The family of Jay Gustafson has filed a lawsuit in Cook County against the manufacturers of the Duragesic fentanyl patch:
4. This suit arises out of the wrongful death of JAY GUSTAFSON, due to the wrongful conduct of Defendants. Defendants sold and delivered to JAY GUSTAFSON Duragesic 100 MCG/HR patches from manufacturing lot No. 0703777. Pursuant to the schedule for changing the patch, JAY GUSTAFSON affixed a new patch on March 16, 2008.
5. 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 Food and Drug Administration (“FDA”) and is generally used to relieve pain.
6. The patch is applied by the patient and delivers Fentanyl through the patient's skin. The Defendants design, manufacture, market, sell and dispense 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 the patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of Fentanyl. JAY GUSTAFSON never abused the patch or used it inappropriately.
7. The Gustafson patches were manufactured on a single machine, the Bodolay I, at the Defendant, ALZA's facility in Vacaville, California. The Gustafson patches were made utilizing a reservoir design which means the fentanyl gel is inserted into a reservoir between two of the patch's layers. The Gustafson patches were part of Lot No. No. 0703777.
NOW COMES the Plaintiff, DENNIS GUSTAFSON, as Executor of the Estate of JAY GUSTAFSON, Deceased, by and through his attorneys PAVALON, GIFFORD & LAATSCH, and complaining of the Defendants, JANSSEN PHARMACEUTICA, INC., a foreign Corporation, ALZA CORPORATION, a foreign Corporation (all wholly owned subsidiaries of Johnson and Johnson Corporation), and WALGREENS CORPORATION, an Illinois Corporation, states as follows:
FACTS
1. At all times relevant hereto, JAY GUSTAFSON, born XX/XX/1975, was married to and lived with his wife, CORINNE GUSTAFSON, in Rockford, Winnebago County, Illinois.
2. At all times relevant hereto, Defendants, JANSSEN PHARMACEUTICA, INC., and ALZA CORPORATION were and are foreign corporations engaged in part in the business and science of researching, developing, manufacturing and distributing chemical compounds, drugs, medicines and medication delivery systems for use by consumers and patients in Cook County, Illinois and throughout the world.
3. At all times relevant hereto, Defendant, WALGREENS CORPORATION, was and is an Illinois Corporation engaged in part in the business of selling and distributing chemical compounds, drugs, medicines and medication delivery systems for use by consumers and patients in Cook County, Illinois and throughout the United States.
4. This suit arises out of the wrongful death of JAY GUSTAFSON, due to the wrongful conduct of Defendants. Defendants sold and delivered to JAY GUSTAFSON Duragesic 100 MCG/HR patches from manufacturing lot No. 0703777. Pursuant to the schedule for changing the patch, JAY GUSTAFSON affixed a new patch on March 16, 2008.
5. 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 Food and Drug Administration (“FDA”) and is generally used to relieve pain.
6. The patch is applied by the patient and delivers Fentanyl through the patient's skin. The Defendants design, manufacture, market, sell and dispense 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 the patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of Fentanyl. JAY GUSTAFSON never abused the patch or used it inappropriately.
7. The Gustafson patches were manufactured on a single machine, the Bodolay I, at the Defendant, ALZA's facility in Vacaville, California. The Gustafson patches were made utilizing a reservoir design which means the fentanyl gel is inserted into a reservoir between two of the patch's layers. The Gustafson patches were part of Lot No. No. 0703777.
8. Prior to and at the time of the manufacture of the Gustafson patches, Defendants knew that they were producing on the Bodolay I defective patches that leaked. Prior to and at the time of manufacture of the Gustafson patches, Defendants knew or should have known that they were producing on the Bodolay I 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 Gustafson patches, Defendants knew or should have known that they were producing on the Bodolay I defective patches that were killing/and or injuring patients. Despite such knowledge, Defendant, 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.
9. The patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of Fentanyl in patients.
10. Another design for Fentanyl patches existed at the time the Gustafson patches were manufactured called the “matrix” design. At all relevant times, Defendants could have made Fentanyl patches of a matrix design, as opposed to the reservoir design. The matrix technology cannot leak Fentanyl.
11. From 2004 through December 2008, Defendants, JANSSEN PHARMACEUTICA, INC. and ALZA CORPORATION, recalled numerous lots of Fentanyl Patches because of leaking defects. Also during 2004, the FDA investigated Defendants' manufacturing practices and quality control/assurance policies and procedures and found them to be deficient.
12. On information and belief, said recall was furnished to Defendant, WALGREENS CORPORATION.
13. On and at all relevant times prior to March 18, 2008, JAY GUSTAFSON used the Fentanyl Patch as prescribed. On March 18, 2008, JAY GUSTAFSON died from the toxic effects of using the Fentanyl Patch.
14. Decedent's father, DENNIS GUSTAFSON, was named Executor of the Estate of JAY GUSTAFSON, Deceased. At the time of his death, decedent was survived by his wife, CORINNE GUSTAFSON and his parents.
COUNT I
STRICT LIABILITY - WRONGFUL DEATH
15. Plaintiff re-alleges Paragraphs 1-15 and incorporates them herein by reference.
a. Strict Products Liability
16. Defendants, JANSSEN PHARMACEUTICA, INC., ALZA CORPORATION and WALGREENS CORPORATION are liable under the theory of product liability as set forth in §§402A and 402B of the Restatement of Torts 2d. These Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying Fentanyl Patches, including the Patch that the decedent, JAY GUSTAFSON, used by prescription. The decedent, JAY GUSTAFSON, received Fentanyl Patches that were in a defective condition at the time they were designed, manufactured, sold, and/or marketed by the Defendants and at the time they left the Defendants' JANSSEN PHARMACEUTICA, INC., and ALZA CORPORATION'S, possession. Due to the defect in the drug's design, the decedent's Fentanyl patches, failed to perform in the manner reasonably to be expected in light of their nature and intended function. The decedent, JAY GUSTAFSON, was unaware of the defect and used the Fentanyl patches as prescribed for their intended medical purpose. There was no other reasonable cause for the Fentanyl Patch's failure to perform as intended. The defective condition in the Fentanyl Patch existed at the time it left the Defendants' control and came into the decedent's possession. The defective condition of the Fentanyl Patch was the proximate cause of the decedent, JAY GUSTAFSON, sustaining a massive and fatal overdose of Fentanyl, additionally causing him physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.
b. Manufacturing Defect
17. The decedent, JAY GUSTAFSON, used multiple Fentanyl Patches which were defective because of a manufacturing flaw rendering it unreasonably dangerous at the time it left the Defendants' control. The defective condition of the Fentanyl Patch was the proximate cause of the decedent, JAY GUSTAFSON, sustaining a massive and fatal overdose of Fentanyl, additionally causing him physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.
c. Marketing Defect
18. Pleading further without waiver of the foregoing, the decedent, JAY GUSTAFSON, used Fentanyl patches that were additionally defective for lack of adequate warnings or instructions. The Defendants, who exercised substantial control over the warnings and/or instructions, knew or should have known of the dangerous propensity of the Fentanyl Patch at the time they were marketed and sold, but failed to provide adequate warnings or instructions concerning the potential for fatal overdose. The absence of adequate warnings or instructions rendered the Fentanyl Patches unreasonably dangerous to the decedent. Defendants' failure to provide such adequate warnings was a proximate cause of the decedent's JAY GUSTAFSON's, inability to determine whether he had ingested a fatal amount of Fentanyl while using the product as instructed, resulting in severe physical and mental pain and anguish, respiratory arrest and ultimately his death, and the damages claimed herein.
d. Design Defect
19. Pleading further and without waiver of the foregoing, the decedent had taken Fentanyl Patches that were defective because of their design, rendering them unreasonably dangerous. Said Fentanyl Patches failed to perform to the safety standards an ordinary patient would expect when used in an intended or reasonably foreseeable manner. The flawed design of the Fentanyl Patch was a proximate cause of JAY GUSTAFSON's death, his physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein. The benefits of the design did not outweigh the risk of danger inherent in such design. Moreover, the Defendants, who participated in the design of the patch, could have provided a safer alternative design. Such a safer alternative design existed at the time the decedent's Fentanyl Patches were manufactured, which would not have substantially impaired the Patch's utility. Additionally, it was economically and technologically feasible at the time the product left the control of the Defendants by the application of existing or reasonably achievable scientific knowledge. Specifically, the Defendants could have utilized the matrix technology to manufacture the Patch instead of the reservoir technology. The matrix technology is a safer alternative design because it is associated with fewer defects involving seal integrity and it was in use by the Defendants and/or other manufacturers of Fentanyl Patches at the time the Defendants manufactured the Patches used by the decedent.
20. For these reasons, the Defendants are strictly liable under Illinois product liability law without regard to proof of negligence or gross negligence.
21. This action is brought pursuant to the Illinois Wrongful Death Act, 740 ILCS 180/1 et seq. for the compensable loss of love, guidance, care, affection and support.
WHEREFORE, Plaintiff prays this Court enter judgment in his favor and against the Defendants in an amount in excess of Fifty Thousand Dollars ($50,000.00) plus costs.
COUNT II
STRICT LIABILITY - SURVIVAL ACTION
22. Plaintiff re-alleges Paragraphs 1-21 and incorporates them herein by reference.
23. This action is brought pursuant to 755 ILCS 5/27-6 for the personal injury, pain, and suffering experienced by JAY GUSTAFSON, prior to his death.
WHEREFORE, Plaintiff prays this Court enter judgment in his favor and against the Defendants in an amount in excess of Fifty Thousand Dollars ($50,000.00) plus costs.
COUNT III
NEGLIGENCE - WRONGFUL DEATH
24. Plaintiff re-alleges Paragraphs 1-15 and incorporates them herein by reference.
25. At all times relevant hereto, each Defendant had a duty to act in a reasonable and careful way in researching, designing, manufacturing, marketing, distributing, and selling Fentanyl Patches so as not to cause injury, harm, or damage to the general public and specifically to the decedent JAY GUSTAFSON.
26. The Defendants breached their duty towards the Plaintiff by negligently and carelessly acting, or failing to act, in one or more of the following ways:
a. Failing to provide adequate and/or sufficient warnings regarding the Fentanyl Patch;
b. Failing to use due care in designing and manufacturing the Fentanyl Patch;
c. Failing to use proper materials reasonably suited to the manufacture of the Patch;
d. Failing to use proper materials reasonably suited to administering the Fentanyl Patch to patients taking it under prescription;
e. Failing to use due care to test and inspect the Patch to determine its durability and functionability for the purpose for which it was intended;
f. Failing to conduct adequate testing and post-marking surveillance to determine the safety of the Fentanyl Patch;
g. Failing to adequately or sufficiently inspect the Fentanyl Patch for defects;
h. Failing to adequately or sufficiently research the safety of Fentanyl Patches prior to sale;
i. Failing to adequately or sufficiently monitor or research the Fentanyl Patch for potential adverse events affecting patients;
j. Failing to provide adequate training, knowledge, or information to physicians, distributors, or sellers of Fentanyl Patches;
k. Failing to adequately warn individuals of the dangerous and lethal side effects of the Fentanyl Patch;
l. Formulating, designing and manufacturing the Fentanyl Patch;
m. Inspecting and testing the Fentanyl Patch;
n. Packaging the Fentanyl Patch;
o. Dispensing the Fentanyl Patch.
27. On or more of the aforementioned negligent acts or omissions was a proximate cause of JAY GUSTAFSON's death, his physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.
28. The Plaintiff's injuries normally would not have occurred in the absence of negligence on the part of Defendants in the research, design, manufacture and distribution of the transdermal Fentanyl delivery system in issue.
29. This action is brought pursuant to the Illinois Wrongful Death Act, 740 ILCS 180/1 et seq. For the compensable losses under the Act suffered by the Decedent's next of kin, including but not limited to loss of love, guidance, care, affection, and support.
WHEREFORE, Plaintiff prays this Court enter judgment in his favor and against the Defendants in an amount in excess of Fifty Thousand Dollars ($50,000.00) plus costs.
COUNT IV
NEGLIGENCE - SURVIVAL
30. Plaintiff re-alleges Paragraphs 1-15 and 22 - 29 and incorporates them herein by reference.
31. This action is brought pursuant to 755 ILCS 5/27-6 for the personal injury, pain, and suffering experienced by JAY GUSTAFSON prior to his death.
WHEREFORE, Plaintiff prays this Court enter judgment in his favor and against the Defendants in an amount in excess of Fifty Thousand Dollars ($50,000.00) plus costs.
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