Duragesic Fentanyl Patch Lawyer, Lawsuit, and Side Effect News

Duragesic Wrongful Death Lawsuit Filed in Cook County, Illinois

On September 2nd of 2009, Duragesic lawyers filed a wrongful death lawsuit against the manufacturers of the Duragesic fentanyl pain patch.  The lawsuit alleges that a defective Duragesic patch was responsible for the death of 33 year old Jay Gustafson.

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.

Makers of Duragesic Patch Sued for Wrongful Death In Illinois

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.

Attorneys File Duragesic Lawsuit in Texas Against Johnson & Johnson

Texas is always a hotbed of Duragesic litigation, and another wrongful death lawsuit was filed In Dallas in July of 2009.  The lawsuit alleges that a defectively designed and manufactured, and that those defects caused the death of Sondra Way.

12. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of Defendants. Decedent was given a prescription for 50 mcg Duragesic (fentanyl transdermal system) patches (i.e., the Way Patches). Decedent was using the Way Patches at the time of her death and they were the cause of her death. The Way Patches were designed, manufactured, marketed and/or distributed by the Defendants. Duragesic (fentanyl transdermal system) patches also came in other sizes such as 25, 50 and 75 mcg. As referenced herein, the “Patch” shall refer to Duragesic (fentanyl transdermal system) patches of any size unless specified otherwise.

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

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

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

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

17. The Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

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

Duragesic lawyers file wrongful death lawsuit in Georgia

In July of 2009, Duragesic lawyers in Georgia and Texas filed a wrongful death lawsuit against ALZA Corporation, Janssen Pharmaceutica Products, LP, Janssen, LP, and Ortho-McNeil-Janssen Pharmaceuticals, Inc.  Those companies, all wholly owned by Johnson & Johnson, are responsible for the design, manufacture, and sale of the Duragesic fentanyl pain patch. 

The Duragesic lawsuit alleges that a defective patch killed Donna Gipson.

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

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

14. The Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

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

16. In 2004, the Defendants recalled numerous lots of Patches because of leaking defects. Also during 2004, the FDA investigated the Defendants' manufacturing practices and quality control/assurance policies and procedures and found them to be deficient. In 2008, the Defendants again recalled patches on two separate occasions.

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

Duragesic Manufacturers Object To Testimony of Plaintiffs Expert Witnesses In Illinois Wrongful Death Lawsuit

In any Duragesic lawsuit, both sides will have to hire expert witnesses to testify.  Each side has a chance to challenge the other side’s expert witnesses.  This is an example of the defendant’s challenge to the plainitff’s expert witnesses.

Plaintiff offers Dr. Blume's opinions that the Duragesic(R) label was inadequate and that defendants should have responded to reports of fentanyl's potential lethality, even when used as indicated, by revising the Duragesic(R) label. (Blume Decl. ¶¶ 34-39, 46-49; Blume 10/17/07 Dep. at 65:13-19, 77:20-79:7,198:5-14,219:20-221:19; Pl.'s Mem. at 6,46.)

Dr. Blume's opinions about the Duragesic(R) label must be excluded because they are irrelevant. As defendants explained in their Motion for Summary Judgment, plaintiff abandoned her failure to warn claim in her First Amended Complaint. (Memorandum in Support of Motion for Summary Judgment at 22.) Consequently, Dr. Blume's opinions about the Duragesic(R) label are not material to any fact at issue in this litigation and must be excluded under Federal Rules of Evidence 401 and 702.

In addition, Dr. Blume's opinions about the adequacy of the Duragesic(R) label are inadmissible because they are not the product of reliable methods. Blume states that her analysis of the World Health Organization (“WHO”) database of adverse event reports associated with Duragesic(R) use showed “a significant increase in the number of deaths from 1999-2000 and 2002-2003,” a sharp rise in the number of “reports of overdose (overdose effect) from 2000-2001 and from 2003-2004, and “significant escalations” in “respiratory depression events” beginning in 2000. (Blume Decl. ¶ 35.) Additionally, she states that the U.S. Adverse Event Reporting System (“AERS”) database showed increases in the number of reports of respiratory failure associated with Duragesic(R) use from 2000 to 2001 and in the following two years, as well as “a significant number of overdoses.” (Blume Decl. ¶ 36.) Based on her own analyses of these databases, Dr. Blume opined: “ALZA should have utilized these accumulated data as the basis for immediately strengthening their Duragesic(R) product label to include sufficient warning relating to the risk of unexplained death following appropriate use of the patch in patients meeting the indication requirements.” (Blume Decl. ¶ 39.)

This challenge was filed in July of 2008 in the case of Kunnemann v. Janssen Pharmaceutica Products.

Wrongful Death Lawsuit Filed in Louisiana Against Manufacturer of Duragesic Fentanyl Pain Patch

In May of 2009, the family of Sylvester Edwards, Senior, filed a wrongful death lawsuit against the manufacturers of the Duragesic fentanyl pain patch.  The lawsuit alleges that the manufacturers were negligent in their sales and promotion of Duragesic.

Defendants were negligent in the following particulars:

(a) By failing to adequately disclose and discuss safety issues and the possible adverse effects of the patch, including, but not limited to, its defective design that allowed more than the expected amount of the pain medication (fentanyl) to be released or leak from the patch, which would, in turn, be absorbed into the consumer's bloodstream in dangerous doses leading to overdose or death;

(b) By aggressively promoting and marketing the Patch to physicians, pharmacists and the general public through strategies which misrepresented the safety and benefits of the Patch;

(c) By engaging in false and misleading advertisements regarding the appropriate use and benefits of the Patch; and

(d) By continuing to promote, market, sell, and distribute the Patch to the public notwithstanding their knowledge of its harmful and dangerous side effects.

Duragesic Manufacturers Sued in New Mexico For Wrongful Death

In September of 2007, the makers of the Duragesic fentanyl patch were sued in New Mexico.  The lawsuit alleges that a defective Duragesic patch killed Niki Martin:

10. The Martin Patch was manufactured on a single machine, the Bodolay I, kept in near constant operation at Defendant ALZA's facility in Vacaville, California. The Martin Patch was made utilizing a reservoir design, which means that the fentanyl gel is inserted into a reservoir between two of the patch's layers. The Martin Patch was part of lot 0403135.

11. Prior to and at the time of the manufacture of the Martin Patch, Defendants knew that they were producing on the Bodolay I defective patches that leaked. Prior to and at the time of the manufacture of the Martin Patch, Defendants knew 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 Martin Patch, Defendants knew or should have known that they were producing on the Bodolay I defective patches that were killing patients and/or injuring patients. Despite the foregoing, Defendants, with reckless and/or intentional disregard for the safety of patients, continued and continue to this day to manufacture fentanyl patches, which kill patients because of the massive revenue being generated by their sale.

12. The Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

13. Another design for Fentanyl patches existed at the time the Martin Patch was manufactured called the “matrix” design. At all relevant times, Defendants could have made fentanyl patches of a matrix design, as opposed to a reservoir design. The matrix technology cannot leak fentanyl.

Lawsuit Alleges Duragesic Makers Failed To Warn Doctors Of Proper Dosing Regimen For Pain Patch

In January of 2008, the family of Jason Lock alleged that the Duragesic manufacturers didn’t adequately warn doctors of the risks of using their fentanyl patch:

14. Defendants Janssen and Alza were negligent in that:

a. Defendants Janssen and Alza failed to adequately warn Dr. Cox and other physicians authorized to prescribe Duragesic of its potential dangers, specifically the risk of severe hypoventilation and death that can result by shortening the dosing interval. If this risk had been known to Dr. Cox, it would have prevented his prescription of Duragesic on a 48-hour dosing schedule.

b. Defendants Janssen failed and Alza to warn Dr. Cox and other prescribing doctors that the Duragesic patch was unsafe, from a life-threatening hypoventilation risk standpoint, when dosed on an interval of less than 3 days.

c. Defendants Janssen and Alza failed to warn in their labeling that, based on what they knew from their clinical trials, and in light of generally recognized and prevailing best scientific and medical knowledge, reducing the dosing intervals would have the effect of raising fentanyl blood levels beyond what the patch was designed to deliver, and that such effect could cause life threatening hypoventilation.

15. The knowledge which Janssen and Alza held as of the time of the events described in this complaint was concealed from the prescribing doctor, Cox, and fraudulently so, which in turn concealed such information from the decedent's survivors, such that they were unable to timely discover their cause of action against the Defendants within two years from the date of death.

16. As a result of the negligence of Defendants Janssen and Alza, Jason Daniel Lock was prescribed Duragesic by Dr. Jeffrey Cox, and on or after March 24, 2004 was prescribed the 100 mcg/hr patch at a dosing interval of two days (48 hours).

Dr. Cox was not adequately warned of the dangers of life threatening hypoventilation by prescribing Duragesic in such a manner, which proximately resulted in a fatal overdose of fentanyl to Jason Daniel Lock from the patch.

Arizona Lawsuit Against ALZA Corporation Alleges Faulty Duragesic Patch Responsible For Death

A lawsuit filed in February of 2008 in Arizona alleges that a faulty Duragesic patch is responsible for the death of Michael Jorgensen.

7. This suit arises out of the wrongful death of Michael Jorgensen, due to the wrongful conduct of Defendants. Michael Jorgensen, while a patient of Beverly Webber, a certified nurse practitioner, was given a prescription for 50 mcg Duragesic (fentanyl transdermal system) patches. Mr. Jorgensen was wearing one of these patches (the “Jorgensen Patch”) at the time of his death and it was the cause of his death. The Jorgensen Patch was designed, manufactured, marketed and/or distributed by Defendants. Duragesic (fentanyl transdermal system) patches also came in other sizes such as 25, 50 and 100 mcg. As referenced herein, the “Patch” shall refer to Duragesic (fentanyl transdermal system) patches of any size unless specified otherwise.

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

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

10. The Jorgensen Patch was manufactured on a single machine, the Bodolay I, kept in near constant operation at Defendant ALZA's facility in Vacaville, California. The Jorgensen Patch was made utilizing a reservoir design which means that the fentanyl gel is inserted into a reservoir between two of the patch's layers. The Jorgensen Patch was part of lot 0606061.

11. Prior to and at the time of the manufacture of the Jorgensen Patch, Defendants knew that they were producing on the Bodolay I defective patches that leaked. Prior to and at the time of the manufacture of the Jorgensen Patch, Defendants knew 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 Jorgensen Patch, Defendants knew or should have known that they were producing on the Bodolay I defective patches that were killing patients and/or injuring patients. Despite the foregoing, Defendants, with reckless and/or intentional disregard for the safety of patients, continued and continue to this day to manufacture fentanyl patches which kill patients because of the massive revenue being generated by their sale.

12. The Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.

13. Another design for Fentanyl patches existed at the time the Jorgensen Patch was manufactured called the “matrix” design. At all relevant times, Defendants could have made fentanyl patches of a matrix design, as opposed to a reservoir design. The matrix technology cannot leak fentanyl.

14. In 2004, Defendants recalled numerous lots of 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.

15. On September 13, 2006, while using the Patch as prescribed, Michael Jorgensen died from the toxic effects of fentanyl.

Lawsuit Filed In Illinois Against Duragesic Manufacturers, and Walgreen

In September of 2008, the family of Daniel Mandziak filed a wrongful death lawsuit against the makers of the Duragesic fentanyl pain patch. The lawsuit alleges that a defect in the Duragesic patch was responsible for the death of Daniel.  The lawsuit also names Walgreen as a defendant:

39. Walgreen Company had a duty to exercise reasonable care in the design, manufacture, marketing, testing, approval, application for approval, inspection, sale and distribution of the Patch into the stream of commerce. Walgreen Company had a duty to exercise reasonable care in the sale, marketing, and distribution of the Patch into the stream of commerce. Walgreen Company failed to exercise ordinary care in the sale, marketing, and/or distribution of the Patch into interstate commerce and thus Walgreen Company was negligent.

40. The negligence of Walgreen Company includes, without limitation, negligence in the following areas and/or in the following respects:

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

b. Misrepresenting that the Patch is safe for use;

c. Failure to list death as an adverse event;

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

41. One or more of the aforementioned negligent acts or omissions was a proximate cause of Decedent's death, his physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.

42. Decedent's injury and resulting death normally would not have occurred in the absence of negligence on the part of Walgreen Company in the distribution of the transdermal fentanyl delivery system in issue.

43. 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 Decedent's next of kin, including but not limited to loss of love, guidance, care, affection and support.

WHEREFORE, Plaintiffs pray this Court enter judgment in their favor and against Walgreen Company in an amount in excess of $50,000.00 plus costs.

North Carolina Lawyers Sue Duragesic Makers Alleging Wrongful Death

In February of 2008, lawyers from North Carolina and South Carolina filed a wrongful death lawsuit against the manufacturers of the Duragesic fentanyl patch.  The attorneys allege that a defective Duragesic patch killed Richard Starling Allen:

55. Richard Starling Allen's tragic and premature death was proximately causes by the Defendants' defective product, the Duragesic patch and the Defendants' negligence, gross negligence, recklessness and wanton conduct in connection with the Duragesic patch. The above described potentially lethal “leakage” defects in the product were well known to each of the Defendants on and prior to May 9, 2004. Despite such knowledge, the Defendants failed to act, to properly warn or to protect Richard Starling Allen and other Duragesic patch users from deadly harm. Indeed, the Defendants sought to cover up the true failure rate and deadly risks its product posed to thousands of consumers each year. While not all fentanyl “leaks” resulted, as here, in death, many hundreds in fact did each year. The Defendants knew it and did not disclose this information to the federal regulators, the prescribing medical professionals or the public. They still have not fully or truthfully done so.

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

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

58. Upon information and belief, the actual number of deaths that were sustained by patients while wearing the Duragesic patch from 1998 through August 2005 was many times greater than the 126 reported by the Defendants to the FDA.

59. Like Richard Starling Allen, hundreds of individuals in the United States were caused to die from “fentanyl toxicity” and/or “fentanyl poisoning” due to the Duragesic patch's defects which caused it to leak fentanyl. The absorption of leaked, bolus administration of fentanyl through the epidermis of the patient causes a lethal overdose of fentanyl in the patient resulting in deaths, such as the one which gives rise to this wrongful death case.

60. The Defendants, in wanton, reckless, grossly negligent and indefensible disregard of the public safety - and that of Richard Starling Allen - failed adequately and appropriately to warn of the true and, known to the Defendants, deadly risk posed by the Duragesic patch.

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