Weeks ended a long winning streak for brand-name manufacturers, with at least 68 decisions under the laws of 24 states rejecting efforts to impose liability on brand-name manufacturers under these circumstances. Prior to Weeks, only two other courts, an appeal court in California and a federal court in Vermont, had imposed liability on brand-name manufacturers when the plaintiffs took only the generic equivalent. See, Conte v. Wyeth, Inc. et al., 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299 (2008) and Kellogg v. Wyeth, et al., 762 F. Supp. 2d 694 (D. Vt. 2010). Now that the dust has settled, lawyers on both sides of this fight are asking whether Weeks will alter the calculus in what has been—up until now—an overwhelming winning record for brand-name manufacturers.
Lawyers for brand-name manufacturers dismiss Weeks as an outlier generated by a state court that lacked the will to issue a harsh but correct legal ruling. On the other hand, plaintiffs' lawyers will embrace the court's post-Mensing analysis and the creative approach that drove the Alabama court's decision. In this article, we analyze the Alabama Supreme Court's decision, the arguments now being offered by both sides in this ongoing litigation, and the implications for brand-name manufacturers who up until now have enjoyed protection from courts reluctant to stretch traditional state-law misrepresentation theories to hold manufacturers liable in this circumstance.
Understanding the Underpinnings of the Weeks Decision
Danny and Vicki Weeksfiled suit in the U.S. District Court for the Middle District of Alabama against three brand-name manufacturers and two generic manufacturers for injuries allegedly suffered as a result of long-term use of metoclopramide. Plaintiffs conceded that only a generic metoclopramide was ingested rather than Reglan. Nevertheless, they asserted that the brand-name manufacturers were liable based on traditional state law fraud, misrepresentation, and/or suppression theories of liability, contending that the brand-name defendants either misrepresented or failed to adequately warn plaintiff's physician about the risks of using Reglan, or its generic equivalent, on a long-term basis.
Specifically, the complaint alleged that the brand-name manufacturer Wyeth "falsely and deceptively misrepresented or knowingly suppressed facts about Reglan or metoclopramide such that Danny Weeks's physician, when he prescribed the drug to Danny, was materially misinformed and misled about the likelihood that the drug would cause the movement disorder tardive dyskinesia and related movement disorders." Plaintiffs alleged that the defendants had a duty to warn Danny's physician about the risks associated with the long-term use of metoclopramide and that the plaintiffs, as third parties, could enforce the alleged breach of that duty. Plaintiffs recently adopted this more refined "fraud on the prescribing physician" theory after courts rejected more technical misrepresentation theories that the plaintiffs were essentially "third party beneficiaries" of alleged misrepresentations made by brand-name manufacturers in their labeling and promotional materials.
Because no appellate court in Alabama had addressed innovator liability and because of a split among the federal district courts in Alabama, the district court agreed to certify the following question to the Supreme Court of Alabama:
Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?
The Supreme Court of Alabama, relying on the fact that generic substitutions are allowed in all 50 states and on the holding in Mensing that generic-drug manufacturers have a duty under federal law to keep the labels for their generic drugs exactly the same as the brand-name manufacturer's labels, held that under Alabama law a brand-name defendant could be held liable for fraud or misrepresentation, by misstatement or omission, even when the plaintiff claims an injury caused by the ingestion or use of a generic drug manufactured by a different company.
The court explained that the lack of a duty to warn by the brand-name manufacturer directly to the generic-using consumer is irrelevant because, under the learned intermediary doctrine, the manufacturer's duty to warn runs to the physician. Thus, if the warning to the physician is inadequate or misrepresents the risk, the court concluded that the brand-name manufacturer remains liable for the injuries sustained by the patient, even if the patient ultimately ingests a generic version of the drug, so long as the patient can show that, "but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient." On the crucial issue of foreseeability, the court said 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." Thus, the Supreme Court of Alabama concluded that:
[i]n the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug 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 by the generic manufacturer.
How the Alabama Supreme Court Tried to Dismiss Foster and Its Progeny
The Weeks court acknowledged that other jurisdictions, primarily relying on Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), had reached a different result on innovator liability. The court then attempted to distinguish Foster on three grounds. First, the court pointed out that the Foster court had, to some extent, relied on the finding that a generic manufacturer of a prescription drug is responsible for the accuracy of labels placed on its product. The Alabama court determined that finding was no longer valid after the Supreme Court's Mensing holding that a generic manufacturer's label must be identical to the brand-name label and that a generic manufacturer cannot unilaterally change its label to update a warning. Second, the Weeks court stated that the Fourth Circuit in Foster confused strict liability and tort law when it stated that there is no legal precedent for using a brand-name manufacturer's statements about its own product as a basis for liability for injuries caused by another manufacturer's products. According to the Weeks court, this reasoning would be sound only if the plaintiff brought a claim related to a manufacturer's production, design or manufacturing defect, but not for a claim based on failure to warn:
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.
Lastly, and perhaps most importantly, the Weeks court took a more expansive view than the Fourth Circuit on the all-important issues of foreseeability and corresponding duty. In Foster plaintiffs argued that the brand-name manufacturers owed a duty because it was foreseeable that misrepresentations regarding the drug at issue could result in personal injury to the users of the generic equivalent. The Fourth Circuit, interpreting Maryland law, disagreed and concluded that to impose a duty in that instance would "stretch the concept of foreseeability too far" since there was no relationship between the plaintiff who was injured and the product about which the allegedly inadequate warnings had been given. The Weeks court had no problem making that leap, stating:
"…[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 the 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."
Other Courts, Post-Mensing, Reach a Different Conclusion
The Weeks court stated that Mensing undermined prior decisions that had rejected brand-manufacturer liability, including Foster and several Alabama federal decisions. The Alabama Supreme Court seized on language in Foster, and cases following it, suggesting the plaintiffs had a valid failure to warn claim against generic manufacturers who could have changed their label, sought FDA permission to do so, sent Dear Doctor letters or withdrawn the product from the market when information became available about increased risks of adverse reactions. The Weeks court reasoned that Mensing completely shut that door and left generic manufacturers with no options regarding the label. Plaintiffs' lawyers are sure to adopt this same theme and will argue that Mensing changed the analysis by clarifying that generic manufacturers cannot, because of conflicting FDA regulations, change their labels or communications with doctors.
However, the Weeks court failed to mention that every other post-Mensing court to have considered such a contention—including the Fifth, Sixth and Eighth Circuits—held that Mensing does not change the state-law principles that require dismissal of claims brought against brand-name defendants by plaintiffs who ingested only generic products manufactured by brand-name defendants' competitors. That is because Mensing addressed a purely federal-law question—specifically, whether (under the Supremacy Clause of the United States Constitution) federal regulations applicable to generic drug manufacturers preempt certain state-law failure-to-warn claims against those manufacturers. See Mensing at131. The Supreme Court held that they do. Id. However, Mensing does not—indeed, under basic principles of federalism, could not—alter the statutory or common-law requirements for stating a state law tort claim. As the Supreme Court stated in Erie Railroad v. Tompkins, 304 U.S. 64 (1938), "Congress has no power to declare substantive rules of common law applicable in a state … be they commercial law or a part of the law of torts. And no clause in the Constitution purports to confer such a power upon the federal courts." Id. at 78.
Recognizing these federalism principles, the Sixth Circuit in Smith v. Wyeth, 657 F.3d 420 (6th Cir. 2011), upheld the grant of summary judgment for brand-name defendants under Kentucky law based on the fact that they did not manufacture the generic metoclopramide the plaintiffs ingested. It reached that result after considering supplemental briefing on the effect of Mensing.
Other post-Mensing courts have agreed with the Sixth Circuit's opinion in Smith. First, in Mensing itself, following remand from the Supreme Court, the clerk of the Eighth Circuit mistakenly vacated the court's earlier judgment in its entirety. See Order Reversing and Reopening Judgment, Mensing v. Wyeth, Inc., No. 08-3850 (8th Cir. Aug. 18, 2011), ECF No. 3819768. After considering brand-name defendants' motion to reinstate, however, the court agreed that the Supreme Court's opinion in Mensing did not affect the part of the court's opinion that rejected brand-name manufacturer liability under Minnesota law. Accordingly, the court reinstated the section of its opinion (Section III) affirming judgment in favor of the brand-name manufacturers. See Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011). Then, in Demahy v. Schwarz Pharma, Inc., the Fifth Circuit affirmed judgment for brand-name defendants in a generic-ingestion case and holding that "the Supreme Court's decision in Mensing had no effect on Louisiana state law." 2012 WL 6698692, at *4. The court further observed that, even though "[t]he Foster court's opinion in dicta on the viability of suits against generic manufacturers was proved wrong [by Mensing], … this fact does not impose on name-brand manufacturers a duty of care to customers using generic products." Id.
Thereafter, at least eleven lower courts have rejected the argument that Mensing alters state law so as to authorize claims by plaintiffs against brand-name manufacturers. See Hogue v. Pfizer, 2012 WL 4466609, at *5; Phares v. Actavis-Elizabeth LLC, 2012 WL 3779227, at *10; Phelps v. Wyeth, Inc., 857 F. Supp. 2d at 1119-21; Guarino v. Wyeth LLC, 2012 WL 1138631, at *2; Fullington v. PLIVA, Inc., 2011 WL 6153608, at *3-*6 (E.D. Ark. Dec. 12, 2011); Metz v. Wyeth LLC, 830 F. Supp. 2d at 1295; Morris v. Wyeth, Inc., No. 3:09-cv-854, 2011 WL 4975317, at *2-*3 (W.D. La. Oct. 19, 2011); Gross v. Pfizer, Inc., No. 10-CV-00110, 2011 WL 4005266, at *2 (D. Md. Sept. 7, 2011); Coundouris v. Wyeth, 2012 WL 2401776, at *2-*3; Huck v. Trimark Physicians Grp., No. LACV018947, slip op. at 2 (Iowa Dist. Ct. Jan. 9, 2012); Dietrich v. Wyeth, Inc., 2009 WL 4924722 (Fla. Cir. Ct. Dec. 21, 2009).
The Weeks court's failure to address any of the post-Mensing decisions that rejected brand-name liability in this situation is a major failing by that court. This alone substantially weakens the Weeks decision.
Weeks Construes the Tort Law of Alabama; May Be Limited in Application
The good news for brand-name manufacturers is that Weeks is firmly based on Alabama tort law, and is therefore potentially limited to cases in that state. The Weeks court began its analysis by reviewing the products-liability law of Alabama and distinguished products-liability claims from those based on fraudulent suppression or misrepresentation. The former are governed by the judicially-created doctrine known as the Alabama Extended Manufacturer's Liability Doctrine (AEMLD) which imposes liability for damage or injuries caused by allegedly defective products. The Weeks court explained that the AEMLD does not subsume common-law tort actions like fraudulent suppression and stated that a fraudulent misrepresentation action is governed by Ala. Code §6-5-101 (1975), which is not specific to product actions. Weeks at 6. The elements of fraud under that section are (1) a false statement, (2) concerning a material fact, (3) relied upon by the plaintiff, and (4) who was damaged as a proximate result. The court also noted that an essential element of this cause of action and fraudulent suppression is a duty to disclose. In moving toward a traditional fraud theory, the Weeks court also relied on an Alabama commercial fraud case that had permitted a third party to recover under a fraud theory even though the misrepresentation was not made directly to the plaintiff. See Delta Health Group, Inc. v. Stafford, 887 So.2d 887 (Ala. 2004). By moving the discussion away from traditional products liability law, the Weeks court sought to avoid traditional notions that a manufacturer is only liable for damages and injuries caused by its product, and not by another's product.
In rebuttal, defense lawyers will be quick to point out that many states have broad products liability statutes or judicially-created doctrines that govern all suits based upon products. There are at least 21 other cases in which courts have applied other states' product-liability acts to dispose of claims analogous to the claims in Weeks. See, e.g., Smith, 657 F.3d at 23-24; Washington v. Medicis Pharms. Corp., No. 3:12-cv-126, slip op. at 3-4 (S.D. Miss. Feb. 7, 2013); Bell v. Pfizer Inc., No. 5:10-CV-00101, 2011 WL 904161, at *2-*4 (E.D. Ark. Mar. 16, 2011); Cooper v. Wyeth, Inc., No. 09-CV-929, 2010 WL 4318816, at *1-*3 (M.D. La. Oct. 26, 2010); Fullington v. Pfizer, Inc., No. 4:10-CV-00236, 2010 WL 3632747, at *1-*3 (E.D. Ark. Sept. 17, 2010); Johnson v. Teva Pharm. USA, Inc., No. 2:10-cv-404, 2010 WL 3271934, at *2-*3 (W.D. La. Aug. 16, 2010); Neal v. Teva Pharm. USA, Inc., No. 09-CV-1027, 2010 WL 2640170, at *2 (W.D. Ark. July 1, 2010); Craig v. Pfizer, Inc., No. 3:10-00227, 2010 WL 2649545, at *2-*4 (W.D. La. May 26, 2010), report and recommendation adopted by 2010 WL 2649544 (W.D. La. June 29, 2010); Phelps v. Wyeth, Inc., No. 09-6168, 2010 WL 2553619, at *2-*3 (D. Or. May 28, 2010), findings and recommendation adopted by 2010 WL 2553614, at *1 (D. Or. June 21, 2010); Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616, 619-21(E.D. Tex. 2010); Couick v. Wyeth, Inc., 691 F. Supp. 2d 643, 645-46 (W.D.N.C. 2010); Morris v. Wyeth, Inc., No. 09-0854, 2009 WL 4064103, at *4-*6 (W.D. La. Nov. 23, 2009); Burke v. Wyeth, Inc., No. G-09-82, 2009 WL 3698480, at *2-*3 (S.D. Tex. Oct. 29, 2009); Stoddard v. Wyeth, Inc., 630 F. Supp. 2d 631, 633-34 (E.D.N.C. 2009); Fields v. Wyeth, Inc., 613 F. Supp. 2d 1056, 1060-61 (W.D. Ark. 2009); Smith v. Wyeth, Inc., No. 5:07-CV-18, 2008 WL 2677051, at *3-*4 (W.D. Ky. June 30, 2008), aff'd 657 F.3d 420 (6th Cir. 2011); Wilson v. Wyeth, Inc., No. 3:07-CV-378, 2008 WL 2677049, at *3-*4 (W.D. Ky. June 30, 2008), aff'd 657 F.3d 420 (6th Cir. 2011); Morris v. Wyeth, Inc., No. 1:07-CV-176, 2008 WL 2677048, at *3-*4 (W.D. Ky. June 30, 2008), aff'd 657 F.3d 420 (6th Cir. 2011); Pustejovsky v. Wyeth, Inc., No. 4:07-CV-103, 2008 WL 314902, at *2 (N.D. Tex. Apr. 3, 2008); Leblanc v. Wyeth, Inc., No. 04-cv-0611, 2006 WL 2883030, at *4-*6 (W.D. La. Oct. 5, 2006); Tarver v. Wyeth, Inc., No. 3-04-2036, 2006 WL 1517546, at *2-*3 (W.D. La. Jan. 26, 2006); Tarver v. Wyeth, Inc., No. 3-04-2036, 2005 WL 4052382, at *2-*3 (W.D. La. June 7, 2005); Sloan v. Wyeth, No. MRSL-1183-04, 2004 WL 5767103 (N.J. Super. Ct. Oct. 13, 2004). To the extent these and other states have strong, exclusive products liability laws, the holding in Weeks will be marginalized.
It remains to be seen what effect Weeks will have on the ongoing assault on brand-name manufacturers. The most likely result is that Weeks will be limited in application to Alabama, but the decision is definitely a new arrow in the quiver for a host of plaintiff's lawyers who have not given up the fight.
Keywords: litigation, products liability, innovator liability, Mensing, Weeks, preemption, generic drugs, brand-name drugs, manufacturers