On Application for Rehearing
The opinion of January 11, 2013, is withdrawn, and the following is substituted therefor.
The United States District Court for the Middle District of Alabama, Southern Division ("the district court"), has certified to this Court the following question pursuant to Rule 18, Ala. R.App. P.:
Facts and Procedural History
In its certification to this Court, the district court provided the following background information:
At the outset, we limit the question posed to manufacturers of prescription drugs and not to any distributors thereof.
We recognize that Wyeth argues that the Weekses' claims are, in essence, "products-liability" claims. In Atkins v. American Motors Corp., 335 So.2d 134 (Ala.1976), in conjunction with Casrell v. Altec Industries, Inc., 335 So.2d 128 (Ala. 1976), this Court adopted the Alabama Extended Manufacturer's Liability Doctrine ("AEMLD"). The AEMLD is "a judicially created accommodation of Alabama law to the doctrine of strict liability for damage or injuries caused by allegedly defective products." Keck v. Dryvit Sys., Inc., 830 So.2d 1, 5 (Ala.2002). This Court has explained that the AEMLD did not subsume a common-law negligence or wantonness claim. Tillman v. R.J. Reynolds Tobacco Co., 871 So.2d 28 (Ala.2003); Vesta Fire Ins. Corp. v. Milam & Co. Constr., 901 So.2d 84 (Ala.2004).
Tillman, 871 So.2d at 34-35. We have also recognized that fraudulent suppression is a claim separate from an AEMLD claim. Keck, supra. Accordingly, for purposes of this certified question, we will not treat the Weekses' claims as AEMLD claims governed by the principles of the AEMLD.
Wyeth argues, based on Pfizer, Inc. v. Farsian, 682 So.2d 405 (Ala.1996), that a plaintiff who in substance alleges physical injury caused by a product has a products-liability claim, no matter the label or labels he uses in his complaint, and that, in a products-liability claim, the plaintiff must prove that the defendant manufactured the product the plaintiff claims injured him or her. We recognize that in Farsian this Court contended that the plaintiff's claim was in substance a products-liability claim and not a fraud claim as he had asserted. In Farsian, a heart-valve recipient's valve had not malfunctioned, although the valves in some other patients who had received the valve made by the manufacturer had malfunctioned. The federal court where the action was filed certified the following question to this Court:
682 So.2d at 406. The manufacturer argued that, although the plaintiff had alleged a risk of possible future malfunction of the valve, it was uncontroverted that his valve was and had been working properly. The manufacturer contended that the plaintiff was really asserting a products-liability claim and that, as such, the action did not accrue until there was an injury-producing malfunction. The manufacturer further argued that an allegation of fraud did not relieve the plaintiff from having to prove an injury-producing malfunction. The plaintiff argued that his fraud claim was not subsumed by products-liability law and that he could recover damages even if he could not prove that his valve was not yet malfunctioning.
In addressing the question, we stated:
682 So.2d at 407. Ultimately, we stated:
682 So.2d at 408. Farsian is distinguishable. This Court's holding there was that, under either a fraud theory or a products-liability theory, the plaintiff did not have a valid cause of action because fear that the valve could fail in the future was not, without more, a legal injury sufficient to support his claim. In the present case, the Weekses are arguing that Wyeth fraudulently misrepresented or suppressed facts to Danny's physician regarding the dangers of the long-term use of Reglan and that, as a result, Danny was injured. This is not a claim that the drug ingested by Danny was defective; instead, it is a claim that Wyeth fraudulently misrepresented or suppressed information about the manner in which (i.e., the duration) the drug was to be taken. In short, the Weekses' claim is based on what Wyeth said or did not say about Reglan and their assertion that those statements or omissions caused Danny's injuries. Farsian does not support a conclusion by this Court that the Weekses'
We note that Alabama's Pharmacy Act, § 34-23-1 et seq., Ala.Code 1975, permits a pharmacist to select in place of a brand-name drug a less expensive drug product that is the pharmaceutical and therapeutical equivalent of the brand-name drug and that contains the same active ingredient or ingredients and is the same dosage-form strength, unless the prescribing physician indicates otherwise on the prescription. § 34-23-8, Ala.Code 1975. In the present case, it appears that Danny's prescription did not prohibit the pharmacist from substituting a generic drug for the brand-name drug. "Currently all states have some form of generic substitution law." PLIVA, Inc. v. Mensing, 564 U.S. ___, ___, 131 S.Ct. 2567, 2583, 180 L.Ed.2d 580 (2011)(Sotomayor, J., dissenting). That a pharmacist acted under § 34-23-8 and gave Danny a generic drug does not preclude Danny's ability to assert a fraudulent-misrepresentation claim against the brand-name manufacturer of the drug. Additionally, many insurance plans are structured to promote the use of generic drugs. PLIVA, 564 U.S. at ___ n. 2, 131 S.Ct. at 2584 n. 2. We now turn to the federal laws governing prescription drugs.
Prescription drugs are unique because of the extensive federal regulation of that product by the Food and Drug Administration ("the FDA"). "Congress has established a comprehensive regulatory scheme, administered by the FDA, to control the design and distribution of prescription drugs." Blackmon v. American Home Prods. Corp., 328 F.Supp.2d 659, 665 (S.D.Tex.2004)(citing 21 U.S.C. §§ 301-393). The FDA has the ultimate authority to determine whether a new prescription drug is safe and effective for use. 21 U.S.C. §§ 355(a) and (d) (prohibiting the distribution of a new drug without FDA approval of a new-drug application showing the drug to be safe and effective). The approval process begins with an investigational new-drug application ("IND") submitted to the FDA, which includes information about the chemistry, manufacturing, pharmacology, and toxicology of the drug. See 21 U.S.C. § 355(b); 21 C.F.R. § 312.21. The IND also includes pre-clinical data (animal pharmacology and toxicology), and protocols for human testing must be detailed.
After clinical trials on humans have been completed, the manufacturer may submit a new-drug application ("NDA") to the FDA. The manufacturer must present "substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling." 21 U.S.C. § 355(d)(5). The NDA shall include: (1) reports of the clinical trials and testing done to determine the safety and effectiveness of the drug; (2) the complete ingredients or components of the drug; (3) the composition of the drug; (4) a complete description of the manufacturing, processing, and packaging
When the patent on a brand-name drug expires, generic manufacturers may seek to replicate a generic version. Generic versions of brand-name drugs contain the same active ingredient as the brand-name original. United States v. Generix Drug Corp., 460 U.S. 453, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). To expedite the approval process for generic drugs in order to bring prescription-drug costs down while at the same time preserving patent protections for brand-name drugs, Congress adopted the Drug Price Competition and Patent Term Restoration Act of 1984. 21 U.S.C. § 355. This Act, also known as the Hatch-Waxman Act, provides for an abbreviated new-drug-application ("ANDA") process for the approval of generic versions of brand-name drugs. The ANDA relies on the FDA's previous determination that the brand-name drug is safe and effective. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990)("The ANDA applicant can substitute bioequivalence data for the extensive animal and human studies of safety and effectiveness that must accompany a full new drug application."). This allows an applicant for a generic version of a drug to avoid the costly and time-consuming process associated with an NDA,
Brand-name manufacturers have a duty to supply the FDA with "postmarketing reports," which include reports of any serious and unexpected adverse reactions suffered by a user of a drug. 21 C.F.R. § 314.80. The brand-name manufacturer must also submit annual reports to the
PLIVA, 564 U.S. at ___, 131 S.Ct. at 2574. "Drug labels are subject to change. New risks may become apparent only after the drug has been used more widely and for longer periods." Mensing v. Wyeth, Inc., 588 F.3d 603, 606 (8th Cir.2009), reversed on other grounds, PLIVA, supra. Under the "Changes Being Effected" or "CBE" rule, a brand-name manufacturer, upon discovering a clinically significant hazard, may modify its label to "add or strengthen a contraindication, warning, precaution, or adverse reaction" without FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A). Ultimately, the FDA will review any CBE modification to a label. 21 C.F.R. § 314.70(c)(7). If the FDA rejects the change, it may order the manufacturer to cease distribution of the drug with the revised label. 21 C.F.R. § 314.70(c)(7).
A "label" is defined as "a display of written, printed, or graphic matter upon the immediate container of any article...." 21 U.S.C. § 321(k). "`[L]abeling' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." 21 U.S.C. § 321(m). The FDA interprets "labeling" broadly, to include:
21 C.F.R. § 202.1(1)(2). The FDA includes in its interpretation of labeling "Dear Doctor" letters, PLIVA, 564 U.S. at ___, 131 S.Ct. at 2576, which are letters drug manufacturers send to health-care providers informing them of critical newly discovered risks or side effects of a medication.
The FDA has determined that a generic manufacturer cannot unilaterally strengthen a warning label for a generic drug or send a "Dear Doctor" letter under the CBE rule because doing so would violate the statutes and regulations requiring the label of a generic drug to match the brand-name manufacturer's label. PLIVA, 564 U.S. at ___, 131 S.Ct. at 2575.
Phelps v. Wyeth, Inc., 857 F.Supp.2d 1114, 1133 (D.Or.2012) (emphasis added). According to the FDA, if a generic manufacturer believes that stronger warnings are needed, then the manufacturer is required to propose such changes to the FDA, and, if the FDA agrees that such changes are necessary, the FDA will work with the brand-name manufacturer to create a new label for both the brand-name and generic drug. PLIVA, 564 U.S. at ___, 131 S.Ct. at 2576.
The Supreme Court, in two cases, has addressed the extent to which manufacturers may change their labels after FDA approval. We note that, because of the extensive federal regulations, both the manufacturers of brand-name drugs and generic drugs in those cases argued that the federal regulations preempted state-law claims. In Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), the plaintiff developed gangrene and her forearm had to be amputated when a physician's assistant injected her artery with the anti-nausea drug Phenergan by using the "IV push" method of intravenous injection. She sued Wyeth, the manufacturer of Phenergan, for failing to provide an adequate warning about the different risks involved with the various methods of administering the drug. She relied on common-law negligence and strict-liability theories. A jury found that Wyeth had failed to provide an adequate warning about the risks involved when Phenergan is administered by the IV push method. On appeal, Wyeth argued that the plaintiff's failure-to-warn claims were preempted by federal regulations regarding drug labeling because it was impossible for a manufacturer to comply with both state laws and federal-labeling obligations. Wyeth also argued that recognition of state-law suits would undermine Congress's intent to entrust labeling to the expertise of the FDA. The Supreme Court rejected both contentions and held that there was no preemption. The Supreme Court concluded that Wyeth failed to demonstrate that it was impossible for it to comply with both federal and state requirements, and it noted that state-law claims are an important complement to the FDA's regulation of prescription drugs. The Supreme Court stated:
555 U.S. at 578-79, 129 S.Ct. 1187 (footnote omitted).
PLIVA, supra, also involved a preemption claim regarding labels, but the manufacturer there produced the generic version of a brand-name drug. "The question presented [was] whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims." 564 U.S. at ___, 131 S.Ct. at 2572. The FDA had issued a labeling requirement regarding Reglan, the brand name of metoclopramide, the generic drug at issue in the present case. The plaintiffs in PLIVA were prescribed Reglan but received the generic form of the drug, which contained the same labeling information the FDA had approved for the brand-name drug. According to the FDA, 57 Fed.Reg. 17961 (1992) requires a generic-drug manufacturer's labeling to be the same as the brand-name-drug manufacturer's labeling because the brand-name drug is the basis for the FDA's approval of the generic drug. 564 U.S. at ___, 131 S.Ct. at 2575. By 2009, the FDA had ordered a "black box" warning for Reglan concerning the dangers associated with its long-term use. The plaintiffs had suffered severe neurological reactions from taking the generic form of the drug and had brought state-law tort claims against the manufacturers of the generic form of the drug for failing to warn them of such danger. The basis of the plaintiffs' claims was that the warning labels for the generic drug were inadequate and that the generic manufacturers had a duty to strengthen their warning labels under the FDA's CBE process. 564 U.S. at ___, 131 S.Ct. at 2575. The Supreme Court found that the FDA's federal-labeling requirement preempted the plaintiffs' state-law claims against the manufacturers of the generic drug because it would have been impossible for the generic manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug match the warning on its brand-name counterpart.
564 U.S. at ___, 131 S.Ct. at 2574. The Supreme Court held that because the FDA prevented the generic manufacturers from independently changing the safety label on their generic drugs, "it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same." 564 U.S. at ___, 131 S.Ct. at 2578.
564 U.S. at ___, 131 S.Ct. at 2581-82.
As noted in the facts set out in the certified question, other federal courts applying Alabama law have held that Alabama law does not allow a person who consumed a generic version of a brand-name drug to sue the brand-name manufacturer based on fraudulent misrepresentation. In Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D.Ala.2010), the plaintiffs did not ingest Reglan but took a generic equivalent manufactured by a generic manufacturer. They sued the brand-name manufacturers of Reglan alleging, among other things, negligent and fraudulent misrepresentation regarding the
Mosley is distinguishable from the present case. The Weekses are not arguing that Wyeth owed them a duty. Instead, they are arguing that Wyeth owed Danny Weeks's physician a duty and that, under the learned-intermediary doctrine, the Weekses are entitled to rely on the representations made to Danny's physician. Also, we note that Mosley was issued before the United States Supreme Court in PLIVA, supra, expressly found that because it was impossible for the generic manufacturers to comply with both their state-law duty to change the drug label to a safer label adequately warning of the dangers inherent in long-term use and their federal-law duty to keep the label the same as the brand-name manufacturer's label, any state-law claims against a generic manufacturer were preempted. Reliance upon the reasoning in Mosley that a generic manufacturer is responsible for its own warning labels and revisions of those labels is unsound.
In Overton v. Wyeth, Inc. (No. CA 10-0491-KD-C, March 15, 2011) (S.D.Ala. 2011) (not reported in F.Supp.2d), the brand-name manufacturers filed a motion to dismiss the plaintiffs' state-law claims of breach of warranty, fraudulent misrepresentation, and negligent misrepresentation where the plaintiffs had ingested the generic versions of the brand-name drug. The plaintiffs argued that the brand-name manufacturers placed false and misleading information in their labels, when they knew the labels would be relied upon by the generic manufacturers in generating their own labels, and that their doing so was a direct and proximate cause of the plaintiffs' injuries. The federal court stated that the dispositive issue on the plaintiffs' misrepresentation claims was whether the brand-name manufacturers owed any duty to plaintiffs who ingested the generic version of their brand-name drug. The federal court held that the plaintiffs presented no evidence indicating that the brand-name manufacturers owed a duty to consumers of the generic version of the drug so that the plaintiffs' injuries could be considered to have been a proximate
In Simpson v. Wyeth, Inc. (No. 7:10-cv-01771-HGD, December 9, 2010) (N.D.Ala. 2010) (not reported in F.Supp.2d), the federal court held that the plaintiffs, who had ingested only the generic version of Reglan, could not recover for the alleged fraudulent misrepresentations made to the plaintiffs' doctor by the manufacturers of Reglan. The brand-name manufacturers argued that, because they did not manufacture the product the plaintiffs had ingested and that allegedly had caused their injuries, the brand-name manufacturers could not be held liable. The plaintiffs alleged that their claim against the brand-name manufacturers was based on the damage caused by the product as a result of the brand-name manufacturers' misinformation to the prescribing doctors, and the plaintiffs argued that they could recover from the brand-name manufacturers even though they were third parties to the alleged deceit or concealment because, they argued, the deceit and concealment perpetrated against the plaintiffs' prescribing doctors proximately caused their damage. In support of their argument, the Simpson plaintiffs relied on Delta Health Group, Inc. v. Stafford, 887 So.2d 887 (Ala. 2004), which held that in certain circumstances a plaintiff may properly state a fraud claim even though the defendant's false representation is made to a third party, rather than to the plaintiff. In discussing Delta Health, the federal court noted that Delta Health went on to hold that a plaintiff must establish that he or she relied on the misrepresentation.
The federal court in Simpson stated that the problem with the plaintiffs' reliance argument was that Alabama courts have repeatedly rejected a theory of liability when the plaintiffs have attempted to hold a brand-name manufacturer responsible for damage caused by a generic brand of its drug, citing Mosley, supra. The federal court also relied on the fact that the FDA regulation did not require a brand-name manufacturer to ensure that the label of the generic version is accurate, citing Swicegood v. PLIVA, Inc., 543 F.Supp.2d 1351 (N.D.Ga.2008). "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." Simpson.
The federal court in Simpson went on to address the learned-intermediary doctrine:
Like Mosley and Overton, Simpson was issued before PLIVA was decided, and the federal court's conclusion in Simpson — that generic manufacturers have their own duty to correctly advise a physician of risks associated with the generic drug regardless of the fact that a generic label is required to be the same as the brand-name label — is questionable. Also, the plaintiffs in Simpson argued that they should be allowed to recover from the brand-name manufacturers even though they were third parties to the alleged fraud perpetrated by those manufacturers upon the plaintiffs' prescribing physicians. The Simpson court stated that, even if the plaintiffs, under the learned-intermediary doctrine, could prove that their physicians had relied upon the brand-name manufacturer's warning, the plaintiffs still had to demonstrate that the brand-name manufacturer owed the plaintiffs a duty before the brand-name manufacturer could be liable.
We recognize that other jurisdictions,
Foster, 29 F.3d at 169-70.
The plaintiffs in Foster argued that the brand-name manufacturers owed a duty because it was foreseeable that misrepresentations regarding Phenergan could result in personal injury to the users of the generic equivalents of Phenergan. The Foster court concluded that to impose duty in that case would be to stretch the concept of foreseeability too far. "The duty required for the tort of negligent misrepresentation arises when there is `such a relation that one party has the right to rely for information upon the other, and the other giving information owes a duty to give it with care,'" and the court concluded that no such relationship existed between the plaintiff who was injured by a product that was not manufactured by the brand-name manufacturer. 29 F.3d at 171 (quoting Weisman v. Connors, 312 Md. 428, 443-44, 540 A.2d 783, 790 (1988)).
A few courts have held otherwise. In Conte v. Wyeth, Inc., 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (2008), the California Court of Appeals, applying state negligence law, held as a matter of first impression that a manufacturer of a brand-name drug may be held liable for injuries suffered by a consumer who purchased a generic form of the drug if the consumer's injuries were foreseeably caused by the negligence of or an intentional misrepresentation by the brand-name manufacturer that developed the drug. Conte, the plaintiff in that case, sued the brand-name manufacturer and three generic manufacturers of Reglan and its generic version, metoclopramide, alleging that her use of metoclopramide over a four-year period caused her to develop tardive dyskinesia. Conte had ingested only the generic drug. "The crux of Conte's claims against all of the drug company defendants [was] that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug's side effect." 168 Cal.App.4th at 95, 85 Cal.Rptr.3d at 305. The trial court entered a summary judgment for all the defendant drug manufacturers, and Conte appealed. The California appellate court reversed the summary judgment in favor of the brand-name manufacturer after concluding that Conte had presented a material factual dispute as to whether her doctor had in fact relied on information disseminated by the brand-name manufacturer of Reglan. Specifically, the appellate court held that the brand-name manufacturer knew or should have known "that a significant number of patients whose doctors rely on its product information for Reglan are likely to have generic metoclopramide prescribed or dispensed to them" and that the brand-name manufacturer's "duty of care in disseminating product information extends to those patients who are injured by generic metoclopramide as a result of prescriptions written in reliance on [the brand-name manufacturer's] product information for
In Kellogg v. Wyeth, 762 F.Supp.2d 694 (D.Vt.2010), the Vermont federal district court held that a brand-name manufacturer of a drug has a duty to use reasonable care to avoid causing injury to consumers who have been prescribed the generic bioequivalent of its drug. Kellogg, the plaintiff in that case, sued the brand-name manufacturer and generic manufacturers of metoclopramide, alleging that her long-term ingestion of metoclopramide caused her to develop tardive dyskinesia; Kellogg had ingested only the generic drug. The crux of Kellogg's argument was that all the defendant manufacturers were liable because, she argued, they failed to adequately warn her doctors about the risks associated with the long-term use of metoclopramide. Both the brand-name manufacturer and each of the generic manufacturers filed a motion for a summary judgment on Kellogg's failure-to-warn claim; the federal district court denied the motions. The court held that, because all the parties agreed that the defendant drug manufacturers owed a duty to provide adequate warning to Kellogg's prescribing physicians, a jury question existed as to whether the defendant drug manufacturers had provided accurate and adequate warnings. The federal district court further held that the defendant drug manufacturers were not entitled to summary judgments for lack of a triable issue on proximate cause. Specifically, the court stated that "[a] reasonable jury could conclude that inadequate, misleading and inaccurate information provided by the [defendant drug manufacturers] was a proximate cause of [Kellogg's] injury." 762 F.Supp.2d at 702. The federal district court finally denied the summary-judgment motion filed by the brand-name manufacturer on Kellogg's negligent-misrepresentation, fraud, and fraud-by-concealment claims in which Kellogg alleged that the brand-name manufacturer of Reglan was liable for failing to use due care in disseminating information about the drug to physicians, thereby causing the physicians to over-prescribe metoclopramide to her. The brand-name manufacturer agreed that it had a duty to provide adequate warnings about Reglan to physicians. However, it contended that it owed no duty to a doctor who prescribes Reglan if the pharmacy fills the doctor's prescription with a generic brand of the drug. Applying Vermont's negligence law, the federal district court noted that "a brand-name manufacturer owes a duty to use reasonable care to avoid causing injury to consumers of the generic bioequivalents of its drugs," 762 F.Supp.2d at 706, because "it is reasonably foreseeable that a physician will rely upon a brand name manufacturer's representations — or the absence of representations — about the risk of side effects of its drug, when deciding to prescribe the drug for a patient, regardless of whether the pharmacist fills the prescription with a generic form of the drug." 762 F.Supp.2d at 709. The federal district court therefore held that Kellogg had presented triable issues of fact regarding whether "her doctors relied on inaccurate and misleading information — or the absence of accurate information — from [the brand-name manufacturer] concerning the risks and effects of long-term use of [metoclopramide]." 762 F.Supp.2d at 710.
In looking at the reasoning in Foster and Conte, we note that the Foster court
Moreover, the analysis in Foster confuses strict liability and tort law. The Foster court stated that there is "[n]o 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." 29 F.3d at 170. If a plaintiff brought a strict-liability claim and the issue was one of a defect in production of the product, then the Foster court's reasoning would be sound. Certainly, a manufacturer will not be held liable for another manufacturer's production, design, or manufacturing defect. However, the Foster court's reasoning that a brand-name manufacturer does not owe a duty to persons taking the generic version of their drug because the brand-name manufacturer did not manufacture that drug is flawed when the cause of action relates to the warnings contained in the labeling relating to the drug and sound in tort. In Foster, the plaintiffs alleged that it was the inadequate warning that caused their daughter's death, not how the drug itself was produced. Because a warning label is not a part of the manufacturing process, we do not agree that the fact that a brand-name manufacturer did not produce the version of the drug ingested by the plaintiff bars the plaintiff's tort action when the plaintiff is arguing that he or she was injured by a failure to warn.
We recognize that the holding in PLIVA did not address foreseeability as the Foster court did. However, the Supreme Court concluded in PLIVA that the labeling for a generic drug is required by federal regulations to be the same as the labeling for the brand-name drug. Therefore, an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product. A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when that patent expires. It is recognized that generic substitutions are allowed in all 50 states. A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.
We now turn to the issue whether Wyeth owed a duty to the Weekses as third parties to the alleged fraud in failing to adequately warn of the risks of Reglan in its labeling. The Weekses rely on Delta Health Group, Inc. v. Stafford, supra, which involved an alleged misrepresentation made to a third party. Tim Stafford and Lana Stafford alleged that Delta Health Group and its insurer, Lumbermens Mutual Casualty Company, had falsely accused Tim Stafford of pilfering from a nursing home owned by Delta Health building material for use on the Staffords' personal residence. After Delta Health filed a claim with Lumbermens for its alleged loss and assigned its rights to
887 So.2d at 899.
Delta Health is not the first time this Court has addressed a fraud claim based on misrepresentations made not to a plaintiff but to a third party. In Thomas v. Halstead, 605 So.2d 1181 (Ala.1992), a patient sued his dentist alleging fraud, specifically alleging that the dentist had obtained payment from the patient's insurer for services that were never rendered. The patient had gone to see the dentist, who took several X-rays of his mouth and told him he needed additional dental work. The patient claimed that the dentist was to submit a form to the patient's insurer to determine the insurance coverage. Instead, the dentist submitted a claim for the additional work on the patient's teeth, which had never been done. The patient argued that, even if the misrepresentation was not made directly to him, "a misrepresentation, made to his insurance carrier, which is legally obligated to pay valid claims submitted to it for dental expenses incurred by him, is sufficient to satisfy the misrepresentation element of fraud." 605 So.2d at 1184. "While generally `[a] stranger to a transaction ... has no right of action [for fraud],' there is an exception to this general rule: `If a third person is injured by the deceit, he may recover against the one who made possible the damages to him by practicing the deceit in the first place.' 37 C.J.S. Fraud § 60, p. 344 (1943), see Sims v. Tigrett, 229 Ala. 486, 158 So. 326 (1934)." 605 So.2d at 1184.
Sims v. Tigrett, 229 Ala. 486, 158 So. 326 (1934), involved deceit in the selling of bonds. This Court stated:
229 Ala. at 491, 158 So. at 330.
Wyeth argues that Delta Health is distinguishable because this Court has never extended third-party fraud beyond the economic realm to claims alleging physical harm. We recognize that Delta Health, Thomas, and Sims did not involve a claim of physical injury. However, physical harm suffered by a consumer of prescription medication would have been reasonably contemplated by a manufacturer who made fraudulent statements on the warning label related to that medication.
Wyeth also argues that this Court has never extended third-party-fraud liability to a defendant who did not manufacture the product about which the plaintiff is complaining. We again note that prescription medication is unlike other consumer products. Unlike "construction machinery," "lawnmowers," or "perfume," which are "used to make work easier or to provide pleasure," a prescription drug "may be necessary to alleviate pain and suffering or to sustain life." Brown v. Superior Court of San Francisco, 44 Cal.3d 1049, 1063, 245 Cal.Rptr. 412, 420, 751 P.2d 470, 479 (1988). Prescription medication is heavily regulated by the FDA. It can be obtained only through a health-care provider who can make a determination as to the benefits and risks of a drug for a particular patient. Also, the Weekses' claims are not based on the manufacturing of the product but instead allege that the label — drafted by the brand-name manufacturer and required by federal law to be replicated verbatim on the generic version of the medication — failed to warn. Moreover, the brand-name manufacturer is under a continuing duty to supply the FDA with postmarketing reports of serious injury and can strengthen its warnings on its own accord. Wyeth v. Levine, supra; 21 C.F.R. § 201.57(c)(6)(I); 21 C.F.R. § 201.56(a)(2)-(b)(1). In contrast, a generic manufacturer's label must be the same as the brand-name manufacturer's label, and the generic manufacturer cannot unilaterally change its warning label.
We recognize that the plaintiff in Delta Health did not succeed in his fraud claim because he failed to present evidence indicating that he relied to his detriment on any of the alleged misrepresentations made by his employer to the employer's insurer. In a fraud case, detrimental reliance is an essential aspect of showing that the injury suffered was caused by the fraud. "[A] fraud claim fully accrues once any legally cognizable damage has proximately resulted, i.e., once the plaintiff has `detrimentally' relied on the fraud." Ex parte Haynes Downard Andra & Jones, LLP, 924 So.2d 687, 694 (Ala.2005). In the present case, the Weekses have alleged that Danny's physician reasonably relied on the representations made by Wyeth regarding the long-term use of Reglan in prescribing Reglan to Danny. In other words, the Weekses are arguing that if a defendant's misrepresentation to a third party causes the third party to take actions resulting in the plaintiff's injuries, then the factual causation link is satisfied and that, here, a misrepresentation to Danny's physician would directly impact the medical care received by Danny.
In Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301 (Ala. 1984), this Court adopted the learned-intermediary doctrine in a case addressing whether a manufacturer's duty to warn extends beyond the prescribing physician to the physician's patient who would ultimately use the drugs. The principle behind
Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974).
The learned-intermediary doctrine recognizes the role of the physician as a learned intermediary between a drug manufacturer and a patient. As the United States Court of Appeals for the Eleventh Circuit has explained:
Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313-14 (11th Cir.2000) (citations omitted).
A prescription-drug manufacturer fulfills its duty to warn the ultimate users of the risks of its product by providing adequate warnings to the learned intermediaries who prescribe the drug. Once that duty is fulfilled, the manufacturer has no further duty to warn the patient directly. However, if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient. The patient must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient's injury. In short, the patient must show that, but for the false representation made in the warning, the prescribing physician
Wyeth argues that there is no relationship between Wyeth and the Weekses so as to create a duty on Wyeth's part to adequately warn the Weekses and that the simple fact that it may be foreseeable that a physician would rely on Wyeth's representations in its warning label in determining whether a prescription drug originally manufactured by Wyeth was appropriate for a particular patient did not create a relationship between Wyeth and the patient. Wyeth argues:
Wyeth's brief, p. 42.
Wyeth's argument completely ignores the nature of prescription medication. The Weekses cannot obtain Reglan or any other prescription medication directly from a prescription-drug manufacturer.
Owen held that an insurer had no duty to disclose that, although premiums on homeowners' insurance were based on the appraisal value of the insured property, the insurer would pay no more than replacement value in the event of a loss. DiBiasi involved an electrocution victim who was injured when he grabbed electrical transmission lines hanging over the roof of a house. The utility company that owned the pole to which the lines were attached argued that it owed no duty (the city supplied the electrical power) to the victim, who was inspecting the roof of the house when, among other things, there was no relationship shown between the owner of the utility pole and the victim. The wire that electrocuted the victim was owned by the city. In Thompson-Hayward, a case that predates the judicial adoption of the AEMLD, this Court held that the plaintiff's complaint failed to allege that the defendant had manufactured an injurious herbicide or to allege that the defendant sold the herbicide to the plaintiffs.
These cases are easily distinguishable from this case. Here, Wyeth authored the label with its warnings, and the generic manufacturers, as required by FDA regulations, copied that label verbatim. Wyeth continues to treat the Weekses' fraud claim as a products-liability claim where privity is needed.
Carter, 743 So.2d at 461-62 (some emphasis added). Stated again, there is a duty not to make a false representation (1) to those to whom a defendant intends, for his own purposes, to reach and influence by the representation; (2) to those to whom the defendant has a public duty created by statute or pursuant to a statute; and (3) to those members of a group or class that the defendant has special reason to expect will be influenced by the representation.
Clearly, prescription drugs differ from lawnmowers, automobiles, and other products because of the FDA's unprecedented control and regulation of prescription drugs; the FDA has the responsibility of weighing (in terms of extremes) the potential benefit of lifesaving medication against potential severe side effects. Those side effects might not become apparent until after a drug has been on the market, and even then the benefits of the drug may outweigh the risks. Wyeth cannot argue that it owes no duty to the Weekses because it lacks a relationship with them.
We answer the certified question as follows: Under Alabama law, a brand-name-drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company. Prescription drugs, unlike other consumer products, are highly regulated by the FDA. Before a prescription drug may be sold to a consumer, a physician or other qualified health-care provider must write a prescription. The United States Supreme Court in Wyeth v. Levine recognized that Congress did not preempt common-law tort suits, and it appears that the FDA traditionally regarded state law as a complementary form of drug regulation: The FDA has limited resources to monitor the approximately 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge; state-law tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly and serve
FDA regulations require that a generic manufacturer's labeling for a prescription drug be exactly the same as the brand-name manufacturer's labeling. The Supreme Court in PLIVA held that it would have been impossible for the generic manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers.
In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated, as allowed by the FDA, by the generic manufacturer.
In answering the question of law presented to us by the federal court, we emphasize the following: We are not turning products-liability law (or tort law for that matter) on its head, nor are we creating a new tort of "innovator liability" as has been suggested. Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation. Nothing in this opinion suggests that a plaintiff can sue Black & Decker for injuries caused by a power tool manufactured by Skil based on labeling or otherwise. The unique relationship between brand-name and generic drugs as a result of federal law and FDA regulations, combined with the learned-intermediary doctrine and the fact that representations regarding prescription drugs are made not to the plaintiff but to a third party, create the sui generis context in which we find prescription medication. Again, the fraud or misrepresentation claim that may be brought under Alabama law against a drug manufacturer based on statements it made in connection with the manufacture of a brand-name prescription drug by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company is premised upon liability not as a result of a defect in the product itself but as a result of statements made by the brand-name manufacturer that Congress, through the FDA, has mandated be the same on the generic version of the brand-name drug.
APPLICATION OVERRULED; OPINION OF JANUARY 11, 2013, WITHDRAWN; OPINION SUBSTITUTED; QUESTION ANSWERED.
STUART, MAIN, WISE, and BRYAN, JJ., concur.
SHAW, J., concurs specially.
MOORE, C.J., and PARKER and MURDOCK, JJ., dissent.
SHAW, Justice (concurring specially).
I concur fully in the Court's answer to the certified question. I write specially to note the following.
First, some preliminary observations:
The certified question asks this Court to apply current Alabama law as it relates to fraud.
When Wyeth's ability to produce and sell metoclopramide exclusively lapsed, generic-drug companies became able to manufacture and sell metoclopramide. Those generic-drug companies may have wished to give Danny's doctor different facts or instructions about the use of metoclopramide, but, for all intents and purposes relevant in this case, the federal government will not allow them to do so. Essentially, federal law requires that those generic-drug companies repeat Wyeth's alleged misrepresentations or omissions. Wyeth
In this context, we look to see whether, "[u]nder Alabama law, [Wyeth may] be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made" about metoclopramide. As discussed below, Alabama law allows a plaintiff to sue a defendant based on the defendant's fraudulent conduct directed to a third person. A prior relationship between the two parties is not necessary. Two factors have been the focus of this case: foreseeability and duty. Although a controlling issue in other jurisdictions, I see no dispute as to foreseeability. As even Justice Murdock's dissenting opinion agrees, it is "eminently" foreseeable "that a generic version of a brand-name drug will be consumed in reliance upon labeling disseminated by the brand-name manufacturer for its brand-name drug."
In cases where fraudulent conduct is directed to third parties, this State's caselaw generally holds that a duty to disclose may be owed to a person with whom the defendant has had no prior dealings, specifically, where there is a "duty" not to make a false representation:
Hines v. Riverside Chevrolet-Olds, Inc., 655 So.2d 909, 919-20 (Ala.1994),
In Hines, this Court held that an automobile manufacturer had a duty to disclose to subsequent purchasers of an automobile it had manufactured that the automobile had been repainted, even though the manufacturer had no relationship with the later purchasers, "[b]ecause the [subsequent purchasers] were members of a group or class of persons who [the manufacturer] expected or had special reason to expect would be influenced by its decision not to disclose information...." 655 So.2d at 920. Thus, they "had a sufficient relationship on which to base a duty to disclose." Id. In Carter, an automobile manufacturer repurchased under the Lemon Law an automobile that was allegedly defective. This fact was disclosed to the party to whom the
In both Carter and Hines there was a duty to not misrepresent or omit facts to those with whom the automobile manufacturers never had contact. Although those cases involved products that were actually manufactured by the defendants, the logic behind the creation of the duty has nothing to do with that fact. Here, federal law has created a scheme in which persons who purchased metoclopramide manufactured by generic-drug companies would have to rely on Wyeth's representations about metoclopramide. Thus, Wyeth had a "special reason to expect" that purchasers of the generic metoclopramide "would be influenced" by its labeling information because that information — owing to federal law — would be the only information purchasers of both brand-name and generic metoclopramide would receive. That the metoclopramide was made by another manufacturer creates no distinction: for purposes of this case, metoclopramide is the same no matter who produced it. As required by federal law, Wyeth's alleged misrepresentations or omissions concerning metoclopramide also applied to metoclopramide manufactured by a generic-drug company. What Wyeth allegedly said (or failed to say) in its "labeling" about metoclopramide was intended to "reach and influence" users (through doctors or other health professionals) of metoclopramide, which, at that time, was manufactured only by Wyeth. This labeling, as required by federal law, also reached and influenced purchasers of generic metoclopramide. This federal law gave Wyeth "special reason to expect" that all users of metoclopramide would be influenced by its labeling.
Our answer to this certified question on original submission has generated many responses, some of which expressed valid concerns, while others either shamefully misrepresented our holding or bordered on the hysterical. Our answer, however, is extraordinarily narrow in scope. The posture in which the certified question is asked (assuming a fraud cause of action), the facts of this case, and the impact of strict federal regulation on the prescription-drug industry drastically confine our holding and wholly remove the facts of this case from situations where parties are allegedly being held liable under general products-liability theories for products they did not make. I cannot see our answer to the certified question as in any way speaking to the applicability of Alabama law outside the narrow context created by federal law in this case.
I must disagree with the implication that our answer is based on a motivation other than stating current Alabama law. Nothing in our answer suggests that this Court is trying to "correct" a "wrong" "with a second `wrong" or to "correct" "unfairness" created by the federal government. 159 So.3d at 685 (Murdock, J., dissenting). Although the members of this Court might respectfully disagree as to what Alabama tort law does or should require, our answer does nothing more than apply established Alabama decisions (which have not been challenged) to a difficult and unique factual and legal scenario.
I also respectfully reject the implication that our answer, applying as it does established Alabama tort law providing a remedy for fraudulent conduct, might "create a climate in which trade and business innovation" cannot flourish or that it prevents "Americans [from] work[ing] hard to produce
MOORE, Chief Justice (dissenting).
I respectfully dissent because I do not think that this Court should accept a certified question when critical facts are not before the Court.
I was not a member of this Court when the certified question from the United States District Court for the Middle District of Alabama was answered on original submission. However, I note that Danny Weeks and Vicki Weeks, the plaintiffs in the federal case, urged this Court at that time to decline to answer. Weekses' brief on original submission (hereinafter "Weekses' original brief"), at 8-13. One of the grounds urged was that "the answer would not be determinative of the cause, which is the purpose of certification." Id. at 13. I believe this suggestion points to the proper resolution of this application for rehearing.
The Alabama rule that provides for answering certified questions from the federal courts reads as follows:
Rule 18(a), Ala. R.App. P. (emphasis added). This Court consented to answer the certified question on October 17, 2011. However, that decision is subject to reconsideration. See Palmore v. First Unum, 841 So.2d 233 (Ala.2002) (declining to answer a certified question from a federal court that had erroneously been accepted).
Rule 18(a) allows a federal court to certify to this Court "questions or propositions of law of this State which are determinative of said cause," namely the proceeding pending before the federal court. In support of this requirement, the certifying court stated that "`[t]he question framed... is "determinative" of this case in the sense that a negative answer would require dismissal of the Weekses' claims against the brand-named defendants ....'" 159 So.3d at 654-55. The certifying court's statement omits any mention of whether a positive answer would also be determinative of the outcome of the case. If this Court's answer to the certified question is "no," the Weekses' claims must be dismissed for failure to state a claim. However, an answer of "yes," as proposed by the majority, will not be "determinative of said cause." In that event, the Weekses may proceed with their cause of action for misrepresentation, but the ultimate success of their claims will depend upon facts not before us. For example, if Danny Weeks's prescribing physician did not rely on the Reglan labeling when prescribing the drug, then the Weekses will have failed to prove causation and their claims will fail. According to the Weekses, neither
Additionally, as the Weekses stated in urging this Court to decline to answer the certified question, both Wyeth, Inc., and Schwarz Pharma, Inc., two of the three brand-name defendants,
Whether the federal-preemption defense will succeed is unknown, but its presence in the case renders an answer of "yes" to the certified question in determinative of the cause. As the Weekses have argued, the certified question "should not be decided because it raises a federal question better addressed by the federal court." Weekses' original brief, at 13. See Palmore, 841 So.2d at 235 (declining to answer a nondispositive certified question "lest our answer resemble an opinion on an abstract point of law irrelevant to the underlying case"). See also Stewart Title Guar. Co. v. Shelby Realty Holdings, LLC, 83 So.3d 469, 472 (Ala.2011) (holding that the "determinative of said cause" requirement of Rule 18(a) prohibits the Court from answering a certified question that "would necessitate our fashioning a broad rule with the possibility that it would have no application to the particular facts presented"); Harrison v. Jones, 880 F.2d 1279, 1283 n. 4 (11th Cir.1989) (refusing to certify a question of law to the Alabama Supreme Court because the question "would not be dispositive" and noting that under Rule 18(a) "questions certified must be determinative").
The problem of factual uncertainty is most likely to occur, as in this case, in the context of a question certified from a federal trial court. Because the question of law before us was certified after the denial of the defendants' motion to dismiss, factual development is still incomplete in the federal case.
In re Richards, 223 A.2d 827, 833 (Me. 1966) (construing Me.Rev.Stat. Ann., tit. 4, § 57). In this case, however, the facts have yet to be determined. See Hanchey v. Steighner, 549 P.2d 1310, 1310-11 (Wyo.
The United States Court of Appeals for the Fourth Circuit, considering certifying a question of state law to the Maryland Court of Appeals, addressed a situation somewhat like the one currently before this Court. If the state court answered "no" to the question, the case would be over, but if it answered "yes," "further proceedings would still be necessary in a federal tribunal and those proceedings might result in an adjudication which would render the certification and the opinion of the [state] court a futile, academic exercise with respect to final disposition of this case." Boyter v. Commissioner, 668 F.2d 1382, 1385 (4th Cir.1981). In those circumstances the Fourth Circuit declined to certify the question of law for determination by the Maryland Court of Appeals "unless and until it appears that the answer is dispositive of the federal litigation or is a necessary and inescapable ruling in the course of the litigation." Id. Similarly, in this case, we should decline to answer a question that may likely not be determinative of the federal case and thus fails to conform to the mandate of Rule 18 that creates our jurisdiction to answer such questions.
I also believe that imposing an industry-wide duty on brand-name manufacturers through the procedural mechanism of a certified question is unwise. I would far prefer to address this issue, if necessary, on a complete record following a final judgment in a state trial court that resolved all factual questions.
For the reasons stated above, I believe that this Court's acceptance of the certified question was in error and that we should decline to answer the certified question. Palmore.
PARKER, Justice (dissenting).
Congressional legislation and regulations of the Food and Drug Administration have created a maze this Court has to navigate to determine the effect of federal preemption on the bedrock legal principles of this State's jurisprudence. As Justice Murdock so comprehensively demonstrated in his dissenting opinion in this case, our legal principles of duty based on privity, see e.g., State Farm Fire and Casualty Co. v. Owen, 729 So.2d 834 (Ala.1998),
This Court's modification of its bedrock legal principles in view of federal legislation and regulations in one area could have grave and unforseen effects in other areas. To guard against this, it is incumbent upon
Nothing in federal legislation or regulations at issue here requires this Court to ignore, modify, or override our bedrock legal principles of duty and privity with regard to the originator of a pharmaceutical drug and a consumer who has not consumed a drug manufactured by the originator of the drug. PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), and Mutual Pharmaceutical Co. v. Bartlett, ___ U.S. ___, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013), have made clear that such a consumer is left without a remedy absent a legislative change by Congress. The United States Supreme Court addressed this implausible result when it stated:
PLIVA, 564 U.S. at ___, 131 S.Ct. at 2582.
Based on the foregoing, I respectfully dissent.
MURDOCK, Justice (dissenting).
There is no good outcome in this case. In fairness to the main opinion, this Court has been put in a position from which it cannot give an answer that yields a just result for both plaintiffs and defendants in cases such as this. My understanding of certain bedrock principles of tort law and of the economic realities underlying those principles, however, compels me to dissent and to explain fully my concerns.
From the beginning, what Alexander Hamilton referred to as "[t]he spirit of enterprise, which characterizes the commercial part of America,"
These dual needs have resulted in an economic and legal system that always has coupled the rewards from the sale of a good or service with the costs of tortious injury resulting from the same. Indeed, this and the corollary notion that parties
The path the Court takes today is in conflict with these notions. Impetus to take this path comes from a newfound and admittedly legitimate concern left in the wake of the United States Supreme Court's holding in PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), that state-law tort claims against manufacturers of generic drugs are preempted by federal law. The resulting concern is that, if manufacturers of brand-name drugs are not responsible under state law for injuries caused by defects in generic drugs and their related labeling, then no one will be.
To see our way clear to placing such responsibility upon brand-name manufacturers, however, we must distance ourselves from the foregoing notions. We must overlook a foundational element of tort law that these notions inform and in which they find voice: the necessity of a "duty" arising from a sufficient "relationship," or nexus, between the injured party and the defendant. We must focus on the role of "foreseeability" in the creation of a duty to the exclusion of "relationship." In doing so, this Court creates a precedent that poses danger for the prescription-medicine industry and, by extension, for all industry.
As discussed in Part II of this writing, almost every one of the 47 reported cases decided before the United States Supreme Court's decision in PLIVA, including cases decided by two United States Circuit Courts of Appeals, held that a manufacturer of a brand-name drug has no duty to the consumer of a generic drug manufactured and sold by another company. Since the Supreme Court's 2011 decision in PLIVA, every one of the two dozen cases that have addressed the issue, including decisions by six United States Circuit Courts of Appeals, has reached this same conclusion.
As these numbers indicate, the Supreme Court's holding in PLIVA — that state-law claims against generic-drug manufacturers are preempted by the federal regulatory scheme — did nothing to undermine the essential rationale in the plethora of pre- and post-PLIVA decisions holding that brand-name manufacturers are not liable for injuries caused by deficient labeling of generic drugs they neither manufactured nor sold. In fact, as discussed below, the opinion in PLIVA expressly says as much, and opinions in post-PLIVA cases are even more explicit in saying so.
It does indeed appear unfair — an "unfortunate hand" in the words of the United States Supreme Court — that a consumer harmed by a generic drug cannot seek compensation from the entity that manufactured and sold that drug. If this is unfair, however, it is an unfairness created by Congress and the Food and Drug Administration ("the FDA") in return for the perceived societal benefit of less expensive generic drugs, or perhaps instead by the manner in which the United States Supreme Court subsequently has applied the preemption doctrine to the legislative and regulatory scheme structured by those entities. It is not an unfairness created by the brand-name manufacturer. The just answer then, if there is to be one, must come from a change of federal policy or preemption jurisprudence. It is not to come from ignoring age-old, elemental precepts of tort law in order to impose liability on an entity with whom the plaintiff has no relationship, in regard to a product that that entity did not manufacture or sell.
"The concept of duty does not exist in a vacuum." State Farm Fire & Cas. Co. v. Owen, 729 So.2d 834, 839 (Ala.1998). It requires a sufficient "relationship," or nexus, between two or more parties. Id. The duty this Court recognizes today is one based solely on "foreseeability." Given the existing federal regulatory scheme, I agree that it is "foreseeable" — indeed, eminently so — that a generic version of a brand-name drug will be consumed in reliance upon labeling disseminated by the brand-name manufacturer for its brand-name drug. But this foreseeability alone is not enough to create a duty. There also must be a "relationship" or nexus between the parties.
For example, it might be foreseeable that one manufacturer would copy the design of an unpatented machine of some nature, which, unbeknownst to that manufacturer, was originally designed in a defective manner, and that a user of the copied device might be injured as a result of a replicated design defect. Nonetheless, the designer of the original machine did not manufacture or sell the copied machine. The law therefore recognizes the lack of any nexus between that designer and the injured party in relation to the machine that caused the injury and thus recognizes no duty on the part of that designer to the injured party.
The same principle applies to claims of misrepresentation and suppression. A viable claim depends upon the existence of a duty on the part of the defendant to the plaintiff. See, e.g., Nesbitt v. Frederick, 941 So.2d 950, 955 (Ala.2006) ("An essential element of fraudulent-misrepresentation and fraudulent-suppression claims is a duty to disclose.").
In Thompson-Hayward Chemical Co. v. Childress, 277 Ala. 285, 291-92, 169 So.2d 305, 312 (1964), the Alabama Supreme Court addressed a common-law claim alleging failure to warn of the dangerous nature of a herbicide:
In a case in which it was foreseeable to the owner of a power pole that a defective power line hanging from its pole could injure someone in the plaintiff's position, this Court held that the lack of any relationship between the owner of the power
DiBiasi v. Joe Wheeler Elec. Membership Corp., 988 So.2d 454, 461-62 (Ala.2008) (emphasis added; footnote omitted). See also, e.g., David G. Owen et al., Madden & Owen on Products Liability § 2:9 (3d ed. 2000) ("As is true in tort law generally, foreseeability, although necessary, is not in
Prescription-Drug Cases Decided Before PLIVA
In the leading case involving the question of liability on the part of the manufacturer of a brand-name drug for harm caused by deficient labeling of the generic version of the drug, the United States Court of Appeals for the Fourth Circuit recognized not only the necessity of a duty owed by the defendant to the plaintiff, but also that the source of that duty must be a relationship created by the plaintiff's consumption of the defendant's product. In Foster v. American Home Products Corp., 29 F.3d 165, 167 (4th Cir.1994), the Court expressly held that "a name brand manufacturer cannot be held liable on a negligent misrepresentation theory for injuries resulting from use of another manufacturer's product."
The plaintiffs attempt to discount Foster and other cases that reach the same conclusion. According to the plaintiffs, the opinions in those cases were based on the assumption that generic manufacturers were available to bear the liability for any deficiencies in the labeling that accompanies their products. Such an assumption, they note, is no longer viable in light of the Supreme Court's decision in PLIVA.
The issue of the generic manufacturer's liability, however, was not the issue in Foster and the dozens of similar cases decided before PLIVA. Although the courts in some of those cases might have taken some comfort in the availability of a generic manufacturer as a responsible party, the conclusion reached by the Foster court and other courts as to the lack of liability on the part of brand-name manufacturers for injuries caused by deficient labeling of generic drugs was not dependent upon that availability. Thus, after expressing in dicta its views as to the potential liability of generic manufacturers, the Foster court proceeded to explain separately as follows:
29 F.3d at 170 (emphasis added).
Furthermore, in a separate portion of its opinion, the court explains unequivocally, and without any reference to the prospects for liability on the part of the generic manufacturer, that a brand-name manufacturer simply has no "duty" to the consumer of a generic drug the brand-name manufacturer did not produce or distribute and that, therefore, the brand-name manufacturer cannot be liable under a negligent-misrepresentation theory:
29 F.3d at 171. The court then expressly rejects the same foreseeability argument urged upon us by the plaintiffs in this case, explaining that foreseeability alone is not enough to create a duty and that a relationship between the parties is necessary:
29 F.3d at 171 (emphasis added).
The United States Court of Appeals for the Eighth Circuit is the court from which the PLIVA case came and to which it was returned on remand by the United States Supreme Court. See Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir.2009), rev'd in part on other grounds sub nom., PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). Before the Supreme Court weighed in, the Eighth Circuit Court of Appeals held that state-law claims against generic-drug manufacturers were not preempted by federal law. 588 F.3d at 611. In the same opinion, however, that court was called upon to decide whether a brand-name manufacturer could be held liable for injuries caused by generic metoclopramide manufactured and sold by another party. In a soundly reasoned opinion, that court answered in the negative:
588 F.3d at 613-14 (some emphasis added; footnote omitted).
In a footnote, the Eighth Circuit also provided this instructive insight:
588 F.3d at 613 n. 9 (emphasis added).
Among the other pre-PLIVA decisions are four decisions from federal district courts in Alabama applying Alabama law: Mosley v. Wyeth, Inc., 719 F.Supp.2d 1340 (S.D.Ala.2010); Simpson v. Wyeth, Inc., No. 7:10-CV-01771-HGD (N.D.Ala. Dec. 9, 2010) (not reported in F.Supp.2d); Overton v. Wyeth, Inc., No. CA 10-0491-KD-C (S.D.Ala. Mar. 15, 2011) (not reported in F.Supp.2d); and Barnhill v. Teva Pharm. USA, Inc., No. 06-0282-CB-M (S.D.Ala. 2007) (not reported in F.Supp.2d). In all four of these cases, the court held that claims could not be maintained under Alabama law against the manufacturer of a brand-name drug for injuries resulting from a consumer's use of a generic version of that drug manufactured and sold by another company. The first of these, Mosley, is representative of the other Alabama federal district court decisions, as well as the other district court decisions identified above. As the federal district court in Mosley explained regarding precisely the same drug, the same defendants, and the same legal issue as are presented in the case at hand:
719 F.Supp.2d at 1344-45. The court rejected this argument because, under Alabama law, no "relationship" existed between the manufacturer of the brand-name drug and the consumer of the generic drug, and thus no "duty" was owed. 719 F.Supp.2d at 1346-47.
Contrary to the main opinion, but consistent with all the foregoing authority, Wyeth's argument does not "ignore the nature of prescription medication." 159 So.3d at 674. Obviously, a duty must be understood to run from a drug manufacturer to a consumer if that consumer is to be able to state a claim against the manufacturer. (If the duty ran only to an intermediary or other third party, such as a physician or pharmacist, then only the intermediary or third party would have a cause of action and be a proper plaintiff.) The controlled nature of prescription drugs, see 21 U.S.C. § 353(b)(1), simply means that the drug manufacturer fulfills its duty of disclosure to the consumer by making disclosures to the consumer's physician and/or pharmacist, who receives the disclosures and acts upon them on behalf of the consumer. In essence, the consumer's physician serves as the agent of the consumer for purposes of receipt of and reliance upon the disclosures, or omissions, of the manufacturer. See, e.g., Stone v. Smith, Kline & French Labs., 447 So.2d 1301, 1305 (Ala.1984) (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974)):
Wyeth's position fully accommodates the notion that a prescription drug is consumed only if it is prescribed by a physician and dispensed by a pharmacist, and that the physician and pharmacist act as agents of the consumer of a generic drug for purposes of receiving and acting upon whatever warnings and representations the drug's manufacturer intends for that consumer. The fact that there is such a "learned intermediary" acting in this manner on behalf of the ultimate consumer does not in itself create a relationship between the brand-name manufacturer and the consumer. Regardless of the fact of, or content of, a given prescription, if a person consumes a generic drug, the nexus created is with the manufacturer of the generic drug. The physician's involvement does nothing to create some sort of relationship between the consumer and some different entity. The consumer has no more relationship with the brand-name manufacturer in such a scenario than he or she would have if the learned intermediaries were not involved and the consumer purchased the generic drug directly from the generic manufacturer.
As the Eighth Circuit Court of Appeals indicated in Mensing, perhaps there is confusion resulting from the fact that, in prescribing or dispensing a generic drug, physicians or pharmacists might in fact rely upon labeling that previously was published by a brand-name manufacturer in conjunction with the marketing by it of its own brand-name drug. As that court also pointed out, however, the labeling of the brand-name manufacturer is not intended for that purpose; it is published by the brand-name manufacturer solely for the purpose of fulfilling the brand-name manufacturer's own duty to provide adequate labeling to the consumers of its product. To say that a physician's or pharmacist's reliance upon a brand-name manufacturer's labeling in prescribing or dispensing a generic drug makes the brand-name manufacturer liable for injuries suffered by the generic-drug consumer is to "bootstrap" into existence a duty on the part of
The present case is not distinguishable from the above-discussed cases on the ground that the present case involves common-law claims of fraud in relation to deficient labeling. Foster, the Eighth Circuit Court of Appeals' Mensing case, Alabama federal district court decisions such as Mosley, and dozens of other well considered decisions cited above involve alleged defects in labeling. Indeed, many, if not most, of them involve common-law claims of misrepresentation of some sort. They consider, and often explain, the necessity of a duty arising from a relationship as no less applicable to claims of defects in the warnings that accompany a product than to defects in the pharmacology of the product.
On June 23, 2011, the United States Supreme Court decided PLIVA. The Court held that state tort-law claims against manufacturers of generic drugs were preempted by the statutory and regulatory scheme that had been adopted by Congress and the FDA. 564 U.S. at ___, 131 S.Ct. at 2581-82. It is clear from the text of the PLIVA opinion itself that PLIVA did not undermine the rationale of the dozens of pre-PLIVA decisions discussed and cited above.
Foremost in this regard is the simple fact that the issue discussed in PLIVA was the effect of the federal law of preemption on the liability of generic manufacturers for their own drugs. Nothing in the Court's reasoning as to this issue has any bearing on the unrelated question under state law of relationship and duty of brand-name manufacturers with respect to drugs they do not manufacture.
Second, the PLIVA Court includes statements in the opinion that contemplate that its ruling as to generic manufacturers does not mean that consumers injured by generic drugs will now be able to turn to manufacturers of brand-name drugs for compensation. The Supreme Court expressly recognizes the "unfortunate hand" that has been dealt to consumers of generic drugs given its decision:
564 U.S. at ___, 131 S.Ct. at 2581-82. As Justice Sotomayor subsequently explained, under the majority decision, a consumer of a generic drug "now has no right to sue." 564 U.S. at ___, 131 S.Ct. at 2592 (Sotomayor, J., dissenting).
Moreover, the Supreme Court expressed its understanding that the consumption of the brand-name manufacturer's drug remained a prerequisite to holding that manufacturer liable for a labeling deficiency: "Had Mensing and Demahy taken Reglan, the brand-name drug ..., Wyeth [v. Levine,
Cases Decided in the Wake of PLIVA
In the year and a half after PLIVA was decided, but before this Court issued its opinion on original submission in this case, 11 decisions applying the law of 10 states were reported. Every one of those decisions held that manufacturers of brand-name drugs had no duty or liability to the consumer of a generic drug manufactured and sold by another company.
Perhaps the most noteworthy of the aforesaid three Court of Appeals' decisions was the short order issued on remand by the Eighth Circuit Court of Appeals in the PLIVA case itself. The same court whose judgment had just been reversed by the United States Supreme Court on the issue of preemption as to the liability of generic manufacturers evidently felt no compunction in deciding expressly to "reinstate Section III of [its original] opinion," the same section quoted at length above in which it had held that brand-name manufacturers were not liable for defects or deficiencies in the labeling of products manufactured and sold by others. Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011).
In Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir.2011), the United States Court of Appeals for the Sixth Circuit also acknowledged, but was unaffected by, the holding in PLIVA. The court began by noting the applicability of the Kentucky Products Liability Act, which, it explained, was merely a codification of preexisting common-law principles, including common-law principles regarding the misrepresentation and "failure-to-warn" claims asserted against the manufacturers of brand-name drugs in that case. 657 F.3d at 423.
657 F.3d at 423-24 (some emphasis added).
In the last of the aforesaid decisions by federal courts of appeals, the United States Court of Appeals for the Fifth Circuit explicitly held in Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 184 (5th Cir. 2012), that PLIVA changed nothing as to brand-name manufacturers:
In Phelps v. Wyeth, Inc., 857 F.Supp.2d 1114 (D.Or.2012), the federal district court for Oregon also explicitly rejected the notion that PLIVA changed anything as to brand-name manufacturers. In an opinion reflective of the other post-PLIVA decisions by federal district courts, it explained:
857 F.Supp.2d at 1119 (emphasis added).
The Oregon court provided an instructive analysis as to the necessity of a relationship in order for there to exist a duty for purposes of a common-law claim based on deficient labeling of drugs:
857 F.Supp.2d at 1120-21 (emphasis added).
Finally, the Oregon court expressed the same understanding of the text of the PLIVA decision that is offered above:
857 F.Supp.2d at 1119-20 (emphasis added).
In an opinion issued not long after PLIVA, a federal district court applied the law of our neighboring state of Florida:
Metz v. Wyeth LLC, 830 F.Supp.2d 1291, 1293-94 (M.D.Fla.2011) (emphasis added).
This Court's Opinion
In addition to dozens upon dozens of cases from other jurisdictions directly addressing the issue before us, Wyeth cites four Alabama cases for the proposition that a duty arising from a relationship or nexus between the parties is necessary: Keck v. Dryvit Systems, Inc., 830 So.2d 1 (Ala.2002); State Farm v. Owen, 729 So.2d 834 (Ala.1998); DiBiasi v. Joe Wheeler Electric Membership Corp., 988 So.2d 454 (Ala.2008); and Thompson-Hayward Chemical Co. v. Childress, 277 Ala. 285, 169 So.2d 305 (1964). The main opinion responds to these four cases by stating: "These cases are easily distinguishable from this case. Here, Wyeth authored the label with its warnings, and the generic manufacturers, as required by FDA regulations, copied that label verbatim." 159 So.3d at 675. The fact that the generic manufacturer's label must contain the same information as the label published by Wyeth, the name-brand manufacturer, is true, but that fact does not make the present case distinguishable from the four cases cited.
In each of those four cases, it was foreseeable that the plaintiff would be injured by the tortious conduct of the defendant. Despite this foreseeability, each of those cases was decided based on the fact that the alleged tortfeasor had no relationship or nexus with the plaintiff giving rise to a duty to the plaintiff.
Likewise, and admittedly without question given the federal regulatory scheme for generic drugs, it was foreseeable that a generic drug might one day be produced and that, if it was, it would replicate any deficiency in Wyeth's brand-name drug, including its labeling, that might have been approved by the FDA. As was true in each of those other cases, however, such foreseeability, no matter how clear, simply is not all that is required. There was no liability in those four cases because the defendant did not have the requisite relationship or nexus with the injured party. Because the same is true here, those cases
The main opinion concludes its analysis by quoting a passage from a 1998 opinion of the Court of Civil Appeals in Carter v. Chrysler Corp., 743 So.2d 456 (Ala.Civ. App.1998), which, in turn, quotes a 1994 decision of the Alabama Supreme Court, Hines v. Riverside Chevrolet-Olds, Inc., 655 So.2d 909, 919-20 (Ala.1994). As a threshold matter, I find the premise of the analysis quoted from Hines circular and confusing: "`"The extent of a legal duty not to make a false representation or to suppress a material fact informs our analysis of whether two parties have a sufficient relationship on which to base a duty to disclose."'" 159 So.3d at 675 (emphasis added). This passage essentially says that "the extent of a legal duty" will determine whether there is enough of a relationship on which "to base a duty."
Leaving aside the circularity of its premise, Hines does state that "the fact that two parties have had no contractual relationship or other dealings does not preclude the finding of a legal duty not to make a material misrepresentation or to suppress a material fact." 655 So.2d at 920. It adds, however, that "whether a duty to disclose exists must be determined by examining the particular facts of each case." Id.
Hines did not involve an attempt to hold a manufacturer liable for injuries where the plaintiff has not used a product manufactured or sold by the defendant. Instead, Hines is a classic "privity" case. The question presented and addressed in Hines is whether the lack of a contract or other direct dealing between the plaintiff and the defendant — lack of privity — prevents the plaintiff from suing the defendant to recover for personal, or bodily, injuries. It is critical to a proper prospective of the Hines decision to note that the injury litigated in that case resulted from the plaintiff's use of the defendant's product.
Carter v. Chrysler and the cases cited in Hines address the same question as did Hines.
Ultimately, the main opinion is inextricably grounded on a single notion: The foreseeability of a deficiency in a brand-name drug, including its labeling, being replicated in a generic drug, including its labeling, is so great that we must recognize a duty owing from the brand-name manufacturer to whomever might be hurt by the deficiency in the generic drug. But the clear foreseeability upon which this notion is based has either been explicitly acknowledged or clearly understood by each of the scores of other federal and state courts that have addressed the issue we now address. Yet, essentially all of them reach a different conclusion than do we. They do so on the same ground that Professor Prosser implores us to remember: Foreseeability alone is not enough. See discussion, infra, citing W. Prosser, Law of Torts, 708 (4th ed.1971). In the words of the main opinion, therefore, I can reach no conclusion other than that the "ground" we plow today is "new." And we are the only court in the nation plowing it.
A "Mountain of Authority" and an "Overwhelming National Consensus"
Aside from the discussion of the four cases and Hines reviewed above, the discussion and rationale offered by the main opinion today on application for rehearing are essentially unchanged from those offered in the opinion on original submission. Therefore, it is noteworthy that, since that original decision, there have been another dozen or more decisions on this issue by federal and state courts around the country, including decisions by four federal courts of appeals, two of them weighing in for the first time. In addition, the United States Supreme Court has now denied certiorari review in Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir.2012), cert. denied, ___ U.S. ___, 134 S.Ct. 57, 187 L.Ed.2d 25 (2013).
Among the courts that have not been persuaded by our original decision is the Court of Appeals for the Fifth Circuit, which has decided two additional cases reaffirming the sound rationale it first embraced in Demahy. See Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir.2014); Del Valle v. Teva Pharm. USA, Inc., 750 F.3d 470 (5th Cir.2014) (consolidated cases).
Likewise, the Court of Appeals for the Eighth Circuit has decided yet another case reaffirming its position. In Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir.2013), the Eighth Circuit held that, under Arkansas law, (i) the plaintiff's contention that
Recent appellate court decisions in Iowa are in accord. In Huck v. Trimark Physicians Group, 834 N.W.2d 82 (Iowa Ct.App. 2013) (unpublished disposition), the Iowa Court of Appeals reaffirmed the settled, common-law rule that "`a plaintiff in a products liability case must prove that the injury-causing product was a product manufactured or supplied by the defendant.'" (Quoting Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 76 (Iowa 1986).) Furthermore, much like decisions of this Court in the past, see, e.g., Pfizer, Inc. v. Farsian, 682 So.2d 405 (Ala.1996), the Huck court explained that plaintiffs who allege physical injuries caused by a product have, "regardless of the theory of liability" asserted, a products-liability claim that requires "product identification," a requirement that cannot be circumvented by pleading claims of "strict liability, negligence, misrepresentation, breach of warranties," and the like. See also note 31, supra.
Shortly before the release of the opinion in this case on rehearing, the Iowa Supreme Court vacated the decision of the Iowa Court of Appeals. It did so, however, in an opinion specifically rejecting this Court's opinion on original submission in the present case and agreeing with the Iowa Court of Appeals' position on the issue before us: "We adhere to [certain] bedrock principles ..., and join the multitude of courts that have concluded brand-name defendants owe no duty to consumers of generic drugs." Huck v. Wyeth, Inc., 850 N.W.2d 353, 380 (Iowa 2014) (also declining, in its words, "to step onto the slippery slope" that could lead to brand-name-manufacturer liability for harm caused by copies of other types of products manufactured by competitors).
Three of the federal courts of appeals that have addressed the issue since our opinion on original submission specifically acknowledge our decision. All three of them, the United States Courts of Appeals for the Sixth, Tenth, and Eleventh Circuits, rejected our reasoning. See Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378 (6th Cir.2013); Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir.2013); and Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013).
Specifically, in Schrock v. Wyeth, the Court of Appeals for the Tenth Circuit joined all the other federal courts of appeals that have addressed the issue by declining to "impose a duty on drug manufacturers to warn of dangers in their competitors' products" because the brand-name defendants "d[id] not have any relationship
This Court continues to stand alone as the only appellate court in the country to hold that a brand-name manufacturer may be responsible for injuries caused to a party who ingests a generic drug that the brand-name manufacturer did not manufacture or sell. According to Wyeth, over 90 cases (a figure that includes trial courts) have now been decided in 25 states, including every state that borders Alabama, the federal circuit court that encompasses Alabama, and all six federal courts of appeals to have considered the issue. With the exception of two or three federal district court decisions already identified, all of them disagree with the position taken by this Court.
If the cases that decide the issue differently than we do were not logical and well reasoned, if they were not based on time-tested, bedrock legal principles, or if they did not resolve all the alleged distinctions between prescription-drug cases and other types of cases that have been raised in the main opinion and in the special concurrence, then perhaps their sheer number would not matter. But they are all these things.
The Eleventh Circuit Court of Appeals has put it this way:
Guarino, 719 F.3d at 1252-53 (emphasis added).
The bedrock principles of tort law in this State are no different than the bedrock principles of tort law in every other state in this country, including the two dozen states whose laws have been considered in what the Eleventh Circuit call an "overwhelming national consensus." There is no reason for this State not to be part of that consensus.
One of the many amici curiae briefs supporting Wyeth asserts, with supporting authority:
Brief of amici curiae, The Chamber of Commerce of the United States of America and the Business Council of Alabama, at 20-24 (emphasis in original; some citations omitted).
Even proponents of the result urged by the plaintiffs admit that such a result is unfair to the brand-name manufacturers. See, e.g., Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers, 60 Duke L.J. 1123, 1181 (Feb.2011) (admitting that "[u]nder the [approach of the California appeals court in] Conte
Another concern is insurability:
Lars Noah, Adding Insult to Injury: Paying for Harms Caused by a Competitor's Copycat Product, 45 Tort Trial & Ins. Prac. L.J. 673, 695 n. 69 (2010).
All of these concerns are elevated by the realization that there will be no correlation between the brand-name manufacturer's continued participation in the marketplace with its own drug and its responsibility for generic drugs manufactured and sold by others. Under the rationale urged by the plaintiffs, and accepted by the majority of the Court today, a brand-name manufacturer's complete departure from the marketplace would offer no logical reason for terminating its responsibility for the deficiencies in the labeling associated with generic versions of its drugs that may be marketed indefinitely thereafter by its former competitors and perhaps even new entrants into the market.
Finally, and most troubling, I see no principled barrier to the extension of the "foreseeability" doctrine to deficient representations or design defects made by developers of other types of popular products copied by competitors. See, e.g., Huck v. Wyeth, supra. The line drawn today between the prescription-drug industry and all other industry exists only because we say it does; it will continue to exist only for so long as we say it does. There may be differences in the degree of foreseeability, but if foreseeability without relationship is to be the test, the line between the prescription-drug industry and other industry is arbitrary, and there is no principle to which this or other courts may anchor themselves in an effort to hold that line.
Again, however, even if somehow this Court could guarantee that the "foresee-ability" analysis embraced today never finds its way into cases involving other products or endeavors, either in this jurisdiction or in others, the potential deleterious effect on the prescription-drug industry
Demuth Dev. Corp. v. Merck & Co., 432 F.Supp. 990, 993-94 (E.D.N.Y.1977). We too should heed Professor Prosser's concerns.
The investment and innovation that over the past 50 years have resulted in the fastest pace of medical advances in human history have depended upon the incentives made available by America's free-market system. As they have for all types of products, the free-market system and the legal framework in which it has operated have coupled the risks and rewards of developing and distributing new medicines and, in so doing, have allowed entrepreneurs and innovators to assume both in corresponding measure. We now disrupt this critical dynamic.
It is not necessary here to grapple with this fundamental question. It is enough for present purposes to recognize that foreseeability alone is not enough to create a duty and that a relationship between the parties is essential.
In addition to Foster, the other pre-PLIVA cases holding that a manufacturer of a brand-name drug has no duty or liability to the consumer of a generic drug manufactured and sold by another company include Barnhill v. Teva Pharmaceuticals USA, Inc., No. 06-0282-CB-M (S.D.Ala. Apr. 24, 2007) (not reported in F.Supp.2d); Leblanc v. Wyeth, Inc., No. CIV A 04-0611 (W.D.La. Oct. 5, 2006) (not reported in F.Supp.2d); Goldych v. Eli Lilly & Co., No. 5:04-CV-1477 (GLS/GJD) (N.D.N.Y. July 19, 2006) (not reported in F.Supp.2d); Colacicco v. Apotex, Inc., 432 F.Supp.2d 514, 540-41 (E.D.Pa.2006), rev'd on other grounds, 521 F.3d 253 (3d Cir.2008), vacated and remanded, 556 U.S. 1101, 129 S.Ct. 1578, 173 L.Ed.2d 672 (2009); Possa v. Eli Lilly & Co., No. 05-1307-JJB-SCR (M.D.La. May 10, 2006) (not reported in F.Supp.2d); Stanley v. Wyeth, Inc., 991 So.2d 31, 34-35 (La.Ct.App.2008); and Flynn v. American Home Products Corp., 627 N.W.2d 342, 350 (Minn.Ct.App.2001).
In addition, according to briefs filed in this case, two Alabama circuit courts also have addressed the issue of liability for injuries allegedly caused by generic metoclopramide, both concluding that the brand-name manufacturer was not liable for injury caused by the generic drug manufactured and sold by another company. See Buchanan v. Wyeth Pharm., Inc., No. CV-2007-900065, Oct. 20 2008; Green v. Wyeth, Inc., No. CV-2006-3917, May 14, 2007.
Kurns v. Railroad Friction Prods. Corp., ___ U.S. ___, ___, 132 S.Ct. 1261, 1268, ___ L.Ed.2d ___ (2012) (emphasis added).
The indistinguishability of labeling and product is even clearer — and more tangible — in the case of prescription drugs. Prescription drugs are approved for sale by the FDA as safe and effective only for use as recommended in the approved labeling. As an amicus brief in another case recently explained:
Brief of the Generic Pharmaceutical Association as amicus curiae in support of the petitioner in Mutual Pharm. Co. v. Bartlett, No. 12-142, Jan. 22, 2013, p. 16 (appellate brief to United States Supreme Court 2013) (emphasis added). See also note 31, infra. Indeed, the United States Supreme Court in PLIVA itself treated the label and warnings that accompanied the drug as an integral part of the drug itself. Adequate warnings, or lack thereof, are an inseparable part of the product purchased and consumed by the plaintiff. (No one, for example, would contend that Tylenol brand acetaminophen sold to consumers as a pain remedy, but without any labels prescribing dosages or warning of the harmful side effects of taking more than the prescribed dosage would amount to the same product as Tylenol sold with a label prescribing a dosage of only two tablets every six hours and warning of harmful side effects if that dosage is exceeded.)
Even this Court has had occasion to express its understanding that the dosing instructions and the warnings of contraindications and side effects set out in a drug's label make the drug what it is. In Stone v. Smith, Kline & French Lab., 447 So.2d 1301, 1304 (Ala.1984), this Court analyzed a "failure to warn" as an aspect of products-liability law, and explained that "the adequacy of the accompanying warning determines whether the drug, as marketed, is defective, or reasonably dangerous."
Cases from jurisdictions decided under a legislatively, or in some cases judicially, crafted "products liability doctrine" that has supplanted or supplemented traditional common-law theories of recovery are entirely apposite to the question at hand. Such doctrines, as in Kentucky, invariably reflect common-law theories of recovery, including misrepresentation and suppression relating to labeling and warnings, and, like the common-law claims alleged here, also require the existence of a duty arising out of a sufficient nexus between the manufacturer and consumer in relation to the product consumed.
For the same reason, it is not necessary to address the issue whether the claims made by the plaintiffs in this case should be considered Alabama Extended Manufacturer's Liability Doctrine claims or may be considered conventional products-liability claims based on common-law theories of fraud and suppression. A duty arising from a relationship or nexus between the parties would be necessary in either case; none exists here.
As did the Oregon federal court in Phelps v. Wyeth, supra, the federal district court in Metz explained how the opinion in PLIVA itself reveals the Supreme Court's understanding that its decision in PLIVA changed nothing as to the lack of a duty on the part of brand-name manufacturers with respect to those injured as a result of deficient labeling of other manufacturers' products:
830 F.Supp.2d at 1294.
As for the persistent suggestion that this "mountain of authority" somehow addresses some issue or issues different than the issue this Court addresses today, I can do little more than once again point the reader to the discussion of and the quotations from so many of the cases that are part of that "mountain," as set out extensively on the several dozen pages that immediately precede this one. As already observed, beginning with Foster, most of this almost endless stream of precedents involves the exact issue addressed here, a claim of "fraud," "suppression," or "misrepresentation" in connection with a generic manufacturer's use of deficient labeling in the "pervasively" regulated prescription-drug industry. And, again, the fundamental legal principles employed in the analysis of this issue in these other cases are as elemental to the law of this State as they are to the law of the states discussed in those decisions.
Finally, although I think it clear enough from the discussion that both precedes and follows this footnote, let me be explicit in stating that any discussion of economic or other practical concerns found herein is not offered out of a perceived need to supplant or to supplement the case authority cited. It is but to further explain the reason and soundness of that authority and, to that end, the ramifications generally and in regard to the prescription-drug industry in particular of an abandonment of the fundamental legal principles that inform that authority.
See also Alissa J. Strong, "But He Told Me It was Safe!": The Expanding Tort of Negligent Representation, 40 U. Mem. L.Rev. 105, 142 (Fall 2009) (explaining that it is "not unreasonable to assume" that the Conte decision could be applied outside the drug context).