This case was last updated from Santa Clara County Superior Courts on 08/14/2019 at 08:03:54 (UTC).

Bard, et al. v. Johnson & Johnson, et al. [Coordinated into JCCP4872 Los Angeles]

Case Summary

On 07/24/2018 Bard filed a Personal Injury - Other Product Liability lawsuit against Johnson Johnson, Coordinated into JCCP4872 Los Angeles. This case was filed in Santa Clara County Superior Courts, Downtown Superior Court located in Santa Clara, California. The Judge overseeing this case is Walsh, Brian C. The case status is Other - Stayed.

Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    ******1733

  • Filing Date:

    07/24/2018

  • Case Status:

    Other - Stayed

  • Case Type:

    Personal Injury - Other Product Liability

  • Court:

    Santa Clara County Superior Courts

  • Courthouse:

    Downtown Superior Court

  • County, State:

    Santa Clara, California

Judge Details

Judge

Walsh, Brian C

 

Party Details

Plaintiffs

Bard, Nancy

Bard, Charles

Defendants

Johnson & Johnson Consumer Inc. fka Johnson & Johnson Consumer Companies, Inc.

Johnson & Johnson

Imerys Talc America, Inc.

Not Classified By Court

Superior Court of California

Attorney/Law Firm Details

Plaintiff Attorneys

Cirsch, Lee Adam

Akselrud, Michael A

Not Classified By Court Attorney

Superior Court of CA, County of Santa Clara

 

Court Documents

Notice

Bard Notice of Court Order of Coord.pdf: Comment: Notice of Court Order Re Coordination of Add-On Cases

Notice

Bard Notice of Submission.pdf: Comment: Notice of Submission of Potential Add-On Cases for Coordination of This Case Into JCCP 4872

Order: Deeming Case Complex

Order Deeming Case Complex and Staying Action Pending Coordination Proceedings: Comment: Order Deeming Case Complex and Staying Action Pending Coordination Proceedings signed/BCW

Civil Lawsuit Notice

Civil Lawsuit Notice: Comment: 1st CMC set for 11/16/18 at 10am in D1; assigned to Hon. Brian C. Walsh

Notice: Related Cases

Notice Related Cases: Comment: JCCP4872 Los Angeles

Summons: Issued/Filed

Summons Issued Filed:

Civil Case Cover Sheet

Civil Case Cover Sheet: Comment: COMPLEX

Complaint (Unlimited) (Fee Applies)

Complaint (Unlimited) (Fee Applies):

 

Docket Entries

  • 11/16/2018
  • Conference: Case Management - Judicial Officer: Walsh, Brian C; Hearing Time: 10:00 AM; Cancel Reason: Vacated; Comment: (1st CMC) Discovery and responsive pleading deadline stayed, as of 8/2/18, when the case was deemed complex. Matter stayed, as of 8/2/18, pending coordination proceedings.

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  • 09/25/2018
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  • Notice - Bard Notice of Court Order of Coord.pdf: Comment: Notice of Court Order Re Coordination of Add-On Cases

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  • 09/10/2018
  • View Court Documents
  • Notice - Bard Notice of Submission.pdf: Comment: Notice of Submission of Potential Add-On Cases for Coordination of This Case Into JCCP 4872

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  • 08/02/2018
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  • Order: Deeming Case Complex - Order Deeming Case Complex and Staying Action Pending Coordination Proceedings: Comment: Order Deeming Case Complex and Staying Action Pending Coordination Proceedings signed/BCW

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  • 07/24/2018
  • View Court Documents
  • Civil Lawsuit Notice - Civil Lawsuit Notice: Comment: 1st CMC set for 11/16/18 at 10am in D1; assigned to Hon. Brian C. Walsh

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  • 07/24/2018
  • View Court Documents
  • Notice: Related Cases - Notice Related Cases: Comment: JCCP4872 Los Angeles

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  • 07/24/2018
  • View Court Documents
  • Summons: Issued/Filed - Summons Issued Filed:

    Read MoreRead Less
  • 07/24/2018
  • View Court Documents
  • Civil Case Cover Sheet - Civil Case Cover Sheet: Comment: COMPLEX

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  • 07/24/2018
  • View Court Documents
  • Complaint (Unlimited) (Fee Applies) - Complaint (Unlimited) (Fee Applies):

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Complaint Information

Lee Cirsch, Esq. (SBN 227668) Michael Akselrud, Esq. (SBN 285033) THE LANIER LAW FIRM, PC 21550 Oxnard Street, 3rd Floor Woodland Hills, CA 91367

Tel.: (310) 277-5100

Fax: (310) 277-5103

lee.cirsch@ lanierlawfirm.com michael.akselrud@ lanierlawfirm.com

Counsel for Plaintiff

E-FILED

7/24/2018 7:48 AM Clerk of Court

Superior Court of CA, County of Santa Clara

18CV331733

Reviewed By: R. Walker

SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF SANTA CLARA

caseno. 18CV331733

COMPLAINT FOR DAMAGES AND DEMAND JURY TRIAL

NANCY BARD AND CHARLES BARD;

Plaintiffs, V.

JOHNSON & JOHNSON, a New Jersey corporation doing business in California;

JOHNSON & JOHNSON CONSUMER INC.

F/K/A JOHNSON & JOHNSON CONSUMER

COMPANIES, INC., a New Jersey corporation doing business in California;

IMERY S TALC AMERICA, INC., a Delaware Corporation with its principal place of business in the State of California;

and DOES 1 through 100, inclusive,

Defendants.

z | | | | | | | | | | | |

1. 2.

3.

6.

9

NEGLIGENCE PRESUMPTION OF NEGLIGENCE PER SE NEGLIGENT FAILURE TO WARN STRICT LIABILITY FAILURE TO WARN STRICT LIABILITY - DESIGN DEFECT STRICT LIABILITY - MANUFACTURING DEFECT

7. BREACH OF WARRANTY 3.

FRAUD - INTENTIONAL MISREPRESENTATION FRAUD - CONCEALMENT

lb. NEGLIGENT

MISREPRESENTATION

follows: PARTIES, JURISDICTION AND VENUE 1. Plaintiff is a competent individual, over the age of 18, and a citizen of the United States. 2. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times,

Defendant, IMERYS TALC AMERICA, INC,, is a Delaware corporation, with its principal place of business in the state of California.

3. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, IMERYS TALC AMERICA, INC,, is the successor or continuation of Luzenac America, Inc., and IMERYS TALC AMERICA, INC. (hereinafter “IMERY S"”) is legally responsible for all liabilities incurred when it was known as Luzenac A merica, Inc.

4, Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, Defendant IMERY S has been in the business of mining, extracting, processing, treating, formulating, promoting, selling, and distributing talcum powder for use in talcum powder based products, including the PRODUCTS.

D. Plaintiff is informed and believes, and based thereon alleges, that at all relevant times Defendant JOHNSON & JOHNSON is a corporation doing business in and authorized to do business in the state of California, and was incorporated in New Jersey in 1887.

0. Plaintiff is informed and believes, and based thereon alleges, that at all relevant times Defendant JOHNSON & JOHNSON maintains an office located at One Johnson & Johnson Plaza, New Brunswick, New Jersey, 08933 as well as several locations within the state of California, and has approximately 127,100 employees worldwide.

7. As stated in JOHNSON & JOHNSON’S Form10-K Annual Report Pursuant to Section 13 of the Securities Exchange Act of 1934 for the fiscal year ended January 3, 2016, JOHNSON & JOHNSON’S primary focus is on products related to human health and well-being.

8. Plaintiff is informed and believes, and based thereon alleges that at all relevant times

Defendant JOHNSON & JOHNSON'S family of companies includes more than 250 operating companies conducting business in 60 countries of the world and organized into three business segments: Consumer, Pharmaceutical and Medical Devices.

9. Plaintiff is informed and believes, and based thereon alleges that at all relevant times the JOHNSON & JOHNSON family of companies includes 121 manufacturing facilities and, within the United States, eight facilities are used by the Consumer segment. In addition to the manufacturing facilities, JOHNSON & JOHNSON maintains numerous offices and warehouses in the United States.

10. Plaintiff is informed and believes, and based thereon alleges that at all relevant times the Consumer segment of the JOHNSON & JOHNSON family of companies includes a broad range of over- the-counter products including, but not limited to, Shower to Shower body powder and Johnson & Johnson’s Baby Powder. These products are marketed to the general public and sold both to retail outlets and distributors throughout the world.

11. Plaintiff is informed and believes, and based thereon alleges that at all relevant times, Defendant JOHNSON & JOHNSON has engaged in substantial, continuous economic activity in California, including marketing, distribution, and sale of billions of dollars in products to Californians including, but not limited to, Shower to Shower body powder and Johnson & Johnson’s Baby Powder, that said activity by Defendant is substantially connected to the Plaintiff’s claims as alleged herein.

12. Plaintiff is informed and believes, and based thereon alleges at all relevant times, Defendant JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC., was a New Jersey Corporation doing business in the state of California, a wholly owned subsidiary of JOHNSON & JOHNSON, and engaged in substantial, continuous economic activity in California, including marketing, distribution, and sale of billions dollars in products to Californians including, but not limited to, Shower to Shower body powder and Johnson & Johnson’s Baby Powder, that said activity by Defendant is substantially connected to the Plaintiff’s claims as alleged herein.

13. JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. are hereinafter referred to collectively as the “JOHNSON & JOHNSON” Defendants.

14. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, the

true names or capacities, whether individual, corporate, or otherwise, of Defendants Does 1 through 100, inclusive, were unknown to Plaintiff at the time of original filing of the underlying complaint in this action and, therefore sue said D efendants by such fictitious names.

15. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, the true names or capacities, whether individual, corporate, or otherwise, of Defendants DOES 1 through 100, inclusive, remain unknown to Plaintiff and, therefore Plaintiff sues said Defendants by such fictitious names. Plaintiff is informed and believes and based thereon alleges that each of the Defendants designated herein by fictitious names is in some manner legally responsible for the events and happenings herein referred to and caused damages proximately and foreseeably to Plaintiff as alleged herein.

16. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, all of said Defendants herein, including the named Defendants, Defendants DOES 1 through 100, inclusive, and the Other Defendants named by Plaintiff in the Complaint are collectively referred to herein as “Defendants” and all acts and omissions of Defendants as alleged herein were undertaken by each of the Defendants or said D efendants agents, servants, employees and/or owners, acting in the course and scope of its respective agencies, services, employments and/or ownerships.

17. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, all allegations concermning Defendants includes Defendants’ parents, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, organizational units of any kind, predecessors, successors and assigns, and their officers, directors, employees, agents, representatives, and any and all other persons acting on behalf of Defendants.

18. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times alleged herein, Defendants, and each of them were the agents of each of the other Defendants, and acting within the course and scope of such agency.

19. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, Defendants were engaged in the business of placing the PRODUCTS into the stream of commerce by designing, manufacturing, marketing, packaging, labeling, distributing and/or selling said PRODUCTS to Californians, including Plaintiff herein, and that JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. designed, developed, manufactured, tested, packaged, promoted, marketed, advertised, distributed, labeled, and sold the PRODUCTS to consumers, and IMERYS TALC AMERICA, INC. mined, extracted, sorted, milled, processed, treated, processed, formulated, packaged, sold, and shipped the talcum powder that comprises the PRODUCTS to JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. for sale, without substantial change, to the general public worldwide and in the state of California.

20. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times, Defendants, designed, developed, patented, manufactured, marketed, advertised, promoted and/or sold the PRODUCTS worldwide and in the state of California.

21. Upon information and belief, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent purchased the PRODUCTS and used said PRODUCTS on a daily basis in and around her perineal regions. The Plaintiff further used the PRODUCTS to dust other parts of her bodies including, but not limited to, her face, under arms and chest in proximity to their breathing zone. The Plaintiff further used the PRODUCTS when diapering her children and on their bed sheets and for other household purposes. The Plaintiff’s parents and others further used the PRODUCTS when diapering Plaintiff.

22. Plaintiff purchased the PRODUCTS and used the PRODUCTS by applying the PRODUCTS to her body in accordance with the instructions for use that accompanied the PRODUCTS and in a reasonably foreseeable manner.

23. Plaintiff is informed and believes, and based thereon allege that, at all relevant times, Defendants were engaged in the business of placing the PRODUCTS into the stream of commerce by designing, manufacturing, marketing, packaging, labeling, and/or selling said PRODUCTS, and that JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. designed, developed, manufactured, tested, packaged, promoted, marketed, advertised, distributed, labeled, and sold the PRODUCTS to consumers and IMERYS TALC AMERICA, INC. mined, extracted, sorted, milled, processed, treated, processed, formulated, packaged, sold, and shipped the talcum powder that comprises the PRODUCTS to JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. for sale, without substantial change, to the general public worldwide and in the state of California.

24. Upon information and belief, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent purchased the PRODUCTS and used the PRODUCTS by applying the PRODUCTS to her body in accordance with the instructions for use that accompanied the PRODUCTS and in a reasonably foreseeable manner.

25. Upon information and belief, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent developed ovarian cancer, and suffered effects and sequelae therefrom, as a direct and proximate result of the unreasonably dangerous and defective nature of talcum powder, the main ingredient of the PRODUCTS, and Defendants’ wrongful and negligent conduct in the research, development, testing, manufacture, production, formulation, processing, packaging, promotion, distribution, marketing, and sale of the PRODUCT'S and/ or the talcum powder that comprises the PRODUCTS.

20. Upon information and belief, as a direct and proximate result of the injuries alleged herein, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent has incurred and will in the future incur both general and special damages as hereinafter alleged.

27. Plaintiff is informed and believes, and based thereon alleges that, all claims in this action are a direct and proximate result of Defendants’ and/or their corporate predecessors negligent, willful, and wrongful conduct as follows: Defendants’ design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, sale, mining, extraction, processing, treatment, formulation, packaging, and distribution of the PRODUCTS.

28. Plaintiff in this action seeks recovery for damages as a result of ovarian cancer, which was directly and proximately caused by such wrongful conduct by Defendants, the unreasonably dangerous and defective nature of the talcum powder, the main ingredient of the PRODUCTS.

29. Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent developed ovarian cancer, and suffered effects attendant thereto, as a direct and proximate result of the unreasonably dangerous and defective nature of the PRODUCTS and the talcum powder therein, and Defendants’ wrongful and negligent conduct as follows: Defendants’ design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, sale, mining, extraction, processing, treatment, formulation, packaging, and distribution of the PRODUCTS, and as a direct and proximate result of these injuries, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering, has endured and will endure loss of enjoyment of life, has endured and will endure other general and special damages, and has otherwise been damaged in a personal and pecuniary nature.

30. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times alleged herein, all Defendants were engaged in the research, development, manufacture, design, testing, sale and marketing of PRODUCTS as follows: Defendants’ design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, sale, mining, extraction, processing, treatment, formulation, packaging, and distribution of the PRODUCTS, and Defendants introduced said PRODUCTS into interstate commerce with knowledge and intent that such PRODUCTS be sold to consumers in the State of California.

31. Plaintiff is informed and believes, and based thereon alleges that, at all relevant times alleged herein, Defendant IMERYS TALC AMERICA, INC. (“IMERYS”) was not merely a raw

materials supplier. Rather, IMERY S actively designs, develops, and formulates talc for specific uses.

FACTUAL ALLEGATIONS

a. Introduction to the PRODUCTS

32. Historically, the PRODUCTS, which include “Johnson’s Baby Powder” and “Shower to Shower,” have represented freshness, cleanliness, and purity.

33. Upon information and belief, at all relevant times alleged herein, the Defendants JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. advertised and marketed “Johnson’s Baby Powder” as the beacon of “freshness” and “comfort,” eliminating friction on the skin, absorbing “excess wetness” helping keep skin feeling dry and comfortable, and “clinically proven gentle and mild”. The Defendants JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. compelled women through advertisements to dust themselves with this product to mask odors. The bottle of “Johnson’s Baby Powder” specifically targets

women by stating, “For you, use every day to help feel soft, fresh, and comfortable.” 34. Upon information and belief, at all relevant times alleged herein, Defendants JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. advertised and marketed the product “Shower to Shower” as safe for

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use by women, as evidenced in its slogan, “A sprinkle a day keeps odor away,” and through advertisements such as, “Y our body perspires in more places than just under your arms. Use SHOWER to SHOWER to feel dry, fresh, and comfortable throughout the day,” and “SHOWER to SHOWER can be used all over your body.”

35. Plaintiff herein used the PRODUCTS to dust her perineum for feminine hygiene purposes. This was an intended and foreseeable use of the PRODUCTS based on the advertising, marketing, and labeling of the PRODUCTS.

36. Upon information and belief, the PRODUCTS are composed almost entirely of magnesium trisilicate, also known as talc. Talc is an inorganic mineral that is mined from the earth.

37. Upon information and belief, at all relevant times, IMERY S supplied its customers, including JOHNSON & JOHNSON, with material safety data sheets for talc. These material safety data sheets are supposed to convey adequate health and warning information to customers.

38. Upon information and belief, since as early as the 1970s, IMERY S and JOHNSON & JOHNSON have been on notice of an association between talc exposure and ovarian cancer, as discussed more fully below.

39. Upon information and belief, since the 1970s, Defendants JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. have nonetheless continually advertised and marketed the PRODUCTS as safe for human use, and IMERY S TALC AMERICA, INC. has marketed and promoted talcum powder, the main ingredient of the PRODUCTS, as safe for human use. Upon information and belief, JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. decided to downgrade the quality of the talc product supplied by IMERY S and informed IMERY S to supply a downgraded version of the talc product to use in its PRODUCT in order to reduce costs and increase profits for JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. 40. At all relevant times alleged herein, a feasible alternative to the PRODUCTS has existed. Comstarch is an organic carbohydrate that is quickly broken down by the body with no known health effects. Comstarch powders have been sold and marketed for the same uses as the PRODUCTS with nearly the same effectiveness.

b. Timeline of the Scientific Literature Analyzing the Relationship Between Talc and

Ovarian Cancer

41. Research published as early as 1961 has established that particles, like talc, can translocate from the exterior genital area to the ovaries in women. See G.E. Egli, and Michael Newton, The Transport of Carbon Particles in the Human Female Reproductive Tract, 12 FERTILITY STERILITY 2,151-155(1961).

42. Due to talc’s potential for transmission, researchers remained concermed about its carcinogenic nature and the effects of use. In 1968, a study concluded that “[a]ll of the 22 talcum products analyzed have a . . . fiber content . . . averaging 19%. The fibrous material was predominantly talc but probably contained minor amounts of tremolite, anthophyllite, and chrysotile [asbestos-like fibers] as these are often present in fibrous talc mineral deposits . . . Unknown significant amounts of such materials in products that may be used without precautions may create an unsuspected problem.” L. J. Cralley et al., Fibrous and Mineral Content of Cosmetic Talcum PRODUCT, 29 AM. INDUSTRIAL HYGIENE Assoc. J. 350-354 (1968). A 1976 follow-up study concluded that “[t]he presence in these products of asbestiform anthophyllite and tremolite, chrysotile, and quartz indicates the need for a regulatory standard for cosmetic talc . . . We also recommend that evaluation be made to determine the possible health hazards associated with the use of these products.” Arthur Rohl, et al., Consumer talcums and powders: mineral and chemical characterization, 2 J] ToxIiCOL ENVIRON HEALTH 255-284 (19706).

43. In 1971, the first study was published that suggested an association between talc and ovarian cancer. This study was published by W. J. Henderson in Cardiff, Wales at the Tenovus Institute. The study found talc particles “deeply embedded” in ten of thirteen ovarian tumors, twelve of twenty-one

cervical tumors, one primary carcinoma of the endometrium and five of twelve “normal” ovaries from women with breast cancer. W. J. Henderson et al., Talc and carcinoma of the ovary and cervix, 78 ]. OBSTET. GYNAECOL. BR. COMMW. 3, 266-272 (1971).

44, In 1982, the first epidemiologic study was published on talc powder use in the female genital area. This study was published by Dr. Daniel Cramer and others. This study found a 92% increased risk in ovarian cancer with women who reported genital talc use. Additionally, it found that talc application directly to the genital area around the time of ovulation might lead to talc particles becoming deeply imbedded in the tissues of the ovary, and perhaps causing foreign body reaction capable of causing growth of epithelial ovarian tissue. This study showed an epidemiologic association between the use of cosmetic talc in genital hygiene and ovarian cancer. Daniel Cramer et al., Ovarian cancer and talc: a case control study, 50 CANCER 372-376 (1982).

45, Since 1982, there have been approximately twenty-two (22) additional epidemiologic studies providing data regarding the association of talc and ovarian cancer. Nearly all of these studies have reported an elevated risk for ovarian cancer associated with genital talc use in women:

e In 1983, Patricia Hartage and Robert Hoover of the National Cancer Institute and Linda Lester and Larry McGowan of the George Washington University Medical Center, published a case- control interview study regarding ovarian cancer. Although no association was proven due to the small sample size, the study found an “excess relative risk” of 2.5 (95% CI=0.7 to 10.0) of ovarian cancer for women who use talc in the genital area. Patricia Hartage et al., Talc and ovarian cancer, 250 JAMA 1844 (1983) available at http://jamanetwork.com/journals/jama/article-abstract/1725023.

e In 1988, a case control study of 188 women diagnosed with epithelial ovarian cancer and 539 controls found that 52% of the cancer patients habitually used talc on the perineum before their cancer diagnosis. The study showed that women using talc daily on their perineum had 1.45 times the risk of ovarian cancer then women that did not use talc daily, showing a positive dose-response relationship. Alice Whittemore et al., Personal and environmental characteristics related to epithelial ovarian cancer. II. Exposures talcum powder, tobacco,

alcohol, and coffee, 128 AM. J. EPIDEMIOL. 6, 1228-1240 (1988). A case control study conducted in 1989 found similar results. The study looked at 235 women diagnosed with epithelial ovarian cancer and 451 controls and found an increased risk in ovarian cancer with women who reported genital talc powder use more than once per week. Margaret Booth et al., Risk factors for ovarian cancer: a case-control study, 60 BR. J. CANCER 4, 592-598 (1989).

A nother case control study conducted in 1989 by Bernard Harlow of Harvard Medical School at Brigham and Women's Hospital, found an increased risk of ovarian cancer generally from genital talc use after bathing, and a statistically significant increased risk of ovarian cancer from women that used talc-containing powders in combination with deodorizing powders on their perineum. This study also found a positive dose-response relationship. Bernard Harlow and Neinke Weiss, A case-control study of borderline ovarian tumors: the influence of perineal exposure to talc, 130 AM. J. EPIDEMIOL. 2, 390-394 (1989).

A 1992 study, also by Dr. Harlow, found that frequent and long term talc use directly on the genital area during ovulation increased a woman’s risk of ovarian cancer threefold. The study also found “[t]he most frequent method of talc exposure was use as a dusting powder directly to the perineum (genitals). Brand or generic ‘baby powder’ was used most frequently and was the category associated with a statistically significant risk for ovarian cancer.” This study looked at 235 ovarian cancer cases compared to 239 controls, concluding that “given the poor prognosis for ovarian cancer, any potentially harmful exposures should be avoided, particularly those with limited benefits. For this reason, we discourage the use of talc in genital hygiene, particularly as a daily habit.” Bernard Harlow et al., Perineal exposure to talc and ovarian cancer risk, 80 OBSTET. GYNECOL. 1, 19-26 (1992).

Also in 1992, a case-control study was conducted by Karin Rosenblatt at the Department of Epidemiology of John's Hopkins School of Hygiene and Public Health. This study showed that the development of ovarian cancer may be associated with genital fiber exposure

(especially talc on sanitary napkins), and a relative risk of 4.8 for ovarian cancer development from talc use on sanitary napkins. Karen Rosenblatt et al., Mineral fiber exposure and the development of ovarian cancer, 45 GYNECOL. ONcOL. 20-25 ( 1992).

Another 1992 case-control study conducted by Yong Chen with 112 diagnosed epithelial ovarian cancer cases and 224 age-matched community controls, found an elevated risk for ovarian cancer in women who applied talc-containing dusting powder to the lower abdomen and perineum for longer than 3 months. Y ong Chen et al., Risk Factors for Epithelial Ovarian Cancer in Beijing, China, 21 INT. J. EPIDEMIOL. 23-29 (1992).

In 1993, the United States National Toxicology Program published a study on the toxicity of non-ashestiform talc and found clear evidence of carcinogenic activity. The study found “some evidence of carcinogenic activity in male rats” and “clear evidence of carcinogenic activity in female rats.” Talc was found to be a carcinogen, with or without the presence of asbestos-like fibers. National Toxicology Program, Toxicology and carcinogenesis studies of talc (CAS No 14807-96-6) in F344/N rats and B6C3F 1 mice (Inhalation studies), Technical Report Series No. 421 (September 1993).

In 1995, a case control study conducted in Australia by David Purdie, involving over 1600 women found a statistically significant 27% increased risk in ovarian cancer for women who regularly use talc in the region of the abdomen or perineum. David Purdie et al., Reproductive and other factors and risk of epithelial ovarian cancer: an Australian case-control study, 62 INT. J. CANCER 6, 678-684 (1995).

In 1996, a case-control study similarly found a statistically significant increased risk of ovarian cancer in women who used talc-based powders in their genital area. See Asher Shushan et al., Human menopausal gonadotropin and the risk of epithelial ovarian cancer, 65 FERTIL. STERIL. 1, 13-18 (1995).

In 1996, the condom industry stopped coating condoms with talc due to the health concerns of ovarian cancer, “[cJoncern about talc as an ovarian carcinogen goes back 50 years in the medical literature. By the 1970s, evidence was mounting that talc particles might migrate into a woman’s fallopian tubes where they could cause scarring and irritation in the ovaries.

Scientists believed in some cases that the scarring led to infertility or cancer.” Marie McCullough, Women’s health concerns prompt condom makers to stop using talc, Jersey Journal (City Ed.) (Jan. 10, 1996).

In 1997, a case-control study of 313 women with ovarian cancer and 422 controls found that the women with cancer were more likely to have applied talc powder to their external genitalia area. Women using these products had a statistically significant 50% to 90% higher risk of developing ovarian cancer. Linda Cook et al., Perineal powder exposure and the risk of ovarian cancer, 145 AM. J. EPIDEMIOL. 459-465 (1997).

In 1997, a case-control study conducted by Stella Chang and Harvey Risch from the Department of Epidemiology and Public Health, Y ale University School of Medicine, which included over 1,000 women found a statistically significant increased risk for ovarian cancer for women who applied talc via sanitary napkins to their perineum. The study indicated that “[c]ommercial talc substitutes often replace talc with comstarch. Furthermore, women may choose to powder or dust with comstarch instead of talc. When cornstarch was assessed in relation to risk of ovarian carcinoma, no associations were found,” concluding “[t]he results of this study appear to support the contention that talc exposure increases risk of ovarian carcinoma. Dusting with talcum powder is not an unusual practice for women, and, given the heterogeneity of the etiology and course of ovarian carcinoma, any possible harmful practices, particularly those with little benefit, should be deliberated.” Stella Chang and Harvey Risch, Perineal talc exposure and risk of ovarian carcinoma, 79 CANCER 12, 2396-2401 (1997).

A 1998 case-control study conducted in Canada by Beatrice Godard found increased risk of ovarian cancer in women who used talc-based powders on their perineum. Beatrice Godard et al., Risk factors for familial and sporadic ovarian cancer among French Canadians: a case- control study, 179 AM. J. OBSTET. GYNECOL. 2, 403-410 (1998).

In 1999, Dr. Cramer conducted a case-control study of 563 women newly diagnosed with epithelial ovarian cancer and 523 controls. The study found a statistically significant 60% increased risk of ovarian cancer in women that used talc-based body powders on their perineum: “[w]e conclude that there is a significant association between the use of talc in

genital hygiene and risk of epithelial ovarian cancer that, when viewed in perspective of published data on this association, warrants more formal public health warnings.” The study was funded by a grant from the National Cancer Institute (“NCI”). Daniel Cramer et al., Genital talc exposure and risk of ovarian cancer, 81 INT. J. CANCER 3, 351-356 (1999).

In 2000, Roberta Ness, from University of Pennsylvania, led a case control study of over 2,000 women. This study found a statistically significant 50% increased risk of ovarian cancer from genital talc use in women. The study also found that talc causes inflammation, and that inflammation contributes to cancer cell development. Roberta Ness et al., Factors Related to Inflammation of the Ovarian Epithelium and Risk of Ovarian Cancer, 11 EPIDEMIOLOGY 2, 111-117 (2000).

Also in 2000, a prospective cohort study found a 40% increase in invasive serous cancers in women who applied talc to their perineum. Dorota Getrig et al., Prospective Study of Talc Use and Ovarian Cancer, 92 J. NATL. CANCER INST. 3, 249-252 (2000).

In 2003, a meta-analysis was conducted which re-analyzed data from 16 studies published prior to 2003, finding a 33% increase in ovarian cancer risk among talc users. Michael Huncharek et al., Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: A meta-analysis of 11,933 subjects from sixteen observational studies, 23 ANTICANCER RES. 2C, 1955-60 (2003).

In 2004, a case-control study of nearly 1400 women from twenty-two counties was performed in Central California. This study found a statistically significant 37% increased risk of epithelial ovarian cancer from women’'s genital talc use. The study also found a 77% increased risk of serous invasive ovarian cancer from women’s genital talc use, compared with women using cornstarch powders as “[c]omstarch is also not thought to exert the same toxicologic reaction in human tissue as does talc.” This study concluded that “users should exercise prudence in reducing or eliminating use,” and “the precautionary principle should be invoked, especially given that this is a serious form of cancer, usually associated with a poor prognosis, with no current effective screening tool, steady incidence rates during the last quarter century and no prospect for successtul therapy. Unlike other forms of environmental

exposures, talcum powder use is easily avoidable.” Paul Mills et al., Perineal talc exposure and epithelial ovarian cancer risk in the Central Valley of California, 112 INT. J. CANCER 458-64 (2004).

In 2008, Margaret Gates performed a combined study of over 3,000 women from a New England-based case-control study and a prospective Nurses’ Health Study (the “Gates Study”). This study was funded by NCI, and found a general 36% statistically significant increased risk of epithelial ovarian cancer from genital talc use. A 60% increased risk of the serous invasive subtype was also found. Dr. Gates noted a pronounced and positive dose- response relationship, increasing risk with increasing talc usage by women. These results “provide additional support for a main effect of genital talc exposure on epithelial ovarian cancer . . . the finding of highly significant trends between increasing frequency of use and risk ‘strengthen[ing] the evidence of an association, because most previous studies have not observed a dose response.”” Notably, the study promoted an alternative to talc, cornstarch, which “has not been shown to increase ovarian cancer risk . . . ” The study concluded that “women should be advised not to use talcum powder in the genital area, based on our results and previous evidence supporting an association between genital talc use and ovarian cancer risk. Physicians should ask the patient about talc use history and should advise the patient to discontinue using talc in the genital area if the patient has not already stopped.” Margaret Gates et al., Talc Use, Variants of the GSTM1, GSTT1, and NAT2 Genes, and Risk of Epithelial Ovarian Cancer, 17 CANCER EPIDEMIOL, B10. & PREV. 9, 2436-2444 (2008).

In October of 2008, Michael Thun, Vice-President of Epidemiology and Surveillance Research at the American Cancer Society commented on the Gates Study. He stated the dose- response relationship between talc and ovarian cancer had finally been confirmed by this study: “[T Jhere are very few modifiable risk factors for ovarian cancer. The mainoral contraceptives, which has been clearly established to lower the risk for ovarian cancer. Others include tubal ligation, hysterectomy, and parity. Then there are factors that ‘probably’ increase the risk for ovarian cancer, and this is where talc fits in, alongside

asbestos, postmenopausal hormone therapy, and radiation.” Zosia Chustecka and Desiree Lie, Talc Use in Genital Area Linked to Increased Risk for Ovarian Cancer, Medscape Medical News (Oct. 8, 2008) available at http://www.medscape.com/viewarticle/581781.

In 2008, Melissa Merritt, from the Australian Cancer Study and A ustralian Ovarian Cancer Study Group, conducted a case-control study of over 3,000 women finding a statistically significant increased risk of ovarian cancer for women who used talc on their perineum was confirmed. This study also confirmed a statistically significant increased risk of ovarian cancer of a serous subtype in women who used talc on their perineum. Melissa Merritt et al., Talcum powder, chronic pelvic inflammation and NSAIDs in relation to risk of epithelial ovarian cancer, 122 INT. J. CANCER 1, 170-176 (2008).

In 2009, a case-control study of over 1,200 women found the risk of ovarian cancer increased significantly with frequency and duration of talc use. The study found an overall statistically significant 53% increased risk of ovarian cancer from genital talc use. The study also found a 108% statistically significant increased risk of ovarian cancer in women with the longest duration and most frequent talc use. In conclusion the study stated, “that risk of ovarian cancer is significantly associated with talc use and with a history of endometriosis, as has been found in recent studies.” Anna Wu et al., Markers of inflammation and risk of ovarian cancer in Los Angeles County, 124 INT. J. CANCER 6, 1409-1415 (2009).

In 2015, Anna Wu looked at the risk factors for invasive epithelial ovarian cancer among Hispanics and African Americans. The study used multivariate logistic regression to examine parity, oral contraceptive use, tubal ligation, endometriosis, family history of ovarian cancer, and talc use and risk of ovarian cancer among Hispanics, African Americans and non- Hispanic W hites using four case control-studies conducted in Los Angeles County. The study found a statistically significant increased risk for ovarian cancer for Non-Hispanics whites of 41% and an additional 14% for every five years of talc use, an increased risk for Hispanics of 77% and an additional 18% for every five years of talc use, and an increased risk for African Americans of 56% and a 15% additional increase for every five years of talc use. Anna Wu et

al., African Americans and Hispanics remain at lower risk of ovarian cancer than non- Hispanic Whites after considering non-genetic risk actors and oophorectomy rates, CANCER EPIDEMIOL BIOMARKERS PREV July; 24(7): 1094-1100 (2015).

e Various meta-analyses conducted have found positive associations between the use of talc in the genital area and ovarian cancer. See generally Bernard Harlow et al., Perineal exposure to talc and ovarian cancer risk, 80 OBSTET. GYNECOL. 1, 19-26 (1992); Andrew Gross, A meta- analytical approach examining the potential relationship between talc exposure and ovarian cancer, b J. EXP0. ANAL. ENVIRON. EPIDEMIOL. 2, 181-195 (1995); Michael Huncharek et al., Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta- analysis of 11,933 subjects from sixteen observational studies, 23 ANTICANCER RES. 1955-60 (2003).

C. Knowledge of the Connection Between Talc Usage and Ovarian Cancer within the

G overnment, within the Medical Community, and within the Defendant Companies

46. Upon information and belief, in 1975, JOHNSON & JOHNSON was aware of Henderson, et al.’s Tenovus data suggesting an association between talc and ovarian cancer, and was thereby on notice of the association as early as the mid-1970s. JOHNSON & JOHNSON sent a donation to the Cardiff Scientific Society in order to obtain information concerning research being conducted Tenovus Institute and JOHNSON & JOHNSON admitted that it was on notice of the talc and ovarian cancer problem.

47. Upon information and belief, shortly after Dr. Cramer’s 1982 study was published, Dr. Semple visited with Dr. Cramer about his study. Dr. Cramer advised Dr. Semple that JOHNSON & JOHNSON should place a warning on its talcum powder PRODUCTS concerning ovarian cancer risks so that women could make an informed decision about their health.

48. Upon information and belief, on August 12, 1982, JOHNSON & JOHNSON publicly recognized the studies linking the use of the PRODUCTS to ovarian cancer. In a New York Times article entitled “Talcum Company Calls Study on Cancer Link Inconclusive,” the company admitted to being aware of the 1982 Cramer article that concluded women who apply talc daily to their genital

areas were three times more likely to contract ovarian cancer. 49, Upon information and belief, JOHNSON & JOHNSON recognized that the safety of cosmetic powders was a concern in a May 1986 Technological Forecast. JOHNSON & JOHNSON recognized that the safety of cosmetic powders was a concern, especially among health professionals, that studies have implicated talc use in the vaginal area with incidents of ovarian cancer and that Johnson’s Baby Powder sales were declining along with the overall cosmetic powders market in a classic mature model curve.” Upon information and belief, JOHNSON & JOHNSON in approximately 1992 was looking for “opportunities to grow” the Baby Powder franchise despite the fact that the same internal document cited cancer linkage as a “major obstacle” and recommended implementing a plan to market to Hispanic and African American’s by launching an adult Hispanic media program and potentially launching an adult black print effort.

50. In 1993, the United States National Toxicology Program published a study on the toxicity of non-asbestiform talc and found clear evidence of carcinogenic activity. Talc was found to be a carcinogen, with or without the presence of asbestos-like fibers.

51. Upon information and belief, on November 10, 1994, the Cancer Prevention Coalition mailed a letter to then JOHNSON & JOHNSON C.B.O, Ralph Larson, informing the company that studies as far back as 1960’s “show conclusively that the frequent use of talcum powder in the genital area pose a serious health risk of ovarian cancer.” Upon information and belief, the letter cited a recent study from Dr. Harlow of Harvard Medical School confirming this fact and quoted a portion of the study where Dr. Harlow and his colleagues discouraged the use of talc in the female genital area. Upon information and belief, the letter further stated that 14,000 women per year die from ovarian cancer and that this type of cancer is very difficult to detect and has a low survival rate. Upon information and belief, the letter concluded by requesting that JOHNSON & JOHNSON withdraw talc products from the market, or at a minimum, place warning information on its talc-based products disclosing the risk of ovarian cancer.

52. Upon information and belief, on September 17, 1997, JOHNSON & JOHNSON was notified that on three separate occasions the CTFA (as an agent of Defendants) had released false information to the public about the safety of talc, that studies had shown a statistically significant

association between hygienic talc use and ovarian cancer, and that anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary.

53. Upon information and belief, in 1998 IMERY S wanted to stop discussions about ovarian cancer in order to free the development in cosmetic applications, avoid the initiation of a process for classification of talc as a carcinogen, and implement a plan to discredit research and scientists.

54. Upon information and belief, on January 30, 2000, IMERY S was on notice of the National Toxicology Program (“NTP”) listing nomination of non-asbestiform talc as carcinogenic and votes in favor of such listing, and acknowledged that the reviewers found that the epidemiology studies associating talc and ovarian cancer providing convincing evidence of talc carcinogenicity in humans.

55. Upon information and belief, as of September 12, 2000, Luzenac was specifically aware, knew, and acknowledged that the general public was not aware of any health issues regarding talc.

56. Upon information and belief, as of October 13, 2000, Luzenac was specifically aware, knew, and explicitly acknowledged that that the company would ultimately be held responsible for placing a harmful product into the stream of commerce.

57. Upon information and belief, in this letter the CTFA admitted that talc was “toxic,” that “some talc particles... can reach the human ovaries,” and acknowledged prior epidemiologic studies have concluded that talc increases the risk of ovarian cancer in women.

58. Upon information and belief, internal reports in 2002, indicated that Luzenac may be asked when the company first learned of the possible association of talc with ovarian cancer, when it began to warn of this risk, and whether company felt a moral and ethical obligation to inform women that the hygienic use of talc may increase their risk for ovarian cancer, or were the company’s profits from mining and selling this potentially dangerous, life-threatening product more important than protecting the health and welfare of the women and children in our society.

59. Upon information and belief, Luzenac considered implementing warnings, including a warning label would warn the consumers the product is not to be used for genital dusting and would report of the possible association between genital dusting and ovarian cancer.

60. In February of 2006, IARC published a paper whereby they classified perineal use of talc

based body powder as a “Group 2B” human carcinogen. JARC, which is universally accepted as the international authority on cancer issues, concluded that studies from around the world consistently found an increased risk of ovarian cancer in women from perineal use of talc. [IARC found that between 16- 52% of women in the world were using talc to dust their perineum and found an increased risk of ovarian cancer in women talc users ranging from 30-60%. IARC concluded: “There is limited evidence in humans for the carcinogenicity of perineal use of talc-based body powder.” By definition “Limited evidence of carcinogenicity” means “a positive association has been observed between exposure to the agent and cancer for which a causal interpretation is considered by the Working Group to be credible, but chance, bias or confounding could not be ruled out with reasonable confidence.”

6l1. In 2006, the Canadian government under The Hazardous Products Act and associated

N u

Controlled Products Regulations classified talc as a “D2A,” “very toxic,” “cancer causing” substance under its Workplace Hazardous Materials Information System (WHMIS). Asbestos is also classified as “D2A”.

62. Upon information and belief, in 2006, IMERY S began placing a warning on the Material Safety Data Sheets (MSDS) it provided to JOHNSON & JOHNSON in conjunction with the talc product it sold to them to be used in the PRODUCTS. These MSDSs provided the warning information about the TARC classification, warning information regarding “States Rights to Know,” and warning information about the Canadian Government's “D2A " talc classification.

63. Upon information and belief, in 2006 Luzenac was on notice of the potential for product liability litigation against the talc producers for failing to warn of the health risks associated with Talc use.

64. Upon information and belief, in spite of the mounting evidence pointing to the carcinogenicity of the PRODUCTS, particularly when used in the perineal region, from 2008 through 2009 JOHNSON & JOHNSON admitted that its marketing was targeting use of JOHNSON & JOHNSON’S baby powder for obese women.

d. Defendants F ailed to Warn Consumers of the Dangers of Talc Use

65. Atall times herein mentioned, Defendants had a duty to know and warn about the hazards associated with the use of the PRODUCTS. 66. Upon information and belief, at all times herein mentioned, despite the mounting scientific and medical evidence regarding talc use and ovarian cancer development over the past several decades, none of the warnings on product labels or in other marketing informed users, or similarly situated individuals, that use of the PRODUCTS in the genital area could lead to an increased risk of ovarian cancer. For example, the only warnings on the Baby Powder label are to “[k]eep powder away from child’s face to avoid inhalation, which can cause breathing problems,” and to “[a]void contact with eyes.” The label also states: “SAFETY TIP: Keep out of reach of children. Do not use if quality seal is broken.” JOHNSON & JOHNSON provides similar warnings on their website: “[f]or external use only. Keep out of reach of children. Close tightly after use. Do not use on broken skin. Avoid contact with eyes. Keep powder away from child’s face to avoid inhalation, which can cause breathing problems.”

67. Upon information and belief, at all times herein mentioned, JOHNSON & JOHNSON continues to represent on the labeling and in their marketing that Johnson’s Baby Powder has “clinically proven mildness,” is “clinically proven to be safe, gentle and mild,” and “that the safety of cosmetic talc is supported by decades of scientific evidence and independent peer reviewed studies.”

68. Upon information and belief, at all times herein mentioned, Defendants failed to inform customers and end users of the PRODUCTS of a known catastrophic health hazard associated with their use.

69. Upon information and belief, at all times herein mentioned, Defendants procured and disseminated false, misleading, and biased information regarding the safety of the PRODUCTS to the public and used influence over governmental and regulatory bodies regarding talc.

70. Upon information and belief, as a direct and proximate result of Defendants’ calculated and reprehensible conduct, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent suffered catastrophic injuries and damages, namely ovarian cancer, which required surgeries and treatments.

e. Defendant IMERYS Failed to Warn Consumers of the Dangers of Talc Use

71. On information and belief, at all relevant times alleged herein, Defendant IMERY S TALC AMERICA, INC., mined, manufactured and sold talc to JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. for sale to the public. 72. At all times herein mentioned, the talcum powder mined, extracted, sorted, milled, processed, treated, formulated, packaged, shipped, supplied, sold, marketed and distributed by IMERY S to JOHNSON & JOHNSON for sale to the public was inherently and extremely dangerous in that, as set forth in detail above, it causes cancer in humans.

73. On information and belief, at all relevant times alleged herein, JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. then packaged and sold said talc in the PRODUCTS they sold to consumers, and IMERY S knew that consumers of the PRODUCT'S were using it to powder their perineal regions.

74. On information and belief, the PRODUCTS had potential risk and side effects that were known or knowable in light of the scientific and medical knowledge that was generally accepted in the scientific community at the time of the manufacture, distribution and sale.

75. On information and belief, the potential risks and side effects presented a substantial danger when the PRODUCTS were used or misused in an intended or reasonably foreseeable way.

76. On information and belief, ordinary consumers would not have recognized the potential risks and side effects described herein.

77. Upon information and belief, IMERY S actively participated in the design, development, and formulation of the PRODUCTS. IMERYSS is the world’s largest talc producer and engages in the development, formulation, treatment, and promotion of talc for specific use in the PRODUCTS. IMERY S has represented publicly that:

e IMERYS spearheads talc milling technology, a complex process where the methods used depend both on the ore type and the final application. To obtain exactly the right particle sizegiven application, we use a variety of techniques including compressed air, steam and impact milling - many of which have been developed in- house. Median particle sizes can range from less than 1 micron to 15 microns, and top cuts from 6 microns to over 100 microns.

e IMERY S implements specific treatments to the talc used in the PRODUCTS by milling, sorting, heating, grinding, and works directly with JOHNSON & JOHNSON on formulations (“... applications specialists work directly with customers on their formulations.”) http://www.imerystalc.com/content/corporate/A boutImerysTalc/Expertise and quality/ Expertise/index.php e IMERY S uses sorting and milling technologies to process talc, laser and image analysis technology, friction sorting, flotation techniques, drying, crushing grounding and micronizing;

e IMERYS specifically promotes its talc for use in body powders and engineers it processing so that the Talc retain perfume (“... surfaces of the talc platelets retain the perfume with the minimum loss of potency.”)

e IMERY S employs end-market specialists to pilot each market sector to match right talc to the right application and leads its products to new innovations... .

e IMERY S employs experts from the specialist markets it serves and provides technical expertise, collaborating on research projects, and supports JOHNSON & JOHNSON in its product development and marketing efforts;

e Working at our technical centers in San José and Toulouse, our R&A teams focus on finding new applications for talc and new formulations to improve existing applications; formulation studies for customers; and fundamental research.

e IMERY S works with JOHNSON & JOHNSON to develop new process technologies for its products;

e IMERYS collaborates JOHNSON & JOHNSON on research to find new applications forits products;

e IMERY S employs teams to find new applications for talc, conducts formulation studies for customers, and conducts fundamental research concerning Talc.

78. Plaintiff is informed and believes, and based thereon alleges that at all times herein

mentioned, IMERY S failed to adequately warn that its talcum powder PRODUCTS presented substantial dangers and risks, which would not have been recognized by ordinary consumers when used in an intended or reasonably foreseeable way, as evidenced through the following conduct:

e Through its mining, extraction, sorting, milling, processing, treating, formulating, packaging and manufacture of the talcum powder that comprises the PRODUCTS, IMERY S had a significant role in creating the finished PRODUCTS, and did not actually or reasonably rely on JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. to convey warnings to end users, and any such reliance would have been unjustified.

e IMERYS did not take the additional steps it should have, including inquiring about JOHNSON & JOHNSON’S and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC.’s warning practices, to ensure that warnings were communicated to consumers.

e IMERY S ignored known facts that would provide notice of a substantial risk that JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. might fail to warn consumers of the risks of talcum powder exposure, and those warnings might fail to reach consumers.

e IMERYS knew there was a substantial likelihood that JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. would not convey the necessary or adequate warnings or information to ultimate consumers of talc PRODUCTS.

e IMERYS knew JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC. were not conveying such warnings or information to consumers, and that said Defendants’ economic motivations were such that they had an incentive to withhold necessary information about talcum powder because warnings would make the products containing talc less attractive to consumers.

79. Plaintiff is informed and believes, and based thereon alleges that at all times herein

mentioned, IMERY S could and should have shared its superior knowledge and information about the

dangers involvedtalcum powder with JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER INC. F/K/A JOHNSON & JOHNSON CONSUMER COMPANIES, INC., and could and should have warned said Defendants and the public of the risks of harm.

80. According to IMERY S’S website (http://www.imerystalc.com/) talc is used in agriculture, ceramics, cosmetics, food, paints and coatings, paper, pharmaceuticals, plastics, and rubber products, and for each broad category of applications IMERY S manufactures and markets talc products with unique features, formulations and physical properties which are designed for specific uses within those categories. IMERY S’S subjective plan of milling, treating and formulating its Talc products for use in JOHNSON & JOHNSON PRODUCTS constitutes a design. The Talc product produced by IMERY S is of common experience, encountered generally in everyday life, and a product on which a jury can rely on its own expectations of safety, and it failed to perform as safely as an ordinary consumer would expect when used in an intended and reasonably foreseeable manner.

81. The talc product sold by IMERY S is inherently dangerous for perineal application, is not substantially changed during the manufacturing of the finished products sold by JOHNSON & JOHNSON to consumers, and IMERY S had more than a limited role in creating the finished product and the PRODUCTS. IMERYS did not have to guess or speculate about the type of use to which its Talc product would be put, but rather IMERY S was aware of and intended that the Talc product supplied would be used in the manner in which it was actually used. The Talc products supplied by IMERY S were specifically designed to meet the needs of JOHNSON & JOHNSON.

82. The talc product designed and sold by IMERY S is itself harmful and, without change in its composition, remains so when incorporated into the PRODUCTS and, renders the PRODUCTS into which it is incorporated harmful, contrary to ordinary consumer expectations. JOHNSON & JOHNSON did not significantly alter the IMERY S Talc product. It is not just a design defect in the manufactured end product that caused the injury, but the defective nature of the IMERY S Talc product contained in the PRODUCTS.

83. Upon information and belief, at all times herein mentioned, the talcum powder mined, extracted, sorted, milled, processed, treated, formulated, packaged, shipped, supplied, sold, marketed and distributed by IMERY S to JOHNSON & JOHNSON for sale to the public was not substantially changed during the manufacturing of the finished PRODUCTS, and Imerys had a significant role in creating the finished PRODUCTS.

84. Upon information and belief, IMERY S actively participated in the design, development, and formulation of the PRODUCTS. Specifically, as stated on IMERYS'S website www.imerystalc.com, IMERY S is the world’s largest talc producer and represents on its website the following:

From mine to market Sorting Sorting the different talc ores according to their talc content and brightness is a key phase of the production process. Techniques include state-of-the-art laser and image analysis technology, friction sorting or flotation techniques. The ores are

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treated to decontaminate them.

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http://www.imerystalc.com/content/corporate/About talc/Extraction and processing/

Formulating for our customers Our applications specialists work directly with customers on their formulations.

Existing formulations are improved and rendered more cost-effective, or replaced by more advanced solutions. Every year, we carry out more than a hundred formulation studies at our research and development facilities in Denver and Toulouse and help customers achieve their performance objectives while saving

them valuable time.

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Qur applications specialists work directly with customers on their formulations. Existing formulations are improved and rendered more cost-effective, or replaced by more advanced solutions. Every year, we camy out more than a hundred formulation studies at our research and development facilities in Denver and Toulouse and help customers achieve their perfiormance objectives while saving them valuable time.

http://www.imerystalc.com/content/corporate/A bout- ImerysTalc/Expertise and quality/Expertise/index.php

Body powders & Creams Imerys talcs make excellent body powders and fragrance carriers for scented powders...

Baby and Body Powders With their soft, silky feel, Imerys talcs make excellent body powder. Applied after bathing, talc dries the skin, preventing chafing, and gives a pleasant, soothing, cool sensation. Imerys talcs are excellent fragrance carriers for scented body powders. The surfaces of the talc platelets retain the perfume with the minimum loss of potency.

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Good understanding of each market segment is vital to matching the right talc to the right application. At Imerys Talc, we have end-market specialists on board who pilot each market sector, leading the way with new innovations... . Working at state of the art R&D facilities and pilot plants in the United States, Europe, and Assia Pacific, our experts - many of whom have been recruited from the specialist markets we serve - are dedicated to:

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The world relies on our minerals, and we rely on one of our most Good understanding of each important resources in finding. mining, processing and delivering market segment is vital to

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Working at state-of-the-art R&D facilities and pilot plants in the applic ation.

United States, Europe, and Asia Pacific, our experts - many of whom

have been recruited from the specialist markets we serve - are dedicated to: At Imerys Talc, we have end-

market specialists on board who pilot each market sector, leading the way with new innovations.

» providing technical expertise and collaborating on research projects to support our customers,

» developing new process technology to increase efficiency and product quality, » Innovation » collaborating on research to improve products and find new

applications. » Product stewardship

http://www .imerystalc.com/content/corporate/A bout-Imerys-

Talc/Expertise and quality/Expertise/index.php

85. Upon information and belief, at all times herein mentioned, IMERY S did not actually or reasonably rely on JOHNSON & JOHNSON to convey warnings to end users, and any such reliance would have been unjustified.

806. Because of the gravity of the risks posed by the talc involved and the severity of the harm to consumers, and because of its unique and sophisticated knowledge of the dangers inherent in its talcum powder, IMERY S could and should have taken additional steps, such as inquiring about JOHNSON &

JOHNSON’S warning practices, to ensure that warnings were communicated to consumers. 87. Upon information and belief, at all times herein mentioned, IMERY S had the legal right to issue notices regarding the safe use of JOHNSON & JOHNSON'S talc products, including end uses of the products. Upon information and belief, at all times herein mentioned, IMERY S also had the legal right to refuse to sell talc to JOHNSON & JOHNSON, if JOHNSON & JOHNSON’S use was improper, unsafe or unlawful.

88. Upon information and belief, however, for twenty-five years, IMERY S disregarded the facts and evidence it had compiled internally regarding the carcinogenicity of talc, as detailed herein, and never exercised its right to refuse to sell talcum power to the JOHNSON & JOHNSON Defendants.

89. Upon information and belief, in 2006, when IMERY S added a warning to its talcum powder label, the company still never required JOHNSON & JOHNSON to convey the same or a substantially similar warning to end users of the product, even though IMERY S knew there was a substantial likelihood that JOHNSON & JOHNSON would not convey the necessary or adequate warnings or information to ultimate consumers of talc, and even though it knew in 20006, as discussed herein, of the potential for talc producers to be liable in product liability litigation in the United States.

90. Upon information and belief, at all times herein mentioned, IMERY S knew for a fact that JOHNSON & JOHNSON was not conveying such warmings or information to consumers, and that said Defendants’ economic motivations were such that they had an incentive to withhold necessary information about talcum powder because warnings would make products containing talc less attractive to consumers.

91. Upon information and belief, at all times herein mentioned, IMERY S could and should have shared its superior knowledge and information about the dangers involvedtalcum powder with JOHNSON & JOHNSON and could and should have wamed said Defendants and the public of the risks of harm.

92. At all times herein mentioned, IMERY S failed to adequately warn that its talcum powder products presented substantial dangers and risks, which would not have been recognized by ordinary

consumers, when used in an intended or reasonably foreseeable way. 93. As a direct and proximate result of IMERY S’ calculated and reprehensible conduct, Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent suffered catastrophic injuries and damages, namely ovarian cancer, which required surgeries and treatments.

f. JOHNSON & JOHNSON and IMERYS Conspired to Conceal the Dangers of Talc

94. Upon information and belief, the JOHNSON & JOHNSON Defendants and IMERY S and/or their predecessors-in-interest knowingly agreed, contrived, combined, confederated and conspired among themselves, in the State of California, to cause injuries, diseases, and/or illnesses by exposing consumers and Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent to the harmful and dangerous PRODUCTS. JOHNSON & JOHNSON and IMERYS knowingly agreed, contrived, confederated and conspired to deprive Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent of the opportunity of informed free choice as to whether to use the PRODUCTS or to expose themselves to the dangers associated with them. JOHNSON & JOHNSON and IMERY S committed the above described wrongs by willfully misrepresenting and suppressing the truth as to the risks and dangers associated with the use of the talcum powder contained within the PRODUCTS.

95. Upon information and belief, in furtherance of said conspiracies, for decades JOHNSON & JOHNSON and IMERY S individually, jointly, and in conspiracy with each other, have been in possession of medical and scientific data, literature and test reports which clearly indicated that ordinary and foreseeable use of their PRODUCTS by women is unreasonably dangerous, hazardous, deleterious to human health, carcinogenic, and potentially deadly.

96. Upon information and belief, in furtherance of said conspiracies, JOHNSON & JOHNSON and IMERY S, despite the medical and scientific data, literature, and test reports possessed by and available to said Defendants, individually, jointly, and in conspiracy with each other, wrongfully, fraudulently, willfully and maliciously agreed among themselves to withhold, conceal and suppress medical information regarding the increased risk of ovarian cancer, as set out hereinabove. Upon information and belief, in furtherance of said conspiracies, JOHNSON & JOHNSON and IMERYS, despite the medical and scientific data, literature, and test reports possessed by and available to said Defendants, individually, jointly, and in conspiracy with each other, caused to be

released, published and disseminated medical and scientific data, literature, and test reports containing information and statements regarding the risks of ovarian cancer which JOHNSON & JOHNSON and IMERYS knew were incorrect, incomplete, outdated, and misleading. Upon information and belief, specifically, through the CTFA, JOHNSON & JOHNSON and IMERYS collectively agreed to release false information to the public regarding the safety of talc on July 1, 1992; July 8, 1992; and November 17, 1994. Upon information and belief, in a letter dated September 17, 1997, JOHNSON & JOHNSON and IMERY S were criticized by their own toxicologist consultant for releasing this false information to the public, as stated hereinabove, yet nothing was done by JOHNSON & JOHNSON and IMERY S to correct or redact this public release of knowingly false information.

97. Upon information and belief, in furtherance of said conspiracies, JOHNSON & JOHNSON and IMERY S, despite the medical and scientific data, literature, and test reports possessed by and available to said Defendants, individually, jointly, and in conspiracy with each other, by these false and fraudulent representations, omissions, and concealments, intended to induce Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent and others to rely upon false and fraudulent representations, omissions and concealments, and to continue to expose themselves to the dangers inherent in the use and exposure to the PRODUCTS.

98. Upon information and belief, individually and in concert with each other, JOHNSON & JOHNSON and IMERY S participated in a common plan to commit the torts alleged herein, and each acted tortiously in pursuance of the common plan to protect and promote the health and safety of talc use, to the known detriment of the public, including Plaintiff or Plaintiff’s Spouse or Plaintift’s Decedent.

99. Plaintiff or Plaintiff’s Spouse or Plaintiff’s Decedent reasonably and in good faith relied upon false representations, omissions, and concealments made by JOHNSON & JOHNSON and IMERY S regarding the nature of the PRODUCTS, and as a result suffered the injuries and damages alleged herein.

100. Defendants conspired and entered into the aforementioned agreements in the State of California, and engaged in the aforementioned acts in furtherance of their conspiracy and agreements together with each other in California, and as a result of the foregoing conduct in furtherance of their conspiracy and agreements, each of the Defendants is derivatively liable for the conduct of the others in

California. 101. As alleged in this Complaint, the term “talcum powder products” or “PRODUCTS” refers to Johnson & Johnson’'s Baby Powder and Shower to Shower products and all constituent elements of those products, including talc, asbestos, fibrous talc, and other constituent and related elements and fibers contained within.”

g. Defendants concealed and failed to warn about the dangers posed by asbestos in the

talcum powder products

102. Plaintiff alleges that the talcum powder products mined, milled, imported, designed, manufactured, marketed, labeled, supplied, distributed, sold and otherwise placed in the stream of commerce by Defendants contained asbestos, including asbestos and asbestiform fibers, e.g., tremolite, chrysotile, and other carcinogens, which Plaintiff used and was exposed to, and that Defendants failed to warn the public, including Plaintiff, about the fact that the talcum powder products contained such carcinogenic substances.

103. Defendants engaged in wrongful conduct and were negligent and created a dangerous and unreasonable risk of harm to others, including Plaintiff, by mining, milling, processing, supplying, distributing, designing, manufacturing, and selling the talcum powder products which contained asbestos which Defendants knew or should have known was dangerous and posed a substantial risk of harm to others, including Plaintiff.

104. Defendants failed to provide information and failed to warn users of the talcum powder products that such products contained asbestos that the harm that such products posed to persons, including Plaintiff. Defendants instead misrepresented and concealed the facts regarding the dangerous of the talcum powder products, including the dangerous posed by such products containing asbestos and the health hazards associated with asbestos.

105. Defendants igored and suppressed medical and scientific information, including laboratory testing, regarding the dangerous posed by the talcum powder products, including the dangers posed by the presence of asbestos in such talcum powder products.

106. Title 21, Section 740.1(a) of the Code of Federal Regulations states: “The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health

hazard that may be associated with the product.” 21 C.F.R. § 740.1(a). Plaintiff alleges that Defendants violated this law and that the violation was a substantial factor in bringing about harm to Plaintiff. The label for the talcum powder product did not provide any warning regarding the health hazard that were or may be associated with the product, including the health hazards associated with talc exposure and/or exposure to asbestos.

107. Defendants, since the early 1990s, were in possession of medical and scientific data that raised concerns regarding the presence of carcinogens, including talc and asbestos, in the talcum powder products and which demonstrated the existence of health hazards to those exposed to such asbestos- containing talcum powder products.

108. Talc is a hydrous magnesium silicate, inorganic material that is mined from the earth. It is used in the manufacture of goods, such as paper, plastic, paint and coatings, rubber, food, electric cable, ceramics, and cosmetics. In its loose form and as used in Defendants’ products, talc is known as “talcum powder.”

109. Geologists, Defendants, the and CTFA—and their suppliers, experts, agents and advisors— have long known that the deposits in the earth that are associated with talc are also associated with the formation of asbestos. Asbestos is a commercial and legal term, rather than a geological or scientific term, referring to six now-regulated magnesium silicate minerals that occur in fibrous form, including the serpentine mineral chrysotile, and the amphibole minerals actinolite, anthophyllite, tremolite, amosite and crocidolite. The United States Geological Survey on Commercial Talc production in 1965, as well as those dating back to the 1800s, note the presence of tremolite, anthophyllite and chrysotile commonly among those minerals found within talc deposits.

110. Defendants have long employed and/or consulted with doctors, scientists, geologists, mineralogists and toxicologists, and that they have long maintained extensive medical and scientific libraries and archives containing materials relating to the health hazards of talc and the presence of carcinogens, including asbestos, in talc and talc deposits.

111. Beginning in the 1930s, medical and scientific literature emerged indicating talc was commonly, if not invariably, contaminated with substances known or suspected of being carcinogenic, such as asbestos, silica, quartz, nickel and arsenic. Within the next several decades, a growing body of

medical and scientific literature demonstrated that direct and secondary exposure to talc, including asbestos-containing talc, was hazardous to exposed persons’ health in that it could cause lung disease, cancer and death.

112. Defendants and their employees, agents and/or suppliers were members of the National Safety Council. In March of 1933, Waldemar C. Dreesen of the United States Public Health Service reported to the National Safety Council the results of a study conducted among tremolite, talc and slate workers. The study indicated that the talc was a hydrous calcium magnesium silicate, being 45% talc and 45% tremolite.

113. In 1968, a study presented at the American Industrial Hygiene Conference & Exposition and published in the American Industrial Hygiene Association Journal concluded that “[a]ll of the 22 talcum products analyzed have a...fiber content...averaging 19%. The fibrous material was predominantly talc but contained minor amounts of tremolite, anthophyllite, and chrysotile as these are often present in fibrous talc mineral deposits... Unknown significant amounts of such materials in products that may be used without precautions may create an unsuspected problem.” L. J. Cralley, et al., Fibrous and Mineral Content of Cosmetic Talcum Products, 29 AM. IND. HY G. ASSOC. ]J. 350-354 (1968).

114. A 1976 follow-up study conducted by researchers at Mount Sinai Hospital in New Y ork concluded that “[t]he presence in these products of asbestiform anthophyllite and tremolite, chrysotile, and quartz indicates the need for a regulatory standard for cosmetic talc... We also recommend that evaluation be made to determine the possible health hazards associated with the use of these products.” Rohl A.N., et al.,, Consumer Talcums and Powders: Mineral and Chemical Characterization, 2 J. TOXICOL. ENVIRON. HEALTH 255-284 (1976). The Mount Sinai study results were published by various newspapers, including the New Y ork Times and the Washington Post.

115. In the early 1970s, the FDA began an inquiry into whether to regulate and require warnings on consumer talcum powder products. Defendants and the CTFA, an exclusive lobbying and advocacy group representing companies engaged in the cosmetic products industry, conspired and worked in concert to block efforts to label and warn consumers regarding the dangers associated with

cosmetic talcum powder products, such as Defendants’ products. 116. In 1968, a scientific study of store-bought, commercially available talcum powders conducted by the Occupational Health Program, National Center for Urban Industrial Health, was published and presented by the American Industrial Hygiene Association revealing that, contrary to popular belief, talcum powders were not entirely pure, but rather contained various fibrous minerals, including tremolite, anthophyllite, and chrysotile. This was not unexpected, as the study explains, because these types of fibers are often present in fibrous talc mineral deposits. Available documents indicate that during the same year and in the years following, at least one company began testing store- bought talcum powders for asbestos content. Despite tests showing some commercial talcum powders contained asbestos, there is no evidence that positive results or the brand names of contaminated products were communicated to any governmental agency, the media or the public.

117. In 1971, the New Y ork City of Environmental Protection Administration Air Resources Board conducted a study of two “leading” brands of talcum powder using transmission electron microscopy (“TEM”) and X-ray diffraction analysis (“XRD”), and found them to contain 5-25% tremolite and anthophyllite asbestos fibers under 5 microns.

118. Soon thereafter, a symposium was held in August of 1971 at the FDA to discuss the issue of asbestos content of talcum powders with the talc industry, government officials, and doctors and scientists from Mt. Sinai Hospital— then the epicenter of the medical and scientific study of asbestos. Among other statements, participants and attendees heard: that asbestos should be banned in talcum powders; models should be set up to measure the levels exposure to asbestos experienced by persons using talcum powder containing asbestos at the lowest level of microscopic detection; and that finding asbestos in talc and talcum powder is extremely difficult, and the only truly reliable way to determine the asbestos content of talc and talcum powder is through TEM and electron diffraction.

119. Defendants and the CTFA, citing costs as well as their fear of the public learning talc was contaminated with asbestos, ignored and completely rejected any measures to meaningfully test talc products to make sure they were free from asbestos and other carcinogens.

120. After this 1971 symposium, Dr. Weissler of the FDA hired Dr. Seymour Z. Lewin to test commercially available talcum powders for asbestos. Dr. Lewin tested 195 samples and found asbestos of

varying amounts in 43. Many of Dr. Lewin’s positive results were eventually corroborated by Pfizer Inc. The results, however, were uncorroborated by two other laboratories, leading the FDA to the conclusion that XRD, optical and electron microscopy, and electron diffraction must be used to detect asbestos in talc and talcum powders.

121. Contemporaneously, evidence began to emerge from testing conducted by various regulatory agencies revealing that asbestos was being found in food, beer and drugs, including intravenously injected medicines. In 1972, and later in 1973, the FDA filed notices of proposed rulemaking requiring talc used in food, food packing and drugs to be asbestos-free. These were some of the same grades of talc used and supplied by Defendants.

122. The talc industry’s response, including that of Defendants, was swift and well-coordinated through the CTFA, an exclusive lobbying and advocacy group representing the cosmetics industry that conspired and worked in concert with Defendants to purposely create a flawed, voluntary testing and surveillance methodology for detecting asbestos in talc and block efforts to label and warn consumers regarding the dangers associated with the talc products, including Defendants’ products.

123. Regarding the FDA’s proposed 1972 ruling-making, the FDA Director of Product Development and Cosmetics, Dr. Schaffner, invited representatives of the talc industry to a meeting in August of 1972 to discuss the results of Dr. Lewin’s study and inform them that the FDA was preparing to release a “Proposed Statement of Policy On Asbestos in Cosmetics Containing Talc.” Dr. Schaffner explained that he was duty-bound and must publicize the brand names of the talcum powders that contained asbestos. CTFA’s president, Dr. Merritt, strongly objected to the FDA alerting the general public and publishing the brand names of the talcum powders, as it would cause the manufactures “economic hardship.”

124. Dr. Merritt also threatenedprevent the disclosure of the brand names. Unsurprisingly, the FDA, Defendants and the CTFA never revealed or publicized the brand names of the talcum powders that contained asbestos, much to the detriment of Plaintiff and the general public.

125. In 1973, the CTFA created a talc subcommittee and the Scientific Advisory Committee to develop a testing methodology for detecting asbestos in talc. Initially, the CTFA designated a group of its members to tests talc grades used in talcum powder utilizing the methodology proposed by the FDA in its

notice of rulemaking. Six samples of talc used in commercially available talcum powders, plus one talc sample purposely spiked with tremolite and chrysotile, were circulated among the members, including representatives of Defendants. Of the eight participating members, four found asbestos in every sample, three did not find asbestos in any sample (including the spiked sample), and one found asbestos only in the spiked sample. In conclusion, all members agreed that the best and most reliable method of detecting asbestos in talc is not optical microscopy, but rather TEM and electron diffraction. The same members, however, dispensed with this analytical method, claiming TEM and electron diffraction equipment was too expensive, despite Defendants then owning or having unfettered access to same.

126. From there, the difference between what Defendants and the CTFA knew diverged from what they were representing to the FDA. Defendants, the CTFA and others in the industry knew that there was no such thing as asbestos-free talc— only talc in which asbestos could not be detected using the prevailing, most economic analytical methodology, XRD, which at the time could not accurately identify chrysotile asbestos in talc, nor detect tremolite asbestos contamination levels below 2-5%.

127. Defendants and the CTFA also did not disclose to the FDA that the overwhelming majority of talcum powder manufacturers and sellers were not testing their products for asbestos, and even if they were testing, it was done so supertficially: only four or so grams per 20 tons of pre-shipment and pre-processed talc. Defendants and the CTFA also failed to the inform the FDA that they were not testing off-the-shelf talc powder products, but rather old samples that were never from the end products themselves. They also failed to inform the FDA that they were limiting their testing of talc to only one type of asbestos fiber to the exclusion of all other fiber types that are commonly found in talc deposits. What is more, to the extent Defendants found asbestos in their samples, these positive results were not reported to the FDA.

128. Instead, on their behalf, the CTFA sent letters to the FDA in March of 1976 fraudulently claiming that industry testing had shown all talcum powder products to be completely free of asbestos.

129. Beginning in 1975 and 1976, researchersResources Board, Mt. Sinai School of Medicine, and the FDA became increasingly concerned that the CTFA, Defendants were slow to address the issue of asbestos in talc and talcum powders. Defendants had not issued any recalls,

provided consumer warnings, informed the FDA of any effort to ensure that talcum powders on the market did not contain asbestos, or developed a reliable methodology or protocol for ensuring that talc and talcum powder did not contain asbestos.

130. Taking matters into their own hands, Mt. Sinai Hospital researchers published a follow-up article to Dr. Lewin’s 1971 study that demonstrated that some of Talc Defendants’ and Talc Supplier Defendants’ talcum powders that were tested contained over 20% asbestos. The researchers concluded that “[t]he presence in these products of asbestiform anthophyllite and tremolite, chrysotile, and quartz indicates the need for a regulatory standard for cosmetic talc... We also recommend that evaluation be made to determine the possible health hazards associated with the use of these products.” The results of the Mount Sinai study were published the same yearTimes and the W ashington Post.

131. Defendants and the CTFA responded to these developments by falsely claiming that the industry was doing “everything” it could to solve the problem; issuing press releases falsely claiming that chrysotile had never been found in talcum powders; and intentionally suppressing data that showed tremolite was commonly found in talc and talcum powder.

132. The CTFA finally began in earnest to produce a voluntary protocol and methodology that would provide Defendants cover from both lawsuits and regulation. Egregiously, as concerned media members, citizens and regulators began asking more questions about which other brands of talcum powder contained asbestos, Defendants and the CTFA falsely represented that talcum powders have never contained asbestos.

133. Defendants and third parties collectively met with and corresponded with the CTFA, as well as collectively met with the FDA, to individually and collectively advocate for the use of “voluntary” XRD testing of miniscule portions of the tons of talc to be used in consumer products.

134. Defendants’ “voluntary” method— that was developed collectively by Defendants and the CTFA and advocated to the FDA in lieu of regulations requiring asbestos labeling or warnings on talcum powder products— was inadequate because levels of ashbestos contamination in talc commonly fell below the detection limit of XRD. Defendants and the CTFA also knew that asbestos contamination was not uniformly distributed, such that the miniscule amounts tested would not reveal the true level of

contamination in talc products, such as those to which Plaintiff was exposed. 135. In support of their voluntary XRD methodology, which was finally published in 1977, the CTFA produced letters to the FDA written by its members, including Defendants, identifying tests conducted showing talcum powder products did not contain asbestos. The CTFA, Defendants and other talc product producers, however, never informed the FDA of the hundreds of positive tests showing talc and talcum powders contained asbestos and other carcinogens.

136. Defendants and the CTFA made and published such representations, claiming that their testing method was adequate, that they were ensuring that talcum powder products were safe, and that the talc reaching consumers was “safe,” despite having substantial knowledge and evidence to the contrary. Defendants intentionally and knowingly did so to avoid FDA regulations that may have required them to place warnings regarding the asbestos content of their products, and thereby inform the public, including Plaintiffs, that talc-containing products contained asbestos.

137. The CTFA then published an article in 1979 stating it conducted over three thousand tests of talcum powders and none of them found chrysotile. The article and report failed to disclose whether the talcum powders tested contained tremolite, anthophyllite or any other form of asbestos. This publication of half-truths was conveyedpublic with the purpose of preventing regulations of cosmetic products. Thereafter, the CTFA’s methodology became the standard by which nearly all talc was analyzed by the entire industry, including talc used in cosmetic and hygiene products today.

138. The CTFA and Defendants have represented to various news media outlets and the public at large that their products are “asbestos-free,” when, in fact, their products did test positive for asbestos and those that did not were merely the result of inadequate and imprecise testing methods. “No asbestos detected” means something much different than “no asbestos,” but due to Defendants’ repeated conflation of the terms, the public has been lead to erroneously believe talc products are safe.

139. Furthermore, since Defendants and the CTFA did not have sufficient testing protocols in place to support the claims that talc products were safe or asbestos-free, such statements were recklessly made, as they had no reason to believe them.

140. Between 1970 and the 1990s, tests conducted by and on behalf of Defendants and the talc

industry continued to show that talc and talcum powder products contained asbestos. None of these positive tests have ever been produced or made known to any regulatory agency, and knowledge of their existence is only because of civil litigation.

141. Defendants’ and the CTFA’s failure to disclose these positive results and the inadequacies of their testing protocols continued through the 1980s, 1990s and 2000s, even when various government agencies raised concerns about the safety of talc, including the issue of asbestos content.

142. To this day, many talc-containing products presently on the market contain asbestos. Instead of publicizing this fact, Defendants and the CTFA continue to deny all the above to protect their pecuniary interests, to the severe detriment of the public in the United States and worldwide, including Plaintiff.

143. Since at least 1979, Defendants have conducted a campaign to convince the public that their products are regulated by the FDA, that their tests are conducted pursuant to FDA regulations, and that talcum powder products are therefore safe. Nothing could be further from the truth: the FDA has never been assigned a budget by Congress to regulate cosmetics, including asbestos and other carcinogens in talcum powders. Defendants’ concerns for the safety of their products have always been voluntary and under the auspices of the CTFA, a private industry group, that in its 40 years has only banned the use of 11 ingredients in all cosmetics ever sold in the United States. Indeed, as of today, asbestos-containing talc in cosmetics has not been banned or otherwise regulated by the CTFA or the FDA.

144. Defendants (and other entities in the talc industry and cosmetic industries, including the CTFA), individually and collectively, failed to report to the FDA tests performed both internally and by outside laboratories confirming the presence of asbestos in both their finished products as well as talc shipments from Talc Supplier D efendants and other sources that were used to produce finished products.

145. Defendants, and even the outside laboratory McCrone Associates, sent letters to the CTFA, to be and which were forwarded collectively to the FDA, stating that results of testing of talc used by them after 1972 had not revealed the presence of amphibole or chrysotile asbestos, when in fact all of these entities had received or performed tests indicating the contrary by 1976, when such false

representations were made. Defendants made and published such representations claiming that their testing method was adequate, they were ensuring that talcum powder products were safe, and that their testing of talc reaching consumers was “safe,” despite knowing the contrary.

146. Defendants intentionally and knowingly did so to avoid FDA regulations that may have required Defendants to place wamings regarding the asbestos content of their products, and thereby inform the public, including Plaintiffs, that talcum powder products contained carcinogens, including asbestos, and were therefore dangerous.

147. After 1976, Defendants and the CTFA continued to obtain and/or receive results of testing performed internally and externally indicating the presence of asbestos in talc.

148. Defendants failed to place any warning on their talc and talcum powder products or ever disclose the fact that these products contained carcinogens, including asbestos, at any point, up to and including the present, despite the clear hazard and direct information that their products did and continue to contain such carcinogens.

149. Defendants and the CTFA, collectively by their agreement and conspiracy, controlled industry standards regarding the testing, manufacture, sale, distribution and use of talcum powder products, and controlled the level of knowledge and information available to the public, including Plaintiffs, regarding the hazards of exposure to carcinogens, including asbestos, from talc and talc- containing products, and intentionally failed to wamn potential users, including NANCY BARD AND CHARLES BARD, of the serious bodily harm and/or death which may result from the inhalation and/or ingestion of asbestos in their talc and talc-containing products. They also knowingly and intentionally released, published and disseminated invalid, inaccurate, outdated and misleading scientific data, literature and test reports containing misinformation and false statements regarding the health risks associated with the use of talc and talcum powder products, including those to which Plaintiff was exposed.

150. Defendants and the CTFA, while cognizant of the aforementioned data, deliberately chose to ignore the health and safety issues raised in said data and embarked upon a plan of deception intended to deprive the public at large, including Plaintiffs, of alarming medical and scientific findings, many of

which remained in their exclusive possession and under their exclusive control. 151. Defendants and the CTFA conspired and/or acted in concert with each other and/or with other entities through agreement and consciously parallel behavior: (a)to withhold from users of their products— and from persons who Defendants knew and should have known would be exposed thereto— information regarding the health risks of asbestos and other carcinogens contained in talc and talcum powder products; (b) to eliminate or prevent investigation into the health hazards of exposure to asbestos and other carcinogens in talc and talcum powder products; (c) to ensure that asbestos-containing talc and talcum powder products became widely used in commerce, irrespective of the potential and actual risk of harm to the users and consumers from the asbestos and other carcinogens therein; and (d) to falsely represent that talc and talcum powder products, including those of Defendants, were safe for use by CONSUMErs.

152. Plaintiff reasonably and in good faith relied upon the false and fraudulent representations, omissions and concealments made by Defendants and their agent, the CTFA, regarding the hazards of talc and talcum powder products, including the failure to warn and disclose the fact that such products contained asbestos and other carcinogens and was, therefore, deprived of an opportunity to make informed decisions concerning use of, exposure to and contact with said products.

153. As alleged above, “asbestos” has become a commercial and legal term, rather than a geological or scientific term, referring to six now-regulated magnesium silicate minerals that occur in fibrous form, including the serpentine mineral chrysotile, and the amphibole minerals actinolite, anthophyllite, tremolite, amosite and crocidolite. XRD determines the crystalline structure of minerals by measuring the diffraction angles of an X-ray beam that has passed through the mineral. While XRD can identify amphibole minerals, it cannot determine if the mineral identified is fibrous or not, and thus it alone is not reliable for asbestos identification. TEM is the most sensitive and reliable instrument for detection and identification of all asbestos types in all size ranges. Finally, an energy-dispersive X -ray detector (“EDX") interfaced with a TEM yields elemental composition, confirming the asbestos fiber's identity. Only TEM can detect and identify the very thin asbestos fibers that are the greatest health hazard. As such, it is the necessary final step to confirm an absence of ashestos contamination. By the

1970’s, TEM was already established as a reliable method for asbestos identification. 154. McCrone Associates, the laboratory selected by several talc producers— including Defendants— to analyze their products, was already using TEM for asbestos analysis. An article by McCrone and Stewart from 1974 describes the advantages of TEM for asbestos analysis and states that the TEM “only recently installed in our laboratory will undoubtedly be the ideal instrument for the detection and identification of very fine asbestos fibers.”

155. Dr. Lewin of New Y ork University disclosed twice in 1972 that asbestos had been found in cosmetic talc. In a report to the FDA on August 3, 1972, Dr. Lewin reported that of 195 talc products, 20 had tremolite, 7 had chrysotile, 9 had both tremolite and chrysotile, and 7 had substantial percentages of one of both. XRD had been used as the first step in analysis and the presence of asbestos and was verified by the use of optical microscopy to disclose the presence of significant numbers of fibers. Shortly thereafter, Dr. Lewin reported to Whittaker, Clark & Daniels Inc. on September 30, 1972, that Italian talc 1615 contained about 2% tremolite and 0.5% chrysotile as determined with XRD and detailed microscopic exam. In a July 31, 1973, review of Dr. Lewin’s testing of 195 talc samples, the FDA found “good semi-quantitative agreement” for tremolite on selected samples re-analyzed using optical microscope analysisPfizer.

156. In 1972, ES Laboratories reported that “1615” talc contained 1% chrysotile and that “4615” talc contained 3% chrysotile and 3% anthophyllite. An August 23, 1973, report by Johns- Manville on TEM analysis of commercial talcs reported that nine of fourteen samples contained chrysotile. Only five samples did not have detectable levels of chrysotile. Pages from the laboratory notebook of Colgate-Palmolive Co. scientist Paul Briscese from March 7, 1976, show that Old Regal (North Carolina) talc tested positive for tremolite, New Montana talc tested positive for anthophyllite and tremolite, and Italian talc tested positive for tremolite.

157. A December 10, 1973, report of the CTFA’s Talc Subcommittee disclosed that optical microscope analyses of talcs from the Italian, Montana I & II, Alabama, Vermont, and North Carolina mines had failed the proposed FDA’s method because of elevated chrysotile concentrations. This December 10, 1973, CTFA report also showed that several laboratories had reported chrysotile in many of the talc samples sent by the CTFA for evaluation of analytical methods as well as the several

identifications of asbestos in talc mentioned. 158. In the early 1970s, the FDA began an inquiry into whether to regulate and require warnings on consumer talcum powder products. The CTFA, an exclusive lobbying and advocacy group representing companies engaged in the cosmetic products industry, including Defendants herein, repeatedly conspired and worked in concert to block efforts to label and warn consumers regarding the dangers associated with cosmetic talcum powder products, such as Defendants’ talcum powder products. On September 3, 1973, the FDA sent the CTFA a letter regarding various means of measuring asbestos in talc, stating that “conventional methods employing X-ray diffraction or differential thermal analysis are not sufficiently reliable to produce quantitative results of the desired precision.” The FDA further advised the CTFA that it “has been exploring refractory optical microscopy as a means of measuring asbestos in talc.” The CTFA responded to the FDA’s public notice on its proposed optical microscopy method on December 26, 1973. The CTFA contended that the proposed method was not “reliable” for the detection of asbestos in talc, recommended a “collaborative effort between FDA and industry to develop such a method,” and urged deferment of the proposed rule. Minutes of the CTFA’s Talc Subcommittee meeting on March 15, 1976, indicate that the FDA’s “Dr. Shaffner suggested the possibility of having industry report periodically on the results of its analysis to the FDA.” Dr. Estrin of the CTFA responded that “the subcommittee would give serious consideration to this suggestion.”

159. The CTFA “Method J4-1,” published on October 7, 1976, states that TEM-SAED “offers greater sensitivity, but is not presented since it is unsuitable for normal quality control applications.” The published method, rather, relies on XRD with “the level of detection of amphibole by this method [being] 0.5% and above.” The CTFA met with and corresponded with Defendants and third parties, to individually and collectively advocateinadequate XRD testing on miniscule portions of the tons of talc obtained from the mining sources to be used in the consumer products, followed by fewer “periodic” tests by TEM. This voluntary method was developed by CTFA, Defendants, and was advocatedCTFA, and Defendants in lieu of regulations requiring labeling and warnings on talcum powder products, even though the CTFA and Defendants knew that the J4-1 method would not reveal the true level of asbestos in the talc that reached consumers. In fact, the first “round robin” tests, which analyzed a “CTFA Tremolite-Spiked Talc,” resulted in 6 of 7

participating laboratories failing to detect the tremolite. 160. In other words, 84% of the industry’s laboratories failed to detect asbestos in a sample known to contain tremolite ashbestos while using the CTFA’s own J4-1 method. There is no evidence that the CTFA or Defendants ever shared this remarkable failure with the FDA or the public.

161. The CTFA, as well as Defendants and other entities in the talc industry and cosmetic industries, individually and collectively, failed to report to the FDA tests performed both internally and by outside laboratories confirming the presence of asbestos in Defendants’ and other CTFA members’ finished products as well as talc shipments from talc suppliers and other sources that were used to produce finished products. Instead, the CTFA sent letters to the FDA stating that results of testing of talc used by them after 1972 had not revealed the presence of amphiboles or chrysotile, when in fact all of these entities had received or performed tests indicating the contrary by 1976, when such intentionally false misrepresentations were made.

162. The CTFA and Defendants made and published such representations claiming that their testing method was adequate, they were ensuring that talcum powder products were safe, and that their testing of talc reaching consumers was “safe,” despite knowing the contrary. The CTFA intentionally and knowingly did so to avoid FDA regulations that may have required Defendants and others to place warnings regarding the presence of asbestos and other carcinogens in talc products, and thereby inform the public, including Plaintiff, that talcum powder products contained ashestos and were, therefore, dangerous.

163. Minutes of the CTFA’s Talc Subcommittee from February 24, 1975, stated: “It was agreed, however, that chrysotile is never found in cosmetic talc, based on numerous analyses by several investigators... ” When referring to the challenge of chrysotile detection, an article entitled “Talc” in the January/March 1976 CTFA Cosmetic Journal, states: “The only known backup method for a positive identification in this event, is [TEM] with selected area diffraction.” However, “despite many efforts, the committee had been unable to find a sample of cosmetic talc containing naturally occurring asbestos... it was asked, “‘Why should we test for chrysotile if there isn’t any?’” CTFA’s Specification for Cosmetic Talc, revised on October 7, 1976, falsely represented that no fibrous asbestos was detected in cosmetic

talc. 164. Even after 1976, the CTFA and Defendants continued to obtain and/or receive results of testing performed internally and externally indicating the presence of asbestos and other carcinogens in the talc being used to manufacture cosmetic products.

165. However, the CFTA continued to represent that no asbestos was detected in cosmetic talc. This material representation adversely and directly impacted the FDA’s attempt to adequately test consumer talc for ashestos and regulate cosmetics. The most sensitive method of identifying or detecting asbestos in cosmetic talc, TEM-SAED, was not used because the CTFA represented that its “ultra sensitivity could be a problem” and that it was too expensive to use. Instead, its J4-1 method relied on XRD alone for detection of asbestos at greater than 0.5%, a concentration that could allow more than a billion asbestos fibers per gram of talc to be passed off as “asbestos-free.”

166. The FDA, and ultimately Plaintiff, directly and/or indirectly relied upon the CTFA’s false representations regarding the safety of cosmetic talc. In fact, a FDA letter dated January 11, 1979, states “In cooperation with scientists from industry, our scientists have been making progress in the development of such regulatory methods.” The continuing lack of FDA awareness regarding the CTFA’s and Defendants’ misrepresentations and concealment was obvious seven years later. In a response to a citizen petition to require an asbestos warning label on cosmetic talc, a July 11, 1986, the FDA states that an “analytical methodology was sufficiently developed” to ensure that “such talc [is] free of fibrous amphibole...” The CTFA’s J4-1 method has continued for the past four decades to be the cosmetic talc industry’s method for “ensuring” “asbestos-free” talc. The use of TEM, recognized by the CTFA as offering “greater sensitivity” for asbestos, continued to increase over the following decades as its advantages were applied to more matrices.

167. In 1990, Kremer and Millette published a TEM method for analysis of asbestos in talc with a theoretical detection limit of about 0.00005%. Despite such improvements in analytical techniques, the cosmetic talc industry continues, four decades later, to use and promote its antiquated and wholly inadequate J4-1 method.

168. Defendants further encouraged the publication of negative studies to support their position. For example, in 1972, WR Dean, Research Director for Johnson & Johnson, Ltd. wrote to TH

Shelley in New Brunswick, New Jersey, detailing the progress that Johnson & Johnson had made on the “Talc Project.” In said letter, WR Dean explained that samples of muscovite, chlorite and anthophyllite sent to the Allen Clark Research Center to test for decoration patterns on said samples.

169. WR Dean anticipated that study would turn out another negative result in that the decoration pattern would be construed as random and unable to characterize a mineral species. WR Dean promised TH Shelley that he would encourage the Allen Clark Research Center to publish the results, they would need to find less reputable journals (because more reputable journals were anxious to publish “negative” findings), and that they “may have to turn this paper around a little in order to get it published in a good journal (as opposed to the ‘Journal of Obstetrics & Gynecology of the British Commonwealth’!!).” Moreover, in the letter, WR Dean informed TH Shelley that, upon hearing that the British Industrial Biological Research A ssociation was preparing to conduct testing on the effects of talc on monkeys, he and Drs. Fuller and Hildick-Smith, both of whom were doctors and researchers for the Johnson & Johnson Defendants, informed Dr. Grasso of the British Industrial Biological Research A ssociation of their “grave misgivings about the various aspects of the [program on the effects of talc in monkeys].” The British Industrial Biological Research A ssociation then changed its research efforts from the effects of talc on monkeys to the effects of carbon particles on monkeys. WR Dean commented that the Johnson & Johnson Defendants’ efforts “appearfed] to have prevailed and the mad rush into experiments with talc [were] checked.”

170. In a letter from Dr. Hildick-Smith to WR Dean, Dr. Hildick-Smith acknowledged WR Dean'’s desire to hold a symposium in England in the Spring of 1974 in “the hope that the data presented there will be such that there will be diminished interest in [the] health hazards of talc.” In an effort to gather the appropriate “investigators” to reach this outcome, Defendants’ funded the transportation of said “investigators” to England for the benefit of themselves.

171. In 1973, IW Sloan, of Johnson & Johnson, Ltd. sent a “UK Work Status” report to doctors and researchers of Johnson & Johnson Consumer, Inc. and Johnson & Johnson “summary[zing] the current status of work being carried out on talcknown.” Said report detailed three types of studies being performed on talc: (1) “Bodies known to J&J and with whom J&]J have contact but no direct influence”; (2) “Individuals who are undertaking discrete studies”; and (3) “Bodies undertaking

work sponsored by J&J.” The report noted that “the number of groups examining talc is disturbing.” Johnson & Johnson Consumer, Inc. and/or Johnson & Johnson wanted this report in order to have some control or coordination over the research and study efforts on talc.

172. During this time period, the report indicated that Johnson & Johnson Consumer, Inc. and/or Johnson & Johnson used Dr. Pooley to re-evaluate all the talc samples imported to the UK using a “new concentration technique for amphiboles” and found actinolite asbestos from the samples imported from Vermont. The report also indicated that the Johnson & Johnson Defendants’ talc research and work efforts would be undertaken by the CTFA because “[t]his undoubtedly withdraws Johnson & Johnson further from the limelight and this is certainly desirable. With [Defendants’ ] knowledge, consultant back up and resources, we shall be able to materially influence any work undertaken.” Moreover, said report details the efforts made by Johnson & Johnson to discredit Mr. Henderson's, of the Tenovus Research Institute, paper on Talc and Carcinoma of the Ovary and Cervix through a sponsored study with Allen Clark Research Laboratory and/or Plessy Ltd. Research, as noted above.

173. The CTFA and Defendants controlled industry standards regarding the testing, manufacture, sale, marketing, distribution and use of asbestos-containing talcum powder products, and controlled the level of knowledge and information available to the public regarding the hazards of exposure to asbestos and other carcinogens from talc and talc-containing products.

174. The CTFA and Defendants failed to warmn potential users, including Plaintiff and her family members, of the serious bodily harm and/or death which may result from perineal use of Defendants’ talc powder products, including as a result of the fact that it contained asbestos and other carcinogens.

175. The CTFA and Defendants, knowingly and intentionally released, published and disseminated invalid, inaccurate, outdated and misleading scientific data, literature and test reports containing misinformation and false statements regarding the health risks associated with the use of talc and talcum powder, including talc and talcum powder used in the production of products to which Plaintiff used and was exposed.

176. The CTFA, which was Defendants’ agent, along with Defendants, suppressed, altered, changed, destroyed and/or revised reports, data, tests, studies and other documents regarding the potential

presence of asbestos and other carcinogens in talc and talc-containing products, including Defendants’ talc powder products to which Plaintiff was exposed. The conduct of Defendants, both acting individually and in concert with others, including the CTFA, was a substantial factor in causing harm to Plaintiff.

177. The conduct of Defendants, independently and collectively and through their agents, constitute a pattern or practice of intentionally wrongful conduct and/or malice resulting in injuries to Plaintiff as alleged in this complaint.

h. Defendants’ wrongful acts are indigenous to the State of California

178. Defendants’ wrongful acts are connected to California in that the PRODUCTS and/or talc (mixed with asbestos fibers such as chyrysotile, anthrophyllite, and tremolite, as well as asbestiform fibers such as fibrous talc) intended for use in the PRODUCTS were analyzed, tested, marketed, advertised, distributed and sold in California and certified by Defendant IMERY S as free of ashestos and asbestiform fibers in California for sale throughout the United States.

179. At all pertinent times, JOHNSON & JOHNSON was and continues to be connected to California through their predecessor ownership in California talc mines, mills and processing plants.

180. JOHNSON & JOHNSON originally sourced all raw talcum powder for Johnson’'s Baby Powder PRODUCTS from domestic mines located in California. California served as the exclusive source of talc for JOHNSON & JOHNSON from the inception of its Johnson's Baby Powder PRODUCTS line until 1926.

181. In 1926, JOHNSON & JOHNSON changed its sourcing of raw talcum powder from domestic mines located in California to talc sourced in Italy.

182. In 1941, due to the outbreak of World War II and the attendant difficulties in procuring talcum powder from its Italian source, JOHNSON & JOHNSON returned to California for sourcing of its talc from approximately 1941 through 1946.

183. Upon information and belief, the raw talc used in the manufacture of the PRODUCTS by Johnson & Johnson has no shelf life, and talc sourced from California mines already in the possession of Johnson & Johnson continued to be used in the manufacture of the PRODUCTS after 1946.

184. 1In 1971, California talc is again investigated by JOHNSON & JOHNSON as a source for its Baby Powder PRODUCTS line when Defendants began the process of evaluating and qualifying the Grantham Mine, located in the Death Valley region of California. The Grantham ore was considered as a potential source of raw talcum powder for use in its PRODUCTS despite the fact that it was shown to contain both tremolite and chrysotile.

185. Tremolite, chrysotile, anthophyllite, other forms of asbestos and asbestiform minerals, as well as known carcinogens such as heavy metals (including nickel and hexa-valent chromium), as well as arsenic, quartz, silica, and lead, were known by JOHNSON & JOHNSON to be constituent minerals that were incapable of being wholly removed from the talcum powder which it used in the manufacture of its Baby Powder and Shower to Shower product lines.

186. For more than half a century JOHNSON & JOHNSON in concert with Defendant IMERY S performed experimental analyses and studies detailing the presence, contamination levels, and inability to mitigate, the amounts of these carcinogens in the raw talcum powder used in the PRODUCTS.

187. At all pertinent times, Defendant IMERY S (formerly known as Luzenac America, and/or its predecessors in interest, were engaged in the business of mining, milling, manufacturing, research and developing, processing and testing talc in California.

188. In 1919, the Inyo Talc Company began producing talc from a mine in Talc City, California, and a processing the talc at a mill at Keeler, California. Inyo changed its name to Sierra Talc and in 1942 Sierra Talc expanded is talc production in California with the purchase of the Pacific Coast Talc, Bay Street Mill, in California. Sierra Talc then purchased Muroc Clay Company, and the Randolph Street Mill, located in Los Angeles, California.

189. In 1953, Defendant opened the Panamint Mine in California which was in operation for over 30 years until its close in 1986.

190. In 1964, Cyprus Mines purchased Sierra Talc, and in 1973 the United Sierra Division became the Cyprus Industrial Minerals Company, and was renamed Cyprus Industrial Minerals Corporation. Shortly thereafter, in 1974, Cyprus Industrial Minerals relocated its headquarters to Los Angeles, California. Cyprus subsequently became a major player in the market for talcum powder,