The following lawsuit was filed on behalf of Amanda Kimble in West Virginia. It alleges that the manufacturers of Reglan (and its generic form Metoclopramide knew) failed to adequately warn of the risks of developing movement disorders from long-term use of the drug.
22. Defendant WYETH and its predecessors in interest had actual knowledge, through
their own studies and studies by independent investigators, that doctors
frequently prescribed Reglan(R)/metoclopramide for long-term use that was not safe
for patients. Defendant WYETH and its predecessors in interest had actual
knowledge, through their own studies and studies by independent investigators,
that nearly one-third of all patients who used Reglan(R)/ metoclopramide received
it on doctor's prescriptions for 12 months or longer, rather than 12 weeks or
less. Defendant WYETH also had actual knowledge, through research by independent
investigators, that the risk of tardive dyskinesia and other extrapyramidal side
effects of Reglan(R)/metoclopramide in patients who receive the drug for 12 weeks
or longer is approximately 100 times greater than disclosed in WYETH's package
insert for Reglan(R) and the Physician's Desk Reference monograph for Reglan(R)
brand metoclopramide. Defendant WYETH also knew, or through the exercise of
reasonable care should have known, that many patients who use Reglan
(R)/metoclopramide are not able to effectively metabolize Reglan(R)/metoclopramide
and that as a foreseeable consequence of their inability to effectively metabolize
Reglan(R)/ metoclopramide, those patients have a greater risk of developing
serious and permanent injuries. Defendant WYETH failed to disclose this
information to the medical community and failed to adequately disclose this
information to the generic pharmaceutical industry. Defendant WYETH was aware that
its failure to disclose this information to the medical community and its failure
to disclose it to the generic pharmaceutical industry would probably result in
serious injury to patients who were prescribed Reglan(R)/metoclopramide by a
physician who was not aware of this information. By failure to disclose this
information to the medical community and the generic pharmaceutical industry,
Defendant WYETH acted in willful and wanton disregard for the rights of persons in
the Plaintiffs class, and this conduct caused serious injury to the Plaintiff.
23. On or about December 27, 2001, Defendant Schwarz became entitled to access to
all of the information and knowledge then possessed by Defendant Wyeth concerning
Reglan(R)/metoclopramide, as more particularly alleged above. Despite this
knowledge, assuming it was transmitted to Schwarz by Wyeth as contemplated in the
Asset Purchase Agreement, Schwarz failed to disclose this information to the
medical community and the generic pharmaceutical industry and thereby acted in
willful and wanton disregard for the rights of persons in the Plaintiff Amanda
Kimble's class, and this conduct caused serious injury to Plaintiff.
24. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 chose to rely on Defendant
WYETH, and its predecessors in interest, to keep abreast of current medical
literature concerning metoclopramide and to inform them concerning its knowledge
of how physicians were using Reglan(R)/metoclopramide and any dangers that were
associated with that use, by properly reporting their knowledge to the PDA,
despite the fact that PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew, or
should have known, that WYETH and its predecessors in interest had a history of
failing to adequately warn physicians about other dangerous products. PLIVA,
PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 failed to exercise reasonable care to
independently monitor their sales of metoclopramide and the medical literature,
which would have alerted them to the fact that Reglan(R)/ metoclopramide was
widely overprescribed as a result of inadequate warnings in the package inserts
and PDR monographs for Reglan(R) brand and generic metoclopramide. PLIVA, PUREPAC
and DRUG COMPANY DOES 1 THROUGH 6 also knew, or should have known in the exercise
of reasonable care, that the package insert for metoclopramide substantially
understated the prevalence of acute dystonic reactions and other acute side
effects of metoclopramide, and failed to use reasonable care to modify the package
insert, and/or seek PDA approval to modify the package insert, in order to
adequately warn physicians and consumers.
United States District Court, S.D. West Virginia.
Amanda Hope KIMBLE, Plaintiff,
v.
WYETH, INC. d/b/a Wyeth, Individually and as Successor-In-Interest to A.H. Robins,
Inc. and American Home Products Corporation; Schwarz Pharma, Inc.; Purepac
Pharmaceutical Co.; Pliva, Inc.; and Drug Company does 1 Through 6, Defendants.
No. 1:04-0815.
2004.
(Jury Trial Demanded)
Complaint
Pullin, Fowler & Flanagan, P.L.L.C., Gary E. Pullin, WV State Bar No. 4528, 707
Virginia Street, East, 1000 Bank One Center, Charleston, WV 25301, (304)
344-0100Jones Martin Parris & Tessener Law Offices, P.L.L.C., John Alan Jones,
N.C. State Bar No. 10376Coleman M. Cowan, N.C. State Bar No. 21997, 410 Glenwood
Avenue, Suite 200, Raleigh, North Carolina 27603, (919)821-0005Medical Legal
Consultants Of, Washington, Ralph D. Pittle, WA State Bar No. 1194, 14205 Se 36th
Street, Suite 100, Bellevue, WA 98006-1553 (425) 644-4394 Attorneys for Plaintiff
PLAINTIFF alleges:
PARTIES AND JURISDICTION
1. Plaintiff Amanda Hope Kimble is an individual and is a resident of Mercer
County, West Virginia.
2. Defendant WYETH, INC. ("WYETH") is a Delaware corporation with its principal
place of business in New Jersey. WYETH is the successor in interest to A.H. Robins
Company, Inc., a Virginia corporation, which first obtained approval by the Food
and Drug Administration to distribute metoclopramide, under the brand name of
Reglan(R), in the United States, WYETH regularly transacts business in West
Virginia. Until December 27, 2001, WYETH manufactured and distributed Reglan(R)
through its Wyeth-Ayerst Laboratories Division in St. Davids, Pennsylvania.
Metoclopramide is the active ingredient of Reglan(R). WYETH also manufactures and
distributes generic metoclopramide through its ownership of ESI Lederle, Inc.
("ESI"), which was formerly a subsidiary of WYETH and was merged into WYETH on
December 15, 1998. On December 27, 2001, WYETH sold the rights and liabilities
associated with Reglan(R) tablets and Reglan(R) syrup to Schwarz Pharma, Inc., a
Delaware corporation with its principal place of business in Wisconsin. Wyeth
regularly transacts business in West Virginia. References in this Complaint to
Wyeth include both WYETH individually and as successor in interest to A.H. Robins,
Inc., American Home Products Corporation, and ESI.
3. Plaintiff is informed and believes that at all relevant times to this lawsuit,
Defendant WYETH and/or one of its predecessors in interest and/or one of its
family of wholly owned divisions did business in the State of West Virginia by
selling Reglan(R) brand and/or generic metoclopramide in the State of West
Virginia.
4. Schwarz Pharma, Inc. ("SCHWARZ") is a Delaware corporation with its principal
place of business in Mequon, Wisconsin. On December 27, 2001, SCHWARZ purchased
the rights and liabilities associated with Reglan(R) tablets and Reglan(R) syrup
from Wyeth pursuant to an Asset Purchase Agreement executed on that date which
obligated it to be responsible for claims relating to or arising out of the
ingestion or use of Reglan from and after March 31, 2002, subject a right to
indemnification by Wyeth up to an amount not presently known by Plaintiff.
Plaintiff is informed and believes that at all relevant times to this lawsuit,
Defendant SCHWARZ and/or one of its predecessors in interest and/or one of its
family of wholly owned divisions did business in the State of West Virginia by
selling Reglan brand metoclopramide in the State of West Virginia.
5. Plaintiff is informed and believes that Defendant Pliva, Inc. ("PLIVA") is a
New Jersey Corporation with its principal place of business in East Hanover, New
Jersey, and is a wholly owned subsidiary of PLIVA D.D, a Croatian corporation with
its principal place of business in Zagreb, Croatia. Plaintiffs are further
informed and believe that PLIVA, DRUG COMPANY DOES 1 THROUGH 3, or a related
entity whose identity is presently unknown to Plaintiff, manufactured, distributed
or contracted for the manufacture and distribution of a generic form of
metoclopramide in the State of West Virginia that was identified with an NDC
number assigned to Pliva, Inc. and that was ingested by Plaintiff. Plaintiff is
further informed and believes that at all times relevant to this lawsuit, PLIVA
regularly conducted business in this State, received substantial revenues in this
State, and manufactured and/or distributed products in this State which have
caused injury to Plaintiff, and is therefore subject to suit in the State of West
Virginia.
6. Plaintiff is informed and believes that Defendant PUREPAC PHARMACEUTICAL CO.
("PUREPAC") is a Delaware corporation with its principal place of business in
Cranford, New Jersey. Plaintiff is informed and believes that PUREPAC is a
subsidiary of ALPHARMA, Inc., a Delaware corporation with its principal place of
business in Fort Lee, New Jersey. Plaintiff is further informed and believes that
PUREPAC, DRUG COMPANY DOES 4 THROUGH 6, or a related entity whose identity is
presently unknown to Plaintiff, manufactured, distributed or contracted for the
manufacture and distribution of a generic form of metoclopramide in the State of
West Virginia that was identified with an NDC number assigned to Purepac
Pharmaceutical Co. and that was ingested by Plaintiff. Plaintiff is further
informed and believes that at all times relevant to this lawsuit, PUREPAC
regularly conducted business in this State, received substantial revenues in this
State, and manufactured and/or distributed products in this State which have
caused injury to Plaintiff, and is therefore subject to suit in the State of West
Virginia.
7. For purposes of this Complaint WYETH, SCHWARZ, PLIVA, PUREPAC and DRUG COMPANY
DOES 1 THROUGH 6 are sometimes referred to as the "Drug Company Defendants."
8. Plaintiff does not know the true names of DRUG COMPANY DOES 1 THROUGH 6, and
therefore sues them by those fictitious names.
9. This Court has jurisdiction pursuant to 28 U.S.C. s 1332, as the matter in
controversy exceeds the sum or value of $75,000, and is between citizens of
different states.
10. Venue is proper in this judicial district pursuant to 28 U.S.C. s 1391 because
a substantial part of the events giving rise to Plaintiffs cause of action arose
in Mercer County, West Virginia in this judicial district.
FACTUAL BACKGROUND
11. Between on or about October 22, 1998 and on or about August 2002, Plaintiff
Amanda Hope Kimble took generic metoclopramide manufactured by PUREPAC, PLIVA,
and/or DRUG COMPANY DOES 1 THROUGH 6 for the treatment of and nausea, dyspepsia,
and/or gastroparesis.
12. Because of the misleading information that the defendants, and each of them,
provided to physicians and the PDA about the true risks associated with the use of
Reglan/metoclopramide and because of the failure of defendants, and each of them,
to adequately inform physicians generally, including plaintiffs physicians, about
the true risks associated with the use of Reglan/metoclopramide, at all times
relevant to this lawsuit, while Plaintiff was taking metoclopramide, she was never
informed of any extrapyramidal or movement disorder side effects associated with
metoclopramide or that metoclopramide was only approved for short term use (up to
12 weeks).
13. Ms. Kimble took the metoclopramide as prescribed throughout the period from on
or about October 22, 1998 until on or about August 2002.
14. In early 1999, Ms. Kimble started experiencing involuntary movements and
dystonic muscle spasms in her legs, feet, and hands. These painful dystonic spasms
got progressively worse and extended to include her torso, back, and neck; causing
her entire body to violently arch backward. On August 8, 2002, Ms. Kimble's
physicians at the Mayo clinic recommended that she stop taking Reglan
(R)/metoclopramide, as it is a dopamine antagonist, can have dystonic and
dyskinetic effects, and may be causing Ms. Kimble's spasms.
15. Use of metoclopramide caused Ms. Kimble to suffer serious, permanent and
disabling injuries including but not limited to injuries of or associated with the
central nervous and extrapyramidal motor systems. Because of the injuries Ms.
Kimble suffered from the use of metoclopramide, Ms. Kimble has experienced and
will continue to experience medical and related expenses, loss of ability to
provide household services for herself, the inability to work, the inability to
attend college classes, disfigurement, disability, pain and suffering,
psychological injury and other injuries and damages.
16. Metoclopramide/ Reglan(R) is approved for short-term use up to twelve weeks in
adults.
17. At all times material hereto, Defendant WYETH, individually and as
successor-in-interest to A.H. Robins Company, was aware of the serious side
effects caused by Reglan(R)/metoclopramide including, but not limited to, central
nervous system disorders, depression with suicidal ideation, akathisia, tardive
dyskinesia, tardive dystonia, visual disturbances and interference with drug
metabolism.
18. At all times material hereto, WYETH and the other DRUG COMPANY DEFENDANTS knew
or should have known that most physicians were not aware of or did not fully
appreciate the seriousness of the risks associated with use of Reglan(R)/
metoclopramide and that consequently there was a widespread tendency for
physicians to prescribe Reglan(R)/metoclopramide for inappropriate long-term use.
Therefore, WYETH and the other DRUG COMPANY DEFENDANTS also knew or should have
known that the package insert and the Physician Desk Reference monograph for
Reglan(R)/metoclopramide did not adequately inform physicians about the risks
associated with Reglan(R)/metoclopramide, particularly for patients whose bodies
do not metabolize Reglan(R)/metoclopramide effectively.
19. WYETH also had access to knowledge concerning the side effects of Reglan
(R)/metoclopramide, the manner in which physicians were prescribing Reglan
(R)/metoclopramide and the fact that physicians did not fully understand the risks
associated with Reglan(R)/metoclopramide through its participation in or its
ability to review data from clinical studies that were not publicly available,
through its review of domestic and international medical literature concerning
Reglan(R)/metoclopramide and through ongoing litigation. Yet, WYETH failed to
adequately warn physicians about the risks associated with Reglan(R)/
metoclopramide, despite the fact that WYETH knew that physicians and the generic
pharmaceutical industry relied on WYETH to disclose what WYETH knew and what it
should have known from a prudent review of the information that it possessed.
20. Defendant WYETH's predecessor in interest, A.H. Robins Company, Inc.,
expressly warranted to some physicians that Reglan(R)/metoclopramide is safe in
long-term use. When A.H. Robins made those representations, Robins knew that those
physicians would share that information with other physicians in their community
and that eventually many physicians would come to rely on Robins' express
warranties about Reglan(R)/metoclopramide's safety in long-term use. Robins'
express warranties about the safety of Reglan(R)/metoclopramide in long-term use
were false.
21. Defendant WYETH knew, or it should have known through the exercise of
reasonable care, that the package insert for Reglan(R)/metoclopramide
substantially understated the prevalence of acute and long-term side effects of
Reglan(R)/metoclopramide. WYETH failed to use reasonable care to modify the
package insert to adequately warn physicians about the true risks of both
short-term use and long-term use, even after several injured patients filed
lawsuits alleging inadequate warnings and produced competent expert testimony
supporting their allegations.
22. Defendant WYETH and its predecessors in interest had actual knowledge, through
their own studies and studies by independent investigators, that doctors
frequently prescribed Reglan(R)/metoclopramide for long-term use that was not safe
for patients. Defendant WYETH and its predecessors in interest had actual
knowledge, through their own studies and studies by independent investigators,
that nearly one-third of all patients who used Reglan(R)/ metoclopramide received
it on doctor's prescriptions for 12 months or longer, rather than 12 weeks or
less. Defendant WYETH also had actual knowledge, through research by independent
investigators, that the risk of tardive dyskinesia and other extrapyramidal side
effects of Reglan(R)/metoclopramide in patients who receive the drug for 12 weeks
or longer is approximately 100 times greater than disclosed in WYETH's package
insert for Reglan(R) and the Physician's Desk Reference monograph for Reglan(R)
brand metoclopramide. Defendant WYETH also knew, or through the exercise of
reasonable care should have known, that many patients who use Reglan
(R)/metoclopramide are not able to effectively metabolize Reglan(R)/metoclopramide
and that as a foreseeable consequence of their inability to effectively metabolize
Reglan(R)/ metoclopramide, those patients have a greater risk of developing
serious and permanent injuries. Defendant WYETH failed to disclose this
information to the medical community and failed to adequately disclose this
information to the generic pharmaceutical industry. Defendant WYETH was aware that
its failure to disclose this information to the medical community and its failure
to disclose it to the generic pharmaceutical industry would probably result in
serious injury to patients who were prescribed Reglan(R)/metoclopramide by a
physician who was not aware of this information. By failure to disclose this
information to the medical community and the generic pharmaceutical industry,
Defendant WYETH acted in willful and wanton disregard for the rights of persons in
the Plaintiffs class, and this conduct caused serious injury to the Plaintiff.
23. On or about December 27, 2001, Defendant Schwarz became entitled to access to
all of the information and knowledge then possessed by Defendant Wyeth concerning
Reglan(R)/metoclopramide, as more particularly alleged above. Despite this
knowledge, assuming it was transmitted to Schwarz by Wyeth as contemplated in the
Asset Purchase Agreement, Schwarz failed to disclose this information to the
medical community and the generic pharmaceutical industry and thereby acted in
willful and wanton disregard for the rights of persons in the Plaintiff Amanda
Kimble's class, and this conduct caused serious injury to Plaintiff.
24. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 chose to rely on Defendant
WYETH, and its predecessors in interest, to keep abreast of current medical
literature concerning metoclopramide and to inform them concerning its knowledge
of how physicians were using Reglan(R)/metoclopramide and any dangers that were
associated with that use, by properly reporting their knowledge to the PDA,
despite the fact that PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew, or
should have known, that WYETH and its predecessors in interest had a history of
failing to adequately warn physicians about other dangerous products. PLIVA,
PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 failed to exercise reasonable care to
independently monitor their sales of metoclopramide and the medical literature,
which would have alerted them to the fact that Reglan(R)/ metoclopramide was
widely overprescribed as a result of inadequate warnings in the package inserts
and PDR monographs for Reglan(R) brand and generic metoclopramide. PLIVA, PUREPAC
and DRUG COMPANY DOES 1 THROUGH 6 also knew, or should have known in the exercise
of reasonable care, that the package insert for metoclopramide substantially
understated the prevalence of acute dystonic reactions and other acute side
effects of metoclopramide, and failed to use reasonable care to modify the package
insert, and/or seek PDA approval to modify the package insert, in order to
adequately warn physicians and consumers.
25. As a result of the misrepresentations, breach of express and implied
warranties and negligence occasioned by PLIVA, PUREPAC and DRUG COMPANY DOES 1
THROUGH 6, Ms. Kimble was prescribed excessive amounts of metoclopramide which
caused her to suffer serious and permanent injuries as described above.
26. All Defendants are jointly and severally liable to Plaintiff for all damages
claimed.
FIRST CAUSE OF ACTION
Strict Products Liability
(As against Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6)
27. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
28. At all relevant times PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 were
engaged in the business of manufacturing, designing, testing, marketing,
promoting, distributing, and/or selling metoclopramide.
29. At all times mentioned in this Complaint, metoclopramide was defective and/or
unreasonably dangerous to Amanda Hope Kimble and other foreseeable users at the
time it left the control of PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6.
30. Metoclopramide was "defective" and "unreasonably dangerous" when the product
initially was patented, and subsequently when it was promoted and entered into the
stream of commerce and was received by Amanda Hope Kimble, in one or more of the
following respects:
(a) At the time metoclopramide left the control of PLIVA, PUREPAC and DRUG COMPANY
DOES 1 THROUGH 6 it was defective and unreasonably dangerous due to a failure to
contain adequate warnings or instructions, or, in the alternative, because it was
designed in a defective manner, or, in the alternative, because the product
breached an express warranty or failed to conform to other expressed factual
representations upon which Amanda Hope Kimble's physicians justifiably relied, or
because it breached an implied warranty, all of which proximately caused the
damages for which Plaintiff seek recovery herein.
(b) Metoclopramide was not reasonably safe as designed, taking into account the
foreseeable risks involved in its use at the time the product left the possession
of PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6, and that such risks clearly
outweighed the utility of the product or its therapeutic benefits.
(c) Metoclopramide was not reasonably safe due to inadequate or defective warnings
or instructions that were known or reasonably scientifically knowable at the time
the product left the possession of the PLIVA, PUREPAC and DRUG COMPANY DOES 1
THROUGH 6. Specifically, although PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6
were well aware that metoclopramide could potentially cause central nervous system
side effects, depression with suicidal ideation, akathisia, akinesia, tardive
dyskinesia, tardive dystonia, visual disturbances and interference with the
metabolism of other prescription drugs and in fact, had significantly greater
prevalence and severity of these side effects in patients with diabetes mellitus,
warnings of such adverse health conditions were either not included on the package
insert for these products or they were not adequate to inform reasonably prudent
physicians and consumers.
(d) The warnings or instructions provided by PLIVA, PUREPAC and DRUG COMPANY DOES
1 THROUGH 6 were not of a nature that a reasonable prudent drug company in the
same or similar circumstances would have provided with respect to the danger.
There were no warnings or instructions that communicated sufficient information on
the dangers and safe use of the product taking into account the characteristics of
the product, and/or the ordinary knowledge common to the physician who prescribes
and consumer who purchases the product, such as the Plaintiff Amanda Hope Kimble.
(e) The metoclopramide manufactured and supplied by PLIVA, PUREPAC and DRUG
COMPANY DOES 1 THROUGH 6 was further defective due to inadequate post-marketing
warning or instruction because, after PLIVA, PUREPAC and DRUG COMPANY DOES 1
THROUGH 6 knew or should have known of the risks of injury from metoclopramide
associated with long-term use as commonly prescribed, they failed to promptly
respond to and adequately warn about extrapyramidal side effects, among other
adverse reactions.
31. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew or in light of
reasonably available scientific knowledge, should have known about the danger
associated with metoclopramide use that caused the injuries for which Plaintiff
seek recovery. A reasonably competent physician who prescribed metoclopramide and
a reasonably competent plaintiff who consumed metoclopramide would not realize its
dangerous condition.
32. PICA,PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew or, in light of reasonably
available scientific knowledge, should have known about the danger associated with
use of metoclopramide that caused the damages for which Plaintiff seek recovery.
33. The reasonably foreseeable use of metoclopramide, that is ingestion as
treatment for nausea or gastroparesis on a long-term basis, involved substantial
dangers not readily recognizable by the ordinary physician who prescribed
metoclopramide or the patient, like Plaintiff Amanda Hope Kimble, who consumed
metoclopramide.
34. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew that the metoclopramide
was to be used by the user without inspection for defects in the product or in any
of its components or ingredients and that metoclopramide was not properly prepared
nor accompanied by adequate warnings of its dangerous propensities that were known
or reasonably scientifically knowable at the time of distribution.
35. Plaintiff Amanda Hope Kimble and her physicians did not know, nor had reason
to know, at the time of the use of the above-described product, or at any time
prior to its use, of the existence of the above-described defects and inadequate
warnings.
36. These defects caused serious injuries to Plaintiff Amanda Hope Kimble when
metoclopramide was used in its intended and foreseeable manner, and in the manner
recommended by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 or in a
non-intended manner that was reasonably foreseeable.
SECOND CAUSE OF ACTION
Negligence
(As against Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6)
37. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
38. At all times mentioned in this Complaint, PLIVA, PUREPAC and DRUG COMPANY DOES
1 THROUGH 6 had a duty to properly manufacture, compound, test, inspect, package,
label, distribute, market, examine, maintain, supply, provide proper warnings, and
prepare for use and sell metoclopramide.
39. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew or should have known
that use of metoclopramide created an unreasonable risk as a result of its design,
testing, and/or manufacturing, including an unreasonable risk of central nervous
system side effects, depression, akathisia, akinesia, tardive dyskinesia, tardive
dystonia, visual disturbances and/or interference with drug metabolism, especially
in female patients diagnosed with diabetes mellitus and more particularly in
patients who are poor metabolizers of metoclopramide.
40. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 were negligent, and breached
duties owed to Plaintiff with respect to metoclopramide in one or more of the
following respects:
(a) Despite knowledge of hazards and knowledge that the product was frequently
prescribed for long-term use, they failed to accompany the product with adequate
warnings and instructions regarding the adverse and long-lasting side effects
associated with the use of metoclopramide and particularly with foreseeable
long-term use;
(b) They failed to conduct adequate testing;
(c) Despite knowledge of hazards, they failed to conduct adequate post-marketing
surveillance to determine the safety of the product;
(d) Despite knowledge of hazards, they failed to adequately warn Plaintiff Amanda
Hope Kimble's physicians or Plaintiff Amanda Hope Kimble that the use of
metoclopramide could result in depression with suicidal ideation, akathisia,
akinesia, tardive dyskinesia, tardive dystonia, visual disturbances and
interference with drug metabolism; and
(e) Despite the fact that the PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6
knew or should have known that metoclopramide caused unreasonably dangerous side
effects, they failed to adequately disclose the known or knowable risks associated
with metoclopramide as set forth above; they willfully and deliberately failed to
adequately disclose these risks, and in doing so, acted with a conscious disregard
of Plaintiff Amanda Hope Kimble's safety or welfare.
41. As a result of the negligence of PLIVA, PUREPAC and DRUG COMPANY DOES 1
THROUGH 6, and their willful and wanton misconduct, metoclopramide was prescribed
to Plaintiff Amanda Hope Kimble for long-term use and was used long-term by her,
thereby causing her to sustain reasonably foreseeable serious and permanent
damages and injuries as alleged in this Complaint.
42. The negligence and the willful and wanton misconduct of PLIVA, PUREPAC and
DRUG COMPANY DOES 1 THROUGH 6 was a proximate cause of Plaintiff Amanda Hope
Kimble's harm and injuries that Plaintiff Amanda Hope Kimble has suffered and will
continue to suffer as previously described.
THIRD CAUSE OF ACTION
Negligence Per Sc
(As against Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6)
43. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
44. Metoclopramide is misbranded within the meaning of 21 U.S.C, s 352(a) and (f)
because the product label and package insert were false and misleading and failed
to give adequate warnings and directions for use by physicians who prescribe
metoclopramide. Because Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH
6 had a statutory duty under 21 U.S.C. s 352(a) and (f) not to misbrand
metoclopramide and because they violated this duty, they were guilty of negligence
per se. In addition, and more particularly, because Defendants PLIVA, PUREPAC, and
DOES 1 THROUGH 6 knew, or should have known, that physicians commonly prescribed
Reglan/metoclopramide for long-term use, beyond the 12 week intended use that was
approved by the PDA, pursuant to 21 CFR 201.128, long-term use became an "intended
use" which required the defendants, and each of them, to provide adequate labeling
for such a drug which accords with such other uses to which the article was
commonly prescribed. Their failure to adequately warn about the magnitude of the
risk associated with long-term use constitutes negligence per se. This negligence
per se proximately caused injury to the Plaintiff Amanda Hope Kimble as described
more fully herein.
FOURTH CAUSE OF ACTION
Fraud
(As against Defendant Wyeth)
45. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
46. As set forth above, WYETH and its predecessors falsely and fraudulently
represented to Plaintiffs physicians, and through them to Plaintiff and members of
the general public, that Reglan(R)/metoclopramide was safe for use to treat nausea
and gastroparesis and that central nervous system side effects and extrapyramidal
symptoms were comparatively rare. These representations were in fact, false. The
true facts were that Reglan(R)/ metoclopramide was not safe for that purpose and
was, in fact, dangerous to the health and body of Plaintiff Amanda Hope Kimble.
47. WYETH and its predecessors made other representations about the safety and
efficacy of Reglan(R)/metoclopramide, and its minimal side effects, all as set
forth above and incorporated here by reference.
48. These representations were, in fact, false. The true facts were that Reglan
(R)/metoclopramide causes central nervous system side effects, and extrapyramidal
symptoms, among other side effects, far more frequently than represented, and
WYETH and its predecessors did not disclose or warn physicians about the actual
prevalence of known side effects of Reglan(R)/metoclopramide, particularly when
Reglan(R)/metoclopramide is used on a long-term basis or when used in patients who
are poor metabolizers of Reglan(R)/metoclopramide, all of which were foreseeable.
WYETH and its predecessors misrepresented the safety of Reglan(R)/metoclopramide
and withheld warnings of the known side effects of Reglan(R)/metoclopramide when
used as commonly prescribed by physicians, as specifically required by 21
CFR201.128.
49. When WYETH and its predecessors made these representations, they knew that
they were false. WYETH made these representations with the intent to defraud and
deceive Plaintiff Amanda Hope Kimble's physicians and through them to defraud and
deceive Plaintiff Amanda Hope Kimble, and with the intent to induce her and her
physicians to act in the manner alleged in this Complaint, that is, to use Reglan
(R)/metoclopramide as pharmaceutical treatment for nausea and gastroparesis for a
period of time that far exceeded the PDA's approved indicated duration of use.
50. At the time WYETH and its predecessors made the above-described
representations, and at the time Plaintiff Amanda Hope Kimble and her physicians
took the actions alleged in this Complaint, Plaintiff Amanda Hope Kimble and her
physicians were ignorant of the falsity of the representations and reasonably
believed them to be true. In reliance upon the representations, Plaintiff Amanda
Hope Kimble's physicians were induced to, and did, prescribe metoclopramide as
described in this Complaint and Plaintiff Amanda Hope Kimble did use
metoclopramide as described in this Complaint.
51. If Plaintiff Amanda Hope Kimble's physicians had known the actual facts, they
would not have prescribed metoclopramide in the manner that they prescribed it and
Plaintiff Amanda Hope Kimble would not have taken metoclopramide in the way that
it was prescribed.
52. The reliance of Plaintiff Amanda Hope Kimble and her physicians upon the
representations of WYETH and its predecessors was justified because the
representations were made by individuals and entities that appeared to be in the
position to know the true facts.
53. As a proximate result of the fraud and deceit of WYETH and its predecessors,
Plaintiff Amanda Hope Kimble sustained the injuries and damages described in this
Complaint.
54. In doing the acts alleged in this Complaint, WYETH and its predecessors acted
with oppression, fraud, and malice and Plaintiff is therefore entitled to punitive
damages to deter WYETH and others from engaging in similar conduct in the future.
This wrongful conduct was done with the advance knowledge, authorization, or
ratification of an officer, director, or managing agent of each of WYETH and its
predecessors.
FIFTH CAUSE OF ACTION
Negligent Misrepresentation
(As against Defendants WYETH and SCHWARZ)
55. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
56. WYETH and SCHWARZ had actual knowledge of facts which demonstrated that
representations in the Reglan(R) package insert, the PDR monograph for Reglan(R)
and literature that they distributed concerning Reglan(R)/ metoclopramide to
physicians were false and misleading. WYETH and SCHWARZ had an absolute duty to
disclose the true facts regarding the safety of Reglan(R)/ metoclopramide to
patients, physicians, pharmacists and the generic metoclopramide industry, which
they negligently failed to do. Furthermore, WYETH and SCHWARZ had a duty to ensure
that they had a reasonable basis for making the representations described above.
57. WYETH expressly and/or impliedly represented to Plaintiff Amanda Hope Kimble,
her physicians, pharmacists, the generic metoclopramide industry, gastroesophageal
reflux disease and members of the general public that Reglan(R)/metoclopramide was
safe for use to treat nausea and/or gastroparesis for durations of use that
exceeded the 12 week duration indicated in WYETH and SCHWARZ'S package inserts and
in the PDR. The representations by WYETH and SCHWARZ, and the lack of them were in
fact, false. The true facts were that Reglan(R)/metoclopramide was not safe for
use in the manner by which it was prescribed and was, in fact, dangerous to the
health and body of Plaintiff Amanda Hope Kimble.
58. WYETH and SCHWARZ made the above-described representations with no reasonable
grounds for believing them to be true. They did not have accurate or sufficient
information concerning these representations. Further, WYETH and SCHWARZ were
aware that without such information, they could not accurately make the
above-described representations.
59. The above misrepresentations or omissions were made to Plaintiff Amanda Hope
Kimble, her physicians, pharmacists, the public and the generic pharmaceutical
industry, all of whom justifiably relied on those representations or omissions.
WYETH'S and SCHWARZ'S misrepresentations or omissions were a proximate cause of
Plaintiff s damages.
SIXTH CAUSE OF ACTION
Fraud by Concealment
(As against Defendant Wyeth)
60. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
61. At all times mentioned in this Complaint, WYETH and its predecessors had the
duty and obligation to disclose to Plaintiff Amanda Hope Kimble and to her
physicians, the true facts concerning Reglan(R)/metoclopramide, that is, that
Reglan(R)/metoclopramide was dangerous and defective, and how likely it was to
cause serious consequences to users, including injuries as described in this
Complaint, and the true level of risk involved in prescribing Reglan(R)/
metoclopramide for the purposes indicated. WYETH and its predecessors made the
affirmative representations set forth above to Plaintiff Amanda Hope Kimble, her
prescribing physicians, and the general public prior to the day Plaintiff was
first prescribed and used Reglan(R)/metoclopramide, while concealing the material
facts set forth below.
62. At all times mentioned in this Complaint, WYETH and its predecessors had the
duty and obligation to disclose to Plaintiff Amanda Hope Kimble and to her
physicians the true facts concerning Reglan(R)/metoclopramide, that is, that long
term use and exposure could cause central nervous system side effects, depression
with suicidal ideation, akathisia, akinesia, tardive dyskinesia and tardive
dystonia. At all times mentioned in this Complaint, WYETH and its predecessors
intentionally, willfully, and maliciously concealed or suppressed the facts set
forth above from Plaintiff Amanda Hope Kimble's physicians, and therefore from
Plaintiff Amanda Hope Kimble, with the intent to defraud as alleged in this
Complaint.
63. At all times mentioned in this Complaint, neither Plaintiff Amanda Hope Kimble
nor her physicians were aware of the facts set forth above. Had they been aware of
those facts, they would not have acted as they did, that is, would not have
utilized Reglan(R)/metoclopramide in the treatment of Plaintiff Amanda Hope
Kimble's gastroesophageal reflux and nausea for periods of time that exceeded 12
weeks duration.
64. As a proximate result of the concealment or suppression of the facts set forth
above, Plaintiff Amanda Hope Kimble was prescribed and took Reglan(R)/
metoclopramide and subsequently became ill, thereby sustaining the injuries and
damages as set forth in this Complaint.
65. In doing the acts alleged in this Complaint, WYETH and its predecessors acted
with oppression, fraud, and malice, and Plaintiff Amanda Hope Kimble is therefore
entitled to punitive damages in an amount reasonably related to Plaintiff actual
damages and to WYETH's wealth, and sufficiently large to be an example to others,
and to deter WYETH and others from engaging in similar conduct in the future.
SEVENTH CAUSE OF ACTION
Breach of Express Warranties
(As against Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6)
66. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
67. PEIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 represented to the medical
community that the most common extrapyramidal side effect of metoclopramide, acute
dystonic reactions, only occurred in one in every 500 patients, despite the fact
that from no later than June 1993, PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH
6 knew, or should have known, that published studies established that the risk was
100 times greater than disclosed in the package inserts and the PDR monograph for
Reglan(R)/metoclopramide is not safe for long-term use and the risk of dystonic
reactions, including tardive dyskinesia from long-term use is much greater than
warranted.
68. The above-described manufacturing, compounding, packaging, designing,
distributing, testing, constructing, fabricating, analyzing, recommending,
merchandizing, advertising, promoting, supplying, and selling of metoclopramide
was expressly warranted by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 to be
safe for use by Plaintiff Amanda Hope Kimble and other members of the general
public.
69. At the time of the making of the express warranties, PLIVA, PUREPAC and DRUG
COMPANY DOES 1 THROUGH 6 had knowledge of the purpose for which metoclopramide was
to be used and warranted it to be, in all respects, fit, safe, and effective and
proper for such purpose. Metoclopramide was not properly prepared nor accompanied
by adequate warnings for its dangerous propensities that were either known or
reasonably scientifically knowable at the time of distribution.
70. Plaintiff Amanda Hope Kimble and her physicians reasonably relied upon the
skill and judgment of PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6, and upon
the above-described express warranties, in using metoclopramide. The warranties
and representations were untrue in that metoclopramide was far more likely to
cause injury than represented by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6,
and it caused severe injury to Plaintiff Amanda Hope Kimble and was unsafe and,
therefore, unsuited for the use for which it was intended. The breach of the
express warranties made by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6, about
metoclopramide could and did thereby proximately cause Plaintiff Amanda Hope
Kimble to sustain damages and injuries as alleged in this Complaint.
71. As soon as the true nature of metoclopramide, the fact that the warranties and
representations made by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 were
false, and the identity of the manufacturers of the metoclopramide ingested by
Plaintiff, were ascertained by Plaintiff Amanda Hope Kimble, PLIVA, PUREPAC and
DRUG COMPANY DOES 1 THROUGH 6 were notified of the breach of their express
warranties.
EIGHTH CAUSE OF ACTION
Breach of Implied Warranties
(As against Defendants PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6)
72. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
73. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew that most physicians who
prescribed metoclopramide were not aware the drug is a dopamine antagonist and/or
a neuroleptic agent, which is just as likely to cause serious extrapyramidal side
effects as other dopamine antagonists and/or other neuroleptic drugs. PLIVA,
PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 also knew that the risks of potentially
irreversible neurological side effects when metoclopramide is used long-term were
much greater than most physicians realized. By failing to give adequate warnings
about the dopamine antagonist and/or neuroleptic properties of metoclopramide and
the risk of long-term use that is associated with those properties, PLIVA, PUREPAC
and DRUG COMPANY DOES 1 THROUGH 6 breached implied warranties of merchantability
and fitness for the ordinary use of metoclopramide.
74. At all times mentioned in this Complaint, PLIVA, PUREPAC and DRUG COMPANY DOES
1 THROUGH 6, manufactured, compounded, packaged, distributed, recommended,
merchandised, advertised, promoted, supplied, and sold metoclopramide, and prior
to the time it was used by Plaintiff Amanda Hope Kimble, PLIVA, PUREPAC and DRUG
COMPANY DOES 1 THROUGH 6 impliedly warranted to Plaintiff Amanda Hope Kimble and
to her physicians that the product was of merchantable quality and safe for the
use for which it was intended.
75. Plaintiff Amanda Hope Kimble relied on the skill and judgment of PLIVA,
PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 in using metoclopramide.
76. Metoclopramide was unsafe for its intended use, nor was it of merchantable
quality, as warranted by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6, in that
it had very dangerous propensities when put to its intended use and would cause
severe injury to the user. Metoclopramide was not properly prepared nor
accompanied by adequate warnings of its dangerous propensities that were either
known or reasonably scientifically knowable at the time of distribution.
Metoclopramide proximately caused Plaintiff Amanda Hope Kimble to sustain damages
and injuries as alleged in this Complaint by virtue of causing Plaintiff Amanda
Hope Kimble's illness.
77. As soon as the true nature of metoclopramide, the fact that the warranties and
representations made by PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 were
false, and the identity of the manufacturers of the metoclopramide ingested by
Plaintiff, were ascertained by Plaintiff Amanda Hope Kimble, PLIVA, PUREPAC and
DRUG COMPANY DOES 1 THROUGH 6 were notified of the breach of their implied
warranties.
NINTH CAUSE OF ACTION
Consumer Protection
(As against Defendant WYETH)
78. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
79. By reason of their conduct as alleged herein, WYETH and its predecessors
violated the provisions of W.V.C. s 46A-6-101, et seq, by inducing the Plaintiff
Amanda Hope Kimble and Plaintiff Amanda Hope Kimble's physicians to use and/or
prescribe the drug metoclopramide through the use of false and/or misleading
advertising, representations and statements.
80. By engaging in the conduct described above, WYETH and its predecessors
violated W.V.C. s 46A-6-101, et seq by, among other things:
(a) Engaging in unfair trade practices as defined in this statute by making false
and misleading oral and written statements that had the capacity, tendency or
effect of deceiving or misleading consumers;
(b) Engaging in unfair trade practices as defined in this statute by making
representations that their products had an approval, characteristic, ingredient,
use or benefit which they did not have, including but not limited to statements
concerning the health consequences of the use of these drugs;
(c) Engaging in unfair trade practices as defined in this statute by failing to
state material facts, the omission of which deceived or tended to deceive,
including but not limited to, facts relating to the health consequences of the use
of these drugs; and
(d) Engaging in unfair trade practices as defined in this statute through
deception, fraud, misrepresentation, and knowing concealment, suppression and
omission of material facts with the intent that consumers rely upon the same in
connection with the use and continued use of the drugs.
81. The violations of W.V.C. s 46A-6-101, et seq by WYETH and its predecessors
proximately caused injury to Plaintiff Amanda Hope Kimble.
82. As a result of the aforesaid statutory violations, Plaintiff Amanda Hope
Kimble is entitled to relief, as allowed by statute and prayed for below.
TENTH CAUSE OF ACTION
Punitive Damages
(As against Defendant WYETH)
83. Plaintiff hereby incorporates by reference all above allegations as if fully
set forth herein.
84. Defendant WYETH (including A.H. Robins Company, Inc., prior to its merger into
WYETH, and as WYETH thereafter) and its predecessors have marketed Reglan
(R)/metoclopramide to physicians in a manner calculated to increase sales of the
drug and resultant profits to the drug company, and in conscious disregard of the
risk of injurious consequences to patients, through the medium of
over-prescription of the drug for patients at excessive dosage and/or for
excessive periods of time and/or for patients for whom safer effective alternative
treatments existed, thereby causing the consequent development of tardive
dyskinesia and other extrapyramidal symptoms ("EPS") among numerous patients, of
whom the Plaintiff is one.
85. WYETH and its predecessors knew that the conditions for which Reglan(R)/
metoclopramide was prescribed, in particular diabetic gastroparesis and
gastroesophageal reflux, are chronic conditions which indicate, for their
treatment, long-term therapy. Despite this knowledge, Defendant WYETH consciously
chose to evaluate the safety and efficacy of the drug through scientific
investigation for periods not exceeding 12 weeks.
86. WYETH and its predecessors knew that Reglan(R)/metoclopramide, as a dopamine
antagonist and/or a neuroleptic drug, is as likely as other dopamine antagonists
and/or other neuroleptic drugs to cause tardive dyskinesia and other EPS,
particularly at higher exposures and longer durations of use. Despite this
knowledge, WYETH consciously sponsored the performance and dissemination of
non-scientific investigations to suggest that Reglan(R)/ metoclopramide is safe
for long-term use, proposed and distributed labeling suggesting that EPS side
effects are rare with metoclopramide use, whether short-term or long-term, and
otherwise systematically suppressed or undercut the dissemination of specific
scientific information about the risks and prevalence of side effects associated
with Reglan(R)/metoclopramide to physicians, to the generic metoclopramide
industry and to the PDA.
87. WYETH and its predecessors knew from its own investigations, including
analysis of sales statistics, and from scientific studies published in
peer-reviewed medical journals, that many physicians were unaware of the extent of
the risks posed by Reglan(R)/metoclopramide therapy at high dosages and/or
long-term exposure, that many physicians were over-prescribing Reglan(R)/
metoclopramide, and that many patients, as a result, developed serious EPS side
effects, including depression with suicidal ideation, akathisia, akinesia, tardive
dyskinesia and tardive dystonia, who would not have developed these side effects
but for their overexposure to Reglan(R)/metoclopramide. Despite this knowledge,
WYETH and its predecessors consciously failed to make or propose any changes in
the Reglan(R)/metoclopramide labeling and consciously declined to disseminate
information to physicians, to the generic metoclopramide industry or to the PDA
that would alert them to the fact or risk of metoclopramide exposure.
88. The Plaintiff specifically references and incorporates herein the allegations
contained in the facts common to all counts and in the misrepresentation count.
The conduct of WYETH and its predecessors undertaken with this knowledge, for
these purposes, evinces a willful, wanton, and conscious disregard for the rights
and safety of patients, including the Plaintiff Amanda Hope Kimble. Plaintiff
suffered injury from WYETH's and its predecessors' disregard for her rights and
safety and therefore she is entitled to an award of punitive damages from WYETH.
JURY DEMAND
Plaintiff Amanda Hope Kimble demands that all issues of fact in this case be tried
to a properly empanelled jury.
PRAYER FOR RELIEF
Plaintiff respectfully pray for relief against Defendants, and each of them, as
follows:
1. General compensatory damages as allowed by law;
2. Special damages as allowed by law;
3. Punitive damages as allowed by law;
4. Costs of suit as allowed by law;
5. Attorneys' fees as allowed by law;
6. Prejudgment and postjudgment interest as allowed by law;
7. Such further or other relief, whether legal or equitable, as the Court deems
proper. Executed this 2nd day of August, 2004.
