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Text of Fusco’s Duragesic Fentanyl Patch Lawsuit

Posted in Duragesic / Fentanyl

Posted below is the complete text of Keicia Fusco’s lawsuit against the manufacturers of the Duragesic fentanyl patch.  This lawsuit alleges that a defectively designed and defectively manufactured patch is responsible for the death of Barbara Province.

Pursuant to Missouri Revised Code § 537.080 et seq., Plaintiffs Keicia Marie Fusco, Steven DuWayne Barton, and Daisy Lorene Howard (“Plaintiffs”) file this Original Complaint and Jury Demand against Alza Corporation, Janssen Pharmaceutica Products, LP, Janssen, LP, Janssen Pharmaceutica, Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (collectively, the “Patch Defendants”), and for cause of action would show:

PARTIES

1. Plaintiff Keicia Marie Fusco is an individual residing in the State of Missouri. Keicia Marie Fusco is the daughter of Barbara Ann Province (“Decedent”). Under Missouri Revised Code § 537.080 et seq., Keicia Marie Fusco is a proper party to bring an action for Decedent's wrongful death.

2. Plaintiff Steven DuWayne Barton is an individual residing in the State of Missouri. Steven DuWayne Barton is Decedent's son. Under Missouri Revised Code § 537.080 et seq., Steven DuWayne Barton is a proper party to bring an action for Decedent's wrongful death.

3. Plaintiff Daisy Lorene Howard is an individual residing in the State of Missouri. Daisy Lorene Howard is Decedent's mother. Under Missouri Revised Code § 537.080 et seq., Daisy Lorene Howard is a proper party to bring an action for Decedent's wrongful death.

4. Defendant ALZA Corporation (“ALZA”), a wholly owned subsidiary of Johnson & Johnson Corporation, was and is a foreign corporation organized and existing under the laws of the State of Delaware. ALZA's home office is at 1010 Joaquin Road, Mountain View, California 94043. ALZA has done and is doing business in Missouri. ALZA may be served with process by delivering a copy of the summons and complaint to Henry Esparza or any other officer or managing agent at 1010 Joaquin Road, Mountain View, CA 94043.

5. Defendant Janssen Pharmaceutica Products, LP, a wholly owned subsidiary of Johnson & Johnson Corporation, is a limited partnership organized and existing under the laws of the State of New Jersey. It has done, and is doing business in Missouri. Janssen Pharmaceutica Products, LP may be served by delivering the complaint along with the summons to Janet Vergis at 1125 Trenton-Harbourton Road, Titusville, NJ 08560, or any other officer or managing agent at such address.

6. Defendant Janssen, LP, a wholly owned subsidiary of Johnson & Johnson Corporation, is a limited partnership organized and existing under the laws of the State of New Jersey. It has done, and is doing business in Missouri. Janssen, LP may be served by delivering the complaint along with the summons to Janet Vergis 1125 Trenton-Harbourton Road, Titusville, NJ 08560, or any other officer or managing agent at such address.

7. Defendant Janssen Pharmaceutica, Inc., a wholly owned subsidiary of Johnson & Johnson Corporation, is a corporation organized and existing under the laws of the State of New Jersey. It has done, and is doing business in Missouri. Janssen Pharmaceutica, Inc. may be served by delivering the complaint along with the summons to Janet Vergis at 1125 Trenton-Harbourton Road, Titusville, NJ 08560, or any other officer or managing agent at such address.

8. Defendant Ortho-McNeil-Janssen Pharmaceuticals, Inc., a wholly-owned subsidiary of Johnson & Johnson Corporation, is a corporation organized and existing under the laws of the State of Pennsylvania. It has done and is doing business in Missouri. Ortho-McNeil-Janssen Pharmaceuticals, Inc. may be served by delivering the complaint along with the summons to its president, Janet Vergis, at 1125 Trenton-Harbourton Road, Titusville, NJ 08560, or any other officer or managing agent at such address. Ortho-McNeil-Janssen Pharmaceuticals and Janssen Pharmaceutica Products, LP shall collectively be referred to herein as “Janssen.”

JURY DEMAND

9. Pursuant to Federal Rule of Civil Procedure 38, Plaintiffs demand a jury trial on all issues.

JURISDICTION AND VENUE

10. This Court has jurisdiction over this case because it is was a lawsuit between parties of diverse citizenship and the amount in controversy exceeds $75,000. See 28 U.S.C. § 1332. Venue is proper in this Court under 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to the claim (i.e., Decedent's fentanyl overdose and resulting death) occurred in this district.

FACTS

11. This suit arises out of the wrongful death of Decedent, due to the wrongful conduct of Defendants. Decedent was given a prescription for 50 mcg Duragesic (fentanyl transdermal system) patches. Decedent was wearing one on these patches (the “Province Patch”) at the time of her death and it was the cause of her death. The Province Patch worn by Decedent at the time of her death was designed, manufactured, marketed and/or distributed by the Patch Defendants.

12. Duragesic (fentanyl transdermal system) patches also came in other sizes such as 25, 75, and 100 mcg. As referenced herein, the “Patch” shall refer to Duragesic (fentanyl transdermal system) patches of any size unless specified otherwise.

13. The Patch is a multi-layer system containing a gel which has the drug fentanyl in it. Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine. Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain.

14. The Patch is applied by the patient and delivers fentanyl though the patient's skin. The Patch Defendants design, manufacture, market and sell the Patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. Decedent never abused the Patch or used it inappropriately.

15. The Province Patch was manufactured at Defendant ALZA's facility in Vacaville, California. The Province Patch was made utilizing a reservoir design which means that the fentanyl gel is inserted into a reservoir between two of the patch's layers.

16. Prior to and at the time of the manufacture of the Province Patch, the Patch Defendants knew that they were producing defective patches that leaked. Prior to and at the time of the manufacture of the Province Patch, the Patch Defendants knew that they were producing defective patches that would produce levels of fentanyl in patients above the intended and designed level. Prior to and at the time of the manufacture of the Province Patch, the Patch Defendants knew or should have known that they were producing defective patches that were killing patients and/or injuring patients. Despite the foregoing, the Patch Defendants, with reckless and/or intentional disregard for the safety of patients, continued and continue to this day to manufacture fentanyl patches which kill patients because of the massive revenue being generated by their sale.

17. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

18. Another design for Fentanyl patches existed at the time the Province Patch was manufactured called the “matrix” design. At all relevant times, the Patch Defendants could have made fentanyl patches of a matrix design, as opposed to a reservoir design. The matrix technology cannot leak fentanyl. A sealed multi-laminate design could have also been used.

19. In 2004, the Defendant ALZA recalled numerous lots of Patches because of leaking defects. Also during 2004, the FDA investigated the ALZA's manufacturing practices and quality control/assurance policies and procedures and found them to be deficient. In 2008, ALZA again recalled patches.

20. At the time the FDA approved the initial proposed labeling for the Patch, it did not have full knowledge of the dangers inherent in the use of the product, potential defects in the product or the nature and degree of the risks accompanying its intended use. Similarly, at the time the FDA approved revised labeling proposed by the Patch Defendants, it did not have full knowledge of product defects and the dangers inherent in the use of the product or the nature and degree of the risks accompanying its intended use. The FDA lacked such information because the Patch Defendants failed to provide the FDA with existing evidence of product defects and the risks associated with Duragesic as such evidence was obtained or should have been obtained. For these reasons, the FDA has never had an opportunity to assess the current labeling for Duragesic in light of existing evidence.

21. Decedent was prescribed the Patch for pain. Decedent filled the prescription in March 2006. Decedent died on April 2, 2006. The toxicology report showed that Decedent had a lethal level of fentanyl in her blood at the time of her death.

CAUSES OF ACTION AGAINST THE PATCH DEFENDANTS

A. FIRST CAUSE OF ACTION: STRICT PRODUCT LIABILITY.

22. The Patch Defendants are liable under the theory of product liability as set forth in §§402A and 402B of the Restatement of Torts 2d. The Patch Defendants at all times material hereto engaged in the business of designing, manufacturing, selling, marketing, and/or supplying the Patch, including the Province Patch. The Province Patch was in defective condition at the time it was designed, manufactured, sold, and/or marketed by the Patch Defendants and at the time it left their possession because it was unreasonably dangerous for its intended or reasonably anticipated use. The defective condition was a direct and proximate cause of Decedent's death and the damages described herein.

23. The Province Patch was in the control of the Patch Defendants at the time the defect occurred. Further, the injury sustained by Decedent, fentanyl intoxication, was the exact type of injury that a defective Patch causes. The Province Patch reached Decedent without any substantial change in its condition. The Province Patch presented an unreasonable risk of injury in that the risk was one which a reasonably prudent person having full knowledge of the risk would find unacceptable. Because of the nature of ingredients or natural characteristics of the Province Patch, use of it involved a substantial risk of injury. The exposure to risk of injury was unreasonable taking into consideration a balancing of the dangers and benefits resulting from the product's use. Without limitation, the Province Patch was defective because it malfunctioned and did not perform as intended and designed.

1. Manufacturing Defect

24. More specifically, the Province Patch was defective because of the existence of a manufacturing flaw that made the product unreasonably dangerous for its intended or reasonably anticipated use at the time it left the Patch Defendants' control. The Province Patch was not reasonably safe for its intended use because it did not conform to its intended design and failed to perform as safely as the intended design would have performed. Decedent used the Province Patch as prescribed and in a reasonably anticipated manner. The manufacturing defect was a direct and proximate cause of Decedent's death and the damages claimed herein. Without limitation, the Province Patch was defective because it malfunctioned and did not perform as intended and designed. Without limitation, the Province Patch was defective because it had a seal defect.

2. Marketing Defect

25. Pleading further and without waiver of the foregoing, the Patch was defective because the Patch Defendants failed to warn of risks and dangers associated with the foreseeable uses of the product at the time the Province Patch was manufactured, distributed, and sold in the course of the Patch Defendants' business. The Patch Defendants, who exercised substantial control over the warnings and/or instructions, had reason anticipate dangers inherent or reasonably foreseeable in the use of the Patch, but failed to provide adequate warnings and/or instructions. The absence of such warnings and/or instructions made the product unreasonably dangerous at the time of sale when used as reasonably anticipated without knowledge of its characteristics. Decedent used the Patch as prescribed and in a reasonably anticipated manner. The Patch Defendants' failure to warn and/or instruct was a direct and proximate cause of Decedent's death and the damages claimed herein.

3. Design Defect

26. Pleading further and without waiver of the foregoing, the defective design of the Patch rendered it unreasonably dangerous for its intended or reasonably anticipated use. The Patch's design was unreasonably dangerous because, inter alia, it failed comply with existing technology or the state of the art. The Patch Defendants could have used a safer alternative design was economically and technologically feasible at the time of the manufacture. Specifically, the Patch Defendants could have utilized the matrix technology or the sealed multi-laminate design to manufacture the Patch instead of the reservoir technology. These technologies are safer alternative designs in that they are associated with fewer defects involving seal integrity and the matrix technology was even in use by the Patch Defendants and/or others to manufacture fentanyl patches at the time the Province Patch was manufactured. Decedent used the Patch as directed and in a reasonably anticipated manner. The design defect was a direct and proximate cause of Decedent's death and the damages claimed herein.

27. For these reasons, the Patch Defendants are strictly liable under applicable products liability law without regard to proof of negligence and gross negligence.
B. SECOND CAUSE OF ACTION: NEGLIGENCE.

28. The Patch Defendants had a duty to exercise ordinary care in the design, manufacture, marketing, sale, or distribution of the Patch into the stream of commerce to ensure that the Patch was safe for its intended or reasonably foreseeable use, including, without limitation, a duty to assure that the Patch did not cause users to suffer from dangerous side effects, including death. The Patch Defendants failed to exercise ordinary care in the design, manufacture, marketing, sale, testing, reporting to the FDA, quality assurance, quality control or distribution of the Province Patch into interstate commerce in that the Patch Defendants knew or should have known that the Patch created a high risk of dangerous side effects, including death.

29. More specifically, the Patch Defendants' negligence in the design, manufacture, marketing, testing and sale of the Patch, includes, without limitation:

a. Providing misleading, inadequate and/or insufficient warnings regarding the product;

b. Failure to use due care in designing and manufacturing the Patch;

c. Failure to use proper materials reasonably suited to the manufacture of the Patch;

d. Failure to provide to the FDA information or data relevant to the safety of the Patch;

e. Failure to obtain easily accessible information or data relevant to the safety of the Patch;

f. Not performing sufficient testing of the Patch to confirm or ensure that is was safe for its intended use;

g. Failure to use due care to test and inspect the Patch to determine its durability and functionality for the purpose for which it was intended;

h. Failure to ensure the Patch is made without seal or other defects;

i. Failure to conduct adequate testing and post-marketing surveillance to determine the safety of the Patch;

j. Misrepresenting that the Patch is safe for use;

k. Inadequate or insufficient inspection for defects;

1. Inadequate and/or insufficient research into the safety of the product prior to sale;

m. Inadequate and/or insufficient monitoring or research regarding adverse events;

n. Failure to list death as an adverse event;

o. Failure to provide adequate training, knowledge or information to physicians, distributors, or sellers of the product;

p. Marketing the Patch for unsafe uses;

q. Failure to adequately warn individuals of the dangerous and lethal side effects of the product;

r. Formulating and designing the product;

s. Making the product;

t. Inspecting and testing the product;

u. Packaging the product; and

v. Other and further particulars as will be proven at trial.

30. The negligent conduct of the Patch Defendants, as alleged above, was a direct and proximate cause of Decedent's death and the damages claimed herein.
C. THIRD CAUSE OF ACTION: NEGLIGENT MISREPRESENTATION.

31. The Patch Defendants represented and marketed the Patch as being safe and effective. After the Patch Defendants knew or should have known of the risk of using the Patch, the Patch Defendants failed to communicate to the FDA, Decedent, physicians, distributors, pharmacists, and/or the general public, that proper use of the Patch could cause serious injury and/or death. The Patch Defendants instead communicated to all such persons/entities that the Patches were safe for use. Specifically, the Patch Defendants' misrepresentations include, without limitation, a representation that the Patches would produce a maximum fentanyl blood concentration that was much lower that the fentanyl concentration found in Decedent's blood at the time of her death and a representation that the Patches were safe for use and a representation that the Patches can be used with other medications

32. Therefore, Plaintiffs bring this cause of action against the Patch Defendants under the theory of negligent misrepresentation for the following reasons:

a. The Patch Defendants failed to warn of the defective condition of the Patch, as manufactured and/or supplied by the Patch Defendants;

b. The Patch Defendants, individually, and through their agents, representatives, distributors and/or employees, negligently misrepresented material facts about the Patch in the course of their business in that they made such misrepresentations when they knew or reasonably should have known of the falsity of such misrepresentations. Alternatively, the Patch Defendants made such misrepresentations without exercising reasonable care to ascertain the accuracy of these representations;

c. The above misrepresentations were made to the FDA, Decedent, physicians, pharmacists, and the general public;

d. The Patch Defendants supplied false information regarding the safety and efficacy of the Patch for the guidance of others, including Decedent;

e. The Patch Defendants failed to exercise reasonable care or competence in obtaining or communicating information regarding the safety and efficacy of the Patch to Decedent and others; and

f. Decedent and others justifiably relied on the Patch Defendants' misrepresentations; and

g. Consequently, Decedent's use of the Patch was to her detriment. The Patch Defendants' negligent misrepresentations were a direct and proximate cause of Decedent's death and the damages claimed herein.
D. FOURTH CAUSE OF ACTION: BREACH OF IMPLIED WARRANTY OF FITNESS.

33. The Patch Defendants had reason to know that the particular purpose for which their products were to be used. The Patch Defendants had reason to know that the buyer was relying on the skill and judgment of the Patch Defendants to select or furnish suitable products. The product supplied by the Patch Defendants was unfit for the particular purposes for which it was purchased. This lack of fitness for the product's purpose was a direct and proximate cause of Decedent's death of and the damages claimed herein.
E. CONSCIOUS DISREGARD.

34. The Patch Defendants showed a complete indifference to or conscious disregard for the safety of others by placing the Patch into commerce even though it was unreasonably dangerous and Defendants had actual knowledge that it was defective. Specifically, the Patch Defendants were conscious (from the knowledge of surrounding circumstances and existing conditions) that their conduct or failure to act would naturally or probably result in injury.

DAMAGES

35. Punitive, Exemplary, and Other Damages. The Defendants showed a complete indifference to or conscious disregard for the safety of others. Specifically, the Patch Defendants were conscious (from the knowledge of surrounding circumstances and existing conditions) that their conduct or failure to act would naturally or probably result in injury. Plaintiffs therefore seek recovery of punitive, exemplary and any other additional damages that the law allows under the causes of action asserted above.

36. Actual Damages. The unlawful acts and practices described above are and were a producing and proximate cause of Decedent's injuries and eventual death. Plaintiffs seek all damages available under Missouri law (or any other applicable law), including, without limitation: (a) pecuniary losses suffered by reason of the death; (b) funeral and burial expenses; (c) the reasonable value of the services, consortium, companionship, comfort, instruction, guidance, counsel, training, and support that Plaintiffs have been deprived of because of Decedent's death; and (d) damages that Decedent suffered (e.g., pain, suffering, mental anguish) between the time of injury and the time of death.

37. All conditions precedent to Plaintiffs' right to recover the relief sought herein have occurred or have been performed.

WHEREFORE, PREMISES CONSIDERED, Plaintiffs pray that the Patch Defendants be cited to appear and answer, and that the Court set the case for jury trial, and that judgment be entered against the Patch Defendants, jointly and severally, for the damages set forth herein above; for pre-judgment and post-judgment interest and costs of suit; and for such other and further relief to which Plaintiffs may be justly entitled.