ORDER

KRISTI K. DuBOSE, District Judge.

This matter is before the Court on Wyeth, Inc. ("Wyeth") and Schwarz Pharma, Inc. ("Schwarz," and, together with Wyeth, the "Reglan manufacturers")' motion for summary judgment (Docs. 73, 74, & 75), reply brief (Doc. 84), and notices of supplemental authority (Docs. 88, 93, 94, 111, & 128), and the plaintiffs' response in opposition (Doc. 83) and notice of supplemental authority (Doc. 98). For the reasons set forth herein, the Reglan manufacturers' motion for summary judgment is GRANTED.

I. Summary Judgment Standard

Summary judgment should be granted only if "there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." FED.R.CIV.P. 56(c).1 The party seeking summary judgment bears "the initial burden to show the district court, by reference to materials on file, that there are no genuine issues of material fact that should be decided at trial." Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir.1991). The party seeking summary judgment also always bears the "initial responsibility of informing the district court of the basis for its motion, and identifying those portions of `the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,' which it believes demonstrate the absence of a genuine issue of material fact." Id. (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)). If the non-moving party fails to make "a sufficient showing on an essential element of her case with respect to which she has the burden of proof," the moving party is entitled to summary judgment. Celotex, 477 U.S. at 323, 106 S.Ct. 2548. However, "[i]n reviewing whether the nonmoving party has met its burden, the court must stop short of weighing the evidence and making credibility determinations of the truth of the matter. Instead, the evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Tipton v. Bergrohr GMBH-Siegen, 965 F.2d 994, 998-999 (11th Cir. 1992), cert. den., 507 U.S. 911, 113 S.Ct. 1259, 122 L.Ed.2d 657 (1993) (internal citations and quotations omitted). The mere existence of a factual dispute will not auto-matically necessitate denial; rather, only factual disputes that are material preclude entry of summary judgment. Lofton v. Secretary of Dept. of Children & Family Serv., 358 F.3d 804, 809 (11th Cir.2004), cert. den., 543 U.S. 1081, 125 S.Ct. 869, 160 L.Ed.2d 825 (2005).

II. Analysis

A. Background2

Metoclopramide is a prescription drug approved by the FDA to treat gastroesophageal reflux disease and diabetic gastroparesis. (Doc. 1, ¶ 3.72; Doc. 74, p. 8; Doc. 83, p. 6). Metoclopramide is available in both brand-name ("Reglan") and generic formulations. (Doc. 74-1, ¶ 6; Doc. 83, p. 6).

At different times during the time period relevant to the Mosleys' complaint, Defendants Wyeth and Schwarz manufactured and distributed Reglan and were each at a relevant point in time the reference-listed drug ("RLD") holder for metoclopramide. (Doc. 74, p. 9; Doc. 83, pp. 6 & 9).

Defendant Actavis-Elizabeth, LLC, a wholly owned subsidiary of Defendant Actavis, Inc. (together with Actavis-Elizabeth, LLC, "Actavis") and the successor to Purepac Pharmaceutical Inc., is a manufacturer and distributor of generic metoclopramide. (Doc. 1, at ¶¶ 1.05, 3.05, & 3.59). Defendant Pliva USA, Inc. ("Pliva") is also a manufacturer and distributor of generic metoclopramide. (See id. at ¶¶ 3.04 & 3.59).

Sometime in 2005, Odessa Mosley's treating physician prescribed Reglan at a dosage of 10 mg to treat her reflux, nausea and vomiting. (Doc. 1, ¶ 3.08). After Mrs. Mosley ingested metoclopramide tablets as prescribed on a long-term basis, she began exhibiting abnormal body movements "which have since been linked to her use of Reglan/metoclopramide" (id. at ¶¶ 3.11-3.13, & 3.15) and ultimately developed a movement disorder called tardive dyskinesia as a result of taking metoclopramide (id. at ¶¶ 3.16).

On February 26, 2009, the federal Food and Drug Administration ("FDA") issued a safety alert and ordered manufacturers of metoclopramide to add a "Black Box Warning" to their labels. (Doc. 83, p. 10). The warning indicates that the prevalence of tardive dyskinesia among patients using metoclopramide beyond twelve weeks may be as high as 20%, 100 times greater than previous warnings had indicated. (Id.).

Plaintiffs Odessa and Ulysses Mosley (together, "the Mosleys") initiated this lawsuit by filing a complaint on May 21, 2009, alleging claims against all defendants of negligence, strict liability, breach of warranty, misrepresentation and fraud, and gross negligence. (Doc. 1, ¶¶ 4.01-5.03).3

On September 4, 2009, the Mosleys served a Notice of Product Identification stating that "based on the available information consisting of the pharmacy records from Target Pharmacy and Walgreen's pharmacy," Mrs. Mosley's prescription records "reflect the following manufacturers of . . . metoclopramide she ingested[:] Pliva, Inc [, and] Purepac (now Actavis)." (Doc. 74-3).

The Reglan manufacturers timely filed the instant motion for summary judgment (Doc. 73) as to "all claims against Wyeth and Schwarz" on the basis that "[t]he undisputed fact that Mrs. Mosley did not purchase or ingest any metaclopramide what were manufactured or sold by Wyeth or Schwarz is dispositive of Plaintiffs' claims under Alabama law." (Doc. 74, p. 24).

According to the plaintiffs, they "do not allege that Wyeth or Schwarz manufactured the metoclopramide which caused Ms. Mosley'[s] injuries, and the theories of liability alleged against these defendants are not in the nature of products liability claims. . . . Plaintiffs' claims for strict liability are reserved for those Defendants that actually manufactured the metoclopramide that Mrs. Mosley ingested, not Wyeth and Schwarz." (Doc. 83, p. 17).

However, the Mosleys contend in opposition to the Reglan manufacturers' motion for summary judgment that the Reglan manufacturers, "as the producer of Reglan, the Reference Listed Drug for [the] generic metaclopramide" that Mrs. Mosley ingested (Id., pp. 6-7), were

(Id., p. 19). The Mosleys insist that "[i]n the regulatory framework for drugs approved by the FDA," a New Drug Application ("NDA") holder is "primarily responsible for the labeling and warnings given to prescribing physicians and patients," and that "an NDA holder [therefore] has a duty to ensure that the information provided is accurate and complete. If an NDA holder negligently or intentionally misrepresents the dangers associated with a drug, even if the drug is properly manufactured, it is foreseeable that an individual may be injured due to the information contained in its label." (Doc. 83, pp. 8, 11-12). The plaintiffs further contend that "[a]s the RLD holder, Wyeth and Schwarz voluntarily assumed heightened duties and responsibilities imposed by the Code of Federal Regulation . . .," citing specific regulations in support of their claims. (Id.).

(Id., p. 7-8).

B. Legal Conclusions

Jurisdiction obtains pursuant to 28 U.S.C. § 1332 (Docs. 1, 18, 19, 27 & 103), and this Court is bound to apply Alabama substantive law. See Erie R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).

1. Misrepresentation Claims

a. Negligent Misrepresentation

In situations "`involving negligent misrepresentations relied upon by third parties, or parties who were not in privity of contract with the person making the misrepresentation,'" Alabama's "Supreme Court has instructed that liability for negligent misrepresentation is predicated upon the existence of a duty." Cooper v. Bristol-Myers Squibb Co., 2009 WL 5206130 (D.N.J.2009) (applying Alabama law and quoting Fisher v. Comer Plantation, Inc., 772 So.2d 455, 461 (Ala.2000)).

The Mosleys argue that Section 552 of the Restatement (Second) of Torts5 governs their negligent misrepresentation claims. (Doc. 83, p. 18). Alabama has adopted Section 552 of the Restatement in cases alleging negligent misrepresentation to "provide[ ] a cause of action for professional negligence." Hewlett-Packard Co. v. Intergraph Corp., No. C03-2517 MJJ, 2004 WL 1918891, at *2 (N.D.Cal.2004) (applying Alabama law); see also Legg v. Wyeth, 428 F.3d 1317 (11th Cir.2005) ("the Alabama Supreme Court has adopted the Restatement (Second) of Torts § 552[ ] as the law of Alabama in cases involving negligent misrepresentation") (citing Fisher v. Comer Plantation, Inc., 772 So.2d 455, 461 (Ala.2000)); Boykin v. Arthur Andersen & Co., 639 So.2d 504, 509-10 (Ala.1994) (adopting the Restatement rule to govern the professional liability of accountants).

Although Alabama's Supreme Court has made clear that its "application of the Restatement approach" is not "restrict[ed]. . . to . . . one class of professionals," it has indicated that the rule "subjects to liability only such persons as make it a part of their business or profession to supply information for the guidance of others in their business transactions." Fisher, 772 So.2d at 462 (citing comment c to Section 552 of the Restatement and concluding that "Section 552 would clearly, by its terms, govern real-estate appraisers, who, as an integral part of their business, facilitate real-estate transactions by issuing opinions regarding the value of real property" and "therefore hold[ing] that real estate appraisers are subject to liability for negligent or wanton misrepresentation, on the same basis that accountants are.").

Under the restatement, drug manufacturers cannot be classed, at least not in the same sense as accountants and real estate appraisers, as "persons [who] make it a part of their business . . . to supply information for the guidance of others in their business transactions." Fisher, 772 So.2d at 462; compare also Boykin, 639 So.2d at 509-10. Moreover under the facts of this case Wyeth and Schwarz did not engage in any business transaction with the Mosleys. See Moretti v. Wyeth, Inc., 2:08-cv-0396-JCM-(GWF), 2009 WL 749532, at *3 (D.Nev. Mar. 20, 2009) (noting that "Nevada law recognizes the tort of negligent misrepresentation as it is defined in § 552, but has limited the application of that tort to business transactions" and concluding that "[b]ecause Plaintiff never purchased a Wyeth or Schwarz metoclopramide product, there is no business transaction and Plaintiffs claims fail"). Given the limited circumstances under which Alabama has recognized a cause of action for negligent misrepresentation, this court concludes that the Mosleys do not have a negligent misrepresentation claim against the Reglan manufacturers. This conclusion is bolstered by the fact that the Alabama Circuit Court of Jefferson County recently dismissed a similar claim of negligent misrepresentation brought against the same Reglan manufacturers by a plaintiff who, like Mrs. Mosley, had consumed only generic metoclopramide. See Green v. Wyeth Pharms., Inc. et al., CV 06-3917 ER, Order at 1, 2007 WL 6428717 (Ala.Cir.Ct. May 15, 2007).

Summary judgment is GRANTED on the plaintiffs' claims of negligent misrepresentation.

b. Fraudulent (Reckless or Willful) Misrepresentation

An action for fraudulent misrepresentation is governed by Section 6-5-101 of the Alabama Code, rather than by Section 552 of the Restatement. See Fisher, 772 So.2d at 463. In order to succeed on a fraudulent misrepresentation claim, a plaintiff must show

Foremost Ins. Co. v. Parham, 693 So.2d 409, 423 (Ala.1997) (citing Section 6-5-101 of the Alabama Code of 1975 ("[m]isrepresentations of a material fact made willfully to deceive, or recklessly without knowledge, and acted on by the opposite party, or if made by mistake and innocently and acted on by the opposite party, constitute legal fraud"); Harrington v. Johnson-Rast & Hays Co., 577 So.2d 437 (Ala. 1991)); see also Bagley v. Promenade Group, L.L.C., Civ. No. 05-0457-M, 2007 WL 2154163, at *5 (S.D.Ala. Jul. 24, 2007).

The Mosleys must also establish that the Reglan manufacturers owed Mrs. Mosley a duty. Nesbitt v. Frederick, 941 So.2d 950 (Ala.2006) ("An essential element of fraudulent-misrepresentation . . . claims is a duty to disclose"). In Alabama, "[t]he existence of a duty is determined by a number of factors, including (1) the nature of the defendant's activity; (2) the relationship between the parties; and (3) the type of injury or harm threatened." Pritchett v. ICN Med. Alliance, Inc., 938 So.2d 933, 937-38 (Ala.2006) (internal quotation omitted); Franklin County School Bd. v. Lake Asbestos of Quebec, Ltd., Civ. A. No. 84-AR-5435-NW, 1986 WL 69060, at *6 (N.D.Ala. Feb. 13, 1986) (noting that the traditional elements of a negligence claim, including duty "necessarily imply a relationship between the plaintiff and the defendant" and concluding that plaintiffs who relied on an enterprise liability/collective liability/market share negligence liability theory could not maintain such claims, which had been rejected by the Eleventh and Fifth Circuits, as well as by an Alabama trial court). However, "[t]he key factor is whether the injury was foreseeable6 by the defendant." Id. (internal citations omitted); see also RSUI Group, Inc. v. Willis of Alabama, Inc., 2007 WL 2469571, at *2 (S.D.Ala.2007).

The plaintiffs present no evidence or argument tending to establish that a relationship existed between the Mosleys and the Reglan manufacturers. The plaintiffs cite no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products. Nor do the Mosleys cite any binding authority for the contention that an injury resulting from consumption of a generic version of the drug can be considered a "proximate consequence" of a manufacturer's alleged misrepresentation regarding the brand-name version of the drug. Indeed, two Alabama circuit courts that recently addressed virtually identical claims concluded that no such duty exists. See Buchanan v. Wyeth Pharm., Inc. et al., CV-2007-900065, Order at 1, 2008 WL 7136137 (Ala. Cir.Ct. Oct. 20, 2008); Green v. Wyeth Pharms., Inc. et al., CV 06-3917 ER, Order at 1, 2007 WL 6428717 (Ala.Cir.Ct. May 15, 2007). Moreover, the vast majority of non-binding decisions from other jurisdictions that have addressed the issue do not recognize a duty giving rise to fraudulent misrepresentation claims. See, e.g., Foster v. Am. Home Prods. Corp., 29 F.3d 165, 171 (4th Cir.1994) (concluding that imposing a duty under circumstances similar to those presented in this case "would be to stretch the concept of foreseeability too far," because the relevant (Maryland state) law duty could arise only "when there is such a relation 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." Id. (internal citations and quotation marks omitted)); Mensing v. Wyeth, 588 F.3d 603, 613 (8th Cir.2009) ("Since Mensing did not purchase or use [the name brand defendants'] product, . . . there was no direct relationship between them. . . ." Id. (internal quotation marks omitted)).

The Mosleys argue that "[i]n the regulatory framework for drugs approved by the FDA," an NDA holder such as the Reglan manufacturers is "primarily responsible for the labeling and warnings given to prescribing physicians and patients," and that "an NDA holder [therefore] has a duty to ensure that the information provided is accurate and complete. If an NDA holder negligently or intentionally misrepresents the dangers associated with a drug, even if the drug is properly manufactured, it is foreseeable that an individual may be injured due to the information contained in its label." (Doc. 83, p. 8). The plaintiffs further contend that "[a]s the RLD holder, Wyeth and Schwarz voluntarily assumed heightened duties and responsibilities imposed by the Code of Federal Regulation . . .," citing specific regulations in support of their claims. (Id.).

FDA regulations cannot supply the duty element of any of the Mosleys' claims. The fact that federal law allowed generic manufacturers to streamline the approval process by relying on the initial warning labels provided by Wyeth and/or Schwarz, does not create a duty between Wyeth/Schwarz and a generic consumer. As thoroughly explained by the undersigned in a previous order in this case, after ANDA approval, generic manufacturers bear the same burden as brand manufacturers of providing a warning that adequately describes the risks associated with the particular drug they are manufacturing. (See Doc. 95, Order Denying Generic Manufacturers' Motions to Dismiss and for Judgment on the Pleadings). In other words, after the initial approval (ANDA approval), the generic manufacturers become responsible for their own warning labels and any necessary revisions.

Accordingly because neither Wyeth nor Schwarz produced or distributed the metoclopramide Mrs. Mosley ingested, the Reglan manufacturers did not owe Mrs. Mosley a duty that would give rise to a cause of action for fraudulent misrepresentation. Summary judgment is GRANTED as to Wyeth and Schwarz on the plaintiffs' claims of fraudulent misrepresentation.

2. Breach of Warranty Claims

Alabama's Supreme Court has specifically affirmed that "[p]laintiff[ ]s may assert breach of implied warranty claims in cases of injury by an unreasonably dangerous product." Rose v. General Motors Corp., 323 F.Supp.2d 1244 (N.D.Ala.2004) (citing Spain v. Brown & Williamson Tobacco Corp., 872 So.2d 101, 111 (Ala.2003)). That is, "a claim alleging breach of an implied warranty of merchantability is separate and distinct from an AEMLD claim and is viable to redress an injury caused by an unreasonably dangerous product." Spain, 872 So.2d at 111.

The Mosleys claim that the Reglan manufacturers are liable to them for breach of warranty based on Alabama Code Section 7-2-318, which states:

Id. The official comments to Alabama Code Section 7-2-318 include the following:

Id., cmt. 2.

And a comment labeled "Alabama Comment" to this section notes that

Id., Alabama cmt.

The Mosleys argue that in interpreting and applying this statute, the Supreme Court of Alabama has held that sellers' warranties, both express and implied, do not require privity between the buyer and seller/manufacturer. The Alabama Supreme Court explained in Bishop v. Sales, 336 So.2d 1340, 1344 (Ala.1976):

Id. (footnotes omitted); see also Rampey v. Novartis Consumer Health, Inc., 867 So.2d 1079, 1087 (Ala.2003) (". . . Alabama's version of UCC § 2-318 has abolished the privity requirements in actions involving natural persons."); Land v. Huffman, 420 F.Supp. 459 (M.D.Ala.1976) (lack of privity not a defense to a breach of warranty claim alleging personal injuries); State Farm Fire & Cas. Co. v. J.B. Plastics, Inc., 505 So.2d 1223, 1227 (Ala.1987) (". . . Alabama's version of U.C.C. § 2-318 has abolished privity requirements in actions involving injuries to natural persons. . ."); Kidd v. Kilpatrick Chevrolet, Inc., 613 So.2d 336, 338 (Ala.1993) ("Alabama has abolished privity requirements in actions involving personal injuries. . . ."); Morris Concrete, Inc. v. Warrick, 868 So.2d 429 (Ala.Civ.App.2003) (concluding that "the implied warranties of merchantability and fitness for a particular purpose" were available to a third-party beneficiary/buyer and that "the trial court [had] properly considered whether [a manufacturer] breached those warranties."); CertainTeed Corp. v. Russell, 883 So.2d 1266, n. 4 (Ala.Civ.App.2003) (noting that under Section 7-2-318, "a seller's warranty extends to any natural person who is `injured in person' when it is reasonable to expect that person to use or be affected by goods under warranty").

"Alternative B" of Uniform Commercial Code ("UCC") Section 2-318 has been interpreted to permit individuals to sue a manufacturer directly for breach of warranty even when they did not purchase the goods directly from the manufacturer, nor did they consume or use the goods at issue, but were nonetheless directly affected by the goods and suffered personal injury as a result. See Nacci v. Volkswagen of Am., Inc., 325 A.2d 617, 619-20 (Del.Super.Ct.1974) (a child who was physically injured when the bicycle she was riding collided with an automobile manufactured and distributed by Volkswagen was held to be within the class of persons to whom the Volkswagen's warranty extended under § 2-318 of the Delaware Code (Alternative B of Section 2-318 of the UCC)); Wasik v. Borg, 423 F.2d 44, 48-49 (C.A.2 Vt.1970) (affirming a lower court's decision to allow a plaintiff who was physically injured when his car was rearended, allegedly as the result of a dangerous defect in design or manufacture that caused the other driver's automobile to suddenly accelerate, to bring a claim for breach of warranty under § 2-318 of the Vermont Code, which was "substantially identical" to Alternative B of the UCC).

However, Mrs. Mosley does not contend that she used or consumed Reglan, the drug produced by the Reglan manufacturers. Nor is there any evidence that she came into contact with and was therefore affected by [Reglan], the "goods" produced by the Reglan manufacturers. Id. Instead, the plaintiffs argue that Mrs. Mosley was affected solely by the alleged breach of warranty pertaining to brandname Reglan:

(Doc. 83, p. 7-8).

Although Section 7-2-318 provides a cause of action for breach of warranty to individuals who, lacking privity with a seller/manufacturer, nonetheless were "affected" by that seller/manufacturer's "goods," it does not, by its terms, provide a cause of action for those who were purportedly affected by the warranty language. The Mosleys cite no authority holding that Section 7-2-318 of the Alabama Code—or Alternative B of the UCC, as adopted in any other jurisdiction—provides a cause of action to plaintiffs who were neither purchases, users, or consumers of, nor in contact with, goods produced by the manufacturer against whom they claim breach of warranty resulting in personal injury. The undersigned declines the plaintiff's invitation to expand Section 7-2-318 to cover the claim against the brand manufacturers.9 Accordingly, summary judgment is GRANTED as to Wyeth and Schwarz on the plaintiffs' breach of warranty claims.

III. Conclusion

As set forth above the Reglan manufacturers' motion for summary judgment (Doc. 73) is GRANTED and all of the Mosleys' claims against Wyeth and Schwarz are hereby DISMISSED with prejudice.