manufacturer owed an independent duty under state law. Thus, such claims are grounded in a traditional category of state law failure-to-warn claims that predate the federal enactments in question, and the claims therefore d0 not exist solely by Virtue 0f those enactments. As a result, such Claims are not impliedly preempted by the MDA. B. Statement of Facts Relating to Preemption Applicable to Plaintiff’s Failure to Warn and Negligence Claims 94. A11 three generations 0f the recalled BIOCELL Textured Breast Implants received premarket approval under PMA Order Nos. P990074 (2000), P020056 (2006), and P040046 (2013). -34- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 95. In 2011 and in 2015, the recalled Natrelle 133 Plus Tissue Expander (K143354) and Natrelle 133 Tissue Expander with Suture Tabs (K102806) were approved for sale under section 510(k), respectively.“ 96. Under federal law and regulation, Allergan was under a continuing duty to monitor its BIOCELL Textured Breast Implants after premarket approval and t0 discover and report t0 the FDA any complaints about the device's performance and any adverse health consequences of which it became aware and that are or may be attributable t0 its BIOCELL Textured Breast Implants. See 21 C.F.R. § 803.50 et seq; 21 C.F.R. § 820.198(a)(3); 21 U.S.C. 3601. 97. Pursuant t0 these regulations, ALLERGAN was obligated to file within a mandatory timeframe detailed medical device reports (MDRS) for all BIA-ALCL events related t0 its BIOCELL Textured Breast Implants that it had knowledge 0f, foreign 0r domestic, and this includes any event that could reasonably be interpreted as possible BIA-ALCL given the nature of the facility, doctor 0r patient complaint. 98. Notwithstanding this obligation, ALLERGAN failed t0 investigate complaints 0f adverse events and submit such adverse events concerning the BIOCELL Textured Breast Implants as MDRS in Violation 0f general medical device regulations designed to ensure patient safety. 99. As a result, Allergan failed to properly perform its duties and failed to inform the FDA of the increased risk of BIA-ALCL associated with its BIOCELL Textured Breast Implants using medical device reports; even though it should have been aware of the many adverse events that did occur and was actually aware of these 11 A medical device marketed after the MDA's effective date may bypass the PMA process if the device is "substantially equivalent" t0 a "grandfathered" pre-MDA device (i.e., a device approved prior t0 1976). This exception t0 premarket approval is known as the ”510(k)" process and simply requires the manufacturer t0 notify the FDA under section 510(k) 0f the MDA of its intent t0 market a device, and t0 explain the device's substantial equivalence to a pre-MDA predicate device. The FDA may then approve the new device for sale in the United States. The MDA does not require an FDA determination that the device is, in fact, substantially equivalent t0 a grandfathered device. -35- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O adverse events-but failed to file medical device reports pursuant to 21 C.F.R. Part 803; 21 C.F.R. § 820.198; and 21 U.S.C. 360i. 1. ALLERGAN violated 21 C.F.R. § 803.50 et seq by failing to file MDRs following receipt of both foreign and domestic complaints of BIA-ALCL 100. A manufacturer must report adverse events no later than 3O calendar days after the day that it received 0r otherwise become aware 0f information, from any source, that reasonably suggests that a device may have caused or contributed to a death 0r serious injury, or malfunctioned. 21 C.F.R. § 803.50 (emphasis added). 101. This reporting duty is triggered not just for events occurring within the United State and its territories, but also adverse events occurring in a foreign country concerning the device. Under the FDA's Medical Device Reporting for Manufacturers Guidance for Industry, the FDA considers an event that occurs in a foreign country reportable under the MDR regulations if it involves a device that has been cleared 0r approved in the United States- 0r a device similar t0 a device marketed by the manufacturer that has been cleared or approved in the United States - and is also lawfully marketed in a foreign country. 102. Thus, even when a device is manufactured t0 modified specifications to meet standards in different countries, if these Changes d0 not substantially alter the performance of the device, then any device events that are MDR reportable events relating to such modified devices should be reported under the MDR regulations. 103. Notwithstanding this reporting obligation for events worldwide, between 2007 and 2010-following premarket approval for its first generation 0f silicone-filled breast implants in 2006-internal ALLERGAN documents show ALLERGAN received 22 worldwide complaints of BIA-ALCL in women implanted with the silicone brand of the breast implants: -36- COMPLAINT AND DEMAND FOR JURY TRIAL OOOVQU'Ii-PQJNH NNNNNNNNNHHHHHHHHHH OOVQCnn-PUJNr-‘ocooummphmmr-‘to Tm [BIDDER ”WEE MM“ AERTm Imam um Ell Ear EL Ell Count at ALCL alum! tar Tsar ‘nl'ulume DB'trlhminn Tall mint Vulumn Year Churn Vulumn Distrlbmlun "fear Enum 01' ALEL ilmvnd Wilul‘l‘ll Hal“ n! AL EM fir ALEL ME Gaunt nr ALEL U1 104. Despite the public health crisis implicated by such statistics, ALLERGAN unlawfully failed to report these events 0f BIA-ALCL to the FDA at 6111.12'13 Moreover, the internal ALLERGAN data set forth above does not account for the untold number of complaints of BIA-ALCL in women implanted with their saline filled brand 0f BIOCELL Textured Breast Implants.” 105. Such information, had it been disclosed by ALLERGAN, would have enabled physicians and patients to take proper precautions to determine whether the 12 The FDA's Manufacturer and User Facility Device Experience (MAUDE database) is available online and can be searched t0 locate MDRs. https://www.accessdata.fda.goV/scripts/Cdrh/cfdocs/cfmaude/search.Cfm. 13 The first instance 0f ALLERGAN filing an adverse event report for a complaint 0f BIA-ALCL in connection with its silicone filled breast implants was received by the FDA 0n May 4, 2011. See https://WWW.accessdata.fda.gov/scripts/cdrh/cfdocs/CfMAUDE/detail.cfm?mdrf0i id=2097844. 14 Due to safety concerns, from April 1992 until November 2006 silicone gel-filled breast implants were only available in the U.S. t0 women enrolled in Clinical studies, whereas saline-filled breast implants remained in the market during this time Via 510(k) approval and, after 2001, premarket approval. -37- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD increased risk of BIA-ALCL should be avoided by electing not t0 use Allergan's BIOCELL textured implants. Or, the FDA would have recalled the BIOCELL textured implants before Plaintiff ever had them implanted. 106. Also under state law, which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety 0f its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, to the FDA. 107. As a result of ALLERGAN'S postmarket failure t0 appropriately report adverse events as required by federal statute and FDA regulations, and as a result 0f ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature 0f the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. 2. ALLERGAN violated 21 C.F.R. §§ 803.50 and 803.52 by concealing pertinent adverse event reports by burying them in unscrutinized spreadsheets 108. As complaints 0f BIA-ALCL continued t0 rise in frequency as outlined in the chart above, rather than complying with the federal statute and regulations on medical device reporting, ALLERGAN began using Alternative Summary Reports (ASRS) to report 0f BIA-ALCL events associated With its BIOCELL Textured Breast Implants.” 109. ASRs differ from MDRS in that eligible events are aggregated into a single periodic report where only rudimentary information about a particular adverse event is set forth in a line item format Within a dense spreadsheet containing thousands of other adverse events. 15 The ASR program is also referred to by the FDA as Postmarket Spreadsheet Reporting (PSR). -38- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ (II H> DJ r0 #4 NNNNNNNNNHHHHHHHHHH 00 \J O\ (J! 4> 00 ho #4 c: \o 00 \q ON (II H> 00 ho +4 CD 110. Whereas 21 C.F.R. § 803.52 mandates that a traditional medical device report must contain dozens of categories and subcategories 0f information, including unique product identification, a detailed event description with a discussion of how the device was involved, and a manufacturer’s narrative, an ASR merely contains generic device and problem coding that was never made available t0 the public 0r physicians before late 2019.16 111. While the FDA allowed manufacturers to use the ASR reporting system to report specific adverse events in lieu 0f MDR reporting, this was only allowed where compliance with some of the reporting requirements ”is not necessary to protect the public health” because such events were ”known and well-documented.” 60 Fed. Reg. 63,592 (December 11, 1995) (emphasis added). In the case 0f breast implants, manufacturers like ALLERGAN could only summarize reports of ”rupture, leaks, deflation/inflation, wrinkling, capsular contracture, and non-specific complaints.”17 112. Moreover, under the FDA's October 19, 2000 ASR Guidance for Industry, the FDA requested that any medical device manufacturer seeking t0 use the ASR reporting system affirmatively apply for an exemption, in writing, for specific device events, as required by 21 C.F.R. § 803.19(b), with the following information: a statement notifying the FDA 0f the request to participate in the ASR program; an explanation why the request is justified; identification of the device manufacturer; the product classification codes for the device that will be included in the ASR report; and the reporting site registration number, contact person, and address 0f the firm Who Will be submitting the ASR reports to the FDA. 113. ALLERGAN failed t0 comply with 21 C.F.R. § 803.19(b) and the corresponding ASR Guidance, and used the ASR reporting system to report BIA-ALCL events associated with its BIOCELL Textured Breast Implants despite never being granted an exemption to d0 so by the FDA. 16 Compare Exhibit A, a single MDR, with Exhibit B,m ASRs. 17 See https://www.accessdata.fda.gov/cdrh docs/pdf/P990074B.pdf. -39- COMPLAINT AND DEMAND FOR JURY TRIAL \DOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOO‘Ir-PQJNHOOOOVQU‘Ip-waHO 114. The FDA's October 19, 2000 ASR Guidance was Clear, device manufacturers could not lawfully use the ASR reporting system under any circumstances for unusual, unique, 0r even uncommon events. BIA-ALCL, and the symptoms associated therewith, are unequivocally an unusual, unique, or uncommon events-but an event type ALLERGAN was aware 0f since at least 1997 when the first known event appeared in the medical literature with a description 0f its characteristics. 115. Likewise, the FDA was unambiguous in its May 2, 2019 statement regarding the agency’s efforts t0 protect women’s health and help t0 ensure the safety 0f breast implants: ”[The ASR] program was established in 1997 to more efficiently review adverse events for well-established risks but was not allowed for patient deaths and unusual, unique 0r uncommon adverse events, which, in the case of breast implants, included BIA-ALCL.” 116. On information and belief, hundreds 0f complaints related t0 BIA-ALCL and symptoms associated therewith surfaced from 1997 t0 2019, and ALLERGAN was aware of these events, and that they were unusual, unique, or uncommon events relating t0 BIA-ALCL. ALLERGAN-rather than reporting these events in compliance With the MDR reporting requirements-misused the ASR reporting system in Violation of 21 C.F.R. § 803.19(b); 21 C.F.R. § 803.50; 21 C.F.R. § 820.198(a)(3); 21 U.S.C. 3601; and its duty t0 report t0 the FDA. 117. The first identified misuse of the ASR system t0 report an event 0f BIA- ALCL occurred in 2009 when a healthcare professional reported t0 an ALLERGAN employee the events of BIA-ALCL and seroma.” However, following the FDA’s decision to end the ASR program due to manufacturer abuse, the FDA in late 2017 also began t0 require manufacturers t0 also submit companion MDRS so that some information collected through the ASR program would be Visible publicly. As a result, it 18 See https://www.accessdata.fda.gov/scripts/Cdrh/cfdocs/chAUDE/detail.cfm?mdrfoi id=2842518. -40- COMPLAINT AND DEMAND FOR JURY TRIAL \DOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOU‘Ir-POJNHOOOONQU‘Ip-bmmr-‘to became known that ALLERGAN has been misusing the ASR program to report ineligible events since as early as March 1997.19 118. In fact, ALLERGAN started late filing hundreds 0f MDRS related t0 BIA- ALCL events it had known about for many years but had buried in the ASR spreadsheets t0 belatedly comply with 21 C.F.R. § 803.50; 21 C.F.R. § 820.198(a)(3); and 21 U.S.C. 360i-and also in Violation of these statute and regulations-after the FDA ended the ASR program in late 2017. Two such examples 0f the now thousands of MDRS recently filed and available only after 2017 in the FDA's Adverse Event Database clearly demonstrate Allergan's years/decades-long delay in filing these MDRs: ALLEN“ fiflflflfl. REA}3m 11E minim!mmfin FLLflm‘rmfl‘rW.mt Bad ID Elammumu HITEHIL, m-ILLID Hm ElhlfiqHm H-Ju'th-H ilfii-i'iifi’ Danna: Fmtl‘lm A:T-erw Earn: WIIJ'ImIt Illumlfitu Burma tar Um Pram EHIH Typl n- :P. Hlnu'flclum Him" ' lal- » 'i ‘ - a- mfi- W141 mama!rympnumalgaph'pmlmnpfulmflmarflmuhm Emancr- garea-JIl-f lyre: nnl 1mm! ailfirqgn u: lfirrmlnrq :L pincamr cqum Tm Err; gr.cnr Em rd’nrrnqflnn Fm mg rgpnl‘lgu rming q-icnl pmrlucl qr flflpnrt Dale U1.-EB.-EEI1F! WlmflMEm1flmmmmmmmmtmm Barnumflmmm m EmW 132k5m trunk Framer“ M-rers-a Exam WWWWm Dem: m UseHm E‘IEI'Hm ‘EE‘EEEE‘ EA E'I'tfllw :‘fgl'j » --.. _. , ”Al I i' 4:: mliri, 7 Aramflmmmmmnnaaflmmmfl mg. nan! mangeu EH meme:mmamw3mmmum mllneufimtrm Waymmlgmmu md‘rnem' regym nnpmn-H nylmnm -| 119. The FDA was not aware, did not consent, and did not grant any exemption to ALLERGAN t0 use ASR reporting for BIA-ALCL events. 120. Medical device reporting serves a critical public safety function and failing to follow the federal statutes and regulations 0n such reporting can cause patients serious injuries. This is precisely Why MDR reporting was required for events or risks, like BIA-ALCL, that were not well-known 0r established. As the FDA plainly stated in their June 21, 2019 statement: "The ASR Program allowed the FDA t0 more efficiently 19 See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/chAUDE/detail.Cfm?mdrfoi id=7326850. -41- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O review reports of well-known, well-understood adverse events, so we [can] focus on identifying and taking action on new safety signals and less understood risks." 121. The FDA did not review or investigate reports for ASR-reported events; and reserved its resources for events requiring a medical device report. ASR reported events were not even available to FDA Supervisory Consumer Safety Officers for review in advance 0f conducting periodic site Visits t0 ALLERGAN’S California headquarters. 122. Because this information about BIA-ALCL was routinely transmitted by ALLERGAN to the FDA in the unscrutinzied spreadsheets, the recall for ALLERGAN'S BIOCELL Textured Breast Implants took approximately 20 years t0 be initiated by the FDA and only because ALLERGAN failed t0 lawfully report BIA-ALCL events t0 the FDA. 123. Use 0f the ASR reporting system buried patient injury events and they were not investigated by the FDA, and could not be discovered by physicians either. Had ALLERGAN lawfully reported BIA-ALCL events from 1997 until the time 0f Plaintiff's implantation or symptoms, she would not have suffered her injuries because either: (a) a recall would have been initiated before Plaintiff's implantation date 0f the subject devices; 0r (b) the risks would have been well-understood and Plaintiff or her physician would have been informed of the risk 0f BIA-ALCL. Instead, the Plaintiff and her physician were both unware of the extent 0f the risk of BIA-ALCL when the subject deivces were implanted causing her serious injuries. 124. Accordingly, Plaintiff WINDY FABE was injured as a result 0f Defendants’ postmarket failure to properly submit MDRs as required (by statute and that FDA'S regulations), and as a result 0f Defendants’ postmarket negligence, ALLERGAN’S BIOCELL Textured Breast Implants belatedly became known to be defective and unreasonably dangerous only after having been implanted in Plaintiff. 125. As a result of its failure to establish and maintain effective post-market surveillance and reporting to ensure defect-free products, Plaintiff suffered severe injuries. -42- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 126. Also under state law, Which does not impose duties or requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety of its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, t0 the FDA. 127. As a result of ALLERGAN'S postmarket failure to appropriately report adverse events as required by federal statute and FDA regulations, and as a result of ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature 0f the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. 3. ALLERGAN failed to investigate and evaluate complaints of BIA-ALCL per 21 C.F.R. §§ 820.198 and 803.18(e) and prepare corresponding medical device reports 128. Pursuant to 21 C.F.R. § 820.198(a), ALLERGAN was required to have a formally designated unit for the purposes 0f receiving, reviewing and evaluating complaints 0f adverse events. 21 C.F.R. §§ 803.17, 803.18, and 820.198. 129. The FDA’s definition 0f ”complaint” is all encompassing and includes ”any written, electronic, 0r oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” 21 C.F.R. § 820.3(b). 130. Typically, complaints are prepared and transmitted t0 the company by physicians, nurse, hospitals, attorneys, and even the patients themselves on the comprehensive FDA Form 35003 for voluntary reporters-designed with the intent 0f streamlining the manufacturer’s reporting by mirroring the information contained in FDA’s Form 3500A for mandatory reporters, like ALLERGAN. 131. Upon receipt 0f a complaint by any employee, ALLERGAN was required t0 evaluate all available information related t0 the complaint to determine whether it -43- COMPLAINT AND DEMAND FOR JURY TRIAL \DOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOan-PDJNHOOOOVOxo‘Ip-war-AO represents an MDR reportable event. 21 C.F.R. §§ 820.198(a) and 803.18. Said evaluation must include information in the manufacturer’s possession 0r that is reasonably available to ALLERGAN, such as information can be obtained by contacting a user facility (e.g. hospital, surgical center), importer 0r other initial reporter related t0 the adverse event. 21 C.F.R. § 803.50. 132. If the adverse event complaint qualifies for reporting to FDA under 21 C.F.R. Part 803-i.e., the device may have caused 0r contributed to a death or serious injury, or malfunctioned-then ALLERGAN was required to conduct an investigation 0f the event. 21 C.F.R. §§ 803.3 and 80350.20 Said investigation must include a determination (1) Whether the device failed to meet specifications; (2) whether the device was being used for treatment 0r diagnosis; and (3) the relationship, if any, 0f the device t0 the reported incident 0r adverse event. 21 C.F.R. § 820.198(d). 133. Accordingly, under these general complaint handling requirements, ALLERGAN was under the continuing duty to receive, evaluate, and investigate such events related t0 BIA-ALCL and make a determination as t0 the relationship between the BIOCELL Textured Breast Implants and BIA-ALCL. 134. Notwithstanding ALLERGAN’S complaint handling obligations for adverse events 0f BIA-ALCL and symptoms associated therewith, 0n numerous occasions ALLERGAN ignored complaints of such events. 135. Two such examples of these ignored complaints further demonstrate ALLERGAN’S cavalier and unlawful attitude towards the risks 0f BIA-ALCL27-1 E "LIED NAMED “LINE MEAHTm?" E'Blztfiu Saudi REHIHE : Ennt Tim HuflnswarFrmndafl ‘ Eh'lhlflmfipfl‘un silt: L'HE-u Hagan lhrs [II had tIILMHraJ hraa'slaugrnmllahun parfurrnad m BIKE! She mafia“?Mam a sammfl Iha'l wars mated md found tu‘h-m-a alums” c9331: Ififlrfimnwi baialfifial Implam Fmvat and hntait‘apfiumlnmg Hm final pmlzm WEI alt! uf‘lha la" hmas! Hflfi-‘HAH HEW“m LF EALINE FMEE EHEAE'I'MTH- Bammfi-‘awm Rasum Hm Mumhir 3&le 300 E'illnt Bil! 12I‘tlifn'lfl1fi Event 'I‘fln Imm‘y Evan! Ducraium F'I hall niculu'fll 2-533! Mina film ImEJLaIflE [1mm nn IttIHfi'J 21315 Fraaflntfld ‘mlh urns light brim; filma m1 1mm 201E Uflrasflum mum mplrmlfin Izlr 55mm perfumed an ILI-Hfl] 201E Ella! ulhmnd and rn‘n sham bluemum rum trans! l'hnd cdhclrun. Afimralad find shaved math md fl! - culls. wading It.- tha magnuais n1 $1 She 1nd Haimal cupsulartmmfi and rimuwt mmmmfi i111 [Mm] 2G1 T Palhfiumr did nul mam an]! Manmn ul mam Inm ma mamas: She 45 curmnfl‘r Damn worked up b3! our mccflaglsfiwfira as wall HE. nurgarueflnsis -44- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 136. Rather than conducting the required investigations in t0 complaints transmitted by concerned physicians and/or patients, ALLERGAN, in violation of their general complaint handling requirements, allowed the complaints to fall on deaf ears. 137. As a result, ALLERGAN never conducted the required evaluation t0 determine whether the complaint qualified for public medical device reporting (instances 0f BIA-ALCL most assuredly qualify), never conducted the required investigation to determine the relationship between the event and the device, and therefore deprived the FDA or public of vital knowledge necessary t0 make informed decisions about the BIOCELL Textured Breast Implants. 138. Such information, had it been disclosed by ALLERGAN, would have enabled physicians and patients t0 take proper precautions to determine whether the increased risk 0f BIA-ALCL should be avoided by electing not t0 use ALLERGAN'S BIOCELL Textured Breast Implants. Or, the FDA would have recalled the BIOCELL Textured Breast Implants before Plaintiff ever had them implanted. 139. Also under state law, Which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety of its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, to the FDA. 140. As a result of ALLERGAN'S postmarket failure t0 appropriately report adverse events as required by federal statute and FDA regulations, and as a result 0f ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature 0f the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. 4. ALLERGAN failed to timely submit reports of BIA-ALCL per 21 C.F.R. § 803.50(a) and attempted to transmit such reports years after first receiving notice of the event -45- COMPLAINT AND DEMAND FOR JURY TRIAL \DOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOCnp-PDJNHOOOONOxmp-bwmr-AO 141. As aforementioned, after ALLERGAN’S misuse of the ASR program came to light in late 2017, ALLERGAN belatedly started late filing thousands of MDRS for a variety adverse event types that were not eligible for ASR reporting dating back t0 1997. Amongst these late reports were hundreds of adverse events related t0 BIA-ALCL and symptoms associated therewith that ALLERGAN had known about for many years, but the existence 0f which the FDA and the public had no knowledge 0f. 142. It was, in part, because 0f these late MDRS establishing the true extent of the nexus between BIA-ALCL and the presence of an ALLERGAN’S BIOCELL Textured Breast Implant, that the FDA was equipped with sufficient knowledge to initiate the July 2019 worldwide recall. 143. Two particularly egregious examples are as follows, revealing ALLERGAN failed to submit the mandatory MDRS until twelve years and twenty-nine years after the underlying adverse event, with latter only being reported to the FDA, and therefore disclosed t0 the public, as recent as December 11, 2019: flLLEHGAH Iflfll-ll REA: IT'I'LE 1HME FELEE MERITIMT mi'l'l-IEEIS. “EAST. flFLA'IIILE.Hm m mfiaarm EALIHE W Catalan Humbm‘ 133-IHD fluvial P{nhllm Mn Mpumnl fldumrsn Ewnl Evlfllfia‘h EIL'D'EJZ‘E-fl'? Evan; TyP-l lmurgr E'IIEMMB-crlpflufl HEMP: prmaa'r-ulnal remand panem ”dammed ma Illa samml. fllmm wnn IHI-ltl nnh1, nasal. 5mm Ia. mdamam Maharllmama mu mfiant ranmal Recamm Limp Ks, mmmmaw and radnal-m thaws: runllnwad hystern: call Irmaphnt pastnpfiwvaly Fm up Imaging wnh pal. nu mzmrnncn ul dlsnnsu Ramalrfl hauflhy' ' Hanulidum: Hin‘lfllre Unique Idemlhar [MI] J-I n01 applicable- erta Letharlmg addmfises lhEr-al were rhu- repumad mnls :1! IWanu-‘alcl. 1w panerfla m I119 mm Elma. in 1m Ehfllllh‘} I'L'Il' Er'fllfilfl Ilf‘lflllfi‘fllfi PCHEMIBI E&PEI’EE' EVEI'IE “LEI I'llfl'r DEE”? will'l '3.le ml-rm thfl'fir lft’llIII-fl'fl ELKQEHI d'I-lihlflfl" IH‘IIJIE’M WDIIJIB. {mflw urJMrmJurn“ Hmnmrlllnn, Implanl. Imw-IL palm Izhungus In nlpjzm 11nd llalnlnr mr‘lsau-za-rl Inlnulnn rimming, myrrmmhgu mmhalg nr‘lplunl dmréarfimntimlgrmlnn. rnprzant pamhllfl'rmsm-Illv. brafi1rafidIn-n- :nrnplltalam'ls hfimatclman’samnu. inwarn -mm51nn. nacmsts. mafia wuund Malina. WEEEI LI'E-EIJE HWUL‘IIWIIEI'ETSI WE" UE1DITFIII'fi EEJEIIJN MWEIE 311d Wfllrlhmnflfllmri'r AMT hrB-BE-‘I Hliflfiflr EUTW‘H m3 I’Dlmm IT’IB'II 'DICIEIJT fll‘lfl'flf DEPEISI. WIH'I vulflng Inlul'lml'r unil'm Eur fl uHr-lnng lunylll uf IlrIr-u hulllulflnlufwlu'nfl Inlfllfllll mthusl-un luluzlcfitfi, Mayud wfillzld flfifllllu-g Hm! hIEEI IifirEau-e Mlqilwunflfil wan unmanllv Elamurn dams"; ran fnrm In 1th mama nap-sula smmlnrlmg 1m ImFlnrfl wflh symFIMHtE- Hm! rn-w Imllm' pam and. finnnflsz: l‘xmphaflhnnpmhy “HE HI'EIZI hB-BFI [EWTEEI'J |fl SUNSW" Wlm lTl'Dl-BHE ll fllpurl am :m‘pmfln u 1 MERE!" H3951?! RICA: ST'I’L'E iflHWE EEL FILLmWMWME.m1; HWIFLAWLE. E&fiii h:-55mm INTERNAL. SILICONE GEL-HLLE Hunk Ending Humble: 12mm Dawni- Fm-blsrn Paflam-Dmma Immahllbp EVII‘II, Dala- 1fl'D-Bfl'fl} Evin! Thin! hiurar Manufacturer Hannfi'm Thu umms nfmulflmrflmmd WWIflHfi-Mlfljfii mmpllflfim‘mnd malaria MEI!mmwmfi ml EmitMin in datmnhinu a pmhafiacausa hr HEM mm. Thu raaaunfvzrmzrpmafimt mfirmflmmra. indium fii and 'h-alnfimtad {Dr ald. " firihm infurmah’nn Mm therm mgardhg wand. pmdufl. arpweni Heiallim ham [equated Nnafiflrfifirm Inanmatim-u lsmums Ha nine. ThemHem parentalMm wank mumin [ha {rum ‘lafllinu Evinet anriptian Hammaare pfmanmnal rammpmlm mntraume. balm grade- III and ‘hauqH-amad Fur m. " paumflmpmm 'jmni palm. mum purl and smrmaafufl a tinbmal a‘mhmu: Iran Mlurlfl II:swammt implants mu II: Hm paling:mm wifl'n lhumm Fn1iln1 nlm- repurl'fid 'mnhilfly b:M. name: in Brimmithas, urging in emam’njaa. m HEB aympbrrha. mama wsiun. Easing spam. mam m5. anxiety. suifidal muupmsg Winn. Efieam ayes.mum alaph In nose :hllla. dlmlfiaffl'maa numb am nnl ranted 1n Eh:mm: Bewm mums rmmeH-d TIME r&mld la1‘nr Helen ‘alde. Him" Dm- llu'l 'h'EElfl-l \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 144. Contrary t0 ALLERGAN’S unlawful reporting practices, MDR reportable events must be submitted t0 the FDA within 30 calendar days after the day the manufacturer becomes aware of the event. 21 C.F.R. §§ 803.10 and 803.50. The only exception is when a medical device report is required to be submitted within 5 work days after the day the manufacturer becomes aware of the need t0 submit such a report. 21 C.F.R. §§ 803.10(C)(2) and 803.53. 145. A manufacturer is considered t0 have ”become aware” 0f an event whenever any 0f its employees becomes aware 0f information that reasonably suggests that an event is required t0 be reported in a 30-day report or in a 5-day report. 21 C.F.R. § 803.3. 146. Notwithstanding these strict and mandatory reporting deadlines, as demonstrated above, ALLERGAN has been submitting late adverse event reports t0 the FDA related to BIA-ALCL, often times many years, sometimes decades, after first receiving knowledge of the event. 147. Such information, had it been timely disclosed by ALLERGAN, would have enabled physicians and patients to take proper precautions to determine whether the increased risk 0f BIA-ALCL should be avoided by electing not t0 use ALLERGAN’S BIOCELL Textured Breast Implants. Or, the FDA would have recalled the BIOCELL Textured Breast Implants before Plaintiff ever had them implanted. 148. Also under state law, which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety 0f its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries -47- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOUIr-PUJNHOOOOVQU‘Ip-war-AO and problems with its devices, including the BIOCELL Textured Breast Implants, t0 the FDA. 149. As a result of ALLERGAN'S postmarket failure to appropriately report adverse events as required by federal statute and FDA regulations, and as a result 0f ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature of the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. 5. ALLERGAN failed to provide all information reasonably known to it per 21 C.F.R. § 803.50(b) in its reports of BIA-ALCL but rather simply regurgitated its misleading and deficient labeling 150. A medical device report must contain all the information required by 21 C.F.R. § 803.52 that is known, 0r reasonably known to the manufacturer. 151. Information considered reasonably known includes any information: 1) that can be obtained by contacting a user facility, importer, 0r other initial reporter; 2) that is in the manufacturer’s possession; 0r 3) that can be obtained by analysis, testing or other evaluation of the device. 21 C.F.R. § 803.50(b). 152. Far from providing all information reasonably known it, as part of its manufacturing narrative in medical device reports concerning BIA-ALCL, ALLERGAN, more often than not, simply recited its device labeling with the unsubstantiated and misleading Claim that ”device labeling addresses” the issue already, thereby indicating that n0 further investigatory 0r remedial action was needed. 153. Notwithstanding the fact that ALLERGAN has had t0 update its device labeling on multiple occasions due to inaccurate information regarding BIA-ALCL, as reflected in the following medical device report dated November 12, 2019 for a BIA- ALCL event occurring in 2010, ALLERGAN has pointed to completely inapplicable parts of its labeling t0 attempt t0 explain away and disregard events of BIA-ALCL: ALLEHEAH {CD‘B‘M RPEM ET‘I'LE 1M EALIHE Humm1 “FLINT“ml. HEART. IWLM'ILELE. IHTEHIAL. Eachmm £ALJHE m Catalan Humbir ‘IL'a'H-Bm mulbe- Pmlflam FlLIld LM Evlnirfim m'mfi'm fl Evan! Thw- Danih Evan;Danman ln'rh'ally. prmm rightsiflnWham cumin": inflatim. inflaflmfinflamm with right mats: implant FI'LJ ?.th lhi 'rrrlplmthsum“;um nmld flu: fl was mun In 1ha nmmgnncy mum hh‘l‘lli was fl'augl'rl ll: bu I right hauntm nr nn inl'ncb'cn TM plm Hun amt lnm lh- inflln‘lirfl gurgau'L “ha - pudfln‘ud an untihiuli: Huh and had Eafl hum fln ultrnlflund HEM. flpmflivu nntnnvm‘m mdfid mid stab, 'nn BI rrghlfiidu. arm imiS-Ed. wemnmm a large unlurrra nr wulam 11nd. This. hm ism Int :unurfl. 'Wefuum a mnmialalymm aalIn-a Implml. Thampsula wan angrymm The pmmlflgy final films: alct; math» alk- mmlnq wiser. The pt was m Baa anmlmt Ma Eaten! um. Mnmcrrfl indn prm-I-da-a‘byMamm'um nntfi that ma ntwas 53m Dy ahaminim lama Imanflhatwfi Farmland wax dlawdm u_. fl__u_n_.. IJ_I__-'__» \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 154. As shown in the November 12, 2019 example-which is just one of many with this deficiency-ALLERGAN has claimed that its representations in the device labeling that ”implants are not considered lifetime devices” 0r ”if any unusual symptoms occur after surgery . . . you should contact your surgeon immediately” constitute a sufficient warning of the risks of BIA-ALCL. 155. Worse yet, the notion that "published studies indicate that breast cancer is n0 more common in women With implants than those without" has any relevancy 0n an event of BIA-ALCL is as ridiculous as it is insulting t0 those affected. Again, BIA-ALCL is a cancer 0f the immune system, and not a type 0f breast cancer-a fact ALLERGAN has been well aware 0f since 1997. 156. By failing to provide all information reasonably known t0 it, and instead misleadingly regurgitating irrelevant and inapplicable parts of its device labeling, ALLERGAN violated 21 C.F.R. §§ 803.50(b) and 803.52. 157. Such information, had it been disclosed by ALLERGAN, would have enabled physicians and patients to take proper precautions t0 determine whether the increased risk 0f BIA-ALCL should be avoided by electing not t0 use ALLERGAN'S BIOCELL Textured Breast Implants. Or, the FDA would have recalled the BIOCELL Textured Breast Implants before Plaintiff ever had them implanted. 158. Also under state law, Which does not impose duties or requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety 0f its products. -49- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O ALLERGAN was under a continuing duty under state law to adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, to the FDA. 159. As a result 0f ALLERGAN‘S postmarket failure t0 appropriately report adverse events as required by federal statute and FDA regulations, and as a result 0f ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature 0f the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. 6. ALLERGAN failed to use the appropriate device problem code for reports of BIA-ALCL instead representing that there was "no apparent adverse event” 160. The FDA receives a significant number 0f MDRs in any given month or year. Accordingly, it has implemented and relied upon a problem coding system to enable FDA officials to conduct trend and risk analysis for a device Without the immediate need to read and review every MDR. 161. There exist four categories 0f problem codes: 1) Device Problem Code; 2) Patient Problem Code; 3) Evaluation Results Code; and 4) Evaluation Conclusion Code. However, only the Device Problem Code 0n MDRs is made publicly available on the FDA’s MAUDE interface. 162. These codes must be provided to the FDA in an adverse event report pursuant t0 21 C.F.R. § 803.52. The codes must represent the manufacturers best knowledge 0f the adverse event and a manufacturer is not limited to more than one code per category for an event. When entering the device problem code, manufacturers are expected t0 select the lowest-level (i.e. most detailed) code or codes that most accurately describe the device failures or problems observed during the event. 163. T0 the extent the FDA’s coding manual does not provide a matching 0r similar code(5) that would best describe the patient or device problem 0r the evaluation -50- COMPLAINT AND DEMAND FOR JURY TRIAL \DOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOUIr-PQJNHOOOOVQU‘Ip-war-AO result and conclusion, a manufacturer has the ability to contact the FDA t0 assign a new code(3) as applicable. 164. However, in violation of 21 C.F.R. § 803.52, rather than providing an accurate device problem code for events 0f BIA-ALCL, ALLERGAN had a pattern and practice 0f providing the Device Problem Code N0. 3189, meaning ”N0 Apparent Adverse Event.” 165. As the title suggests, Device Problem Code N0. 3189: N0 Apparent Adverse Event has a unique meaning t0 the FDA that ”[a] report has been received but the description provided does not appear to relate to an adverse event. This code allows a report to be recorded for administration purposes, even if it doesn’t meet the requirements for adverse event reporting.”22 166. ALLERGAN knew this code was ”for FDA use only” because ”an event that is not an adverse event is, by definition, not a reportable adverse event.”23 167. ALLERGAN nevertheless utilized this code in their medical device reporting for events of BIA-ALCL, Which had the intended consequence of excluding these reports from the FDA’s trend analysis. 168. As a result 0f ALLERGAN’S deceitful coding practices in Violation 0f 21 C.F.R. § 803.52, for years the FDA was deprived 0f the necessary information to expeditiously determine the need for regulatory action, such as a recall, Without having to first review and analyze each MDR for the device. 169. If the FDA’s trend analysis had not been undermined by ALLERGAN’S reporting practices, the recall would have been initiated before Plaintiff's implantation date 0f the subject devices; 0r the risks would have been well-understood and Plaintiff 0r her physician would have been informed of the risk of BIA-ALCL. 170. Worse yet, this practice 0f representing events 0f BIA-ALCL as ”no apparent adverse event” was not limited t0 its domestic reporting practices, but also was 22 See https://www.fda.gov/media/l09148/d0wn10ad. 23 See https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-faqs. -51- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O ALLERGAN’S standard operating procedure internationally. On multiple occasion in its Incident Report Forms to European regulatory authorities, ALLERGAN ranked cases of BIA-ALCL in the fields 0f ”A11 Other Reportable Incident” and ”N0 Threat of Public Health.” As a result, ALLERGAN was reprimanded by French regulatory authorities in May 2015. Nonetheless, ALLERGAN continued t0 use the ”N0 Apparent Adverse Event” code domestically for events 0f BIA-ALCL. 171. Such information, had it been disclosed by ALLERGAN, would have enabled physicians and patients to take proper precautions to determine whether the increased risk 0f BIA-ALCL should be avoided by electing not to use ALLERGAN‘S BIOCELL textured implants. Or, the FDA would have recalled the BIOCELL textured implants before Plaintiff ever had them implanted. 172. Also under state law, which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety 0f its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, t0 the FDA. 173. As a result 0f ALLERGAN'S postmarket failure t0 appropriately report adverse events as required by federal statute and FDA regulations, and as a result 0f ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature of the product became known only after having been implanted in Plaintiff, and otherwise never would have been implanted in the Plaintiff at all. C. Statement of Facts Relating to Preemption Applicable to Plaintiff’s Manufacturing Defect and Negligence Claims 174. As noted above, ALLERGAN has received pre-market approval from the FDA for all three generations 0f BIOCELL Textured Breast Implants. As such, ALLERGAN was under a continuing duty t0 follow the manufacturing and design -52- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD specifications mandated by the FDA as part of the PMAs, as well as the general requirements set forth current good manufacturing practices (”CGMPS”) provisions 0f the MDA governing the safety and effectiveness of a PMA medical device. See 21 U.S.C. 351; 21 C.F.R. Part 820. 175. Pursuant to the CGMPS regulations, ALLERGAN was obligated t0 implement and maintain quality control systems t0 validate processes and conduct inspections and testing to ensure the purity and stability of the implants and not produce adulterated implants, specifically those with excessive particles on the implant surface at the time of manufacture in Violation 0f 21 U.S.C. 351; 21 C.F.R. §§ 820.70 and 820.75. 176. Notwithstanding this obligation, ALLERGAN produced, at times, adulterated BIOCELL Textured Breast Implants that had numerous unwanted particles and solid fragments 0f silicone on the implant surface in violation of manufacturing/ design specifications and CGMP regulations designed to ensure device quality and patient safety. 177. As a result, ALLERGAN failed t0 properly perform its duties and failed t0 implement and maintain quality control systems with respect to the texturization process for manufacturing its BIOCELL Textured Breast Implants, even though it was aware that its textured implants regularly contained contaminants, fragments, particles, and impurities in Violation of 21 C.F.R. Part 820 and 21 U.S.C. 351. 178. On information and belief, BIOCELL Textured Breast Implants were adulterated within the meaning 0f 21 U.S.C. 351(h) when they were placed in the stream 0f commerce by ALLERGAN, in that the methods used in, 0r the facilities 0r controls used for, their manufacture, packing, storage, or installation were not in conformity with the manufacturing/design specifications and CGMP design controls enumerated in 21 C.F.R. Part 820 designed t0 prevent exposing patients t0 risks 0f serious injury or death when the device is used as intended by the surgeon. -53- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 179. ALLERGAN violated these regulations, in part, by failing to establish norms and guidelines for biocompatibility, mechanical properties of the shell, modes of sterilization, packaging, and most importantly, surface texturing. As a result, ALLERGAN’S BIOCELL textured surface-produced through its unique lost-salt technique-leaves many irregular depressions 0n the surface 0f the shell. These pores are-in both diameter and height-significantly larger and much more aggressive than the manufacturing and design specifications mandated by the FDA as part of the PMAs, as well as industry standards where nodules are typically a fraction of the size. 180. Moreover, this extreme texturing process routinely leads to the shedding 0f debris from the implant surface, resulting in significantly greater quantities 0f silicone particles in the surrounding capsules than the industry standard and the product specifications. These shredded particles, over time, give rise to chronic inflammation which in turn leads to BIA-ALCL. 181. It was the duty of ALLERGAN t0 comply with the PMAs and the FDA's Quality System Regulations and Current Good Manufacturing Practices. Yet notwithstanding this duty, ALLERGAN violated the FDCA and the regulations promulgated pursuant to it. 182. As a consequence, ALLERGAN violated 21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820 by introducing or delivering for introduction into interstate commerce a device that was adulterated. 183. ALLERGAN violated 21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820 by receiving in interstate commerce a device that was adulterated and delivering the device for pay or otherwise. 184. ALLERGAN violated 21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820 by manufacturing a device that was adulterated. 185. ALLERGAN violated 21 C.F.R. § 820.30 by failing t0 establish and maintain procedures for validating the device design of BIOCELL Textured Breast Implants to -54- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD ensure that the implants conformed to patients’ needs and intended uses, including failing to test production units under actual or simulated use conditions. 186. ALLERGAN violated 21 C.F.R. § 820.50 by failing to establish and maintain procedures t0 ensure that all purchased 0r otherwise received product and services conform t0 specified requirements, including evaluating and selecting potential suppliers, contractors, and consultants 0n the basis of their ability to meet quality requirements; defining the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results; and establishing and maintaining records of acceptable suppliers, contractors, and consultants. 187. ALLERGAN violated 21 C.F.R. § 820.70(a) by failing to develop, conduct, control, and monitor production processes to ensure that the BIOCELL Textured Breast Implants conformed t0 their specifications, as well as maintaining process controls t0 ensure conformance to specifications. This includes, but is not limited t0, ensuring that the any BIOCELL Textured Breast Implants did not exceed the maximum allowable roughness. 188. ALLERGAN violated 21 C.F.R. § 820.70(h) with respect to its lost-salt process of texturizing by failing t0 establish and maintain procedures for the use and removal of such manufacturing materials to ensure that the amount of silicone particles embedded on the implant due t0 this texturizing process is limited t0 an amount that does not adversely affect the device's quality. 189. ALLERGAN violated 21 C.F.R. § 820.90(a) by failing t0 establish and maintain procedures to control texturized implants that do not conform t0 specification, including failing to adequately identify, document, evaluate, segregate, and dispose 0f nonconforming implants. 190. ALLERGAN, in Violation 0f 21 C.F.R. § 820.100(a), failed t0 establish and maintain procedures for implementing corrective and preventive action in order to properly detect recurring quality problems related t0 the lost-salt process, investigate -55- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O causes of nonconformities, identifying necessary action to correct and prevent recurrence of nonconforming implants, implementing Changes in methods to correct such quality problems, and validating the corrective and preventive action. 191. ALLERGAN violated 21 C.F.R. § 820.22 by failing t0 establish procedures for quality audits to determine the effectiveness 0f the quality system and t0 ensure corrective action related t0 BIOCELL Textured Breast Implants be taken as necessary. 192. ALLERGAN failed to adequately inspect, test, and validate BIOCELL Textured Breast Implants after completion of assembly and immediately before delivery for implantation into consumers, like Plaintiff WINDY FABE, to mitigate the development 0f bacterial accumulation and other risks which cause BIA-ALCL, as mandated by 21 C.F.R. § 820.160. 193. Upon information and belief, when BIOCELL Textured Breast Implants were manufactured, ALLERGAN had the technological capability t0 manufacture BIOCELL Textured Breast Implants in a reasonably safe manner and ALLERGAN is held to the level of knowledge 0f an expert in the field. ALLERGAN itself had alternative measures t0 make a safer product, but Chose not t0 d0 so in the interests of further its profits. 194. Plaintiff WINDY FABE was injured as a result 0f Defendants’ postmarket failure to properly implement Good Manufacturing Practices, and as a result of Defendants’ postmarket negligence, ALLERGAN’S BIOCELL Textured Breast Implants belatedly became known t0 be defective and unreasonably dangerous only after having been implanted in Plaintiff. 195. As a result of its failure to establish and maintain effective post-market quality control standards and good manufacturing practices t0 ensure defect-free products, Plaintiff suffered severe injuries. 196. Also under state law, Which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must adequately inspect, test, and validate its product and its components, and monitor its -56- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD manufacturing and quality control processes to ensure there are no deviations from product specifications or regulations that could affect the safety of its products, such as the BIOCELL Textured Breast Implants. 197. As a result 0f ALLERGAN’S postmarket failure t0 properly implement quality control procedures required by federal statute and FDA regulations, as a as a result 0f ALLERGAN'S postmarket negligence, the products were defective and unreasonably dangerous when implanted in Plaintiff. / / / / / / / / / / / / D. Statement of Facts Applicable to Plaintiff’s Intentional and Negligent Misrepresentation Claims 1. ALLERGAN spends years downplaying or dismissing the growing link between BIA-ALCL and the presence of an ALLERGAN BIOCELL Textured Breast Implant 198. The first line 0f BIOCELL Textured Breast Implants was submitted for PMA in November 1999 and approved by the FDA in May 2000 under PMA N0. P990074. These previously unregulated implants were then known as McGhan Medical RTV Saline-Filled Breast Implants and utilized ALLERGAN’S BIOCELL lost-salt technology. 199. But approximately three years prior t0 that approval, in 1997, the first reported case 0f ALCL in a patient With a MCGhan Medical RTV Saline-Filled Breast Implant (Style 168-one 0f the recalled implant styles) was published in the journal 0f Plastic and Reconstructive Surgery. Notably, the location for the lymphoma was encased in the right breast area, evidencing it was related to the implant itself. -57- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 200. Since then, there have been dozens of medical studies and regulatory alerts examining the progression of BIA-ALCL related knowledge, with one of the earliest studies being commissioned by ALLERGAN. 201. In 2003, a team of ALLERGAN consultants, advisers, and research coordinators initiated a 14-year prospective clinical study concerning 42,035 BIOCELL Textured Breast Implants and their link to BIA-ALCL. 202. Importantly, the ALLERGAN Study was not designed to determine whether there exists a link between BIOCELL Textured Breast Implants to BIA-ALCL- thatfact was already presumed by the ALLERGAN Study. Instead, the ALLERGAN Study was seeking t0 determine if employing certain sterilization techniques at the time 0f implantation 0f a BIOCELL Textured Breast Implants would mitigate the risk 0f developing BIA-ALCL in light 0f the disease’s nexus t0 bacterial accumulation.” 203. Also in 2003, a case report and review 0f the literature in The Archives of Pathology and Laboratory Medicine, Anaplastic Large Cell Lymphoma Arising in a Silicone Breast Implant Capsule: A Case Report and Review 0f the Literature, that a silicone gel-filled implant placed in the left breast in 1991 resulted in BIA-ALCL in the left breast diagnosed in March 2000. Notably, pathology 0f the left breast capsule showed refractile material consistent With silicone particles in close proximity to the tumor cells. 204. In 2007, ALLERGAN received at least three complaints of BIA-ALCL in women implanted with silicone filled breast implants, two 0f which were confirmed to have been implanted with ALLERGAN textured breast implants. The number 0f complaints received by ALLERGAN of BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 205. BIA-ALCL first garnered attention after 2008, When a study described four patients With a CD30-positive T-cell lymphoproliferative disorder surrounding breast implants. 24 Macrotextured Breast Implants with Defined Steps t0 Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants. Plastic and Reconstructive Surgery. 140. 427-431. -58- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 206. In November 2008, the Journal of the American Medical Association published a study by a group 0f Dutch researchers that had identified 11 patients with breast implants and reported BIA-ALCL of the breast diagnosed between 1990 and 2006. The study found a positive association between breast implants and the development 0f ALCL, with an odds ratio 0f 18:1 -meaning that patients with implants were 18 times more likely t0 develop BIA-ALCL than patients without breast implants. 207. In 2008, ALLERGAN received at least nine complaints 0f BIA-ALCL in women implanted with silicone filled breast implants, five of which were confirmed to have been implanted ALLERGAN textured breast implants. The number of complaints received by ALLERGAN of BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 208. On November 24, 2008, a healthcare professional reports to an ALLERGAN employee the events of BIA-ALCL and seroma. Rather than reporting the event t0 the FDA in an MDR, ALLERGAN buries the complaint in the 2009 Alternative Summary Reporting spreadsheet. 209. In 2009, ALLERGAN received at least six complaints of BIA-ALCL in women implanted with silicone filled breast implants, three 0f which were confirmed t0 have been implanted with ALLERGAN textured breast implants. The number of complaints received by ALLERGAN of BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 210. In 2010, ALLERGAN received at least four complaints of BIA-ALCL in women implanted with silicone filled breast implants. The number of complaints 0f BIA- ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 211. On May 25, 2010, ALLERGAN files an MDR for the first time following an event of BIA-ALCL associated with one 0f their saline filled breast implants which resulted in the death 0f the patient. The entirety 0f ALLERGAN’S manufacturer -59- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O narrative for this death was redacted by ALLERGAN as ”(b)(4)” meaning the information constitutes ”trade secrets and commercial 0r financial information.” 212. In January 2011, the FDA issued a report titled ”Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants.” The report stated that ”in a thorough review 0f scientific literature published from January 1997 through May 2010, the FDA identified 34 unique cases 0f ALCL.” The FDA concluded, ”The FDA believes that there is a possible association between breast implants and ALCL.” The FDA further noted that, ”ALCL has been found more frequently in association with breast implants having a textured outer shell rather than a smooth outer shell.” 213. Despite the FDA’s January 2011 Report, a spokeswoman for ALLERGAN, whose products were linked t0 the cases, downplayed the concerns in an emailed statement: ”A woman is more likely to be struck by lightning than get this condition,” said Caroline Van Hove. ”Patients’ safety is Allergan’s absolute first priority and we continue all efl’orts t0 collect and analyzefurther information about the very rare occurrence ofALCL in patients with breast implants.” 214. In 2011, ALLERGAN received at least nine complaints 0f BIA-ALCL in women implanted with silicone filled breast implants, all nine 0f which were confirmed t0 have been implanted with ALLERGAN textured breast implants. The number 0f complaints received by ALLERGAN of BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 215. On March 16, 2011, the FDA received the first MDR from ALLERGAN for an event 0f BIA-ALCL associated with one of their silicone filled breast implants Where the operative notes described a ”moderate brown liquid” in the implant capsule. 216. In 2012, the first cases of BIA-ALCL in women with breast implants began t0 be reported in Australia. This prompted ALLERGAN t0 publish a second study, in May 2012, estimating the incidence 0f developing BIA-ALCL at 1.46 for every 100,000 breast implants. -60- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 217. The ALLERGAN-sponsored study was described as using ”crude figures,” but nevertheless was used by the company to downplay the risk to patients and effectively served t0 silence debate among academics and regulators on the emerging issue. 218. In 2012, ALLERGAN received at least seventeen complaints 0f BIA-ALCL in women implanted with silicone filled breast implants, fourteen 0f Which were confirmed to have been implanted with ALLERGAN textured breast implants. The number of complaints received by ALLERGAN of BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 219. In 2013, ALLERGAN received at least twenty-two complaints 0f BIA- ALCL in women implanted with silicone filled breast implants, twenty-one of Which were confirmed to have been implanted with ALLERGAN textured breast implants. The number of complaints received by ALLERGAN 0f BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 220. On December 8, 2014, a major analysis 0f the breast implant and BIA- ALCL connection was published, which identified 173 cases 0f BIA-ALCL. The authors reviewed 37 articles in the world literature reporting 0n 79 patients and collected another 94 unreported cases. The study confirmed that there are n0 known pure smooth implant cases. Additionally, the study determined that out 0f 170 breast implants, in 61 cases the manufacturer was unknown yet in 97 cases (or 56%) the implants were BIOCELL Textured Breast Implants. 221. In 2014, ALLERGAN received at least twenty-six complaints 0f BIA-ALCL in women implanted with silicone filled breast implants, eighteen 0f which were confirmed to have been implanted with ALLERGAN textured breast implants. The number of complaints received by ALLERGAN 0f BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 222. Also, in March 2015, the French National Cancer Institute (Agence Nationale de Sécurité du Médicament, ”ANSM”) announced, ”There is a clearly -61- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O established link between the occurrence of this disease and the presence of a breast implant.” 223. In 2015, ALLERGAN received at least thirty-six complaints of BIA-ALCL in women implanted with silicone filled breast implants, thirty-two 0f which were confirmed to have been implanted with ALLERGAN textured breast implants. The number of complaints received by ALLERGAN 0f BIA-ALCL in women implanted with saline filled breast implants for the same time period is still unknown. 224. In 2016, more information continued to come out addressing the link between breast implants and BIA-ALCL as regulatory agencies around the world began making more definitive and stronger statements alerting of the link. For example, in May 19, 2016, the World Health Organization (”WHO”) issued a guidance definitively linking breast implants to ALCL and officially named the disease ”breast implant associated ALCL.” 225. In July 2016, the ANSM released an update stating that, based upon 29 cases of ALCL reported, and due to the predominance 0f textured cases, it was calling for all implant manufacturers selling in France to submit Clear data for textured implants within the year 0r their respective devices would be restricted from sale. 226. In November 2016, Australia’s Therapeutic Goods Administration (”TGA”) convened an expert advisory panel t0 discuss the association between breast implants and BIA-ALCL and to provide ongoing advice. In December 2016, the TGA issued a report about BIA-ALCL which indicated a substantially higher risk associated with textured versus smooth implants. Furthermore, the TGA-reported incidence rate was in the range 0f 1:1,000-10,000 for patients With textured implants 227. On December 28, 2016, ALLERGAN sponsored a third study purported to examine the incidence 0f capsular contracture, malposition and late seroma in patients that received the ALLERGAN’S Style 410 breast implant. The study found that out 0f the 17,656 patients, four developed ALCL. This would in fact suggest an incidence rate, at the time 0f the study, 0f close t0 124,000 for the now recalled Style 410 implants. -62- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Nevertheless, the study found that the incidence of capsular contracture, implant malposition and late seroma were 10w enough t0 conclude that, ”[t]hese data reaffirm the safety 0f the Natrelle 410 breast implant.” 228. In April 2017, researchers from the MD. Anderson Cancer Center in Houston performed a literature review 0n the etiology of ALCL and confirmed that ”textured implants are commonly implicated in the development” 0f BIA-ALCL. Additionally, the study pulled information from the adverse events reports from the FDA’s MAUDE database to determine the distribution of BIA-ALCL by manufacturer. The data showed that out of the US cases reported to the FDA MAUDE database, 184 (or 80.3%) of the ALCL cases reported were ALLERGAN’s BIOCELL Textured Breast Implants. 229. In March 2018, the FDA issued an update which reported a total of 414 received reports of BIA-ALCL- up from 359 a year earlier. The report stated that the lifetime risk for BIA-ALCL is between 1 in 3,817 and 1 in 30,000 women with textured breast implants. 230. In August 2018, the FDA reported that of the 272 cases of BIA-ALCL for which the implant surface was known, approximately 89% were textured. The FDA further noted that the real number of cases and size of the risk was not known, because there was a lack of information about how many women in the United States and worldwide had received implants. 231. On August 3, 2018, researchers from the MD. Anderson Cancer Center reported that the risk of BIA-ALCL for patients implanted With ALLERGAN’S BIOCELL Textured Breast Implants after a decade 0f could be as great as 1 in 2,200. This estimate was extrapolated from ALLERGAN’S own two studies of its Style 410 BIOCELL Textured Breast Implants, published on December 28, 2016, as discussed above. At the time the study was published, four women out 0f 17,656 had developed BIA-ALCL. By August 2018, eight women of the 17,656 had developed BIA-ALCL. -63- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 232. As discussed further below, and despite these mounting issues, ALLERGAN continued to downplay and dismiss the prevalence of BIA-ALCL in connection with its Textured Breast Implants, and continued to market, sell, distribute, and push those implants onto consumers, including Plaintiff, around the world. 2. As early as 2010, when ALLERGAN would publicly address BIA-ALCL in its adverse event reports, they were riddled with half-truths and misrepresentations 233. Despite actually possessing exclusive knowledge about the risks of BIA- ALCL particular to the BIOCELL Textured Breast Implants, for decades ALLERGAN failed t0 publish, disseminate, or otherwise communicate, in any form, and by any means, the true risk 0f BIA-ALCL. ALLERGAN omitted material information about the disease not just to the FDA, but also t0 the medical and scientific community, device user facilities, and consumers like Plaintiff as part of a deliberate and intentional effort to induce such persons and entities t0 rely 0n the omissions and t0 allow the BIOCELL Textured Breast Implants t0 be in and remain in the marketplace for purchase. Through its omissions alone, ALLERGAN actively conspired to and did conceal the risks 0f BIA- ALCL associated with the BIOCELL Textured Breast Implants. 234. Moreover, despite the growing number of complaints, studies and concerns regarding the link between textured implants and BIA-ALCL, ALLERGAN continued to make false and misleading statements regarding BIA-ALCL and the presence of an ALLERGAN BIOCELL Textured Breast Implant. 235. In particular, ALLERGAN’S false and incomplete statements surfaced in its hundreds 0f adverse event reports prepared following events of BIA-ALCL. 236. As described above, the reporting requirements under 21 C.F.R. § 803.52 are stringent and a medical device manufacturer ”must include” in the medical device reports information ”reasonably known” t0 it, including: (1) an identification 0f the adverse event 0r product problem; -64- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O (2) a description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (3) a summary of the evaluation of the device, 0r an explanation of why an evaluation was not perform; (4) evaluation codes (including event codes, method of evaluation, result, and conclusion codes); (5) whether remedial action was taken and the type of action; and (6) an explanation 0f why any required information was not provided in the MDR and the steps taken to obtain this information. 237. A medical device report must contain such information if it is known, or reasonably known to the manufacturer. 21 C.F.R. § 803.50(b). Information considered reasonably known includes any information: 1) that can be obtained by contacting a user facility, importer, or other initial reporter; 2) that is in the manufacturer’s possession; 0r 3) that can be obtained by analysis, testing 0r other evaluation 0f the device. 21 C.F.R. § 803.50(b)(i)-(iii). 238. Thus, ALLERGAN had a duty 0n all matters related t0 events of BIA- ALCL associated with their BIOCELL Textured Breast Implants to report in a manner that avoided omitting any material fact required by 21 C.F.R. § 803.52 that was known or reasonably known t0 it. 239. However, as part 0f a scheme designed t0 downplay the risks of BIOCELL Textured Breast Implants in the MDRS and t0 induce the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff into believing that there was n0 unique risks 0f BIA-ALCL associated with their BIOCELL Textured Breast Implants in order t0 sell more implants, ALLERGAN willfully concealed and failed to disclose all required information reasonably known to it in the adverse event reports. -65- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 240. In hundreds of adverse event reports following complaints from health care facilities, hospitals, physicians, nurse, and the patients themselves pertaining to events related to BIA-ALCL, rather than providing an honest account of the relationship between the device and the occurrence 0f BIA-ALCL in the report based 0n the knowledge in its possession as required by the applicable regulations, ALLERGAN for years provided incomplete information and/or simply quoted its device labeling. 241. For example, in an MDR dated November 1, 2010, ALLERGAN stated in its narrative for an event of BIA-ALCL: Device labeling addresses [. . .] There were no reported events of cancer including lymphoma for patients in the a95/r95 study included in the labeling for saline breast implants [. . .] "If unusual symptoms occur after surgery, such as fever 0r noticeable swelling 0r redness in one breast, you should contact your surgeon immediately. ". (Ratified by ALLERGAN Director 0f Global Product Support, Lee Champion, 71 South Los Carneros, Goleta, California 93117.) 242. Again, in a medical device report regarding BIA-ALCL dated March 25, 2011, ALLERGAN stated: Device labeling addresses: there were no reported event of lymphoma/alcl for pts in the (b)(4) study included in the labeling for saline breast implants. "if unusual symptoms occur after surgery, such as fever or noticeable swelling or redness in one breast, you should contact your surgeon immediately. ". (Ratified by ALLERGAN Director of Global Product Support, Lee Champion, 71 South Los Carneros, Goleta, California 93117) 243. On July 5, 2012: Device labeling reviewed: there were n0 reported events of lymphoma/alcl, for pts in the core study, in the labeling for silicone implants. (Ratified by ALLERGAN Director of Global Product Surveillance, Karen Herrera, 71 South LOS Carneros, Goleta, California 93117.) 244. On December 27, 2012: Allergan product labeling for saline implants: there were no reported events 0f lymphoma/alcl, for patients in the (b)(4) study, as well as the -66- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O (b)(4) study ((b)(4) study) included in the labeling for saline breast implants. (Ratified by ALLERGAN Director 0f Global Product Surveillance, Karen Herrera, 71 South Los Carneros, Goleta, California 93117) 245. On May 2, 2014: Device labeling reviewed: there were no reported events 0f lymphoma/alcl observed in the care study, in the labeling for silicone implants. There were n0 reported events 0f lymphoma/alcl observed in the (b)(4) study included in the labeling for saline breast implants. (Ratified by ALLERGAN Director 0f Global Product Surveillance, Karen Herrera, 71 South Los Carneros, Goleta, California 93117.) 246. On March 5, 2015: Potential adverse events that may occur With saline-filled breast implant surgery include: [. . .] Published studies indicate that breast cancer is n0 more common in women With implants than those without implants. A large, long-term follow-up found no significant increases in the risk rates for a wide variety 0f cancers, including stomach cancer, leukemia, and lymphoma. (Ratified by ALLERGAN Quality Assurance Associate, Krista Alvarado, 301 W Howard Lane #100, Austin, Texas 78753.) 247. On June 25, 2015: Based 0n the info reported t0 fda and found in medical literature, a possible association has been identified between breast implants and the rare development 0f anaplastic large cell lymphoma (alcl), a type 0f non- hodgkins' lymphoma. Women with breast implants may have a very small but increased risk of developing alcl in the fluid or scar capsule adjacent to the implant. Alcl has been reported globally in pts with an implant history that includes allergan’s and other mfrs’ breast implants. (Ratified by ALLERGAN Quality Assurance Associate, Krista Alvarado, 301 W Howard Lane #100, Austin, Texas 78753.) 248. On March 31, 2016: Device labeling addresses: "lymphoma, including anaplastic large t-cell lymphoma (alcl) - information from medical literature has suggested a possible association, without evidence 0f causation, between breast implants and the very rare occurrence of alcl in the breast. The disease is exceptionally rare, may present as a late occurring peri-prosthetic seroma, -67- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O and occurs in women with and without breast implants. (Ratified by ALLERGAN Director 0f Global Product Surveillance, Suzanne Wojcik, 301 W Howard Lane #100, Austin, Texas 78753.) 249. On July 26, 2017: Device labeling: alcl has been reported globally in patients with an implant history that includes allergan’s and other manufacturers’ breast implants. You should consider the possibility of alcl when you have a patient with late onset, persistent peri-implant seroma. (Ratified by ALLERGAN Director 0f Global Product Surveillance, Suzanne Wojcik, 301 W Howard Lane #100, Austin, Texas 78753.) 250. Finally, after a decade 0f disinformation but nonetheless still inadequately, 0n February 24, 2018, ALLERGAN begins t0 state: Based 0n information reported to global regulatory agencies and found in medical literature, an association has been identified between breast implants and the development 0f anaplastic large cell lymphoma (alcl), a type of non-hodgkin’s lymphoma. Women With breast implants may have a very small but increased risk 0f developing breast implant associated alcl (bia-alcl) in the fluid or scar capsule adjacent t0 the implant, with documented potential for local, regional, and distant spread of the cancer with mortality reported in rare cases. Bia-alcl has been reported globally in patients with an implant history that includes allergan’s and other manufacturers’ breast implants with various surface properties, styles, and shapes. Most of the cases in the literature reports describe a history of the use of textured implants. (Ratified by ALLERGAN Director of Global Product Surveillance, Suzanne Wojcik, 301 W Howard Lane #100, Austin, Texas 78753.) 251. In light of ALLERGAN’S sophisticated knowledge 0f the nature of the BIA- ALCL and its relationship to its BIOCELL Textured Breast Implant-which was exclusively known internally within ALLERGAN as early as 2003-each of the above- representations by ALLERGAN, and the hundreds more like them, were false, incomplete, and misleading in the context in Which they were made, and were known t0 be so when made. -68- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 252. The principle fraudulent omission in these adverse events was the failure to acknowledge that BIA-ALCL is exclusively found in textured implants and that ALLERGAN’S BIOCELL Textured Breast Implants are, byfar, associated With more cases than any other type 0f textured implant. 253. These representations created the false impression that the full extent of BIA-ALCL’S relationship with the textured breast implants was already a known and disclosed risk, and further that ALLERGAN'S breast implants were no more likely to be found in individuals suffering from BIA-ALCL than other companies' products. 254. Plaintiff, by and through the FDA, medical and scientific community, and her device user facility, justifiably relied upon ALLERGAN’S misleading and incomplete representations concerning BIA-ALCL and its nexus to the BIOCELL Textured Breast Implants. Unaware of the true risks 0f BIA-ALCL, Plaintiff succumbed to the misrepresentations of ALLERGAN, and 0n 0r about February 2017, was implanted with BIOCELL Textured Breast Implants. 255. Had Plaintiff known the true facts relating t0 BIA-ALCL and its nexus to the BIOCELL Textured Breast Implants, Plaintiff would not have elected t0 be implanted with BIOCELL Textured Breast Implants, but rather would have Chosen a different style of implant or forwent implantation altogether. E. Statement of Facts Relating to Causation Applicable to A11 Counts 1. The connection between ALLERGAN’S failure to report and Plaintiff’s injuries 256. As a result of Allergan's failure t0 appropriately file MDRs t0 the FDA as required by 21 U.S.C. 360i and 21 C.F.R. § 803.50-its BIOCELL textured implants were misbranded postmarket. 257. Plaintiff further alleges that Defendants failed to take reasonable postmarket corrective action to warn, either directly 0r through an appropriate channel, -69- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD physicians who had implanted its devices, and patients in whom they had been implanted, of the risks of BIA-ALCL. 258. Such warnings, had they been given, would have caused physicians and patients, like Plaintiff, to take proper precautions t0 determine whether the substantially increased risk 0f BIA-ALCL should be avoided by electing not t0 use ALLERGAN'S BIOCELL Textured Breast Implants. Or, the FDA would have recalled the BIOCELL Textured Breast Implants before Plaintiff ever had them implanted. 259. Allergan was 0r should have been aware as early as 1997 that its BIOCELL Textured Breast Implants carried a much greater risk of BIA-ALCL than other textured implant products, or compared t0 smooth implant products-yet Allergan failed t0 give effective postmarket notice to the FDA, physicians, and patients to put them 0n adequate notice 0f the problem, and failed to inform them of how t0 avoid that risk. 260. Also under state law, which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must timely and appropriately report adverse events concerning the safety 0f its products. ALLERGAN was under a continuing duty under state law t0 adequately report injuries and problems with its devices, including the BIOCELL Textured Breast Implants, to the FDA. 261. As a result of Allergan's postmarket failure to properly implement procedures required by federal statute and FDA regulations, and as a result of ALLERGAN'S postmarket negligence, the defective and unreasonably dangerous nature 0f the product became known only after having been implanted in Plaintiff, and otherwise would have never would have been implanted in the Plaintiff at all. 2. The connection between ALLERGAN’S failure to implement quality control systems and Plaintiff’s injuries 262. As a result of ALLERGAN’S failure to establish such quality systems as required by 21 C.F.R. Part 820-its BIOCELL Textured Implants were adulterated within -70- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O the meaning of 21 U.S.C. 351(h) when they were placed in the stream of commerce by ALLERGAN. 263. Plaintiff further alleges that Defendants failed to take reasonable postmarket corrective and preventive action in order t0 properly detect recurring quality problems related t0 the lost-salt process and implement changes in methods t0 correct such quality problems. 264. Such corrective and preventive action, had they been implemented, would have prevented Plaintiff from being exposed to an aggressive, potentially fatal form of lymphoma. Or, the FDA would have recalled the BIOCELL Textured Breast Implants before Plaintiff ever had them implanted. 265. Also under state law, Which does not impose duties 0r requirements materially different from those imposed by federal law, the manufacturer must adequately inspect, test, and validate its product and its components, and monitor its manufacturing and quality control processes to ensure there are n0 deviations from product specifications or regulations that could affect the safety of its products, such as the BIOCELL Textured Breast Implants. 266. As a result of ALLERGAN'S postmarket failure t0 properly implement quality control procedures required by federal statute and FDA regulations, as a as a result of ALLERGAN'S postmarket negligence, the products were defective and unreasonably dangerous when implanted in Plaintiff. 267. ALLERGAN was 0r should have been aware as early as 1997 that its BIOCELL Textured Breast Implants carried a much risk 0f BIA-ALCL than other textured implant products, or compared to smooth implant products -yet ALLERGAN failed to implement effective postmarket action t0 mitigate 0r eliminate the risk of BIA- ALCL, and failed to inform physicians and patients of how that risk could be avoided. 3. The connection between ALLERGAN’S misrepresentations and Plaintiff’s injuries -71- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 268. As discussed above, adverse event reports published in the FDA’s MAUDE database represent a public communication by a manufacturer about a device’s performance and its relationship to a particular adverse health event. 269. These adverse event reports are routinely reviewed by the FDA t0 monitor device performance, detect potential device-related safety issues, and contribute t0 benefit-risk assessments 0f these products. 270. Moreover, such reports are relied upon by the medical and scientific community, including cancer researchers as described above, as a valuable source of information in learning about the genesis 0f an adverse health event and any adverse health trends associated With a medical device. 271. Device user facilities, including hospitals, outpatient facilities, nursing homes and surgical facilities, routinely analyze the medical device reports when determining the risks of selling one particular medical device over another, 0r one brand over another. For example, with respect to breast implants, a device user facility relies upon the information contained in the medical device reports when deciding whether to sell smooth 0r textured implants, 0r ALLERGAN’S brand over a competitor. 272. T0 the extent the medical device reports contain false, inaccurate, 0r incomplete information, the FDA is deprived of Vital information needed t0 detect potential device-related safety issues and disseminate public alerts about particular device problem and/or its association to a particular disease. 273. Likewise, the medical and scientific community is deprived 0f the information needed to educate their patients and obtain informed consent about the risks in Choosing a particular device. 274. Further, device user facilities are unable to make informed decisions about the risks of offering for purchase a particular medical device over others on the market. 275. ALLERGAN fraudulently omitted in its adverse event reports associated with the BIOCELL Textured Breast Implants that BIA-ALCL is exclusively found in -72- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O textured implants and that ALLERGAN’S BIOCELL Textured Breast Implants are associated With more cases than any other type of textured implant. 276. These incomplete representations created the false impression that the full extent 0f BIA-ALCL’S relationship with the textured breast implants was already a known and disclosed, and further that ALLERGAN'S breast implants were no more likely t0 be found in individuals suffering from BIA-ALCL than other companies' products. 277. Moreover, ALLERGAN had actual knowledge of the material facts as alleged herein regarding the risks of BIA-ALCL and the presence 0f an ALLERGAN BIOCELL Textured Breast Implant. However, for decades, ALLERGAN outright failed 0r refused disclose such facts in any form, Whether it by through their adverse event reports 0r any other communication, although such facts were readily available. 278. Plaintiff, by and through the FDA, medical and scientific community, and her device user facility, justifiably relied upon ALLERGAN’S omissions, and misleading and incomplete representations concerning BIA-ALCL and its nexus t0 the BIOCELL Textured Breast Implants. Unaware 0f the true risks 0f BIA-ALCL, Plaintiff succumbed t0 the omissions and misrepresentations 0f ALLERGAN, and 0n 0r about February 2017, was implanted with BIOCELL Textured Breast Implants. 279. As a result of Allergan's failure to disclose all of the known risks associated with BIOCELL Textured Breast Implants and BIA-ALCL, including in the adverse event reports, and as a result 0f ALLERGAN'S fraudulent misrepresentations and omissions, the defective and unreasonably dangerous nature of the product became known only after having been implanted in Plaintiff, and otherwise would have never would have been implanted in the Plaintiff at all. FIRST CAUSE OF ACTION (Strict Product Liability-Failure to Warn) Against All Defendants -73- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 280. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 281. At all times pertinent hereto, Defendants directly or through their agents, apparent agents, servants 0r employees designed, manufactured, tested, marketed, and commercially distributed its BIOCELL Textured Breast Implants t0 clinics, hospitals and plastic surgeons, Who ultimately operated and implanted them in consumers' bodies. 282. Defendants directly or through their agents, apparent agents, servants 0r employees designed, manufactured, tested, marketed, and commercially distributed the BIOCELL Textured Breast Implants implanted into Plaintiff’s body. 283. The BIOCELL Textured Breast Implants that were implanted into Plaintiff were defective and unreasonably dangerous when they left the possession 0f the Defendants as a result of inadequate warnings, including: (a) failing t0 provide adequate warnings, information, 0r both, to alert consumers and their prescribing physicians that the BIOCELL Textured Breast Implants posed an unreasonably high risk of causing BIA-ALCL once implanted; (b) failing t0 properly market the BIOCELL Textured Breast Implants in light of the BIOCELL Textured Breast Implants’ cancerous propensities; (c) failing to ensure the performance of the BIOCELL Textured Breast Implants conformed to the representations made by Defendants concerning the risk 0f BIA-ALCL; and (d) representing that the BIOCELL Textured Breast Implants were suitable for their intended use; and (e) failing t0 handle the BIOCELL Textured Breast Implants in a manner that conformed t0 applicable federal laws and regulations. 284. Such warnings, if given, would have caused such physicians and patients t0 be informed When selecting the appropriate breast implant and would have enabled patients, including Plaintiff, t0 avoid the risks of developing BIA-ALCL. -74- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 285. Rather, Defendants continued to disseminate product labeling that was inadequate and defective despite having received postmarket information regarding BIA-ALCL after the FDA approved such labeling-information Defendants failed to report t0 FDA in Violation 0f the MDA and the regulations promulgated thereunder. 286. At all relevant times, under federal law and regulation, Defendants were under a continuing duty t0 monitor the product after premarket approval, and t0 discover and report to the FDA any complaints about the product's performance and any adverse health consequences 0r AERS 0f which it became aware and that are, or may be, attributable t0 the product. 287. Defendants failed to submit appropriate medical device reports t0 inform the FDA 0f the danger 0f developing BIA-ALCL in connection with the BIOCELL Textured Breast Implants, as required by 21 C.F.R. § 803.50, even though they should have been aware 0f such adverse incidents and were actually aware of such incidents, including at least 22 events of BIA-ALCL Defendants had received between 2007-2010. 288. Instead, ALLERGAN exploited the FDA’s non-public ASR program to bury evidence of its BIOCELL Textured Breast Implants causing BIA-ALCL. As a result, Defendants failed t0 fulfill its duty t0 report to the FDA per 21 C.F.R. § 803.50, and warn physicians or patients-including Plaintiff-implanted with ALLERGAN’S BIOCELL Textured Breast Implants 0f the dangers of BIA-ALCL. 289. In addition to its unlawful use of the ASR program, ALLERGAN failed to: (a) Investigate and evaluate complaints 0f BIA-ALCL per 21 C.F.R. §§ 820.198 and 803.18(e) and prepare corresponding medical device reports; (b) Timely submit reports of BIA-ALCL per 21 C.F.R. § 803.50(a) and instead attempted to transmit such reports years after first receiving notice of the event; (c) Provide all information reasonably known t0 it per 21 C.F.R. § 803.50(b) in its reports 0f BIA-ALCL but rather simply regurgitated its misleading and deficient labeling; and -75- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O (d) Use the appropriate device problem code for reports of BIA-ALCL per 21 C.F.R. § 803.52 but instead represented there was ”no apparent adverse event.” 290. Defendants, as developers and manufacturers 0f the BIOCELL Textured Breast Implants, are held t0 the level 0f knowledge of experts in the field of that type 0f breast implant, and had a duty t0 warn its consumers and prescribing physicians 0f the dangers associated with the implants and failed t0 d0 so. 291. At the time Plaintiff’s physician implanted the BIOCELL Textured Breast Implants, her physician did not have substantially the same knowledge as the Defendants about the unreasonably high risks of causing BIA-ALCL because the Defendants failed t0 provide adequate warnings 0f those risks. 292. As the direct and proximate result of Defendants’ failure t0 warn 0f the defective condition 0f the BIOCELL Textured Breast Implants, the Plaintiff was implanted with BIOCELL Textured Breast Implants and suffered, 0r will suffer, painful removal procedures t0 mitigate the risk 0f developing BIA-ALCL, as well as any treatment, therapy, recovery, and expense associated With the removal 0f the BIOCELL Textured Breast Implants, the potential for the development of BIA-ALCL, and any condition or symptoms associated with BIA-ALCL or the prevention 0f that issue. 293. As a further proximate result of Defendants’ failure to warn of the defective condition of the BIOCELL Textured Breast Implants, Plaintiff suffered debilitating physical pain and mental suffering, was/Will be required t0 undergo additional surgeries and other procedures, incurred substantial hospital, medical, nursing and pharmaceutical expenses therefrom; suffered emotional distress, anxiety, depression and disability; loss of earnings; and loss of quality 0f life, and all 0f these injuries are permanent and continuing. 294. The FDCA contains an express preemption provision, 21 U.S.C. 360k(a), which as relevant, states: ”no State 0r political subdivision 0f a State may establish or continue in effect with respect t0 a device intended for human use any requirement-- (1) -76- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD which is different from, or in addition to, any requirement applicable under this Act to the device, and (2) which relates to the safety or effectiveness 0f the device or to any other matter included in a requirement applicable t0 the device under this Act.” 295. This cause 0f action is based 0n the Defendants’ postmarket Violations 0f federal safety statutes and regulations. 296. Moreover, Plaintiff does not bring the underlying action as an implied statutory cause 0f action but rather she is pursuing parallel state common law claims based upon Defendants’ Violations 0f the applicable federal statutes and regulations. 297. Plaintiff’s strict product liability for failing t0 warn Claim is, thus, not preempted by Section 360k(a), because the Violations alleged are all based 0n federal statutory and regulatory standards which includes n0 ”requirement which is different from, 0r in addition t0, any requirement applicable under” the FDCA and regulations promulgated thereunder. As such, the claims set forth in this cause 0f action contain requirements that are parallel to the FDCA and regulations promulgated thereunder. SECOND CAUSE OF ACTION (Strict Product Liability-Manufacturing Defect) Against All Defendants 298. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 299. At all times material hereto, Defendants, directly or indirectly, created, manufactured, assembled, designed, sterilized, tested, packaged, labeled, marketed, promoted, advertised, sold and/or distributed into the stream 0f commerce BIOCELL Textured Breast Implants, including the BIOCELL Textured Breast Implants implanted into Plaintiff. 300. Defendants directly or through their agents, apparent agents, servants 0r employees designed, manufactured, tested, marketed, and commercially distributed the BIOCELL Textured Breast Implants implanted into Plaintiff’s body. -77- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 301. The BIOCELL Textured Breast Implants that were implanted into Plaintiff were defective and unreasonably dangerous when they left the possession 0f the Defendants in one or more of the following ways: (a) (b) (d) (e) (f) (g) (h) manufacturing and selling BIOCELL Textured Breast Implants that differ from the specifications set forth in the PMA, its Supplements, the Conditions 0f Approval, and/or other federal regulations; manufacturing and selling BIOCELL Textured Breast Implants with nonconforming materials and uncertified components, inconsistent With the specifications set forth in the PMA, its Supplements, the Conditions of Approval, 0r other federal regulations; manufacturing, distributing, and selling BIOCELL Textured Breast Implants knowing, 0r while capable 0f knowing, that they created an unreasonably high risk of causing BIA-ALCL when implanted into patients, including the Plaintiff; incorporating components into BIOCELL Textured Breast Implants that could not stand up to normal usage; failing or refusing t0 properly meet the applicable standard of care by not complying with applicable federal laws and regulations in manufacturing, marketing, selling, and distributing the BIOCELL Textured Breast Implants; failing 0r refusing t0 exercise reasonable care in its inspecting and testing of the BIOCELL Textured Breast Implants both before and after they were placed on the market which, if properly performed, would have shown that the device caused serious side effects, including BIA-ALCL; failing or refusing to exercise reasonable care in its manufacturing and quality control processes; and placing an unsafe and defective breast implant into the stream 0f COIIIIIIQI'CQ. -78- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 302. Such measures, if implemented, would have mitigated or eliminated the risk posed by silicone particles shredding from the BIOCELL Textured Breast Implants and would have enabled patients, including Plaintiff, to avoid the risks of developing BIA-ALCL. 303. At all relevant times, under federal law and regulation, Defendants were also required t0 comply with the FDA'S Quality System Regulations and Current Good Manufacturing Practices under 21 C.F.R. Part 820, which, among other things, requires that each manufacturer put procedures in place to test products for compliance with product specifications, document and Check compliance With product specifications before products are accepted for sale and use, and identify and control all products that fail t0 conform with product specifications. 304. It was the duty of the Defendants to comply with the FDCA, and the regulations promulgated pursuant to it. Yet, notwithstanding this duty, Defendants violated the FDCA and regulations in one 0r more of the following ways: (a) introducing or delivering for introduction into interstate commerce a device that was adulterated due to differences from the specifications set forth in the PMA, its Supplements (21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820); (b) receiving in interstate commerce a device that was adulterated and delivering the device for pay or otherwise (21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820); (C) manufacturing a device that was adulterated (21 U.S.C. §§ 331, 351(h) and 21 C.F.R. Part 820); (d) failing to establish and maintain procedures for validating the device design of BIOCELL Textured Breast Implants to ensure that the implants conformed t0 patients’ needs and intended uses, including failing t0 test production units under actual 0r simulated use conditions (21 C.F.R. §820.30); -79- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD (e) (f) (g) (h) (i) failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including evaluating and selecting potential suppliers, contractors, and consultants 0n the basis of their ability t0 meet quality requirements; defining the type and extent 0f control t0 be exercised over the product, services, suppliers, contractors, and consultants, based 0n the evaluation results; and establishing and maintaining records of acceptable suppliers, contractors, and consultants (21 C.F.R. §820.50); failing to develop, conduct, control, and monitor production processes to ensure that the BIOCELL Textured Breast Implants conformed t0 their specifications, as well as maintaining process controls t0 ensure conformance to specifications. This includes, but is not limited t0, ensuring that the any BIOCELL Textured Breast Implants did not exceed the maximum allowable roughness (21 C.F.R. §820.70(a)); failing t0 establish and maintain procedures With respect to its lost-salt process of texturizing for the use and removal 0f such manufacturing materials to ensure that the amount of silicone particles embedded on the implant due t0 this texturizing process is limited t0 an amount that does not adversely affect the device's quality (21 C.F.R. §820.70(h)); failing to establish and maintain procedures to control texturized implants that do not conform to specification, including failing t0 adequately identify, document, evaluate, segregate, and dispose 0f nonconforming implants (21 C.F.R. §820.90(a)); failing t0 establish and maintain procedures for implementing corrective and preventive action in order to properly detect recurring quality problems related t0 the lost-salt process, investigate causes 0f nonconformities, identifying necessary action to correct and prevent recurrence 0f nonconforming implants, implementing changes in methods -80- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O to correct such quality problems, and validating the corrective and preventive action (21 C.F.R. §820.100(a)); (j) failing to establish procedures for quality audits to determine the effectiveness 0f the quality system and to ensure corrective action related t0 BIOCELL Textured Breast Implants be taken as necessary (21 C.F.R. §820.22); (k) failing to adequately inspect, test, and validate BIOCELL Textured Breast Implants after completion of assembly and immediately before delivery for implantation into consumers, like Plaintiff, t0 mitigate the development 0f bacterial accumulation and other risks which cause BIA-ALCL (21 C.F.R. §820.160); and (1) failing t0 monitor, receive, review, and evaluate and/or investigate complaints received from breast implant patients and their physicians, failing t0 timely identifying any problems With one of its devices and, failing t0 take appropriate corrective actions to ensure consumer safety (21 C.F.R. § 820.198). 305. Because Defendants failed to follow specifications, regulations, and required good manufacturing practices, Plaintiff’s BIOCELL Textured Breast Implants were at a heightened risk of causing the development of BIA-ALCL. 306. Upon information and belief, Defendants had the technological capability t0 manufacture BIOCELL Textured Breast Implants in a reasonably safe manner and is held to the level of knowledge 0f an expert in the field. 307. As the direct and proximate result 0f Defendant's acts and omissions concerning the BIOCELL Textured Breast Implants, the Plaintiff was implanted with BIOCELL Textured Breast Implants and suffered, or will suffer, painful removal procedures to mitigate the risk of developing BIA-ALCL, as well as any treatment, therapy, recovery, and expense associated With the removal 0f the BIOCELL Textured -81- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Breast Implants, the potential for the development of BIA-ALCL, and any condition or symptoms associated with BIA-ALCL or the prevention of that issue. 308. As a further proximate result of Defendant's acts and omissions concerning the BIOCELL Textured Breast Implants, Plaintiff suffered debilitating physical pain and mental suffering, was/will be required to undergo additional surgeries and other procedures, incurred substantial hospital, medical, nursing and pharmaceutical expenses therefrom; suffered emotional distress, anxiety, depression and disability; loss 0f earnings; and loss of quality of life, and all of these injuries are permanent and continuing. 309. The FDCA contains an express preemption provision, 21 U.S.C. 360k(a), which as relevant, states: ”no State 0r political subdivision 0f a State may establish 0r continue in effect with respect t0 a device intended for human use any requirement-- (1) which is different from, or in addition t0, any requirement applicable under this Act t0 the device, and (2) which relates t0 the safety 0r effectiveness 0f the device or t0 any other matter included in a requirement applicable to the device under this Act.” 310. This cause 0f action is based on the Defendants’ postmarket Violations 0f federal safety statutes and regulations. 311. Moreover, Plaintiff does not bring the underlying action as an implied statutory cause 0f action but rather she is pursuing parallel state common law claims based upon Defendants’ Violations 0f the applicable federal statutes and regulations. 312. Plaintiff’s manufacturing defect claim is, thus, not preempted by Section 360k(a), because the Violations alleged are all based 0n federal statutory and regulatory standards which includes n0 ”requirement which is different from, 0r in addition t0, any requirement applicable under” the FDCA and regulations promulgated thereunder. As such, the claims set forth in this cause of action contain requirements that are parallel t0 the FDCA and regulations promulgated thereunder. THIRD CAUSE OF ACTION -82- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD (Negligence) Against All Defendants 313. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 314. At all times pertinent hereto, Defendants directly 0r through their agents, apparent agents, servants 0r employees designed, manufactured, tested, marketed, and commercially distributed their BIOCELL Textured Breast Implants to clinics, hospitals and plastic surgeons, who ultimately operated and implanted them in consumers' bodies. 315. Defendants directly or through their agents, apparent agents, servants 0r employees designed, manufactured, tested, marketed, and commercially distributed the BIOCELL Textured Breast Implants implanted into Plaintiff’s body. 316. Defendants owed Plaintiff, and the public, a duty to use reasonable care in testing and inspecting their BIOCELL Textured Breast Implants, in designing the BIOCELL Textured Breast Implants placed into Plaintiff and in manufacturing and marketing those BIOCELL Textured Breast Implants. 317. The BIOCELL Textured Breast Implants that were implanted into Plaintiff were defective and unreasonably dangerous when they left the possession 0f the Defendants in that the BIOCELL Textured Breast Implants did not conform to applicable federal laws and regulations. 318. At all relevant times, Defendants violated the FDA'S Quality System Regulations and Current Good Manufacturing Practices under 21 C.F.R. Part 820, because ALLERGAN produced adulterated BIOCELL Textured Breast Implants that had numerous unwanted particles and solid fragments of silicone on the implant surface in Violation of CGMP regulations designed t0 ensure device quality and patient safety. 319. Such measures, if implemented, would have caused mitigated 0r eliminated the risk posed by silicone particles shredding from the BIOCELL Textured -83- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Breast Implants and would have enabled patients, including Plaintiff, to avoid the risks 0f developing BIA-ALCL. 320. Defendants also violated the above described post-market reporting requirements under 21 C.F.R. Part 803 for the BIOCELL Textured Breast Implants, by Virtue 0f their abuses 0f the FDA’s ASR Program and other reporting Violations. As a result, Defendants negligently failed t0 adequately warn 0f the dangers 0f BIA-ALCL, and test its product before Plaintiff was implanted with ALLERGAN’S BIOCELL Textured Breast Implants. 321. Such warnings, if given, would have enabled the FDA, as well as the medical and scientific community, to ensure physicians and patients were adequately informed when selecting the appropriate breast implant and would have enabled patients, including Plaintiff, t0 avoid being exposed to BIA-ALCL. 322. Plaintiff was implanted with BIOCELL Textured Breast Implants without adequate warning and with manufacturing defects, in Violation 0f the general regulatory requirements, resulting in serious injury t0 Plaintiff. The injuries Plaintiff suffered are expected t0 have resulted from such defects. Plaintiff and her physician were unaware that the BIOCELL Textured Breast Implants were defective at the time 0f implant and thereafter. 323. As the direct and proximate result of Defendant's negligent acts and omissions concerning the BIOCELL Textured Breast Implants, the Plaintiff was implanted with BIOCELL Textured Breast Implants and suffered, 0r will suffer, painful removal procedures t0 mitigate the risk 0f developing BIA-ALCL, as well as any treatment, therapy, recovery, and expense associated With the removal of the BIOCELL Textured Breast Implants, the potential for the development of BIA-ALCL, and any condition or symptoms associated with BIA-ALCL or the prevention 0f that issue. 324. As a further proximate result of Defendant's negligent acts and omissions concerning the BIOCELL Textured Breast Implants, Plaintiff suffered debilitating physical pain and mental suffering, was/will be required to undergo additional surgeries -84- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD and other procedures, incurred substantial hospital, medical, nursing and pharmaceutical expenses therefrom; suffered emotional distress, anxiety, depression and disability; loss of earnings; and loss of quality of life, and all of these injuries are permanent and continuing. 325. The FDCA contains an express preemption provision, 21 U.S.C. § 360k(a), which as relevant, states: ”no State 0r political subdivision of a State may establish 0r continue in effect with respect to a device intended for human use any requirement-- (1) which is different from, or in addition to, any requirement applicable under this Act to the device, and (2) which relates t0 the safety 0r effectiveness 0f the device or t0 any other matter included in a requirement applicable t0 the device under this Act.” 326. This cause 0f action is based on the Defendants’ postmarket Violations of federal safety statutes and regulations. 327. Moreover, Plaintiff does not bring the underlying action as an implied statutory cause 0f action but rather she is pursuing parallel state common law Claims based upon Defendants’ Violations 0f the applicable federal statutes and regulations. 328. Under California's doctrine 0f negligence per se, failure t0 exercise due care is presumed from a Violation 0f a ”statute, ordinance, 0r regulation 0f a public entity.” Cal. Evid. Code, § 669(a)(1). By its terms, this doctrine applies to the law 0f any public entity, not just California public entities. See, e.g., DiRosa v. Showa Denko KK. (1996) 44 Cal.App.4th 799, 808. Thus, under California law, a money damages remedy exists for negligent Violation 0f the FDCA and regulations promulgated thereunder which proximately cause injuries, and there is n0 need for California’s Legislature t0 act in order to create such a remedy. 329. Plaintiff’s negligence claim is, thus, not preempted by Section 360k(a), because the violations alleged are all based on federal statutory and regulatory standards which includes n0 ”requirement which is different from, 0r in addition t0, any requirement applicable under” the FDCA and regulations promulgated thereunder. As -85- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O such, the claims set forth in this cause of action contain requirements that are parallel to the FDCA and regulations promulgated thereunder. FOURTH CAUSE OF ACTION (Fraud - Intentional Misrepresentation and Concealment) Against All Defendants 330. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 331. Each Defendant actively participated in, agreed t0, aided and abetted, conspired in, and/or furthered a fraudulent scheme, as set forth herein, which conduct constitutes fraud and deceit. 332. Defendants superior knowledge and expertise, their relationship of trust and confidence with doctors and the public, their specific knowledge regarding the risks and dangers 0f BIA-ALCL and their international dissemination of promotional and marketing information about BIOCELL Textured Breast Implants for the purpose 0f maximizing its sale, each give rise t0 the affirmative duty to meaningfully disclose important material facts concerning the safety of the BIOCELL Textured Breast Implants, specifically regarding the risks of developing BIA-ALCL. 333. Defendants omitted material information to the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff as part of a deliberate and intentional effort t0 induce such persons and entities t0 rely on the omissions and t0 allow the BIOCELL Textured Breast Implants to be in and remain in the marketplace for purchase. Through their omissions, Defendants actively conspired to and did conceal the risks 0f BIA-ALCL associated with the BIOCELL Textured Breast Implants. 334. Defendants omitted material information regarding the risks of BIA-ALCL and the presence 0f an ALLERGAN BIOCELL Textured Breast Implants With intent t0 -86- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD defraud the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff. 335. Defendants intentionally failed to disclose material facts to the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff that they had a duty to disclose, including the risks 0f BIA-ALCL associated with the BIOCELL Textured Breast Implants. Each Defendant was aware 0f and/or approved the material omissions by or on behalf of Defendants. 336. Moreover, Defendants made representations about BIA-ALCL but did not disclose facts which materially qualified the facts disclosed, Which rendered their disclosure likely t0 mislead. The true facts about BIA-ALCL and the presence 0f an ALLERGAN BIOCELL Textured Breast Implants were known t0 Defendants, and Defendants knew they were not known to 0r reasonably discoverable by Plaintiff. 337. Defendants knew that their half-truths, concealment and failure t0 disclose t0 Plaintiff, by and through the FDA, medical and scientific community, and her device user facility, all information reasonably available to them related to the nexus between BIA-ALCL and their BIOCELL Textured Breast Implants, would mislead Plaintiff by creating the false impression that the full extent of BIA-ALCL’S relationship with the BIOCELL Textured Breast Implants was already a known and disclosed by ALLERGAN, and further that ALLERGAN'S breast implants were no more likely to be found in individuals suffering from BIA-ALCL than other companies' products. Defendants also knew that if Plaintiff became aware 0f the cancerous propensities associated the BIOCELL Textured Breast Implants, Plaintiff would not agree to purchase said implants. 338. Nevertheless, in willful disregard 0f Plaintiff's rights and the duties owed t0 Plaintiff by Defendants, and each 0f them, concealed and failed to disclose t0 Plaintiff all information reasonably available to them related to the nexus between BIA-ALCL and their BIOCELL Textured Breast Implants with the express purpose of inducing Plaintiff against her own interest to purchase their cancerous breast implants. -87- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 339. Likewise, Defendants had a statutory and regulatory duty on all matters related t0 adverse events of BIA-ALCL associated with their BIOCELL Textured Breast Implants to report in a manner that avoided making any written or oral communication containing an untrue statement 0r omitting any material fact necessary t0 make statements made, in light 0f the Circumstances under which they were made, not misleading. 340. However, as part of their scheme designed to downplay the risks of BIOCELL Textured Breast Implants in the medical device reports and to induce the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff into believing that there was n0 unique risks 0f BIA-ALCL associated with their BIOCELL Textured Breast Implants in order t0 sell more implants, Defendants willfully concealed and failed to disclose all information reasonably known to it in the MDRs. 341. The principle fraudulent omission in these MDRs was the failure to acknowledge that BIA-ALCL is exclusively found in textured implants and that ALLERGAN’S BIOCELL Textured Breast Implants are associated with more cases than any other type 0f textured implant-by far. 342. Moreover, Defendants omitted, suppressed, and concealed material facts concerning the dangers and risks of injuries associated with BIOCELL Textured Breast Implants and BIA-ALCL, including by exploiting the FDA’s non-public ASR program to hide evidence of it BIOCELL Textured Breast Implants causing BIA-ALCL. Specifically, Defendants deliberately failed to file medical device reports associated with BIA-ALCL events despite its obligations under 21 U.S.C. 360 and 21 C.F.R. § 803.50-and deliberately and willfully concealed the increased risk 0f BIA-ALCL associated with its BIOCELL Textured Breast Implants when it either did not reports these events in any form to the FDA, or unlawfully used the ASR reporting system t0 report these complaints. 343. Defendants intended the FDA, the medical and scientific community, and device user facilities, and patients t0 rely on the Defendants’ important material -88- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD representations and concealment regarding the safety of the BIOCELL Textured Breast Implants and their link to BIA-ALCL. 344. Plaintiff, by and through the FDA, medical and scientific community, and her device user facility, did in fact rely 0n and were induced by Defendants’ misrepresentations, omissions, 0r active concealment 0f the dangers 0f BIOCELL Textured Breast Implants and the link t0 BIA-ALCL. 345. Plaintiff, her physician, her device user facility, and the medical and scientific community did not know that the representations made by the Defendants were false and were justified in relying upon Defendants' representations. 346. As the direct and proximate result 0f Defendant’s fraudulent misrepresentations and intentional concealment 0f facts concerning the BIOCELL Textured Breast Implants, upon which Plaintiff reasonably relied, she was implanted with BIOCELL Textured Breast Implants and suffered, or will suffer, painful removal procedures to mitigate the risk 0f developing BIA-ALCL, as well as any treatment, therapy, recovery, and expense associated With the removal 0f the BIOCELL Textured Breast Implants, the potential for the development 0f BIA-ALCL, and any condition or symptoms associated with BIA-ALCL 0r the prevention 0f that issue. 347. As a further proximate result of Defendant's fraudulent misrepresentations and intentional concealment of facts concerning the BIOCELL Textured Breast Implants, Plaintiff suffered debilitating physical pain and mental suffering, was/will be required to undergo additional surgeries and other procedures, incurred substantial hospital, medical, nursing and pharmaceutical expenses therefrom; suffered emotional distress, anxiety, depression and disability; loss 0f earnings; and loss of quality 0f life, and all of these injuries are permanent and continuing. 348. Defendants’ fraudulent misrepresentations evidenced their callous, reckless, willful, and depraved indifference to the health, safety, and welfare 0f consumers, including Plaintiff, as well as their goal to place company profits over the safety of hundreds of thousands of consumers, subjecting Defendants to punitive and -89- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O exemplary damages according to the reprehensibility of their conduct and based on the wealth of said Defendants. FIFTH CAUSE OF ACTION (Negligent Misrepresentation and Concealment) Against All Defendants 349. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: 350. Each Defendant negligently participated in, agreed t0, aided and abetted, conspired in, and/or furthered a fraudulent scheme, as set forth herein, which conduct constitutes negligent misrepresentation and concealment. 351. Defendants superior knowledge and expertise, their relationship of trust and confidence with doctors and the public, their specific knowledge regarding the risks and dangers 0f BIA-ALCL and their international dissemination of promotional and marketing information about BIOCELL Textured Breast Implants for the purpose of maximizing its sale, each give rise t0 the affirmative duty to meaningfully disclose important material facts concerning the safety of the BIOCELL Textured Breast Implants, specifically regarding the risks of developing BIA-ALCL. 352. Defendants negligently omitted material information to the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff which induced such persons and entities t0 rely on the omissions and t0 allow the BIOCELL Textured Breast Implants t0 be in and remain in the marketplace for purchase. Through their negligent omissions, Defendants concealed the risks 0f BIA-ALCL associated With the BIOCELL Textured Breast Implants. 353. Defendants negligently omitted material information regarding the risks of BIA-ALCL and the presence 0f an ALLERGAN BIOCELL Textured Breast Implants t0 the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff. -90- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 354. Defendants negligently failed to disclose material facts to the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff that they had a duty to disclose, including the risks of BIA-ALCL associated with the BIOCELL Textured Breast Implants. Each Defendant was aware 0f and/or approved the material omissions by 0r 0n behalf of Defendants. 355. Moreover, Defendants made representations about BIA-ALCL but did not disclose facts which materially qualified the facts disclosed, Which rendered their disclosure likely to mislead. The true facts about BIA-ALCL and the presence 0f an ALLERGAN BIOCELL Textured Breast Implants were known t0 Defendants, and Defendants knew they were not known t0 0r reasonably discoverable by Plaintiff. 356. Defendants knew that their half-truths, concealment and negligent failure t0 disclose to Plaintiff, by and through the FDA, medical and scientific community, and her device user facility, all information reasonably available to them related to the nexus between BIA-ALCL and their BIOCELL Textured Breast Implants, would mislead Plaintiff by creating the false impression that the full extent of BIA-ALCL’S relationship with the BIOCELL Textured Breast Implants was already a known and disclosed by ALLERGAN, and further that ALLERGAN'S breast implants were n0 more likely t0 be found in individuals suffering from BIA-ALCL than other companies' products. Defendants also knew that if Plaintiff became aware of the cancerous propensities associated the BIOCELL Textured Breast Implants, Plaintiff would not agree t0 purchase said implants. 357. Nevertheless, in a negligent disregard 0f Plaintiff's rights and the duties owed to Plaintiff by Defendants, and each 0f them, concealed and negligently failed t0 disclose to Plaintiff all information reasonably available t0 them related t0 the nexus between BIA-ALCL and their BIOCELL Textured Breast Implants, thereby inducing Plaintiff against her own interest to purchase their cancerous breast implants. 358. Likewise, Defendants had a statutory and regulatory duty 0n all matters related t0 adverse events 0f BIA-ALCL associated with their BIOCELL Textured Breast -91- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O Implants t0 report in a manner that avoided making any written 0r oral communication containing an untrue statement or omitting any material fact necessary t0 make statements made, in light of the circumstances under which they were made, not misleading. 359. However, Defendants negligently downplayed the risks of BIOCELL Textured Breast Implants in the medical device reports, thereby inducing the FDA, the medical and scientific community, device user facilities, and consumers like Plaintiff into believing that there were n0 unique risks of BIA-ALCL associated with their BIOCELL Textured Breast Implants. As a result, ALLERGAN negligently concealed and failed to disclose all information reasonably known to it in the MDRS. 360. The principle fraudulent omission in these MDRS was the failure t0 acknowledge that BIA-ALCL is exclusively found in textured implants and that ALLERGAN’S BIOCELL Textured Breast Implants are associated with more cases than any other type 0f textured implant-by far. 361. Moreover, Defendants negligently omitted, suppressed, and concealed material facts concerning the dangers and risks 0f injuries associated with BIOCELL Textured Breast Implants and BIA-ALCL, including by exploiting the FDA’s non-public ASR program t0 hide evidence 0f it BIOCELL Textured Breast Implants causing BIA- ALCL. Specifically, Defendants negligently failed to file medical device reports associated with BIA-ALCL events despite its obligations under 21 U.S.C. 360 and 21 C.F.R. § 803.50-and negligently concealed the increased risk 0f BIA-ALCL associated with its BIOCELL Textured Breast Implants when it either did not reports these events in any form to the FDA, 0r unlawfully used the ASR reporting system. 362. Defendants intended the FDA, the medical and scientific community, and device user facilities, and patients t0 rely 0n the Defendants’ important material representations regarding the safety of the BIOCELL Textured Breast Implants and its link to BIA-ALCL. -92- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ CH #> DJ h) #4 h) F0 F0 PO h) FJ b9 b9 b0 #4 #4 Pd #4 hd hd #4 #4 pd pd 00 \J O\ (II H> OJ h) #4 CD \O 00 \J O\ CH fi> DJ h) #4 CD 363. Plaintiff, by and through the FDA, the medical and scientific community, and her device user facility, did in fact rely 0n and were induced by Defendants’ negligent misrepresentations, omissions, or concealment of the dangers of BIOCELL Textured Breast Implants and the link to BIA-ALCL. 364. Plaintiff, her physician, her device user facility, and the medical and scientific community did not know that the representations made by the Defendants were false and were justified in relying upon Defendants' representations. 365. As the direct and proximate result 0f Defendant’s negligent misrepresentations and concealment of facts concerning the BIOCELL Textured Breast Implants, upon which Plaintiff reasonably relied, she was implanted with BIOCELL Textured Breast Implants and suffered, 0r will suffer, painful removal procedures to mitigate the risk of developing BIA-ALCL, as well as any treatment, therapy, recovery, and expense associated with the removal of the BIOCELL Textured Breast Implants, the potential for the development of BIA-ALCL, and any condition or symptoms associated with BIA-ALCL or the prevention 0f that issue. 366. As a further proximate result of Defendant's negligent misrepresentations and concealment 0f facts concerning the BIOCELL Textured Breast Implants, Plaintiff suffered debilitating physical pain and mental suffering, was/will be required t0 undergo additional surgeries and other procedures, incurred substantial hospital, medical, nursing and pharmaceutical expenses therefrom; suffered emotional distress, anxiety, depression and disability; loss 0f earnings; and loss 0f quality 0f life, and all 0f these injuries are permanent and continuing. PUNITIVE DAMAGE ALLEGATIONS (Brought by Plaintiff Against Defendants) 367. Plaintiff incorporates by reference all preceding paragraphs of this Complaint as if fully set forth herein and further alleges as follows: -93- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘li-PQJNH NNNNNNNNNHHHHHHHHHH mVIQU‘lr-PUJNHOOOOVQU'IVPUJNb-‘O 368. The acts, conduct, and omissions 0f Defendants, and each of them, as alleged throughout this Complaint were willful and malicious and were done with a conscious disregard for the rights of Plaintiff as a user of Defendants' BIOCELL Textured Breast Implants and for the primary purpose 0f increasing Defendants' profits from the sale and distribution 0f BIOCELL Textured Breast Implants. Defendants' outrageous and unconscionable conduct warrants an award 0f exemplary and punitive damages against each Defendant in an amount appropriate to punish and make an example 0f each Defendant. 369. Prior to the manufacturing, sale, and distribution 0f BIOCELL Textured Breast Implants, Defendants and each 0f them knew that said implants were in a defective condition as previously described herein and knew that those who were implanted with BIOCELL Textured Breast Implants would be at a heightened risk 0f developing BIA-ALCL, and would therefore experience and did experience severe physical, mental and emotional injuries. Further, Defendants and each 0f them through their officers, directors, managers, and agents, had knowledge that the BIOCELL Textured Breast Implants presented a substantial and unreasonable risk of harm due t0 BIA-ALCL t0 the public, including Plaintiff, and as such, was unreasonably subjected to the risk of injury or death from the implantation of BIOCELL Textured Breast Implants. 370. Despite such knowledge, Defendants, and each of them, acting through their officers, directors and managing agents for the purpose of enhancing Defendants' profits, knowingly and deliberately failed t0 remedy the known defects in said BIOCELL Textured Breast Implants and failed t0 warn the public, including Plaintiff, of the risk of developing BIA-ALCL occasioned by said defects inherent in said BIOCELL Textured Breast Implants. Said Defendants and their individual agents, officers, and directors intentionally proceeded with the manufacturing, sale, distribution, and marketing of said BIOCELL Textured Breast Implants knowing persons would be exposed t0 serious danger in order t0 advance Defendants' own pecuniary interests and monetary profits. -94- COMPLAINT AND DEMAND FOR JURY TRIAL \OOOVQU‘lI-PUJNH NNNNNNNNNHHHHHHHHHH OOVOO‘Ir-POJNr-‘OOOOVQU‘Ip-PDJNHO 371. Defendants conduct was despicable, and so-contemptible that it would be looked down upon and despised by ordinary decent people, and was carried on by Defendants with willful and conscious disregard for the safety of Plaintiff, entitling Plaintiff to exemplary damages. /// /// /// /// /// Dated: April 22, 2020 PRAYER FOR RELIEF THEREFORE, Plaintiff demands judgment for the following: 1. 2. NQ‘P‘FP Past and future medical and incidental expenses, according to proof; Past and future loss of earnings and/or earning capacity, according to proof; Past and future general damages, according t0 proof; Punitive and exemplary damages in an amount to be determined at trial; Prejudgment and post judgment interest; Costs to bring this action; and Such other and further relief as the court may deem just and proper. PANISH SHEA & BOYLE LLP BENTLEY & MORE LLP By; //@L/ fir L. Kaufman nsel for the Plaintiff -95- COMPLAINT AND DEMAND FOR JURY TRIAL \O 00 \J O\ (II H> 00 PO #4 NNNNNNNNNHHHHHHHHHH co \J O\ (II 4> 00 ho #4 CD \o 00 \q ON (II 4> 00 ho FA CD IURY DEMAND Plaintiff demands a trial by jury 0n all issues so triable. Dated: April 22, 2020 PANISH SHEA & BOYLE LLP BENTLEY & MORE LLP By; /@2/- PfiL. Kaufman C nsel for the Plaintiff -96- COMPLAINT AND DEMAND FOR JURY TRIAL