In June of 2004, attorneys representing the family of Timothy Berry filed a wrongful death lawsuit against Mylan Pharmaceuticals. The lawsuit alleges that a defective Mylan fentanyl pain patch is responsible for the death of Timothy Berry. Of particular interest is this passage in the lawsuit:
12. At the time the FDA approved the initial proposed labeling for the Patch, it did not have full knowledge of the dangers inherent in the use of the product, potential defects in the product or the nature and degree of the risks accompanying its intended use. Similarly, at the time the FDA approved revised labeling proposed by Defendants, it did not have full knowledge of the product defects and the dangers inherent in the use of the product or the nature and degree of the risks accompanying its intended use. The FDA lacked such information because Defendants failed to provide the FDA with existing evidence of product defects and the risks associated with fentanyl as such evidence was obtained or should have been obtained. For these reasons, the FDA has never had an opportunity to assess the current labeling for fentanyl in light of existing evidence. (Emphasis added.)
If in fact Mylan did conceal information from the FDA, it will probably come back to haunt them in the form of a large jury verdict and perhaps a large fine.
1. Plaintiffs BARBARA E. BERRY and GINA MILLER are individuals residing
in the City of Stockton, and City of Lodi, respectively, San Joaquin County, State of California,
and are the appointed Guardians ad Litem of CHELSEA BERRY, a minor, the daughter of
Timothy Edgar Berry, deceased ("Decedent"). Plaintiff BARBARA E. BERRY is a proper
party to bring a claim for the wrongful death of Timothy Edgar Berry. Plaintiff BARBARA E.
BERRY and Plaintiff GINA MILLER also bring this action on behalf of Decedent's Estate in
their capacity as special co-administrators of the estate. They were appointed as special coadministrators
by order of Judge Duane Martin of the Superior Court of California, County of
San Joaquin, in action number 39-2009-00212988-PR-LA-STK, entitled Estate of Timothy
Edgar Berry, Decedent, on June 3, 2009. As special co-administrators of the Estate, they have
the power to bring this action pursuant to Probate Code section 8544(a)(3) and California Code
of Civil Procedure sections 377.30 and 377.34.
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 the State
of California and may be served with process by delivering a copy of the summons and
complaint to its President, Robert J. Coury, at 78 I Chestnut Ridge Road, Morgantown, West
Virginia 26505, or any other officer or managing agent at such address.
3. Defendant MYLAN PHARMACEUTICALS, INC. ("MPI"), a subsidiary of
Defendant MYLAN, INC., is a corporation organized and existing under the laws of the State
of West Virginia. MPI has done and is doing business in the State of California, and may be
served with process by delivering a copy of the summons and 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.
4. Defendant MYLAN TECHNOLOGIES, INC. ("MTI"), a subsidiary of
Defendant MYLAN, INC., is a corporation organized and existing under the laws of the State
of West Virginia. MTI has done and is doing business in the State of California and may be
served with process by delivering a copy of the summons and complaint to its President,
Carolyn Myers, at 1500 Corporate Drive, Suite 400, Cannonsburg, Pennsylvania 15317 or any
other officer or managing agent at such address.
JURISDICTION AND VENUE
5. 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. See 28 U.S.c. §
1332. Venue is proper in this Court under 28 U.S.C. § 1391 because a substantial part of the
events or omissions gi ving rise to the claim (i.e., Decedent's fentanyl overdose and resulting
death) occurred in this district.
FACTS
6. This suit arises from the wrongful death of Decedent, due to the wrongful
conduct of Defendants. On or about June 3, 2007, Decedent Timothy Edgar Berry, age 40, was
given a prescription for 25mcg Mylan (fentanyl transdermal system) patches by his physician,
Dr. Rene Relos, in Stockton, San Joaquin County, California, for treatment of pain resulting
from fractures he suffered in a motorcycle accident. Decedent was using these patches (the
"Berry Patches") at the time of his death and it was the cause of his death. The Berry Patches
were designed, manufactured, marketed and/or distributed by Defendants. Mylan (fentanyl
transdermal system) patches come in 25, 50, 75 and 100 mcg sizes. As referenced herein, the
"Patch" shall refer to Mylan (fentanyl transdermal system) 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 Food and Drug Administration (FDA)
and is ge nerally used to relieve pain.
8. 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
the fentanyl. Decedent never abused the Patch or used it inappropriately.
9. The Patch is unreasonably dangerous because it can and does leak, causing
lethal levels of fentanyl in patients.
10. Prior to and at the time of the manufacture of the Berry Patches, Defendants
knew that they were producing defective patches that leaked. Prior to and at the time of the
manufacture of the Berry Patches, Defendants knew that they were producing defective patches
that would produce levels of fentanyl in patients above the intended and designed level. Prior to
and at the time of the manufacture of the Berry Patches, Defendants knew or should have
known that they were producing defective patches that were killing and/or injuring patients.
11. Despite the foregoing, Defendants, with reckless and/or intentional disregard for
the safety of patients, continued and continue to this day to manufacture fentanyl patches that
kill patients because of the massive revenue being generated by their sale.
12. At the time the FDA approved the initial proposed labeling for the Patch, it did
not have full knowledge of the dangers inherent in the use of the product, potential defects in
the product or the nature and degree of the risks accompanying its intended use. Similarly, at
the time the FDA approved revised labeling proposed by Defendants, it did not have full
knowledge of the product defects and the dangers inherent in the use of the product or the
nature and degree of the risks accompanying its intended use. The FDA lacked such
information because Defendants failed to provide the FDA with existing evidence of product
defects and the risks associated with fentanyl as such evidence was obtained or should have
been obtained. For these reasons, the FDA has never had an opportunity to assess the current
labeling for fentanyl in light of existing evidence.
13. On June 7, 2007, while using the Patch as prescribed, Decedent died from the
toxic effects of fentanyl at his home in Linden, County of San Joaquin, State of California.
CAUSES OF ACTION
A. FIRST CAUSE OF ACTION: STRICT PRODUCT LIABILITY
14. Plaintiff incorporates by reference paragraphs 1 through 13 as though fully set
forth herein.
15. Defendants are liable under the theory of product liability as set forth in §§
402A and 402B of the Restatement of Torts 2d. Defendants at all times material hereto
engaged in the business of designing, manufacturing, assembling, selling, marketing, and/or
supplying the Patch, including the Berry Patches. The Berry Patches were in a defective
condition at the time they were designed, manufactured, sold, and/or marketed by Defendants
and at the time they left Defendants' possession because they were unreasonably dangerous for
their intended or reasonably foreseeable use. The defective condition was a direct and
proximate cause of Decedent's death and the damages described herein.
16. The Berry Patches were in the control of Defendants at the time the defect
occurred. Further, the injury sustained by Decedent, fentanyl intoxication, was the exact type of
injury that a defective Patch causes. The Berry Patch reached Decedent without any substantial
change in condition. The Berry Patch presented an unreasonable risk of injury in that the risk
was one which a reasonably prudent person having full knowledge of the risk would find
unacceptable. Because of the nature of ingredients or natural characteristics of the Berry Patch,
use of it involved a substantial risk of injury. The exposure to risk of injury was unreasonable
taking into consideration a balancing of the dangers and benefits resulting from the product's
use. Without limitation, the Berry Patch was defective because it malfunctioned and did not
perform as intended or designed.
1. Manufacturing Defect
17. More specifically, the Berry Patch was defective because of the existence of a
manufacturing flaw that made the product unreasonably dangerous for its intended or
reasonably anticipated use at the time it left Defendants' control. The Berry Patch was not
reasonably safe for its intended use because it did not conform to its intended design and failed
to perform as safely as the intended design would have performed. Decedent used the Berry
Patch as prescribed and in a reasonably anticipated manner. The manufacturing defect was a
direct and proximate cause of Decedent's death and the damages claimed herein. Without
limitation, the Berry Patch was defective because it malfunctioned and did not perform as
intended and designed. Without limitation, the Berry Patch was defective because it had a seal
defect.
2. Marketing Defect
18. Pleading further and without waiver of the foregoing, the Patches were defective
because they lacked adequate warnings and instructions. There was a risk of hann that was
inherent in the Patches or that arose from the intended or reasonably foreseeable use of the
Patches that was scientifically discoverable at the time of the exposure. The Defendants, who
exercised 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 Berry Patches, but failed to provide
warnings of the dangers or instructions for the 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 Berry Patches also suffered
from a marketing defect because the Defendants marketed the Patch for unsafe uses. Such
failure to warn and/or instruct was a proximately cause of Decedent's death and the damages
asserted herein.
3. Design Defect
19. Pleading further and without waiver of the foregoing, the defective design of the
Patch rendered it unreasonably dangerous for its intended or reasonably anticipated use. The
Patch's design was unreasonably dangerous because, inter alia, it failed comply with existing
technology or the state of the art. Defendants, who participated in the design of the Patch,
could have used a safer alternative design which was economically and technologically feasible
at the time of manufacture. Further, there was a safer alternative design that in reasonable
probability would have prevented or significantly reduced the risk of Decedent's death without
substantially impairing the Patch's utility and that 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. Such design defects were a proximate and/or
producing cause of Decedent's death and the damages asserted herein.
20. For these reasons, Defendants are strictly liable under applicable products
liability law without regard to proof of negligence and gross negligence.
B. SECOND CAUSE OF ACTION: NEGLIGENCE
21. Plaintiffs incorporate by reference paragraphs 1 through 13 as though fully set
forth herein.
22. Defendants had a duty to exercise ordinary care in the design, manufacture,
marketing, sale, and distribution of the Patch into the stream of commerce to ensure that the
Patch was safe for its intended or reasonably foreseeable use, including, without limitation, a
duty to assure that the Patch did not cause users to suffer from dangerous side effects, including
death. Defendants failed to exercise ordinary care in the design, manufacture, marketing, sale,
testing, reporting to the FDA, quality assurance, quality control or distribution of the Berry
Patches into interstate commerce in that Defendants knew or should have known that the Patch
created a high risk of dangerous side effects, including death.
23. More specifically, Defendants' negligence III the design, manufacture,
marketing, testing and sale of the Patch, includes, without limitation:
a. Providing misleading, inadequate and/or insufficient warnings regarding the
product;
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;
Failure to provide to the FDA information or data relevant to the safety of the
Patch;
Failure to obtain easily accessible information or data relevant to the safety of
the Patch;
Failure to perform sufficient testing of the Patch to confirm or ensure that it was
safe for its intended use;
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;
Failure to ensure that the Patch is made without defects;
Failure to conduct adequate testing and post-marketing surveillance to determine
the safety of the Patch;
Misrepresenting that the Patch is safe for use;
Inadequate or insufficient inspection for defects;
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;
Failure to provide adequate training, knowledge or information to physicians,
distributors, or sellers of the product;
Marketing the Patch for unsafe uses;
Failure to adequately warn individuals of the dangerous and lethal side effects of
the product;
Formulating and designing the product;
s. Making the product;
t. Inspecting and testing the product;
u. Packaging the product; and
v. Other and further particulars as will be proven at trial.
24. The negligent, careless and reckless conduct of Defendants, as alleged above,
was a proximate cause of Decedent's death and the damages claimed herein.
C. THIRD CAUSE OF ACTION: NEGLIGENT MISREPRESENTATION
25. Plaintiffs incorporate by reference paragraphs 1 through 14 as though fully set
forth herein.
26. Defendants represented and marketed the Patch as being safe and effective.
After Defendants became aware of the risk of using the Patch, however, Defendants failed to
communicate to the FDA, Decedent, physicians, distributors, pharmacists, and/or the general
public, that proper use of the Patch could result in serious injury and/or death. Defendants
instead communicated to all such persons/entities that the Patches were safe for use.
Specifically, Defendants' misrepresentations include, without limitations, 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 his 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 Defendants under the
theory of negligent misrepresentation for the following reasons:
a. Defendants failed to warn of the defective condition of the Patch, as
manufactured and/or supplied by Defendants;
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, Defendants made such misrepresentations without exercIsmg
reasonable care to ascertain the accuracy of these representations;
The above misrepresentations were made to the FDA, Decedent, physicians,
pharmacists, and the general public;
Defendants supplied false information regarding the safety and efficacy of the
Patch for the guidance of others, including Decedent;
e. Defendants failed to exercise reasonable care or competence in obtaining or
communicating information regarding the safety and efficacy of the Patch to
FDA, Decedent, physicians, pharmacists, and others;
f. Decedent and other justifiably relied on Defendants' misrepresentations; and
g. Consequently, Decedent's use of the Patch was to his detriment. Defendants'
negligent misrepresentations were a proximate cause of Decedent's death and
the damages asserted herein.
D. FOURTH CAUSE OF ACTION: BREACH OF WARRANTY
28. Plaintiffs incorporate by reference paragraphs I through 27 as though fully set
forth herein.
29. Defendants impliedly and expressly warranted to Decedent that the Berry
Patches, including each and every component thereof, were 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 Berry Patch, including each and every component thereof, was not free
from such defects or fit for the purposes for which it was to be used and was, in fact,
defectively manufactured and designed and imminently dangerous to consumers and users.
The Berry 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 Berry Patch unsafe
and dangerous for use by the consumer or user.
31. On June 7, 2007, as a direct and proximate cause of each breach of warranty by
Defendants, while Decedent was using the Berry Patch in the fashion intended and foreseen by
Defendants, Decedent suffered a fatal fentanyl overdose as a result of the Berry Patch's failure
to work as warranted and represented.
DAMAGES
32. As a direct and proximate result of Defendants' conduct, Plaintiff CHELSEA
BERRY, a minor, suffered the loss of Decedent's love, companionship, comfort, care,
assistance, protection, affection, society, moral support, training and guidance.
33. At the time of the events described herein, Decedent was gainfully employed
and as a result of his death, unable to provide support to his daughter.
34. As a proximate result of the actions of Defendants, Decedent was required to
and did employ physicians and surgeons to examine, treat, and care for him, and did incur
medical and incidental expenses.
35. At all times herein mentioned, Defendants knew that the Patch could fail and
"leak" lethal levels of fentanyl in users in the position of Decedent. Notwithstanding this
knowledge, Defendants, in willful and conscious disregard of the safety of such persons and of
the Plaintiffs herein, continually allowed the Patch to be used and marketed the same. Also, in
failing to warn doctors and/or potential users of the Patch and/or take it off the market,
Defendants acted with malice and oppression as defmed in California Civil Code section 3294.
WHEREFORE, Plaintiffs demand judgment against Defendants as follows:
1. For general damages in an amount in excess of the minimal 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 punitive damages according to proof;
6. For costs of suit incurred herein; and
7. For such other and further relief as this Court may deem just and proper.
Plaintiffs hereby demand trial by jury.
DATED: June 3, 2009
Attorney for Plaintiffs
