Case 2:14-cv Document 1 Filed 11/20/14 Page 1 of 21 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA SECTION

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1 Case 2:14-cv Document 1 Filed 11/20/14 Page 1 of 21 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA PETER MANALE, JR., individually and on behalf of HILDA MANALE, deceased, v. Plaintiff, JANSSEN RESEARCH & DEVELOPMENT, LLC f/k/a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC.; JANSSEN ORTHO, LLC, JANSSEN PHARMACEUTICALS, INC. f/k/a JANSSEN PHARMACEUTICA INC., f/k/a ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC., BAYER CORPORATION, BAYER AG, BAYER HEALTHCARE LLC, and BAYER HEALTHCARE PHARMACEUTICALS INC., CIVIL ACTION NO. COMPLAINT JURY TRIAL DEMANDED SECTION MAGISTRATE Defendants. COMPLAINT Plaintiff, PETER MANALE, JR., individually and on behalf of decedent, HILDA MANALE, by and through undersigned counsel, hereby submits this Complaint and hereby alleges upon information and belief: PARTIES 1. Plaintiff, Peter Manale, Jr., the surviving spouse of Hilda Manale, is a person of the full age of majority and at all relevant times hereto, was a resident of St. Bernard Parish Louisiana. Hilda Manale ( Ingesting Plaintiff suffered severe damages as a direct result of her ingestion of the pharmaceutical product Xarelto. 2. Defendant, JANSSEN RESEARCH & DEVELOPMENT, LLC f/k/a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC ( J&J is a limited liability company organized, under the laws of New Jersey, with corporate headquarters

2 Case 2:14-cv Document 1 Filed 11/20/14 Page 2 of 21 located at One Johnson & Johnson Plaza, New Brunswick, Middlesex County, New Jersey, Defendant J&J is the holder of the approved New Drug Application ( NDA for Xarelto as well as the supplemental NDA. 3. Defendant, JANSSEN ORTHO, LLC ( Ortho is a limited liability company with a principal place of business at Bo. Mamey, Carr. 933 Km 0.1, Gurabo, Puerto Rico Ortho is a subsidiary of Johnson & Johnson. At all times relevant hereto, Defendant Ortho manufactures, and continues to manufacture Xarelto. At all times relevant hereto, Defendant Ortho derived, and continues to derives, substantial revenue from goods and products disseminated and used in the State of Louisiana. 4. Defendant, JANSSEN PHARMACEUTICALS, INC. f/k/a JANSSEN PHARMACEUTICA INC., f/k/a ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. ( Janssen, at all relevant times hereto was, and currently is still, a corporation, duly existing under and by virtue of the laws of the Commonwealth of Pennsylvania with a principal place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey At all times relevant and material hereto, Janssen was, and still is, a pharmaceutical company involved in the manufacturing, distribution, sale, and release for use to the general public of pharmaceuticals, including Xarelto, in New Orleans, Orleans Parish, the State of Louisiana and throughout the United States. 5. Defendant BAYER CORPORATION ( Bayer Corp is, and at all times relevant was, a corporation organized under the laws of the State of Indiana with its headquarters and principal place of business at 100 Bayer Road Pittsburgh, Pennsylvania. 6. Defendant, BAYER AG ( Bayer is a foreign company with its principal place of business in Leverkusen, Germany, who licensed Xarelto. 7. Defendant, BAYER HEALTHCARE LLC ( Bayer HC is a limited liability company with corporate communication headquarters located at 100 Bayer Road, Pittsburgh, PA Bayer HC s North American Headquarters are located at 100 Bayer Blvd, Whippany, NJ 2

3 Case 2:14-cv Document 1 Filed 11/20/14 Page 3 of Bayer HC is a subsidiary of Bayer and jointly developed Xarelto with J&J. Bayer s cooperation partner, J&J, submitted the new drug application for Xarelto to the FDA. 8. Defendant, BAYER HEALTHCARE PHARMACEUTICALS INC. ( Bayer Pharma is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 340 Changebridge Road, P.O. Box 1000, Montville, New Jersey Bayer Pharma is the U.S.-based pharmaceuticals operation of Bayer HC, a division of Bayer. Bayer Pharma is a subsidiary of Bayer and jointly developed Xarelto with J&J. At all times relevant and material hereto, Bayer Pharma was, and still is, a pharmaceutical company involved in the manufacturing, distribution, sale, and release for use to the general public of pharmaceuticals, including Xarelto in New Orleans, Orleans Parish, State of Louisiana and throughout the United States. Corporation Service Company accepts service of process for Defendant Bayer Pharma at 2595 Interstate Drive, Suite 103, Harrisburg, Pennsylvania Bayer s cooperating partner J&J submitted the new drug application to the FDA for Xarelto. 10. Defendants J&J, Ortho, Janssen, Bayer, Bayer HC, and Bayer Pharma shall be referred to herein individually by name or jointly as Defendants. 11. At all times alleged herein, Defendants shall include any and all named or unnamed parent companies, parent corporations, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and any organizational units of any kind, their predecessors, successors, successors in interest, assignees, and their officers, directors, employees, agents, representatives and any and all other persons acting on their behalf. 12. At all times herein mentioned, each of the Defendants was the agent, servant, partner, predecessor in interest, aider and abettor, co-conspirator, and joint venturer of each of the remaining Defendants herein. 13. At all times herein mentioned, each of the Defendants was the agent, servant, partner, predecessor in interest, aider and abettor, co-conspirator, and joint venturer of each of 3

4 Case 2:14-cv Document 1 Filed 11/20/14 Page 4 of 21 the remaining Defendants thereby operating and acting with the purpose and scope of said agency, service, employment, partnership, conspiracy and joint venture. 14. At all times relevant and material hereto, Defendants were engaged in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, and or introducing into interstate commerce throughout the United States, and in the State of Louisiana, either directly or indirectly, through third-parties, subsidiaries and/or related entities, the anti-coagulant pharmaceutical Xarelto. JURISDICTION AND VENUE 15. This Court has jurisdiction over this action pursuant to 28 U.S.C. 1332, because the amount in controversy as to Plaintiff exceeds $75,000.00, exclusive of interest and costs, and because there is complete diversity of citizenship between Plaintiff and the Defendants. 16. Venue is proper in this jurisdiction pursuant to 28 U.S.C. 1391, because a substantial part of the events or omissions giving rise to the claim occurred in this District, and because Defendants conduct substantial business in this District. 17. This Court has personal jurisdiction over the Defendants because they have done business in the State of Louisiana have committed a tort in whole or in part in the State of Louisiana, have substantial and continuing contact with the State of Louisiana, and derive substantial revenue from goods used and consumed within the State of Louisiana. The Defendants actively sell, market and promote its pharmaceutical product Xarelto to physicians and consumers in this state on a regular and consistent basis. NATURE OF THE CASE 18. This is an action for personal injury and loss of consortium on behalf of Plaintiff, against Defendants who were responsible for the prescription drug Xarelto that proximately caused the Plaintiff to sustain injuries and damages. 19. Defendants, directly or by and through their agents, apparent agents, servants or employees designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold Xarelto as an anti-coagulant primarily used to reduce the risk of stroke and systemic 4

5 Case 2:14-cv Document 1 Filed 11/20/14 Page 5 of 21 embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis ( DVT, to treat pulmonary embolisms ( PE, and/or to reduce the risk of recurrence of DVT and or PE. 20. Defendants applied for an initial NDA for Xarelto in July of Xarelto was approved by the Food and Drug Administration ( FDA on July 1, 2011 reduces risk of blood clots, DVT, and PE following knee and hip replacement surgery. On November 4, 2011 Xarelto was approved as an anti-coagulant primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. On November 2, 2012 the FDA expanded the use of Xarelto to the treatment of patients with DVT and PE as well as long-term treatment to prevent recurrence of the same. 22. According to the Defendants marketing and informational materials, referenced in the paragraphs below, and widely disseminated to the consuming public, Xarelto is the first and only once-a day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke without routine blood monitoring As the Defendants state on their website, XARELTO has been proven to lower the chance of having a stroke if you have atrial fibrillation (AFib, not caused by a heart valve problem. XARELTO is an anticoagulant, or blood-thinning medicine that works by helping to keep blood clots from forming. The Defendants further claim that it s been prescribed to more than seven million people around the world to help treat or reduce their risk of dangerous clots and that it begins working a few hours after you start taking it, and keeps working for as long as take it Defendants further declare that XARELTO is proven to help treat and prevent DVT and PE blood clots and that Xarelto reduc[es] the risk of these dangerous clots [from] happening again esbyfda/warninglettersandnoticeofviolationletterstopharmaceuticalcompanies/ucm pdf

6 Case 2:14-cv Document 1 Filed 11/20/14 Page 6 of Defendants claim that patients with AFib, DVT, or PE taking Xarelto do not need regular blood monitoring and there are no known dietary restrictions. In addition, patients with AFib only need to take Xarelto once a day with an evening meal Defendants claim that patients with AFib are 5 times more likely than a person without Afib to suffer from a stroke and that disability is more likely to be severe and the outcome is almost twice as likely to be fatal and the chances of having another major stroke go up Rivaroxaban is an oxazolidinone derivative optimized for inhibiting both free Factor Xa and Factor Xa bound in the prothrombinase complex. It is a highly selective direct Factor Xa inhibitor with oral bioavailability and rapid onset of action. Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated Factor II. 28. Defendants routinely marketed Xarelto as a one size fits all drug; In their fervent marketing of Xarelto, Defendants misinformed patients, and their healthcare providers, as to the necessity to routinely monitor any patient requiring a blood thinning agent. In essence, the Defendants have created a new drug, Xarelto, that is not better than warfarin from a safety perspective, and at best, perhaps slightly easier to use and administer. The idea of this apparently easier-to-use anticoagulant evidently appealed to physicians, who were subject to extreme marketing and promotion by the Defendants, but ignores patient safety. 29. The Defendants marketing materials suggest that Xarelto represented a therapeutic simplification and therapeutic progress because it did not require patients to undergo periodic monitoring with blood tests and because there were no dietary restrictions. 4 and

7 Case 2:14-cv Document 1 Filed 11/20/14 Page 7 of Defendants boxed warning did not address the increased risk for serious and fatal bleeding, despite the fact that the information listed on their website originating from the Rocket AF clinical trial sponsored by Defendants state that in comparison to warfarin, patients taking Xarelto have more gastrointestinal bleeds and need more transfusions. In spite of this reference regarding bleeds, the information is still wholly inadequate because, this information was not conveyed in the boxed warning on the Xarelto label According to Institute for Safe Medication Practices, QuarterWatch Report, issued on October 3, 2012, the primary reported adverse event related to Xarelto use was not the well understood risk of hemorrhage. Instead, the largest identifiable category was serious blood-clot related injury most frequently pulmonary embolism the very events rivaroxaban is intended to prevent. This lack of efficacy for short term users of Xarelto post hip and knee replacement surgery resulted in about 44% of the reported adverse effects from taking Xarelto. 32. FDA clinical reviewers have stated that rivaroxaban should not be approved unless the manufacturer conducts further studies to support the efficacy and safety of rivaroxaban and the FDA website notes that [a]dverse event reports of thrombocytopenia and venous thromboembolic events were identified in relationship to Xarelto. 7 However, this information was not portrayed in the warning section on the warning label. The lack of efficacy of the medication for patients taking Xarelto post hip and knee surgery were not disclosed resulting in patients ingesting Xarelto and physicians prescribing Xarelto without sufficient information to make an accurate decision. 33. Defendants fervently marketed Xarelto using print advertisements, online marketing on their website, and video advertisements with no regard to the accuracy and repercussions of their misleading advertising in favor of increasing sales

8 Case 2:14-cv Document 1 Filed 11/20/14 Page 8 of In the January/February 2013 issue of WebMD magazine, Defendants placed a print advertisement that resulted in the Office of Prescription Drug Promotion (OPDP of the U.S. Food and Drug Administration (FDA to send an untitled letter stating that their print advertisement was false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Furthermore, the advertisement states there are no dosage adjustments in conflict with the product labeling approved by the FDA As a result of Defendants intense marketing, [a]bout 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012 resulting in large profits as Xarelto costs approximately $3,000 a year versus $200 for generic warfarin As a result of Defendant s extreme marketing tactics, within the United Kingdom, Defendants also made 219 million Euros in sales from Xarelto, more than three times as much as during the same period last year Due to the defective nature of Xarelto, persons who were prescribed and ingested Xarelto, for even a brief period of time, including the Ingesting Plaintiff herein, were at increased risk for developing life-threatening bleeds. Due to the flawed formulation of Xarelto, which according to Defendants does not require regular blood monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, bleeding, and blood clots if not taken properly or absorbed properly, particularly in patients with poor renal function. In addition, 8 DA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM pdf, June 6, 2013 FDA Untitled Warning Letter 9 Ransdell Pierson. Pradaxa and Xarelto: Top Heart Doctors Concerned Over New Blood Thinners Huffpost Healthy Living. 14 th June Frank Siebelt, Hans Seidenstuecker, and Christoph Steitz. Reports of side-effects from Bayer s Xarelto grow: Spielgel 8

9 Case 2:14-cv Document 1 Filed 11/20/14 Page 9 of 21 [p]rominent U.S. [cardiologists and health care professionals] stress that neither new drug [Xarelto] has a known antidote for a bleeding emergency, as warfarin does Defendants pharmaceutical Xarelto led to 968 suspected undesirable side-effects including 72 cases of death in Germany in just the first eight months of In addition, The Institute for Safe Medication Practices reported that: A clinical trial with 14,000 patients had shown that rivaroxaban was no worse than warfarin. [40] But reviewers noted that warfarin had not been optimally used. If rivaroxaban were really inferior to optimally used warfarin but this was not proven, only suspected its use could lead to increased death and injury. [41] Reviewers also questioned the convenient once-a-day dosing scheme, saying blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing. As with other anticoagulants, the rate of clinically relevant bleeding in clinical studies was high 15% per year of treatment. 13 In other words, the insufficient testing conducted and the deadly consequences of Xarelto did not go unnoticed. 40. Even more significantly, in the first quarter of 2012, The Institute for Safe Medication Practices identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug. The report more than doubled from the previous quarter total of 128 cases. 14 However, when the findings were discussed with Defendants, the company told us that it had reviewed the same data and saw no signal of a safety issue that 11 Ransdell Pierson. Pradaxa and Xarelto: Top Heart Doctors Concerned Over New Blood Thinners Huffpost Healthy Living. 14 th June Frank Siebelt, Hans Seidenstuecker, and Christoph Steitz. Reports of side-effects from Bayer s Xarelto grow: Spielgel 13 Institute for Safe Medication Practices, QuarterWatch Report, October 3, Id. 9

10 Case 2:14-cv Document 1 Filed 11/20/14 Page 10 of 21 needed to be addressed. 15 Defendants placed more value into ensuring that their profits would continue instead of working on minimizing the serious, disabling, or fatal injuries that were occurring due to the drug they were marketing and promoting. 41. Defendants concealed their knowledge that Xarelto can cause life threatening, irreversible bleeds from the Ingesting Plaintiff, other consumers, the general public, and the medical community. Indeed, the Defendants did not properly warn of the irreversible nature of Xarelto in the Warnings and Precautions section of the products warning label. The only warnings provided by Defendants were as follows: Specifically, Defendants did not adequately inform consumers and the prescribing medical community about the risks of uncontrollable bleeds associated with Xarelto usage, nor did Defendants warn or otherwise advise on how to intervene and stabilize a patient should a bleed occur. 42. As seen in the Full Prescribing Information provided by Defendants, Defendants reveal that they did not test for all the possible reversal agents for this dangerous drug since [a] specific antidote for rivaroxaban is not available and [u]se of procoagulant reversal agents such as prothrombin complex concentrate (PCC, activated prothrombin complex 15 Id. 10

11 Case 2:14-cv Document 1 Filed 11/20/14 Page 11 of 21 concentrate (APCC or recombinant factorvlla (rfvlla may be considered but has not been evaluated in clinical trials. However, this is buried in small print. 43. Importantly, Xarelto still does not have a black box warning informing patients or prescribing doctors know that Xarelto can cause irreversible bleeds. In fact, the August 2013 Highlights of Prescribing Information only has a black box warning stating the following: 44. Even in the Warnings and Precautions section of the August 2013 Highlights of Prescribing Information, the irreversible nature of the medication Xarelto was not revealed to patients or their prescribing doctors. Defendants merely indicated that there was a risk for bleeding and side-stepped the important issue of reversing the effects of Xarelto should a bleed occur as seen below: 11

12 Case 2:14-cv Document 1 Filed 11/20/14 Page 12 of Aside from the warning labels, Defendants did not issue a Dear Doctor letter that sufficiently outlined the dangers of administering Xarelto to a patient. In the September 2013 letter to healthcare professionals, Defendants do not mention the lack of an antidote in Xarelto should serious and fatal bleeding occur while a patient was taking Xarelto. 46. The current warning is simply inadequate. The Defendants have failed and continue to fail in their duties to warn and protect the consuming public, including the Ingesting Plaintiff herein. 47. Even if the warnings were sufficient, which Ingesting Plaintiff strongly denies, Xarelto still lacks any benefit sufficient to tolerate the extreme risk posed by the ingestion of this drug. Xarelto is quite simply dangerous and defective as formulated. The Defendants should withdraw Xarelto from the market. 48. Defendants willfully, wantonly and with malice withheld the knowledge of increased risk of irreversible bleeds in users of Xarelto to prevent any chances of their product s registrations being delayed or rejected by FDA. 49. As the manufacturers and distributors of Xarelto, Defendants knew or should have known that Xarelto use was associated with irreversible bleeds. 50. With the knowledge of the true relationship between use of Xarelto and irreversible bleeds, rather than taking steps to pull the drug off the market, provide strong 12

13 Case 2:14-cv Document 1 Filed 11/20/14 Page 13 of 21 warnings, or create an antidote, Defendants promoted and continue to promote Xarelto as a safe and effective treatment for AFib. 51. Defendants Xarelto is estimated to be the 19th-best-selling drug in the world by 2018, according to the report. Worldwide sales of Xarelto are expected to jump from $596 million in 2012 to $3.7 billion in While Defendants enjoy great financial success from their expected blockbuster drug, Xarelto, they continue to place American citizens at risk of severe bleeds and death. 53. Consumers, including Ingesting Plaintiff, Hilda Manale, who have used Xarelto to reduce the risk of stroke due to Afib or to reduce the risk of blood clots, DVT and PE following knee or hip replacement surgery, have several alternative safer products available to treat the conditions and have not been adequately warned about the significant risks and lack of benefits, associated with Xarelto therapy. 54. Defendants, through their affirmative misrepresentations and omissions, actively concealed from Ingesting Plaintiff and Ingesting Plaintiff s physicians the true and significant risks associated with Xarelto use. 55. As a result of Defendants actions, Ingesting Plaintiff Hilda Manale and Ingesting Plaintiff s physicians were unaware, and could not have reasonably known or have learned through reasonable diligence, that Ingesting Plaintiff would be exposed to the risks identified in this Complaint. The increased risks and subsequent medical damages associated with Ingesting Plaintiff s Xarelto use were the direct and proximate result of Defendants conduct. FACTUAL ALLEGATIONS 56. On March 3, 2014 Ingesting Plaintiff, Hilda Manale, was first prescribed and began taking Xarelto upon direction of her prescribing physician. Subsequently, as a direct 13

14 Case 2:14-cv Document 1 Filed 11/20/14 Page 14 of 21 result of Ingesting Plaintiff s ingestion of Xarelto, she suffered severe pulmonary embolisms and was admitted on March 11, 2014 to St. Bernard Parish Hospital in Chalmette, Louisiana. 57. As a direct result of being prescribed Xarelto for this period of time, Ingesting Plaintiff suffered significant injuries, such as those described above, which ultimately caused her untimely death on April 9, As a proximate result of Defendants acts and omissions, Ingesting Plaintiff suffered serious and dangerous side effects described hereinabove due to Plaintiff s ingestion of Xarelto, which caused her death on April 9, Plaintiff accordingly seeks compensatory damages associated with these injuries. 60. Ingesting Plaintiff would not have used Xarelto had Defendants properly disclosed the risks associated with its use. WHEREFORE, Plaintiff prays for judgment against Defendants, jointly and severally, in an amount, which will compensate the Plaintiff for his injuries EQUITABLE TOLLING OF APPLICABLE STATUTES OF LIMITATION 61. Plaintiffs incorporate by reference each and every paragraph of this Complaint as if fully set forth herein and further alleges as follows: 62. The running of any statute of limitations has been tolled by reason of Defendants fraudulent concealment. Defendants, through failing to disclose, for three years, the truth about the safety and efficacy of Xarelto, to Ingesting Plaintiff s physicians and/or Ingesting Plaintiff, and misrepresenting Xarelto as safe and efficacious for its intended use, actively concealed from said individuals the true risks associated with the use of Xarelto drug products. 63. Ingesting Plaintiff had no knowledge that Defendants were engaged in the wrongdoing alleged herein. Because of the fraudulent acts of concealment of wrongdoing by the 14

15 Case 2:14-cv Document 1 Filed 11/20/14 Page 15 of 21 Defendants, the Ingesting Plaintiff could not have reasonably discovered the wrongdoing at any time prior to the commencement of this action. 64. Ingesting Plaintiff, nor Ingesting Plaintiff s physicians, could not have possibly determined the nature, extent and identity of related health risks associated with Xarelto. Ingesting Plaintiff and Ingesting Plaintiff s physicians reasonably relied on Defendants to disseminate truthful and accurate safety and efficacy information about its drug and warn of the side effects complained of herein. 65. Furthermore, Defendants are estopped from relying on any statute of limitations because of their fraudulent concealment of the defective nature of Xarelto. Defendants were under a duty to disclose the true character, quality, and nature of Xarelto because this was nonpublic information over which the Defendants have, and continue to have, exclusive control, and because Defendants knew this information was not available to the Ingesting Plaintiff or her physicians. In addition, the Defendants are estopped from relying on any statute of limitations because of their concealment of these facts. WHEREFORE, Plaintiffs pray for judgment against Defendants, jointly and severally, in an amount, which will compensate the Plaintiffs for their injuries. COUNT ONE LOUISIANA PRODUCTS LIABILITY ACT 66. Plaintiffs hereby restate and re-allege each and every allegation set forth above, with the same force and effect as if herein repeated and set forth at length. 67. Defendants were at all times relevant to this suit, and is now, engaged in the business of designing, manufacturing, testing, marketing, and/or placing in the stream of commerce pharmaceuticals for sale to, and use by, members of the public, including the Xarelto at issue in this lawsuit. The Xarelto placed into the stream of commerce by 15

16 Case 2:14-cv Document 1 Filed 11/20/14 Page 16 of 21 Defendants reached Ingesting Plaintiff without substantial change and was ingested as directed. The Xarelto was defective and unreasonably dangerous when it entered into the stream of commerce and when used by Ingesting Plaintiff. 9: ( Defendants are believed to be a manufacturer under Louisiana Revised Statute 69. Plaintiff hereby sets forth that the Defendants are liable to Plaintiff under the Louisiana Products Liability Act, LA. R.S. 9: , et seq.: a. At the time Xarelto left the control of the Defendants it was defective and unreasonably dangerous due to a failure to contain adequate warnings or instructions, or in the alternative, because the product breached an express warranty or failed to conform to the other expressed factual representations upon which Plaintiff and/or Plaintiff s physician s justifiably relied, or because it breached an implied warranty, all of which proximately caused the damages for which Plaintiff seeks recovery herein; b. Xarelto was not reasonably safe as designed, taking into account the foreseeable risks involved in its use at the time the product left the possession of the Defendants, and that such risks clearly outweighed the utility of the product or its therapeutic benefits; c. At the time Xarelto left the control of the Defendants it possessed a dangerous characteristic that may cause damage, and it was not reasonably safe due to inadequate or defective warnings or instructions that were known or reasonably scientifically knowable at the time the product left the possession of the Defendants. Specifically, although the Defendants were well aware that Xarelto could potentially cause irreversible bleeding, warnings of such adverse health conditions were either not included on the package insert for these products or they were not adequate to inform consumers. The Defendants failed to use reasonable care to provide an adequate warning of these dangerous characteristics to handlers and users of Xarelto. d. The Defendants warnings or instructions were not of a nature that a reasonably prudent drug company in the same or similar circumstances would have provided with respect to the danger. There were no warnings or instructions that communicated sufficient information on the dangers and safe use of the product taking into account the characteristics of the product, and/or the ordinary knowledge common to the consumer, such as the Plaintiff. 16

17 Case 2:14-cv Document 1 Filed 11/20/14 Page 17 of At all times pertinent and material hereto, there existed alternative feasible drugs to provide comparable benefits of Xarelto to Ingesting Plaintiff without the attendant risks of irreversible bleeding. 71. At all times pertinent and material hereto, Defendants knew that Xarelto was unreasonably dangerous and/or defective as set forth herein. 72. In the alternative, Defendants should have, at all times pertinent and material hereto, known of the unreasonably dangerous and/or defective characteristics and/or conditions of Xarelto, had they reasonably employed then-existing scientific and/or technical knowledge, reasonable testing, and/or other reasonable and then-accepted methods of quality assurance and/or quality control. 73. The Xarelto manufactured by Defendants is unreasonably dangerous due to an inadequate warning that, at the time the drug left Defendants control, possessed a characteristic that might cause damage or injury to Ingesting Plaintiff, and yet Defendants failed to use reasonable care to provide an adequate warning of such characteristics and/or dangers to prescribing physicians and/or users of the drug. 74. In addition, and in the alternative, the Xarelto manufactured by Defendants is unreasonably dangerous in design, in that at the time the drug left the Defendants control, there existed, upon information and belief, an alternative design for the drug that was capable of preventing Ingesting Plaintiff s injuries, and the likelihood of causing the Ingesting Plaintiff s injuries and the gravity of that harm outweighed the burden (if any on Defendants in adopting such alternative design and the adverse effect (if any on the utility of the drug. 75. The Defendants knew or in light of reasonably available scientific knowledge should have known about the danger that caused the injuries for which Plaintiff seeks recovery. 17

18 Case 2:14-cv Document 1 Filed 11/20/14 Page 18 of 21 Despite this knowledge, Defendants failed to provide consumers, including Plaintiff, and Ingesting Plaintiff s physicians with warnings and other clinically relevant information and data regarding the risks and dangers associated with Xarelto as it became or could have become available to Defendants. 76. A reasonably ordinary consumer who ingested Xarelto would not readily recognize ingestion of the drug involved substantial dangers. 77. Plaintiffs did not know, nor had reason to know, at the time of Ingesting Plaintiff s usage of Xarelto, or at any time prior to its use, of the existence of the abovedescribed defects and inadequate warnings. 78. Those defects caused serious injuries to Ingesting Plaintiff when the product was used in its intended and foreseeable manner, and in the manner recommended by Defendants or in a nonintended manner that was reasonably foreseeable. 79. Defendants failed to provide adequate warnings based on what it knew or should have known about the adverse effects of Xarelto. 80. As a direct and proximate cause of Defendants breach of Louisiana Products Liability Act, LSA R.S. 9: et seq. Plaintiff has suffered and will continue to suffer actual damages. COUNT TWO VIOLATION OF WARRANTY OF REDHIBITION 81. Plaintiffs hereby restate and re-allege each and every allegation set forth above, with the same force and effect as if herein repeated and set forth at length. 82. Defendants were aware of the substantial risks associated with Xarelto but failed to fully disclose the same. 18

19 Case 2:14-cv Document 1 Filed 11/20/14 Page 19 of Defendants, as the manufacturer of Xarelto, is deemed to be aware of its redhibitory defects pursuant to LSA-C.C. Article Had Ingesting Plaintiff been aware of the defects contained in Xarelto, She would not have purchased or ingested Xarelto. This characteristic rendered it unfit for its intended purposes. 85. Defendants are liable to Plaintiff under the theory of redhibition as a consequence of the sale to Plaintiff of a product unfit for its intended use. 86. Plaintiffs are entitled to the return of any purchase price paid, including but not limited to, insurance co-payments, interest on these amounts from the date of purchase, attorneys fees and costs, pecuniary and non-pecuniary damages, as well as any other legal and equitable relief to which Plaintiff may be entitled. COUNT THREE LOSS OF CONSORTIUM 87. Plaintiffs hereby restate and re-allege each and every allegation set forth above, with the same force and effect as if herein repeated and set forth at length. 88. Plaintiffs, Peter Manale, Jr. and Hilda Manale, were legally married, and as such are entitled to the comfort, enjoyment, society and services of one another. 89. As a direct and proximate result of the foregoing, Plaintiff Peter Manale, Jr. has been deprived of the comfort and enjoyment of the services and society of his spouse and has suffered and will continue to suffer economic loss, and has otherwise been emotionally and economically injured. Plaintiff s injuries and damages are permanent and will continue into the future. Plaintiff seeks compensatory and punitive damages from the Defendant as alleged herein. 19

20 Case 2:14-cv Document 1 Filed 11/20/14 Page 20 of 21 PRAYER FOR RELIEF WHEREFORE, Plaintiff demands judgment against the Defendants on each of the above-referenced claims and Causes of Action and as follows: 1. Awarding compensatory damages in excess of the jurisdictional amount, including, but not limited to pain, suffering, emotional distress, loss of life, wrongful death, loss of chance of survival, loss of consortium and other non-economic damages in an amount to be determined at trial of this action; 2. Awarding economic damages in the form of medical expenses, out of pocket expenses, lost earnings and other economic damages in an amount to be determine at trial of this action; 3. Prejudgment interest; 4. Postjudgment interest; 5. Awarding Plaintiff reasonable attorneys fees; 6. Awarding Plaintiff the costs of these proceedings; and 7. Such other and further relief as this Court deems just and proper. DEMAND FOR JURY TRIAL Plaintiff hereby demands trial by jury as to all issues. Dated: November 20, 2014 Respectfully submitted, /s/ James R. Dugan, II James R. Dugan, II, Esq. (LSBA# jdugan@dugan-lawfirm.com Douglas R. Plymale, Esq. (LSBA# David B. Franco, Esq. (TXSBA# dfranco@dugan-lawfirm.com Chad Primeaux, Esq. (LSBA# cprimeaux@dugan-lawfirm.com Lanson Bordelon, Esq. (LSBA#34251 lbordelon@dugan-lawfirm.com 20

21 Case 2:14-cv Document 1 Filed 11/20/14 Page 21 of 21 THE DUGAN LAW FIRM, APLC One Canal Place 365 Canal Street, Suite 1000 New Orleans, LA Tel: ( Fax: ( And Frank J. D Amico, Jr. (LSBA #17519 LAW OFFICES OF FRANK J. D AMICO, JR. 622 Baronne Street New Orleans, Louisiana Telephone: ( Facsimile: ( Counsel for Plaintiff 21

22 Case 2:14-cv Document 1-1 Filed 11/20/14 Page 1 of 3 JS 44 (Rev. 12/07 CIVIL COVER SHEET The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON THE REVERSE OF THE FORM. I. (a PLAINTIFFS DEFENDANTS PETER MANALE, JR., INDIVIDIDUALLY AND ON BEHALF OF HILDA janssen Researech & Development, LLC f/k/a Johnson And Johnson MANALE, DECEASED Pharmaceutical Reasearch and Development LLC; Janssen Ortho, LLC, Janssen Phamaceuticals, INC. f/k/a Ortho-McNeil_Janssen (ne (b County of Residence of First Listed Plaintiff St. Bernard Parish, LA County of Residence of First Listed Defendant Somerset, NJ (EXCEPT IN U.S. PLAINTIFF CASES (IN U.S. PLAINTIFF CASES ONLY NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE LAND INVOLVED. (c Attorney s (Firm Name, Address, and Telephone Number Attorneys (If Known James R. Dugan, II, The Dugan Law Firm, One Canal Place, 365 Canal St., Suite 1000, New Orleans, ( II. BASIS OF JURISDICTION (Place an X in One Box Only III. CITIZENSHIP OF PRINCIPAL PARTIES(Place an X in One Box for Plaintiff (For Diversity Cases Only and One Box for Defendant 1 U.S. Government 3 Federal Question PTF DEF PTF DEF Plaintiff (U.S. Government Not a Party Citizen of This State 1 1 Incorporated or Principal Place 4 4 of Business In This State 2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated and Principal Place 5 5 Defendant (Indicate Citizenship of Parties in Item III of Business In Another State Citizen or Subject of a 3 3 Foreign Nation 6 6 Foreign Country IV. NATURE OF SUIT (Place an X in One Box Only CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES 110 Insurance PERSONAL INJURY PERSONAL INJURY 610 Agriculture 422 Appeal 28 USC State Reapportionment 120 Marine 310 Airplane 362 Personal Injury Other Food & Drug 423 Withdrawal 410 Antitrust 130 Miller Act 315 Airplane Product Med. Malpractice 625 Drug Related Seizure 28 USC Banks and Banking 140 Negotiable Instrument Liability 365 Personal Injury - of Property 21 USC Commerce 150 Recovery of Overpayment 320 Assault, Libel & Product Liability 630 Liquor Laws PROPERTY RIGHTS 460 Deportation & Enforcement of Judgment Slander 368 Asbestos Personal 640 R.R. & Truck 820 Copyrights 470 Racketeer Influenced and 151 Medicare Act 330 Federal Employers Injury Product 650 Airline Regs. 830 Patent Corrupt Organizations 152 Recovery of Defaulted Liability Liability 660 Occupational 840 Trademark 480 Consumer Credit Student Loans 340 Marine PERSONAL PROPERTY Safety/Health 490 Cable/Sat TV (Excl. Veterans 345 Marine Product 370 Other Fraud 690 Other 810 Selective Service 153 Recovery of Overpayment Liability 371 Truth in Lending LABOR SOCIAL SECURITY 850 Securities/Commodities/ of Veteran s Benefits 350 Motor Vehicle 380 Other Personal 710 Fair Labor Standards 861 HIA (1395ff Exchange 160 Stockholders Suits 355 Motor Vehicle Property Damage Act 862 Black Lung ( Customer Challenge 190 Other Contract Product Liability 385 Property Damage 720 Labor/Mgmt. Relations 863 DIWC/DIWW (405(g 12 USC Contract Product Liability 360 Other Personal Product Liability 730 Labor/Mgmt.Reporting 864 SSID Title XVI 890 Other Statutory Actions 196 Franchise Injury & Disclosure Act 865 RSI (405(g 891 Agricultural Acts REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS 740 Railway Labor Act FEDERAL TAX SUITS 892 Economic Stabilization Act 210 Land Condemnation 441 Voting 510 Motions to Vacate 790 Other Labor Litigation 870 Taxes (U.S. Plaintiff 893 Environmental Matters 220 Foreclosure 442 Employment Sentence 791 Empl. Ret. Inc. or Defendant 894 Energy Allocation Act 230 Rent Lease & Ejectment 443 Housing/ Habeas Corpus: Security Act 871 IRS Third Party 895 Freedom of Information 240 Torts to Land Accommodations 530 General 26 USC 7609 Act 245 Tort Product Liability 444 Welfare 535 Death Penalty IMMIGRATION 900Appeal of Fee Determination 290 All Other Real Property 445 Amer. w/disabilities Mandamus & Other 462 Naturalization Application Under Equal Access Employment 550 Civil Rights 463 Habeas Corpus - to Justice 446 Amer. w/disabilities Prison Condition Alien Detainee 950 Constitutionality of Other 465 Other Immigration State Statutes 440 Other Civil Rights Actions V. ORIGIN 1 Original Proceeding (Place an X in One Box Only 2 Removed from State Court VI. CAUSE OF ACTION VII. REQUESTED IN COMPLAINT: VIII. RELATED CASE(S IF ANY DATE FOR OFFICE USE ONLY 3 Remanded from Appellate Court 4 Reinstated or Reopened 5 Transferred from another district (specify 6 Multidistrict Litigation 7 Appeal to District Judge from Magistrate Judgment Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity: 1332 Brief description of cause: Xarelto - Product Liability CHECK IF THIS IS A CLASS ACTION DEMAND $ CHECK YES only if demanded in complaint: UNDER F.R.C.P. 23 JURY DEMAND: Yes No (See instructions: JUDGE SIGNATURE OF ATTORNEY OF RECORD 11/20/2014 /s/ James R. Dugan, II DOCKET NUMBER RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE MDL No. 2592

23 JS 44 Reverse (Rev. 12/07 Case 2:14-cv Document 1-1 Filed 11/20/14 Page 2 of 3 INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44 Authority For Civil Cover Sheet The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of Court for each civil complaint filed. The attorney filing a case should complete the form as follows: I. (a Plaintiffs-Defendants. Enter names (last, first, middle initial of plaintiff and defendant. If the plaintiff or defendant is a government agency, use only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then the official, giving both name and title. (b County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land condemnation cases, the county of residence of the defendant is the location of the tract of land involved. (c Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting in this section (see attachment. II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a, F.R.C.P., which requires that jurisdictions be shown in pleadings. Place an X in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below. United States plaintiff. (1 Jurisdiction based on 28 U.S.C and Suits by agencies and officers of the United States are included here. United States defendant. (2 When the plaintiff is suing the United States, its officers or agencies, place an X in this box. Federal question. (3 This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes precedence, and box 1 or 2 should be marked. Diversity of citizenship. (4 This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the citizenship of the different parties must be checked. (See Section III below; federal question actions take precedence over diversity cases. III. Residence (citizenship of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this section for each principal party. IV. Nature of Suit. Place an X in the appropriate box. If the nature of suit cannot be determined, be sure the cause of action, in Section VI below, is sufficient to enable the deputy clerk or the statistical clerks in the Administrative Office to determine the nature of suit. If the cause fits more than one nature of suit, select the most definitive. V. Origin. Place an X in one of the seven boxes. Original Proceedings. (1 Cases which originate in the United States district courts. Removed from State Court. (2 Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section When the petition for removal is granted, check this box. Remanded from Appellate Court. (3 Check this box for cases remanded to the district court for further action. Use the date of remand as the filing date. Reinstated or Reopened. (4 Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date. Transferred from Another District. (5 For cases transferred under Title 28 U.S.C. Section 1404(a. Do not use this for within district transfers or multidistrict litigation transfers. Multidistrict Litigation. (6 Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C. Section When this box is checked, do not check (5 above. Appeal to District Judge from Magistrate Judgment. (7 Check this box for an appeal from a magistrate judge s decision. VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service VII. Requested in Complaint. Class Action. Place an X in this box if you are filing a class action under Rule 23, F.R.Cv.P. Demand. In this space enter the dollar amount (in thousands of dollars being demanded or indicate other demand such as a preliminary injunction. Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded. VIII. Related Cases. This section of the JS 44 is used to reference related pending cases if any. If there are related pending cases, insert the docket numbers and the corresponding judge names for such cases. Date and Attorney Signature. Date and sign the civil cover sheet.

24 Case 2:14-cv Document 1-1 Filed 11/20/14 Page 3 of 3 Janssen Pharmaceutica Inc., f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc. Bayer Corporation, Bayer AG, Bayer Heathcare LLC, and Bayer Heathcare Pharmaceuticals Inc.,

25 Case 2:14-cv Document 1-2 Filed 11/20/14 Page 1 of 2 AO 440 (Rev. 06/12 Summons in a Civil Action UNITED STATES DISTRICT COURT for the Eastern District of of Louisiana PETER MANALE, JR., individually and on behalf of HILDA MANALE, deceased Plaintiff(s v. Civil Action No. JANSSEN RESEARCH & DEVELOPMENT, LLC f/k/a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC, et al. Defendant(s To: (Defendant s name and address SUMMONS IN A CIVIL ACTION JANSSEN ORTHO, LLC Bo. Marney, Carr. 933 Km 0.1 Gurabo, Puerto Rico A lawsuit has been filed against you. Within 21 days after service of this summons on you (not counting the day you received it or 60 days if you are the United States or a United States agency, or an officer or employee of the United States described in Fed. R. Civ. P. 12 (a(2 or (3 you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff or plaintiff s attorney, whose name and address are: James R. Dugan, II The Dugan Law Firm 365 Canal Street; Suite 1000 New Orleans, LA If you fail to respond, judgment by default will be entered against you for the relief demanded in the complaint. You also must file your answer or motion with the court. CLERK OF COURT Date: Signature of Clerk or Deputy Clerk