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Lawsuit filed in New York against makers of Duragesic fentanyl patch

Posted in Duragesic / Fentanyl

This fentanyl lawsuit alleges that Charles Addison died of acute fentanyl intoxication while wearing a Duragesic fentanyl patch.  Judging by the date of his death, it’s possible he was wearing one of the Duragesic fentanyl patches that was included in the recall notice sent out in 2008.

INTRODUCTION

Plaintiff Lucille Lilly, individually and in her capacity as the duly appointed Administratrix of the Estate of Charles Edward Addison (“Charles Edward Addison”) hereby brings suit against the above named defendants, Johnson & Johnson, Janssen Pharmaceutica Products, L.P., and ALZA Corporation and alleges as follows:

PARTIES

1. Plaintiff Lucille Lilly (“Ms. Lilly”) is an individual residing in Baltimore, Maryland. She is the mother of the late CHARLES EDWARD ADDISON and Administratrix of the Estate of CHARLES EDWARD ADDISON. Hereinafter, the Estate and Ms. Lilly (individually and in her capacities as the Administratrix of the Estate are collectively referred to as “Plaintiffs.”

2. Pursuant to an Order by the New York State Surrogate's Court for the County of Erie dated February 5, 2009, plaintiff Lucille Lilly was awarded Letters of Limited Administration for the Estate of Charles Edward Addison for the purpose of commencing this lawsuit. A copy of said Letters of Limited Administration is annexed hereto and incorporated herein by reference as Exhibit A.

3. Decedent CHARLES EDWARD ADDISON expired on or about February 27, 2008 as a result of “Acute Fentanyl Intoxication” while utilizing a defective Duragesic (fentanyl) patch.

4. Defendant Johnson & Johnson (“J&J”) is a New Jersey corporation with a substantial presence worldwide in the Consumer, Pharmaceutical, and Medical Device and Diagnostics markets. J&J is based in New Brunswick, New Jersey, at Johnson & Johnson Plaza, and first began to operate in New Jersey in 1886. J&J has a substantial and ongoing presence in the State of New York such that it is subject to general jurisdiction of courts within the State of New York. J&J is the sole shareholder of defendant ALZA Corporation and the sole shareholder of the general partner of defendant Janssen, L.P., a New Jersey limited partnership.

5. In its 2004 Annual Report to its shareholders, J&J reported revenues from sales of the product at issue in this action, its Duragesic patch, in fiscal 2004 of $2.083 billon, up 27.7% from $1.631 billion in 2003, which itself was up 35.6% from its 2002 sales of $1.203 billion of the product. On information and belief, a significant portion of these revenues were realized from sales made in New York.

6. J&J, through its Pharmaceutical Resource Group – Americas, based in Raritan, New Jersey, was directly involved in the assessment of the safety and quality control systems utilized by defendant ALZA Corporation in the manufacture of the Duragesic patch, and has further contended before Federal regulatory authorities that the manufacturing processes and quality control systems utilized by ALZA Corporation to manufacture the Duragesic patches were, at all relevant times, adequate to protect the health and safety of patients utilizing the Duragesic patch. The Pharmaceutical Resource Group – Americas integrates J&J's pharmaceutical operations and quality assurance organizations within the Americas, across the various subsidiary and affiliate entities through which J&J operates in this part of the world, including New York.

7. J&J, through its Pharmaceutical Sourcing Group – Americas division, is responsible for running ALZA Corporation's commercial operations, including its production of the Duragesic patch product.

8. Defendant ALZA Corporation (“ALZA”) is a Delaware corporation with its primary office located in Mountain View, California. ALZA is a wholly owned subsidiary of J&J.

9. At all times relevant hereto, ALZA was engaged in the business of manufacturing, marketing, selling, distributing and/or promoting the Duragesic patch in New York and myriad other locations nationally. ALZA at all times relevant to this case — alone and/or in partnership with Janssen and/or J&J – was doing business in New Jersey and nationwide as the manufacturer, seller, distributor and promoter of the Duragesic patch.

10. ALZA manufactured, sold, distributed and promoted the Duragesic patch at issue in this litigation. ALZA placed the defective and leaking Duragesic patch at issue in the national stream of commerce resulting in its sale to the Plaintiffs' decedent, CHARLES EDWARD ADDISON, in New York in December 2006.

11. Defendant Janssen, L.P. f/k/a Janssen Pharmaceutica Products, L.P. (“Janssen”) is a New Jersey limited partnership with its principal office located in Titusville, New Jersey. Janssen Pharmaceutica, Inc., the general partner of Janssen and a wholly owned subsidiary of J&J, is a Pennsylvania corporation with its principal place of business in Titusville, New Jersey. At all times relevant to this case Janssen transacted and was doing business in the State of New York, including, inter alia, the sale, marketing, promotion, distribution or manufacturing of the Duragesic patch. The economic activity and business operations of Janssen – alone and/or in partnership with ALZA Corporation and/or J&J – in New York is and was substantial and subjects it to suit in this jurisdiction in this wrongful death case.

12. At all times relevant hereto, Janssen was engaged in the business of manufacturing, marketing, selling, distributing, and/or promoting the sale of the Duragesic patch in New York and myriad other locations nationally. It is that chronic pain medication which is at issue in this case. Janssen at all times relevant to this case was doing business in New York and nationwide as the manufacturer, seller, distributor and promoter of the Duragesic patch.

13. Defendant Janssen placed millions of Duragesic patches each year in the stream of commerce in New York and nationwide resulting in its sale to Plaintiffs decedent, CHARLES EDWARD ADDISON in December 2006.

JURISDICTION AND VENUE

14. Pursuant to 28 U.S.C. § 1332 (a) (1), this Court has jurisdiction over this action because the matter in controversy exceeds $75,000, and it is between citizens of different states.

15. Certain of the acts and omissions that form the basis of this complaint occurred within the State of New York and the jurisdictional boundaries of this Court.

16. The named Defendants each have sufficient dealings or affiliations with the State of New York to make it reasonable to require said defendants to defend this lawsuit. Said Defendants' activities in New York include, but are not limited to, designing, manufacturing, selling, distributing or otherwise placing in the stream of commerce the Duragesic patch which was sold and used by Plaintiffs' decedent, and which caused the injuries which form the basis of this complaint.

17. At all times relevant, the Defendants' activities in the State of New York were continuous and systematic and this action relates to that activity.

18. The Defendants' contacts with the State of New York are sufficiently substantial and of such a nature as to make the assertion of jurisdiction reasonable.

19. The Defendants are subject to the jurisdiction of this Court as the acts and omissions which provide the basis for the present complaint arose out of acts and omissions of the defendants that occurred in the State of New York.

20. Venue properly lies in this Court pursuant to 28 U.S.C.A. 1391 (a) (2) and (3), because a substantial part of the events or omissions giving rise to the claims that are the subject of this action occurred in this district, and each of the Defendants are subject to personal jurisdiction in this district.

FACTS COMMON TO ALL COUNTS

21. Duragesic is the registered name for a transdermal patch which is available only by prescription. This patch contains a gel form of fentanyl, a powerful synthetic opioid that is up to one hundred times more potent than morphine.

22. The Duragesic patch is applied directly to the skin of the user, and is supposed to deliver this strong pain medication at a regulated rate for up to seventy-two (72) hours. The Duragesic patch is supposed to relieve chronic moderate to severe pain, such as that which was suffered by Plaintiffs' decedent, CHARLES EDWARD ADDISON.

23. At all relevant times, J&J was in the business of designing, licensing, promoting, manufacturing, marketing, selling and distributing pharmaceuticals and other products, including Duragesic patches.

24. J&J does business, and does business by agent, in the State of New York. At all relevant times, J&J designed, developed, licensed, marketed, manufactured, sold and placed in the stream of commerce Duragesic patches, including those at issue in this lawsuit. J&J did this throughout the United States, including New York.

25. At all relevant times, J&J acted in conjunction with other affiliated, related, jointly owned or controlled entities, including Defendant Jannssen, L.P. and Defendant ALZA Corporation.

26. At all relevant times, Janssen was in the business of designing, licensing, promoting, manufacturing, marketing, selling and distributing pharmaceuticals and other products, including Duragesic patches. At all relevant times, Janssen designed, developed, licensed, marketed, manufactured, sold and placed in the stream of commerce Duragesic patches, including the ones at issue in this lawsuit. Janssen did this throughout the United States, including New York.

27. At all relevant times, Janssen acted in conjunction with other affiliated, related, jointly owned or controlling entities, including Defendant J&J and Defendant ALZA Corporation.

28. At all relevant times, ALZA was in the business of designing, licensing, promoting, manufacturing, marketing, selling and distributing pharmaceuticals and other products, including drug delivery systems such as the ones used on the Duragesic patches at issue in this lawsuit. ALZA did this throughout the United States, including New York.

29. At all relevant times, ALZA was affiliated with J&J and Janssen, through merger, joint venture, joint or common ownership or otherwise, and in conjunction and in combination with J&J and Janssen designed, licensed, promoted, manufactured, marketed, distributed, sold and placed in the stream of commerce Duragesic patches, including the ones at issue in this lawsuit.

30. The Duragesic patch in question was designed, manufactured, distributed, sold and placed in the stream of commerce by J&J, Janssen and ALZA. The Defendants designed and manufactured these patches using a patented drug delivery method developed by ALZA. In this drug delivery system, a drug is placed inside a patch, and that patch is designed to be placed on the skin of the user. In theory, the drug will then be introduced to the user at a controlled rate over a period of time.

31. On February 16, 2004, the Defendants provided notice that there was a defect in one lot of Duragesic 75 mcg/hour patches, being lot number 0327192. Subsequently, the Food and Drug Administration (“FDA”) issued a Class I recall, meaning there was a serious health risk, for this lot of 75 mcg/hour Duragesic patches. The recall was deemed necessary as there was the potential for the opiate medication in these patches to leak causing injury to the user. The Defendants advised the FDA that exposure to a defective patch could cause an increased drug effect, including nausea, sedation, drowsiness, respiratory depression or other life threatening conditions. The February recall only related to patches with control number 0327192, as that was the only lot that the Defendants advised the FDA was defective. The presence of defects in this lot of patches did not come to the Defendants' attention as the result of their quality control and quality assurance processes, but came to the Defendants' attention only when consumers began to return leaking patches from this lot to the Defendants. In truth, the defect that afflicted Lot 0327192 was not the only defect present in the Duragesic patches manufactured by the Defendants that created a risk that a leaking patch would be sold and used by a consumer without knowledge of the defect or the risk it posed. In fact, Defendants themselves referred to one kind of leaking patch that was routinely released for distribution to the public as an “inherent,” “classic” leaker.

32. Despite knowing of the defect that affected Lot 0327192 and the presence of other defective patches in other lots of Duragesic patches prior to the date CHARLES EDWARD ADDISON used the patch in question, the Defendants took inadequate steps to advise physicians, hospitals, nursing homes, other health care providers, and patients of the defect and the significant dangers to users of the Duragesic patches.

33. Despite knowing of these defects prior to the date CHARLES EDWARD ADDISON used the patch in question, the Defendants took inadequate steps to advise consumers, including CHARLES EDWARD ADDISON, of these defects and the significant dangers they presented to those using the patch. The Defendants also failed to take adequate steps to ensure that other lots that they had manufactured were safe for the public.

34. On April 2, 2004, the Defendants advised physicians (only by letter) that four (4) additional lots of Duragesic 75 mcg/hour patches were afflicted with the same defect found in Lot 0327192 and posed a risk to anyone using them. Each lot of 75 microgram/hr Duragesic patches is comprised of approximately 500,000 patches. Thus, some two million (2,000,000) patches were affected by the 2004 recalls.

35. The additional lots the defendants stated could contain defective Duragesic patches were lots numbers 0327193, 0327294, 0327295, and 0330362. In fact, in the course of the Defendants' internal investigation into the defects present in the five (5) lots recalled in 2004, Defendants determined that the same defect found in the 2004 recalled lots had been present in a lot manufactured by Defendants in 2001. The Defendants response to learning of the defect in 2001 had been solely to “heighten awareness” of the manufacturing workers to the potential for the defect. The steps taken by the Defendants in 2001 were patently inadequate to prevent the release of dangerous and defective leaking patches to the consuming public.

36. Notwithstanding their awareness that the manufacturing process used by Defendants to manufacture Duragesic patches was resulting in the release of potentially fatal defective and leaking patches to the consuming public, Defendants took few and inadequate steps to prevent the release of such patches to the consuming public.

37. In fact, on February 12, 2008, Defendants recalled all lots of 25 microgram/hr Duragesic patches then in distribution due to the presence of defects in said patches that could lead to the delivery of an excessive amount of fentanyl to users and caregivers and result in death or significant injuries. On information and belief the February 2008 recall involved some thirty eight million (38,000,000) patches, and demonstrates that Defendants' manufacturing processes have been inadequate to prevent the release of defective leaking patches to the consuming public since at least 2001.

38. The Duragesic patch used by CHARLES EDWARD ADDISON on or about February 27, 2008, was defective in that it allowed an excess amount of fentanyl to come in to contact with the decedent's skin and therefore be absorbed at toxic levels into CHARLES EDWARD ADDISON's bloodstream. As a result of using said Duragesic patch, CHARLES EDWARD ADDISON received an overdose of the potent opioid fentanyl and died as a direct and proximate result of said exposure.

39. J&J, Janssen and ALZA were each aware of the defects in the Duragesic patches referred to herein, they knew the risks and dangers such defects posted to those using the patches, and these defendants aided, abetted, ratified, authorized, and acted in concert in the wrongful conduct set forth herein.

40. Defendants J&J, Janssen and ALZA acted jointly and/or as each others' agents, within the course and scope of the agency, with respect to the conduct alleged in this complaint.

41. There exists, and at times relevant herein existed, a unity of interest and ownership between J&J, Janssen and ALZA with regard to the manufacture and distribution of the Duragesic patches in question, and with regard to other related conduct, such that any individuality and separateness between these Defendants had ceased and these Defendants became the alter-ego of one another.

42. The Defendants have widely promoted the use of Duragesic patches as a safe and effective method of dealing with chronic and severe pain. This included representations about the safety and effectiveness of using the transdermal delivery method used in the Duragesic patches and known as a “reservoir” system.

43. In addition to the numerous steps they have taken to increase sales of Duragesic patches, the Defendants have also fought to extend their patent rights and to keep other companies from entering in to this lucrative area. For example, certain of the Defendants sued Mylan Laboratories, Inc., asserting that Mylan's generic version of a transdermal patch to deliver fentanyl violated the Defendants' patents. Certain of the Defendants also sought, and obtained, a six-month extension of the marketing exclusivity for Duragesic patches. This exclusivity had been scheduled to end in July, 2004.

44. As a result of Defendants' efforts and actions, the sales of Duragesic patches have become an enormous source of profits for these Defendants, their affiliates, and other related entities involved in the manufacturing and distribution of this product.

45. Accordingly, the Defendants, individually and/or collectively, had a significant financial incentive to suppress, misrepresent and/or conceal any potential dangers or risks associated with Duragesic patches.

46. Plaintiff asserts that J&J, Janssen and ALZA acted for the purpose of maximizing profits at the expense of the health of CHARLES EDWARD ADDISON, and the health of others using Duragesic patches. Plaintiff further asserts that these Defendants had actual or constructive knowledge that a percentage of the patches they placed into the stream of commerce were defective and posed a significant danger to anyone who used these patches, yet failed to take adequate or timely actions to ensure that potential users or distributors of these patches were advised of the defect and warned not to use the patches.

47. J&J, Janssen and ALZA acted together, with a common profit motive, in failing to adequately or appropriately disclose material information relating to the defects in Duragesic patches. As a result, users of these patches, including CHARLES EDWARD ADDISON, were unaware of the defects in these Duragesic patches, and were therefore unable to avoid injury caused by using these defective products.

48. CHARLES EDWARD ADDISON had a significant medical history of chronic pain.

49. To manage his chronic pain and other medical problems, CHARLES EDWARD ADDISON was evaluated and treated by various physicians. As a result of this extensive treatment plan, his physicians initiated opioid medication for management of his chronic pain over a several year period. Over this several year period prior to his death in 2008, he was treated at various times with oral analgesics, and the Duragesic patch.

50. CHARLES EDWARD ADDISON complied with the treatment plans prescribed by his physicians over the several years prior to his death during which he was experiencing pain. CHARLES EDWARD ADDISON died on or about February 27, 2008, while following the prescribed treatment plan that included application of a 100 microgram per hour Duragesic patch. At autopsy, it was determined that CHARLES EDWARD ADDISON had died as the consequence of acute fentanyl toxicity.

51. CHARLES EDWARD ADDISON's tragic and premature death was proximately caused by the Defendants' defective product, the Duragesic patch and the defendants' negligence, gross negligence, recklessness and wanton conduct in connection with the Duragesic patch. The above described potentially lethal “leakage” defects in the product were well known to each of the defendants on and prior to February, 2008. Despite such knowledge, the defendants failed to act, to properly warn or to protect CHARLES EDWARD ADDISON and other Duragesic patch users from deadly harm. Indeed, the defendants sought to cover up the true failure rate and deadly risks its product posed to thousands of consumers each year. While not all fentanyl “leaks” resulted, as here, in death, many hundreds in fact did each year. The defendants knew it and did not disclose this information to the federal regulators, the prescribing medical professionals or the public. They still have not fully or truthfully done so.

52. CHARLES EDWARD ADDISON's death deprived the heirs -at-law of his ongoing love, society, companionship, guidance and support. The plaintiffs seek full and complete damages for the pecuniary, economic/income, and all other lost economic support to which each heir-at-law is entitled. In addition, the Plaintiffs seek full compensation for all intangible damages legally to which they are entitled.

53. In August 2005, the FDA issued an Advisory Warning that, according to data supplied to it by the defendants, 126 deaths had occurred since 1998 of patients wearing the Duragesic patch for pain management or pain alleviation.

54. On information and belief, the actual number of deaths that were sustained by patients while wearing the Duragesic patch from 1998 through December 2006 was many times greater than that number and continues to climb.

55. Like CHARLES EDWARD ADDISON, hundreds of individuals in the United States were caused to die from “fentanyl toxicity” and/or “fentanyl poisoning” due to the propensity of Duragesic “reservoir” design patches to leak fentanyl. The absorption of leaked, bolus administrations of fentanyl through the epidermis of the patient causes a lethal overdose of fentanyl in the patient resulting in deaths, such as the one which gives rise to this wrongful death case.

56. The Defendants, in wanton, reckless, grossly negligent and indefensible disregard of the public safety – and that of CHARLES EDWARD ADDISON – failed adequately and appropriately to warn of the true and, known to the Defendants, deadly risk posed by the Duragesic patch.

57. Without limitation of the foregoing, prior to CHARLES EDWARD ADDISON's death the Defendants were aware that thousands of Duragesic patches each year in the United States: (a) leaked fentanyl; (b) posed a deadly risk to patients and consumers: (c) that the actual number of Duragesic patch deaths were many multiples of the 126 cases reported or known to the FDA; (d) the Defendants each grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals and the public of the lethal risk of “fentanyl toxicity” and fentanyl death the Duragesic patch presented due to inherent and customary manufacturing defects and imperfections in the product.

FIRST CAUSE OF ACTION

Wrongful Death: Negligence (Against all Defendants)

58. Plaintiffs incorporate by this reference the allegations set forth above in Paragraphs 1-57 as if fully set forth herein.

59. The Defendants J&J, Janssen and ALZA manufactured, sold, distributed and/or promoted and placed in the stream of commerce the Duragesic patch which proximately caused CHARLES EDWARD ADDISON's death.

60. The Defendants J&J, Janssen and ALZA, as manufacturers, sellers, distributors, marketers and/or promoters of the Duragesic patch that was used by CHARLES EDWARD ADDISON, had a duty to properly design, construct and manufacturer the Duragesic patch so it did not leak fentanyl and equally had a duty to adequately and fully warn of all serious adverse drug reactions which they knew, or had reason to know, are inherent in the use of the Duragesic patch.

61. Prior to February 17, 2008, the Defendants J&J, Janssen and ALZA, as manufacturers, sellers, distributors, marketers and/or promoters of the Duragesic patch – including those used by CHARLES EDWARD ADDISON — had a duty to timely, fully and accurately warn regarding the lethal dangers, risks and known number of fatalities presented by the Duragesic patch when they knew or had reason to know of the dangers associated with fentanyl leakage and other serious risks and serious injuries associated with the patch's use.

62. The Defendants J&J, Janssen and ALZA had a duty to conduct adequate clinical trials before releasing their fentanyl-containing product into the market.

63. Prior to CHARLES EDWARD ADDISON's fatal use of the Duragesic patch that caused his death, the Defendants J&J, Janssen and ALZA knew or should have known that the Duragesic patch posed the risk of fatal fentanyl leakage and other risks and serious injuries associated with its use.

64. In light of their knowledge, the Defendants J&J, Janssen and ALZA had a duty to (a) timely, fully and adequately warn consumers of the known or suspected risks of, inter alia, fatal fentanyl overdose arising from use of the Duragesic patch; (b) conduct adequate clinical trials and tests on animals and humans to determine the safety of the Duragesic patch; and (c) timely remedy the patch's leakage defect or, alternatively, recall all fentanyl-containing Duragesic patches.

65. The Defendants J&J, Janssen and ALZA committed numerous acts of negligence, including but not limited to (1) failing to timely and adequately warn consumers of the actual known risk of lethal fentanyl leakage; (2) failing to conduct adequate clinical trials and tests on humans and animals to determine the safety on the Duragesic patch; and/or (3) failing to timely remedy the patch's leakage defect or, alternatively, recall the Duragesic patch when they had actual knowledge of the risk of lethal fentanyl leakage and other associated risks of serious injury.

66. As a direct and proximate result of the negligence of the Defendants, Janssen and ALZA and their agents and employees, CHARLES EDWARD ADDISON suffered a fatal overdose of the potent opiate fentanyl and died on or about February 27, 2008. For such injuries, the Plaintiffs seek all the damages to which they are legally entitled.

SECOND CAUSE OF ACTION

Wrongful Death: Strict Products Liability (Against all Defendants)

67. Plaintiffs incorporate by this reference the allegations set forth above in Paragraphs 1-66 as if fully set forth herein.

68. The Defendants J&J, Janssen and ALZA caused to be manufactured, sold, distributed, marketed and/or promoted for sale the Duragesic patch that was purchased by and used by CHARLES EDWARD ADDISON.

69. The Duragesic patch used by CHARLES EDWARD ADDISON was expected to and did reach him without a substantial change in condition.

70. CHARLES EDWARD ADDISON used the Duragesic patch for the purpose and in the manner it was normally intended and could not, by the exercise or reasonable care, have discovered or avoided the risk of death associated with its use.

71. The Duragesic patch used by CHARLES EDWARD ADDISON was defective and unreasonably dangerous in light of the life threatening fentanyl leakage and other risks of serious injuries associated with its use, particularly when compared the potential benefit it offered as a pain medication.

72. The Duragesic patch used by CHARLES EDWARD ADDISON was also defective and unreasonably dangerous in light of the lack of an adequate warning of the life threatening fentanyl leakage risk, and other serious injuries associated with its use.

73. The Duragesic patch used by CHARLES EDWARD ADDISON was also defective because prior to February 27, 2008, a safer alternative design for the transdermal delivery of fentanyl for pain relief existed and was commercially feasible. Said design is known in the industry as a “matrix” design, and does not pose the risk of leakage and resulting overdose posed by the Duragesic “reservoir” design. In fact, prior to February 27, 2008, J&J's wholly owned affiliates in the European pharmaceutical market had ceased manufacturing and marketing the “reservoir” design fentanyl patch marketed in the United States, and substituted instead a “matrix” design patch that does not pose the risk of leakage and resulting overdose posed by the Duragesic “reservoir” design. Had Defendants followed the same course in the United States prior to February 27, 2008, CHARLES EDWARD ADDISON would never have received a “reservoir” designed patch, and would not have been exposed to the leaking patch that caused his death.

74. As a direct and proximate result of these defects, CHARLES EDWARD ADDISON was caused to suffer a fatal overdose of the potent opiate fentanyl and die on or about February 27, 2008. Defendants J&J, Janssen and ALZA are strictly liable in products liability for all damages sustained by Plaintiffs and for the wrongful death of CHARLES EDWARD ADDISON. For such injuries, Plaintiffs respectfully seek all damages to which they are legally entitled.

THIRD CAUSE OF ACTION

Wrongful Death: Breach of Implied Warranty (Against all Defendants)

75. Plaintiffs incorporate by this reference the allegations set forth above in Paragraphs 1-74 as if fully set forth herein.

76. The Defendants J&J, Janssen and ALZA caused to be manufactured, sold, distributed, marketed and/or promoted for sale the Duragesic patch that was used by CHARLES EDWARD ADDISON, and this fentanyl delivery device was expected to and did reach him without a substantial change in condition.

77. Said Defendants and their agents and employees, in manufacturing, selling, distributing, supplying, marketing and/or promoting the Duragesic patch, impliedly warranted that said drug was not unreasonably dangerous and was merchantable and fit for its intended use by CHARLES EDWARD ADDISON.

78. Said Defendants and their agents and employees, breached said warranties in that the Duragesic patch was not safe for its ordinary purpose as a pain medication in light of, inter alia, the fentanyl leakage and risk of death therefrom and in light of other risks of serious injuries it posed to users.

79. Said Defendants and their agents and employees, failed to provide adequate warnings with the Duragesic patch, rendering it unreasonably dangerous and unfit for the ordinary purposes for which it was used, in breach of warranty.

80. As a direct and proximate result of the Defendants' breaches of warranty, warranties upon which CHARLES EDWARD ADDISON relied in using the Duragesic patch, he was caused to suffer a fatal overdose of the potent opiate fentanyl and die as a result thereof. For such breaches of Implied Warranty of Merchantability, the Plaintiffs respectfully seek all damages to which they are legally entitled.

FOURTH CAUSE OF ACTION

Wrongful Death: Breach of Express Warranty (Against all Defendants)

81. Plaintiffs incorporate by this reference the allegations set forth above in Paragraphs 1-80 as if fully set forth herein.

82. The Defendants J&J, Janssen and ALZA manufactured, sold, distributed, supplied, marketed and/or promoted the Duragesic patch used by CHARLES EDWARD ADDISON, and this drug delivery device was expected to and did reach him without a substantial change in condition.

83. Said Defendants and their agents and employees, in manufacturing, selling, distributing, supplying, marketing and/or promoting the Duragesic patch, expressly warranted that said drug delivery system was safe and effective for use as a pain medication.

84. Said Defendants and their agents and employees, breached said warranty in that the Duragesic patch was not safe and effective for use as a pain medication in light of the risk of death from fentanyl overdose associated with its use and in light of other risks of serious injuries it posed to users.

85. Said Defendants and their agents and employees, failed to provide adequate warnings with the Duragesic patch, rendering it unreasonably dangerous and unfit for the ordinary purposes for which it was used by CHARLES EDWARD ADDISON, in breach of warranty.

86. As a direct and proximate result of said Defendants' breaches of warranty, warranties upon which CHARLES EDWARD ADDISON relied in purchasing and using the Duragesic patch, he was caused to suffer a fatal overdose of the potent opiate fentanyl and die as a result thereof. For such breach of Express Warranty, the Plaintiffs respectfully seek all damages to which they are legally entitled.

FIFTH CAUSE OF ACTION

Wrongful Death (Against all Defendants)

87. Plaintiffs incorporate by this reference the allegations set forth above in Paragraphs 1-86 as if fully set forth herein.

88. The negligent and other wrongful acts and omissions of the Defendants J&J, Janssen and ALZA, as set forth above, proximately caused or contributed to CHARLES EDWARD ADDISON's untimely death on February 27, 2008 – said acts and omissions of the Defendants include but are not limited to negligent design, manufacture and/or distribution of the Duragesic patch and failures to adequately warn of known adverse effects inherent in the use of ‘reservoir” design fentanyl delivery devices and to remove the fentanyl-delivering products from sale to consumers in a timely manner. For such acts and omissions causing CHARLES EDWARD ADDISON's wrongful death, the Plaintiffs are entitled to a judgment awarding special, general, pecuniary, punitive and loss of companionship and society damages to and among the Plaintiff and the heirs at law of the Estate of CHARLES EDWARD ADDISON, and consistent therewith, in an amount to be determined at trial and as set forth in the Prayer for Relief.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff Lucille Lilly, individually and in her capacity as the Administratrix of the Estate of CHARLES EDWARD ADDISON requests that judgments issue against the above-named Defendants, Johnson & Johnson, Janssen, L.P., f/k/a Janssen Pharmaceutica Products, L.P. and ALZA Corporation as follows:

i. judgment be entered against Defendants Johnson & Johnson, Janssen, L.P. and ALZA Corporation on all counts of this Complaint jointly and severally;

ii. the Plaintiffs be awarded their full, fair and complete compensation, including but not limited to all general, special, pecuniary, loss of companionship and society damages suffered by the Plaintiffs;

iii. the Plaintiffs be awarded all appropriate costs, attorneys' fees and interest authorized by law on the judgments that enter in her behalf; and

iv. the Plaintiffs be awarded punitive damages; and

v. for such other relief as the Court deems just.

Plaintiff respectfully demands trial by jury on all issues presented.

DATED: March 4, 2009