On August 14th of 2009, Florida Duragesic lawyers filed a lawsuit against Johnson & Johnson, the manufacturer of brand-name Duragesic fentanyl patches, and against Novartis & Sandoz, the sellers of a generic Duragesic patch. Johnson & Johnson actually manufactures the Sandoz/Novartis patches, which is why I include news about those patches on this website.
The lawsuit alleges that a defective 75 mcg/hr patch killed Carey Wayne Cooper: The lawsuit also names the doctor who prescribed the fentanyl patch:
COUNT I BREACH OF THE STANDARD OF CARE BY MICHAEL PAUL WIDICK, M.D.
45. The Plaintiff re-alleges and incorporates by reference paragraphs I through 44.
46. On or between August 16, 2007, and August 17, 2007, Widick fell below the accepted standard of care in the treatment and care of Cooper in one or more of the following respects:
a. Prescribing the Fentanyl Transdermal System 75 Mcg/H to Cooper when Cooper was not properly dosed or converting from an equivalent dose of opiate analgesic, contrary to a “Black Boxed Warning” that was required by the FDA to be in the manufacturer's package insert labeling materials;
b. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for acute, post-surgical pain, when Widick knew or should have known that the Fentanyl Transdermal System 75 Mcg/Hr is contraindicated for acute or post-surgical pain management;
c. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper even though Cooper was “opiate naive” (was not already taking opium-based drugs), when Widick knew or should have known that being “opiate naive” is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
d. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for post-surgical pain, when other less potent analgesics would have been safe and effective;
e. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for post-surgical pain, when Widick knew or should have known that having post-surgical pain is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
f. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for acute pain, when Widick knew or should have known that having acute pain is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
g. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper, when Widick knew or should have known that the chief hazard of the Fentanyl Transdermal System 75 Mcg/Hr was respiratory depression, given that Widick knew or should have known that Cooper's pre-surgical diagnoses (sleep apnea and chronic nasal obstruction), as well as the post-surgical packing placed in Cooper's nose, limited his respiration or blunted his respiratory drive;
h. Prescribing Cooper the second highest dosage formulation of the fentanyl transdermal system available (75 mcg/hr) when Widick knew or should have known that overestimating the dosage can result in fatal overdose with the first dose of the Fentanyl Transdermal System;
i. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper on an “as needed” basis for pain, when Widick knew or should have known that it is contraindicated to prescribe the Fentanyl Transdermal System 75 Mcg/Hr on an “as needed” basis for pain;
j. After prescribing the Fentanyl Transdermal System 75 Mcg/Hr for Cooper, failing to ensure that Cooper's breathing was carefully monitored by trained professionals from the time the patch was first placed on his skin until at least 24 hours after it was removed; and
k. Failing to adequately warn Cooper or his family of the dangers of using the Fentanyl Transdermal System 75 Mcg/Hr.
47. Widick's breach of the accepted standard of care in the treatment and care of Cooper caused, or directly contributed to cause, the death of Cooper on or between August 16, 2007, and August 17, 2007, and caused, or directly contributed to cause, damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
48. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
49. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses.
50. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, or Cameron W. Cooper's death.
51. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
Circuit Court of Florida.
Eighteenth Judicial Circuit,
Brevard County
Aaron C. COOPER, as the Personal Representative of the Estate of Carey Wayne Cooper, Deceased, Plaintiff,
v.
Michael Paul WIDICK, M.D. d/b/a Atlantic Otolantic Cocoa Beach FL, L.L.C., a Florida Limited Liability Company, Novartis Pharmaceuticals Corporation f/k/a Sandoz, Inc., a foreign corporation, Alza Corporation, a foreign corporation, and Johnson & Johnson, Inc., a foreign corporation, Defendants.
No. 05-2009-CA-051165.
August 14, 2009.
Complaint
Christepher Shakib, Esquire, Terrell Hogan Ellis Yegelwel, P.A., 233 East Bay Street, 8th Floor, Jacksonville, Florida 32202, Telephone: (904) 632-2424, Facsimile: (904) 632-2027, Email: shakib@terrellhogan.com, Florida Bar No.: 0947865, Attorney for the Plaintiffs.
The Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, sues the Defendants, MICHAEL PAUL WIDICK, M.D. d/b/a ATLANTIC OTOLARYNGOLOGY; CVS EGL ATLANTIC COCOA BEACH FL. L.L.C., a Florida limited liability company; NOVARTIS PHARMACEUTICALS CORPORATION f/k/a SANDOZ, INC., a foreign corporation; ALZA CORPORATION, a foreign corporation; and JOHNSON & JOHNSON, INC., a foreign corporation; and alleges the following:
GENERAL ALLEGATIONS
1. This is an action for damages that exceed the sum of $15,000.00, exclusive of interest, costs, and attorney's fees.
2. At all times material to this Complaint, the Plaintiff, AARON C. COOPER, was and is a resident of Duval County, Florida. Furthermore, the Plaintiff was duly appointed by the Probate Court of Brevard County as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased. A copy of the Letters of Administration are attached and incorporated by reference as Exhibit “A.”
3. At all times material to this Complaint, the Defendant, MICHAEL PAUL WIDICK, M.D. d/b/a ATLANTIC OTOLARYNGOLOGY (hereinafter “Widick”), was and is a medical doctor licensed by the State of Florida, practicing in the medical specialty of otolaryngology, and maintaining his primary place of business in Cocoa Beach, Brevard County, Florida. At various times, Widick has practiced under the fictitious name “Atlantic Otolaryngology.”
4. At all times material to this Complaint, the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C. (hereinafter “CVS”), was and is a Florida limited liability company, existing and operating under the laws of Florida, with its principal place of business being CVS Pharmacy Number 0246, which is located at 4292 North Atlantic Avenue, Cocoa Beach, Brevard County, Florida; its principal mailing address is located at One CVS Drive, Woonsocket, Rhode Island 02895. CVS may be found for service of process through its Registered Agent, the CT Corporation, 1200 South Pine Island Road, Plantation, Florida 33324.
5. At all times material to this Complaint, the Defendant, NOVARTIS PHARMACEUTICALS CORPORATION f/k/a SANDOZ, INC. (hereinafter “Novartis”), was and is a foreign corporation, existing and operating under the laws of the State of New Jersey, with its principal place of business in East Hanover, New Jersey. Novartis may be found for service of process in Florida through its Registered Agent, Corporation Service Company, 1201 Hays Street, Tallahassee, Florida 32301.
6. At all times material to this Complaint, Novartis was authorized to do business in the State of Florida, and was in fact engaged in business in Brevard County, Florida, to-wit: the science and business of researching, developing, manufacturing, distributing, marketing, promoting or selling chemical compounds, drugs, medicines and medication delivery systems, including a generic version of Duragesic 75 Mcg/Hr, referred to as the Fentanyl Transdermal Patch System 75 Mcg/Hr, under a licensing agreement with the Defendant, ALZA CORPORATION, and/or the Defendant, JOHNSON & JOHNSON, INC.
7. At all times material to this Complaint, Novartis exercised its privilege of dealing goods within the State of.Florida and, in particular, Brevard County, in anticipation of economic gain.
8. At all times material to this Complaint, Novartis manufactured, assembled, designed, packaged, distributed, marketed, promoted, or sold-or was the corporate successor in interest to the company that was the manufacturer, assembler, designer, packager, distributor, marketer, promoter, or seller - of the Fentanyl Transdermal System 75 Mcg/Hr.
9. At all times material to this Complaint, the Defendant, ALZA CORPORATION (hereinafter “Alza”), was and is a foreign corporation, existing and operating under the laws of the State of Delaware, with its principal place of business in the State of California. Alza may be found for service of process through its Registered Agent, The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801.
10. At all times material to this Complaint, Alza was engaged in business in Brevard County, Florida, to-wit: the business and science of researching, developing, manufacturing, or distributing chemical compounds, drugs, medicines and medication delivery systems, including a generic version of Duragesic 75 Mcg/Hr, referred to as the Fentanyl Transdermal System 75 Mcg/Hr.
11. At all times material to this Complaint, Alza exercised its privilege of dealing goods within the State of Florida and, in particular, Brevard County, in anticipation of economic gain.
12. At all times material to this Complaint, Alza manufactured, assembled, designed, packaged, distributed, or was the corporate successor in interest and owner of the manufacturer, assembler, designer, packager, or distributor of the Fentanyl Transdermal System 75 Mcg/Hr.
13. At all times material to this Complaint, the Defendant, JOHNSON & JOHNSON, INC. (hereinafter “Johnson & Johnson”), was and is a foreign corporation, existing and operating under the laws of the State of New Jersey, with its principal place of business in New Brunswick, New Jersey. Johnson & Johnson may be found for service of process through its Registered Agent, CT Corporation System, 820 Bear Tavern Road, Suite 305, Trenton, New Jersey 08628-1021.
14. At all times material to this Complaint, Johnson & Johnson was engaged in business in Brevard County, Florida, to-wit: the business and science of researching, developing, manufacturing, distributing, marketing, promoting, or selling healthcare products, chemical compounds, drugs, medicines, medication delivery systems, including a generic version of Duragesic 75 Mcg/Hr, referred to as the Fentanyl Transdermal System 75 Mcg/Hr.
15. At all times material to this Complaint, Johnson & Johnson exercised its privilege of dealing goods within the State of Florida and, in particular, Brevard County, in anticipation of economic gain.
16. At all times material to this Complaint, Johnson & Johnson manufactured, assembled, designed, packaged, distributed, marketed, promoted, or sold - or was the corporate successor in interest to the company that manufactured, assembled, designed, packaged, distributed, marketed, promoted, or sold the Fentanyl Transdermal System 75 Mcg/Hr. Johnson & Johnson is also the sole shareholder of Alza.
17. Johnson & Johnson, through its Pharmaceutical Resource Group-Americas, based in Raritan, New Jersey, was and is directly involved in the assessment of the safety and quality control systems utilized in the manufacture of the Fentanyl Transdermal System 75 Mcg/Hr patch. Johnson & Johnson has contended before federal regulatory authorities that the manufacturing processes and quality control systems utilized to manufacture the Fentanyl Transdermal System 75 Mcg/Hr were, at all times relevant to this Complaint, adequate to protect the health and safety of patients using the Fentanyl Transdermal System 75 Mcg/Hr. The Pharmaceutical Research Group-Americas integrates Johnson & Johnson's pharmaceutical operations and quality assurance organizations within the Americas, including within the State of Florida, across the various subsidiary and affiliate entities through which Johnson & Johnson operates, such as Alza.
18. This lawsuit is brought pursuant to Fla. Stat. §§ 768.16 - 768.26 (2007), the “Florida Wrongful Death Act.”
FACTUAL BACKGROUND
Fentanyl Transdermal System
19. Duragesic (and its generic, known as the Fentanyl Transdermal System) is a transdermal system providing continuous, systematic delivery of fentanyl, a potent opioid analgesic, for 72 hours.
20. Duragesic (and its generic, known as the Fentanyl Transdermal System) is classified as a Schedule II (hereinafter “CII”) controlled substance by the United States Food and Drug Administration (hereinafter “FDA”) because it is a strong narcotic pain medication.
21. Duragesic (and its generic, known as the Fentanyl Transdermal System) is a rectangular, transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to the skin, these layers are: (1) A backing layer of polyester film; (2) A drug reservoir of fentanyl and alcohol USP gelled with hydroxyethyl cellulose; (3) An ethylene-vinyl acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and (4) A fentanyl containing silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded.
22. On or about February 16, 2004, the Defendants, Novartis, Alza, and/or Johnson & Johnson, recalled one lot of the 75 Mcg/Hr Duragesic patches NDC # 50458-0035-05 (control # 0327192) dispensed after December 15, 2003 (at all times material to this Complaint, the 75 Mcg/Hr Duragesic patches were and are manufactured in the same facility, with the same equipment as the generic Fentanyl Transdermal System 75 Mcg/Hr). A document was also released entitled “Key Information Statement for Patients and Caregivers,” which included the following information:
If the medication leaks directly onto the skin, a higher than intended amount can be absorbed through the skin into the body, causing nausea, sedation, drowsiness, or potentially life threatening complications.”
The recall notice also stated that the 75 Mcg/Hr patches are used to treat “moderate to severe chronic pain.
23. On or about April 2, 2004, the Defendants, Novartis, Alza, and/or Johnson & Johnson, issued or sent healthcare professionals an URGENT DRUG RECALL, expanding the February recall of Duragesic (fentanyl transdermal system) CII 75 Mcg/Hr patches to include five manufacturing lots (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362). This demonstrated that the Defendants, Novartis, Alza, or Johnson & Johnson, knew or should have known that at least some Fentanyl Transdermal System patches “may leak medication due to improper sealing of one of the edges.” The Defendants, Novartis, Alza, and/or Johnson & Johnson warned that if medication leaked out of a patch, exposure to the medication could result in inadvertent ingestion or an increased transdermal absorption of the active opiate component, fentanyl, leading to potentially life-threatening complications.
24. On or about April 7, 2004, the Defendants, Novartis, Alza, and/or Johnson & Johnson, issued or sent pharmacists a letter informing them of an expanded recall to users of Duragesic (and its generic, known as the Fentanyl Transdermal System) 75 Mcg/Hr.
25. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, were aware of at least three different types of manufacturing defects associated with certain Fentanyl Transdermal System patches. The three types of defects are known as (1) the “stringer leaker” defect, or classic “leaker;” (2) patches with the seal completely or partly cut off during the manufacturing process; and (3) the “foldover defect,” which involved the improper handling of the sheets of material used to make the patches in a machine known as “Bodalay I.”
26. Despite knowing of the defects in the recalled lots, and of the presence of other defective Duragesic and generic Fentanyl Transdermal System patches prior to August 16, 2007, the Defendants, Novartis, Alza, and/or Johnson & Johnson, took inadequate steps to advise physicians, hospitals, nursing homes, other health care providers, and patients of the defects and the significant dangers to users of Duragesic and generic Fentanyl Transdermal System patches.
27. Furthermore, Despite knowing of the defects in the recalled lots, prior to August 16, 2007, the Defendants, Novartis, Alza, and/or Johnson & Johnson, took inadequate steps to advise consumers, including CAREY WAYNE COOPER, DECEASED (hereinafter “Cooper”), of these defects and of the significant dangers they presented posed to those using such patches. The Defendants, Novartis, Alza, and/or Johnson & Johnson, also failed to take adequate steps to ensure that other lots that they had manufactured were safe for the public.
28. On February 12, 2008, the Defendants, Novartis, Alza, and/or Johnson & Johnson, recalled all lots of Duragesic and generic Fentanyl Transdermal System 25 Mcg/Hr patches then in distribution dues to the presence of the aforementioned defects in those patches, too. On information and belief, the February 2008 recall involved approximately 38,000,000 patches, and demonstrated that the manufacturing process of the Defendants, Novartis, Alza, and/or Johnson & Johnson, have been inadequate to prevent the release of defective, leaking patches to the consuming public since at least 2001.
29. The Defendants, Novartis, Alza, and/or Johnson & Johnson, were aware of the defects in the Duragesic and generic Fentanyl Transdermal System patches, they knew the risks and dangers the defects posed to those using the patches, but the Defendants, Novartis, Alza, and/or Johnson & Johnson, aided, abetted, ratified, authorized, and acted in concert in the wrongful conduct set forth herein.
30. The Defendants, Novartis, Alza, and/or Johnson & Johnson, acted jointly and/or as each other's agents, within the course and scope of the agency, with respect to the wrongful conduct set forth herein.
31. At all times material to this Complaint, the package insert for the Fentanyl Transdermal System included a “Black Boxed Warning” required by the FDA which stated that the Fentany Transdermal System should only be used by patients who are already receiving opioid therapy and who have demonstrated opioid tolerance; patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.
32. At all times material to this Complaint, the aforesaid “Black Boxed Warning” also stated the following:
Because serious or life-threatening hypoventilation could occur... (fentanyl transdermal system) is contraindicated:
● in patients who are not opioid-tolerant
● in the management of acute pain or in patients who require opioid analgesia for a short period of time
● in the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
● in the management of mild ain
● in the management of intermittent pain [e.g., use on an as needed basis (prn)].
33. At all times material to this Complaint, the aforesaid “Black Boxed Warning” also stated the following:
[fentanyl transdermal system] is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the [fentanyl transdermal system] dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean elimination half-life of 17 hours of [fentanyl transdermal system], patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.
34. Prior to August 16, 2007, 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 and generic Fentanyl Transdermal System “reservoir” design. In fact, Johnson & Johnson's wholly owned affiliates in the European pharmaceutical market have ceased manufacturing and marketing the “reservoir” design fentanyl patch marketed in the United States. Instead, the European wholly owned affiliates have substituted the “matrix” design patch because that design does not pose the risk of leakage and resulting overdose posed by the “reservoir” design. Had the Defendants, Novartis, Alza, and/or Johnson & Johnson, followed the same course of action in the United States prior to August 16, 2007, Cooper would not have been exposed to the leaking patch that caused or contributed to his death.
Carey Wayne Cooper, Deceased
35. On or about August 15, 2007, Widick performed the following procedures on Cooper at Cape Canaveral Hospital in Cocoa Beach, Florida: uvulopalatopharyngoplasty; septoplasty; left and right inferior turbinoplastics; and left and right inferior turbinate outfracture.
36. After the above surgical procedures were performed, Cooper was kept overnight and released on or about August 16, 2007. Before Cooper was released, however, he complained of pharyngeal pain, for which he was prescribed Roxicet Elixir and Percocet.
37. Several hours after Cooper was released from Cape Canaveral Hospital on or about August 16, 2007, he called Widick's office and complained of continued severe pharyngeal pain, that he was vomiting up the elixir, and that the elixir made his throat feel like it was going to close, In response, Widick prescribed Duragesic 75 Mcg/Hr, with instructions to apply the patch to his chest “every 3 days as needed for pain.”
38. After the prescription was written, Cooper called Widick's office again and spoke with a staff member who “reassured him,” and who told him to call Widick if he had any problems, “even in the middle of the night.”
39. A few minutes after Cooper called Widick's office the second time on or about August 16, 2007, a member of Cooper's family went to Widick's office and picked up the prescription. Widick's prescription was then filled at CVS Pharmacy Number 0246 on North Atlantic Avenue in Cocoa Beach, Florida, which was owned and operated by CVS. The pharmacy staff at CVS Pharmacy Number 0246 filled the prescription that same day with the generic fentanyl transdermal patch system, Fentanyl Transdermal System 75 Mcg/Hr, which was and is manufactured, assembled, designed, packaged, distributed, marketed, promoted, sold, or otherwise placed into the stream of commerce by Novartis, Alza, Johnson & Johnson, and/or by the corporation for which Novartis, Alza, or Johnson & Johnson is the successor in interest.
40. On or about August 16, 2007, after Widick's prescription was filled at CVS Pharmacy Number 0246, the Fentanyl Transdermal System 75 Mcg/Hr was brought to Cooper.
41. On or between August 16, 2007, and August 17, 2007, Cooper placed the Fentanyl Transdermal System 75 Mcg/Hr on his body and later died due to fentanyl intoxication.
42. The potential beneficiaries of THE ESTATE OF CAREY WAYNE COOPER (other than THE ESTATE OF CAREY WAYNE COOPER itself), their relationship to Cooper, and their dates of birth, are as follows:
Name
Relationship
Date of Birth
Melody E. Cooper
Wife
XX/XX/57
Aaron C. Cooper
Son, Personal Representative
XX/XX/80
Crystal B. Cooper
Daughter, Mother of Emmy R. Lippold
XX/XX/83
Jeremy I. Cooper
Son
XX/XX/88
Cameron W. Cooper
Son
XX/XX/97
Emmy R. Lippold
Granddaughter
XX/XX/06
Conditions Precedent and Certification
43. The Plaintiff has complied with all common law and statutory conditions precedent to the filing of the action.
44. The undersigned attorney for the Plaintiff hereby certifies that a reasonable investigation has been undertaken in connection with this case, and said investigation has given rise to a good faith belief that grounds exist for an action against each named defendant.
COUNT I BREACH OF THE STANDARD OF CARE BY MICHAEL PAUL WIDICK, M.D.
45. The Plaintiff re-alleges and incorporates by reference paragraphs I through 44.
46. On or between August 16, 2007, and August 17, 2007, Widick fell below the accepted standard of care in the treatment and care of Cooper in one or more of the following respects:
a. Prescribing the Fentanyl Transdermal System 75 Mcg/H to Cooper when Cooper was not properly dosed or converting from an equivalent dose of opiate analgesic, contrary to a “Black Boxed Warning” that was required by the FDA to be in the manufacturer's package insert labeling materials;
b. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for acute, post-surgical pain, when Widick knew or should have known that the Fentanyl Transdermal System 75 Mcg/Hr is contraindicated for acute or post-surgical pain management;
c. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper even though Cooper was “opiate naive” (was not already taking opium-based drugs), when Widick knew or should have known that being “opiate naive” is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
d. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for post-surgical pain, when other less potent analgesics would have been safe and effective;
e. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for post-surgical pain, when Widick knew or should have known that having post-surgical pain is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
f. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper for acute pain, when Widick knew or should have known that having acute pain is a contraindication for prescribing the Fentanyl Transdermal System 75 Mcg/Hr;
g. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper, when Widick knew or should have known that the chief hazard of the Fentanyl Transdermal System 75 Mcg/Hr was respiratory depression, given that Widick knew or should have known that Cooper's pre-surgical diagnoses (sleep apnea and chronic nasal obstruction), as well as the post-surgical packing placed in Cooper's nose, limited his respiration or blunted his respiratory drive;
h. Prescribing Cooper the second highest dosage formulation of the fentanyl transdermal system available (75 mcg/hr) when Widick knew or should have known that overestimating the dosage can result in fatal overdose with the first dose of the Fentanyl Transdermal System;
i. Prescribing the Fentanyl Transdermal System 75 Mcg/Hr to Cooper on an “as needed” basis for pain, when Widick knew or should have known that it is contraindicated to prescribe the Fentanyl Transdermal System 75 Mcg/Hr on an “as needed” basis for pain;
j. After prescribing the Fentanyl Transdermal System 75 Mcg/Hr for Cooper, failing to ensure that Cooper's breathing was carefully monitored by trained professionals from the time the patch was first placed on his skin until at least 24 hours after it was removed; and
k. Failing to adequately warn Cooper or his family of the dangers of using the Fentanyl Transdermal System 75 Mcg/Hr.
47. Widick's breach of the accepted standard of care in the treatment and care of Cooper caused, or directly contributed to cause, the death of Cooper on or between August 16, 2007, and August 17, 2007, and caused, or directly contributed to cause, damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
48. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
49. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses.
50. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, or Cameron W. Cooper's death.
51. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
COUNT II NEGLIGENCE OF CVS EGL ATLANTIC COCOA BEACH FL, L.L.C.
52. The Plaintiff re-alleges and incorporates by reference paragraphs 1 through 44.
53. At all times material to this Complaint, CVS owed a duty to Cooper to use due and proper care in filling the prescription for the Fentanyl Transdermal System 75 Mcg/Hr.
54. A Florida pharmacist is a health care professional whose standard of care is that level of care and skill which, in light of the relevant circumstances, is recognized as acceptable and appropriate to other reasonably prudent pharmacists.
55. CVS's pharmacy personnel, in filling Cooper's prescription, knew or should have known, solely by looking at the prescription itself, without consulting a physician and without reviewing any other document or record, that the above-referenced prescription was inappropriate in that it called for Cooper to apply the patch to his chest “every 3 days as needed for pain.” This was in contravention of the aforesaid “Black Boxed Warning” required by the FDA which stated that, because of the risk of hypoventilation, the fentanyl transdermal system is contraindicated in the management of intermittent pain (e.g., use on an “as needed” basis).
56. CVS's pharmacy personnel, in filling Cooper's prescription, knew or should have known, solely by looking at the prescription itself, without consulting a physician and without reviewing any other document or record, that Cooper was opioid naive at the time the prescription was filled, and that the Fentanyl Transdermal System 75 Mcg/Hr. was contraindicated for the initiation of opioid therapy.
57. At all times material to this Complaint, CVS undertook a duty to offer consultation or counseling to all patients at the time new completed prescriptions, such as the instant one, were picked up.
58. At all times material to this Complaint, CVS undertook to use professional judgment in explaining to customers, including Cooper: (1). the name and description of the drug; (2). the dosage form, dose, route of administration, and administration of drug therapy; (3). The intended use of the drug, and its expected action; (4). special directions and precautions for preparation, administration, and use by the patient; (5). common severe side effects, adverse effects, or interactions, and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur; (6). techniques for self-monitoring drug therapy; (7). proper storage; (8). prescription refill information; (9). action to be taken in the event of a missed dose; and (10). the pharmacist's comments relevant to the patient's drug therapy (including any other information peculiar to the specific patient or drug).
59. Cooper relied upon CVS's pharmacy personnel to counsel him and to use reasonable and appropriate professional judgment as described above.
60. If CVS's pharmacy personnel had counseled Cooper or used good professional judgment, such personnel would have known that the fentanyl transdermal system had been prescribed to Cooper for intermittent pain, that the fentanyl transdermal system had been prescribed to Cooper for acute, post-surgical pain, and that Cooper was opioid naive.
61. CVS, through its employees or agents, breached its duty to Cooper and was negligent in the following ways:
(a). Failing to counsel Cooper prior to filling the prescription;
(b). Failing to use reasonable and appropriate professional judgment;
(c). Failing to recognize that Cooper had been prescribed the fentanyl transdermal system for intermittent pain;
(d). Failing to recognize that Cooper had been prescribed the fentanyl transdermal system for acute, post-surgical pain;
(e). Failing to recognize that Cooper was opioid naive;
(f). Failing to recognize that the Fentanyl Transdermal System 75 Mcg/Hr. was contraindicated for the initiation of opioid therapy;
(g). Failing to warn Cooper that the fentanyl transdermal system should not be used for intermittent pain;
(h). Failing to warn Cooper that the fentanyl transdermal system should not be used for acute, post-surgical pain;
(i). Failing to warn Cooper that the fentanyl transdermal system should not be used by persons like Cooper who were opioid naive;
(j). Failing to warn Cooper that the Fentanyl Transdermal System 75 Mcg/Hr. was contraindicated for the initiation of opioid therapy; and
(k). Failing to warn Cooper that once he applied the aforesaid patch, he would require monitoring and/or medical treatment from the time the patch was first placed on his skin until at least 24 hours after it was removed.
62. CVS's negligence caused, or directly contributed to cause, the death of Cooper on or between August 16, 2007, and August 17, 2007, and caused, or directly contributed to cause, damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
63. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
64. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b.Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d.Medical and funeral expenses.
65. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, and Cameron W. Cooper's deaths.
66. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
COUNT III STRICT LIABILITY OF CVS EGL ATLANTIC COCOA BEACH FL, L.L.C. FOR DEFECTIVE PRODUCT
.67. The Plaintiff re-alleges and incorporates by reference paragraphs 1 through 44,
68. CVS sold or introduced into the stream of commerce in the regular course of its business, the Fentanyl Transdermal System 75 Mcg/Hr.
69. At all times material to this Complaint, CVS expected the Fentanyl Transdermal System 75 Mcg/Hr to reach, and it did reach, consumers in the State of Florida, including Cooper, without substantial changes in the condition in which it was sold.
70. The Fentanyl Transdermal System 75 Mcg/Hr used by Cooper was in fact defective and in an unreasonably dangerous condition at the time it was placed into the stream of commerce, and when put to a reasonably anticipated use, in one or more of the following ways:
a. Design
(1). It delivered fentanyl in an unpredictable rate, as the narcotic medicine was released into the skin and the circulatory system at a rate faster than the advertised rate of 75 Mcg/Hr;
(2). Its protective liner and functional layers leaked and failed to deliver fentanyl from the drug reservoirs at the declared constant amount per unit of time of 75 Mcg/Hr;
(3). It delivered too much fentanyl for the use intended;
(4). It delivered a lethal dose of fentanyl into the skin and circulatory system of Cooper, causing his death;
(5). Prior to August 16, 2007, 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 and generic Fentanyl Transdermal System “reservoir” design. In fact, Johnson & Johnson's wholly owned affiliates in the European pharmaceutical market have ceased manufacturing and marketing the “reservoir” design fentanyl patch marketed in the United States. Instead, the European wholly owned affiliates have substituted the “matrix” design patch because that design does not pose the risk of leakage and resulting overdose posed by the “reservoir” design; and/or
(6). It was unreasonably dangerous in light of the life-threatening fentanyl leakage and other risks of serious injury or death associated with its use when compared to the potential benefit it offered as a pain medication.
b. Manufacture
It contained one or more of the following three types of leak defects:
(1). The “stringer leaker” defect, or classic “leaker”;
(2). The seal was completely or partly cut off during the manufacturing process; or
(3). The “foldover defect,” which involved the improper handling of the sheets of material used to make the patches in a machine known as “Bodalay I.”
c. Warning
(1). It contained an inadequate warning to potential users or consumers as to the dangerous, life-threatening risk of fentanyl leakage and other risks of serious injury or death associated with its use; and/or
(2). It contained an inadequate warning to potential users or consumers as to the dangers associated with its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
d. Instruction
(1). It contained inadequate instructions to potential users or consumers to examine it for potential leaks before using; and/or
(2). It contained inadequate instruction to potential users or consumers as to its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
71. Cooper used the Fentanyl Transdermal System 75 Mcg/Hr in a manner reasonably anticipated by CVS.
72. The defective condition of the Fentanyl Transdermal System 75 Mcg/Hr subjected users or consumers such as Cooper to an increased risk of fatal respiratory depression, cardiac arrest and other complications, which exceeded the benefits of the product, and for which safer products were available. This defective condition made the product unreasonably dangerous when put to a reasonably anticipated use as a treatment for pain relief, the use for which the Fentanyl Transdermal System 75 Mcg/Hr was designed.
73. The defective condition of the Fentanyl Transdermal System 75 Mcg/Hr directly caused, or directly contributed to cause, Cooper's death and the damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
74. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
75. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses,
76. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, and Cameron W. Cooper's deaths.
77. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
COUNT IV BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY BY CVS EGL ATLANTIC COCOA BEACH FL, L.L.C.
78. The Plaintiff re-alleges and incorporates by reference paragraphs 1 through 44.
79. On or about August 16, 2007, Cooper, either directly or through the actions of agents acting upon his behalf, purchased for valuable consideration the Fentanyl Trandermal System 75 Mcg/Hr from CVS.
80. At the time of the aforesaid purchase, by operation of Florida law, an implied warranty of merchantability was created for the benefit of Cooper and others in his household.
81. CVS breached the implied warranty of merchantability owed to Cooper in that the Fentanyl Transdermal System 75 Mcg/Hr., at the time that it was purchased, was defective and unreasonably dangerous when put to a reasonably anticipated use, in one or more of the following ways:
a. Design
(1). It delivered fentanyl in an unpredictable rate, as the narcotic medicine was released into the skin and the circulatory system at a rate faster than the advertised rate of 75 Mcg/Hr;
(2). Its protective liner and functional layers leaked and failed to deliver fentanyl from the drug reservoirs at the declared constant amount per unit of time of 75 Mcg/Hr;
(3). It delivered too much fentanyl for the use intended;
(4). It delivered a lethal dose of fentanyl into the skin and circulatory system of Cooper, causing his death;
(5). Prior to August 16, 2007, a safer alternative design for the transdermal delivery of fentanyl for pain .relief existed and was commercially easible. 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 and generic Fentanyl Transdermal System “reservoir” design. In fact, Johnson & . Johnson's wholly owned affiliates in the European pharmaceutical market have ceased manufacturing and marketing the “reservoir”' design fentanyl patch marketed in the United States. Instead, the European wholly owned affiliates have substituted the “matrix” design patch because that design does not pose the risk of ,leakage and resulting overdose posed by the “reservoir” design; and/or
(6). It was unreasonably dangerous in light of the life-threatening fentanyl leakage and other risks of serious injury or death associated with its use when compared to the potential benefit it offered as a pain medication.
b. Manufacture
It contained one or more of the following three types of leak defects:
(1). The “stringer leaker” defect, or classic “leaker”;
(2). The seal was completely or partly cut off during the manufacturing process; or
(3). The “foldover defect,” which involved the improper handling of the sheets of material used to make the patches in a machine known as “Bodalay I.”
c. Warning
(1). It contained an inadequate warning to potential users or consumers as to the dangerous, life-threatening risk of fentanyl leakage and other risks of serious injury or death associated with its use; and/or
(2). It contained an inadequate warning to potential users or consumers as to the dangers associated with its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
d. Instruction
(1). It contained inadequate instructions to potential users or consumers to examine it for potential leaks before using; and/or
(2). It contained inadequate instruction to potential users or consumers as to its use
(a). Post-operatively;
(b). Successively;
(c). In increasin dosaes; and/or
(d). In conjunction with other drugs.
82. Cooper used the Fentanyl Transdermal System 75 Mcg/Hr in a manner reasonably anticipated by CVS.
83. The defective condition of the Fentanyl Transdermal System 75 Mcg/Hr subjected users or consumers such as Cooper to an increased risk of fatal respiratory depression, cardiac arrest and other complications, which exceeded the benefits of the product, and for which safer products were available. This defective condition made the product unreasonably dangerous when put to a reasonably anticipated use as a treatment for pain relief, the use for which the Fentanyl Transdermal System 75 Mcg/Hr was designed.
84. On or about August 14, 2009, the Plaintiff, through his agents or attorneys, and by U.S. Certified Mail, notified CVS of the breach of the implied warranty of merchantability owed to Cooper as a result of the defective and unreasonably dangerous nature of the Fentanyl Transdermal System 75 Mcg/Hr.
85. CVS's breach of the implied warranty of merchantability owed to Cooper and members of his household directly caused, or directly contributed to cause, Cooper's death and the damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
86. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
87. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses.
88. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I, Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, and Cameron W. Cooper's deaths.
89. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant, CVS EGL ATLANTIC COCOA BEACH FL, L.L.C., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
COUNT V NEGLIGENCE OF NOVARTIS, ALZA, AND JOHNSON & JOHNSON
90. The Plaintiff re-alleges and incorporates by reference paragraphs 1 through 44.
91. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, as the manufacturers, assemblers, designers, packagers, distributers, marketers, promoters, or sellers of the Fentanyl Transdermal System 75 Mcg/Hr, or as those who otherwise placed the Fentanyl Transdermal System 75 Mcg/Hr into the stream of commerce, had a duty to properly design, construct, or manufacture the Fentanyl Transderal System 75 Mcg/Hr so that it did not create an unreasonable risk of death or serious bodily injury to its users or consumers.
92. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, as the manufacturers, assemblers, designers, packagers, distributers, marketers, promoters, or sellers of the Fentanyl Transdermal System 75 Mcg/Hr, or as those who otherwise placed it into the stream of commerce, had a duty to provide labels that adequately and fully warned users or consumers of the dangers (including fentanyl leakage) associated with it, as well as to adequately and fully instruct users or consumers as to the proper and safe use of the Fentanyl Transdermal System 75 Mcg/Hr.
93. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, as the manufacturers, assemblers, designers, packagers, distributers, marketers, promoters, or sellers of the Fentanyl Transdermal System 75 Mcg/Hr, or as those who otherwise placed it into the stream of commerce, had a duty to conduct adequate clinical trials before releasing it into the stream of commerce to ensure that the Fentanyl Transdermal System 75 Mcg/Hr was reasonably safe for its intended use.
94. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, as the manufacturers, assemblers, designers, packagers, distributers, marketers, promoters, or sellers of the Fentanyl System 75 Mcg/Hr, or as those who otherwise placed it into the stream of commerce, had an ongoing duty to maintain an adequate program of pharmacovigilance after its release into the stream of commerce to ensure that the Fentanyl Transdermal System 75 Mcg/Hr was reasonably safe for its intended use.
95. Before Cooper used or consumed the aforesaid Fentanyl Transdermal System 75 Mcg/Hr on or about August 16, 2007, the Defendants, Novartis, Alza, and/or Johnson & Johnson, knew or should have known that the Fentanyl Transdermal System 75 Mcg/Hr posed an unreasonable risk of death or serious bodily injury to its users or consumers.
96. On or about August 16, 2007, Cooper used or consumed the aforesaid Fentanyl Trandermal System 75 Mcg/Hr in a manner reasonably anticipated by the Defendants, Novartis, Alza, and/or Johnson & Johnson.
97. The Defendants, Novartis, Alza, and/or Johnson & Johnson, breached the duties owed consumers or users of the Fentanyl Transdermal System 75 Mcg/Hr, including Cooper, in one or more of the following ways:
a. By designing it such that:
(1). It delivered fentanyl in an unpredictable rate, as the narcotic medicine was released into the skin and the circulatory system at a rate faster than the advertised rate of 75 Mcg/Hr;
(2). Its protective liner and functional layers leaked and failed to deliver fentanyl from the drug reservoirs at the declared constant amount per unit of time of 75 Mcg/Hr;
(3). It delivered too much fentanyl for the use intended;
(4). It delivered a lethal dose of fentanyl into the skin and circulatory system of users or consumers;
(5). It failed to use an available, commercially feasible, and safer alternative design for the transdermal delivery of fentanyl for pain relief. 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 and generic Fentanyl Transdermal System “reservoir” design. In fact, Johnson & Johnson's wholly owned affiliates in the European pharmaceutical market have ceased manufacturing and marketing the “reservoir” design fentanyl patch marketed in the United States. Instead, the European wholly owned affiliates have substituted the “matrix” design patch because that design does not pose the risk of leakage and resulting overdose posed by the “reservoir” design; and/or
(6): It was unreasonably dangerous in light of the life-threatening fentanyl leakage and other risks of serious injury or death associated with its use when compared to the potential benefit it offered as a pain medication.
b. By manufacturing it such that it contained one or more of the following three types of leak defects:
(1). The “stringer leaker” defect, or classic “leaker”;
(2). The seal was completely or partly cut off during the manufacturing process; or
(3). The “foldover defect,” which involved the improper handling of the sheets of material used to make the patches in a machine known as “Bodalay I.”
c. By failing to adequately warn potential users or consumers as to either or both of the following:
(1). The dangerous, life-threatening risk of fentanyl,leakage and other risks of serious injury or death associated with its use; or
(2). The dangers associated with its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; or
(d). In conjunction with other drugs.
d. By failing to adequately instruct potential users and consumers as to either or both of the following:
(1). To examine it for potential leaks before using or consuming it; and/or
(2). To use or consume in a manner that was safe and effective
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
98. The breach of the duty or duties owed to Cooper by the Defendants, Novartis, Alza, and/or Johnson & Johnson, caused or contributed to cause Cooper's death and the damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
99. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
100. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses.
101. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, and Cameron W. Cooper's deaths.
102. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendants, NOVARTIS PHARMACEUTICALS CORPORATION f/k/a SANDOZ, INC., ALZA CORPORATION, and/or JOHNSON & JOHNSON, INC., together with the costs of this action, as well as interest (both pre- post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
COUNT VI STRICT LIABILITY OF NOVARTIS, ALZA, AND JOHNSON & JOHNSON FOR DEFECTIVE PRODUCT
103. The Plaintiff re-alleges and incorporates by reference paragraphs 1 through 44.
104. The Defendants, Novartis, Alza, and/or Johnson & Johnson, manufactured, assembled, designed, packaged, distributed, marketed, promoted, or sold the Fentanyl Transdermal System 75 Mcg/Hr, or otherwise placed the Fentanyl Transdermal System 75 Mcg/Hr into the stream of commerce, in the regular course of their business.
105. At all times material to this Complaint, the Defendants, Novartis, Alza, and/or Johnson & Johnson, expected the Fentanyl Transdermal System 75 Mcg/Hr to reach, and it did reach, consumers in the State of Florida, including Cooper, without substantial changes in the condition in which it was sold.
106. The Fentanyl Transdermal System 75 Mcg/Hr used by Cooper was in fact defective and in an unreasonably dangerous condition at the time it was placed into the stream of commerce, and when put to a reasonably anticipated use, in one or more of the following ways:
a. Design
(1). It delivered fentanyl in an unpredictable rate, as the narcotic medicine was released into the skin and the circulatory system at a rate faster than the advertised rate of 75 Mcg/Hr;
(2). Its protective liner and functional layers leaked and failed to deliver fentanyl from the drug reservoirs at the declared constant amount per unit of time of 75 Mcg/Hr;
(3). It delivered too much fentanyl for the use intended;.
(4). It delivered a lethal dose of fentanyl into the skin and circulatory system of Cooper, causing his death;
(5). Prior to August 16, 2007, 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 and generic Fentanyl Transdermal System “reservoir” design. In fact, Johnson & Johnson's wholly owned affiliates in the European pharmaceutical market have ceased manufacturing and marketing the “reservoir” design fentanyl patch marketed in the United States. instead, the European wholly owned affiliates have substituted the “matrix” design patch because that design does not pose the risk of leakage and resulting overdose posed by the “reservoir” design; and/or
(6). It was unreasonably dangerous in light of the life-threatening fentanyl leakage and other risks of serious injury or death associated with its use when compared to the potential benefit it offered as a pain medication.
b. Manufacture
It contained one or more of the following three types of leak defects:
(1). The “stringer leaker” defect, or classic “leaker”;
(2). The seal was completely or partly cut off during the manufacturing process; or
(3). The “foldover defect,” which involved the improper handling of the sheets of material used to make the patches in a machine known as “Bodalay I.”
c. Warning
(1). It contained an inadequate warning to potential users or consumers as to the dangerous, life-threatening risk of fentanyl leakage and other risks of serious injury or death associated with its use; and/or
(2). It contained an inadequate warning to potential users or consumers as to the dangers associated with its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
d. Instruction .
(1). It contained inadequate instructions to potential users or consumers to examine it for potential leaks before using; and/or
(2). It contained inadequate instruction to potential users or consumers as to its use
(a). Post-operatively;
(b). Successively;
(c). In increasing dosages; and/or
(d). In conjunction with other drugs.
107. Cooper used the Fentanyl Transdermal System 75 Mcg/Hr in a manner.reasonably anticipated by the Defendants, Novartis, Alza, and/or Johnson & Johnson.
108. The defective condition of the Fentanyl Transdermal System 75 Mcg/Hr subjected users or consumers such as Cooper to an increased risk of fatal respiratory depression, cardiac arrest and other complications, which exceeded the benefits of the product, and for which safer products were available. This defective condition made the product unreasonably dangerous when put to a reasonably anticipated use as a treatment for pain relief, the use for which the Fentanyl Transdermal System 75 Mcg/Hr was designed.
109. The defective condition of the Fentanyl Transdermal System 75 Mcg/Hr directly caused, or directly contributed to cause, Cooper's death and the damages to the Plaintiff, THE ESTATE OF CAREY WAYNE COOPER, and the beneficiaries of THE ESTATE OF CAREY WAYNE COOPER.
110. As a result of Cooper's death, the Plaintiff seeks damages on behalf of THE ESTATE OF CAREY WAYNE COOPER for funeral and medical expenses incurred, and for a loss of prospective net accumulations.
111. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Melody E. Cooper for the following:
a. The value of lost support and services from the date of Cooper's death until the date of Melody E. Cooper's death;
b. Lost companionship and protection from the date of Cooper's death until the date of Melody E. Cooper's death;
c. Mental pain and suffering from the date of Cooper's death until the date of Melody E. Cooper's death; and
d. Medical and funeral expenses.
112. As a result of Cooper's death, the Plaintiff seeks damages on behalf of Crystal B. Cooper, Jeremy I. Cooper, and Cameron W. Cooper for the following:
a. The value of lost support and services;
b. Lost parental companionship, instruction, and guidance; and
c. Mental pain and suffering,
from the date of Cooper's death until the date of Crystal B. Cooper's, Jeremy I. Cooper's, and Cameron W. Cooper's deaths.
113. At the time of Cooper's death, he was wholly or partly supporting his granddaughter, Emmy R. Lippold. Accordingly, as a result of Cooper's death, the Plaintiff seeks damages on behalf of Emmy R. Lippold for the value of lost support and services from the date of Cooper's death until the date of Emmy R. Lippold's death.
WHEREFORE, the Plaintiff, AARON C. COOPER, as the Personal Representative of THE ESTATE OF CAREY WAYNE COOPER, Deceased, demands judgment for damages against the Defendant Defendants, NOVARTIS PHARMACEUTICALS CORPORATION f/k/a SANDOZ, INC., ALZA CORPORATION, and/or JOHNSON & JOHNSON, INC., together with the costs of this action, as well as interest (both pre- and post-judgment), and the Plaintiff respectfully demands a trial by jury on all issues so triable.
Dated this 14th day of August, 2009.
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