Yet another movement disorder lawsuit was filed against the various manufacturers of the brand-name drug Reglan and its generic equivalent, Metoclopramide. Hundreds of Reglan lawyers across the country are filing lawsuits similar to this one, which alleges that long-term use of Reglan leads to movement disorders. Ever since the FDA issued its black box warning for Reglan, there has been little scientific debate over whether users of Reglan could develop movement disorders like tardive dyskinesia. The legal battle is waged over whether the manufacturers adequately warned Reglan users of the risks of developing movement disorders.
44. This case involves, in part, Defendants' failure to warn doctors and patients
of information within their knowledge or possession which indicated that the
subject Reglan/metoclopramide, when taken for long periods of time, caused
serious, permanent and debilitating side effects, including tardive dyskinesia.45. Defendants jointly and severally marketed, manufactured and distributed
Reglan/metoclopramide and encouraged the long term use of these drugs,
misrepresented the effectiveness of these drugs and concealed the drug's dangerous
side effects.46. Reglan/metoclopramide is indicated as short-term therapy for symptomatic
gastroesophageal reflux and acute and recurrent diabetic gastric stasis.47. Reglan/metoclopramide is indicated for use for no greater than twelve weeks;
however, Defendants represented that Reglan/metoclopramide was safe for use to
treat nausea and/or esophageal reflux for durations that exceed twelve weeks.48. Patients who use Reglan/metoclopramide for long periods are at a significantly
increased risk of developing a severe and permanent neurological movement
disorder.
Circuit Court of Florida.
Seventeenth Judicial Circuit
Palm Beach County
Gayle DIETRICH and William H. Dietrich, Plaintiffs,
v.
WYETH, INC. d/b/a Wyeth, Individually and as Successor-In-Interest to A.H. Robbins
Company, Inc. and American Home Products Corporation; ESI Lederle, Inc.; Schwarz
Pharma, Inc.; Wyeth Pharmaceuticals, Inc.; McKesson Corporation; Purepac
Pharmaceutical Co.; Alpharma USPD, f/k/a Barre-National, Inc.; Alpharma, Inc.;
Actavis, Inc.; Actavis Mid Atlantic, LLC; Actavis Elizabeth, LLC; Barre Parent
Corporation; Pliva, Inc., f/k/a/ Sidmak Laboratories, Inc.; Barr Pharmaceuticals,
Inc.; Craig G. Sultan, D.O., and Craig G. Sultan, D.O., P.A., Defendants.
No. 50 2009 CA 021586XXXXMB.
June 24, 2009.
Complaint
The Maher law Firm, A Professional Association, 631 W. Morse Blvd., Suite 200,
Winter Park, FL 32789, Phone: 407-839-0866, Fax: 407-425-7958, Attorneys for
Plaintiffs, Steven R. Maher, Florida Bar # 887846.
COME NOW the Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, by and through
their undersigned counsel, and sue WYETH, INC. d/b/a WYETH, Individually and as
Successor-in-interest to A.H. ROBBINS COMPANY, INC., AMERICAN HOME PRODUCTS
CORPORATION and ESI LEDERLE, INC.; SCHWARZ PHARMA, INC.; WYETH PHARMACEUTICALS,
INC.; MCKESSON CORPORATION; PUREPAC PHARMACEUTICAL CO.; ALPHARMA USPD, f/k/a
BARRE-NATIONAL, INC.; ALPHARMA, INC.; ACTAVIS, INC.; ACTAVIS MID ATLANTIC, LLC;
ACTAVIS ELIZABETH, LLC; BARRE PARENT CORPORATION; PLIVA, INC., f/k/a/ SIDMAK
LABORATORIES, INC.; BARR PHARMACEUTICALS, INC.; CRAIG G. SULTAN, D.O., and CRAIG
G. SULTAN, D.O., P.A., and allege as follows:
PARTIES
Plaintiffs
1. Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, are individuals who, at all
times material to this action, are residents and citizens of Palm Beach County,
State of Florida.
2. At all times material to this cause, Plaintiffs GAYLE DIETRICH and WILLIAM H.
DIETRICH were lawfully married.
Defendants
3. Defendant, WYETH, INC., d/b/a WYETH (hereinafter "WYETH") is a Delaware
corporation with its principal place of business at 5 Giralda Farms, Madison, New
Jersey 07940.
4. References in this Complaint to "WYETH" include individually and collectively
all divisions and/or subsidiaries, including but not limited to, WYETH as
successor in interest to A.H. ROBINS, INC., AMERICAN HOME PRODUCTS CORPORATION,
and ESI, LEDERLE, INC.
5. At all times material hereto, WYETH was engaged in the business of testing,
developing, manufacturing, labeling, marketing, distributing, promoting, and/or
selling, either directly or indirectly, through third parties, as successor in
interest, or other related entities, Reglan/metoclopramide in the State of Florida
and in interstate commerce. WYETH may be served with process through its
registered agent, Prentice Hall Corporation Systems, 2711 Centerville Rd., Suite
400, Wilmington, Delaware 19808. WYETH is subject to the jurisdiction and venue of
this Court.
6. WYETH manufactures and distributes generic metoclopramide through its ownership
of ESI LEDERLE, INC. (hereinafter "ESI"), a former subsidiary which merged into
WYETH.
7. Defendant, WYETH PHARMACEUTICALS, INC. (hereinafter "WYETH PHARMA"), is a
Delaware Corporation with its principal place of business at Five Giralda Farms,
Madison, New Jersey 07940.
8. At all times material hereto, WYETH PHARMA was engaged in the business of
testing, developing, manufacturing, labeling, marketing, distributing, promoting
and/or selling, either directly or indirectly, through third parties or related
entities, Reglan/metoclopramide in the State of Florida and in interstate
commerce. The Defendant, WYETH PHARMA, may be served with process through its
agent for service: Corporation Service Company, 2711 Centerville Road, Suite 400,
Wilmington, Delaware 19808. WYETH PHARMA is subject to the jurisdiction and venue
of this Court.
9. Defendant, SCHWARZ PHARMA, INC., (hereinafter "SCHWARZ") is a Delaware
corporation, duly qualified to do business in the State of Florida with its
principal place of business at 6140 W. Executive Drive., Mequon, Wisconsin 53092.
10. Defendant, SCHWARZ, one of its predecessors in interest, and/or one of its
families of wholly owned divisions was engaged in the business of testing,
developing, manufacturing, labeling, marketing, distributing, promoting, and/or
selling, either directly or indirectly, through third parties, as successor in
interest, or other related entities, Reglan/metoclopramide in the State of Florida
and in interstate commerce. SCHWARZ may be served with process through its
registered agent, Corporation Service Company, 2711 Centerville Road, Wilmington,
Delaware 19808. SCHWARZ PHARMA, INC. is subject to the jurisdiction and venue of
this Court.
11. Defendant, MCKESSON CORPORATION (hereinafter "MCKESSON"), is a Delaware
corporation that is the parent company of MCKESSON PHARMACEUTICAL, with the latter
having its principal place of business at One Post Street, San Francisco,
California 94104.
12. At all times material hereto, MCKESSON was engaged in the business of testing,
developing, manufacturing, labeling, marketing, distributing, promoting and/or
selling, either directly or indirectly, through third parties or related entities,
Reglan/metoclopramide and/or metoclopramide HC1 tablets in the State of Florida
and in interstate commerce. MCKESSON may be served with process through its agent
for service: The Prentice-Hall Corporation System, Inc., 2711 Centerville Road,
Suite 400, Wilmington, Delaware 19808. MCKESSON is subject to the jurisdiction and
venue of this Court.
13. Defendant, ALPHARMA, INC. ("ALPHARMA") is a foreign corporation organized
under the laws of Delaware with its principal offices in Bridgewater, New Jersey.
At all times material to this civil action, ALPHARMA has transacted business in
the State of Florida by selling and distributing to purchasers in the State of
Florida pharmaceutical products that are the subject of this action. ALPHARMA may
be served with process by serving its registered agent at the following registered
address: Corporation Service Company, 2711 Centerville Road, Suite 400,
Wilmington, Delaware.
14. ALPHARMA USPD, INC., f/k/a BARRE-NATIONAL, INC. ("ALPHARMA USPD"), is a
foreign corporation organized under the laws of Maryland with its principal
offices in Baltimore, Maryland. ALPHARMA USPD was a subsdiary of ALPHARMA. In
about December, 2005, ALPHARMA USPD was acquired by Activis Group, a corporation
organized under the laws of Iceland with its principal offices in Hamarfjordur,
Iceland. As further described herein below, ACTAVIS MIDATLANTIC LLC ("ACTAVIS
MIDATLANTIC"), a corporation organized under the laws of Delaware with its
principal offices in Dover, Delaware, is the surviving entity that acquired
ALPHARMA USPD pharmaceutical products that are the subject of this action. To the
extent the acts of ALPHARMA USPD at issue here were performed on behalf of or are
otherwise attributable to any corporate affiliate or subsidiary, including
ALPHARMA, ACTAVIS GROUP or ACTAVIS MIDALTANTIC, LLC, then judgment should be
entered against such affiliates or subsidiaries where appropriate. At all times
material to this action, ALPHARMA USPD, ACTAVIS GROUP, or ACTAVIS MID ALTANTIC has
transacted business in the State of Florida by selling and distributing to
purchasers in the State of Florida pharmaceutical products that are the subject to
this action. ALPHARMA USPD may be served with process through its registered agent
United Corporate Services, Inc., 20 South Charles St., Suite 120, Baltimore,
Maryland 21201.
15. PUREPAC PHARMACEUTICAL CO. ("PUREPAC") was a corporation authorized under the
laws of Delaware with its principal offices in Cranford, New Jersey. In about
December, 2001, ALPHARMA USPD acquired PUREPAC. In about December, 2005, ALPHARMA
USPD was acquired by ACTAVIS GROUP. As further described herein below, ACTAVIS
ELIZABETH LLC ("ACTAVIS ELIZABETH"), is a corporation organized under the laws of
Delaware with its principal office in Pitcataway, New Jersey, is the successor to
the PUREPAC pharmaceutical products acquired by Actavis Group. To the extent the
acts of PUREPAC at issue here were performed on behalf of or are otherwise
attributable to its corporate affiliates ALPHARMA, ALPHARMA USPD, ACTAVIS GROUP or
ACTAVIS ELIZABETH, or any other subsidiary or affiliate, then judgment should be
entered against such subsidiary or affiliate where appropriate. At all times
material to this civil action, PUREPAC and ACTAVIS ELIZABETH transacted business
in the State of Florida by selling and distributing to purchasers in the State of
Florida pharmaceutical products that are the subject of this action. PUREPAC may
be served with process by serving its registered agent at the following registered
address: Corporation Service Company, 2711 Centerville Road, Suite 400,
Wilmington, Delaware.
16. ACTAVIS MID ATLANTIC, LLC ("ACTAVIS MID ATLANTIC") is a foreign corporation
organized under the laws of Delaware and doing business in the State of Florida.
ACTAVIS MID ATLANTIC may be served with process by serving its registered agent at
the following registered address: United Corporate Service, Inc., 874 Walker Road,
Suite C, Dover, Delaware 19904.
17. Defendant, ACTAVIS ELIZABETH LLC, (hereinafter referred to as "ACTAVIS
ELIZABETH") is a Delaware corporation with its principal place of business in New
Jersey. ACTAVIS ELIZABETH is a wholly owned subsidiary of ACTAVIS, INC. ACTAVIS
ELIZABETH may be served with process through its agent for service; United
Corporate Services, Inc., 874 Walker Road, Suite C, Dover, Delaware 19904.
ACTAVIS, INC. is being sued herein as the owner of ACTAVIS ELIZABETH and may be
served with process at United Corporate Service, Inc., 874 Walker Rd., Sutie C,
Dover, Delaware 19904. Hereafter, ACTAVIS ELIZABETH, ACTAVIS, INC. and ACTAVIS MID
ATLANTIC, LLC will be collectively referred to as "ACTAVIS."
18. At all times material hereto, ACTAVIS was engaged in the business of testing,
developing, manufacturing, labeling, marketing, distributing, promoting and/or
selling, either directly or indirectly, through third parties or related entities,
Reglan/metoclopramide and/or metoclopramide HC1 tablets in the State of Florida
and in interstate commerce. ACTAVIS is subject to the jurisdiction and venue of
this Court.
19. BARRE PARENT CORP. ("BARRE") is a foreign corporation organized under the laws
of Delaware with its principal place of business in Baltimore, Maryland, and
doing, or has done, business in the State of Florida. At all relevant times, BARRE
was the immediate corporate parent of ALPHARMA USPD. ALPHARMA is the ultimate
corporate parent of BARRE. To the extent the acts of BARRE at issue here were
performed on behalf of or are otherwise attributable to ALPHARMA, or any other
affiliate or subsidiary, then judgment should be entered against ALPHARMA, and any
such subsidiary or affiliate, where appropriate. At all times material to this
action, BARRE, has transacted business in the State of Florida by selling and
distributing to purchasers in the State of Florida pharmaceutical products that
are the subject of this action. BARRE may be served with process by serving its
registered agent at the following registered address: Corporation Service Company,
2711 Centerville Road, Suite 400, Wilmington, Delaware.
20. PLIVA, INC., f/k/a SIDMAK LABORATORIES, INC. is a corporation organized under
the laws of New York with its principal offices in East Hanover, New Jersey. In
about July, 2002, Sidmak Laboratories, Inc. ("SIDMAK") was acquired by PLIVA d.d.
and was renamed PLIVA, INC. ("PLIVA"). PLIVA d.d. is a corporation organized under
the laws of the Republic of Croatia with its principal offices in Zagreb, Croatia.
In about October, 2006, PLIVA d.d. and PLIVA, Inc. were acquired by BPI. To the
extent the acts of PLIVA at issue herein were preformed on behalf of or are
otherwise attributable to BPI or any subsidiary or affiliate thereof, then
judgment should be entered against BPI or any such subsidiary ro affiliate, where
appropriate. At all times material to this civil action, PLIVA has transacted
business in the State of Florida by selling and distributing to purchasers in the
State of Florida pharmaceuticals products that are the subject of this action.
PLIVA may be served through its general counsel, 225 Summit Avenue, Montvale, New
Jersey 07645.
21. BARR PHARMACEUTICALS, INC. ("BPI") is a foreign corporation organized under
the laws of Delaware with its principal offices in Woodcliff Lakes, New Jersey. To
the extent that the acts of BARR and/or PLIVA at issue herein were performed on
behalf of or are otherwise attributable to BPI or any subsidiary or affiliate
thereof, then judgment should be entered against BPI and any such subsidiary or
affiliate where appropriate. At all times material to this action, BPI has
transacted business in the state of Florida by, including, but not limited to,
selling and distributing to purchasers in the State of Florida pharmaceutical
products that are the subject of this action. BPI may be served with process by
serving its registered agent at the following registered address: Corporation
Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware.
22. At all times material to this cause, the Defendant, CRAIG G. SULTAN, D.O., was
licensed to practice medicine in the State of Florida, held himself out as a
physician specially trained in the practice of family practice, and practiced that
specialty in Broward County, Florida.
23. At all times material to this cause, the Defendant, CRAIG G. SULTAN, D.O.,
P.A., was a Florida corporation for the practice of medicine, whose principal
place of business was in Broward County, Florida.
VENUE AND JURISDICTION
24. Plaintiffs seek in excess of $15,000.00, excluding costs and interest.
25. Plaintiffs are citizens and residents of Palm Beach County, Florida.
26. Plaintiffs' causes of action accrued in Palm Beach County, Florida as
Plaintiff, GAYLE DIETRICH, ingested Reglan/metoclopramide in Palm Beach County,
Florida and was subsequently diagnosed with Tardive Dyskinesia and/or other injury
due to her ingestion of Reglan/metoclopramide while in Palm Beach County, Florida.
ALLEGATIONS COMMON TO COUNTS (I) - (V)
27. Plaintiff, GAYLE DIETRICH, was prescribed and ingested Reglan/metoclopramide
in or about 2003 and continued until in or about October of 2006 while a resident
and citizen of Palm Beach County, State of Florida.
28. Plaintiff, GAYLE DIETRICH, developed Tardive Dyskinesia and/or other injuries
after ingesting Reglan/ metoclopramide.
29. Plaintiff, GAYLE DIETRICH'S, injuries, including Tardive Dyskinesia, were
diagnosed in 2006 while she was a resident and citizen of Palm Beach County, State
of Florida.
30. Plaintiff, GAYLE DIETRICH, brings this action for the purpojse of recovering
damages for the personal injuries he has suffered as a result of being prescribed
and ingesting Reglan, metoclopramide and/or metoclopramide HC1 (hereinafter
referred to as "Reglan/metoclopramide").
31. Plaintiff, GAYLE DIETRICH, was prescribed Reglan to treat Plaintiff, GAYLE
DIETRICH'S gastroesophageal reflux disease (GERD).
32. The active ingredient, metoclopramide and metoclopramide HC1 is a dopamine
antagonist.
33. Upon information and belief, the physician who prescribed Reglan/
metoclopramide to Plaintiff, GAYLE DIETRICH, on a long-term basis relied upon
information published in the package inserts and/or the Physicians' Desk Reference
(hereinafter referred to as "PDR") or otherwise disseminated by the Reference
Listed Drug Company (hereinafter referred to as "RLD") and/or the New Drug
Application Holder (hereinafter referred to as "NDA Holder").
34. Plaintiff, GAYLE DIETRICH, ingested the Reglan/metoclopramide as prescribed.
35. Plaintiff, GAYLE DIETRICH, used the pharmaceutical drugs Reglan/metoclopramide
without substantial change in the condition of the drugs between the time of
design and manufacture of the drugs and the time Plaintiff, GAYLE DIETRICH, used
the drugs as directed.
36. Plaintiff, GAYLE DIETRICH'S long-term ingestion of the Reglan/metoclopramide
caused her injuries.
37. The Reglan/metoclopramide ingested by Plaintiff, GAYLE DIETRICH was
manufactured, marketed and distributed by one or more of the Defendants in this
cause of action.
38. Plaintiff, GAYLE DIETRICH was not aware of information different from or
contrary to the inaccurate, misleading, materially incomplete, false and/or
otherwise inadequate information disseminated in the PDR, RLD, or by the NDA
Holders.
39. In or about October of 2006, Plaintiff, GAYLE DIETRICH'S Reglan/metoclopramide
was discontinued due to the clinical presentation of abnormal movements, including
but not limited to severe tremors, shaking and pacing. The abnormal movements were
later linked to her use of Reglan/metoclopramide.
40. Plaintiff, GAYLE DIETRICH'S use of Reglan/metoclopramide, as prescribed,
resulted in overexposure to the drugs which have caused Plaintiff 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 Tardive Dyskinesia, a severe and often permanent disfiguring
neurological movement disorder.
41. Plaintiff, GAYLE DIETRICH'S serious and permanent injuries, as described
above, came about as a foreseeable and proximate result of Defendants'
dissemination of inaccurate, misleading, materially incomplete, false and
otherwise inadequate information concerning the potential effects of exposure to
and long term ingestion of Reglan/metoclopramide to the medical community,
Plaintiff, GAYLE DIETRICH, and other foreseeable users of the drug.
42. Plaintiff, GAYLE DIETRICH, has experienced and will continue to experience
medical and related expenses, loss of ability to provide household services,
disfigurement, disability, pain, suffering, psychological injury and other
injuries and damages due to the prescription and ingestion of this drug.
43. Plaintiff, WILLIAM H. DIETRICH, has experienced and will continue to
experience the loss of the care, comfort, companionship of his wife, GAYLE
DIETRICH, due to the injuries she has suffered as a direct and proximate result of
her ingestion of Reglan/metoclopramide.
Drug Company Defendants' Wrongful Conduct pertaining to Counts I - V
44. This case involves, in part, Defendants' failure to warn doctors and patients
of information within their knowledge or possession which indicated that the
subject Reglan/metoclopramide, when taken for long periods of time, caused
serious, permanent and debilitating side effects, including tardive dyskinesia.
45. Defendants jointly and severally marketed, manufactured and distributed
Reglan/metoclopramide and encouraged the long term use of these drugs,
misrepresented the effectiveness of these drugs and concealed the drug's dangerous
side effects.
46. Reglan/metoclopramide is indicated as short-term therapy for symptomatic
gastroesophageal reflux and acute and recurrent diabetic gastric stasis.
47. Reglan/metoclopramide is indicated for use for no greater than twelve weeks;
however, Defendants represented that Reglan/metoclopramide was safe for use to
treat nausea and/or esophageal reflux for durations that exceed twelve weeks.
48. Patients who use Reglan/metoclopramide for long periods are at a significantly
increased risk of developing a severe and permanent neurological movement
disorder.
49. Other serious side effects caused by ingesting Reglan/metoclopramide for long
periods include, but are not limited to, central nervous system disorders,
depression with suicidal ideation, akathesia, tardive dyskinesia, tardive
dystonia, visual disturbances and interference with drug metabolism.
50. Patients who use Reglan/metoclopramide for long periods who are not able to
effectively metabolize it are at a greater risk of developing these serious and
permanent injuries.
51. Tardive dyskinesia, one of the serious side effects associated with the
ingestion of Reglan/metoclopramide is a debilitating neurological disorder that
often results in involuntary and uncontrollable movements of the head, neck, face,
arms, legs and trunk, in addition to facial grimacing, uncontrollable tongue
movements and other involuntary movements. Presently, there is no cure for tardive
dyskinesia.
52. Plaintiff, GAYLE DIETRICH'S diagnosed tardive dyskinesia, caused by the
ingestion of metoclopramide, is permanent.
53. WYETH is the successor in interest to A.H. ROBINS COMPANY, INC., which first
obtained approval by the United States Food and Drug Administration (hereinafter
referred to as "FDA") to distribute metoclopramide, under the brand name "Reglan"
under the FDA's New Drug Application (NDA)[FN1] schema in 1983.
FN1. Upon information and belief, Wyeth is the holder of multiple NDAs for
Reglan, metoclopramide and metoclopramide HC1.
54. Defendant, WYETH's predecessor-in-interest, A.H. ROBINS COMPANY, INC.
expressly warranted to some physicians that Reglan/metoclopramide is safe for
long-term use.
55. A.H. ROBINS knew that its warranties regarding safety for long-term use would
be relied upon by ordinary, reasonable and prudent physicians who would share that
information with other physicians in their communities and that eventually
physicians would come to rely on A.H. ROBINS' express warranties about
Reglan/metoclopramide's safety for long-term use.
56. A.H. ROBINS' express warranties about the safety of Reglan/metoclopramide for
long-term use were false and intentionally and negligently misleading.
57. As successor-in-interest to A.H. ROBINS, COMPANY, INC., WYETH is legally
responsible for the conduct, fraudulent and negligent acts, intentional and
willful omissions, and misleading representations and warranties made by A.H.
ROBINS COMPANY, INC. concerning the safety and adequacy of Reglan/metoclopramide,
and all liabilities stemming therefrom.
58. WYETH manufactured, marketed and distributed Reglan, metoclopramide, and/or
metoclopramide HC1 through its Wyeth-Ayerst Laboratories Division in St. Davids,
Pennsylvania and through its ownership of "ESI."[FN2]
FN2. Upon information and belief, ESI was a former subsidiary which merged
into Wyeth on or about December 15, 1998.
59. WYETH knew that it must fully disclose material safety data and information
regarding a new drug's chemistry, proposed manufacturing process, proposed model
labeling, including warnings about risks and side effects, and test results
involving animal studies, clinical studies, and the drug's bioavailability.
60. WYETH knew that the data and information would be relied upon by the medical
community, physicians, Plaintiff and other foreseeable users of
Reglan/metoclopramide once the NDA was approved and WYETH was listed as the
Reference Listed Drug Company for the drug.
61. WYETH intentionally and negligently disseminated misleading information to
physicians across the county, through the PDR, about the risks of long-term
ingestion of Reglan/metoclopramide and the increased risk of extrapyramidal side
effects, including tardive dyskinesia.
62. Defendant, SCHWARZ purchased from WYETH the rights and liabilities associated
with Reglan/metoclopramide, the terms of which, upon information and belief,
obligated SCHWARZ to be responsible for claims related to the ingestion or use of
Reglan/metoclopramide.
63. Defendant, SCHWARZ entered into an indemnification agreement with WYETH over
the purchase of the innovator, WYETH's, Reglan, which included disclosure of
clinical studies on Reglan/metoclopramide that were not publicly available.[FN3]
FN3. Plaintiffs do not have information regarding the maximum amount of
liability under the defendants' indemnification agreement.
64. Because Defendant, SCHWARZ acquired Defendant, WYETH's Reglan/metoclopramide
assets and liabilities while WYETH was involved in on-going litigation regarding
Reglan/metoclopramide, and nevertheless agreed to indemnify WYETH against all
claims related to the ingestion of the drug, SCHWARZ knew or should have known
that the NDA label for Reglan/metoclopramide (Wyeth's label) misrepresented the
safety of the drug, withheld warnings of the known side effects of the drug, and
knew or should have known of the safety issues surrounding it.
65. Under the FDA schema, WYETH was and is the Reference Listed Drug Company
(RLD), under a specific NDA, for Reglan/metoclopramide.
66. Under the FDA schema, Defendant, SCHWARZ was and remains the RLD and/or NDA
Holder for Reglan/metoclopramide.
67. At all times material hereto, Defendants, WYETH and SCHWARZ, as the NDA Holder
and/or RLD companies, were aware of the serious side effects caused by
Reglan/metoclopramide including, but not limited to, central nervous system
disorders, depression with suicidal ideation, akathesia, tardive dyskinesia,
tardive dystonia, visual disturbances and interference with drug metabolism.
68. Defendants, WYETH and SCHWARZ, have a duty to ensure their warnings to the
medical community are accurate and adequate, to conduct safety surveillance of
adverse events for the drug, and to report any data related to the safety and/or
accuracy of the warnings and information disseminated regarding the drug.
69. Defendants, WYETH and SCHWARZ, represented that Reglan/metoclopramide was safe
for use to treat gastritis/gastroesophageal reflux knowing that the drug was not
safe for that purpose and was dangerous to the health and body of Plaintiff.
70. Defendants, WYETH and SCHWARZ, represented that Reglan/metoclopramide caused
minimal side effects knowing that the drug caused central nervous system side
effects, and extrapyramidal symptoms, among other side effects, far more
frequently than represented.
71. Defendants, WYETH and SCHWARZ, had actual knowledge, through their own studies
and studies by independent investigators, that doctors frequently prescribed
Reglan/metoclopramide for long-term use that was not safe for patients.
72. Defendants, WYETH and SCHWARZ had, through their own studies and studies by
independent investigators, that nearly one-third of all patients who used
Reglan/metoclopramide received it on doctor's prescriptions for 12 months or
longer, rather than 12 weeks or less.
73. Defendants, WYETH and SCHWARZ also had actual knowledge, through research by
independent investigators, that the risk of tardive dyskinesia and other
extrapyramidal side effects of Reglan/metoclopramide in patients who receive the
drug for 12 weeks or longer is approximately 100 times greater than disclosed in
package inserts and the PDR.
74. Defendants, WYETH and SCHWARZ knew, or through the exercise of reasonable care
should have known, that many patients who use Reglan/metoclopramide are not able
to effectively metabolize it and that as a foreseeable consequence of their
inability to effectively metabolize, those patients have a greater risk of
developing serious and permanent injuries.
75. Defendants, WYETH and SCHWARZ had actual knowledge of facts which demonstrated
that representations in the Reglan/metoclopramide package insert, the PDR and
literature they distributed to physicians were false and misleading.
76. Defendants, WYETH and SCHWARZ failed to correct their monograph and/or
disclose that knowledge to the medical community, Plaintiff, GAYLE DIETRICH, and
other foreseeable users.
77. It is the public policy of the United States and of this state, as reflected
in the Hatch-Waxman Act, 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.
78. Defendants, WYETH and SCHWARZ, as prescription drug manufacturers and/or
distributors, knew or should have realized that so-called "drug product selection
laws," enacted in every state, including this state, authorize or require a
prescription for a drug identified by product brand name or by generic name to be
filled, subject to certain limitations, with a generic drug product that is
therapeutically equivalent to the name brand drug product.
79. Defendants, WYETH and SCHWARZ, knew or ought to have realized that generic
drug manufacturers customarily copy verbatim the package insert for the name brand
prescription drug product to give the impression that the information contained in
the package inserts accompanying their own generic prescription drugs is accurate
and not misleading.
80. Defendants, WYETH and SCHWARZ, knew or ought to have known that the generic
drug manufacturers also typically rely upon the marketing efforts of the name
brand manufacturer to generate sales of their own products.
81. Defendants, WYETH and SCHWARZ, knew or ought to have realized that physicians
commonly consult the information disseminated by the name brand manufacturer, in
the PDR or otherwise, and rely upon that information in their decisions concerning
the prescribing of those products for their patients.
82. Defendants, WYETH and SCHWARZ knew of should have known, specifically, that
physicians would rely upon the information disseminated to them by the name brand
manufacturer, regardless of whether the prescriptions might be filled with either
the name brand product, Reglan, or generic Reglan/metoclopramide, and that many
patients, in accordance with those prescriptions, would be likely to ingest
generic Reglan/metoclopramide.
83. Defendants, ACT AVIS and PLIVA submitted an Abbreviated New Drug Application
(ANDA) to the FDA, based on representations made by the RLD companies, requesting
permission to manufacture, market, and distribute generic Reglan/metoclopramide.
84. Under the ANDA process, the Code of Federal Regulations required ACTAVIS and
PLIVA to submit labels for Reglan/metoclopramide initially identical in all
material aspects to the reference listed drug label.
85. Under the Code of Federal Regulations, ACTAVIS and PLIVA had a duty to ensure
it's Reglan/metoclopramide warnings to the medical community were accurate and
adequate, to conduct post market safety surveillance, to review all adverse drug
event information, and to report any information bearing on the risk and/or
prevalence of side effects caused by Reglan/metoclopramide.
86. Under the Code of Federal Regulations, if ACTAVIS and PLIVA discovers
information in the course of the fulfillment of it's duties as outlined above, it
must report that information to the medical community, Plaintiff and other
foreseeable users of Reglan/metoclopramide to ensure that their warnings are
continually accurate and adequate.
87. Defendants, ACTAVIS and PLIVA failed to investigate the accuracy of it's
metoclopramide and/or metoclopramide HC1 drug labels.
88. Defendants, ACTAVIS and PLIVA failed to review the medical literature for the
metoclopramide drug and/or metoclopramide HC1 drug.
89. Defendants, ACTAVIS and PLIVA relied upon the name brand manufacturer and the
referenced listed drug companies to review the aforementioned medical literature
for Reglan/metoclopramide.
90. Under the FDA scheme, if the FDA approves a label change as requested by an
ANDA holder, the NDA holder (also referred to as the RLD company) must also amend
its label.
91. Defendants, ACTAVIS and PLIVA failed to communicate the true and accurate
risks and/or prevalence of severe neurological side effects resulting from the
ingestion of drugs containing Reglan/metoclopramide.
92. All Defendants to this action who have manufactured, marketed and distributed
generic Reglan/metoclopramide have failed in the same manner as Defendants,
ACTAVIS and PLIVA.
93. Defendants disseminated to physicians, through package inserts, the
publication of the PDR, and otherwise, information concerning the properties and
effects of Reglan/metoclopramide, with the intention that physicians would rely
upon that information in then-decisions concerning the prescription of drug
therapy for their patients.
94. Defendants knew, or should have known through the exercise of reasonable care,
that the package insert for Reglan/metoclopramide substantially understated the
prevalence of acute and long-term side effects on ingesting the drug.
95. Defendants failed to use reasonable care to modify the package insert to
adequately warn physicians about the true risks of both short-term and long-term
use, even after several injured patients filed lawsuits alleging inadequate
warnings and produced competent expert testimony supporting their allegations.
96. Defendants owed a duty in all of their several undertakings, including the
dissemination of information concerning Reglan/metoclopramide, to exercise
reasonable care to ensure that they did not create unreasonable risks of personal
injury to others.
97. Reglan/metoclopramide was widely advertised by Defendants as a safe and
effective treatment of diabetic gastroparesis, gastroesophageal reflux disease
(GERD) and other gastrointestinal disorders.
98. Defendants failed to conduct and report post market safety surveillance on
Reglan/metoclopramide.
99. Defendants failed to review all adverse drug event information[FN4] and to
report any information bearing upon the adequacy and accuracy of their warnings,
efficacy, or safety, including the risks and/or prevalence of side effects caused
by Reglan/metoclopramide.
FN4. Pharmaceutical Defendants are required to review all adverse drug
experience information obtained or otherwise received . . . from any source
. . . including derived from postmarketing clinical investigations,
postmarketing epidemiological/surveillance studies, reports from the
scientific literature, and unpublished scientific reports. 21 C.F.R. s
317.80(b).
100. Defendants failed to monitor all relevant scientific literature related to
Reglan/metoclopramide.
101. Defendants failed to disclose material safety information regarding the
serious and permanent side effects caused by taking Reglan/metoclopramide for long
periods of time.
102. Defendants failed to report data, regardless of the degree of significance,
regarding the adequacy and/or accuracy of their warnings, efficacy or safety of
Reglan/ metoclopramide.
103. Defendants knowingly concealed from physicians material facts bearing on the
interpretation of package insert disclosures that exposure to
Reglan/metoclopramide can lead to tardive dyskinesia and other extrapyramidal side
effects, that the risk is "believed" to increase with duration of therapy and
total cumulative dose, and that therapy for longer than twelve weeks "cannot be
recommended."
104. Defendants concealed the fact that earlier false information disseminated by
A.H. ROBINS COMPANY, INC. and/or WYETH representing long-term
Reglan/metoclopramide therapy to be reasonably safe, was unscientific and false.
105. Defendants concealed the fact that Reglan/metoclopramide is a neuroleptic
agent and dopamine antagonist, which can be expected to lead to tardive dystonia
and other extrapyramidal side effects with approximately the same high frequency,
particularly in longer term use, as other neuroleptic drugs and that
epidemiological studies have consistently confirmed this expectation.
106. Defendants also concealed the fact that the treatment of chronic or
intermittent gastroesophageal reflux and/or diabetic gastroporesis and/or other
gastric disorders with Reglan/metoclopramide for longer than twelve weeks is
unlikely to be reasonably safe.
107. Some or all of the other Defendants, as a result of their participation as
defendants in previous litigation concerning Reglan/metoclopramide products
received clear notice of Wyeth's suppression of important safety information
concerning Reglan/metoclopramide, yet despite this notice chose to ignore the
information and join consciously in the suppression.
108. Hereinafter, Defendants, WYETH, INC. d/b/a WYETH, Individually and as
Successor-in-interest to A.H. ROBBINS COMPANY, INC. and AMERICAN HOME PRODUCTS
CORPORATION; ESI LEDERLE, INC.; SCHWARZ PHARMA, INC.; WYETH PHARMACEUTICALS, INC.;
MCKESSON CORPORATION; PUREPAC PHARMACEUTICAL CO.; ALPHARMA USPD, f/k/a
BARRE-NATIONAL, INC.; ALPHARMA, INC.; ACTAVIS, INC.; ACTAVIS MID ATLANTIC, LLC;
ACTAVIS ELIZABETH, LLC; BARRE PARENT CORPORATION; PLIVA, INC., f/k/a/ SIDMAK
LABORATORIES, INC.; BARR PHARMACEUTICALS, INC. may also be collectively referred
to as "DRUG COMPANY DEFENDANTS".
COUNT I
NEGLIGENCE AS AGAINST DRUG COMPANY DEFENDANTS
109. Plaintiffs hereby incorporate by reference all of the above allegations as if
fully set forth herein.
110. Defendants owed a duty to the general public and specifically to Plaintiff to
exercise reasonable care in the design, study, development, manufacture,
promotion, sale, marketing and distribution of their prescription medications,
including the Reglan/ metoclopramide at issue in this lawsuit. Defendants failed
to exercise reasonable care in the design of Reglan/metoclopramide because as
designed, it was capable of causing serious personal injuries such as those
suffered by Plaintiff, GAYLE DIETRICH during foreseeable use. Defendants also
failed to exercise reasonable care in the marketing of Reglan/metoclopramide
because they failed to warn that, as designed, Reglan/metoclopramide was capable
of causing serious personal injuries such as those suffered by Plaintiff, GAYLE
DIETRICH during foreseeable use.
111. Defendants breached their duty and were negligent in their actions,
misrepresentations, and omissions toward Plaintiff, GAYLE DIETRICH in that
Defendants:
a. Failed to use due care in developing, testing, designing and manufacturing
Reglan/metoclopramide so as to avoid the aforementioned risks to individuals when
Reglan/metoclopramide was being used for treatment of patients;
b. Failed to accompany their product with proper or adequate warnings regarding
adverse side effects and health risks associated with the use of
Reglan/metoclopramide and the comparative severity and duration of such adverse
effects;
c. Failed to accompany their product with proper or adequate rate of incidence or
prevalence of permanent irreversible neurological damage;
d. Failed to provide warnings that accurately reflected the symptoms, scope or
severity of the side effects and health risks;
e. Failed to conduct adequate pre-clinical and clinical testing and post-marketing
surveillance to determine the safety of Reglan/metoclopramide;
f. Failed to provide adequate training or information to medical care providers
for appropriate use of Reglan/metoclopramide;
g. Failed to adequately warn consumers and medical prescribers (but instead
actively encouraged the sale of Reglan/metoclopramide), about the following: (1)
that Reglan/metoclopramide should not be prescribed for more than twelve weeks;
(2) that Reglan/metoclopramide can cause neuromuscular side effects, including,
but not limited to, tardive dystonia; (3) that Reglan/metoclopramide should be
discontinued in the face of involuntary facial, tongue, jaw, limb or trunk
movements; and (4) that the health risks posed by Reglan/metoclopramide may become
debilitating, difficult, and painful, necessitating lengthy and/or repeated visits
to the doctor, clinic, or hospital;
h. Failed to adequately test and/or warn about the use of Reglan/metoclopramide,
including, without limitation, the possible adverse side effects and health risks
caused by the use of Reglan/metoclopramide;
I. Failed to adequately warn users, consumers and physicians about the severity,
scope and likelihood of neurological damage and related dangerous conditions to
individuals taking Reglan/metoclopramide; and
j. Representing to physicians, including but not limited to GAYLE DIETRICH'S
prescribing physician, that this drug was safe and effective for use.
112. The Reglan/metoclopramide was in substantially the same condition when it was
ingested by Plaintiff, GAYLE DIETRICH as it was in when it left the control of
Pharmaceutical Defendants. Reglan/metoclopramide's capability to cause serious
personal injuries and damages such as those suffered by Plaintiff, GAYLE DIETRICH
was not due to any voluntary action or contributory negligence of Plaintiff. The
Reglan/metoclopramide was consumed by Plaintiff, GAYLE DIETRICH as directed and
without change in its form or substance.
113. Defendants' failure to exercise reasonable care in the design and/or
marketing of Reglan/metoclopramide was a proximate cause of Plaintiffs' injuries
and damages. Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH seek all damages
to which they may be justly entitled.
COUNT II
STRICT LIABILITY AS AGAINST DRUG COMPANY DEFENDANTS
114. Plaintiffs hereby incorporates by reference paragraphs 1 through 108 as if
fully set forth herein.
115. Plaintiffs claim that Defendants are liable to them under the theory of
strict products liability. Defendants were at all times relevant to this suit, and
now are, engaged in the business of designing, manufacturing, testing, marketing,
and placing into the stream of commerce pharmaceuticals for sale to, and use by,
members of the public, including the Reglan/metoclopramide at issue in this
lawsuit. The Reglan/metoclopramide manufactured by Defendants reached Plaintiff,
GAYLE DIETRICH without substantial change and was ingested as directed. The
Reglan/metoclopramide was defective and unreasonably dangerous when it entered
into the stream of commerce and when used by Plaintiff, GAYLE DIETRICH.
116. Reglan/metoclopramide was unreasonably defective in design, considering the
utility of the product and the risk involved in its use, because as designed,
Reglan/metoclopramide could cause injuries such as those suffered by Plaintiff
during foreseeable use. This fact was known to Defendants at the time
Reglan/metoclopramide was placed into the stream of commerce, but was not readily
recognizable to an ordinary consumer, including Plaintiff. Nonetheless, Defendants
failed to warn that Reglan/metoclopramide as designed was capable of causing
serious personal injuries such as those suffered by Plaintiff, GAYLE DIETRICH
during foreseeable use. Such a failure to warn rendered the Reglan/metoclopramide
unreasonably dangerously defective as marketed.
117. The defective and unreasonably dangerous nature of Reglan/metoclopramide was
a direct, proximate and producing cause of Plaintiffs' injuries and damages. Under
strict products liability theories set forth in Restatement (Second) of Torts,
Pharmaceutical Defendants are liable to Plaintiffs for all damages claimed in this
case.
COUNT III
BREACH OF WARRANTIES AS AGAINST DRUG COMPANY DEFENDANTS
118. Plaintiffs hereby incorporates by reference paragraphs 1 through 108 as if
fully set forth herein.
119. Defendants were at the time of the acts forming the basis of this lawsuit,
and now are, merchants with respect to the Reglan/metoclopramide at issue in this
lawsuit. Defendants marketed and promoted their Reglan/metoclopramide as safe and
efficacious for its intended uses. The Reglan/metoclopramide consumed by
Plaintiff, GAYLE DIETRICH, reached her without substantial change in its condition
and was used by Plaintiff as intended by Defendants. Defendants expressly and
impliedly warranted that the Reglan/metoclopramide were not unreasonably dangerous
and instead were merchantable and fit for its intended use by Plaintiff, GAYLE
DIETRICH.
120. Defendants breached these warranties (both express and implied) as the
Reglan/metoclopramide was not merchantable, was unfit for its intended use and was
unreasonably dangerous when comparing the benefits to the risks associated with
its use. Plaintiffs were injured as a result of these breaches of warranties.
COUNT IV
MISREPRESENTATION AND FRAUD AS AGAINST DRUG COMPANY DEFENDANTS
121. Plaintiffs hereby incorporates by reference paragraphs 1 through 108 as if
fully set forth herein.
122. Defendants, through their advertising, labeling, marketing, and sales/detail
persons, made significant representations, which were false, knowing that such
representations were false and/or with reckless disregard for the truth or falsity
of such representations, with the intent that Plaintiff rely on such material
representations; Plaintiff, GAYLE DIETRICH acted in actual and justifiable
reliance on such material misrepresentations and was injured as a result.
123. In addition, and in the alternative if necessary, Defendants knowingly
omitted and downplayed material information, which omission constitutes a positive
misrepresentation of material fact, with the intent that Plaintiff, GAYLE DIETRICH
rely on Defendants' misrepresentations; Plaintiff, GAYLE DIETRICH acted in actual
and justifiable reliance on Defendants' representations and was injured as a
result.
124. Defendants committed constructive fraud by breaching one or more legal or
equitable duties owed to Plaintiff, GAYLE DIETRICH relating to the
Reglan/metoclopramide at issue in this lawsuit, said breach or breaches
constituting fraud because of their propensity to deceive others or constitute an
injury to public interests or public policy.
125. Defendants misrepresented to the FDA, Plaintiff, GAYLE DIETRICH, and the
health care industry the safety and effectiveness of Reglan/metoclopramide and/or
fraudulently, intentionally and/or negligently concealed material information,
including adverse information regarding the safety and effectiveness of
Reglan/metoclopramide.
126. Defendants made these misrepresentations and actively concealed adverse
information at a time when they knew, or should have known, that
Reglan/metoclopramide had defects, dangers, and characteristics that were other
than what they had represented to Plaintiff, GAYLE DIETRICH and the health care
industry generally. Specifically, Defendants misrepresented to and/or actively
concealed from Plaintiff, GAYLE DIETRICH and the consuming public that:
a. Reglan/metoclopramide had statistically significant increases in neuromuscular
side effects which could result in serious injury;
b. Patients on Reglan/metoclopramide should not take it more than twelve weeks;
c. Reglan/metoclopramide was not fully and adequately tested for the neuromuscular
side effects.
127. As a direct and proximate result of the fraudulent acts and omissions,
suppression and misrepresentation of Defendants, Plaintiffs, GAYLE DIETRICH and
WILLIAM H. DIETRICH, suffered significant and ongoing injuries and damages.
Further, because Defendants' conduct was willful, reckless, intentional and
maliciously fraudulent, Plaintiffs are entitled to an award of exemplary damages.
COUNT V
NEGLIGENCE PER SE AS AGAINST DRUG COMPANY DEFENDANTS
128. Plaintiffs hereby incorporates by reference paragraphs 1 through 108 as if
fully set forth herein.
129. The product label and package insert for Reglan/metoclopramide is misbranded
within the meaning of 21 U.S.C. s 352(a) and (f) because it was false and
misleading and failed to give adequate warnings and directions for use by
physicians who prescribe Reglan/metoclopramide. Because the Defendants each had a
statutory duty under 21 U.S.C. s 352(a) and (f) not to misbrand
Reglan/metoclopramide and because each of them violated this duty, they were
guilty of negligence pers se. In addition, and more particularly, because the
Defendants 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 FDA, 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 Plaintiffs, GAYLE DIETRICH and WILLIAM H.
DIETRICH, as described more fully herein.
COUNT VI
MEDICAL NEGLIGENCE AS AGAINST DEFENDANT. CRAIG G. SULTAN. P.O.
130. Plaintiffs hereby incorporates by reference paragraphs 1, 2, 22 and 23 as if
fully set forth herein.
131. At all times material to this cause, the Defendant, CRAIG G. SULTAN, D.O.,
was licensed to practice medicine in the State of Florida, held himself out as a
physician specially trained in the practice of family practice, and practiced that
specialty in Broward County, Florida.
132. At all times material to this cause, the Defendant, CRAIG G. SULTAN, D.O.,
P.A., was a Florida corporation for the practice of medicine, whose principal
place of business was in Broward County, Florida.
133. At all times material to this cause, the Defendant CRAIG G. SULTAN, D.O., was
an employee, agent or servant of CRAIG G. SULTAN, D.O., P.A., acting within the
course and scope of such employment, agency or master-servant relationship.
134. Prior to October, 2006, the Plaintiff, GAYLE DIETRICH, became a patient of
the Defendant, CRAIG G. SULTAN, D.O., and the Defendant accepted GAYLE DIETRICH as
a patient.
135. CRAIG G. SULTAN, D.O. has prescribed metoclopramide (Reglan) for GAYLE
DIETRICH on a long term basis for the treatment of gastroesophageal reflux disease
(GERD).
136. On or about October 29, 2006, GAYLE DIETRICH called CRAIG G. SULTAN, D.O. due
to the onset of numerous symptoms, including but not limited to severe tremors,
shaking, pacing and being cold and pale.
137. CRAIG G. SULTAN, D.O. thereafter instructed GAYLE DIETRICH to discontinue
taking metoclopramide (Reglan).
138. GAYLE DIETRICH saw CRAIG G. SULTAN, D.O. at his office on or about October
30, 2006 at which time he first advised GAYLE DIETRICH that the symptoms she was
experiencing were a result of taking metoclopramide (Reglan) and further
instructed GAYLE DIETRICH to take high doses of Benedryl orally.
139. GAYLE DIETRICH was later diagnosed with Tardive Dyskinesa.
140. As a result of the negligence of CRAIG G. SULTAN, D.O., GAYLE DIETRICH
suffered injury, including, the development of Tardive Dyskinesa.
141. As a further direct and proximate result of injury, the Plaintiff has
incurred debts for medical care and expenses, and will be compelled to incur such
debts in the future; Plaintiff has been severely and permanently injured, has
suffered aggravation of prior medical conditions, suffered pain from such
injuries, has incurred medical treatment and suffered physical handicap,
disability, disfigurement, mental anguish, and loss of capacity for the enjoyment
of life, and one or more of such injuries are permanent in nature within
reasonable medical probability. Additionally, Plaintiff has lost income and has
suffered a loss of earning capacity which will be permanent.
142. As further direct and proximate result of GAYLE DIETRICH'S injuries,
Plaintiff WILLIAM H. DIETRICH suffered the loss of care, comfort, and support from
his wife, GAYLE DIETRICH.
143. Plaintiffs have complied with all conditions precedent to this action,
including but not limited to the service of a Notice of Intent and completion of a
pre-suit period.
144. The undersigned has conducted reasonable investigation of this matter, and
has good faith belief of each Defendant's liability alleged herein.
145. Defendant, CRAIG G. SULTAN, D.O., owed Plaintiff, GAYLE DIETRICH, a duty to
evaluate and treat within the prevailing standard of care for a similarly
qualified doctor under similar facts and circumstances.
146. Defendant, CRAIG G. SULTAN, D.O., breached his duty to Plaintiff, GAYLE
DIETRICH, in the following ways:
a. Unnecessarily prescribing metoclopramide (Reglan) for GAYLE DIETRICH on a
long-term basis for the treatment of gastroesophageal reflux disease (GERD);
b. Failing to adequately warn GAYLE DIETRICH of the risks of movement disorders
including tardive dyskinesa, akathasia, and dystonia;
c. Failing to adequately and specifically monitor GAYLE DIETRICH for the
occurrence of neurological side effects and movement disorders;
d. Failing to timely recognize and diagnose such movement disorders in Plaintiff;
e. Failing to timely discontinue metoclopramide (Reglan) on the first emergence of
neurological side effects and/or involuntary movements; and
f. Failure to refer GAYLE DIETRICH to neurology for diagnosis and management of
metoclopramide (Reglan)-related movement disorder.
147. The negligence of CRAIG G. SULTAN, D.O. was a substantial contributing cause
of the damages suffered by Plaintiffs and more fully described herein.
WHEREFORE, Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, sue Defendant,
CRAIG G. SULTAN, D.O., for compensatory damages in an amount within the
jurisdictional limits of this court, in excess of Fifteen Thousand Dollars
($15,000.00), exclusive of interest and costs, for joint and several liability of
those economic damages for which joint and several liability is available at law,
and demand trial by jury of all issues triable as of right by jury.
COUNT VII - VICARIOUS LIABILITY AS AGAINST DEFENDANT. CRAIG G. SULTAN. P.O.. P.A.
148. Plaintiffs hereby incorporates by reference paragraphs 1, 2, 22, 23 and
130-147 as if fully set forth herein.
149. Defendant, CRAIG G. SULTAN, D.O., P.A., as the employer, principal or master
in that corporation's relationship with Plaintiff, is vicariously liable as a
matter of law for the acts and omissions of CRAIG G. SULTAN, D.O., which are
alleged herein.
WHEREFORE, Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, sue CRAIG G.
SULTAN, D.O., P.A., for compensatory damages in an amount within the
jurisdictional of this Court, more than Fifteen Thousand Dollars ($15,000.00),
exclusive of interest and costs, for joint and several liability of those economic
damages for which joint and several liability is available as a matter of law, and
demand trial by jury of those issues triable as of right by a jury.
DAMAGES AS TO ALL COUNTS
150. As a direct and proximate result of the above-described acts and omissions of
Defendants, Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, have incurred
actual damages in excess of $ 15,000.00, including but not limited to the
following:
(a) Reasonable and necessary medical expenses incurred in the past;
(b) Reasonable and necessary medical expenses reasonably likely to be incurred in
the future;
(c) Conscious physical pain and suffering experienced in the past;
(d) Conscious physical pain and suffering reasonably likely to be experienced in
the future;
(e) Mental anguish in the past;
(f) Mental anguish likely to be experienced in the future;
(g) Physical disfigurement in the past;
(h) Physical disfigurement likely to be experienced in the future;
(I) Physical impairment in the past;
(j) Physical impairment likely to be experienced in the future;
(k) Loss of earnings in the past;
(l) Loss of earnings/earning capacity likely to be experienced in the future;
(m) Loss of consortium;
(n) Pre and post-judgment interest at the lawful rate;
(o) Exemplary damages; and
(p) Such other applicable damages as the Court deems appropriate.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs, GAYLE DIETRICH and WILLIAM H. DIETRICH, pray that upon
final determination of these causes of action Plaintiffs receive a judgment
against Defendants as follows:
(a) Actual damages as alleged, jointly and/or severally against Defendants, in
excess of the jurisdictional minimum;
(b) Costs of court and reasonable attorney fees necessary for preparation of this
case for trial;
(c) Prejudgment interest at the highest rate allowed by law;
(d) Interest on the judgment at the highest legal rate from the date of judgment
until collected; and
(e) All such other and further relief at law and in equity to which Plaintiffs,
GAYLE DIETRICH and WILLIAM H. DIETRICH may show themselves to be justly entitled.
JURY DEMAND
Plaintiffs hereby demands a trial by jury.
Dated this 23rd day of June, 2009.
