REPORT AND RECOMMENDATION

HARWELL DAVIS, Magistrate Judge

Defendants Pfizer, Inc. (Pfizer), Schwarz Pharma, Inc. (Schwarz), and Wyeth, Inc. (Wyeth) have filed a Motion to Dismiss the Complaint, Or In The Alternative, Motion For Summary Judgment. (Docs. 16 17). The magistrate judge construed the motion as one for summary judgment. (Doc. 19, Order).

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). 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, 2553, 91 L.Ed.2d 265 (1986)). If the nonmoving 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. at 2552. 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, 998-99 (11th Cir. 1992), cert. denied, 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 automatically necessitate denial; rather, only factual disputes that are material preclude entry of summary judgment. Lofton v. Secretary of Dep't of Children Family Servs., 358 F.3d 804, 809 (11th Cir. 2004), cert. denied, 543 U.S. 1081, 125 S.Ct. 869, 160 L.Ed.2d 825 (2005).

ANALYSIS

Plaintiffs, Shirley Simpson and Freda Cole, allege in a complaint filed June 30, 2010, that they suffered injuries arising from the use of the prescription drug metoclopramide (MCP). (Doc. #1, Complaint, at ¶¶ 3-4, 6-7). Metoclopramide is available under the brand name Reglan and in generic formulations. ( See id. at ¶ 24). After taking the drug for an extended period of time, both plaintiffs developed a movement disorder called tardive dyskinesia (TD) and Parkinsonism. Subsequently, it came to light that the prevalence of TD among patients using MCP beyond 12 weeks may be 100 times greater than previous warnings had indicated. Plaintiffs assert seven causes of action against Wyeth, Pfizer and Schwarz: strict liability; failure to warn; negligence; breach of express warranty; breach of implied warranty; fraud by misrepresentation; and fraud by concealment, suppression or omission of material facts. Defendants allege that each of these claims fails as a matter of law because these defendants did not manufacture the product that the plaintiffs ingested and allegedly caused their injuries.

In their response, plaintiffs concede that they ingested only generic formulations of MCP made and sold by defendants Teva Pharmaceuticals USA and Pliva, Inc. They do not contend that they ingested MCP, whether brand or generic, manufactured by Wyeth or Schwarz, or by Pfizer, which acquired Wyeth in 2009 and is sued solely in its capacity as Wyeth's parent company. ( See id. at ¶ 11). Plaintiffs offer no arguments in support of their claims for strict liability, negligence, and breach of warranty claims against the brand name defendants. Although plaintiffs concede that they did not ingest and were not injured by Reglan, only the generic form of MCP, they, nonetheless, oppose summary judgment as to these defendants with regard to the claims of fraud by misrepresentation, fraud by concealment or suppression and failure to warn. ( See Doc. 30, Response to Motion for Summary Judgment, at 5). Plaintiffs assert that they have stated viable claims for fraud by misrepresentation, fraud by concealment or suppression and failure to warn because Wyeth and Schwarz, as former manufacturers of the brand name drug Reglan, failed to adequately warn plaintiffs' physicians about the risks associated with generic MCP manufactured by other companies which was ingested by plaintiffs, causing them injury.

For instance, plaintiffs allege that suppression of a material fact occurred when and after the brand-name defendants entered into a relationship with plaintiffs' prescribing physicians that required them to notify those physicians of the truth of Reglan's propensity to cause TD and Parkisonism. According to plaintiffs, had the brand name drug companies warned plaintiffs' physicians about this problem with Reglan, plaintiffs' physicians never would have prescribed the generic or brand name form of MCP to plaintiffs. Plaintiffs allege that their claim against the brand name defendants is the damage caused by the product as a result of these defendants' misinformation to the prescribing doctors. According to plaintiffs, they can recover from the brand name defendants even though they are third parties to their alleged deceit or concealment because the deceit and concealment perpetrated against plaintiffs' prescribing doctors proximately caused damage to plaintiffs.

As authority for this proposition, plaintiffs cite Delta Health Group, Inc. v. Stafford, 887 So.2d 887, 898-99 (Ala. 2004). Delta Health Group does reflect the general rule that, in certain circumstances, a plaintiff may properly state a fraud claim even though the defendant makes a false representation to a third party, rather than to the plaintiff. However, it goes on to note that a plaintiff also must establish that he relied on the misrepresentation. To establish this element of the cause of action, plaintiffs rely on the doctrine of the learned intermediary which allows patients to rely on their doctors' judgment and knowledge of a drug's risks. See Walls v. Alphapharma USPD, Inc., 887 So.2d 883-86 (Ala. 2004). Thus, according to plaintiffs, because the brand name manufacturers of Reglan misstated the risks of taking Reglan to their prescribing physicians by 100 times ( i.e., the risk of developing TD or Parkinsonism to a patient taking this drug for a long term is 100 times greater than that claimed by the brand name manufacturers in their literature sent to doctors with the drug), they are entitled to rely on this misrepresentation under the learned intermediary doctrine to establish the necessary reliance sufficient to establish a third-party claim for suppression.

While this argument seems to make sense at first glance, there are several problems with it. Alabama courts have repeatedly rejected a theory of liability wherein plaintiffs have attempted to hold a brand name drug manufacturer responsible for damages caused by a generic brand of their drug manufactured and distributed by a different, unrelated drug company. In Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D.Ala. 2010), a similar claim was made against Wyeth, Inc. The plaintiffs in Mosley did not argue that the defendants' product caused them harm, but rather that their dissemination of false and misleading information, which they knew would be relied upon by the generic manufacturers in generating their own labels, was a direct and proximate cause of plaintiffs' injuries.

As noted in Mosley, id. at 1346, in an action for fraudulent misrepresentation under Ala. Code § 6-5-101, a plaintiff must show

1) a misrepresentation of material fact, 2) made willfully to deceive, recklessly, without knowledge, or mistakenly, 3) which was justifiably relied on by the plaintiff under the circumstances, and 4) which caused damage as a proximate consequence.

Given the fact that it was conceded in Mosley that plaintiff did not take Reglan manufactured by Wyeth, Inc., but a generic equivalent manufactured by another company, the Court held that Wyeth could not be liable for the damages caused by the generic MCP because the plaintiff failed to establish that Reglan manufacturers owed plaintiff a duty. Mosley, 719 F.Supp.2d at 1346-47. The Court in Mosley explained its decision as follows:

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.

Plaintiffs make an attempt to distinguish Mosley (and Buchanan and Green, cited in Mosley) from their cause of action by asserting that, unlike Mosley, Buchanan and Green, the allegations here are undisputed. This is simply incorrect. Because the motion to dismiss or for summary judgment was filed before a responsive pleading was filed by defendants, it is unknown what may or may not be disputed about plaintiffs' allegations.

Plaintiffs also aver that none of these earlier cases invoke the Delta Health Group case or mention the learned intermediary doctrine. They also allege that they have not had the opportunity to undertake discovery to determine if their doctors relied on the brand name defendants' package inserts before prescribing MCP. However, even assuming all of this to be true, plaintiffs still must demonstrate that the brand name defendants owed them a duty before they can be liable.

In addition to the authority cited by Mosley, supra, see Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351, 1356 (N.D.Ga. 2008) ("The [federal] regulation does not require a name brand manufacturer to ensure that the generic brand's label is accurate."). Thus, it is the duty of the generic drug manufacturer to correctly advise a physician using its product of any associated risks, not the brand name manufacturer.

Likewise, "[u]nder the learned intermediary doctrine, a manufacturer's duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product." Walls v. Alphapharma USPD, 887 So.2d at 883. Thus, the duty to warn of risks related to the use of a drug is owed to the prescribing physician by the drug manufacturer, not some other manufacturer of the same or a similar product. As a matter of law, the manufacturers of Reglan have no duty to communicate any information regarding the risks of taking this product to anyone other than their own customers. There is no liability based on their failure to warn users of a product supplied by their competitors. These competitors have their own duties to make sure the product is safe to those who use it.

Accordingly, because neither Wyeth, Pfizer, or Schwarz produced or distributed the metoclopramide ingested by plaintiffs, the Reglan manufacturers do not owe a duty that gives rise to a cause of action for fraudulent misrepresentation or failure to warn. Therefore, it is RECOMMENDED that the motion for summary judgment by Wyeth, Inc., Pfizer, Inc., and Schwarz Pharma, Inc. be GRANTED and that these defendants be DISMISSED WITH PREJUDICE from this action.

NOTICE OF RIGHT TO OBJECT

The parties are DIRECTED to file any objections to this Report and Recommendation within a period of fourteen (14) days from the date of entry. Any objections filed must specifically identify the findings in the magistrate judge's recommendation objected to. Frivolous, conclusive, or general objections will not be considered by the district court.

Failure to file written objections to the proposed findings and recommendations of the magistrate judge's report shall bar the party from a de novo determination by the district court of issues covered in the report and shall bar the party from attacking on appeal factual findings in the report accepted or adopted by the district court except on grounds of plain error or manifest injustice. Nettles v. Wainwright, 677 F.2d 404 (5th Cir. Unit B 1982). See Stein v. Reynolds Securities, Inc., 667 F.2d 33 (11th Cir. 1982). See also Bonner v. Prichard, 661 F.2d 1206 (11th Cir. 1981) ( en banc), adopting as binding precedent all of the decisions of the former Fifth Circuit handed down prior to the close of business on September 30, 1981.