As a rule of thumb, Reglan lawyers prefer to file their Reglan lawsuits in state court, instead of federal court. That’s because it is generally cheaper and easier to prosecute a Reglan lawsuit in a state court than in a federal court. But sometimes, due to procedural rules that are beyond the scope of this blog, a Reglan attorney will have to file in federal court. This is an example of a Reglan lawsuit filed in a California federal court.
35. The Plaintiff's use of metoclopramide products, as prescribed by his
physicians, resulted in his overexposure to the drug metoclopramide, which caused
him to suffer serious, permanent and disabling injuries, including but not limited
to injuries of or associated with the central nervous and extrapyramidal motor
systems, specifically (for the past approximately 20 years) tardive dyskinesia and
(for the past several years) consequent clinical depression. The Plaintiff
discovered the cause of the afflictions from which he has been suffering, as
confirmed by Veterans Administration doctors in April 2009, only this year, after
happening upon publicity in the media concerning the connection between various
movement disorders and long term therapy using Reglan and/or other metoclopramide
products.36. Because of these injuries the Plaintiff has experienced and will continue to
experience disfigurement, disability, embarrassment, loss of ability to provide
household services for himself, pain and suffering, medical and related expenses,
and other damages.37. The Plaintiff's serious and permanent injuries, as described above, came about
as a foreseeable and proximate result of Wyeth's dissemination to physicians of
inaccurate, misleading, materially incomplete, and otherwise false information
concerning the potential effects of exposure to metoclopramide through the
ingestion of a metoclopramide product such as Reglan.
Regardless of whether the lawsuit is filed in a state or a federal courthouse, the allegations will be the same: That the manufacturers of Reglan knew that long-term use of the drug could cause movement disorders like tardive dyskinesia.
United States District Court, S.D. California.
Ronald HESTAND and Marcia Hestand, husband and wife, Plaintiffs,
v.
WYETH, INC. d/b/a Wyeth, a/k/a A.H. Robins Company and American Home Products
Corporation and by other aliases; and Doe Drug Companies, #1 Through #20.,
Defendants.
No. 309CV01146.
May 27, 2009.
Complaint for Damages (Fraud, Fraud By Concealment, Negligent Misrepresentation,
Strict Products Liability, Negligence, Negligence Per Se, Breach of Implied
Warranty, Breach of Express Warranty, Unfair Trade Practices, and Punitive Damages
Jury Demand
Justin Brooks (CSBN 214187), California Western School of Law, 225 Cedar Street,
San Diego, Ca 92101, (Telephone: 619.525.7079), jpb@cwsl.edu.Ralph D. Pittle, Esq.
Pro Hac Vice Pending, Medical Legal Consultants of Washington, 14205 S.E. 36th
Street, Suite 100, Bellevue, WA 98006, Telephone: (425) 644-4394, Facsimile: (425)
746-8310, rpittle@mlcofwa.com, Attorneys for Plaintiffs.
LAINTIFFS allege:
I. PARTIES
1. Ronald Hestand (referred to hereinafter as "the Plaintiff") is an individual
and is a resident of San Diego, San Diego County, California.
2. Marcia Hestand is an individual and is a resident of San Diego, San Diego
County, California.
3. Plaintiffs Ronald Hestand and Marcia Hestand are husband and wife, and have
been husband and wife since August 31, 1994.
4. Defendant Wyeth is a Delaware corporation with its principal place of business
in New Jersey. Wyeth regularly transacts business in the State of California.
Wyeth was formerly named the American Home Products Corporation. The company known
as the A.H. Robins Company, was merged with and into a wholly-owned subsidiary of
the American Home Products Corporation in 1989, which was merged into its parent
corporation, American Home Products, as a separate division, in August 1998.
5. Plaintiff does not know the true names of defendant Doe Drug Companies #1
through #20 and therefore identifies these companies by description and sues them
by those fictitious names.
II. JURISDICTION
6. This Court has subject matter jurisdiction over this matter pursuant to 28
U.S.C.A. s1332 (diversity jurisdiction). The amount in controversy exceeds
$75,000.00 and there is complete diversity of citizenship between Plaintiffs and
Defendants.
7. Venue is proper in this District pursuant to 28 U.S.C.A. s 1391. Defendant
marketed, advertised and distributed the dangerous product and the false and
misleading information in this district, thereby receiving substantial financial
benefit and profits from sales of the dangerous product in this district, and
reside in this district under 28 U.S.C.A. s 1391 (c), such that venue is proper.
8. At all relevant times herein, Defendants were in the business of designing,
manufacturing, marketing, developing, testing, labeling, promoting, distributing,
warranting and selling their product, Reglan or generic metoclopramide. Defendants
at all times relevant hereto designed, developed, manufactured, promoted,
marketed, distributed, tested, warranted and sold in interstate commerce
(including California) the aforementioned prescription drug information and the
foregoing prescription drug products. Defendants do substantial business in the
State of California and within this Federal Judicial District, advertise in this
district, distribute information and warnings in this district, receive
substantial compensation and profits from sales of Reglan and generic
metoclopramide in this District, and made material omissions and
misrepresentations and breaches of warranties in this District so as to subject
them to in personam jurisdiction in this District. In engaging in the conduct
alleged herein each defendant acted as the agent for each of the other defendants,
or those defendants's predecessors in interest.
III. FACTUAL BACKGROUND
9. At all relevant times the defendants have been engaged in the business of
manufacturing, designing, testing, marketing, promoting, distributing, and/or
selling prescription drug products.
Reglan and Metoclopramide Products
10. At all relevant times up to the end of 2001, Wyeth (as the A.H. Robins Company
and/or American Home Products Corporation and/or Wyeth-Ayerst Laboratories
Division and/or Wyeth) marketed and manufactured and/or distributed a certain
prescription drug product known as Reglan.
11. The term "Reglan" is the brand name for a drug known generically as
metoclopramide, or metoclopramide hydrochloride or metoclopramide HC1, terms which
also refer to the drug substance that is the sole active ingredient in Reglan.
12. At all relevant times, defendant Doe Drug Companies, #1 through #20, marketed
and manufactured and/or distributed generic drug products known variously by such
names as "generic metoclopramide" or "metoclopramide tablets" or "metoclpramide
syrup."
13. These generic metoclopramide products contain the same active ingredient as
Reglan, and are equivalent to Reglan in dosage, strength, and all other
therapeutically material respects, including potentially beneficial effects and
side effects, and differ from Reglan only in therapeutically non-relevant respects
such as color, shape, inactive ingredients, and source of manufacture.
14. The terms "Reglan" and "metoclopramide" are both frequently and
interchangeably employed, in common usage in the medical community, to refer to
all or any of the metoclopramide products, including both the name brand product (
Reglan) and its generic equivalents.
(In this Complaint, the term "Reglan" refers to the name brand product; "generic
metoclopramide" to the generic equivalent products; "metoclopramide products" to
both name brand and generic products; and "metoclopramide" to the drug substance.)
Promoting the Use of Reglan and Metoclopramide Products
15. As required by federal law for all prescription drug products, the
manufacturers of Reglan and of each of the generic metoclopramide products
included, in "package inserts" placed on or within the containers from which the
products (including "product samples," if any) were to be dispensed, the product's
"labeling," as approved by the federal Food and Drug Administration (FDA). The
labeling includes information on the product's active and inactive ingredients,
clinical pharmacology, "indications" and usage, contraindications, warnings,
precautions, and side effects (adverse reactions and overdosage).
16. The package inserts for Reglan and for each of the generic metoclopramide
products are materially identical, except for therapeutically non-relevant
differences among the products, such as color, shape, inactive ingredients, and
source of manufacture.
17. The labeling for Reglan was developed by the A. H. Robins Company, prior to
its merger into the wholly-owned Wyeth subsidiary, and revised from time to time,
after that merger and also after the subsidiary's subsequent merger into Wyeth, by
Wyeth as the A.H. Robins Company, the American Home Products Corporation,
Wyeth-Ayerst Division, and Wyeth.
18. Defendant Wyeth (as the A.H. Robins Company, the American Home Products
Corporation, Wyeth-Ayerst Division, and Wyeth) arranged for publication in the
Physician's Desk Reference (PDR), for all years in which it distributed Reglan,
the Reglan labeling (the verbatim content of the Reglan package insert) as a
so-called "monograph" for the product. The PDR is an annual compilation, updated
semiannually, of such "monographs," typically for name brand prescription drug
products. The annual edition and the supplements are distributed free of charge to
physicians in the United States, and widely relied upon by physicians as a
pharmaceuticals reference.
19. Wyeth knew that 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. Wyeth also knew that the conditions for which Reglan
would likely be prescribed, in particular bloating (such as "diabetic
gastroparesis") and heartburn (such as "gastroesophageal reflux disease," or
"GERD"), are often long-term chronic or intermittent conditions.
20. Defendant Wyeth chose to extend the duration of clinical trials for evaluating
the safety and efficacy of the drug Reglan to periods of not more than 12 weeks.
21. In order to increase sales, Wyeth (as the A.H. Robins Company, Inc., prior to
its merger) sponsored the performance of non-scientific investigations to suggest
that metoclopramide is safe for long-term use, wrote up the non-scientific results
of the investigations, and caused them to be published as if they were designed,
performed, and written up by outside independent investigators.
22. Wyeth, in connection with this promotion of Reglan use, also published and
disseminated other information, in the Reglan labeling, through the PDR, and in
other materials, to indicate or suggest that EPS side effects are comparatively
rare with metoclopramide use, whether short-term or long-term, and systematically
suppressed or downplayed contrary evidence about the risks and prevalence of side
effects associated with metoclopramide.
23. Wyeth 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
metoclopramide therapy at high dosages and/or long-term exposure, that many
physicians were over-prescribing metoclopramide products, and that many patients,
who would not have developed these side effects but for their overexposure to
metoclopramide, developed serious EPS side effects, including depression with
suicidal ideation, akathisia, akinesia, tardive dyskinesia, and tardive dystonia.
24. Wyeth declined to make or propose any changes in the Reglan labeling or other
promotional materials that would alert physicians to the risks of long term
metoclopramide exposure, and continued to disseminate information about Reglan and
metoclopramide to physicians implying that metoclopramide was not shown to be
unsafe for long term therapy.
25. The manufacturers of generic metoclopramide products adopted, as the package
inserts for their own products, the verbatim content of the package insert for
Reglan (as revised from time to time), modified only to reflect the
therapeutically non-relevant differences, such as color, shape, inactive
ingredients, and source of manufacture, among the therapeutically equivalent
products.
26. Indicated uses for the metoclopramide products, as reflected in the product
labeling and in the PDR monograph for Reglan, included "short term (4 to 12 weeks)
therapy for symptomatic gastroesophogeal reflux" and "relief of symptoms
associated with acute and recurrent diabetic gastroporesis." The text further
disclosed that exposure to metoclopramide could cause extrapyramidal syptoms,
including tardive dyskinesia and tardive distonia, and other afflictions involving
the central nervous system, and that the risk of developing tardive dyskinesia was
"believed to increase with duration of treatment and total cumulative dose."
27. At all relevant times, Wyeth and Doe Drug Companies #1 through #20 knew, or by
the exercise of known scientific methods could have known, and, in the exercise of
reasonable care toward patients who would be expected to ingest metoclopramide
products, should have known, inter alia, that:
a) Metoclopramide is a neuroleptic drug, classified as such (because of its
effects on the central nervous system, specifically as a dopamine antagonist) with
other neuroleptic drugs, which are also classified (because of their use in
treating schizophrenia) as antipsychotic drugs.
b) Specific neuroleptic drugs, in the absence of data specific to the drug, are
expected to lead to tardive dyskinesia in approximately 5% of patients/year who
are exposed to the drug in usual therapeutic doses for periods of 6months to a
year or more.
c) Clinical trials over periods longer than the periods for the Reglan clinical
trials, namely up to three months, would reveal the effects of longer term
cumulative exposure to metoclopramide specifically.
d) The results of epidemiological studies, published in peer-reviewed scientific
and medical literature, have consistently shown, for many years, a high prevalence
of tardive dyskinesia and other EPS among metoclopramide product users,
particularly those exposed to the drug for prolonged periods.
e) These published epidemiological studies represent the best scientific evidence
then available for evaluating the association between metoclopramide exposure and
the prevalence or incidence of tardive dyskinesia and other EPS.
f) Heartburn and gastric bloating are typically and often experienced chronically
or intermittently over long periods of time.
g) Neuroleptic drugs identified as such are commonly recognized, among internists,
family and general practitioners, and gastroenterologists, as leading to a high
incidence of tardive dyskinesia and related EPS when used for prolonged periods of
six months to a year or more.
h) Physicians commonly prescribe metoclopramide products, as treatment or relief
for heartburn and delayed gastric emptying, for prolonged periods of six months to
a year or more: nearly one-third of all patients who used metoclopramide products
during one relevant period received it on doctor's prescriptions for 12 months or
longer rather than 12 weeks or less.
28. The package inserts for metoclopramide products, and the materially identical
PDR monograph for Reglan, contained false and/or misleading statements and omitted
information material to the foreseeable and ordinary contemplated uses of the
products. These statements and omissions include:
a) The statement that the most common EPS occurred in approximately 1 in 500
patients using metoclopramide products. This statement is without scientific
evidence of any sort capable of supporting it and it is contradicted by data in
the Reglan pre-market clinical trials.
b) The omission of any reference to epidemiological studies and other evidence
suggesting that the prevalence of tardive dyskinesia among patients exposed to
metoclopramide for six months or longer is as much as 100 times greater than 1 in
500.
c) The statement that use of metoclopramide products for longer than 12 weeks "had
not been evaluated" and therefore "cannot" be recommended. The statement
misleadingly implies that no evaluation whatever of longer term use has been
undertaken, or that use for longer than 12 weeks would be recommended if only
formal evaluations or clinical studies for such periods had been performed.
d) The statement that the risk of tardive dyskinesia from exposure to
metoclopramide is "believed" to increase with duration of treatment and total
cumulative dose. The statement misleadingly implies that the "belief" is not
supported, or not strongly supported, by scientific evidence.
e) The omission of any statement that therapy with metoclopramide products should
not extend beyond three months, which implies, in context, that no scientific
evidence suggests, or strongly suggests, that longer term use increases
substantially the risks of overexposure.
29. Through published materials and other promotional efforts toward introducing a
metoclopramide product into the United States market, defendant Wyeth (as the A.
H. Robins Company, prior to its merger) planted and cultivated, among physicians,
the idea that long term use of metoclopramide was both safe and effective, and
since that time has profited from those efforts. Such promotions included
presentations by sales representatives (known as "detail men") emphasizing the
drug's gastroenterological effects, in particular gastric emptying, at the expense
of its extrapyramidal effects; the sponsoring of talks and seminars with company
sponsored speakers, who would discuss the supposed benefits and safety of longer
term use; and the ghost-authoring, company-sponsored publication, and further
dissemination of at least one junk science study calculated to "demonstrate" the
safety of long term metoclopramide use. Defendant Wyeth has never repudiated the
substance of these promotions nor acted to neutralize the effects of the
promotions in spreading misinformation about metoclopramide side effects among the
medical community.
Reglan and Metoclopramide Therapy for the Plaintiff and Consequent Injury
30. Between approximately 1985 and April 2009, for approximately 25 years,
plaintiff Ronald Hestand's physicians, at the United States Veterans
Administration, a federal government agency, and elsewhere, prescribed "Reglan"
and/or "metoclopramide" for him, on a more or less continuous and/or intermittent
basis, as a means of relieving more or less chronic delayed gastric emptying,
bloating and/or heartburn.
31. The Plaintiff's pharmacists filled the prescriptions with Reglan and/or
generic metoclopramide products, as authorized or required by state law, including
Sections 4073 and 4122 of the California Business and Professions Code and similar
so-called "drug product selection laws" enacted in every state.
32. In prescribing the metoclopramide products for the Plaintiff as they did, the
Plaintiff's physicians reasonably relied upon the information published in the PDR
or otherwise disseminated by Wyeth (as the A. H. Robins Company and by other
names), as the manufacturer/distributor of the name brand product Reglan, and were
not aware of information different from or contrary to the inaccurate, misleading,
materially incomplete, false, and/or otherwise inadequate information thus
disseminated.
33. All else being equal, a physician's reliance on the information concerning the
properties and effects of a drug or name brand prescription drug product as
contained in the PDR monograph for that drug, and in other materials disseminated
by the drug's manufacturer and/or distributor, is foreseeable and reasonable - and
equally foreseeable and reasonable as to the properties and effects of
therapeutically equivalent generic products.
34. The Plaintiff took the metoclopramide products, as prescribed by his
physicians and dispensed by his pharmacies, more or less continuously from
approximately 1985 through April 2009.
35. The Plaintiff's use of metoclopramide products, as prescribed by his
physicians, resulted in his overexposure to the drug metoclopramide, which caused
him to suffer serious, permanent and disabling injuries, including but not limited
to injuries of or associated with the central nervous and extrapyramidal motor
systems, specifically (for the past approximately 20 years) tardive dyskinesia and
(for the past several years) consequent clinical depression. The Plaintiff
discovered the cause of the afflictions from which he has been suffering, as
confirmed by Veterans Administration doctors in April 2009, only this year, after
happening upon publicity in the media concerning the connection between various
movement disorders and long term therapy using Reglan and/or other metoclopramide
products.
36. Because of these injuries the Plaintiff has experienced and will continue to
experience disfigurement, disability, embarrassment, loss of ability to provide
household services for himself, pain and suffering, medical and related expenses,
and other damages.
37. The Plaintiff's serious and permanent injuries, as described above, came about
as a foreseeable and proximate result of Wyeth's dissemination to physicians of
inaccurate, misleading, materially incomplete, and otherwise false information
concerning the potential effects of exposure to metoclopramide through the
ingestion of a metoclopramide product such as Reglan.
38. The Plaintiff's serious and permanent injuries, as described above, came about
as a foreseeable and proximate result of the failure of Wyeth and Doe Drug
Companies, #1 through #20, to disseminate to physicians (or their patients)
adequate warnings concerning the potential effects of exposure to metoclopramide
through the ingestion of their respective metoclopramide products.
IV. FIRST CAUSE OF ACTION: FRAUD (Defendant Wyeth)
39. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
40. Wyeth (as and through the A. H. Robins Company, the American Home Products
Corporation, and Wyeth-Ayerst Laboratories Division) disseminated the false
information, as referenced above, to physicians and, indirectly, to their
patients, knowing the information to be false or in conscious disregard of whether
it was false or not false, with the intention to deceive the physicians, and
indirectly their patients, and to induce the physicians to prescribe Reglan, and
in particular to prescribe Reglan for prolonged periods of time, with knowledge
that the patients were likely to ingest other, materially identical metoclopramide
products in addition to or in place of Reglan.
41. As a foreseeable and proximate result of this knowing dissemination of
knowingly and/or recklessly false information, as referenced above, the Plaintiff
suffered grievous bodily injury and consequent economic and other loss, as
described above, when his physicians, in foreseeable and reasonable reliance upon
this false information disseminated by Wyeth, and believing the information to be
true, prescribed for the Plaintiff the use of Reglan and/or metoclopramide
products for a prolonged and unwarranted period of time, and he ingested, per
those prescriptions, Reglan and/or other metoclopramide products, leading to his
toxic overexposure to metoclopramide.
V. SECOND CAUSE OF ACTION: FRAUD BY CONCEALMENT (Defendant Wyeth)
42. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
43. Defendant Wyeth (as and through the A. H. Robins Company, the American Home
Products Corporation, and Wyeth-Ayerst Laboratories Division), with the intention
of deceiving physicians and their patients, and to induce physicians to prescribe,
and their patients to ingest, Reglan for prolonged periods of time, informed
physicians, through the PDR and the dissemination of other materials, that
exposure to metoclopramide can lead to tardive dyskinesia and other ESP, that the
risk is "believed" to increase with duration of therapy and total cumulative dose,
and that therapy for longer than 12 weeks "cannot be recommended," but knowingly
concealed from the physicians material facts bearing on the interpretation of
those disclosures, including the fact that earlier false information, disseminated
by A.H. Robins Company, and representing long term metoclopramide therapy be
reasonably safe, was unscientific and false; that metoclopramide is a neuroleptic
agent and dopamine antagonist, which can be expected to lead to tardive dyskinesia
and other ESP with approximately the same high frequency, particularly in longer
term use, as other neuroleptic drugs; that epidemiological studies have
consistently confirmed this expectation; and that the treatment of chronic or
intermittent heartburn or delayed gastric emptying with Reglan and/or other
metoclopramide products for longer than 12 weeks is unlikely to be reasonably
safe.
44. The Plaintiffs physicians, in reasonable reliance upon the information thus
disseminated by Wyeth, and without knowledge of the undisclosed and knowingly
concealed facts, determined erroneously that the benefits of prolonged
metoclopramide therapy outweighed the risks for their patient, the Plaintiff, and
prescribed a prolonged course of therapy for him with metoclopramide products.
5. As a proximate and foreseeable result of Wyeth's knowing and fraudulent
concealment of material facts, as described above, the Plaintiff suffered grievous
bodily injury and consequent economic and other loss, as described above, when his
physicians, in reasonable reliance upon the information disseminated by Wyeth, and
in ignorance of the facts concealed from them in the materials thus disseminated,
prescribed for the Plaintiff the use of Reglan and/or metoclopramide for a
prolonged and unwarranted period of time and he ingested, per those prescriptions,
metoclopramide products, leading to his toxic overexposure to metoclopramide.
VI. THIRD CAUSE OF ACTION: NEGLIGENT MISREPRESENTATION (Defendant Wyeth)
46. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
47. Defendant Wyeth owed a duty in all of its several undertakings, including the
dissemination of information concerning Reglan and metoclopramide, to exercise
reasonable care to ensure that it did not, in those undertakings, create
unreasonable risks of personal injury to others.
48. Defendant Wyeth disseminated to physicians, through the publication of a PDR
monograph and otherwise, information concerning the properties and effects of
metoclopramide and Reglan, with the intention that physicians would rely upon that
information in their decisions concerning the prescription of drug therapy for
their patients.
49. It is the public policy of the United States and of this state, as reflected
in the Hatch-Waxman Act and in Sections 4073 and 4122 of the Business and
Professions Code and Section 14105.45 of the Welfare and Institutions Code, to
encourage the availability of cheaper, generic drug products that are
therapeutically equivalent to name brand products and to encourage the
substitution, as appropriate, of such generic products for name brand products in
patients' medical therapy.
50. Defendant Wyeth, as a prescription drug manufacturer and/or distributor, knew
or ought to have realized that so-called "drug product selection laws," enacted in
every state, including this state (see California Business and Profession Code
s4073), authorize or require a prescription for a drug identified by product brand
name or by generic name to be filled, subject to certain limited exceptions, with
a generic drug product that is therapeutically equivalent to the name brand drug
product.
51. Defendant Wyeth, as a prescription drug manufacturer and/or distributor, knew
or ought to have realized that the manufacturers and/or distributors of generic
products, as a custom, typically and simply copy verbatim, for those package
inserts, the therapeutically relevant content of the package insert for the name
brand prescription drug product, for which the generic products are therapeutic
equivalents; and, further, that the manufacturers of the counterpart generic
products typically rely upon the marketing efforts of the name brand manufacturer
to generate sales of their own products.
52. Defendant Wyeth, as a prescription drug manufacturer and/or distributor, knew
or ought to have realized that physicians, to obtain basic information about the
properties and effects of a drug or drug product that is available in both name
brand and generic formulations, commonly and typically consult the information
disseminated by the manufacturer/distributor of name brand product, in PDR
monographs or otherwise, and rely upon that information in their decisions
concerning the prescribing of those products for their patients, whether by brand
name or generic name, and that the patients are likely to receive and ingest, per
those prescriptions, one or more generic products that are therapeutically
equivalent to the name brand product.
53. Defendant Wyeth, as a prescription drug manufacturer and/or distributor, knew
or ought to have realized, specifically, that physicians, in weighing the
potential benefits and potential risks of using metoclopramide products, whether
name brand or generic or either, and in writing prescriptions for either "Reglan"
or "metoclopramide," would rely upon information disseminated to them by the
manufacturer of the name brand drug product, regardless of whether the
prescriptions might be filled with either the name brand product, Reglan, or
generic metoclopramide products, and that many patients, in accordance with those
prescriptions, would be likely to ingest generic metoclopramide products as
properly dispensed by their pharmacies.
54. Defendant Wyeth, as a prescription drug manufacturer and/or distributor, knew
or ought to have realized that patients receiving prescriptions for Reglan or
generic metoclopramide written in reliance upon information that it disseminated
as the manufacturer/distributor of Reglan, the name brand metoclopramide product,
would be placed in peril of grievous personal injury if the information thus
disseminated and relied upon was materially inaccurate, misleading, or otherwise
false.
55. Defendant Wyeth failed to exercise reasonable care to ensure that the
information it disseminated to physicians concerning the properties and effects of
Reglan (and of metoclopramide) was accurate and not misleading, and as a result
disseminated information to physicians that was negligently and materially
inaccurate, misleading, false, and unreasonably dangerous to patients such as the
Plaintiff, whether ultimately they purchased and ingested Reglan, generic
metoclopramide products, or both.
56. As a proximate and foreseeable result of this negligence, the Plaintiff
suffered grievous bodily injury and consequent economic and other loss, as
described above, when his physicians, in reasonable reliance upon the negligently
inaccurate, misleading, and otherwise false information disseminated by Wyeth, and
believing the information to be true, prescribed for the Plaintiff the use of
Reglan and/or metoclopramide products for a prolonged and unwarranted period of
time and he ingested, per those prescriptions, metoclopramide products, leading to
his toxic overexposure to metoclopramide.
VII. FOURTH CAUSE OF ACTION: STRICT PRODUCTS LIABILITY (All Defendants)
57. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
58. The dangerous propensities of metoclopramide products (including Reglan), as
referenced above, were known to Wyeth and Doe Drug Companies, #1 through #20, or
scientifically knowable to them, through appropriate research and testing by known
methods, at the time they distributed, supplied, or sold their respective
products, and not known to ordinary physicians who would be expected to prescribe
the drug for their patients or to their patients.
59. The metoclopramide products (including Reglan), as distributed by Wyeth and
Doe Drug Companies, #1 through #20, were defective and unreasonably dangerous
prescription drug products, inasmuch as the defendants failed to provide warnings
and instructions that were appropriate and adequate to render the products
reasonably safe for their ordinary, intended, and reasonably foreseeable uses, in
particular the common, foreseeable, and intended use of the products for long term
metoclopramide therapy. Specifically:
A. Defendant Wyeth disseminated, through the PDR and otherwise, warnings and
instructions that were not appropriate and adequate to render the products
reasonably safe for their ordinary, intended, and reasonably foreseeable uses, in
particular the common, foreseeable, and intended use of the products for long term
metoclopramide therapy.
B. The defendant manufacturers of generic metoclopramide products, knowing or
culpably ignorant of the inadequacy of the information disseminated to doctors by
co-defendant Wyeth, failed utterly to communicate any warnings or instructions at
all concerning their products to doctors (or their patients). Rather than
disseminating product information in a manner reasonably calculated to be seen and
read by doctors (or patients), these defendants disseminated such information
(namely the information contained in each product's "package inserts") only on or
within containers from which the products were to be dispensed by pharmacies to
consumers.
C. Alternatively, the defendant manufacturers of generic metoclopramide products
relied on co-defendant Wyeth to communicate appropriate information to doctors
about Reglan, and thereby to communicate to doctors appropriate information about
their own materially identical products, knowing or culpably ignorant of the
inadequacy of the information Wyeth disseminated to doctors. The information
contained in their products' package inserts, which were not distributed in a
manner reasonably calculated to be seen or read by physicians (or their patients),
contained in any event no additional material information at all.
60. As a foreseeable and proximate result of these defects, as described, in the
metoclopramide products which he ingested, and which had been manufactured,
supplied, and/or sold in that defective condition by defendants Wyeth and Doe Drug
Companies, #1 through #20, the Plaintiff suffered grievous bodily injuries and
consequent economic and other losses, as referenced above, when his physicians,
lacking adequate warnings and other appropriate facts that were misrepresented or
omitted from the information (if any) the defendants provided to physicians for
their respective products, prescribed for the Plaintiff the use of metoclopramide
products for a prolonged and unwarranted period of time and he ingested, per those
prescriptions, metoclopramide products manufactured by these defendants, leading
to his toxic overexposure to metoclopramide.
VIII. FIFTH CAUSE OF ACTION: NEGLIGENCE (All Defendants)
61. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
62. As manufacturers of prescription drug products, specifically metoclopramide
products, defendants Wyeth and Doe Drug Companies, #1 through #20, each owed a
duty toward foreseeable users of their respective metocloparamide products,
including the Plaintiff, to exercise reasonable care to ensure that the
metoclopramide products they manufactured and/or distributed were reasonably safe
for their ordinary and intended uses and, specifically, to ensure through adequate
testing, labeling, and otherwise, that physicians (or their patients) were
adequately informed as to the potential effects of using the products in ordinary
and foreseeable ways, in particular the risks inherent in such use.
63. Wyeth and Doe Drug Companies #1 through #20 each breached the duties they owed
to exercise reasonable care for the safety of users of their products, including
the Plaintiff, by failing to exercise reasonable care in testing the products for
their effects in ordinary and foreseeable uses, including long term use.
64. Wyeth and Doe Drug Companies #1 through #20 each also breached the duties they
owed to exercise reasonable care for the safety of users of their products,
including the Plaintiff, by negligently failing to disseminate, in a manner
reasonably calculated to be seen and read by physicians (or patients), information
concerning their respective products' effects which was accurate, nonmisleading,
and otherwise adequate to enable to physicians (or patients) to make informed
choices concerning the reasonably safe use of the products. Specifically:
A. Defendant Wyeth disseminated warnings and instructions that were negligently
inappropriate and inadequate to render the products reasonably safe for their
ordinary, intended, and reasonably foreseeable uses, in particular the common,
foreseeable, and intended use of the product for long term metoclopramide therapy.
B. The defendant manufacturers of generic metoclopramide products, knowing or
negligently ignorant of the inadequacy of the information disseminated to doctors
by co-defendant Wyeth, negligently failed utterly to communicate any warnings or
instructions at all concerning their products to doctors (or patients). Rather
than disseminating product information in a manner reasonably calculated to be
seen and read by doctors (or patients), these defendants disseminated such
information, namely the information contained in each product's "package inserts,"
only on or within containers from which the products were to be dispensed by
pharmacies to consumers.
C. Alternatively, the defendant manufacturers of generic metoclopramide products
negligently relied solely on co-defendant Wyeth to communicate appropriate
information to doctors about Reglan, and thereby to communicate to doctors
appropriate information about their own materially identical products, knowing or
negligently ignorant of the inadequacy of the information Wyeth disseminated to
doctors. (In any event, the information contained in their products' package
inserts, which were not distributed in a manner reasonably calculated to be read
or seen by any physician (or patient), contained no additional material
information at all.)
65. As a foreseeable and proximate result of these breaches by Wyeth and Doe Drug
Companies #1 through #20 of the duties they owed to exercise reasonable care for
the safety of users of their respective products, namely by their negligently
failing to adequately test their respective products and negligently failing to
provide adequate warnings and instructions for their respective products, the
Plaintiff suffered grievous bodily injury and consequent economic and other loss,
as described above, when his physicians, lacking adequate warnings and other
appropriate facts that were misrepresented or omitted from the information (if
any) the defendants provided to physicians for their respective products,
prescribed for the Plaintiff the use of metoclopramide products for a prolonged
and unwarranted period of time and he ingested, per those prescriptions,
metoclopramide products manufactured by these defendants, leading to his toxic
overexposure to metoclopramide.
IX. SIXTH CAUSE OF ACTION: NEGLIGENCE PER SE (All Defendants)
66. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
67. As part of their duty to exercise reasonable care for the safety of persons,
including the Plaintiff, who would be expected to use their products, defendants
Wyeth and Doe Drug Companies, #1 through #20, were obliged to follow public laws
and regulations enacted and promulgated to protect the safety of such persons,
including 21 U.S.C. ss 331(a) and 352 and California Health and Safety Codes ss
111330 -111510, which make it unlawful to misbrand prescription drug products.
68. The package inserts (and other labeling, if any) for each of the
metoclopramide products failed to conform to the requirements of 21 U.S.C. s352,
including subsections (a), (c), and (f), or the requirements of 21 C.F.R. s
201.100(c)(1), and therefore violated 21 U.S.C. s 331(a), and also violated
California Health and Safety Codes ss 111330 111510, inasmuch as the package
inserts and/or other labeling failed to contain, inter alia, information,
including warnings and instructions for use, adequate to enable the use of the
product in an ordinary, foreseeable, and intended manner that was reasonably safe,
taking into account the potential benefits and potential risks entailed in such
use, or to bear "information for its use, including... any relevant hazards,
contraindications, side effects, and precautions" that were adequate to enable
doctors to "use the drug safely and for the purposes for which it is intended;"
and, in addition, contained false, inaccurate, and/or misleading statements
concerning the their respective products' side effects.
69. Accordingly, defendants Wyeth and each of the Doe Drug Companies, #1 through
#20, in distributing the metoclopramide products labeled in violation of these
statutes and associated regulations, were negligent per se, that is, as a matter
of law.
70. As a foreseeable and proximate result of the negligence per se of Wyeth and
each of the John Doe Drug Companies, #1 through #20, specifically their violations
described of the above referenced statutes and regulations, the Plaintiff suffered
grievous bodily injury and consequent economic and other loss, as described above,
when his physicians, in reasonable but unjustified reliance upon the defendants'
compliance with these health and safety laws and regulations, prescribed for the
Plaintiff the use of metoclopramide products for a prolonged and unwarranted
period of time and he ingested, per those prescriptions, metoclopramide products
manufactured by these defendants, leading to his toxic overexposure to
metoclopramide.
X. SEVENTH CAUSE OF ACTION: BREACH OF EXPRESS WARRANTIES (All Defendants)
71. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
72. The Reglan and/or therapeutically equivalent generic metoclopramide products
materially failed to conform to those representations which the the several
defendants made, in package inserts and otherwise, concerning the properties and
effects of the metoclopramide products which they respecively manufactured and/or
distributed and sold, and which the Plaintiff purchased and ingested in direct or
indirect reliance upon these express representations. That failure constituted a
material breach of express warranties made, directly or indirectly, to the
Plaintiff, concerning the products thus sold to the Plaintiff.
73. As a foreseeable and proximate result of these breaches of express warranties
on the part of defendants Wyeth and Doe Drug Companies, #1 through #20, the
Plaintiff suffered grievous bodily injury and consequent economic and other loss,
as described above, when his physicians, in reasonable reliance upon the express
warranties, prescribed for the Plaintiff the use of metoclopramide products for a
prolonged and unwarranted period of time and he purchased and ingested, per those
prescriptions, metoclopramide products manufactured by these defendants, leading
to his toxic overexposure to metoclopramide.
74. The Plaintiff notified of the Wyeth of the breaches of express warranties as
soon as the breaches were ascertained and made known to him and will so notify Doe
Drug Companies #1 through #20 promptly upon obtaining sufficient evidence of their
specific identities.
XI. EIGHTH CAUSE OF ACTION: BREACH OF IMPLIED WARRANTIES (All Defendants)
75. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
76. Wyeth and each of the Doe Drug Companies, #1 through #20, impliedly warranted
their respective metoclopramide products, which they manufactured and/or
distributed and sold, and which the Plaintiff purchased and ingested, to be of
merchantable quality and fit for the common, ordinary, and intended uses for which
the products were sold, including specifically long term metoclpramide therapy for
the treatment of chronic and/or intermittent heartburn and bloating.
77. Wyeth and each of the Doe Drug Companies, #1 through #20, breached their
implied warranties of the metoclopramide products sold to the Plaintiff, because
these products were not fit for their common, ordinary, and intended use in long
term therapy for the treatment of chronic and/or intermittent heartburn and/or
bloating.
78. As a foreseeable and proximate result of these breaches of implied warranties
on the part of Wyeth and each of the Doe Drug Companies, #1 through #20, the
Plaintiff suffered grievous bodily injury and consequent economic and other loss,
as described above, when her physicians, in reasonable reliance upon the implied
warranties, prescribed for the Plaintiff the use of metoclopramide products for a
prolonged and unwarranted period of time and he purchased and ingested, per those
prescriptions, metoclopramide products manufactured by these defendants, leading
to his toxic overexposure to metoclopramide.
79. The Plaintiff notified Wyeth of the breaches of implied warranties as soon as
the breaches were ascertained and made known to him and will so notify Doe Drug
Companies, #1 through #20, promptly upon obtaining sufficient evidence of their
specific identities.
XII. NINTH CAUSE OF ACTION: UNFAIR TRADE PRACTICES (All Defendants)
80. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
81. Wyeth and Doe Drug Companies, #1 through #20, through the use of false and/or
misleading advertising, representations, and statements, as described above,
induced the Plaintiff (through his physicans, as learned intermediaries between
himself and the drug companies) to use and consume the metoclopramide products
which they manufactured and/or distributed and sold, all in violation the
California Business and Professions Code, Division 7, Part 2, Preservation and
Regulation of Competition, which proscribes, among other things:
a) Engaging in unfair trade practices as defined in this statute by making false
and misleading written statements that have 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 a use or benefit which they did not have,
including but not limited to statements concerning the health consequences of the
use of drugs;
c) Engaging in unfair trade practices as defined in this statute by failing to
state material facts, the omission of which deceive or tend 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.
82. As a result of the aforesaid statutory violations, Plaintiff is entitled to
relief, as prayed for below.
XIII. TENTH CAUSE OF ACTION: CONSORTIUM (All Defendants)
83. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
84. At all times mentioned herein, plaintiff Ronald Hestand and plaintiff Marcia
Hestand were husband and wife
85. Before suffering the injuries described herein, plaintiff Ronald Hestand was
able to and did perform all the duties of a husband and did perform all these
duties, including assisting in maintaining the home, and providing love,
companionship, affection, society, sexual relations, moral support, and solace to
plaintiff Marcia Hustand. As a direct and proximate result of the injuries
suffered by Ronald Hestand, as more fully described above, Ronald Hestand has been
unable to fully and effectively perform the duties of a husband and he has not
been able to fully participate in family, recreational, or social activities with
plaintiff Marcia Hustand or contribute fully to the household income. Due to the
nature of the injuries sustained by Ronald Hustand and the severe physical and
psychological strains they cause him, plaintiff Ronald Hustand is no longer able
to provide plaintiff Marcia Hustand with love, companionship, affection, society,
moral support, and solace in the same manner and to the same degree he was able to
perform and did perform before he was injured as a result of defendants' tortious
conduct, as more fully described above. Because of these injuries, plaintiff
Ronald Hustand will be unable to perform these duties in the future. Plaintiff
Marcia Hustand is therefore deprived and will be permanently deprived of her
spouse's consortium, all to her damage, in a total amount to be established by
proof at trial.
XIV. PUNITIVE DAMAGES
86. The plaintiffs incorporate by reference all allegations of fact made
hereinabove, as if set out word for word in this paragraph.
87. At the expense of and in conscious disregard for the health and safety of
those who consequently would develop tardive dyskinesia and other EPS due to
over-prescription of the drug at excessive dosage and/or for excessive periods of
time, defendant Wyeth (as the A.H. Robins Company, prior to its merger into Wyeth,
and as Wyeth and by other names thereafter) marketed Reglan to physicians, as
hereinabove described, in a manner calculated to increase sales of the drug and
resultant profits to the drug company.
88. As part of promotional efforts intentionally aimed at increasing
inappropriately unsafe but profitable prescribing of Reglan, defendant Wyeth (as
the A.H. Robins Company, prior to its merger into Wyeth, and as Wyeth and by other
names thereafter), sponsored the performance of knowingly non-scientific
investigations, and created and disseminated reports from those investigations, to
suggest that metoclopramide is safe for long-term use; chose to develop and
disseminate other information, including the Reglan product labeling, to suggest
falsely and/or misleadingly that EPS side effects are rare with metoclopramide
use, whether short-term or long-term; and otherwise systematically suppressed or
downplayed, in the information it disseminated, specific scientific information
about the risks and prevalence of side effects associated with metoclopramide.
89. By this conduct, defendant Wyeth (as the A.H. Robins Company, prior to its
merger into Wyeth, and as Wyeth and by other names thereafter) acted with
oppression, fraud, and malice, evincing a willful, wanton, and conscious disregard
for the rights, health, and safety of patients, including the Plaintiff, who would
be expected to be induced, by the conduct, to ingest uwarranted amounts of
metoclopramide for prolonged and unwarranted periods of time, leading to grievous,
debilitating, and potentially permanent personal injury.
90. Defendant Wyeth's conduct, as alleged, warrants an exaction of punitive
damages assessed (a) in an amount reasonably related to the plaintiffs' actual
damages and defendant Wyeth's wealth and profits from the willful, wanton, and
reckless conduct alleged and proved, and (b) sufficiently large to set an example
for others and deter similar conduct in the future.
XV. PRAYER FOR RELIEF
The plaintiffs respectfully pray for relief against the Defendants, and each of
them, as follows:
1. General 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.
JURY DEMAND
Plaintiff demands that all issues of fact in this case be tried to a properly
empanelled jury.
Appendix not available.
Ronald HESTAND and Marcia Hestand, husband and wife, Plaintiffs, v. WYETH, INC.
d/b/a Wyeth, a/k/a A.H. Robins Company and American Home Products Corporation and
by other aliases; and Doe Drug Companies, #1 Through #20., Defendants.
