The lawyers for Wyeth and Schwarz filed this motion for summary judgment in Nevada. One of the issues raised is whether Wyeth, as the firm that first brought Reglan to market, can be held liable if someone is injured while taking Metoclopramide, the generic form of Reglan.
People who have used Metoclopramide or Reglan for longer than 12 weeks are at risk of developing movement disorders like Tardive Dyskinesia. Movement disorders are known Reglan side effects.
Pursuant to Fed. R. Civ. P. 56, Defendants Wyeth (incorrectly sued as “Wyeth, Inc.”) and Schwarz Pharma, Inc. (“Schwarz”) respectfully submit their Motion for Summary Judgment, Narrative Statement of Undisputed Facts and Memorandum in Support of Their Motion for Summary Judgment.
This is a products liability action. Plaintiff alleges that she suffered injuries after ingesting the prescription drug metoclopramide. Plaintiff admits, however, that she did not ingest any metoclopramide manufactured or distributed by Wyeth or Schwarz. Nonetheless, Plaintiff asserts that Wyeth and Schwarz (who at different times manufactured brand name Reglan) can be held liable for allegedly failing to adequately warn Plaintiff and her doctors about the risks associated with generic metoclopramide manufactured by other companies. Because Plaintiff never purchased or ingested a Wyeth or Schwarz metoclopramide product, these claims fail as a matter of law.
Under well-settled Nevada law, a plaintiff asserting product liability claims must establish, among other things, that the defendant manufactured or sold the specific product that caused plaintiff's alleged injuries. A defendant cannot be liable for any harm caused by another manufacturer's product. Further, Nevada law imposes no duty upon a brand name drug manufacturer (such as Wyeth and Schwarz) to warn about the risks associated with the use of a generic drug manufactured and sold by another company. Accordingly, Plaintiff simply cannot establish essential elements of her claims.
The proposition advanced by Plaintiff in this case – that one manufacturer can be held liable for injuries caused by another manufacturer's product has been rejected by every court that has considered it. Indeed, fourteen decisions in eleven different states have already rejected such claims brought against Wyeth and Schwarz as the brand name manufacturers of Reglan(R). For these reasons, and for the reasons set forth below, the Court should grant this Motion and enter judgment in favor of Wyeth and Schwarz on all claims.
NARRATIVE STATEMENT OF UNDISPUTED FACTS
On September 7, 2007, Plaintiff filed her Complaint in the United States District Court for the District of Minnesota. The Complaint asserts a variety of product liability claims against four manufacturers of metoclopramide: Wyeth, Schwarz, Pliva, Inc. (“Pliva”) and Teva Pharmaceuticals, USA, Inc. (“Teva”).[FN1] On February 22, 2008, Plaintiff filed her First Amended Complaint. (“FAC,” Docket #58). The FAC asserts thirteen claims: strict products liability; breach of express and implied warranties; negligence; misrepresentation by omission; constructive fraud; violation of the Minnesota Deceptive Trade Practice Act, the Minnesota Prevention of Consumer Fraud Act, and the Minnesota False Statement in Advertising Act; intentional and negligent infliction of emotional distress; negligent misrepresentation; and fraud by concealment. Id. All of these claims seek relief for alleged injuries Plaintiff suffered as a result of ingesting metoclopramide.-[FN2]/ Id.
FN1. / Metoclopramide is a prescription drug used to treat gastroesophageal reflux disease, acute and recurrent diabetic gastric stasis, and other conditions. (FAC at T 19, 32.)
As with many prescription drugs, metoclopramide is available in either brand name (Reglan(R)) or generic versions. (Affidavit of Paul Minicozzi (“Minicozzi Aff.”) at 2, attached as Exhibit A.) At different times, both Wyeth and Schwarz manufactured and distributed name brand Reglan(R). Id. at 1. Wyeth manufactured and distributed name brand Reglan(R) tablets from approximately 1989 through December 2001.[FN3] Id. In the December 2001, Wyeth sold the rights to name brand Reglan(R) tablets to Schwarz; since then, Wyeth has neither sold nor distributed any Reglan(R) tablets. Id. at 2. Thereafter, Schwarz manufactured and distributed brand name Reglan(R) tablets through and including April 2004; however, Schwarz has never manufactured nor owned any rights associated with generic metoclopramide tablets.[FN4]/ A number of companies, including defendants Pliva and Teva, manufacture and distribute generic metoclopramide. (FAC at ¶¶ 10, 12.)
FN2. Defendants subsequently answered and filed a motion to transfer venue pursuant to 28 U.S.C. § 1404. On March 17, 2008, the District of Minnesota granted these motions. (Docket #67). This Court received the transfer on March 21, 2008.
FN3. /By way of background, Wyeth manufactured and distributed Reglan in three different forms: tablet, syrup and injectable. Wyeth manufactured and distributed name brand Reglan syrup from approximately late 1989 through 2001 and name brand Reglan injectable from approximately late 1989 through 2002. In late December 2001, Wyeth withdrew its New Drug Application (NDA) for name brand Reglan syrup. In late December 2002, Wyeth sold the rights to Reglan injectable. (Minicozzi Aff. at 1, 2.)
FN4. / See Sharp v. Leichus, 04-CA-643, 2006 WL 515532, at *1 (Fla. Cir. Ct. Feb. 17, 2006), aff'd per curiam, 952 So. 2d 555 (Fla. 1st DCA 2007).
Plaintiff's FAC failed to: (1) identify whether she ingested brand-name Reglan(R) or generic metoclopramide, and (2) identify the manufacturer(s) of the metoclopramide that she ingested. Accordingly, the Court ordered Plaintiff to clarify what metoclopramide she ingested by producing all “product identification information.” (Docket 78 and 80).
Plaintiff has since provided this information in a “Notice of Filing Product Identification” (the “Notice”) dated August 8, 2008. (Docket #127). The Notice (and its attached pharmacy records) establish that:
● Plaintiff did not ingest any metoclopramide product manufactured by Wyeth or Schwarz. Id. at 1.
● Plaintiff ingested only metoclopramide manufactured by Teva and Pliva during the period May 2003 through April 2004. Id. at 2.
In a stipulation executed by Plaintiff, Wyeth and Schwarz, Plaintiff further admits that she: (1) “ingested only generic metoclopramide”; and (2) “did not ingest any metoclopramide, whether generic or brand name (Reglan(R)), manufactured or distributed by Wyeth or Schwarz.” (Stipulation, attached as Exhibit B).
Notwithstanding the undisputed fact that she never ingested any metoclopramide manufactured by either Wyeth or Schwarz, Plaintiff seeks to maintain 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. As explained below, her arguments and claims must be rejected as a matter of law.
I. SUMMARY JUDGMENT STANDARD.
Summary judgment allows a court to dispose of factually unsupported claims. Bagdadi v. Nazar, 84 F.3d 1194, 1197 (9th Cir. 1996). “The purpose of summary judgment is to avoid unnecessary trial when there is no dispute as to the material facts before the court.” Nw. Motorcycle Ass'n v. U.S. Dep't of Agric., 18 F.3d 1468, 1471 (9th Cir. 1994). Summary judgment is appropriate when the evidence “show[s] that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Id., citing FED. R. Civ. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).
An issue is “genuine” only if there is a sufficient evidentiary basis on which a reasonable fact finder could find for the nonmoving party, and a dispute is “material” only if it could affect the outcome of the suit under the governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-49 (1986). When the nonmoving party bears the burden of proof at trial, summary judgment is warranted if the nonmovant fails to “make a showing sufficient to establish the existence of an element essential to [its] case.” at 322. The party opposing the motion may not rest on the mere allegations or denials of its pleadings, but must set forth specific facts showing that there is a genuine issue for trial. Anderson, 477 U.S. at 248.
II. THE COURT SHOULD ENTER SUMMARY JUDGMENT IN FAVOR OF WYETH AND SCHWARZ ON ALL CLAIMS.
Plaintiff's attempt to hold Wyeth and Schwarz liable for the alleged harm caused by their competitors' product fails as a matter of law. Summary judgment is proper because Plaintiffs claims are contrary to Nevada law (infra. at 7-14) and have been rejected by every court that has considered the issue (infra. at 14-24).
A. Wyeth And Schwarz Cannot Be Held Liable Under Nevada Law For Injuries Caused By Another Manufacturer's Product.
Plaintiff improperly attempts to hold Wyeth and Schwarz liable for injuries even though neither defendant made the product that allegedly caused those injuries. Nevada law simply does not recognize such claims, for two reasons: (1) Nevada law requires the defendant to have manufactured or sold the specific product that caused the alleged harm; and (2) Plaintiff cannot satisfy the specific elements – particularly the element of duty -necessary for each of her thirteen claims against Wyeth and Schwarz.
1. A Products Liability Plaintiff Must Show That The Defendant Manufactured Or Sold The Product That Caused The Injury.
Regardless of the theory of liability advanced, it is hornbook law (and Nevada law) that one manufacturer cannot be held liable for injuries caused by another manufacturer's product. See Allison v. Merck & Co., 110 Nev. 762, 767, 878 P.2d 948, 952 (1994) (requiring that, where a product has caused injury, responsibility be placed on the manufacturer of that product); Kite v. Zimmer US, Inc., 2:06-cv-00745, 2006 WL 3386765, at *4 (D. Nev. Nov. 22, 2006) (dismissing negligence and negligent misrepresentation claims against defendant because it did not supply the product in question and therefore owed no duty to plaintiff); Shoshone Coca-Cola Co. v. Dolinski, 82 Nev. 439, 443, 420 P.2d 855, 858 (1966) (holding that plaintiff was required to show defect in the product manufactured by the defendant); Badillo v. Am. Tobacco Co., 202 F.R.D. 261, 264 (D. Nev. 2001) (denying class certification and noting that plaintiffs had not established that each of the defendants was a manufacturer of the tobacco products that allegedly injured plaintiffs).
Nevada courts are not alone in imposing such a requirement. As one commentator has observed:
It is axiomatic that a plaintiff must prove that the proximate cause of his or her injuries was the defendant's product. Stated another way, a plaintiff in a products liability case bears the burden of proving by a preponderance of evidence that the defendant caused the harm that is the subject of the litigation. The identification element of causation-in-fact requires the plaintiff to establish a sufficient connection between the product and its alleged manufacturer or supplier.
Louis R. FRUMER and MELVIN I. FRIEDMAN, PRODUCTS LIABILITY § 3.04 (2002). Indeed, this “product identification” element is an essential prerequisite for imposing liability:
Regardless of the theory which liability is predicated upon, whether negligence, breach of warranty, strict liability in tort, or other grounds, it is obvious that to hold a producer, manufacturer, or seller liable for injury caused by a particular product, there must first be proof that the defendant produced, manufactured, sold or was in some way responsible for the product, and this rule is supported in all of the cases examined in this annotation.
Annotation, 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 (2007).
In this case, the undisputed facts conclusively establish that Plaintiff did not purchase or ingest a metoclopramide product manufactured by Wyeth or Schwarz – i.e., there has been no product identification with respect to these defendants. As a consequence, neither Wyeth nor Schwarz caused Plaintiff's purported injuries, and, thus, her claims fail. Judgment should be entered on all claims.
2. Wyeth And Schwarz Do Not Owe A Duty to Plaintiff – For This And Other Reasons, Plaintiff Cannot Establish The Specific Elements of Any Of Her Thirteen Claims.
In a futile effort to avoid this dispositive law, Plaintiff asserts as her attorneys unsuccessfully have asserted in numerous other Reglan(R)/ metoclopramide cases that this is not a product liability case. Specifically, Plaintiff argues that brand name manufacture like Wyeth and Schwarz can be held liable on theories of “negligence,” “misrepresentation” and “fraud” because generic pharmaceutical manufacturers customarily adopt and rely upon labels and warnings issued by the brand name manufacturers. (FAC at ¶ 67). But Plaintiff's argument ignores the legal reality that Weth and Schwarz siml do not owe a leal duty to Plaintiff.
Under Nevada law, an indispensable predicate for all of Plaintiff's tort-based claims is the existence of a duty of care owed by the alleged wrongdoer to the person injured. See Turney v. Sullivan, 89 Nev. 554, 516 P.2d 738 (1973); REST. 2D, TORTS § 314 (1965). In this case, there is no relationship between Plaintiff, on the one hand, and Wyeth or Schwarz, on the other hand, that would create such a duty. Plaintiff's alleged injuries were caused by products that, she admits, were neither Wyeth's nor Schwarz's product. She never purchased or used Wyeth's or Schwarz's product. Moreover, nothing about Wyeth or Schwarz's activities or Plaintiff's alleged injuries supports the creation of a duty of care.[FN5]/ There is no Nevada authority that imposes or suggests a duty on a manufacturer ( such as Wyeth or Schwarz) to warn of the risks associated with its competitor's products. To the contrary, manufacturers should be liable only for the injuries caused by the products they actually make and sell.
FN5. / Indeed, Wyeth no longer held the NDA at the time Plaintiff ingested the generic metoclopramide of its competitors (see supra, n.3).
For the convenience of the Court, Wyeth and Schwarz explain (below) that Plaintiff cannot establish a duty or other elements necessary for each claim. Accordingly, the Court should enter judgment on all claims.
a. Negligence (Count 4).
Under Nevada law, a claim for negligence must be based on an existing duty of care. Turner v. Mandalay Sports Entm 't,LLC, 180 P.3d 1172, 1175 (Nev. 2008) (“A claim for negligence in Nevada requires that the plaintiff satisfy four elements: (1) an existing duty of care, (2) breach, (3) legal causation, and (4) damages.” Equip. Co. of Nev., 79 Nev. 441, 444, 386 P.2d 396, 397 (1963) ( “liability based on negligence does not exist in the absence of a breach of duty”). Only the manufacturer or seller of an allegedly defective product owes a duty of care to the purchaser. See Kite, 2006 WL 3386765, at *4 (“Because Zimmer Frey did not supply the [product], it cannot be liable for negligent product liability or negligent misrepresentation because it did not owe the Plaintiffs a duty of care”). Further, summary judgment is appropriate in a negligence ac where no duty exists. Butler v. Bayer, 123 Nev. Adv. Rep. 44, 168 P.3d 1055, 1063 (2007). Because neither Wyeth nor Schwarz manufactured the metoclopramide that purportedly injured Plaintiff, neither owes a duty to Plaintiff Therefore, judgment should be entered on Plaintiff's negligence claim.
b. Misrepresentation By Omission (Count 5) And Negligent Misrepresentation (Count 12).
Like any negligence claim, misrepresentation by omission and negligent misrepresentation require the existence of a duty. Kite, 2006 WL 3386765, at *4. Because Wyeth and Schwarz did not manufacture or sell Plaintiff's metoclopramide, they had no duty to Plaintiff, and her misrepresentation claims fail as a matter of law. Id.; see also Barmettler v. Reno Air, Inc., 114 Nev. 441, 446-47, 956 P.2d 1382, 1386 (1998) (Plaintiff has the burden of proving each element of a fraudulent misrepresentation claim by clear and convincing evidence).
Moreover, a negligent misrepresentation claim can only lie when one “supplies false information for the guidance of others in their business transactions.” Barmettler, 114 Nev. at 449 (citing Bill Stremmel Motors, Inc. v. First Nat'l Bank of Nev., 94 Nev. 131, 134, 575 P.2d 938, 940 (1978)). Because Plaintiff never purchased a Wyeth or Schwarz metoclopramide product, there has been no transaction, and thus her negligent misrepresentation claim fails for this additional reason.
c. Intentional And Negligent Infliction Of Emotional Distress (Counts 10 and 11).
The existence of a duty is a required element of both intentional and negligent infliction of emotional distress. See Dillard Dep't Stores, Inc. v. Beckwith, 115 Nev. 372, 378, 989 P.2d 882, 886 (1999); Star v. Rabello, 97 Nev. 124, 125, 625 P.2d 90, 92 (1981) (intentional infliction of emotional distress requires breach of duty, actual or proximate cause, and damages); Turner, 180 P.3d at 1178 (negligent infliction of emotional distress requires duty, breach of duty, causation, and damages) (citing Moon v. Guardian Postacute Servs., Inc., 95 Cal. App. 4th 1005, 116 Cal. Rptr. 2d 218, 220-21 (Ct. App. 2002)). Because Wyeth and Schwarz neither manufactured nor sold the metoclopramide that allegedly injured Plaintiff, they owed her no duty, and these claims should be dismissed.
d. Constructive Fraud (Count 6) And Fraud By Concealment (Count 13).
For a mere omission to constitute actionable fraud, a defendant must have had a duty to disclose the facts at issue. Epperson v. Roloff, 102 Nev. 206, 213, 719 P.2d 799, 803-04(1986). Generally, an action in deceit will not lie for nondisclosure. Id. The duty to disclose requires, at a minimum, some form of relationship between the parties. Dow Chem. Co. v. Mahlum, 114 Nev. 1468, 970 P.2d 98, 110-11 (1998); cf. In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 113 F.3d 1484, 1497 (8th Cir. 1997) (without some kind of relationship, there can be no duty to disclose). Because Wyeth and Schwarz lack any connection to or relationship with Plaintiff, Wyeth and Schwarz owed no duty to disclose to Plaintiff. Therefore, Plaintiffs fraud and fraudulent concealment claims fail as a matter of law.
e. Strict Product Liability (Count 1).
Under Nevada law, a plaintiff who asserts a strict product liability claim must establish that the defendant manufactured or sold the specific product that allegedly injured the plaintiff. See Shoshone Coca-Cola Co., 82 Nev. at 443, 420 P.2d at 858 (plaintiff must “establish that his injury was caused by a defect in the product, and that such defect existed when the product left the hands of the defendant”). Because the product at issue must have passed through the “hands of the defendant,” only those who manufactured or sold the product can be liable on a product liability claim. Allison, 110 Nev. at 767, 878 P.2d at 952 (1994) (where defendant had not sold the allegedly harmful vaccine, it could not be liable for any potential harm caused by the vaccine); Thompson v. Medtronic, Inc., 2:06-cv-00675, 2006 WL 3544937, at *2 (D. Nev. Dec. 8, 2006) (“only individuals who sell or contract to sell products may be held liable for subsequent injuries caused by products.”) Wyeth and Schwarz did not manufacture or sell the metoclopramide that allegedly injured Plaintiff. Accordingly, this claim should likewise be dismissed.
f. Breach Of Express And Implied Warranties (Counts 2 and 3).
Under Nevada law, only sellers of products can provide express and implied warranties. Nev. Rev. Stat. § 104.2113-2315 (2007). Plaintiff admits that Wyeth and Schwarz did not sell her the metoclopramide that allegedly caused her injuries. Therefore, no warranties were ever created, much less breached. Because there was no sale and no warranty, judgment must be entered on Plaintiff's breach of implied and express warranty claims.
g.Violation Of Minnesota Trade Practice And Consumer Statutes (Counts 7, 8, and 9).
Finally, Counts 7, 8 and 9 are purported claims for violations of Minnesota trade practice and consumer protection laws. Such claims are not viable here because they do not exist under Nevada law. But even under Minnesota law, Plaintiff, a Nevada resident, with no apparent nexus to Minnesota, lacks standing to bring claims under that State's consumer protection statutes, because she did not purchase any metoclopramide manufactured by Wyeth or Schwarz. Tremco, Inc. v. Holman, No. C8-96-2139, 1997 WL 423575, at *7 (Minn. App. July 29, 1997) (dismissing claim under the Minnesota Consumer Protection Act because plaintiff did not allege it was a consumer of the services provided by defendant and therefore did not have standing to bring such a claim); Cooperman v. R.G. Barry Corp., 775 F. Supp. 1211, 1213-14 (D. Minn. 1991) (“Plaintiff itself has bought nothing, and has encountered no fraud in the context of a sale.”). Accordingly, the Court must enter judgment on these claims.
B. Courts Have Uniformly Held That Brand Name Manufacturers Cannot Be Held Liable For Injuries Caused By Generic Products, Including The Generic Product At Issue Here.
Nevada law does not stand alone on this issue. Every court confronting such claims has held that a brand name 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); Swicegoodv. Pliva, Inc., 543 F. Supp. 2d 1351, 1354-59 (N.D. Ga. 2008); Barnhillv. 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., — So.2d —, 2007-2080, 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. 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, fourteen different decisions in eleven different states have specifically held that Wyeth and/or Schwarz, as the manufacturers of brand name Reglan(R), may not be held liable for injuries allegedly caused b the ingestion of generic metocloramide.[FN6]
FN6. /Copies of the unpublished orders are attached to the Declaration of Lisa Wong Lackland, Exhibit C hereto.
1. Foster – The Leading And Universally Accepted Authority.
The leading case on whether a brand name 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 brand name 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 brand name manufacturers like Wyeth could be held liable because they “know that generic manufacturers rely on their studies and duplicate their labeling.” Id. argued, Wyeth was liable for the decedent's injuries to the extent that warning was defective. Id. at 169. The Fourth Circuit rejected these arguments for three separate and independent reasons, each of which applies with force to the present case.
First, the Court reasoned that all of the Fosters' claims regardless of their theory of liability failed as a matter of law because Wyeth did not manufacture or sell the specific product that caused the alleged injuries. Id. at 168. In so holding, the Court found that the plaintiffs were trying to disguise product liability claims as claims for misrepresentation in order to avoid the necessity of demonstrating that Wyeth manufactured the allegedly harmful product: “the allegations of negligent misrepresentation are an effort to recover for injuries caused by a product without meeting the requirements the law imposes in product liability actions.” the Foster court:
The Fosters 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. In short, the Fourth Circuit held, “regardless of the recovery theory,” a products liability plaintiff must establish product identification. Id. As explained above, this requirement applies equally under Nevada law (supra at 7-8).
Second, the Foster court concluded that no legal precedent or FDA law or regulation imposes liability the brand name manufacturer for injuries caused by the drug of its generic competitors. Id. at 171. The Foster court recognized that “[n]ame brand manufacturers undertake the expense of developing pioneer, drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information.” Id. After reviewing FDA statutes and regulations, common law, and public policy implications, the court rejected the Fosters' theory of liability:
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 had no control. This would be especially unfair when, as here the generic reaps the benefits of the name brand manufacturer's statements by copying the labels and riding on the coattails of its advertising. The premarketing approval scheme Congress established for generic equivalents of previously approved drugs cannot be construed to create liability of a name brand manufacturer when another manufacturer's product has been consumed.
Id. The court further commented that “[m]anufacturers of generic drugs, like all other manufacturers, are responsible for the representations they make regarding their products.” Id. at 170. This second rationale – the absence of any legal or regulatory basis for liability also defeats Plaintiff's claims here.
Third, the court concluded that Wyeth did not owe a duty to the Fosters to warn about the risks associated with the generic drug. Like Plaintiff in this case, the Fosters argued that it was “foreseeable to Wyeth that misrepresentations could result in personal injury to users of. … generic equivalents.” Id. at 171. The court rejected these arguments, concluding that “Wyeth is under no duty of care” to consumers of other companies' generic drugs:
We think to impose a duty in the circumstances of this case would be to stretch the concept of foreseeability too far. The duty required … arises when there is such a relationship that one party has the right to rely for information upon the other, and the other giving the information owes a duty to give it with care. There is no such relationship between the parties to this case, as Brandy Foster was injured by a product that Wyeth did not manufacture.
Id. at 170-171 (internal quotations and citations omitted). This final rationale – the absence of any duty – is consistent with Nevada law (supra at 8-9). Because Plaintiff did not purchase or use Wyeth or Schwarz's metoclopramide products, there is no duty running to Plaintiff.
The three rationales of Foster accord with Nevada law, as described above. Further, Foster 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 brand name 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 brand name 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 plaintiff's “assertion] 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 brand name 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, 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 brand name 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(R) 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 p 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 g the Alabama court granted summary judgment in favor of Wyeth and Schwarz. Id.
11. Swicegood (Georgia) -Rejected These Same Claims.
Applying Georgia law, a federal court recently 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 brand name 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 plaintiff's claims under Georgia law. Id. at 1356 (the court further concluded 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. Pustejovskv (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 brand name 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 brand name 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 L 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.” 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 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 brand name manufacturers responsible for every injury caused by equivalent products made by every generic manufacturer in the United States. 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 plaintiff's 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”).
7 For the above reasons and authority, this Court should grant the Motion and enter judgment in favor of Wyeth and Schwarz on all claims.
DATED this 20th day of October, 2008.