One of the biggest issues in Reglan litigation is whether the manufacturer of a generic version of Reglan can be held liable for not updating the warning label included with the drug. In most cases, the generic version of a label is identical to that of the brand-name. However, the law requires all manufacturers to adequately warn of the risks of their products. Generic drug manufacturers argue that they are not legally allowed to change the label of their drug, while injured plaintiffs argue that generic drug manufacturers are in fact allowed to do so. My analysis is that generic manufacturers are so allowed.
1. Wyeth is the innovator and original manufacturer of REGLAN(R), a medication
which has been on the market for more than 20 years and which is used primarily
for gastroenterological purposes. Reglan's generic name is metoclopramide. A
prescription drug is accompanied by a label, often referred to as a "package
insert," which includes drug indications, contraindications, instructions for use,
WARNINGS and similar information.[FN1] Wyeth is also the author/manufacturer of
the deficient and misleading product information by which the drug is
prescribed-whether it be brand name or generic-and that has been continuously
published in the Physicians Desk Reference (PDR) from 1990 to 2002 (a marketing
privilege for which Wyeth paid handsomely).[FN2] Plaintiffs Complaint does not
relate to the composition or manufacture of the metoclopramide pills she ingested,
but rather focuses on the inaccurate and insufficient (mis)information promulgated
by Movants and by which the pills were prescribed (and the false sense of security
and safety regarding metoclopramide that was created thereby)-all of which caused
or contributed to its misuse by Plaintiffs prescribing doctor and, consequently
led directly to the severe damages sustained by Plaintiff.FN1. The regulations governing the approval of drug products includes the
submission and approval of all labeling of the drug product, including the
actual package insert as well as all accompanying labeling (i.e. boxes,
cartons, package insert), and all advertising and promotional materials used
to advertise or promote the sale and distribution of the product. See
Section 505(b)(1) of the Food and Drug Cosmetic Act.FN2. See e.g. Wyeth's package inserts (labeling) which were published in the
Physician's Desk Reference and are attached as Exhibits 1 to 11.2. As a direct result of the Plaintiff's 44 weeks of exposure to metoclopramide
spanning from May 2008 March 2009, Plaintiff developed severe and persistent TD-to
include the variants, tardive dystonia and tardive akathesia (herein collectively
referred to as "TD").3. TD, by definition, is a drug induced neurological disease permanently affecting
the patients' brain chemistry and loosely resembling a drug induced Parkinson's
disease and/or Tourrette's condition. The disease is disfiguring and debilitating
and affects the patient physically, emotionally, vocationally and socially.
nited States District Court, N.D. Georgia.
Atlanta Division
Elaine FORRESTER, Plaintiff,
v.
WYETH, INC. d/b/a Wyeth Ani Pharmaceuticals, Inc. Schwarz Pharma, Inc.,
Defendants.
No. 109CV01362.
July 20, 2009.
Electronically Filed
Plaintiff's Response to Defendants Wyeth, Inc. And Schwarz Pharma, Inc.'s Motion
to Dismiss
Matthews & Associates, David P. Matthews, Texas Bar No. 13206200, Adam T. Funk,
Texas Bar No. 24058657, 2905 Sackett St., Houston, TX 77098, (713) 222.8080, (713)
535.7182 fax, [email protected], afunk @thematthewslawfirm.com.Gary
Martin Hays & Assoc., Gary Martin Hays, Georgia Bar No. 34095, P.O. Box 956669,
Duluth, GA 30095, (770) 934-8000, (770) 934-1631 (Facsimile), gary
@garymartinhays.com, Attorneys for Plaintiff.
COMES NOW, Plaintiff, by and through counsel, and hereby responds to Defendants
Wyeth, Inc. and Schwarz Pharma, Inc.'s Motion to dismiss Plaintiffs Complaint
pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure as follows:
1. Wyeth is the innovator and original manufacturer of REGLAN(R), a medication
which has been on the market for more than 20 years and which is used primarily
for gastroenterological purposes. Reglan's generic name is metoclopramide. A
prescription drug is accompanied by a label, often referred to as a "package
insert," which includes drug indications, contraindications, instructions for use,
WARNINGS and similar information.[FN1] Wyeth is also the author/manufacturer of
the deficient and misleading product information by which the drug is
prescribed-whether it be brand name or generic-and that has been continuously
published in the Physicians Desk Reference (PDR) from 1990 to 2002 (a marketing
privilege for which Wyeth paid handsomely).[FN2] Plaintiffs Complaint does not
relate to the composition or manufacture of the metoclopramide pills she ingested,
but rather focuses on the inaccurate and insufficient (mis)information promulgated
by Movants and by which the pills were prescribed (and the false sense of security
and safety regarding metoclopramide that was created thereby)-all of which caused
or contributed to its misuse by Plaintiffs prescribing doctor and, consequently
led directly to the severe damages sustained by Plaintiff.
FN1. The regulations governing the approval of drug products includes the
submission and approval of all labeling of the drug product, including the
actual package insert as well as all accompanying labeling (i.e. boxes,
cartons, package insert), and all advertising and promotional materials used
to advertise or promote the sale and distribution of the product. See
Section 505(b)(1) of the Food and Drug Cosmetic Act.
FN2. See e.g. Wyeth's package inserts (labeling) which were published in the
Physician's Desk Reference and are attached as Exhibits 1 to 11.
2. As a direct result of the Plaintiff's 44 weeks of exposure to metoclopramide
spanning from May 2008 March 2009, Plaintiff developed severe and persistent TD-to
include the variants, tardive dystonia and tardive akathesia (herein collectively
referred to as "TD").
3. TD, by definition, is a drug induced neurological disease permanently affecting
the patients' brain chemistry and loosely resembling a drug induced Parkinson's
disease and/or Tourrette's condition. The disease is disfiguring and debilitating
and affects the patient physically, emotionally, vocationally and socially.
4. In 2001, Wyeth sold the rights to manufacture and distribute name brand Reglan
tablets to Schwarz Pharma, Inc. (hereinafter also referred to as "Schwarz").
5. Prior to that transaction, REGLAN(R) became available for generic manufacture.
Thereafter, several companies, including co-defendant ANI Pharmaceuticals, Inc.,
began marketing and selling metoclopramide, taking advantage of the federal
regulations which encouraged and accelerated the otherwise burdensome process of
conducting extensive research requiring the filing of a New Drug Application
(NDA).[FN3] Generic manufacturers are allowed to file an Abbreviated New Drug
Application (ANDA) which allows them to save time and expense by relying upon the
NDA sponsor's [Wyeth] research and labeling (including WARNINGS) information, as
contained in the NDA which is compiled and maintained by the NDA sponsor.[FN4]
Although it does not exonerate the generic manufacturer from all responsibility
involving the accuracy, sufficiency and safety of the NDA sponsor's label, the
ANDA process allows cheaper generic drugs to be introduced to the market while
holding all manufacturers to a high duty of ensuing safety to patients who ingest
their products.[FN5]
FN3. A key component of the new drug approval process is the consideration
of information regarding the safety and efficacy of a proposed drug. A New
Drug application (NDA) must contain a section covering clinical data
regarding the proposed new drug. See 21 C.F.R. s 314.50(d)(5). The NDA
should also include a description of any other data or information relevant
to the evaluation of the safety and effectiveness of the drug obtained or
otherwise received by the applicant from any source, foreign or domestic,
including commercial marketing experience, reports, reports in the
scientific literature,and unpublished scientific papers. See 21 C.F.R. s
314.50(d)(5)(iv).
FN4. See e.g. ANDA filed by AN1 Pharmaceuticals, Inc.
FN5. See e.g. H.B. 3580, 110th Cong. (2007), pp. 511832-511833, attached as
Exhibit 12.
6. Although the pills that Plaintiff took were admittedly not the product of
Movants, the (mis)information under which her doctor prescribed them was the
undeniable (and grossly deficient) product of Movants-and herein lies the crux of
the issue: Can Movants escape responsibility for the damages they directly and
proximately caused through the dissemination of (mis)information spanning 20
years, (and the sense of drug confidence and safety created thereby) simply
because they did not manufacture the pill(s) Plaintiff ingested, or is the
determination of whether Movants voluntarily undertook a duty and then breached
that duty leading directly to the mis-use of metoclopramide?
7. In most product liability lawsuits, the manufacturer of the offending product
and the manufacturer responsible for the WARNINGS of the drug labeling are the
same entity. But, in the regulatory framework for drugs approved by the FDA in the
U.S., specifically in the case of generic drugs, the manufacturer of the generic
drug ingested is frequently different than the brand name manufacturer who is
primarily responsible for the WARNINGS information given to the doctor and the
patient. Nonetheless, the entity primarily responsible for the WARNINGS given to
the doctors owes a duty to make sure the information is accurate and not
misleading. If the drug company negligently or intentionally misrepresents the
dangers associated with that drug, even if the drug itself is properly
manufactured, then it is foreseeable that a patient would still be injured by
mis-use.
I. INTRODUCTION
8. Georgia law imposes a "general duty one owes to all the world not to subject
them to an unreasonable risk of harm .... Bradley Center v. Wessner, 250 Ga. 199,
201, 296 S.E.2d 693 (1982).
9. Movants have engaged in the manufacture of the drug metoclopramide, with the
name brand REGLAN(R). Wyeth sought and became the Referenced Listed Drug (RLD)
[FN6] holder for this drug. This means that Wyeth became responsible for the
accuracy, sufficiency and updating the package insert for all metoclopramide
drugs, regardless of manufacturer. Later, in 2002, Schwarz sought and became the
RLD holder.[FN7] Other than Wyeth and Schwarz, no other manufacturer has been the
RLD holder for metoclopramide. By choosing to be the RLD holder, Movants
voluntarily undertook a duty and obligation to exercise ordinary care and
diligence so as to avoid injury to anyone that ingested metoclopramide, including
Plaintiff.
FN6. The phrase "Reference Listed Drug" refers to drugs which are approved
for marketing and that serves, initially, as the basis for a generic drug
application.
FN7. See FDA Label and. Approval History for NDA 017854 Metoclopramide [
REGLAN(R)] tablets for Schwarz Pharma, attached as Exhibit 13; see also
Schwarz Pharma's label attached as Exhibit 14.
10. As the RLD holders, Movants voluntarily assumed heightened duties and
responsibilities imposed by the Code of Federal Regulations as the RLD holder.
[FN8] The NDA/RLD labeling language is not set in stone. Rather, drug companies
are required to alter (or trigger the process to alter) drug labels under certain
circumstances. For instance, FDA regulations provide that the NDA/RLD labeling
shall be "revised to include a warning as soon as there is reasonable evidence of
an association of a serious hazard with a drug[.]" See 21 C.F.R. s 201.57(e); see
also 21 C.F.R. 314.70(b)(2)(v) (requiring label to be in approved form.) To comply
with this regulation, label changes can be proposed by either the NDA/RLD holder
[Movants] and/or the generic company [ANI]. See generally id. ss 314.70, 314.71,
314.97; see also id. at s 314.70(c)(6)(iii)(A), (C)2; see also 44 Fed. Reg. 37434,
37447 (1979). Further, revised WARNINGS maybe made by various means, including
labeling changes and "Dear Doctor Letters." Id. Under the regulations, both
Movants and ANI have an individual and joint duty to trigger a label change if a
serious hazard or "signal" in the marketplace is associated with the use of
metoclopramide. Id.
FN8. See e.g. 21 C.F.R. 314.50(d)(5)(vi)(b) (requiring applicant to
periodically update its pending application with new safety information
learned about the drug that may reasonably affect the safety information in
the labeling).
11. In this case, Movants took no action, and either negligently or intentionally
distributed false and misleading information into the stream of commerce by paying
for and placing such (mis) information into the PDR, which they knew prescribing
doctors would rely upon when prescribing REGLAN(R) or any generic metoclopramide
equivalent. Movants should be held accountable for this breach of their duties.
12. If the FDA had known what Wyeth and Schwarz knew about the risk of TD when
ingesting metoclopramide on a long-term basis, it would not have approved
metoclopramide for its suggested uses.[FN9] The benefits of long-term use simply
do not outweigh the risks.[FN10] The drug information provided in the label was
neither accurate nor sufficient, as Movants' own corporate personnel have
admitted.[FN11] Had the NDA/RLD metoclopramide labeling been changed (an event
either movants or their co-defendant could/should have initiated) to reflect the
true dangers of TD, then Plaintiffs injuries would not have occurred.
FN9. See e.g. FDA Memorandum, Eric P. Bastings, M.D., Acting Team Leader,
Neurology, pp. 6-10 (recommending that the FDA not approve MT 100 [a drug
consisting of metoclopramide and naproxen sodium] due to the safety concerns
regarding long term use of metoclopramide as it relates to tardive
dyskinesia. (May 18, 2004), attached as Exhibit 15, at pp. 7, 9, and 10.
FN10. Id; see also Minutes from Gastrointestinal Drug Advisory Committee,
dated October 15, 1979, attached as Exhibit 16; see also Letter from World
Health Organization, WHO Collaborating Center for Internal Drug Monitoring,
dated May 12, 1981, attached as Exhibit 17.
FN11. See the deposition testimony of Axel Olsen and Frederick Wilson in
Swicegood v. Wyeth, et al., Cause No: 1:07-cv-1671; Northern District Court
of Georgia, Atlanta Division
13. In their Motion, Movants very pointedly make no mention of their
responsibilities and duties as the New Drug Applicant Sponsor and/or the
Referenced Listed Drug Holder. NDA/RLD status imposes heightened duties and
obligations upon the RLD holder because it is the RLD holder's labeling language
that is, and will be, primarily relied upon, by all entities that manufacture
metoclopramide.[FN12]
FN12. See generally 21 C.F.R. ss 314.70, 314.71, 314.97; see also C.F.R. s
314.70(c)(6)(iii)(A)(C)2; see also 44 Fed. Reg. 37434, 37447 (1979); see
also Deposition testimony of Robert Pollock in Swicegood v. Wyeth, et al.,
Cause No: 1:07-cv-1671; Northern District Court of Georgia, Atlanta
Division. See Pustejovsky V. Wyeth, et. al., Case No. 4:07-CV-00103, Pacer
Document 33, at p. 6, (discussing PLIVA's, another generic manufacturer of
Reglan, reliance upon Wyeth's metoclopramide labeling);
14. Both the NDA/RLD and the generic manufacturer have the affirmative duty to
trigger a chain reaction which will change the metoclopramide labeling. (See
C.F.R. s 201.80(e) mandating a labeling change as soon as there is reasonable
evidence that a drug is associated with a serious hazard, [FN13] see also 21
C.F.R. s 314.70(C)(6)(iii)(c)) promulgating procedure to "add or strengthen"
warning to increase safe use of drug.) (emphasis added). See 21 C.F.R. s 314.80(b)
. See also e.g. 21 U.S.C. s 352(a), 21 U.S.C. s 355 (j)(2)(A)(iii) and (iv) and
(4); 21 U.S.C. 314.80, 314.105(d) (promulgating individual and joint duty upon
NDA/RLD holder and generic company to individually and jointly conduct
pharmacovigilance activities, including reviewing adverse event drug event
reports, including those obtained from the post marketing experience and to report
those "signals" to the FDA). Id. Again, these non-delegable duties are held
jointly with Defendant ANI.
FN13. Indeed, FDA has made clear that generic drug manufacturers must
provide updated safety information to the agency for purposes of revising
their labels. See 57 Fed. Reg. 17950, 17961 (1992) (discussing approval of
an ANDA, and duties thereafter).
15. Thus, both Movants and PLIVA are required to revise the NDA/RLD metoclopramide
labeling to warn about the serious and increased hazards of TD associated with
metoclopramide. Yet, these risks are still not warned about in the current NDA/RLD
labeling [which is owed by Schwarz].[FN14]
FN14. Nevertheless, 25 years later, the RLD/NDA metoclopramide label remains
unchanged despite movants knowledge that the WARNINGS language in the label
is inadequate and inaccurate. (See chart comparing labels 1990-2002, Exhibit
18).
16. Indeed, as stated above, both Movants and ANI must revise their labeling
whenever there is reasonable evidence of an association between the drug and a
serious hazard. Thus, movants had not only a duty to exercise ordinary care in the
dissemination of its warning, but were under a heightened duty to warn of the true
risks of TD and could do so without running afoul of, and indeed, as specifically
contemplated by FDA regulations. A breach of these duties by Defendants gives rise
to the imposition of state common law liability for failure to warn.[FN15]
FN15. The great majority of trial courts which have addressed the question
have come to the same conclusion. See e.g. In re Zyprexa Prods. Liab. Litig.
(E.D.N.Y. 2007) 489 F. Supp.2d 230, 270-78; Sarli V. Mylanl Bertek
Pharmaceuticals, Inc. 2007 WL 2111577 (M.D.N.C. July 19, 2007); In re Vioxx
Prods. Liab. Litig., F.Supp. 2d _,2007 WL 1952964 (E.D. La. July 3, 2007);
Jackson v. Pfizer, lnc.(D.Neb. 2006) 432 F. Supp. 2d 964; Laisure-Radke v.
Par Pharm., Inc. (W.D.Wash. 2006) 426 F. Supp. 2d 1163, 1169; Peters v.
Astrazeneca, LP (W.D. Wis. 2006) 417 F. Supp. 2d 1051, 1054-57; Witczak v.
Pfizer, Inc. (D. Minn. 2005) 377 F. Supp. 2d 726, 728-32; Cartwright v.
Pfizer, Inc. (E.D. Tex. 2005) 369 F. Supp.2d 876, 881-87; McNell's v.
Pfizer, Inc., 2005 WL 3752269 (D.N.J. Dec. 29, 2005) Zikis v. Pfizer, Inc.
2005 WL 1126909 (N.D. Ill. May 9, 2005; Motus v. Pfizer, Inc. (C.D. Cal.
2000) 127 F. Supp. 2d 1085, 1091-1100, aff'g dismissal on other grounds, 358
F. 3d 659 (9th Cir. 2004); In re Paxil Litig. 2002WL 31375497, *1 (C.D. Cal.
Oct. 18, 2002); Eve Sandoz Pharm. Corp., 2002 WL 181972 (S.D. Ind. Jan. 28,
2002); Caraker v. Sandoz Pharm. Corp. (S.D. Ill. 2001) 172 F. Supp. 2d 1018,
1029-44; Globetti v. Sandoz Pharm. Corp. 2001 WL 419160 (N.D. Ala. Mar. 5,
2001); Mazur v. Merck & Co., (E.D. Pa. 1990) 742 F. Supp. 239, 245-48;
Kociemba V. Searle & Co. (D. Minn. 1988) 680 F. Supp. 1293, 1298-1300;
Graham v. Wyeth Labs. (D. Kan. 1987) 666 F. Supp. 1483, 1488-93; Stephens v.
(E.D. Searle (E.D. Mich. 1985) 602 F. Supp. 379, 382; Kelly v. Wyeth, 22
Mass. L. Rptr. 384, 2007 WL 1302589, at *1 (Mass. Super. Apr. 12, 2007).
17. Because Movants primarily control what was (and still is) written on the label
of all metoclopramide products, and what literature was reported to the FDA for
the drug, Movants are responsible for the inaccurate and misleading information
given to the FDA, doctors, and patients. Movants are also responsible for any and
all injuries related to the mis-use of the drug regardless of who manufactured it,
if such mis-use arose out of the (mis) information and WARNINGS Movants provided.
II. MOTION TO DISMISS STANDARD
18. The standard of review on a motion for judgment on the pleadings is:
A court may grant a motion to dismiss [now, a motion for judgment on the
pleadings] if it finds that the plaintiff cannot prove any set of facts consistent
with the complaint which would entitle him or her to relief. [Cite omitted.]
Defendants bear 'the very high burden' of showing that the plaintiff cannot
conceivably prove any set of facts that would entitle them to relief. [Cite
omitted.]
Neal v. Euifax Credit Information Services Inc., 2004 U.S. Dist. LEXIS 26497, *9
(N.D.Ga. 3/11/04).
19. When considering a motion for judgment on the pleadings, "a federal court is
to accept as true 'all facts set forth in the plaintiffs complaint.' Further, the
court must draw all reasonable inferences in the light most favorable to the
plaintiff. Thus, a complaint may not be dismissed under Rule 12(b)(6) 'unless it
appears beyond doubt that the plaintiff can prove no set of facts in support of
his claim which would entitle him to relief." [Cites omitted.] Ross v. Metro.
Church of God, 2007 U.S. Dist. LEXIS 4784, *34 (N.D. Ga. 2007). The issue is not
whether Plaintiff will win, but whether she is entitled to offer evidence in
support of her claims.
III. LAW AND ARGUMENT
20. In addition to strict liability claims, Plaintiff has alleged claims of
negligence, fraudulent misrepresentation, negligent misrepresentation, and
fraudulent concealment against Movants. Plaintiffs claims are meritorious and
should not be dismissed.
A. MOVANTS VOLUNTARILY UNDERTOOK AND THEN REACHED THEIR DUTY TO WARN, AND THEIR
BREACH FORESEEABLY CAUSED PLAINTIFF'S INJURIES
21. The (mis)information disseminated by Movants, whether through the Physician' s
Desk Reference, or in the NDA/RLD metoclopramide package inserts, promotional
materials, or otherwise, was materially false, incomplete and misleading, and
thus, caused or contributed to Plaintiffs injuries.
22. Movants, as the NDA/RLD holder [voluntary disseminator and promulgator] of the
NDA/RLD metoclopramide labeling, have a statutory duty, (under the FDA
regulations, they have a heightened duty over generics), to exercise reasonable
care to ensure that drug safety information in their labeling is accurate and not
misleading. Movants voluntarily undertook and therefore owe a duty to any patient
whose doctor would reasonably rely upon the information in prescribing medicine,
regardless of whether the pharmacy utilized by Plaintiff filled the prescription
with a generic instead of the brand name drug that was prescribed.
1. Movants Promulgated and Distributed Inaccurate and Inadequate WARNINGS Even
Though They Knew the Risk of Contracting Dystonic Reactions was Substantially
Greater Than Reported
23. The estimates of the risks for TD among patients treated with metoclopramide
are much higher than what is stated and/or implied by the statements made in the
ADVERSE REACTIONS section of the NDA/RLD's metoclopramide labeling, which states:
Extrapyramidal symptoms, manifested primarily as acute Dystonic reactions occur in
approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40
mg/day of metoclopramide. (emphasis added).[FN16]
FN16. See NDA/RLD Labeling, attached as Exhibits 1-11.
24. Movants have long known that the warning to prescribing doctors and consumers
found in their label profoundly underestimated the actual risks of TD.[FN17]
FN17. Even though metoclopramide has been promoted and widely used to treat
chronic heartburn and other gastroesophogeal ailments that typically persist
over many years, Movants failed to disclose in the NDA/RLD label that
metoclopramide was a neuroleptic, which is expected to produce comparatively
high incidences of tardive dyskinesia in long-term drug therapy. See
Exhibits 1-11.
25. Wyeth knew about these increased risks as early as 1989, and neglected and/or
chose not to update the NDA/RLD labeling and/or to even report these findings to
the FDA.[FN18]
FN18. The earliest literature warning of the risks of TD associated with
metoclopramide dates back to 1989.
26. In fact, as noted above, Wyeth affirmatively ignored the literature as
evidenced by its own internal memorandums.[FN19] Wyeth's first internal memorandum
is evidence that Wyeth decided to take "no action" to report Linda Ganzini's
findings to the FDA, despite its duty under the Code of Federal Regulations to do
so. The second memorandum evidences that Wyeth also failed to take action to
report a key piece of scientific literature to the FDA.[FN20] Such inaction is
inexplicable, reprehensible, and put patients such as Plaintiff at risk.
FN19. See Swicegood v. Wyeth, et al., Cause No: 1:07-cv-1671; Northern
District Court of Georgia, Atlanta Division Pacer Document No. 31-27.
FN20. See Swicegood v. Wyeth, et al., Cause No: 1:07-cv-1671; Northern
District Court of Georgia, Atlanta Division Pacer Document No. 31-28.
27. Despite the presence of overt safety "signals," Movants failed to report these
profoundly important "signals" detected in the literature and to monitor the FDA
Med-Watch database for reported cases of EPS disorders, both of which would
indicate that metoclopramide was associated with substantially increased risk of a
serious side effects, greater than previously known to prescribing doctors.
Despite these "signals," Movants failed to tell anyone about the safety hazards.
2. It Was Foreseeable to Movants that the NDA/RLD's Metoclopramide Labeling Would
be Relied Upon by Plaintiffs Treating Physician.
28. Plaintiff was dispensed, and ingested, generic metoclopramide for a period
from May 2008 to March 2009. In prescribing REGLAN(R) to Plaintiff's physician,
like most other doctors in his field, relied upon information contained in the
NDA/RLD metoclopramide labeling as published in the Physician's s Desk Reference
[Movants' labeling] Wyeth paid to put the NDA/RLD metoclopramide labeling into the
PDR and to promote it. Wyeth knew the PDR was a national circulation that doctors
routinely rely upon the PDR as an authoritative source for information about
prescription drugs.
29. Movants have argued that it was not foreseeable that a doctor would rely upon
the PDR. Why then, would Movants pay money to publish the NDA/RLD labeling into
the PDR? If the NDA/RLD labeling, published in the PDR (adeptly named the
Physician's Desk Reference), is inaccurate as to risks of TD, then doctors relying
on that publication have not been adequately warned.
30. Movants were the entities primarily responsible for warning doctors and/or
patients as to the risks associated with metoclopramide, and did so insufficiently
and inadequately. Given the (mis)information promulgated by Movants, it is
foreseeable that a patient could be injured from a drug her doctor wrongfully
prescribed, but that the doctor would not have prescribed if he had been properly
apprised of the risks.
B. MOVANTS VOLUNTARILY UNDERTOOK, AND ARE REQUIRED TO PERFORM, A DUTY TO WARN
PLAINTIFF OF THE RISKS ASSOCIATED WITH METOCLOPRAMIDE
1. Heightened Duties Are Imposed Upon Movants Under Regulatory Framework
31. Section 505 of the Food, Drug and Cosmetic Act (FDCA), forbids the
distribution of any drug unless an application for that drug has been submitted
and approved by the FDA. See 21 C.F.R. s 355 (b) (pioneer drugs) and (j) (generic
drugs).
32. Under 21 C.F.R. s 355(j) the Hatch-Waxman Act, a generic manufacturer [here
ANI] is allowed to rely upon the accuracy and adequacy of drug safety and WARNINGS
made by the original NDA sponsor. Id.
33. Defendant ANI must initially rely upon the representations and statements in
the NDA/RLD metoclopramide labeling by the NDA/RLD holder, if it seeks to market
the generic under the spirit (speeding a generic to market) of the Hatch-Waxman
Act. See 21 C.F.R. s 355(j). However, after initial approval, both Movants and ANI
must periodically review the label for accuracy and upon discovery of new and
pertinent information (or old pertinent information), promptly report and/or act
upon such information; to ensure the label contains the necessary summary of
essential scientific information needed for safe and effective use; and to ensure
that the label is not false or misleading in any respect. (See 21 C.F.R. s 201.56
& 21 C.F.R. s 201.57).
34. Because NDA/RLD metoclopramide labeling provides information used by doctors
to prescribe and administer an approved drug, FDA's regulations detail the proper
form and content for labeling. See generally 21 C.F.R. Part 201.
35. As explained above, the package insert or FDA-approved labeling appears in the
Physician's Desk Reference, which is a reference book published annually, and
distributed to doctors. The labeling only appears in the PDR book if the NDA/RLD
holder [here Movants] paid the publishers of the PDR to put the FDA-approved
metoclopramide labeling into their publication.
36. The NDA/RLD labeling language is not set in stone. Rather, drug companies are
required to alter (or trigger the process to alter) drug labels under certain
circumstances. FDA regulations provide that the NDA/RLD labeling shall be "revised
to include a warning as soon as there is reasonable evidence of an association of
a serious hazard with a drug[.]" See 21 C.F.R. s 201.57(e); see also 21 C.F.R.
314.70(b)(2)(v) (requiring label to be in approved form.) To comply with this
regulation, label changes can be proposed by either the NDA/RLD holder [Movants]
and/or the generic company [ANI]. See generally id. ss 314.70, 314.71, 314.97; see
also id. at s 314.70(c)(6)(iii)(A), (C) 2; see also 44 Fed. Reg. 37434, 37447
(1979). Revised WARNINGS may be made by various means, including labeling changes
and "Dear Doctor Letters." Id. Under the regulations, both Movants and ANT have an
individual and joint duty to trigger a label change if a serious hazard or
"signal" in the marketplace is associated with the use of metoclopramide. Id.
37. Both the NDA/RLD and the generic have the affirmative duty to trigger a chain
reaction which will change the NDA/RLD metoclopramide labeling. (See C.F.R. s
201.80(e) mandating a labeling change as soon as there is reasonable evidence that
a drug is associated with a serious hazard;[FN21] see also 21 C.F.R. s 314.70
(C)(6)(iii)(c)) promulgating procedure to "add or strengthen" warning to increase
safe use of drug.) (emphasis added). See 21 C.F.R. s 314.80(b). See also e.g. 21
U.S.C. s 352(a), 21 U.S.C. s 355 (j)(2)(A)(iii) and (iv) and (4); 21 U.S.C.
314.80, 314.105(d) (promulgating individual and joint duty upon NDA/RLD holder and
generic company to individually and jointly conduct pharmacovigilance activities,
including reviewing adverse event drug event reports, including those obtained
from the post marketing experience and to report those "signals" to the FDA. Id.
Movants must comply with the FDA postmarketing safety and reporting requirements,
found under 21 C.F.R. s 314.80 and 21 C.F.R. s 314.81, as long as they continue to
be the NDA/RLD holder. Those duties under these FDA regulations only terminate if
they decide to withdraw their NDA, and thus, no longer serve as the RLD holder. As
noted above, Schwarz remains the RLD holder for metoclopramide to this day.
Further, Movants have not withdrawn the specific NDA at issue in this lawsuit for
metoclopramide.
FN21. FDA has made it clear that generic drug manufacturers must provide
updated safety information to the agency for purposes of revising their
labels. See 57 Fed. Reg. 17950, 17961 (1992).
38. Movants and Defendant ANI, breached their duties to provide accurate and
adequate WARNINGS for the risk of TD in their respective NDA/RLD metoclopramide
labeling.
2. Georgia Law Imposes Liability for Negligent Performance of a Voluntary
Undertaking
39. Under Georgia law, "a person may be held liable for the negligent performance
of a voluntary undertaking." Osowski v. Smith, 262 Ga. App. 538, 540(1), 586
S.E.2d 71 (2003). Further, "one who undertakes to do an act or perform a service
for another has the duty to exercise care, and is liable for injury resulting from
his failure to do so, even though his undertaking is purely voluntary or even
though it was completely gratuitous, and he was not under any obligation to do
such act or perform such service, or there was no consideration for the promise or
undertaking sufficient to support an action ex contractu based thereon." Id.
40. Movants voluntarily chose to become the Referenced Listed Drug Holder (RLD)
for metoclopramide. As noted above, Schwarz remains the RLD for the drug to this
day. As such, Movants voluntarily undertook the duties imposed on them by the
FDCA, as described above, and are liable for their negligent performance of their
duties.
3. The Cases Cited by Movants are Distinguishable
41. Movants have cited this court to decisions from other jurisdictions to support
their arguments. However, all of these cases are distinguishable from Plaintiffs
case because none of those cases were decided utilizing Georgia law. Further, the
majority of the cases cited by Movants were decided under a summary judgment
standard (Foster v. AHP; LeBlanc v Wyeth; Galdych v. Eli Lilly; Flynn v. AHP,
Sharp v. Leichus; Green v. Wyeth; Sheeks v. AHP, and Beutella v. A.H. Robins),
which differs from the standard on a motion to dismiss or motion for judgment on
the pleadings. The remaining cases are distinguishable in that none of the Courts
deciding them considered the duties voluntarily undertaken by Movants relating to
the NDA and RLD for metoclopramide. Movants clearly breached such duties and such
breach caused Plaintiffs injuries in this case.
4. Negligent Misrepresentation
42. Georgia law has long recognized (a distinction) between negligence and strict
liability theories of liability. Banks v. ICI Americas, 266 Ga. 607, 735, 469
S.E.2d 171 (1996). These are separate and distinct claims arising from different
duties owed by the manufacturer to consumers. The distinction between these causes
of action reflects the different duties that devolve upon manufacturers. Moore v.
ECI Management, 246 Ga.App. 601, 542 S.E.2d 115 (2000).
43. As explained above, Movants voluntarily undertook a duty to warn of the risks
associated with metoclopramide by becoming the NDA and RLD holders. "Where a duty
to warn arises..., this duty may be breached by (1) failing to adequately
communicate the warning to the ultimate user or (2) failing to provide an adequate
warning of the product's potential risks." Camden Oil Co., LLC v. Jackson, 270
Ga.App. 837, 840, 609 S.E.2d 356 (2004).
44. Contrary to Movants' argument that they cannot be liable in this case, "even
'where (the) representations are made to the public at large, or to a particular
class of persons,' as long as they are given 'with the intention of influencing
any member of the public or of the class to whom they may be communicated, any one
injured through the proper reliance thereon may secure redress. "Starling Starling
v. Seaboard Coast Line R. Co., 533 F. Supp. 183, 192, n. 11, (SD Ga. 1982), citing
Hines v. Wilson, 164 Ga. 888, 889, 139 S.E. 802 (1927).
45. The fact that misrepresentations are not made directly to the Plaintiff does
not preclude an action for fraud. Potts v. UAP-GA AG CHEM, Inc., S.E.2d ---, 2002
WL 1291967 (Ga. App. 2002); Florida Rock and Tank Lines, Inc. v. Moore, 365 S.E.2d
386 (Ga. 1998). This is consistent with the Restatement of Torts, s 22 533, which
provides that the "maker of a fraudulent misrepresentation is subject to liability
for pecuniary loss to another who acts in a justifiable reliance upon it if the
misrepresentation, although not directly made to the other, is made to a third
person and the maker intends or has reason to expect that its terms will be
repeated or its substance communicated to the other, and that it will influence
its conduct.
46. The cases cited by Movants that have held that no duty exists on the part of
the entity that set forth the warnings in the PDR are of little value in deciding
the present Motion. Pursuant to Georgia law, as Movants voluntarily undertook a
duty to warn via the NDA and RLD, they are liable to Plaintiff for breaching said
duty and the injuries caused by that breach.
5. Foster v. American Home Products was not a Well Reasoned Decision
47. Movants rely on the erroneous holding of Foster v. American Home Products, 29
F.3d 165 (1994) to avoid accountability. Such reliance is misplaced, however, as
Foster erroneously concluded that the information disseminated by the defendants
could not reasonably be relied upon because the information disseminated only
pertained to the manufacturer's product. Id. at 170-171. This is incorrect and
overlooks the fact that the information promulgated and distributed by the NDA/RLD
sponsor is the safety information in the drug labeling that is relied upon for all
drugs, whether generic or name brand. Furthermore, it is not only reasonable, but
expected that doctors, pharmacists and patients will rely upon information
distributed in the NDA/RLD metoclopramide labeling, whether by publication in the
PDR, via package insert, or through promotional materials and/or the promotion of
a certain standard of care in response thereto. In the present case, the NDA/RLD
metoclopramide labeling was written and published by the Movants, and said
labeling not only failed to properly disclose the increased risks and frequency of
the dangers of TD, but affirmatively misrepresented same.
IV. CONCLUSION
48. In moving to dismiss Plaintiffs Complaint, Movants bear 'the very high burden'
of showing that the plaintiff cannot conceivably prove any set of facts that would
entitle them to relief. They have not met that burden. By voluntarily becoming the
NDA and RLD holders for metoclopramide, Movants undertook duties to Plaintiff,
breached those duties, and Plaintiff was injured as a result. For the reasons
stated above, Movants' Motion to Dismiss should be denied.
Respectfully submitted this 20th day of June 2009.
