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

Another fentanyl lawsuit filed against Mylan Pharmaceuticals

Posted in Duragesic / Fentanyl

This fentanyl lawsuit was filed in California because the plaintiffs are citizens of California.  Some of the lawsuits against Mylan have been filed in West Virginia, because that’s where the company is based.  As a rule of thumb, California is a good venue for plaintiffs. 

No matter what state you live in, if you have a fentanyl claim, your lawyer will need to determine which states you MAY file your lawsuit in, and which state you SHOULD file it in.  I’d be happy to help you find the right fentanyl attorney – just contact me and tell me a little about your potential case.

Plaintiffs Candace Gholson and Kristy Gholson (“Plaintiffs”), wrongful death heirs of Philip Gholson (“Decedent”) complains against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (collectively, “Defendants”), and alleges as follows:

PARTIES

1. Plaintiff Candace Gholson is a citizen of the State of California, County of Napa and is the wife of Decedent Plaintiff Kristy Gholson is a citizen of State of California, County of Napa and is the daughter of Decedent.

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 California and may be served by delivering a summons and copy of the complaint to its President, Robert I. Coury, at 781 Chestnut Ridge Road, Morgantown, WV 26505, or any other officer or managing agent at such address.

3. 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 do 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.

4. 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 to its President, Carolyn Myers, at 1500 Corporate Drive, Suite 400, Cannonsburg, PA 15317, or any other officer or managing agent at such address.

JURISDICTION AND VENUE

5. 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. 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

6. This suit arises out of the wrongful death of Decedent, due to the wrongful conduct of Defendants. Decedent, while a patient of Kessler S. Corby, M.D., was given a prescription for 100 mcg Mylan (fentanyl ??) patches. Decedent was wearing one of these patches (the “Gholson Patch”) at the time of his death and it was the cause of his death. The Gholson Patch was designed, manufactured, marketed and/or distributed by the 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.

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

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

10. Decedent was prescribed the Patch by Dr. Corby for pain. December filled the prescription in May 2007. Decedent was found dead in Napa County on June 4, 2007. The cause of death listed on the death certificate is acute fentanyl toxicity.

CAUSES OF ACTION

FIRST CAUSE OF ACTION: STRICT PRODUCTS LIABILITY

(By Plaintiffs against Defendants Mylan, Inc., Mylan Phamaceuticals, Inc., and Mylan Technologies, Inc)

a. Strict Products Liability

11. Plaintiffs repeat and re-allege each and every allegation contained in Paragraphs 1 through 10 and make such allegations a part hereof by reference.

12. The Defendants are liable under the theory of product liability. The Defendants at all times material hereto engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or supplying the Patch, including the Gholson Patch. The Gholson Patch was in a defective condition at the time it was designed, manufactured, sold, and/or marketed by the 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 Gholson Patch at the time he used the product in the manner and for the purpose which it was intended. The defective condition was a producing and proximate cause of Decedent's death and the damages described herein. The Gholson 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 Gholson Patch reached Decedent without any substantial change in its condition. Because of the nature of ingredients or natural characteristics of the Gholson Patch, use of it involved substantial risk of injury. The exposure to risk of injury from the Gholson Patch outweighed any benefits from the product's use. Without limitation, the Gholson Patch was defective because it malfunctioned and did not perform as intended and designed

b. Manufacturing

13. More specifically, the Gholson 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 Gholson Patch was defective because it malfunctioned and did not perform as intended and designed.

c. Marketing Defect

14. Pleading further and without waiver of the foregoing, the Gholson Patch was defective because it lacked adequate warnings and instructions. There was a risk of harm that was inherent in the Patch or that arose from the intended or reasonably foreseeable use of the Patch that was scientifically discoverable at the time of the exposure. The 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 Gholson 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 Gholson Patch also suffered from a marketing defect because the Defendants marketed the Patch for unsafe uses. Such failure to warn and/or instruct was a proximate cause of Decedent's death and the damage asserted heroin.

15. For these reasons, the 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.)

16. Plaintiffs repeat and re-allege each and every allegation contained in Paragraphs 1 through 15, inclusive of the First Cause of Action, and make such allegations a part hereof by reference.

17. The 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 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 Gholson Patch into interstate commerce in that the Defendants knew or should have known that the Patch created a high risk of dangerous side effects, including death.

18. More specifically, the 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;

l. 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

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

THIRD CAUSE OF ACTION: NEGLIGENT MISREPRESENTATION

(By Plaintiffs against Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc.)

20. Plaintiffs repeat and re-allege each and every allegation contained in Paragraphs 1 through 19, inclusive of the First and Second Causes of Action, and make such allegations a part hereof by reference,

21. The 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 ailed 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 Defendants instead communicated to all such persons/entities hat the Patch was safe for use. Specifically, the 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.

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

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

b. The 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 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 Defendants supplied false information regarding the safety and efficacy of the Patch for the guidance of others, including Decedent;

e. The 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 Defendants' misrepresentations; and

g. Consequently, Decedent's use of the Patch was to his detriment The Defendants' negligent misrepresentations were a proximate 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 Pharmaceutical, Inc., and Mylan Technologies, Inc.)

23. Plaintiffs repeat and re allege each and every allegation contained in Paragraphs 1 through 22, inclusive of the First, Second, and Third Causes of Action, and make them a part hereof by reference.

24. The Defendants impliedly and expressly warranted to Decedent that the Gholson Patch, including each and every component part thereof, was fit for the purpose for which it was to be used an was free from design and manufacturing defects to consumers and users thereof.

25. The Gholson 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 Gholson 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 Gholson Patch unsafe and dangerous for use by the consumer or user.

26. On June 4, 2007, as a direct and proximate cause of each breach of warranty by Defendants, while Decedent was using the Gholson Patch in the fashion intended and foreseen by Defendants, Decedent suffered a fatal fentanyl overdose as a result of the Gholson Patch's failure to work as warranted and represented.

WHEREFORE, Plaintiffs pray for judgment against the 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: May 7, 2009

MAGANA, CATHCART & MCCARTHY

By: <<signature>>

CLAY ROBBINS III,

Attorney for Plaintiffs

Of Counsel:

James Craig Orr Jr.

Texas Bar No. 153135 50

Charles W. Miller

Texas Bar No. 24007677

Heygood, Orr, Reyes & Bartolomei

2331 W. Northwest Highway, 2nd Floor

Dallas, TX 75220

214-526-7900 Telephone

214-526-7910 Facsimile

DEMAND FOR JURY TRIAL

Pursuant to Federal Rule of Civil Procedure 38, Plaintiffs hereby demand trial by jury on all issues.

DATED: May 7,2009

MAGANA, CATHCART & McCARTHY