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Fentanyl lawsuit against Mylan Pharmaceuticals filed in Georgia

Posted in Duragesic / Fentanyl

Here’s the text of a fentanyl lawsuit filed against Mylan Pharmaceuticals.  This one was filed in Georgia.

COMPLAINT FOR DAMAGES

Plaintiff, GLORIA STOYLES, (herein alternatively referred to as “Plaintiff”), residing at 682 Saddlebrook Drive, Dallas, GA 30132, by and through her attorneys C. Andrew Childers, Esq. and M. Brandon Smith, Esq., Childers & Schlueter, LLP, 260 Peachtree Street NW, Suite 1601, Atlanta, GA 30303 and of counsel Andrew G. Finkelstein, Esq., Kenneth B. Fromson, Esq., and Mary Ellen Wright, Esq., Finkelstein & Partners, LLP, 1279 Route 300, P.O., Box 1111, Newburgh, NY 12551, file this her Complaint For Damages against Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (collectively referred herein after as “Defendants” or “Mylan Defendants”) herein alleges upon information and belief the following:

STATEMENT OF THE CASE

1. Plaintiff brings this action to recover damages for personal injuries sustained by, and the wrongful death of Plaintiff's Decedent, RONNIE STOYLES, as the direct and proximate result of defendants' wrongful conduct in connection with the designing, developing, manufacturing, distributing, labeling, advertising, marketing, promoting, and selling of the prescription Fentanyl Patch, which was marketed and sold by the defendants, MYLAN, INC., MYLAN PHARMACEUTICALS, INC., and MYLAN TECHNOLOGIES, INC.

PARTIES AND JURISDICTION

a) PLAINTIFFS

2. Plaintiff GLORIA STOYLES is an individual residing and domiciled in Paulding County, Georgia. Plaintiff GLORIA STOYLES is the surviving wife and next of kin of RONNIE STOYLES (“Decedent”). Plaintiff GLORIA STOYLES, as Administrator of the Estate of Ronnie Stoyles, brings this action on behalf of Decedent's Estate and on behalf of Decedent's wrongful death beneficiaries.
b) DEFENDANTS

3. Defendant Mylan, Inc. (formally known as Mylan Laboratories, Inc.) is a foreign corporation organized and existing under the laws of the State of Pennsylvania with its principle place of business located at 1500 Corporate Drive, Suite 400, Canonsburg, PA 15317. Mylan, Inc. has done and is doing business in Georgia. Defendant Mylan, Inc. may be served with process by and through its Registered Agent, Corporation Service Company, 209 West Washington Street, Charleston, West Virginia 25302. Defendant Mylan, Inc. is subject to the jurisdiction and venue of this Court.

4. Defendant Mylan Pharmaceuticals, Inc. is a foreign corporation organized and existing under the laws of the state of West Virginia with its principal place of business located at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. Upon information and belief, Mylan Pharmaceuticals, Inc. is a wholly owned subsidiary of Mylan, Inc. Mylan Pharmaceuticals has done and is doing business in Georgia. Defendant Mylan Pharmaceuticals may be served with process by and through its Registered Agent, Corporation Service Company, 209 West Washington Street, Charleston, West Virginia 25302. Defendant Mylan Pharmaceuticals, Inc. is subject to the jurisdiction and venue of this Court.

5. Defendant Mylan Technologies, Inc., is a foreign corporation organized and existing under the laws of the State of West Virginia with its principal place of business located at 110 Lake Street, Saint Albans, VT 05478. Upon information and belief, Mylan Technologies, Inc. is a wholly owned subsidiary of Mylan, Inc. Defendant Mylan Technologies, Inc. may be served with process by and through its Registered Agent, Corporation Service Company, 209 West Washington Street, Charleston, West Virginia 25302. Defendant Mylan Technologies, Inc. is subject to the jurisdiction and venue of this Court.

VENUE

6. This Court has jurisdiction over this action pursuant to 28 U.S.C. Section 1332 because there is complete diversity between the parties and the amount in controversy exceeds $75,000, exclusive of interest and costs.

7. Venue in this District is appropriate under 28 U.S.C. Section 1391 because a substantial part of the events giving rise to this claim occurred in the district as Plaintiff's Decedent was prescribed and used the Defendant's fentanyl Patch in this District and because Plaintiff at all relevant times has resided and was domiciled in this District.

FACTS

8. This suit arises out of the wrongful death of Plaintiff's Decedent, due to the wrongful conduct of Defendants. Decedent was given a prescription for fentanyl patches. Decedent filled his prescription with Mylan fentanyl patches. Decedent was using Mylan fentanyl patches at the time of his death and they were the cause of his death. The patches were designed, manufactured, marketed and/or distributed by the Mylan Defendants.

9. Mylan (fentanyl transdermal system) patches came in sizes such as 25, 50, 75 and 100 mcg. As referenced herein, the “Patch” or “Patches” shall refer to Mylan (fentanyl transdermal system) patches of any size unless specified otherwise.

10. The Patch is a matrix patch containing the drug fentanyl. 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.

11. The Patch is applied by the patient and delivers fentanyl though the patient's skin.

12. The Patch is unreasonably dangerous because it can and does cause lethal levels of fentanyl in patients such as Plaintiffs Decedent.

13. Decedent was prescribed the Patch for pain. Decedent filled the last prescription on April 9, 2007. Decedent was found dead on April 24, 2007.

COUNT I STRICT LIABILITY

14. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.
a. Strict Products Liability

15. Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying the Patch. The Patches were in a defective condition at the time they were designed, manufactured, sold, and/or marketed by the Defendants and at the time they left their possession that made the Patches unreasonably dangerous. In giving Decedent a fatal dose of fentanyl, the Patch failed to perform in the manner reasonably to be expected in light of their nature and intended function. The patch presented an unreasonable risk of injury because of the nature of its ingredients and natural characteristics of the patch. A reasonably prudent person having full knowledge of the risk would find it unacceptable. Decedent was unaware of the defect and used the Patches in a normal manner, as prescribed, and for the purpose for which they were intended. There was no other reasonable cause for the Patches' failure to perform as intended. The defective condition in the Patches existed at the time they left the Mylan Defendants control and reached Decedent without any substantial change in their condition. The defective condition of the Patch 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. Without limitation, the Patch was defective because it malfunctioned and did not perform as designed.
b. Manufacturing Defect

16. More specifically, the Patches were defective because of the existence of a manufacturing flaw which rendered the product unreasonably dangerous at the time they left the Defendants. The defect 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. Without limitation, the Patch was defective because it malfunctioned and did not perform as intended and designed during normal use.
c. Marketing Defect And Failure To Warn

17. Pleading further and without waiver of the foregoing, the Patches were defective because they lacked 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 Patch at the time that they marketed and sold the Patches, but failed to provide adequate warnings or instructions concerning such dangers. The absence of adequate warnings or instructions rendered the Patches unreasonably dangerous. The Defendants failure to provide such adequate warnings or instructions 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.
d. Design Defect

18. Pleading further and without waiver of the foregoing, the Patches were defective because their design rendered them unreasonably dangerous. The Patches failed to perform as safely as an ordinary consumer, such as Decedent, would expect when used in an intended or reasonably foreseeable manner. The Patches' design 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. The benefits of the design do not outweigh the risk of danger inherent in such design. Moreover, the Defendants, who participated in the design of the Patches, could have provided a safer alternative design. Such a safer alternative design existed at the time the Patches were manufactured, and it would not have substantially impaired the Patches' utility. Further, 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.

19. For these reasons, the Defendants are strictly liable under Georgia's product liability laws without regard to proof of negligence or gross negligence.

COUNT II BREACH OF WARRANTY

20. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

21. Defendants, through description, affirmation of fact, and promise expressly warranted to the FDA, prescribing physicians, and the general public, including Plaintiff, that their fentanyl patch products were both efficacious and safe for the intended use.

22. The Fentanyl Patch manufactured and sold by Defendants did not conform to these express representations because it caused serious injury and death to consumers when used as recommended.

23. Defendants breached their express warranties to Plaintiff by manufacturing, marketing, packaging, labeling, and selling the Fentanyl Patch to the Plaintiff's Decedent in such a way that misstated the risks of injury, without warning or disclosure thereof by package and label of such risks to Plaintiff's Decedent, thereby causing Plaintiff's Decedent serious physical injury and death.

24. Defendants conduct in this regard, including but not limited to, its breach of express warranty, was a contributing cause of the injuries and damages sustained by the Plaintiff as set forth above.

25. As a direct and proximate result of Defendant's breach of warranty, Plaintiff has suffered serious injury, economic loss and other harm damages to be proven at trial.

26. At the time Defendants designed, manufactured, marketed, sold and distributed their Fentanyl Patch for use by Plaintiff's Decedent, Defendants knew of its intended use and impliedly warranted the product to be of merchantable quality, including the warranty that it was fit for the ordinary purpose for which it was to be used and was safe for usage, pursuant to O.C.G.A Sections 11-2-314 and 11-2-315.30.

27. Defendants had reason to know the particular purpose for which its products were to be used. Defendants had reason to know that the buyer or supplier was relying on the skill and judgment of the Defendants to select or furnish suitable products. The product supplied by Defendants was unfit for the particular purpose for which it was purchased. This lack of fitness for the product's purpose 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. Defendants are liable to Plaintiff for breach of these warranties, including but not limited to, the implied warranty of fitness.

28. Defendants had reason to know that Plaintiff's Decedent was relying on the express and implied warranties.

COUNT III NEGLIGENCE

29. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

30. Defendants 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. Defendants failed to exercise ordinary care in the design, manufacture, marketing, testing, approval, application for approval, inspection, sale, quality assurance, reporting to the FDA, quality control and/or distribution of the Fentanyl Patches into interstate commerce and thus the Defendants were negligent in all of these areas.

31. The negligence of the Defendants 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. Failure to use due care in designing and manufacturing the Patch;

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

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

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

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

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

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

i. Misrepresenting that the Patch is safe for use;

j. Inadequate or insufficient inspection for defects;

k. Inadequate and/or insufficient research into the safety of the product prior to sale; Inadequate and/or insufficient monitoring or research regarding adverse events; Failure to list death as an adverse event;

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

m. Marketing the Patch for unsafe uses;

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

o. Formulating and designing the product;

p. Making the product;

q. Inspecting and testing the product; and/or

r. Packaging the product.

32. 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.

33. Decedent's injury and resulting death normally would not have occurred in the absence of negligence on the part of the Mylan Defendants in the research, design, manufacture, and distribution of the transdermal fentanyl delivery system in issue.

34. This action is further brought pursuant to the Georgia Wrongful Death Act, 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.

COUNT IV NEGLIGENT MISREPRESENTATION

35. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

36. Defendants knew or should have known that the Patch created a high risk of unreasonable, dangerous side effects, including that proper use of the Patch can cause death, but the Mylan Defendants failed to communicate to the FDA, Decedent, Decedent's physicians, distributors, pharmacists, and/or the general public, that proper use of the Patch could cause serious injury and/or death. Defendants instead communicated to all such persons/entities that the Patch was safe for use. Specifically, Defendants' misrepresentations include, without limitation, a representation that the Patch would produce a maximum fentanyl blood concentration that was much lower that the fentanyl concentration found in Decedent's blood at the time of his death and a representation that the Patch was safe for use and a representation that the Patch can be used with other medications.

37. Therefore, Plaintiff brings this cause of action against the Defendants under the theory of negligent misrepresentation for the following reasons:

a. Defendants failed to provide true and accurate information, warnings and instructions as set forth herein;

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

c. The above misrepresentations were made to the FDA, Decedent, Decedent's physicians, pharmacists, as well as the general public;

d. The Defendants intended to induce others to rely on their representations, including, without limitation, Decedent, physicians, and pharmacists;

e. Decedent and others, including, without limitation, Decedent's physician(s) and her pharmacist(s), justifiably relied on the Defendants' misrepresentations; and

f. Consequently, Decedent's use of the Patches was to his detriment. The Defendants' negligent misrepresentations were a direct and proximate cause of the Decedent's death, his physical and mental pain and anguish and respiratory arrest prior to his death, and the damages claimed herein.

COUNT V FRAUD

38. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

39. At all relevant times during the course of dealing between Defendants and Decedent, Defendants misrepresented, omitted, and suppressed that the Patch was not safe or effective for its intended use.

40. Defendants were under a duty to disclose to Decedent, the medical community, and the general public, the defective nature of the Patch, and had full access to material facts concerning the defective nature of the Patch and the propensity of the Patch to cause injuries to patients who used the drug.

41. Defendants intentionally, knowingly, and/or recklessly misrepresented that the Patch was safe and effective for its intended use, even though Defendants know the dangers associated with the drug.

42. Defendants' misrepresentations, concealment, suppression and omissions were made purposefully, willfully, wantonly, uniformly, deliberately or recklessly to Decedent, the medical community, and the public, to induce the purchase and use of the Patch. Decedent and/or his physicians reasonably relied upon the misrepresentations and omissions made by the Defendants.

43. Defendants knew the Decedent and his physicians had no way to determine that the Defendants' representations about the Patch were false and misleading, and that they included material omissions.

44. As a direct and proximate result of Defendants' wrongful conduct, Decedent sustained severe physical injuries and death, severe emotional distress, mental anguish, economic losses and other damages for which Plaintiff is entitled to compensatory and punitive damages in an amount to be proven at trial.

COUNT VI PRE-DEATH INJURY AND PAIN AND SUFFERING

45. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

46. As a direct and proximate result of the acts and omissions of each Defendant, RONNIE STOYLES was injured and suffered damages prior to his death, for which Plaintiff may recover including, but not limited to: pre-death physical injury; pre-death physical pain and suffering, pre-death mental pain and suffering; pre-death impairment, disability and disfigurement; loss of capacity to enjoy life; loss of capacity to work or earn a living; loss of time in life that could have been spent doing things other than going to doctors, physically suffering, and undergoing medical procedures; pre-death expenses of hospitalization, medical care, nursing care, other treatment and medical monitoring; pre-death fear and mental anguish associated with RONNIE STOYLES' impending death; as well as all other special and general damages permitted under law.

COUNT VII WRONGFUL DEATH

47. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

48. As a result of the individual, combined and concurring acts and omissions of Defendants as set forth herein above, each above-named Defendant, caused or contributed to cause injuries to RONNIE STOYLES for which Plaintiff may recover. Such damages include damages which may be recovered for:

a) The wrongful death of RONNIE STOYLES, deceased, entitling Plaintiff to recover the full value of RONNIE STOYLES' life, as well as all other damages permitted under law;

b) Expenses associated with the last illness, death and burial of RONNIE STOYLES;

c) Pre-death physical injury, pain and suffering, disability, impairment, lost capacity to enjoy life, mental anguish, and lost earnings of RONNIE STOYLES in an amount to be proven at trial which may be recovered by Plaintiff; and

d) Pre-death medical expenses of RONNIE STOYLES in an amount to be proven at trial; and pre-death fear and mental anguish of RONNIE STOYLES concerning existing and future medical problems from the Patch and all other medical problems associated therewith in an amount to be proven at trial.

COUNT VIII PUNITIVE DAMAGES

49. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

50. The conduct of each Defendant, as set forth herein above was intentional, willful, wanton, oppressive, malicious, and reckless, evidencing such an entire want of care as to raise the presumption of a conscious indifference to the consequences in that each Defendant acted only out of self interest and personal gain. Such conduct evidences a specific intent to cause harm to Plaintiff as provided under O.C.G.A. § 51-12-5.1. Accordingly, punitive damages should be imposed against each Defendant pursuant to O.C.G.A. § 51-12-5.1 and other applicable laws, to punish and deter each Defendant from repeating or continuing such unlawful conduct.

DAMAGES

51. Plaintiff incorporates by reference all preceding paragraphs and allegations of this Complaint as though fully set forth herein.

52. Plaintiff seeks damages for the full value of the life of RONNIE STOYLES, pursuant to O.C.G.A. § 51-4-1, et seq.;

53. Plaintiff seeks general and special damages that the Decedent could have recovered during his lifetime, including, but not limited to, damages for his medical expenses, lost wages, pain and suffering, and other damages;.

54. Plaintiff seeks punitive damages due to the grossly negligent, intentional, willful or wanton misconduct of Defendants.

55. Plaintiff seeks attorneys' fees and expenses pursuant to O.C.G.A. § 13-6-11.

56. Plaintiff seeks any and all other damages as provided by O.C.G.A. §§ 10-1-370, et seq., 10-1-390, et seq., or such other and further relief as deemed just and proper by the Court.

REQUEST FOR A JURY TRIAL

57. Plaintiff requests a trial by jury.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff prays for relief as follows:

a. Full refund and costs associated with Decedent's use of the Patch;

b. The full value of the life of RONNIE STOYLES, pursuant to O.C.G.A. § 51-4-1, et seq., in an amount in excess of $75,000.00;

c. General and special damages that the Decedent could have recovered during his lifetime, including, but not limited to, damages for his medical expenses, lost wages, pain and suffering, and other damages;

d. Punitive damages due to the grossly negligent, intentional, willful or wanton misconduct of Defendants;

e. Attorney fees, expenses, interests, and costs of this action;

f. Any and all damages as provided by O.C.G.A. §§ 10-1-370, et seq., 10-1-390, et seq.; and

g. Such further relief as this Court deems necessary, just and proper.

This the 23rd day of April, 2009.