In July of 2009, the family of Kathie Christy filed a wrongful death lawsuit against Mylan Pharmaceuticals, the maker of a generic fentanyl pain patch:
8. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of the Mylan Defendants. Decedent, while a patient of Rebecca Talley, M.D., was given a prescription for 100 mcg Mylan (fentanyl transdermal) patches. Decedent was wearing one of these patches (the “Christy Patch”) at the time of her death and it was the cause of her death. The Christy Patch was designed, manufactured, marketed, and/or distributed by the Mylan Defendants. Mylan (fentanyl transdermal) patches also came in other sizes such as 25, 50, and 75 mcg. As referenced herein, the “Patch” shall refer to Mylan (fentanyl transdermal) patches of any size unless specified otherwise.
9. 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.
10. The Patch is applied by the patient and delivers fentanyl through the patient's skin. The Mylan 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.
11. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients.
12. Decedent was prescribed the Patch by Dr. Talley for pain. Decedent filled the prescription in July 2007. Decedent was found dead on July 30, 2007. Decedent had a fatal blood fentanyl concentration at the time of her death.
The lawsuit alleges that the Mylan patch in question had a manufacturing defect at the time it left Mylan’s factory. It also alleges that Mylan’s design – called a Matrix design – is defective.
NOW COMES, Michael Salmon, as surviving spouse of Kathie Elaine Christy (Decedent), and Craig Salmon, as personal representative of the Estate of Kathie Elaine Christy, and files this 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 Michael Salmon is an individual residing in Georgia and the surviving spouse of Kathie Elaine Christy (Decedent), whose death is the subject of this lawsuit. Plaintiff Michael Salmon brings this lawsuit on behalf of Dededent's wrongful death beneficiaries pursuant to O.C.G.A. § 51-4-2.
2.
Plaintiff Craig Salmon is a resident of the State of Georgia and is the duly appointed personal representative of the Estate of the Decedent.
3.
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 Georgia and may be served by delivering a summons and copy of the Complaint to its President, Robert J. Coury at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, or any other officer or managing agent at such address.
4.
Defendant Mylan Pharmaceuticals, Inc., a subsidiary of Mylan, Inc., is a corporation organized and existing under the laws of West Virginia. Mylan Pharmaceuticals, Inc., has done and is doing business in Georgia and may be served by delivering a summons and copy of the Complaint to its President, Harry A. Korman at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, or any other officer or managing agent at such address.
5.
Defendant Mylan Technologies, 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 and is doing business in Georgia and may be served with process by delivering a summons and copy of the Complaint to its President, Carolyn Myers at 1500 Corporate Drive, Suite 400, Cannonsburg, Pennsylvlania 15317, or any other officer or managing agent at such address.
JURISDICTION AND VENUE
6.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
7.
Pursuant to 28 U.S.C. § 1332, this Court has jurisdiction over this case because it is a lawsuit between parties of diverse citizenship and the amount in controversy exceeds $75,000.00. Venue is proper in this Court under 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to the claim (i.e., Decedent's fentanyl overdose and resulting death) occurred in this District.
FACTS
8.
This suit arises out of the wrongful death of Decedent due to the wrongful conduct of the Mylan Defendants. Decedent, while a patient of Rebecca Talley, M.D., was given a prescription for 100 mcg Mylan (fentanyl transdermal) patches. Decedent was wearing one of these patches (the “Christy Patch”) at the time of her death and it was the cause of her death. The Christy Patch was designed, manufactured, marketed, and/or distributed by the Mylan Defendants. Mylan (fentanyl transdermal) patches also came in other sizes such as 25, 50, and 75 mcg. As referenced herein, the “Patch” shall refer to Mylan (fentanyl transdermal) patches of any size unless specified otherwise.
9.
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.
10.
The Patch is applied by the patient and delivers fentanyl through the patient's skin. The Mylan 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.
11.
The Patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients.
12.
Decedent was prescribed the Patch by Dr. Talley for pain. Decedent filled the prescription in July 2007. Decedent was found dead on July 30, 2007. Decedent had a fatal blood fentanyl concentration at the time of her death.
CAUSES OF ACTION COMMON ALLEGATIONS FOR STRICT PRODUCT LIABILITY COUNTS I, II, AND III
13.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
14.
The Mylan Defendants are liable under the theory of strict product liability under O.C.G.A. § 51-1-11. The Mylan Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying the Mylan (fentanyl transdermal system) Patch, including the Christy Patch. The Christy Patch was in a defective condition which rendered them unreasonably dangerous at the time it was designed, manufactured, sold, and/or marketed by the Mylan Defendants and at the time it left the Mylan Defendants' control. Decedent was unaware of the defective condition of the Christy Patch at the time she used the product in the manner and for the purpose which it was intended. The defective condition was a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described herein. The Christy Patch was in the control of the Mylan Defendants at the time the defect occurred. Further, the injury sustained by Decedent, fentanyl toxicity, is the exact type of injury that a defective Patch causes. The Christy Patch reached Decedent without any substantial change in its condition.
COUNT I STRICT LIABILITY - MANUFACTURING DEFECT
15.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
16.
The Christy Patch was defective because of the existence of a manufacturing flaw which rendered the product unreasonably dangerous at the time they left the Mylan Defendants' possession and such defects were a producing and proximate cause of Decedent's death and Plaintiffs' damages. It was unreasonably dangerous beyond that which would be contemplated by the ordinary user. Without limitation, the Christy Patch was defective because it malfunctioned and did not perform as intended and designed. Without limitation, the Christy Patch was defective because it deviated from the manufacturer's intended design or production specifications. Such manufacturing defects proximately caused Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
COUNT II STRICT LIABILITY - FAILURE TO WARN
17.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
18.
Pleading further and without waiver of the foregoing, the Christy Patch was defective because it lacked adequate warnings and instructions. 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 the exposure. The Mylan Defendants, who exercised substantial control over the content of the warnings and/or instructions, knew, or should have known, of the risks at the time they marketed and sold the Christy Patch, but failed to provide warnings of the dangers or instructions for safe use and/ or failed to provide adequate warnings and/ or instructions. The Mylan Defendants also failed to adequately communicate to ultimate users, such as Decedent, warnings provided. The absence of such warnings and/or instructions rendered the product unreasonably dangerous to ultimate users, like Decedent. Such failure to warn and/or instruct was a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
COUNT III STRICT LIABILITY - DESIGN DEFECT
19.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
20.
The Patch was defectively designed so as to render it unreasonably dangerous, taking into consideration the utility of the product and the risks involved in its use. The Mylan Defendants, who participated in the design of the Patch, could have provided a safer alternative design. The safer alternative design, in reasonable probability, would have prevented, or significantly reduced, the risk of Decedent's death without substantially impairing the Patch's utility and was economically and technologically feasible at the time the product left the control of the Mylan Defendants by the application of existing or reasonably achievable scientific knowledge. Such design defect was a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
21.
For these reasons, the Mylan Defendants are strictly liable to Plaintiffs under applicable products liability law without regard to proof of negligence and gross negligence.
COUNT IV NEGLIGENCE
22.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
23.
The Mylan 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. The Mylan Defendants failed to exercise ordinary care in the design, manufacture, marketing, testing, approval, application for approval, inspection, sale, quality assurance, quality control, and/ or distribution of the Christy 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.
24.
More specifically, the Mylan Defendants negligence in the design, manufacture, marketing, testing, and sale of the Patch, includes, but is not limited to their:
a. 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 entire the Patch was made without defects;
i. Failure to conduct adequate testing and post-marketing surveillance to determine the safety of the Patch;
j. Misrepresenting that the Patch was safe for use;
k. Inadequate or insufficient inspection for defects;
1. Inadequate and/or insufficient research into the safety of the product prior to sale;
m. Inadequate and/or insufficient monitoring or research regarding adverse events;
n. Failure to list death as an adverse event;
o. Failure to provide adequate training, knowledge, or information to physicians, distributors, or sellers of the product;
p. Marketing the Patch for unsafe uses;
q. Failure to adequately warn individuals of the dangerous and lethal side effects of the product;
r. Formulating and designing the product;
s. Making the product;
t. Inspecting the testing the product; and/ or
u. Packaging the product.
25.
The negligent conduct of the Mylan Defendants, as alleged above, was a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
COUNT V NEGLIGENT MISREPRESENTATION
26.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
27.
The Mylan Defendants represented and marketing the Patch as being safe and effective. After the Mylan Defendants became aware of the risk of using the Patch, however, the Mylan Defendants failed to communicate to the FDA, Decedent, physicians, distributors, pharmacists, and/ or the general public that the use of this drug could cause serious injury and/or death.
28.
Therefore, Plaintiffs bring this cause of action against the Mylan Defendants under the theory of negligent misrepresentation 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 misrepresentations when they knew, or reasonably should have known, of the falsity of such misrepresentations. Alternatively, the Mylan 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, physicians, pharmacists, as well as the general public;
d. The Mylan Defendants supplied false information regarding the safety and efficacy of the Patch for the guidance of others, including Decedent;
e. The Mylan Defendants failure to exercise reasonable care or competence in obtaining or communicating information regarding the safety and efficacy of the Patch to Decedent and others;
f. Decedent and other justifiably relied on the Mylan Defendants' misrepresentations; and
g. Consequently, Decedent's use of the Patch was to her detriment. The Mylan Defendants' negligent misrepresentations proximately caused Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
COUNT VI IMPLIED WARRANTY OF FITNESS
29.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
30.
The Christy Patch was subject to an implied warranty of fitness under O.C.G.A. § 11-2-315, which was not excluded or modified. Mylan Defendants had reason to know that the particular purpose for which their products were to be used. The Mylan Defendants had reason to know that the buyer or supplier was relying on the skill and judgment of Mylan Defendants to select or furnish suitable products. The product supplied by Mylan 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, her conscious pain and suffering prior to death, and the damaged described herein.
COUNT VII IMPLIED WARRANTY OF MERCHANTABILITY
31.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
32.
The Christy Patch was subject to an implied warranty of merchantability under O.C.G.A. § 11-2-314, which was not excluded or modified. The Christy Patch did not comply with the implied warranty of merchantability because: (1) it was not of fair or average quality within the description; (2) it was unfit for the ordinary purposes for which fentanyl patches are used; (3) it was inadequately packaged and labeled; and (4) it did not conform to the affirmations of fact made on the label concerning, inter alia, the blood fentanyl concentration that would result from the use of the patch. The breaches of the implied warranty of merchantability were a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described herein.
COUNT VIII BREACH OF EXPRESS WARRANTY
33.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
34.
The Mylan Defendants made affirmations of fact or promises regarding the safety and effectiveness of the Christy Patch (including the safe, time-released delivery of fentanyl) which became part of the basis of the bargain. Pursuant to O.C.G.A. § 11-2-314, an express warranty was formed regarding the Christy Patch. The Mylan Defendant's breach of their affirmations of fact or promise regarding the Christy Patch was a proximate cause of Decedent's death, her conscious pain and suffering prior to death, and the damages described in this Complaint.
COUNT IX ACTUAL DAMAGES - WRONGFUL DEATH
35
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
36.
The unlawful acts and practices described above are and were proximate cause of Decedent's injuries and eventual death. Plaintiff Michael Salmon seeks all damages available under Georgia law (or any other applicable law), including, without limitation: the full value of the life of his wife consisting of the economic value of her life and the intangible value of her life including, but not limited to, her society, advice, example, and counsel without any deduction for necessary or personal expenses that would have been incurred by his wife had she lived.
COUNT X ACTUAL DAMAGES - ESTATE CLAIM
37.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
38.
Plaintiff Craig Salmon, as representative of Decedent's Estate, brings this action to recover medical and funeral expenses, and any and all related expenses, and to recover damages for the pain and suffering of the Decedent as a result of the wrongful conduct of the Mylan Defendants as set forth herein.
COUNT XI PUNITIVE DAMAGES - ESTATE CLAIM
39.
Plaintiffs incorporate by reference the consistent allegations of the preceding paragraphs.
40.
Plaintiff Craig Salmon, as representative of Decedent's Estate, brings this action to recover punitive damages pursuant to the provisions of O.C.G.A. § 51-12-5.1, in that the conduct of the Mylan Defendants in deliberately committing a physical injury upon the Decendent, during the events described above, show willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which would raise the presumption of a conscious indifference to consequences.
DEMAND FOR JURY TRIAL
41.
Pursuant to Federal Rule of Civil Procedure 38, Plaintiffs hereby demand a jury trial on all claims so triable in this action.
RELIEF REQUESTED
WHEREFORE, Plaintiffs request that this Court enter judgment against Mylan Defendants as follows:
a. Compensatory damages in an amount supported by the evidence at trial;
b. The full value of the life of the Decedent consisting of the economic value of the Decedent's life and the intangible value of Decedent's life, including, but not limited to, Decedent's society, advice, example, and counsel, without any deduction for necessary or other personal expenses that would have been incurred by the Decedent had she lived;
c. Damages on behalf of Decedent's Estate including: pain, mental anguish, impairment and disfigurement Decedent suffered before her death, medical or ambulance expenses of Decedent associated with her injury and death, and funeral and burial expenses.
d. Punitive damages on behalf of Decedent's Estate;
e. An award for attorney's fees, pre-judgment and post-judgment interest, and costs of suit, as provided by law; and
f. Such other legal and equitable relief as this Court deems just and proper.
Submitted this 23rd of July, 2009.
