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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Text of Complaint in Mylan Fentanyl Patch Lawsuit, and Mylan’s Response

Posted in Duragesic / Fentanyl

I’m starting to see more fentanl lawsuits filed against Mylan, the makers of a fentanyl patch that competes with the Duragesic patch.  The Mylan patch uses a matrix design in which the fentanyl is in the patch adhesive, as opposed to the reservoir design of the Duragesic patch.  Since there is no reservoir of gel, it isn’t possible for the Mylan patch to leak fentanyl, but there have apparently been several deaths of people wearing Mylan patches attributed to fentanyl toxicity.

As far as I know, there haven’t been any trials yet in any Mylan fentanyl lawsuits.

If you were injured or a loved one was injured or killed by what you believe to be a fentanyl patch of any brand, feel free to contact me and I’ll put you in contact with fentanyl attorneys who will investigate your claim.

Come now Plaintiffs Walter Richardson, Michael Rameraz, Sam Bloom, Chriss Bloom, and Stephanie Leewright (collectively, “Plaintiffs”), the wrongful death heirs of Sandra Richardson (“Decedent”), and for causes of action against defendants, and each of them, complain and allege as follows:

PARTIES

1. Plaintiff Walter Richardson is a citizen of the State of California and is the husband of Decedent.

2. Michael Remeraz is a citizen of the State of California and is the daughter of Decedent.

3. Sam Bloom is a citizen of the State of California and is the son of Decedent.

4. Chriss Bloom is a citizen of the State of California and is the daughter of Decedent.

5. Stephanie Leewright is a citizen of the State of California and is the daughter of Decedent.

6. 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 California 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, WV 26505, or any other officer or managing agent at such address.

7. Defendant Mylan Pharmaceuticals, Inc., a subsidiary of Mylan, Inc., is a corporation organized and existing under the laws of the West Virginia. Mylan Pharmaceuticals, Inc. has done and is doing business in California 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, WV 26505, or any other officer or managing agent at such address.

8. 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 California and may be served with process by delivering a summons and copy of the complaint its President, Carolyn Myers, at 1500 Corporate Drive, Suite 400, Cannonsburg, PA 15317, or any other officer or managing agent at such address.

9. The true names or capacities, whether individual, corporate, or otherwise, of Defendants Does 1-100, inclusive, are unknown to Plaintiffs who therefore sue said Defendants by such fictitious names. Plaintiffs believe and allege that each of the Defendants designated herein by fictitious names is in some manner legally responsible for the events and happenings herein referred to and caused damages legally and foreseeably to Plaintiffs as alleged herein.

VENUE

10. Under Cal. Civ. Proc. Code § 395, venue is proper in this county because the injury causing Decedent's death occurred in this county.

FACTS

11. This suit arises out of the wrongful death of Decedent due to the wrongful conduct of Defendants. Decedent was given a prescription for 100 mcg Mylan (fentanyl transdermal system) patches. Decedent was wearing one of these patches (the “Richardson Patch”) at the time of her death and it was the cause of her death. The Richardson Patch was designed, manufactured, marketed and/or distributed by Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (collectively, 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.

12. 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.

13. The Patch is applied by the patient and delivers fentanyl though 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.

14. The Patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients.

15. Decedent was prescribed the Patch for pain. Decedent died on March 10, 2007.

CAUSES OF ACTION FIRST CAUSE OF ACTION: STRICT PRODUCTS LIABILITY

(By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc., and Does 1-100)
A. Strict Products Liability

16. Plaintiffs repeat and re-allege each and every consistent allegation contained in Paragraphs 1 through 15 and make such allegations a part hereof by reference.

17. 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, assembling, selling, marketing, and/or supplying the Patch, including the Richardson Patch. The Richardson 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 the Defendants' possession that rendered the Patch unsafe for its intended or reasonably foreseeable use. Decedent was unaware of the defective condition of the Richardson Patch at the time she used the product in the manner and for the purpose which it was intended. The defective condition was a producing and legal cause of Decedent's death and the damages described herein. The Richardson Patch was in the control of the Defendants at the time the defect occurred. Further, the injury sustained by Decedent, fentanyl toxicity, was the exact type of injury that a defective Patch causes, The Richardson Patch reached Decedent without any substantial change in its condition. Because of the nature of ingredients or natural characteristics of the Richardson Patch, use of it involved substantial risk of injury. The exposure to risk of injury from the Richardson Patch outweighed any benefits from the product's use. Without limitation, the Richardson Patch was defective because it malfunctioned and did not perform as intended and designed.
B. Manufacturing

18. More specifically, the Richardson Patch was defective because of the existence of a manufacturing flaw that rendered the Patch unsafe for its intended or reasonably foreseeable use at the time it left the Defendants and such defect was a proximate cause of Decedent's death and the damages asserted herein. Without limitation, the Richardson Patch was defective because it malfunctioned and did not perform as intended and designed.
C. Failure to Warn

19. Pleading further and without waiver of the foregoing, the Richardson Patch was defective because it lacked adequate warnings and instructions. There was a risk of harm, which risk is inherent in the Patch or may arise from the intended or reasonably foreseeable use and/or misuse of the Patch, and which risks were scientifically discoverable at the time of the sale and 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 Richardson 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 absence of such warnings and/or instructions rendered the product unsafe for its intended or reasonably foreseeable use. The Richardson Patch also suffered from a marketing defect because the Mylan Defendants marketed the Patch for unsafe uses. Such failure to warn and/or instruct was a legal cause of Decedent's death and the damages asserted herein.

20. For these reasons, the Mylan Defendants are strictly liable under applicable products liability law without regard to proof of negligence.

SECOND CAUSE OF ACTION: NEGLIGENCE (By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc., and Does 1-100)

21. Plaintiffs repeat and re-allege each and every consistent allegation contained in Paragraphs 1 through 20, inclusive of the First Cause of Action, and make such allegations a part hereof by reference.

22. 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, but not limited to, a duty to assure that the Patch did not cause users to suffer from dangerous side effects, including death. The Mylan 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 Richardson Patch into interstate commerce in that the Mylan Defendants knew or should have known that the Patch created a high risk of dangerous side effects, including death.

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

j. Misrepresenting that the Patch is safe for use;

k. Inadequate or insufficient inspection for defects;

I. 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 and testing the product; and/or

u. Packaging the product; and

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

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

THIRD CAUSE OF ACTION: NEGLIGENT MISREPRESENTATION (By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc., and Does 1-100)

25. Plaintiffs repeat and re-allege each and every consistent allegation contained in Paragraphs 1 through 24, inclusive of the First and Second Causes of Action, and make such allegations a part hereof by reference.

26. The Mylan Defendants represented and marketed the Patch as being safe and effective. After the Mylan Defendants became aware of the risk of using the Patch, however, the 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. The Mylan 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 that the fentanyl concentration found in Decedent's blood at the time of her death and a representation that the Patch was safe for use and a representation that the Patch can be used with other medications.

27. 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 failed to exercise reasonable care or competence in obtaining or communicating information regarding the safety and efficacy of the Patch to the FDA, Decedent, physicians, pharmacists, and others;

f. Decedent and others 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 was a legal cause of the death of Decedent and the damages asserted herein.

FOURTH CAUSE OF ACTION: BREACH OF WARRANTY (By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc., and Does 1-100)

28. Plaintiffs repeat and re-allege each and every consistent allegation contained in Paragraphs 1 through 27, inclusive of the First, Second, and Third Causes of Action, and make them a part hereof by reference.

29. The Mylan Defendants impliedly and expressly warranted to Decedent that the Richardson 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.

30. The Richardson 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 Richardson Patch was capable of causing, and did cause, Decedent's death while being used in an intended and/or reasonably foreseeable manner, thereby rendering the Richardson Patch unsafe and dangerous for use by the consumer or user.

31. On March 10, 2007, as a direct and legal cause of each breach of warranty by Defendants, while Decedent was using the Richardson Patch in the fashion intended and foreseen by Mylan Defendants, Decedent suffered a fatal fentanyl overdose as a result of the Richardson Patch's failure to work as warranted and represented. The Mylan Defendants' breach of warranty was a legal cause of the death of Decedent and the damages asserted herein.

DAMAGES

32. The unlawful acts and practices described above are and were a legal cause of Decedent's injuries and death. Plaintiffs are Decedent's wrongful death heirs at law. The following damages are sought, past and future where applicable: loss of love; affection; society; companionship; economic loss; support; right of support; expectation of future support; counseling; solace; and moral support in a general amount that will be stated according to proof. In addition, Plaintiffs are seeking all actual damages allowed by law caused by the Mylan Defendants' defective product and their wrongful acts and/or omissions alleged herein.

WHEREFORE, Plaintiffs pray for judgment against the Mylan Defendants, and each of them:

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, according to proof;

4. For prejudgment interest and post-judgment interest until paid;

5. For costs of suit incurred herein; and,

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

DATED: 3/6/09

COMES NOW Defendants Mylan Inc. (erroneously named herein as Mylan, Inc.); Mylan Technologies Inc. (erroneously named herein as Mylan Technologies, Inc.) and Mylan Pharmaceuticals Inc. (erroneously named herein as Mylan Pharmaceuticals, Inc.) (“Mylan”) and hereby answer the Complaint (the “Complaint”) filed by Plaintiffs Walter Richardson, Michael Remeraz, Sam Bloom, Chriss Bloom and Stephanie Leewright (“Plaintiffs”) as follows:

I. GENERAL DENIAL

In accordance with the provisions of Code of Civil Procedure § 431.30(d), Mylan denies, generally and specifically, each, every and all allegations, statements, matters and purported causes of action contained in the Complaint, and the whole thereof, and without limiting the generality of the foregoing, deny, generally and specifically, that Mylan has engaged in any wrongful act or omission with respect to Plaintiffs and/or Plaintiffs' Decedent, or that Plaintiffs and/or Plaintiffs' Decedent has been damaged or injured in the manner or sums alleged, or in any way at all, as the result of any alleged wrongful act or omission on the part of Mylan.

II. AFFIRMATIVE DEFENSES

Mylan, by and through counsel, reserves the right to rely upon the following affirmative defenses to the claims asserted in Plaintiffs' Complaint to the extent supported by evidence later developed or facts later learned, without now assuming the burden of proof on any such defense that would otherwise rest on Plaintiffs and with the reservation of its right to amend or supplement its responses to Plaintiffs' Complaint, as well as its affirmative defenses, as information is gathered through discovery:

First Affirmative Defense (Failure to State a Claim for Relief)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs' Complaint fails in whole or in part to state a claim for relief.

Second Affirmative Defense (Preemption)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs' Complaint is preempted by applicable state or federal law.

Third Affirmative Defense (Estoppel)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs are estopped to pursue relief in this action against Mylan to the extent that Plaintiffs proceed with prosecution of any other class, consolidated, or individual action in any jurisdiction against Mylan, including, but not limited to, those certain actions instituted prior to or subsequent to this action.

Fourth Affirmative Defense (Acts of Third Parties)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that any damage caused to Plaintiffs or Decedent, if any, was the proximate result of the conduct of third parties over whom or which Mylan exercised no control and/or of Plaintiffs and/or of Decedent and not that of Mylan.

Fifth Affirmative Defense (Pre-existing, Intervening, or Superseding Cause)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs' and Decedent's alleged injuries were caused by a pre-existing, intervening, or superseding cause.

Sixth Affirmative Defense (Plaintiffs' Negligence)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs' claims are barred, in whole or in part, by Plaintiffs' and/or Plaintiffs' Decedent's own fault and/or negligence.

Seventh Affirmative Defense (Comparative Fault or Apportionment)

In the alternative and only in the event that this Court should find the accident in question to have resulted from some fault on the part of Mylan, which Mylan strictly denies, Mylan would show that the fault of those for whom Mylan is not responsible, including third parties, Plaintiffs and/or Plaintiffs' Decedent, should be used to reduce any recoverable damages herein in proportion to the degree or percentage of fault attributable to them, in accordance with the law.

Eighth Affirmative Defense (Primary Jurisdiction)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that some or all of Plaintiffs' claims are not properly before this Court because of the doctrine of primary jurisdiction. This Court should abstain and defer to the jurisdiction of public agencies, including but not limited to, the U.S. Food and Drug Administration and applicable state agencies.

Ninth Affirmative Defense (Compliance With Laws)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that at all material times, Mylan complied with applicable statutory, regulatory, and common law requirements. Accordingly, some or all of the Plaintiffs' claims are or may be barred by Mylan's compliance with all applicable state, federal and local laws and regulations.

Tenth Affirmative Defense (Misuse)

Any and all damages alleged by Plaintiffs were caused by misuse of the product at issue in this case, failure to use the product properly, and/or alteration or negligent use of the product.

Eleventh Affirmative Defense (Assumption of Risk)

Plaintiffs' claims are barred by Plaintiffs' and/or Decedent's express and/or implied assumption of the risks, if any, inherent in the alleged use of the product or products at issue.

Twelfth Affirmative Defense (Duty to Warn Satisfied)

Any warnings which Mylan gave were lawful, transmitted to the prescribing physicians and/or health care providers, and give rise to no liability on Mylan's behalf.

Thirteenth Affirmative Defense (Learned Intermediary)

Plaintiffs' claims are barred by the intervention of a learned intermediary or intermediaries whose acts, omissions, or fault are the cause of Plaintiffs' injuries, damages, or losses, if any.

Fourteenth Affirmative Defense (Compliance, Approval & Preemption)

Mylan has complied with all requirements of the Food and Drug Administration of the United States Department of Health and Human Services, and the product or products at issue were approved pursuant to the applicable statutes and regulations. Pursuant to such, the product or products at issue could only be used pursuant to the prescription of a licensed prescriber. The package insert for the product or products at issue was also approved by the Food and Drug Administration, and the marketing was conducted in conformity with the regulations of the Food and Drug Administration. Therefore, Plaintiffs' claims are preempted.

Fifteenth Affirmative Defense (Statute of Limitations)

Plaintiffs' claims are barred by the applicable statute(s) of limitations, including but not limited to Cal. Code Civ. Proc. § 335.1.

Sixteenth Affirmative Defense (Unknown and Unforeseeable Risk)

The extent of any risk associated with the use of Mylan's product, the existence of which is not admitted, was, at the time of the distribution of the product by Mylan, unknown and could not have been known by the use of ordinary care by Mylan.

Seventeenth Affirmative Defense (Voluntary Exposure to Risk)

Plaintiffs and Plaintiffs' Decedent knew of the existence of the risks complained of in the Complaint, realized and appreciated the possibilities of injury as a result of the risk, and having had a reasonable opportunity to avoid it, voluntarily exposed themselves/herself to the risk.

Eighteenth Affirmative Defense (Failure to Join Necessary Parties)

Plaintiffs have failed to join all necessary and indispensable parties.

Nineteenth Affirmative Defense (Failure to Mitigate Damages)

Plaintiffs' claims are barred because Plaintiffs have failed and refused to mitigate their alleged damages.

Twentieth Affirmative Defense (Pre-Market Approval)

Plaintiffs' claims are barred, in whole or in part, under the applicable state law because Fentanyl Transdermal System was subject to and received pre-market approval by the Food and Drug Administration under 52 Stat. 1040, 21 U.S.C. § 301.

Twenty-First Affirmative Defense (Punitive Damages Violate Commerce Clause)

Any award of punitive damages against Mylan in this matter based on Mylan's conduct outside of this jurisdiction would impose unreasonable state limitations on interstate commerce in violation of the Commerce Clause of the United States Constitution and would be in violation of the United States Supreme Court's holding in State Farm v. Campbell, 538 U.S. 408, 154 L. Ed. 2d 585, 123 S.Ct. 1513(2003).

Twenty-Second Affirmative Defense (Punitive Damages Violates Fourteenth Amendment)

Any award of punitive damages against Mylan in this matter would violate Mylan's guarantees of due process, equal protection, property and protection against excessive fines under the Fourteenth Amendment to the United States Constitution and under applicable law of this jurisdiction.

Twenty-Third Affirmative Defense (Punitive Damages)

Punitive damages may not be awarded:

a. Without proof of every element beyond a reasonable doubt, or in the alternative without proof by clear and convincing evidence;

b. Without bifurcating the trial of all punitive issues, including punitive liability;

c. With no limits, including the maximum amount that a jury may impose in this jurisdiction;

d. With no limits, including the constitutional prohibition against punitive damages awards being greater than a single-digit multiplier of any compensatory damages award, See State Farm v. Campbell, 538 U.S. 408, 154 L. Ed. 2d 585, 123 S. Ct. 1513 (2003);

e. Which improperly compensates Plaintiffs for elements of damage not otherwise recognized under the laws of this jurisdiction;

f. Without standards or sufficient clarity for determining the appropriateness of appropriate size of the award;

g. Without consideration of the three constitutional guideposts of reprehensibility, ratio and civil penalties, See State Farm v. Campbell, 538 U.S. 408, 154 L. Ed. 2d 585, 123 S.Ct. 1513 (2003);

h. Without appropriate instructions on the limits of punitive damages imposed by the applicable principles of deterrence and punishment;

i. Under a vague and arbitrary standard that does not define the necessary conduct or mental state required for punitive damages; and

j. Without judicial review on the basis of objective standards, including the three constitutional guideposts of reprehensibility, ratio and civil penalties, See State Farm v. Campbell, 538 U.S. 408, 154 L. Ed. 2d 585, 123 S. Ct. 1513 (2003).

Twenty-Fourth Affirmative Defense (Punitive Damages Violates Fifth and Fourteenth Amendments)

Any award of punitive damages against Mylan in this matter would violate Mylan's guarantees of due process protection against double jeopardy, excessive fines and multiple punishments under the Fifth and Fourteenth Amendments to the United States Constitution and under applicable law of this jurisdiction because Mylan is subject to multiple punitive awards for the same alleged wrong or conduct.

Twenty-Fifth Affirmative Defense (No Involvement with Product)

Mylan Inc. is a holding company and was not responsible for the development, manufacture and/or distribution of fentanyl transdermal systems and, therefore, all claims against Mylan Inc. should be dismissed with prejudice.

Twenty-Sixth Affirmative Defense (No Responsibility for Does 1 through 100)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that it is not legally responsible for the acts and/or omissions of those defendants named herein as DOES 1 through 100.

Twenty-Seventh Affirmative Defense (No Justifiable Reliance)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that at no time mentioned herein did Plaintiffs or Plaintiffs' Decedent, their agents, servants, representatives or predecessors in interest, justifiably rely on any promises, warranties (express or implied), or representations which may have been made by it.

Twenty-Eighth Affirmative Defense (Pre-existing Condition)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that Plaintiffs' claims against Mylan are barred because any alleged injuries or damages sustained by Plaintiffs' Decedent were caused by a pre-existing or unrelated medical condition, disease or condition.

Twenty-Ninth Affirmative Defense (Injuries Not Foreseeable)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that any alleged injuries or damages to Plaintiffs and/or Plaintiffs' Decedent were legally caused by the allergies, sensitivities, medical conditions and idiosyncrasies peculiar to the Decedent, not found in the general public and unknown or unknowable to Defendant. Such injuries, if any, were not reasonably foreseeable to Mylan.

Thirtieth Affirmative Defense (State of the Art)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that it did not breach any duty to Plaintiffs or Plaintiffs' Decedent because the product at issue was designed, manufactured and marketed in accordance with the then-current state of the art, and because the then-current state of medical, scientific and industrial knowledge, art, and practice was such that Mylan did not and reasonably could not know that such product might pose a risk of harm, the existence of which is not admitted, with knowable, foreseeable use.

Thirty-First Affirmative Defense (Violation of California Constitution)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that any claims for punitive damages are barred by Article I of the California Constitution.

Thirty-Second Affirmative Defense (Reserving Right to Remove)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan reserves the right to remove and intends to remove this action to Federal Court. This responsive pleading is filed for the defensive purpose of preserving the status quo pending removal.

Thirty-Third Affirmative Defense (Additional Defenses)

As a separate and distinct affirmative defense, and while denying each of the material allegations contained therein, Mylan asserts and alleges that it reserves the right to raise any additional defenses as may be revealed by discovery or investigation in this matter.

PRAYER FOR RELIEF

Wherefore, Mylan prays for judgment as follows:

1. That Plaintiffs' prayer for relief be denied;

2. That Plaintiffs take nothing by way of their complaint herein;

3. For Mylan's costs of suit; and,

4. For such other and further relief as the court deems just and proper.