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Text of Fentanyl Lawsuit Filed Against Mylan

Posted in Duragesic / Fentanyl

The complete text of the original complaint filed in Ross v. Mylan is posted below.  This fentanyl lawsuit is against Mylan, the makers of a generic Duragesic fentanyl patch.  Unlike Duragesic, which uses a reservoir design, the Mylan patch uses a matrix design that can not leak fentanyl gel.

Pursuant to Tennessee Statutes, TCA 20-5-106 et seq., Plaintiff Rebecca Ross as Personal Representative of the Estate of Elisa A. Bell, files this Original Complaint and Jury Demand against Mylan, Inc., Mylan Pharmaceuticals, Inc. And Mylan Technologies, Inc. (collectively, the “Mylan Defendants”) and for cause of action would show:

Parties

1 Plaintiff Rebecca Ross is an individual residing in Germantown, Tennessee. Plaintiff is the sister of Elisa A. Bell(“Decedenf”) and the duly appointed personal representative of the Decedent's estate. Under Tennessee Statutes, Plaintiff brings this action on behalf of the Decedent's Estate and on behalf of the Decedent's wrongful death beneficiaries, Rebecca Ross( Decedent's sister), Gene Bell(Decedent's brother) and William Bell(Decedent's brother). Rebecca Ross is 47 and lives in Germantown, TN. Gene Bell is 51 and William Bell is 52 and they both live in Germantown, TN.

2. Defendant Mylan, Inc. Is a corporation organized and existing under the laws of the State of Pennsylvania. Mylan, Inc. has done and is doing business in Tennessee, but it does not maintain an agent for service of process in this state. Mylan, Inc. May be served by delivering a summons and copy of the complaint to Louis Debone or any other officer or managing agent at 1030 Century Building, Pittsburgh, PA 15222.

3. Defendant, Mylan Pharmaceuticals, Inc., a subsidiary of Mylan Inc. is a corporation organize and existing under the laws of West Virginia. Mylan Pharmaceuticals, Inc. has done and is doing business in Tennessee, but it does not maintain an agent for service of process in this state and may be served by delivering a summons and a copy of the complaint to its President, Harry A. Korman at 781 Chestnut Ridge Road, Morgantown, WV 26505, or any other officer or managing agent at such address.

4. Defendant Mylan Technology, Inc. a subsidiary of Mylan, Inc. Is a corporation organized and existing under the laws of the State of West Virginia. Mylan Technologies Inc. has done business in the state of Tennessee and may be served with process by serving its President, Carolyn Myers, at 1500 Corporate Drive, Suite 400, Cannonsburg, PA 15317, or any other officer or managing agent at such address.

VENUE

5. The decedent died in the State of Tennessee and the Plaintiff submits to the jurisdiction and venue of this Honorable Court.

Facts

6. The suit arises out of the wrongful death of the Decedent, due to the wrongful conduct of the Defendants. Decedent, while a patient of Dr. Robert Cooper was given a prescription for 50 mcg Mylan (fentanyl transdermal system) patches. The prescription was filled with 50 mcg Mylan (Fentanyl transdermal system) patches from a local pharmacy. Decedent had been wearing one of these patches prior to her death and it was the cause of her death. The Patch that the Decedent had worn prior to her death was designed, manufactured, marketed, and distributed by the Mylan Defendants.

7 .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.

8. The Patch is applied by the patient and delivers fentanyl through the patients skin.

9. Decedent was prescribed Duragesic 50 mcg patches on March 3, 2008. Decedent was found dead on March 7, 2008. In an autopsy performed on the Decedent's body, the State of Tennessee coroner ruled that the cause of death is acute fetanyl intoxication.

CAUSES OF ACTION FIRST CAUSE OF ACTION: STRICT PRODUCT LIABILITY

10. The Plaintiff repeat and re-allege each and every allegation contained in Paragraphs 1 through 9 and make such allegations a part hereof by reference. The Mylan Defendants are liable under the theory of product liability. The Mylan Defendants at all times material hereto engaged in the business of designing, manufacturing, selling, marketing, and/or supplying the Patch, including the Bell Patch. The Bell patch was in a defective condition at the time it was designed, manufactured, sold, and/or marketed by the Mylan Defendants and at the time it left their possession because it was unreasonably dangerous. The Bell Patch was unreasonable and, therefore, defective because, inter alia, it gave Decedent a much higher dose of fentanyl than a properly functioning patch should have been given her. As discussed below, Defendants failed to warn of the Bell Patch's defective condition or utilize a safer alternative design. Decedent was unaware of the defective condition of the Bell Patch at the time she used the product in the manner and for the purpose it was intended. The defective condition was the legal cause of the Decedent's death and the damages described herein. The Bell Patch was in the control of the Mylan Defendants at the time the defect occurred. Further, the injury sustained by the Decedent, Fentanyl intoxication was the exact type of injury that a defective Patch causes. The Bell patch reached Decedent without any substantial change in its condition. Because of the nature of ingredients or natural characteristic of the Bell Patch, use of it involved substantial risk of injury. The exposure to risk of injury from the Bell Patch outweighed any benefits from the product's use. Without limitation, the Bell Patch was defective because it malfunctioned and did not perform as intended and designed. The exposure to risk of injury was unreasonable taking into consideration and balancing the dangers and benefits resulting from the product's use.

Manufacturing Defect

11. More specifically, the Bell Patch was defective because of the existence of a manufacturing flaw which rendered the product unreasonably dangerous at the time it left the Mylan Defendant's control. The Bell Patch was unreasonably dangerous because it did not conform to its intended design and failed to perform as safely as the intended design would have performed. The Bell Patch was unreasonably dangerous beyond that which would be contemplated by the ordinary user. The manufacturing defect was a legal cause of Decedent's death and the damages claimed herein.

Marketing Defect

12. Pleading further and without waiver of the foregoing, the Patch was defective because the Mylan Defendants failed to warn of risks that were known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time the Bell Patch was manufactured and distributed. There was a risk of harm, which risk is inherent in the Patch or that may arise from the intended or reasonably foreseeable or scientifically discoverable at the time of exposure. The Mylan Defendants knew or had reason to know the Patch was or was likely to be unreasonably dangerous in the use for which it was made. The danger was open obvious. The Mylan Defendants failed to exercise reasonable care to warn the Decedent of the dangerous condition or the facts that made it dangerous. The Mylan Defendants's failure to warn was a legal cause of Decedent's death and the damages claimed herein.

Design Defect

13. Pleading further and without waiver of the foregoing, the defective design of the Patch made it unreasonably dangerous because it (a) failed to perform as safely as an ordinary consumer would expect when used as intended or in a manner reasonably foreseeable by the Defendants and/or (b) the risk of danger in the design outweighed the benefits. The Mylan Defendants were aware or had reason to know that the design of the Patch was defective and that another design was feasible. The manufacturing defect was a legal cause of Decedent's death and the damages claimed herein.

14. For these reasons, the Defendants are strictly liable under applicable products law without regard to proof of negligence or gross negligence. However, if it be necessary, Plaintiff would show that the Bell Patch was designed, manufactured, sold, supplied, and/or marketed in a negligent, grossly negligence, and defective condition and such negligence, gross negligence, malice, and defects were a legal cause of Decedent's death and the damages claimed herein.

SECOND CAUSE OF ACTION: NEGLIGENCE

15. Plaintiff repeats and re-allege each and every allegation contained in Paragraphs 1-14, inclusive of the First Cause of Action, and make such allegations a part hereof by reference. The Mylan Defendants had a duty to exercise reasonable care in the design, manufacture, marketing, sale, or distribution of the Patch into the stream of commerce, including, without limitation, a duty to assure that the Patch did not cause users to suffer from unreasonable, dangerous side effects, including death. The Mylan Defendants failed to exercise ordinary care in the design, manufacture, marketing, sale, testing, quality assurance, quality control or distribution of the Bell Patch into interstate commerce in that the Mylan Defendants knew or should have known that the Patch created a high risk of unreasonable, dangerous side effects, including death.

16. More specifically, the Mylan Defendant's negligence in the design, manufacture, marketing, testing, and sale of the Patch, inclusive, without limitation:

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

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

f. Failure to obtain and/or distribute easily accessible information or data relevant to the safety of the Patch especially in view of the number of deaths due to Fentanyl;.

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

h. Failure to conduct adequate testing and post-marketing surveillance to determine the safety of the patch;

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

j. Inadequate or insufficient inspection for defects;

k. Inadequate and/or insufficient research into the safety of the product prior to sale;

1. Inadequate and/or insufficient monitoring or research regarding adverse events;

m. Failure to list death as an adverse event and to provide training, knowledge, or information to distributors or sellers of the product;

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;

r. Packaging the product; and

s. Other and further particulars as will be proven at trial.

17. The negligent, careless and reckless conduct of the Defendants, as alleged above, was a proximate cause of Decedent's death and the damages asserted herein.

THIRD CAUSE OF ACTION: NEGLIGENT MISPRESENTATION

18. Plaintiff repeats and re-alleges each and every allegation contained in Paragraphs 1 through 17 , inclusive of the First and Second Causes of Action, and make such allegations a part hereof by reference.

19. The Mylan 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. The Mylan Defendants represented and marketed the Patch as being safe and effective. After the Defendants became aware of the risk of using the Patch, however, the Defendants failed to communicate to the FDA, Decedent, distributor, pharmacists and/or the general public, that the use of this product could cause serious injury and/or death. The Defendants instead communicated to all such persons/entities that the Patch was safe for use. Specifically, the Mylan Defendants misrepresentations include, without limitation, a representation that the Patch would produce a maximum fentanyl blood concentration that was much lower than the fentanyl concentration found in Decedent's blood at the time of her death and a representation that the Patch was safe for use.

20. Therefore, Plaintiffs bring this cause of action against the Mylan Defendants under the theory of negligent representation for the following reasons:

a. The Mylan Defendants failed to warn of the defective condition of the Patch, as manufactured and/or supplied by the Mylan Defendants.

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

c. The above representations were made to the FDA, Decedent, pharmacists, as well as the general public and the Mylan Defendants intended to induce others to rely on their representations.

d. Decedent and others justifiably relied on the Decedent's misrepresentation.

e. Consequently, Decedent's use of the Patch was to his detriment. The Mylan Defendants' negligent misrepsentation was the legal proximate cause of the death of Decedent and the damages claimed herein.

FOURTH CAUSE OF ACTION: BREACH OF WARRANTY

21. Plaintiffs repeat and re-allege each and every allegation contained in Paragraphs 1 through

20, inclusive of the First, Second, and Third Causes of Action, and make them a part hereof by reference.

22. The Mylan Defendants impliedly and expressly warranted to Decedent that the Bell Patch, including each and every component part thereof, was fit for the purpose for which it was to be used and was free from design and manufacturing defects to consumers and users thereof. The Mylan Defendants had reason to know that the buyer was relying on the skill and judgement of the Mylan Defendant to select or furnish suitable products. The Mylan Defendants had reason to know that the particular purpose for which their products were to be used.

23. The Bell Patch, including each and every component part thereof, was not free from such defects or fit for the purpose for which it was to be used and was, in fact, defectively manufactured and designed and imminently dangerous to consumers and users. The Bell Patch manufactured and distributed by the Mylan Defendants was capable and did cause , Decedent's the damages claimed in the lawsuit. Therefore, Plaintiff, on behalf of Decedent's estate seeks all damages available under Tennessee law including, without limitation: (a) Loss of earnings, pensions, and prospective net accumulations; and (b) medical and funeral expenses paid on behalf of Decedent. In addition, Plaintiff on behalf of Decedent's wrongful death beneficiaries, seeks all damages available under Tennessee law including, without limitation, past and future where applicable: loss of love; loss affection; society; companionship; economic loss; support; right of support; expectation of future support; counseling; solace; lost of beloved family member and mental pain and suffering on behalf of all family members.

WHEREFORE, Plaintiff prays for judgement against the Defendants, jointly and severally:

1. General damages in an amount in excess of the minimum jurisdictional limits of this Court;

2. For funeral, burial and memorial expenses according to proof at the time of trial, together with interest on all such amounts;

3. For loss of support, affection, companionship, mental pain and suffering;

4. For Punitive damages in an amount to be determined;

5. For costs of suit incurred herein; and

6. For such other and further relief as this Court may deem just and proper.