ORDER
This mаtter 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).
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The party seeking summary judgment bears “the initial burden to show the district court, by refеrence to materials on file, that there are no genuine issues of material fact that should be decided at trial.”
Clark v. Coats & Clark, Inc.,
II. Analysis
A. Background 2
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 tо 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 disordеr 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 wаrranty, 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 un
According to the plaintiffs, they “do not allege that Wyeth or Schwarz manufactured the metoclopramide which caused Ms. Mosley’fs] 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 metoclopramide” that Mrs. Mosley ingested (Id., pp. 6-7), were
responsible for authoring and disseminating misrepresentations regarding the risk of tardive dyskinesia with long-term use of metoclopramide for which they had no scientific support. Both defendants were aware of the increased risk associated with prolonged use of metoclopramide, and chose to withhold this information from the FDA and health care providers....
(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.).
The Mosleys also explain that their
claims against Wyeth and Schwarz do not relate to the composition or manufacture of the metoclopramide [Mrs. Mosley] ingested, but rather focus[ ] on the inaccurate and insufficient information promulgated by [the Reglan manufacturers] and by which the drug was prescribed. This false information created a sense of security and safety regarding metoclopramide which caused or contributed to the misuse of the drug by Plaintiffs prescribing doctor, and led directly to the severe damages suffered by Plaintiff.
The argument is not that Defendants’ product caused Plaintiff harm, 4 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 the direct and proximate cause of Plaintiffs injuries.
(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,
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.,
The Mosleys argue that Section 552 of the Restatement (Second) of Torts
5
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,
Although Aabama’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,
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,
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,
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.
Foremost Ins. Co. v. Parham,
The Mosleys must also establish that the Reglan manufacturers owed Mrs. Mosley a duty.
Nesbitt v. Frederick,
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 а 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,
The Mosleys argue that “[i]n the regulatory framework for drugs approved by the FDA,” an NDA holder such as the Reglan
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 rеsponsible 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.,
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:
A seller’s warranty, whether express or implied, 7 extends to any natural personif it is reasonable to expect that such person may use, consume, or be affected by the goods and who is injured in person by breach of the warranty. A seller may not exclude or limit the operation of this section.
Id. The official comments to Alabama Code Section 7-2-318 include the following:
The рurpose of this section is to give certain beneficiaries the benefit of the same warranty which the buyer received in the contract of sale, thereby freeing any such beneficiaries from any technical rules as to “privity.” It seeks to accomplish this purpose without any derogation of any right or remedy resting on negligence. It rests primarily upon the merchant-seller’s warranty under this Article that the goods sold are merchantable and fit for the ordinary purposes for which such goods are used rather than the warranty of fitness for a particular purpose. Implicit in the section is that any beneficiary of a warranty may bring a direct action for breach of warranty against the seller whose warranty extends to him.
Id., cmt. 2.
And a comment labeled “Alabama Comment” to this section notes that
As originally enacted, this section differed from the Uniform Commercial Code, as it then existed, in that the words “who is in the family or household of his buyer or who is a guest in his home” were omitted after the words “natural person.” In 1966, the Uniform Commercial Code was amended to provide three alternatives for § 2-318. This section is substantially the same as present Alternative B of the Uniform Commercial Code. The “Official Comment” set out above is thаt of the amended Uniform Commercial Code for Alternative B.
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,
The proposed [Uniform Commercial Code] loosened the privity requirements [in breach of warranty suits]. Its intent was to place the buyer’s family or household, or a guest in the buyer’s home in the same shoes as the buyer with respect to injuries in person. Official Comment No. 3 to the section made it clear that ‘[b]eyond this, the section is neutral and is not intended to enlarge or restrict the developing case law on whether the seller’s warranties, given to his buyer who resells, extend to other persons in the distributive chain.’ The Official Comments to the 1962 version of the U.C.C. were placed in the Alabama Commercial Code immediately following § 2-318; however, comments numbered 2 and 3 are inappropriate to the section as enacted in view of Alabama’s modified version.
[By contrast, Section] 2-318, as enacted [in Alabama], excluded the words, ‘who is in the family or household of his buyer or who is a guest in his home.’ By removing these words, the legislature intended to remove the privity requirement horizontally from more situations than did the uniform version.
.... Sellers and buyers are not limited by definition to retailers and consumers.By its terms, a seller is anyone who sells, including a manufacturer or distributor. Thus a manufacturer’s or distributor’s warranty extends to ‘any natural person if it is reasonable to expect that such person may use, consume, or be affected by the goods and who is injured in person by the breach of the warranty.’ A manufacturer or distributor intends the products he sells to eventually arrive in the hands of consumers. Thus, by the terms of the statute, a manufacturer’s or distributor’s wаrranty would extend to the final buyer-consumer of the product (as well as to other possible parties horizontally) 8 if he is injured in person by the breach of the warranty.
Id.
(footnotes omitted);
see also Rampey v. Novartis Consumer Health, Inc.,
“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 consumе 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.,
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 brand-name Reglan:
Plaintiffs claims against Wyeth and Schwarz do not relate to the composition or manufacture of the metoclopramide [Mrs. Mosley] ingested, but rather focus[ ] on the inaccurate and insufficient information promulgated by [the Reglan manufacturers] and by which the drug was prescribed. This false information created a sense of security and safety regarding metoclopramide which caused or contributed to the misuse of the drug by Plaintiffs prescribing doctor, and led directly to the severe damages suffered by Plaintiff.
The argument is not that Defendants’ product caused Plaintiff harm, but rather that their dissemination of false and misleading information, which they knеw would be relied upon by the generic manufacturers in generating their own labels, was the direct and proximate cause of Plaintiffs injuries.
(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 — providеs 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 plaintiffs 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
Notes
. Rule 56(c) of the Federal Rules of Civil Procedure, provides that “summary judgment shall be granted if 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 judgment as a matter of law.” Fed.R.Civ.P. 56(c).
. All factual allegations are construed in the light most favorable to the plaintiff.
See, e.g., Brower v. County of Inyo,
. Odessa Mosley’s husband, Ulysses Mosley, seeks damages for lack of consortium. (Doc. 1, at 24).
. The Mosleys alleged in their complaint that “Wyeth manufactures and distributes generic metoclopramide through its ownership of ESI Lederle, Inc. (hereinafter "ESI’’), a former subsidiary which merged into Wyeth,” (Doc. 1, ¶¶ 1.02, 3.02). As previously noted, the Reglan manufacturers moved for summary judgment as to all of the plaintiffs' claims. In their opposition to the motion, however, the Mosleys included no evidence or argument suggesting that Mrs. Mosley consumed generic metoclopramide produced by ESI.
Accordingly, summary judgment is GRANTED as to any and all putative claims against Wyeth based on ESI’s actions or omissions, which the Mosleys have failed to prosecute.
See Ledford v. Peeples,
. Section 552 of the Restatement (Second) of Torts states as follows:
(1) One who, in the course of his business, profession or employment, or in any other transactiоn in which he has a pecuniary interest, supplies false information for the guidance of others in their business transactions, is subject to liability for pecuniary loss caused to them by their justifiable reliance upon the information, if he fails to exercise reasonable care or competence in obtaining or communicating the information.
(2) Except as stated in Subsection (3), the liability stated in Subsection (1) is limited to loss suffered (a) by the person or one of a limited group of persons for whose benefit and guidance he intends to supply the information or knows that the recipient intends to supply it; and (b) through reliance upon it in a transaction that he intends the information to influence or knows that the recipient so intends or in a substantially similar transaction.
(3)The liability of one who is under a public duty to give the information extends to loss suffered by any of the class of persons for whose benefit the duty is created, in any of the transactions in which it is intended to protect them.
Id. (emphasis added).
. Regarding the “key” factor of foreseeability, it is worthy to note that Section 34-23-8(1) of the Code of Alabama provides that a pharmacist may substitute a generic for a branded drug only if the physician "expressly authorizes such selection” by signing on а signature line labeled “product selection permitted” or by giving another form of written or oral authorization to dispense a generic product in place of a brand name product designated on the prescription.
See
Ala.Code. § 34-23-8(1) & (4). The plaintiffs point to only one court holding that manufacturers of name-brand drugs may be held liable to plaintiffs who, like Mrs. Mosley, only ingested the generic version of a drug.
See Conte v. Wyeth,
. Section 7-2-313 of the Alabama Code states that "[ejxpress warranties by the seller are created” when a “seller” makes "[a]ny affirmation of fact or promise ... to the buyer which relates to the goods and becomes part of the basis of the bargain....” Ala.Code. § 7-2-313(l)(a) (1975). Such affirmation or promise “creates an express warranty that the goods shall conform to the affirmation or promise.” (Id.). The same section provides that "[a]ny description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.” (Id. at (l)(b)).
Section 7-2-314 of the Alabama Code states that, with certain exceptions, "a warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind....” Id.
Section 7-2-315 of the Alabama Code provides that "[w]here the seller at the time of contracting has reason to know any particular purpose for which the goods are required and that the buyer is relying on the seller's skill or
. It is worthy to note that the court used the word "parties” rather than "purchasers.” In any event, some authorities have maintained that an individual need not be a purchaser in order to obtain "horizontal privity”: “ 'Horizontal privity’ describes the relationship between the original supplier and any non-purchasing party who uses or is affected by the product, such as the family of the ultimate purchaser or a bystander.”
Garcia v. Texas Instruments, Inc.,
.
See United States v. Bailey,