ONTARIO SUPERIOR COURT OF JUSTICE

Transcription

1 BETWEEN: ONTARIO SUPERIOR COURT OF JUSTICE KIMBERLY BABIN -and- Plaintiff INC., BAYER PHARMA AG, and BAYER OY Defendants TO THE DEFENDANTS STATEMENT OF CLAIM A LEGAL PROCEEDING HAS BEEN COMMENCED AGAINST YOU by the plaintiff. The claim made against you is set out in the following pages. IF YOU WISH TO DEFEND THIS PROCEEDING, you or an Ontario lawyer acting for you must prepare a Statement of Defence in Form 18A prescribed by the Rules of Civil Procedure, serve it on the Plaintiffs lawyer or, where the Plaintiff does not have a lawyer, serve it on the Plaintiff, and file it, with proof of service, in this court office, WITHIN TWENTY DAYS after this Statement of Claim is served on you, if you are served in Ontario. If you are served in another province or territory of Canada or in the United States of America, the period for serving and filing your Statement of Defence is forty days. If you are served outside Canada and the United States of America, the period is sixty (60) days. Instead of serving and filing a Statement of Defence, you may serve and file an otice of Intent to Defend in Form 18B prescribed by the Rules of Civil Procedure. This will entitle you to ten (1 0) more days within which to serve and file your Statement of Defence. IF YOU FAIL TO DEFEND THIS PROCEEDING, WDGMENT MAY BE GIVEN AGAINST YOU IN YOUR ABSENCE AND WITHOUT FURTHER NOTICE TO YOU. IF YOU WISH TO DEFEND THIS PROCEEDING BUT ARE UNABLE TO PAY LEGAL FEES,

2 LEGAL AID MAY BE AVAILABLE TO YOU BY CONTACTING A LOCAL LEGAL AID OFFIC~ 0 ~~ jtwlsu/3..j-d/3 Date..../..... TO: BAYER INC. 77 Belfield Road Toronto, Ontario M9W 1G6 Issued by... G/..... e:.r~.(l~cal Registrar Y. Grant Registrar Address of court office loth Floor, 393 University Avenue Toronto, Ontario.-- IYl!50 I c b - Jl-- 2 AND TO: AND TO: BAYER PHARMA AG Miillerstrasse Berlin Germany BAYEROY Pansiontie Turku Finland

3 3 1. The plaintiff claims: a. damages in the amount of $500,000,000 b. aggravated damages in the amount of$25,000,000 c. punitive damages in the amount of$25,000,000; d. restitution damages in an amount equal to the defendants' gross, or in the alternative, net profits from their sale respective of the subject devices in Canada e. an order certifying the herein action as a class proceeding pursuant to the Class Proceedings Act, 1992; f. pre-judgment interest pursuant to section 130 or, in the alternative, section 128 of the Courts of Justice Act, R.S.O. 1990, c. C-43; g. post judgment interest pursuant to section 130 or, in the alternative, section 129 of the Courts of Justice Act, R.S.O. 1990, c. C-43; h. costs on a complete indemnity basis; and 1. such further and other relief as this Honourable Court deems just. THE PARTIES 2. The plaintiff is an individual residing in the City ofhamilton, in the Province of Ontario. 3. The defendant Bayer Inc. is a corporation incorporated pursuant to the Laws of Canada with its registered head office located in the City of Toronto in the Province of Ontario.

4 4 4. The defendant Bayer Phanna AG, formerly known as Bayer Schering Phanna AG, and before that known as Schering AG, is a phannaceutical company incorporated under the laws of the Federal Republic of Germany, having a principal place of business at Berlin, Germany. 5. The defendant Bayer Oy is a phannaceutical company incorporated under the laws of the Republic of Finland, having its principal place of business in Turku, Finland. 6. The defendants shall sometimes hereafter be referred to collectively as "Bayer". 7. All the Bayer defendants are affiliated within the meaning of Rule of the Rules of Civil Procedure, R.S.O. 1990, c.c.38, because they are all subsidiaries of Bayer AG, the ultimate Bayer parent domiciled in Germany, or because they are all controlled, directly or indirectly, by Bayer AG. 8. At all material times, the defendants were engaged in the business of developing, designing, licensing, manufacturing, distributing, selling and marketing, either directly or indirectly through third parties, subsidiaries or related entities, the contraceptive device, Mirena. 9. Mirena was developed in Finland by a company then known as Leiras Oy. Leiras Oy was, at the time when it developed Mirena, an affiliate of Schering AG. Schering AG later acquired Leiras Oy in In 2006, Schering AG was itself acquired by Bayer AG, which

5 5 is the ultimate Bayer parent company. As of January 2011, Bayer's and Schering's operations in Finland were merged and currently operate under the name of the defendant Bayer Oy. 10. Mirena is manufactured in Finland by Bayer Oy. 11. The plaintiff pleads that, by virtue of the acts described herein, each of the companies comprising Bayer, as set out above, is vicariously liable for the act and omissions of the others for the following reasons: (a) Each was the agent of the other; (b) Each defendant's business was operated so that it was inextricably interwoven with the business of the other; (c) Each defendant entered into a common advertising and business plan with the other to distribute and sell Mirena; (d) Each defendant operated pursuant to a common business plan to distribute and sell Mirena; (e) Each defendant intended that the businesses be run as one business organization; and (f) All or some of the defendants are related, associated or affiliated.

6 6 OVERVIEW 12. Mirena is a contraceptive intra uterine device (illd). 13. The injured plaintiff had the Mirena IUD inserted on or about June 15, The injured plaintiff experienced light cramping and increasing abdominal pain for the 4 days following insertion. 15. The plaintiffs pain did not abate. An x-ray established that the Mirena IUD had migrated approximately 13 inches past her uterine wall and was inverted sideways. 16. Upon the determination that the Mirena IUD had migrated from the uterus, the plaintiff immediately underwent surgery to have the device removed. 17. Neither the injured plaintiff nor similarly situated putative class members were made aware by the defendants, or any of them, of the risk of serious injury associated with, and caused by, using Mirena. Such injury includes migration of the device within the uterus or outside of the uterus into other tissues and organs, sepsis, organ damage, infertility, irregular bleeding and the need for surgical removal of the device ("Gynecological Adverse Events").

7 7 18. Neither the injured plaintiffs, nor similarly situated putative class members', healthcare providers were made aware of the risk of Gynecological Adverse Events associated with and caused by Mirena. 19. The injured plaintiff and injured putative class members would not have used Mirena IUD had Bayer properly disclosed the full extent of the risks of Gynecological Adverse Events associated with and caused by the device. 20. At the time the plaintiff used Mirena, none of the device's label, the package insert, the package containing the product, or advertisements provided adequate warnings that using Mirena carried a risk of experiencing Gynecological Adverse Events including such injury as experienced by the plaintiff. Mirena' s product monograph makes no mention of the risk of migration or complications arising out of migration. A product monograph is a document prepared by a health product's manufacturer, in this case, Bayer Inc., containing dosage and usage indications, and is intended to provide healthcare professionals and patients with the necessary information for the safe and effective use of a drug. 21. Migration of Mirena throughout the body is related to uterine perforation. Uterine perforation describes the condition whereby Mirena either partially or complete perforates the uterine wall. Mirena' s monograph currently includes a "serious warning and precaution" that uterine perforation may occur; however, perforation is described as an "uncommon" serious side effect. Both perforation and migration can lead to serious complications, which complications are not adequately or at all enumerated in the product

8 monograph. Perforation and migration often require complicated, expensive and painful treatment to correct Even as of the date of this pleading, as set forth below, the information on the device's Canadian label/monograph provides inadequate information and fails properly to warn consumers and medical professionals of the risks associated with using the device. 23. Accordingly, the defendants have failed to discharge their duty to warn the plaintiff and other putative class members about the risk of of Gynecological Adverse Events associated with Mirena. MIRENA INTRAUTERINE DEVICE 24. Mirena is at-shaped contraceptive device that is inserted inside a woman's uterus. It is in a category of devices known as intrauterine systems ("IUSs") or intrauterine devices ("IUDs"). Mirena slowly releases the hormone, levonorgestrel, continuously over a period of 5 years in order to prevent pregnancy. 25. If continued use is desired after five years, the old system must be removed and a new one inserted. 26. The anticipated means of removing the device is a simple, non-surgical, procedure.

9 27. Mirena was approved for sale in the United States in December 2000, and subsequently approved for sale in Canada in February In Canada, the health risks associated with Mirena are contained within the device's product monograph. Mirena's monograph currently warns about the risk of uterine perforation, but makes no mention of the related risk that Mirena can migrate to other parts of the body and cause organ damage. This is in contrast with Mirena's U.S. label, which has warned about the risk of migration since as early as The Canadian monograph for Mirena indicates only that perforation can result during insertion of the Mirena device. In reality, perforation can occur long after insertion. 30. The product monograph and the U.S. label also fail to identify infertility as a possible outcome from perforation and migration. 31. From the time when it was approved and up to the date this claim was issued, there have been 234 reports to Health Canada identifying uterine perforation as an adverse reaction associated with Mirena. 32. The monograph continues to describe perforation as an "uncommon" event notwithstanding that a large number of complaints of perforation and migration have been received by Bayer since the product was introduced into the market. Indeed, the volume of these complaints was large enough so as to cause Bayer Inc., at Health Canada's direction,

10 10 to issue a public communication and a "Dear Healthcare Professional" letter in June 2010 reminding that Bayer Inc. continues to receive reports of uterine perforation. Notably, that letter indicates that uterine perforation may occur only at the time of insertion, and makes no reference to the possibility of perforation after the insertion. 33. The plaintiff and other putative class members did not receive the June 2010 public communication or the Dear Healthcare Professional letter. The plaintiff pleads and relies upon the doctrine of discoverability. CAUSES OF ACTION Negligence 34. Bayer owed the plaintiff and putative class members a duty of care as follows: a) to ensure that Mirena was thoroughly and appropriately tested so as to determine if there were any potentially adverse side effects in using the device; b) to ensure that Mirena was fit for its intended or reasonably foreseeable use; c) to warn the plaintiff and the putative class members that use of Mirena carried significant, specifically enumerated health risks including infertility, migration of the device within the uterus or outside of the uterus into other tissues and organs, organ damage, irregular bleeding, the need for surgical removal of the device, and the risks of reduced contraceptive efficacy; d) to conduct adequate tests and clinical trials to determine the degree of risk associated with using the device;

11 e) to ensure that prescribing physicians, the plaintiff and the putative class members were apprised and fully and regularly informed of all of the health risks associated with using Mirena; f) to conduct ongoing tests and clinical trials with long term follow-up to determine the long-term effects and risks associated with the long-term use ofmirena; g) to inform Health Canada and other regulatory agencies fully, properly, and in a timely manner of the health risks and complaints, including those listed herein, associated with the use of Mirena; h) to monitor the post-market effects ofmirena; and i) to exercise reasonable care in designing, researching, developing, testing, manufacturing, marketing, packaging, promoting, distributing, licensing, inspecting, labeling, advertising, supplying and selling Mirena Bayer breached its duty of care owed to the plaintiff and putative class members. The particulars of Bayer's negligence are as follows: (a) It failed to ensure that Mirena was not dangerous to consumers and that the device was fit for its intended purpose and of merchantable quality; (b) It failed to conduct appropriate testing to determine whether and to what extent the use ofmirena poses serious health risks;

12 (c) It failed adequately to test Mirena in a manner that would fully disclose the serious side effects and the magnitude of the risks associated with its use; 12 (d) It failed to conduct any or adequate follow-up studies on the efficacy and safety of Mirena; (e) In the alternative to sub-paragraphs (c) and (d) above, it failed to recognize and/or heed the results of studies Bayer conducted or were conducted by others; (f) It failed to provide the plaintiff, putative class members and their physicians with any or adequate warnings of the inherent risks associated with Mirena; (g) It failed to provide any or adequate updated and current information to the plaintiff, class members and their physicians respecting the risks and effects of Mirena as such information became available; (h) It failed to provide prompt warning of potential risks and adverse side effects associated with Mirena on the product monograph and in the product labeling. More particularly, Bayer, contrary to its marketing campaign, knew that a disproportionally high number of its Mirena products were migrating and harming patients post-insertion. Bayer was aware of many complaints made to the Food and Drug Administration ("FDA") in the U.S. and to Health Canada

13 13 regarding the migration of their Mirena products from the uterus. Migration from the uterus often requires complicated, expensive and painful treatment to correct; (i) Indeed, Bayer deliberately obscured the risks of Gynecological Adverse Events. In March 2009, the FDA sent a warning letter to Bayer, expressing concern that Bayer's sponsored links on internet search engines were misleading because they made representations and/or suggestions that were misleading in failing to communicate any risk information. The FDA letter warned Bayer that advertisements for drugs and medical devices must include risk information. By omitting important risk information, including the most frequently occurring risks and side effects, the ads misleadingly suggested that Mirena is safer than it really is. Bayer made the same representations in Canada; G) In December 2009, the FDA sent a second warning letter to Bayer due to a promotional program for Mirena. The FDA warned that the program presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. The FDA also pointed out that, contrary to what Bayer was claiming in that program, many women do not "feel better". Bayer made the same representations in Canada.

14 (k) It failed to warn the plaintiff, putative class members and their physicians about the need for comprehensive regular medical monitoring to ensure the device did not migrate, and to ensure that, if migration did occur, that this was detected early; 14 (1) After receiving actual or constructive notice of migration associated with Mirena, it failed to issue adequate or timely warning, withdraw or recall the device, publicize the problems and otherwise act properly and in a timely manner to alert the public, the plaintiff and putative class members and their physicians and health regulators of the device's inherent dangers; (m)it failed to establish any adequate procedures to educate their sales representatives and prescribing physicians respecting the usage of Mirena and the risks associated with the device; (n) It falsely stated and or implied that Mirena was safe and fit for its intended purpose when it knew or ought to have known that these statements were false; ( o) It misstated the state of research, opinion and medical literature pertaining to the purported benefits of Mirena and its associated risks; (p) It failed to cease the manufacture and or distribution of Mirena when it knew

15 or ought to have known that the device caused or could cause significant injury and death; 15 ( q) It disregarded reports of symptoms of adverse events among patients who participated in clinical trials ofmirena; (r) It failed to instruct its employees properly to monitor and record complaints of adverse effects ofmirena; (s) It failed accurately and promptly to disclose to Health Canada information relating to increased risks associated with Mirena and to modify the product monograph and product labeling accordingly in a timely manner or at all; (t) It failed to monitor and to initiate a timely rev1ew, evaluation, and investigation of reports of adverse events associated with Mirena in Canada and around the world; (u) It marketed and sold Mirena without disclosing the device's risks when it knew or ought to have known of the adverse events associated with the device's use; (v) It failed to warn the plaintiff, putative class members, and health professionals that Mirena was not as safe as other available contraceptives;

16 16 (w)it failed to warn the plaintiff, putative class members, and health professionals that the risks of adverse events with Mirena are higher than those of other available contraceptives; (x) It failed to provide any or adequate warning to the health profession and to the plaintiff and putative class members; (y) It failed properly to investigate cases of adverse events and reactions caused bymirena; (z) It failed to conform with applicable disclosure and reporting regulations; (aa) In respect of the foregoing, it hired incompetent personnel and appointed incompetent officers; (bb) In respect of the foregoing, it failed to instruct its servants, agents, officers, and directors to act ethically and responsibly; ( cc) In respect of the foregoing, it failed to properly supervise its employees, its subsidiaries, and its related, associated and affiliated corporations; ( dd) It encouraged its employees to increase sales volumes while neglecting to inform consumers (including the plaintiff and putative class members),

17 ---~~ retailers, hospitals, physicians and pharmacists of the increased risks of adverse events associated with Mirena; ( ee) It failed to withdraw or recall Mirena because of the cost, loss of profit, and the negative publicity to Bayer. For the same reasons, it failed to market and sell Mirena with adequate and appropriate monograph warnings in Canada; (ff) It falsely understated the risks of Mirena, while at the same time falsely overstating the safety and efficacy of the device; (gg) It failed to make the injured plaintiff's healthcare providers aware of the risk of serious injury and death associated with and caused by Mirena; (hh) It failed to ensure that the injured plaintiffs healthcare providers were aware of the risk of serious injury associated with and caused by Mirena; (ii) It failed to exercise reasonable care in designing, developing, manufacturing, testing, manufacturing, inspecting, licensing, labeling, packaging, advertising, marketing, distributing, supplying and selling Mirena; and

18 Gj) It manufactured Mirena without adequate quality control protocols in place, or in disregard of those protocols But for Bayer's negligence as aforesaid, the harm or increased risk of harm that the injured plaintiff and other injured class members are likely to sustain or have already sustained would not have occurred. Bayer's conduct as aforesaid has caused or will cause the injured plaintiff and other injured class members to have suffered serious personal injuries, including, but not limited to, the increased risk of perforation, migration, and the injuries resulting from same. 37. The injured plaintiff and other injured class members would not have used Mirena but for Bayer's negligence as aforesaid. The plaintiff and/or the plaintiff's healthcare providers reasonably relied upon the skill and judgment of Bayer as to whether Mirena was of merchantable quality and safe and fit for its intended use. Conspiracy 38. At all material times, the defendants, by their directors, officers, servants and agents, wrongfully, unlawfully, and maliciously conspired and agreed together and with persons unknown as set out below. 39. The plaintiff pleads that the defendants' conspiracy involved unlawful means with the predominant purpose of causing the injured plaintiff and putative class members to use Mirena. In conspiring unlawfully to develop, design, license, manufacture, distribute, sell,

19 and market this unsafe product, the defendants knew or ought reasonably to have known that such use would cause harm to the plaintiff and putative class members More particularly, the defendants engaged in the said conspiracy for the purpose, inter alia, of: (a) causing the injured plaintiff and injured class members to use Mirena. (b) maximizing profit from the sale of Mirena; (c) increasing or maintaining their market share; (d) avoiding adverse publicity; (e) placing their economic interests above the safety of the injured plaintiff and injured class members; (f) maintaining their brand and corporate image; and (g) keeping the plaintiff and other putative class members, their physicians, and Health Canada in the dark regarding the dangerous properties and effects of Mirena. 41. In furtherance of the conspiracy, the following, inter alia, are some of the acts carried out by the defendants: (a) They submitted false, inaccurate and misleading information to Health Canada for the purpose of obtaining approval to market and sell Mirena in Canada; (b) They concealed and disguised information about the dangerous properties and effect of Mirena from Health Canada, from health practitioners and from the injured plaintiff and injured class members;

20 20 (c) They misled the plaintiff and other putative class members, health practitioners and others about the efficacy, safety and effect ofmirena; (d) They refused to issue warnings and to make monograph changes regarding the use of Mirena or to stop selling the device even after its harmful effects and properties became manifest; (e) They developed and used marketing and promotional strategies that covered up the truth about Mirena's dangerous properties and side effects. 42. As a result of the said conspiracy, the plaintiff and putative class members used Mirena and thereby have suffered damage and loss. Waiver of Tort 43. The plaintiff and class members are entitled to waive the tort and require Bayer to account for all the revenue it received from the sale of Mirena in Canada. 44. The plaintiff pleads that such election may be appropriate for the following reasons, among others: (a) Such revenue was acquired m such circumstances that Bayer cannot m good conscience retain it: (b) The integrity of the pharmaceutical regulations and marketplace would be undermined if the court did not require an accounting:

21 21 (c) Mirena could not have been marketed, and Bayer would not have received any revenue from its sale in Canada, absent Bayer's egregious conduct; (d) Bayer engaged in wrongful conduct by putting into the marketplace a medical product which causes or has the potential to cause increased risks of injury; and (e) Bayer would be unjustly enriched if it was permitted to retain revenues realized from the sale of Mirena in Canada. Unjust Enrichment 45. Bayer voluntarily accepted and retained profits and benefits, derived from the plaintiff and other putative class members, with full knowledge and awareness that, as a result of its conscious and intentional wrongdoings, the plaintiff and other putative class members did not receive a product of the quality, nature or fitness that had been represented by Bayer or reasonably expected by the plaintiff and other putative class members. 46. By virtue of the conscious wrongdoings alleged, Bayer has been unjustly enriched at the expense of harm to the plaintiff and other putative class members. 47. There is no juristic reason for Bayer's enrichment. 48. The plaintiff claims a constructive trust in favour of the class over those proceeds that were received by Bayer as a result of this unjust enrichment.

22 22 DAMAGES AND OTHER SUBROGATED CLAIMS 49. The Ontario Ministry of Health and Long-Term Care provide coverage for healthcare services to Ontario residents through OHIP. Similar programs are available in other provmces. 50. The plaintiff and other putative class members required hospitalization and other medical services as a result of the conduct of Bayer as aforesaid. These medical services were paid for by OHIP and other provincial health insurers. 51. OHIP and other provincial health insurers will continue to provide treatment in the future to the plaintiff and other class members. 52. The subrogated interest of OHIP and all other provincial health insurers includes the cost of all past and future insured services for the benefit of the plaintiff and all other class members. 53. The cost of the purchase of Mirena by the Plaintiff and Class Members was covered, in whole or in part, individually or by third parties, including private or group health insurers and private drug benefit plans, or by provincial health insurers and public drug benefit plans. 54. Class members who paid for their own Mirena device seek a full, or in the alternative, partial indemnification of the purchase price. Third party payors have a subrogated interest

23 Q in their expenditures for Mirena on behalf of the plaintiff and other members of the class and they seek a full indemnification of the purchase price The plaintiff states that she and the other putative class members would not have used Mirena or would not have paid the prices they did for Mirena if Bayer had acted reasonably and responsibly. 56. The plaintiff and the other putative class members are entitled to recover from Bayer as special damages the cost of purchasing Mirena. But for Bayer's wrongdoing as particularized above, the plaintiff and other putative class members would not have incurred the expense of purchasing Mirena. 57. As a result of Bayer's negligence and other actionable conduct as set out above, the plaintiff and the other putative class members have suffered and will continue to suffer damages and loss including: (a) Personal injury; (b) Out of pocket expenses including those connected with medical care and treatment, medications, the cost of Mirena as paid for by Class Members and by OHIP, and other provincial health insurers and drug benefit plans, and private third party payers as set out above; (c) Cost of past medical and other care and services; (d) Cost of future medical and other care and services; (e) Past loss of income and future loss of income.

24 As a result of Bayer's negligence and other actionable conduct as set out above, the resulting injuries to the plaintiff and other putative class members, members of the family class have suffered loss and damage. They have incurred out-of-pocket expenses for the benefit of the plaintiff and other class members. They have suffered and will continue to suffer loss of income. They have paid for or provided nursing, housekeeping and other services. They have suffered a loss of support, guidance, care and companionship that they might reasonably have expected to receive if the injuries to the Plaintiff and other class members had not occurred. 59. The plaintiff pleads that Bayer's conduct as particularized above in the research, design, development, testing, manufacturing, licensing, distribution, marketing, production, and sale of Mirena and the delayed warnings about the risks associated with the use of Mirena was high-handed, outrageous, reckless, egregious, deliberate, disgraceful, wilful, callous, and in wanton disregard of the rights and safety of the plaintiff and of the other members of the class. Bayer's conduct was indifferent to the consequences and motivated by economic considerations such as the maintaining of profits and market share. Such conduct renders the defendants liable to pay punitive damages to the plaintiff and other members of the class. 60. Bayer's conduct, as aforesaid, was injurious to the feelings of pride, dignity and selfrespect of the plaintiff and other class members and, therefore, Bayer is liable to the plaintiff and other class members for aggravated damages.

25 25 DEFINITION OF THE CLASS 61. The plaintiff seeks certification of the following class: (a) All persons throughout Canada who used Mirena during the Class Period and who claim damages as a result and their estates, administrators or other legal representatives ("the Class"); and (b) All persons who have a derivative claim on account of a family relationship with a person in (a) ("the Family Class"). 62. "Class Period" means, in respect of Mirena, from the time of the first sale in Canada until the present. COMMON ISSUES 63. The plaintiff and putative class members have issues in common in that each suffered injury and loss as a consequence of, directly or indirectly, the use of Mirena. 64. The plaintiff and putative class members have issues in common in that each suffered damages, directly or indirectly, as a consequence of the use ofmirena. 65. Individual putative class members do not have a significant need individually to control the prosecution of their claims. Individual actions would present the potential for varying, inconsistent and contrary judgments and would magnify the delay and expense to all parties. The inherent cost of pursuing individual actions concerning the herein claim would effectively deny individual claimants' access to justice.

26 Thousands of putative class members used Mirena in circumstances similar to the injured plaintiff; namely, without being informed or sufficiently informed that the use of Mirena is dangerous and unsafe. 67. There are common legal and factual issues which may be determined without reference to the individual circumstances of the putative class members. These include: a) Did the use of Mirena cause or increase the likelihood of Gynecological Adverse Events in patients? b) Was Mirena defective or unfit for the purpose for which it was intended and designed, developed, fabricated, manufactured, sold, imported, distributed, marketed or otherwise placed into the stream of commerce in Canada by one or more of the defendants? If so, in what way or ways was Mirena defective or unfit? c) Did the defendants breach a duty of care owed to class members by designing, developing, fabricating, manufacturing, selling, importing, distributing, marketing or otherwise placing Mirena into the stream of commerce in Canada? d) If the answer to a) is yes, did any of the defendants breach a duty to warn the users of Mirena? If so, when? e) Did any of the defendants breach a statutory duty under the Competition Act, R.S. 1985, c. C-34 and, if so, when and how? f) Is each of the defendants responsible in law for the acts or omissions of either one or both of the other defendants in respect of the design, development, fabrication, manufacture, sale, import, distribution, and/or marketing ofmirena in Canada? g) By virtue of unjust enrichment and/or waiver of tort, are the defendants liable on a restitutionary basis:

27 to account to any of the Classes, including provincial insurers which have subrogated claims, for any part of the proceeds of the sale of Mirena? If so, in what amount and for whose benefit is such accounting to be made? Or, in the alternative, ii. such that a constructive trust is to be imposed on any part of the gross revenue from the sale of Mirena for the benefit of the Classes, including the provincial insurers which have subrogated claims, and, if so, in what amount, and for whom are such proceeds held? h) Are Class Members entitled to recover the medical costs incurred in the screening, diagnosis and treatment of medical conditions caused by taking Mirena? i) Are Class Members entitled to recover as damages an amount equal to the purchase price ofmirena, or part of the purchase price ofmirena? If so, why and in what amount? j) Can damages of Class Members be determined, in whole or in part, on an aggregate basis? If so, who should pay what amount, to whom and why? k) Should one or more of the defendants pay punitive damages? Should punitive damages be assessed in the aggregate? If so, in what amount and how should punitive damages be distributed? 1) Should the defendants, or any of them pay prejudgment and post-judgment interest, at what annual interest rate, and should the interest be compound interest? m) Should the defendants, or any of them, pay the cost of administering and distributing any monetary judgment and/or the cost of determining eligibility and/or the individual issues? If so, who should pay what cost, why, in what amount and to what extent? 68. The claim of the plaintiffs is typical of that of the putative class members.

28 The only notable difference among putative class members involves the extent of damages suffered. The question of damages can readily be determined through individual assessment and ought not to be a bar to certification of this action as a class proceeding. STATUTES 70. The plaintiff pleads and relies upon s.101 of the Courts of Justice Act, R.S.O. 1990, c.43, Rule 40 of the Ontario Rules of Civil Procedure and, inter alia, upon the following legislation: Ontario Class Proceedings Act, R.S.O. 1992, S.O. 1992, c.6; Consumer Protection Act, 2002 S.O. 2002, c.30, Sched. A; Courts of Justice Act, R.S.O. 1990, c.43; Family Law Act, R.S.O. 1990, c. F.3; Health Insurance Act, R.S.O. 1990, c. 11.6; Negligence Act, R.S.O. 1990, c. N.1; Sale ofgoods Act, R.S.O. 1990, c. S.1; Trustee Act, R.S.O. 1990, c. T.23 Alberta Alberta Health Care Insurance Act, R.S.A., 2000, C.A-20 Domestic Relations Act, R.S.A. 2000, c. D10.5, was repealed by R.S.A. 2003, c. F-4.5 [Family Law Act] Fatal Accidents Act, R.S.A. 2000, c. F-8

29 29 Hospital's Act, R.S.A. 2000, c. H-12 Sale of Goods Act, S-2 R.S.A 2000 Tort Feasors Act, R.S.A. 2000, c. T-5 British Columbia Business Practices and Consumer Protection Act, S.B.C. 2004, c.2 Hospital's Insurance Act, R.S.B.C. 1996, c. 204 [en. 1994, c. 37, s. 4; am. 1996, c. 24, s. 1(3)] Sale ofgoods Act, R.S.B.C. 1996, c.410 Current to Gazette Vol. 49:19 (October 20, 2006) Manitoba Fatal Accidents Act, C.C.S.M. c. F50, as amended Manitoba Public Insurance Corporation Act, C.C.S.M. c. P215 Sale of Goods Act, C.C.S.M. c. S10 The Consumer Protection Act, C. C. S.M. c. C200 The Health Services Insurance Act, R.S.M. 1987, c. H35 Trustee Act, C.C.S.M. c.t160 Current to Gazette Vol. 13 5:44 (November 4, 2006) New Brunswick Consumer Product Warranty and Liability Act, Chap. C-18.1 Fatal Accidents Act, R.S.N.B. 1973, c. F-7 Hospital Services Act, R.S.N.B. 1973, c. H-9 Sale of Goods Act, RS.N.B. 1973, c.s-1 Current to Gazette Vol. 164:1901 (November 29, 2009)

30 () 30 Newfoundland Consumer Protection Act, R.S.N.L c. C-31 Fatal Accidents Act, R.S.N.L. 1990, c. F-6 Hospital Insurance Agreement Act, R.S.N.L. 1990, c. H-7 Medical Care Insurance Act, 1999 S.N. 1999, c. 5.1 Sale of Goods Act, R.S.N.L. 1990, c.s-6 Current to Gazette Vol. 81:46 (November 17, 2006) Northwest Territories Consumer Protection Act, R.S.N.W.T. 1988, c. C-17 Fatal Accidents Act, R.S.N.W.T. 1988, c. F-3 Hospital Insurance and Health and Social Services Administration Act, R.S.N.W.T. 1988, c. T-3 Sale of Goods Act, R.S.N.W.T. 1988, c. S-2 Trustee Act RSNWT 1988, C.S-2 Current to Gazette Vol. XXVII:10 (October 31, 2006) Nova Scotia Consumer Protection Act, R.S., c.92 Fatal Injuries Act, R.S.N.S. 1989, c. 163, amended 2000, c. 29, ss 9-12 Health Services and Insurance Act, R.S.N.S. 1989, c. 197 Sale of Goods Act, R.S., c.408 Current to Gazette Vol. 30:21 (November 10, 2006) Nunavut Hospital Insurance and Health and Social Services Administration Act, R.S.N.W.T. 1988, c. T-3 Current to Gazette Vol. 8:10 (October 31, 2006)

31 .~ () 31 Prince Edward Island Consumer Protection Act, R.S.P.E.I. 1988, c. C-19 Fatal Accidents Act, R.S.P.E.I. 1988, c. F-5, as amended Hospital and Diagnostic Services Insurance Act, R.S.P.E.I. 1988, c H-8 Sale of Goods Act, R.S.P.E.I. 1988, c. S-1 Current to Gazette Vol. 132:47 (November 25, 2006) Quebec Civil Code of Quebec Book 5 Consumer Protection Act, R.S.Q. chapter P-40.1 Saskatchewan Department of Health Act, R.S.S. 1978, c. D-17 Fatal Accidents Act, R.S.S. 1978, c. F-11 as amended The Consumer Protection Act, 1996, c. C-30.1 The Sale of Goods Act, R.S.S. 1978, c. S-1 Current to Gazette Vol. 102:44 (November 3, 2006) Yukon Consumers Protection Act, R.S.Y. 2002, c. 40 Hospital Insurance Services Act, R.S.Y. 2002, c. 112 Sale of Goods Act, R.S.Y. 2002, c. 198 Current to Gazette Vol. 25:10 (October 15, 2006) Canada Food and Drugs Act, (R.S., 1985, c. F-27) and all relevant amendments thereto.

32 THE REAL AND SUBSTANTIAL CONNECTION BETWEEN THE SUBJECT MATTER OF THIS ACTION AND ONTARIO There is a real and substantial connection between the subject matter and the Province of Ontario among others for the following reasons: (a) All the defendants carry on business in Ontario; (b) The plaintiff and numerous putative class member reside in Ontario; (c) The plaintiff and numerous other class members used Mirena in Ontario; (d) The plaintiff and numerous other class members suffered damages from their use of Mirena in Ontario; and (e) The regulatory approval in Canada for Mirena was granted in Ottawa, Ontario. SERVICE OUTSIDE ONTARIO 72. This originating process may be served without court order outside Ontario in that the claim is: (a) In respect of a tort committed in Ontario (Rule 17.02(g) ); (b) In respect of damages sustained in Ontario arising from a tort or breach of contract wherever committed (Rule 17.02(h) ); (c) In respect of property in Ontario (Rule (a)); (d) Against a person outside Ontario who is a necessary or proper party to a proceeding properly brought against another person served in Ontario (Rule (o) ); and (e) Against a person carrying on business in Ontario (Rule (p) ).

33 c. (~ The Plaintiff proposes that this action be tried at the City oftoronto. Date: June 13,2013 McPHADDEN SAMAC TUOVI LLP Lawyers Suite King Street East Toronto, Ontario M5C 1B5 Bryan C. McPhadden (LSUC #28160K) Zoran Samac (LSUC #2863 7T) Rohan Hate (LSUC #62873W) Tel: (416) Fax: (416) Lawyers for the plaintiff

34 .: =:. ;~ t.~ ~-,1 -: KIMBERLY BABIN v. BAYER INC. ET AL ~(/' /3-411/66 f- Csmrt File No. Vet' (/ ONTARIO SUPERIOR COURT OF JUSTICE Proceedings commenced at Toronto Proceedings under the Class Proceedings Act; 1992 STATEMENT OF CLAIM McPHADDEN, SAMAC, TUOVI LLP Barristers & Solicitors King Street East Toronto, Ontario M5C 1B5 Bryan C. McPhadden (LSUC# 28160K) Zoran Samac (LSUC #28637T) Idan Erez (LSUC#57090M) Peter E. Tuovi (LSUC#31328E) Tel: (416) Fax: (416) Lawyers for the plaintiff