Reglan lawyers are allowed to file what is called a motion for summary judgment. In that motion, the lawyers tell the court that there are no factual issues to decide, but only legal issues. If there truly are no factual issues, then the court may decide the summary judgment motion. The loser is “thrown out of court.” In this case, the Reglan lawyers representing the Reglan manufacturers filed this motion:
This is a products liability case. Plaintiff Shirley Brinkley alleges that she
suffered injuries after ingesting the prescription drug metoclopramide. Cmplt. PP 8-10, 15-16.[FN1] After the completion of product identification discovery, Plaintiff conceded that she did not ingest any product manufactured by Wyeth or Schwarz. Nonetheless, Plaintiff asserts numerous claims against these defendants, arguing that Wyeth and Schwarz (who, at different times manufactured the name brand version of the drug) can be held liable for allegedly failing to adequately warn Plaintiff and her doctors about the risks associated with generic drugs manufactured by other companies. Because Plaintiff never purchased or ingested a Wyeth or Schwarz metoclopramide product, these claims fail as a matter of law.FN1. Citations to Plaintiffs Complaint, Doc. No. 2, filed 1/7/08, shall take the form "Cmplt. P [ ]."
Under well-settled Missouri law, a plaintiff asserting products liability claims
must establish, among other things, that the defendant manufactured or distributed the specific product that injured the plaintiff. A defendant cannot be liable for any harm allegedly caused by another manufacturer's product. In line with this well-settled principle, no Missouri authority -- case law, statute or otherwise -- requires a name brand drug manufacturer (such as Wyeth and Schwarz) to warn about the risks associated with the use of a generic drug manufactured and distributed by another company.
United States District Court, S.D. Illinois,
East St. Louis Division.
Shirley BRINKLEY, Plaintiff,
v.
WYETH, INC., et al., Defendants.
No. 08-012-DRH.
September 30, 2008.
Defendants Wyeth and Schwarz Pharma, Inc.'s Motion for Summary Judgment and
Memorandum of Law In Support of Motion for Summary Judgment
Wyeth, Inc., Schwarz Pharma, Inc., One of Their Attorneys, Larry E. Hepler,
#01195603, Beth A. Bauer, #0627453, Hepler, Broom, MacDonald, Hebrank, True & Noce
LLC, 103 W. Vandalia St., Suite 300, Edwardsville, IL 62025-0510, Phone:
618/656-0184, [email protected], [email protected] R. Pilkington
(admitted pro hac vice), Thomas H. Wagner (admitted pro hac vice), Davis Graham &
Stubbs LLP, 1550 Seventeenth Street, Suite 500, Denver, CO 80202, Phone: (303)
892-7513, Fax: (303) 893-1379, jeff.pilkington @dgslaw.com, [email protected].
Henninger S. Bullock (admitted pro hac vice), Andrew J. Calica (admitted pro hac
vice), Mayer Brown LLP, 1675 Broadway, New York, NY 10019, Phone: (212) 506-2500,
Fax: (212) 262-1910, [email protected], [email protected].
Pursuant to Fed. R. Civ. P. 56, Defendants Wyeth ("Wyeth") and Schwarz Pharma,
Inc. ("Schwarz") respectfully submit this Motion for Summary Judgment and
Memorandum of Law in Support of Motion for Summary Judgment.
INTRODUCTION
This is a products liability case. Plaintiff Shirley Brinkley alleges that she
suffered injuries after ingesting the prescription drug metoclopramide. Cmplt. PP
8-10, 15-16.[FN1] After the completion of product identification discovery,
Plaintiff conceded that she did not ingest any product manufactured by Wyeth or
Schwarz. Nonetheless, Plaintiff asserts numerous claims against these defendants,
arguing that Wyeth and Schwarz (who, at different times manufactured the name
brand version of the drug) can be held liable for allegedly failing to adequately
warn Plaintiff and her doctors about the risks associated with generic drugs
manufactured by other companies. Because Plaintiff never purchased or ingested a
Wyeth or Schwarz metoclopramide product, these claims fail as a matter of law.
FN1. Citations to Plaintiffs Complaint, Doc. No. 2, filed 1/7/08, shall take
the form "Cmplt. P [ ]."
Under well-settled Missouri law, a plaintiff asserting products liability claims
must establish, among other things, that the defendant manufactured or distributed
the specific product that injured the plaintiff. A defendant cannot be liable for
any harm allegedly caused by another manufacturer's product. In line with this
well-settled principle, no Missouri authority -- case law, statute or otherwise --
requires a name brand drug manufacturer (such as Wyeth and Schwarz) to warn about
the risks associated with the use of a generic drug manufactured and distributed
by another company.
The proposition advanced by Plaintiff in this case -- that one manufacturer can be
held liable for injuries allegedly caused by another manufacturer's product -- has
been rejected by every court that has considered it. Indeed, courts in eleven
different states have already rejected such claims brought against name brand
Reglan(R) manufacturers. Thus, as explained below, this Motion should be granted.
UNDISPUTED FACTS
Plaintiff filed her Complaint on January 7, 2008. In the Complaint, Plaintiff
alleges injuries resulting from the ingestion of generic metoclopramide.[FN2]
Cmplt. PP 8-10, 15-16. Plaintiff asserts product liability claims against three
different manufacturing defendants -- Schwarz, Wyeth, and Pliva, Inc. Id. PP 2-4;
82-111.
FN2. Reglan(R), the name brand version of metoclopramide, is a prescription
drug used to treat, among other things, gastric reflux symptoms. Cmplt. PP
1-2, 8.
Both name brand metoclopramide ( Reglan(R)) and generic metoclopramide are
available for prescription use. Id. PP 1-2. At different times, Wyeth and Schwarz
manufactured and distributed name brand metoclopramide ( Reglan(R)). Id. PP 2, 4.
From approximately 1989 through late December 2001, Wyeth manufactured and
distributed name brand Reglan(R) tablets. Schwarz acquired the rights to name
brand Reglan(R) tablets in late December 2001 and continued to manufacture and
distribute the name brand version of the drug at the time Plaintiff stopped taking
metoclopramide in April 2007. Id. P 4.
In a stipulation executed between Plaintiff, on the one hand, and Wyeth and
Schwarz, on the other, Exhibit A attached hereto, Plaintiff admits that: (1) at
all times relevant to this case, Plaintiff ingested only generic metoclopramide;
and (2) at all times relevant to this case, Plaintiff did not ingest any
metoclopramide, whether generic or name brand ( Reglan(R)), manufactured or
distributed by Wyeth or Schwarz. Notwithstanding the undisputed fact that she
never ingested any metoclopramide manufactured by either Wyeth or Schwarz,
Plaintiff asserts a variety of product liability claims against both defendants.
In a nutshell, Plaintiff argues that Wyeth and Schwarz should be held liable
because they failed to adequately warn Plaintiff or her doctors about the risks
associated with the use of generic metoclopramide manufactured and distributed by
other companies. Cmplt. PP 15-29.
ARGUMENT
I. MOTION FOR SUMMARY JUDGMENT STANDARD.
Summary judgment is appropriate where the pleadings, the discovery and disclosure
materials on file, and any affidavits show that there is no genuine issue as to
any material fact and that the movant is entitled to a judgment as a matter of
law. Faas v. Sears, Roebuck & Co., 532 F.3d 633, 640 (7th Cir. 2008); Murray v.
Greenwich Ins. Co., 533 F.3d 644, 648 (8th Cir. 2008) (citing Fed. R. Civ. P.
56(c)). To survive summary judgment, the nonmoving party must make a sufficient
showing of evidence for each essential element of its case on which it bears the
burden at trial. Sellars v. City of Gary, 453 F.3d 848, 850 (7th Cir. 2006);
Boerner v. Brown & Williamson Tobacco Corp., 260 F.3d 837, 841 (8th Cir. 2001).
The mere existence of a scintilla of evidence in support of the non-movant is
insufficient; there must be sufficient evidence upon which a jury could reasonably
find for the non-movant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
(1986). If the evidence presented is "merely colorable" and not "significantly
probative," the court may decide the legal issue and grant summary judgment. Id.
(citation omitted).
In this case, Plaintiff cannot point to any evidence that would allow a jury to
find that Wyeth or Schwarz may be held liable for Plaintiffs alleged injuries.
Accordingly, the Court should enter summary judgment in favor of Wyeth and Schwarz
and dismiss all claims asserted against them.
II. THE COURT SHOULD DISMISS ALL CLAIMS ASSERTED AGAINST THESE DEFENDANTS.
As shown below, Plaintiffs claims, which attempt to hold Wyeth and Schwarz liable
for injuries caused by their competitors' products, are contrary to Missouri law (
infra. at 4-10) and have been rejected by every court that has considered the
issue (infra. at 10-20).
A. Wyeth And Schwarz Cannot Be Held Liable Under Missouri Law For Injuries Caused
By Another Manufacturer's Product.
Plaintiff improperly attempts to hold Wyeth and Schwarz liable for her injuries
even though neither defendant made the product that allegedly caused those
injuries. Missouri does not recognize such claims because: (1) Missouri law
requires that the defendant manufactured or distributed the specific product that
caused the alleged harm; and (2) Plaintiff cannot satisfy the specific elements of
each of her eight claims against Wyeth and Schwarz.[FN3]
FN3. Plaintiffs Complaint appears to contend that Missouri law applies to
this case. See, e.g., Cmpl. PP 88-97. Without conceding this point, the
present Motion assumes that Missouri law applies and shows that no liability
can attach to Wyeth or Schwarz under Missouri law.
1. Missouri Law Requires A Products Liability Plaintiff To Prove That The
Defendant Manufactured Or Distributed The Product That Caused The Injury,
Regardless Of The Theory Asserted.
Regardless of the theory of liability advanced, Missouri law requires that a
products liability plaintiff prove that the defendant manufactured or distributed
the specific product that allegedly caused the plaintiffs injury. See, e.g., City
of St. Louis v. Benjamin Moore & Co., 226 S.W.3d 110, 115 (Mo. 2007) (en bane)
("where a plaintiff claims injury from a product, actual causation can be
established only by identifying the defendant who made or sold that product");
Zafft v. Eli Lilly & Co., 676 S.W.2d 241, 244 (Mo. 1984) (en bane) ("to recover
under strict liability, as with any other tort theory, plaintiff must establish
some causal relationship between the defendant and the injury-producing agent")
(emphasis added); Ahearn v. Lafayette Pharmacal, Inc., 729 S.W.2d 501, 504 (Mo.
Ct. App. 1987) (summary judgment appropriate where defendant "never supplied [the
product] to the hospitals where plaintiff was treated.").
As one Missouri court has explained:
It is fundamental to the law of torts that, regardless of the legal theory upon
which liability is predicated in a case where the underlying alleged wrongful
conduct is the manufacture or marketing of a harmful product (whether negligence,
strict liability, breach of warranty, misrepresentation, nuisance or other
grounds), it is necessary in order to hold a manufacturer or seller liable for
injury caused by a product that there must first be proof that the defendant being
sued actually produced, manufactured, sold or was in some way responsible for the
particular product that caused the harm. This "product identification" requirement
(also sometimes called the manufacturer identification" [sic] requirement) is an
element of proximate causation, and serves the function of assigning
blameworthiness to culpable parties and limiting the scope of potential liability.
City of St. Louis v. Lead Indus. Ass'n. Inc., No. 002-245, 2006 WL 4547877, at *4
(Mo. Cir. Ct. Jan. 18, 2006) (citing annot., Products Liability: Necessity and
Sufficiency of Identification of Defendant as Manufacturer or Seller of Product
Alleged to Have Caused Injury, 51 A.L.R. 3D 1344) (emphasis added).[FN4]
FN4. An appendix containing copies of unpublished opinions has been attached
hereto as Exhibit B.
Here, Plaintiff seeks to hold Wyeth and Schwarz liable for her alleged injuries
even though she concedes that she never ingested a product manufactured by either
Wyeth or Schwarz. Because Missouri tort law does not allow for such recovery under
any theory of liability, Plaintiffs claims against these defendants must be
dismissed.
2. Plaintiff Cannot Establish The Specific Elements Of Each Of Her Eight Claims.
Plaintiffs failure to meet the most basic "product identification" requirement
should be dispositive. Id. Even were it not, this Court also should dismiss
Plaintiffs claims because Plaintiff cannot allege the requisite elements of her
eight theories of relief: (a) strict products liability; (b) negligence; (c)
fraud; (d) negligent misrepresentation; (e) misrepresentation; (f) breach of
express warranty; (g)breach of implied warranties; and (h) violation of the
Missouri Fair Merchandising Practices Act.
a. Strict Products Liability.
In support of her strict liability claim, Plaintiff alleges both that the generic
metoclopramide she ingested was defectively designed, and that Wyeth and Schwarz
failed to warn her about the risks associated with the drug. Cmplt. PP 82-87. To
recover from Wyeth or Schwarz under either theory, Plaintiff must prove that these
defendants sold generic metoclopramide to Plaintiff in the course of their
business. See, e.g., Campbell v. Am. Crane Corp., 60 F.3d 1329, 1331 (8th Cir.
1995) (failure to warn claim); Lachance v. Am. Home Prods. Corp., No.
01-0890-CV-W-ODS, 2006 WL 89850, at *4 (W.D. Mo. Jan. 13, 2006) (design defect
claim); Mouser v. Caterpillar, Inc., No. 4:98CV744 FRB, 2000 WL 35552637, at *12
(E.D. Mo. Oct. 6, 2000) (failure to warn claim). Plaintiff concedes that she never
ingested any metoclopramide manufactured by Wyeth or Schwarz, but instead
purchased and ingested only generic metoclopramide manufactured by other
companies. Therefore, the Court should dismiss Plaintiffs strict liability claim
as against Wyeth and Schwarz.
b. Negligence.
Plaintiffs negligence claim also requires proof that Wyeth and Schwarz
manufactured or distributed the metoclopramide tablets that Plaintiff ingested.
See, e.g., Lead Indus. Ass'n. Inc., 2006 WL 4547877, at *4. Because Plaintiff
never ingested any metoclopramide manufactured by Wyeth or Schwarz, her negligence
claim should be dismissed on this ground alone.
Plaintiffs negligence claim also fails because Plaintiff cannot prove that Wyeth
or Schwarz owed a duty to Plaintiff -- a necessary element of any negligence
claim. Hill v. General Motors Corp., et al., 637 S.W.2d 382, 384 (Mo. Ct. App.
1982). Plaintiffs attempt to impose a duty on these defendants for harm allegedly
caused by another manufacturer's product runs counter to well-settled principles
of negligence as well as public policy. First, there is no Missouri authority that
imposes a duty on one manufacturer to warn about the risks associated with another
manufacturer's product. Second, there is no Missouri authority that imposes a duty
on a manufacturer to exercise reasonable care to ensure that another
manufacturer's product is reasonably safe. To the contrary, and as explained
above, a manufacturer may only be held liable for the injuries caused by its
product; it cannot be held liable for injuries caused by another manufacturer's
product. See Lead Indus. Ass'n. Inc., 2006 WL 4547877, at *4. Accordingly, the
Court should dismiss Plaintiffs negligence claim for this additional reason.
c. Fraud, Negligent Misrepresentation, and Misrepresentation.
Plaintiff also asserts that Wyeth and Schwarz should be held liable because each
defendant was the manufacturer of name brand metoclopramide ( Reglan(R)) during
parts of the period in which Plaintiff allegedly ingested generic metoclopramide.
Plaintiff argues that manufacturers of name brand drugs can be held liable under
theories of "misrepresentation" and "fraud" for injuries caused by generic
products because generic pharmaceutical manufacturers routinely adopt and rely
upon the pharmaceutical labels and warnings that are issued by name brand
manufacturers such as Wyeth and Schwarz. See, e.g., Cmplt. P 17. In essence,
Plaintiff argues that Wyeth and Schwarz should be held liable for the
representations of their competitors, generic drug manufacturers. This claim fails
for several reasons.
First, designating claims as "misrepresentation" or "fraud" cannot mask the fact
that these claims are grounded on an alleged injury from a product. Rather, as the
Supreme Court of Missouri expressly explained in both Zafft and Benjamin Moore &
Co., a plaintiff seeking to recover under any tort theory in a products liability
action must prove that the defendant's product was the actual cause of the
plaintiffs injury. See Benjamin Moore & Co., 226 S.W.3d at 115-16; Zafft, 676
S.W.2d at 244.
Second, Plaintiff cannot make the requisite showing of duty. An essential element
of both fraudulent and negligent misrepresentation is "the existence of a duty to
disclose." Kesselring v. St. Louis Group, Inc., 74 S.W.3d 809, 813 (Mo. Ct. App.
2002). As noted above, there is no authority for the proposition that a
manufacturer owes a duty of care to the consumers of another manufacturer's
product.
Finally, it would violate public policy to hold Wyeth and Schwarz liable here
under theories of fraud, negligent misrepresentation, or misrepresentation. As one
court explained, construing analogous facts, to impose such liability would
require name brand manufacturers to serve as absolute insurers for generic
manufacturers' products:
It ... seems unfair to hold the pioneer manufacturer liable as insurer for not
only its own production but also its generic competitors, especially when the
latter enjoys the full financial benefits but no risks regarding the product....
[T]o adopt plaintiffs contention here would tend to discourage development of new
drugs because of the unlimited exposure to the non-benefiting developer of the
original product.
Conte v. Wyeth, Inc., CGC-04-437382 at 7 (Cal. Super. Ct. Jan. 29, 2007); see also
Zafft, 676 S.W.2d at 247 (recognizing "legitimate concerns that liability will
discourage desired pharmaceutical research and development while adding little
incentive to production of safe products" if companies were to face potential
liability even if their product was not ingested). Accordingly, the Court should
dismiss Plaintiffs claims for fraud, negligent misrepresentation, and
misrepresentation.
d. Breach of Express Warranty and Implied Warranties.
Plaintiffs claims for breach of express warranty and breach of implied warranties
each require, among other things, proof that Plaintiff purchased a product sold by
Wyeth or Schwarz. See Mo. ANN. STAT. s 400.2-313 (2007) (stating that any
purported express warranty must be "part of the basis of the bargain"); Mo. ANN.
STAT. s 400.2-314 (2007) (stating that implied warranty of merchantability arises
only in context of a sale of goods to purchaser); Mo. ANN. STAT. s 400.2-315
(2007) (stating that implied warranty of fitness arises only when "the buyer is
relying on the seller's skill or judgment"). Plaintiff concedes that she purchased
only generic metoclopramide and not any name-brand Reglan(R) tablets manufactured
by Schwarz or Wyeth. Therefore, the Court should dismiss each of Plaintiff's
breach of warranty claims.
e. Violation of the Missouri Fair Merchandising Practices Act.
Finally, Plaintiff seeks recovery under the Missouri Fair Merchandising Practices
Act ("MPA"). See Cmplt. PP 88-97; Mo. ANN. STAT. s 407.020 (2007). Section 407.025
sets out the elements for an MPA violation: a plaintiff must allege that she has
purchased merchandise for personal, family, or household purposes and suffered an
ascertainable loss of money or property as a result of an act declared unlawful by
section 407.020. Hess v. Chase Manhattan Bank, USA, N.A., 220 S.W.3d 758, 773 (Mo.
2007) (en banc).
Here, however, Plaintiff has no standing to assert a claim under the MPA because
she never purchased Wyeth's or Schwarz's products. Lavender v. Wolpoff & Abramson,
L.L.P., No. 07-0015-CV-W-FJG, 2007 WL 2507752, slip op. at *2 (W.D. Mo. Aug. 20,
2007) (dismissing plaintiffs' MPA claim for lack of standing because defendants
did not sell any goods or merchandise or provide any services to plaintiffs).
Accordingly, Plaintiffs MPA claim fails.
B. Courts Have Uniformly Held That Name Brand Manufacturers Cannot Be Held Liable
For Injuries Caused By Generic Products, Including The Generic Product At Issue
Here.
Missouri law does not stand alone in rejecting Plaintiffs broad theories of
liability. Every court that has confronted the issue has held that a name brand
manufacturer cannot be held liable for injuries caused by the ingestion of a
generic manufacturer's product. See Foster v. Am. Home Prods. Corp., 29 F.3d 165,
171 (4th Cir. 1994); Smith v. Wyeth, Inc., No. 5:07-CV-18-R, 2008 WL 2677051, at
*4 (W.D. Ky. June 30, 2008); Wilson v. Wyeth, Inc., No. 3:07-CV-378-R, 2008 WL
2677049, at *4 (W.D. Ky. June 30, 2008); Morris v. Wyeth, Inc., No. 1:07-CV-176-R,
2008 WL 2677048, at *4 (W.D. Ky. June 30, 2008); Pustejovsky v. Wyeth, Inc., No.
4:07-CV-103-Y, 2008 WL 1314902, at *2 (N.D. Tex. Apr. 3, 2008); Swicegood v.
Pliva, Inc., 543 F. Supp. 2d 1351, 1354-59 (N.D. Ga. 2008); Barnhill v. Teva
Pharmaceuticals USA, Inc., No. Civ. A. 06-0282-CB-M, Order at 4 (S.D. Ala. Apr.
24, 2007); LeBlanc v. Wyeth, Inc., No. Civ. A 04-0611, 2006 WL 2883030, at *6
(W.D. La. Oct. 5, 2006); Goldych v. Eli Lilly & Co., No. 5:04-CV-1477, 2006 WL
2038436, at *3-*6 (N.D.N.Y. July 19, 2006); Colacicco v. Apotex, Inc., 432 F.
Supp.2d 514, 540-41 (E.D. Pa. 2006); Tarver v. Wyeth, No. Civ. A. 3-04-2036, 2005
WL 4052382, at *2 (W.D. La. June 7, 2005); Block v. Wyeth, Inc., 02-CV-1077, 2003
WL 203067, at *2 (N.D. Tex. Jan. 28, 2003); Stanley v. Wyeth, Inc., 2008 WL
1930154, at *2-*3 (La. App. 1 Cir. May 2, 2008); Flynn v. Am. Home Prods. Corp.,
627 N.W. 2d 342, 350 (Minn. Ct. App. 2001); Sharp v. Leichus, 04-CA-643, 2006 WL
515532, at *4 (Fla. Cir. Ct. Feb. 17, 2006), aff'd per curiam, 952 So.2d 555 (Fla.
1st DCA 2007); Green v. Wyeth Pharmaceuticals, Inc., et al., CV-06-3917 ER, Order
at 1 (Ala. Cir. Ct. May 15, 2007); Conte v. Wyeth, Inc., CGC-04-437382, at 7 (Cal.
Super. Ct. Jan. 29, 2007); Kelly v. Wyeth, 03-CV-3314, 2005 WL 4056740, at *2
(Super. Ct. Mass. May 6, 2005); Sheeks v. Am. Home Prods. Corp., No. 02CV337, 2004
WL 4056060, at *2 (Colo. Dist. Ct. Oct. 15, 2004); Sloan v. Wyeth, No.
MRS-L-1183-04, slip op. at 5 (N.J. Super Ct. Oct. 13, 2004); Beutella v. A.H
Robins Co., Inc., No. 05-CV-2372, 2001 WL 35669202, at *2 (Utah Dist. Ct. Dec. 10,
2001).
Thus, courts have rejected such claims under the laws of fifteen different states:
Alabama, California, Colorado, Florida, Georgia, Kentucky, Louisiana, Maryland,
Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Texas and Utah.
There is not a single decision to the contrary. Indeed, as explained below, twelve
different courts in eleven different states have specifically held that Wyeth
and/or Schwarz, as the manufacturers of name brand Reglan(R), may not be held
liable for injuries allegedly caused by the ingestion of generic metoclopramide.
1. Foster - The Leading And Universally Accepted Authority.
The leading case on whether a name brand manufacturer can be held liable for
injuries allegedly resulting from the use of a generic equivalent drug is Foster
v. American Home Products Corp., which has been adopted by every court that has
addressed the issue. Colacicco, 432 F. Supp. 2d at 540 ("a review of caselaw [sic]
reveals that every state and federal district which has confronted the issue of
innovator drug-manufacturer liability has either adopted the Foster reasoning or
cited Foster with approval").
In Foster, the parents of a child who died after ingesting generic promethazine
brought suit against Wyeth, the manufacturer of Phenergan(R), the name brand
version of the drug. 29 F.3d at 167. Even though the parents conceded that only
the generic product had been ingested, they argued (as Plaintiff does in this
case) that Wyeth, the name brand manufacturer, could be held liable because it
knew that generic manufacturers were using and relying upon its product warning
information. Id. at 168. Thus, the parents argued, Wyeth was liable for the
decedent's injuries to the extent that warning was defective:
The [plaintiffs] argue that because generic drugs are required by federal law to
be equivalent to their name brand counterparts, any representations Wyeth makes
when advertising Phenergan also apply to generic promethazine, and name brand
manufacturers, such as Wyeth, know that generic manufacturers rely on their
studies and duplicate their labeling, and that if the name brand manufacturer does
not issue a warning, it will simply not be made. Wyeth is also aware that when
Phenergan is prescribed, the patient may actually receive generic promethazine.
Id. at 169 (emphasis added).
The Fourth Circuit rejected the Fosters' argument and ruled that one manufacturer
cannot be held liable for injuries resulting from another manufacturer's product:
The [plaintiffs] are attempting to hold Wyeth liable for injuries caused by
another manufacturer's product, and we are persuaded that Maryland courts would
reject this effort to circumvent the necessity that a defendant be shown to have
manufactured the product that caused an injury prior to being held liable for such
injury.
Id. at 168 (emphasis added).
Explaining its decision, the Fourth Circuit noted that generic manufacturers are
independently responsible for issuing adequate warnings about their products:
We do not accept the assertion that a generic manufacturer is not responsible for
negligent misrepresentations on its product labels if it did not initially
formulate the warnings and representations itself. When a generic manufacturer
adopts a name brand manufacturer's warnings and representations without
independent investigation, it does so at the risk that such warnings and
representations may be flawed.
Manufacturers of generic drugs, like all other manufacturers, are responsible for
the representations they make regarding their products.
Id. at 169, 170 (emphasis added).
The court then specifically held that name brand manufacturers cannot be held
liable for injuries allegedly caused by a generic manufacturer's product:
We also reject the contention that a name brand manufacturer's statements
regarding its drug can serve as the basis for liability for injuries caused by
another manufacturer's drug.
There is no legal precedent for using a name brand manufacturer's statements about
its own product as a basis for liability for injuries caused by other
manufacturers' products, over whose production the name brand manufacturer has no
control.
The [plaintiffs'] negligent misrepresentation action against Wyeth also fails
because Wyeth is under no duty of care to the [plaintiffs].
We think to impose a duty in the circumstances of this case would be to stretch
the concept of foreseeability too far.
Id. at 170, 171 (emphasis added).
The Foster decision is consistent with Missouri law, as described above.
Furthermore, it has been accepted and applied in every case that has examined its
holding, including fourteen cases involving generic metoclopramide. In those
fourteen cases, as in the case at hand, plaintiffs asked the court to hold Schwarz
and/or Wyeth liable for "fraud" or "misrepresentation" for injuries resulting from
the ingestion of generic metoclopramide. As explained below, each time the court
refused.
2. Beutella (Utah) - Rejected These Same Claims.
In Beutella, the court held that A.H. Robins (a Wyeth predecessor company) owed no
duty to a patient who consumed only generic metoclopramide. 2001 WL 35669902, at
*3. The court then adopted the reasoning and holding of Foster -- that a name
brand manufacturer may not be held liable for injuries caused solely by the
ingestion of generic metoclopramide: "This Court is persuaded that the conclusions
of the Foster case are sound and reasonable, and are sufficiently similar to this
case to impel the same conclusion here." Id. at *3.
3. Block (Texas) - Rejected These Same Claims.
In Block, the plaintiff abandoned his strict liability claim against Wyeth, and
instead sought liability "under theories of negligence, negligent
misrepresentation, fraud, conspiracy, and malice." 2003 WL 203067, at *1. The
court dismissed the claims, holding that a name brand pharmaceutical maker did not
"owe[ ] a legal duty to consumers of a generic equivalent arising out of the
content of product labeling and descriptions formulated for the name brand drug."
Id.
4. Sloan (New Jersey) - Rejected These Same Claims.
In Sloan, the court rejected plaintiffs "assert[ion] that there is a distinction
to be drawn by the Court, that defendant Wyeth was a 'disseminator' of negligently
false and misleading information, rather than a 'manufacturer' of a defective
product." Docket No. MRS-L-1183-04, slip. op. at 5. The court held that neither
the "New Jersey or the Federal authorities intended to expand prescription drug
manufacturer liability to injuries sustained by generic drug companies which use
formulations developed by the brand name company." Id. at 9. The court further
held that imposing a duty would place an undue burden on name brand manufacturers
because such "manufacturers would be less likely to develop new products if
liability were imposed upon these companies for injuries wrought by products of
generic manufacturers." Id.
5. Sheeks (Colorado) - Rejected These Same Claims.
In Sheeks, the court rejected the same claims, holding that "[r]egardless of how
termed, the action brought by the [plaintiffs] is a product liability action."
2004 WL 4056060, at *1. Therefore, because Wyeth did not make or sell the generic
metoclopramide allegedly ingested, Colorado law, which imposes liability only on
the manufacturer of the product used by plaintiff, barred the plaintiffs' claims.
Id. According to the Court, "Wyeth owed no duty to Plaintiffs to warn of a drug
that it did not manufacture or supply." Id. at *3.
6. Kelly (Massachusetts) - Rejected These Same Claims.
In Kelly, the court rejected plaintiffs' argument that Wyeth, as the brand name
manufacturer had "a duty towards patients for whom, not only Regian [sic] is
prescribed, but also towards those who actually ingest a pharmecologically [sic]
identical generic equivalent." 2005 WL 4056740, at *3. Relying heavily on Foster,
the court observed:
The reasoning of Foster has been adopted in other cases where a brand name drug
manufacturer has been sued by plaintiffs who were injured after taking its generic
equivalent.
The statutory scheme governing premarketing approval for drugs simply does not
evidence Congressional intent to insulate generic drug manufacturers from
liability for misrepresentations made regarding their products, or to otherwise
alter state product liability law. Manufacturers of generic drugs, like all other
manufacturers, are responsible for the representations they make regarding their
products.
Id. at *3, *5.
7. Tarver (Louisiana) - Rejected These Same Claims.
In Tarver, the court dismissed claims against Schwarz when the plaintiff ingested
only generic metoclopramide because "[t]he law is clear that Louisiana imposes on
a manufacturer no duty to warn of the dangers of another company's product." 2005
WL 4052382 at *2 (citations omitted). The Tarver court subsequently granted
Wyeth's motion for judgment on the pleadings on the same basis. Tarver v. Wyeth,
Inc., No. Civ A. 3-04-2036, 2006 WL 1517546, at *2-*3 (W.D. La. Jan. 26, 2006).
8. Sharp (Florida) - Rejected These Same Claims.
In Sharp, the court entered summary judgment in favor of Schwarz and Wyeth on the
plaintiffs' claims for fraud/intentional misrepresentation, negligent
misrepresentation, and fraud by concealment involving Reglan(R) and generic
metoclopramide, noting: "[i]t is abundantly clear that the Plaintiffs' case is, in
fact, a products liability case." 2006 WL 515532, at *6. The court also rejected
the plaintiffs' argument that Schwarz and Wyeth owed a duty of care to patients
who might consume the generic equivalents of name brand Reglan(R), stating that "a
legal duty is not established by evidence of foreseeability alone ... there must
also be evidence or allegations showing that ... defendant's conduct created or
controlled the risk." Id. at *7 (emphasis in original) (citations and quotations
omitted).
Subsequently, the First District Court of Appeals affirmed the Sharp court's grant
of final summary judgment in favor of Schwarz and Wyeth per curiam, adopting
wholesale the reasoning and analysis of Foster. See Sharp v. Wyeth, 952 So.2d 555
(Fla. 1st DCA 2007) (per curiam).
9. Conte (California) - Rejected These Same Claims.
In Conte, the court granted summary judgment in favor of Wyeth because Wyeth "had
no connection with plaintiffs injuries save the fact it developed the product and
prepared the description and other pharmaceutical literature on the drug Reglan
when the Food and Drug Administration approved it." CGC-04-437382 at 4. The court
ruled that Wyeth had no duty to plaintiff because she never ingested Wyeth's
product. Id. at 7.
10. Green (Alabama) - Rejected These Same Claims.
In Green, plaintiffs lawyers attempted to assert claims for fraud, negligent
misrepresentation and strict liability against Wyeth and Schwarz in Alabama even
though "Wyeth and Schwarz did not manufacture the [ Reglan(R)] syrup formulation
ingested by plaintiff, Tyler Green." CV-06-3917 ER, Order at 1. Remarking that the
courts "that have considered the issues presented in this case have found that
only the manufacturer of the generic drug which was sold [is] liable," the Alabama
court granted summary judgment in favor of Wyeth and Schwarz. Id.
11. Swicegood (Georgia) - Rejected These Same Claims.
Less than five months ago, a federal court applying Georgia law dismissed claims
against Wyeth and Schwarz in the Reglan(R)/generic metoclopramide context. "This
Court joins with other courts nationwide in rejecting the claim that the
manufacturer of the branded product is liable for misrepresentation in the
labeling of the generic product." Swicegood, 543 F. Supp. 2d at 1358 (citing
Foster with approval). In Swicegood, it was undisputed that the plaintiff did not
ingest a metoclopramide product manufactured or distributed by Wyeth or Schwarz.
Nevertheless, the plaintiff once again sought to rely on the theory that had
repeatedly failed before: that Wyeth and Schwarz, as the name brand manufacturers,
could be held liable for statements contained in the label of the generic
metoclopramide that the plaintiff actually ingested. Id. at 1354. Plaintiff fared
no better in Swicegood, as the court systematically rebutted and dismissed each of
plaintiffs claims under Georgia law. Id. at 1356 (concluding that the FDA
regulations for prescription drug labeling do "not require a name brand
manufacturer to ensure that the generic brand's label is accurate.").
12. Pustejovsky (Texas) - Rejected These Same Claims.
In April of this year, another federal court in Texas joined the ranks of the
courts to reject brand name liability for ingestion of generic metoclopramide.
Pustejovsky, 2008 WL 1314902, at *2. The Pustejovsky court applied Texas law to
grant summary judgment in favor of Wyeth and Schwarz when plaintiff (once again)
asserted claims against the name brand manufacturers even though she had ingested
only the generic version of metoclopramide. Id. at * 1. The court phrased the
question as one of legal duty and answered it squarely in favor of Wyeth and
Schwarz: "In this case, Wyeth's and Schwartz [sic] Pharma's lack of a duty to
Plaintiff is fatal to all of her common-law claims, including negligence, fraud,
and negligent misrepresentation." Id. at *2.
13. Smith, Wilson and Morris (Kentucky) - Rejected These Same Claims.
Most recently, a Kentucky federal court dismissed various product liability claims
asserted against Wyeth and Schwarz, as the name brand manufacturers of Reglan(R),
by three plaintiffs who had consumed only generic metoclopramide. See Smith, 2008
WL 2677051, at *4; Wilson, 2008 WL 2677049, at *4; Morris, 2008 WL 2677048, at *4.
In each case, the court concluded that: "As a product liability action under
Kentucky law, Plaintiff must show that Reglan was the legal cause of her [Tardive
Dyskinesia]. Because Plaintiff does not allege that [Plaintiff] ever took Reglan,
[Plaintiff] has not alleged a claim under Kentucky products liability law." Smith,
2008 WL 2677051, at *3; Wilson, 2008 WL 2677049, at *2; see also Morris, 2008 WL
2677048, at *3.
Further, the court rejected plaintiffs' argument that Schwarz's and Wyeth's
respective warnings, labeling and marketing concerning Reglan(R) "should also be
seen as the warning, labeling and marketing of products manufactured by companies
that are Defendants' direct competitors in the prescription drug market." Smith,
2008 WL 2677051, at *3; Wilson, 2008 WL 2677049, at *3; Morris, 2008 WL 2677048,
at *3. "Upon examination of applicable Kentucky law, the Court finds that in the
generic drug context, Kentucky does not recognizes [sic] a cause of action against
a manufacturer for its representations concerning its own product, based on an
injury caused from the use of another manufacturer's product." Smith, 2008 WL
2677051, at *4; Wilson, 2008 WL 2677049, at *4; Morris, 2008 WL 2677048, at *4.
14. Plaintiff In This Case Cannot Maintain A Claim Against Defendants For Injuries
Allegedly Caused By Generic Metoclopramide.
Despite the fact that all previous attempts to hold Schwarz and/or Wyeth liable
for injuries allegedly caused by generic metoclopramide have failed, Plaintiffs
counsel comes before this Court making the very same arguments made in each of the
previous fourteen metoclopramide cases. The result in this case should be the same
-- Plaintiff should not be allowed to impose liability on Wyeth or Schwarz when
Plaintiff concedes that she never ingested a product manufactured by these
defendants and, therefore, that neither Wyeth's nor Schwarz's products caused her
injuries.
To hold otherwise would improperly make name brand manufacturers responsible for
every injury caused by equivalent products made by every generic manufacturer in
the United States. Indeed, such an inequitable, unprecedented, and illogical
result would have a devastating impact on the entire pharmaceutical industry. See,
e.g., Foster, 29 F.3d 170 (observing that such liability would be "especially
unfair" because "the generic manufacturer reaps the benefits of the name brand
manufacturer's statements by copying its labels and riding on the coattails of its
advertising"). For these very reasons, courts have uniformly refused to extend
tort law into such "new and uncharted territory." Block, 2003 WL 203067, at *3;
see also Colacicco, 432 F. Supp. 2d at 543 (rejecting plaintiffs invitation "to
drastically expand the boundaries of Pennsylvania tort law without precedent or
policy to support his position" because "the Supreme Court of Pennsylvania would
not accept this invitation").
CONCLUSION
Plaintiff did not ingest any product that was manufactured, sold, or distributed
by Wyeth or Schwarz, and Missouri law does not recognize Plaintiffs broad theories
of recovery. This Court should grant Wyeth and Schwarz's motion for summary
judgment and dismiss all of Plaintiffs claims against them.
Dated: September 30, 2008
WYETH, INC.
SCHWARZ PHARMA, INC.
by: /s/ Beth A. Bauer
One of Their Attorneys
Larry E. Hepler, #01195603
Beth A. Bauer, #0627453
HEPLER, BROOM, MacDONALD,
HEBRANK, TRUE & NOCE LLC
103 W. Vandalia St., Suite 300
Edwardsville, IL 62025-0510
Phone: 618/656-0184
/s/ Jeffrey R. Pilkington (with consent)
Jeffrey R. Pilkington (admitted pro hac vice)
Thomas H. Wagner (admitted pro hac vice)
Davis Graham & Stubbs LLP
1550 Seventeenth Street, Suite 500
Denver, CO 80202
Phone: (303) 892-7513
Fax: (303) 893-1379
/s/ Henninger S. Bullock (with consent)
Henninger S. Bullock (admitted pro hac vice)
Andrew J. Calica (admitted pro hac vice)
Mayer Brown LLP
1675 Broadway
New York, NY 10019
Phone: (212) 506-2500
Fax: (212) 262-1910
