Duragesic Fentanyl Patch Lawyer, Lawsuit, and Side Effect News

Florida Duragesic Attorneys Sue Makers of Generic Fentanyl Patch

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.

Duragesic Attorneys File Lawsuit In Missouri Against Sandoz Over Allegedly Defective Duragesic Pain Patch

Sandoz makes a generic version of the Duragesic fentanyl pain patch.  The patch uses the same design as the Duragesic patch, and is in fact manufactured in the same factory as the brand name Duragesic patches.  This lawsuit alleges that the Sandoz fentanyl patches are designed, manufactured, and sold with a defect.

1. Manufacturing Defect

20. More specifically, the Vogel 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 Vogel 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 Vogel 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 Vogel Patch was defective because it malfunctioned and did not perform as intended and designed. Without limitation, the Vogel Patch was defective because it had a seal defect.

2. Marketing Defect

21. 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 Vogel 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 to 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

22. 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 that 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 Vogel 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. '

This lawsuit alleges that a defective Sandoz patch killed Louise Vogel.

Fentanyl Lawsuit Filed in New Jersey Against Manufacturers of Generic Duragesic Fentanyl Patch

In July of 2009, attorneys filed a wrongful death lawsuit against Sandoz, and Novartis, two manufacturers of a generic Duragesic fentanyl pain patch.

10. Fentanyl Transdermal System is the registered name for a transdermal patch which is available only by prescription. This patch contains fentanyl, a synthetic opioid that is up to 100 times stronger than morphine.

11. The Fentanyl Patch is applied directly to the skin of the user, and is supposed to deliver this strong pain medicine at a regulated rate for up to seventy-two (72) hours. The Fentanyl Patch is supposed to be prescribed to relieve chronic moderate to severe pain, such as that which was suffered by Plaintiff's decedent, Michael Locascio.

12. At all relevant times, Sandoz, Inc. was in the business of designing, licensing, promoting, manufacturing, marketing, selling and distributing pharmaceuticals and other products, including Fentanyl Patches. Sandoz Inc. does business, and does business by agent, in the State of New Jersey. At all relevant times, Sandoz, Inc. designed, developed, licensed, marketed, manufactured, sold and placed in the steam of commerce Fentanyl Patches, including the patch at issue in this lawsuit.

13. The Fentanyl Patch in question was designed, manufactured, distributed, sold and placed in the stream of commerce by the Defendants. The patch is designed to be placed on the skin of the user and, to be worn for a period of seventy-two (72) hours. In theory, the fentanyl in the patch will then be introduced to the user at a controlled rate over this period of time.

14. Defendants knew, or had reason to know, before the date decedent Michael Locascio used the patch in question, of the danger that patches could deliver a greater than stated amount of fentanyl or otherwise cause an excessive and deadly amount of fentanyl to enter the body of the person using the patch.

15. The Defendants took inadequate steps to advise consumers, including decedent, Michael Locascio, of this danger and the significant risks it presented to those using the patch.

16. The Fentanyl Patch used by Michael Locascio on or about July 16, 2007, was defective in that it allowed an excess amount of fentanyl to come into contact with the decedent's skin or otherwise caused or allowed an excessive amount of fentanyl to enter his body, resulting in his death. As a direct and proximate result of using said Fentanyl Patch, Michael Locascio received a fatal overdose of the opioid fentanyl.

In addition to naming Sandoz and Novartis as defendants, the plaintiffs also named “Doe” defendants, which allows them to add another company at a later date if need be.  Since Johnson & Johnson manufactures many of Sandoz’ patches, it is possible that it will be added as a defendant later.

Wrongful Death Lawsuit Filed Against Makers of Generic Duragesic Lawsuit

In June of 2009, the family of Kevin Waters filed a lawsuit against the makers of a generic version of the Duragesic fentanyl patch.  The lawsuit alleges that a defective generic Duragesic patch killed Kevin Waters:

15. The Sandoz Fentanyl pain patch is the generic brand of transdermal pain patch that is available only by prescription.

16. The Sandoz Fentanyl pain patch contains a gel form of Fentanyl, an opoid pain medication that is 100 times more powerful that Morphine.

17. The Sandoz Fentanyl pain patch is manufactured by Johnson & Johnson and its subsidiary, ALZA Corporation.

18. The Fentanyl pain patch was designed and manufactured with a reservoir containing a three day dose of Fentanyl and was designed to deliver the Fentanyl medication at a regulated rate for up to Seventy-Two (72) hours. The patch is applied directly to the skin of the user.

19. The Fentanyl pain patch was designed and marketed for patients suffering from moderate to severe chronic pain and was designed and marketed for use by patients who were already taking other narcotic pain killers.

20. Upon information and belief, Defendants' Fentanyl Transdermal System was first approved by the FDA in 1990 and the generic version approved in early 2005.

21. The Food and Drug Administration has received hundreds of reports of fatalities associated with both the Duragesic and Sandoz Fentanyl Transdermal System due to manufacturing and design defects such as cuts and seal breaches which allow the Fentanyl gel to leak from the patch, killing the user with a lethal dose of Fentanyl.