Tinа JOHNSON, Plaintiff-Appellant v. TEVA PHARMACEUTICALS USA, INCORPORATED; Qualitest Pharmaceuticals, Incorporated; Wyeth, L.L.C.; Schwarz Pharma, Incorporated; Alaven Pharmaceutical, L.L.C.; Generics Bidco I, L.L.C., doing business as Qualitest Pharmaceuticals, Incorporated, Defendants-Appellees.
No. 12-31011.
United States Court of Appeals, Fifth Circuit.
July 11, 2014.
758 F.3d 605
v.
TEVA PHARMACEUTICALS USA, INCORPORATED; Qualitest Pharmaceuticals, Incorporated; Wyeth, L.L.C.; Schwarz Pharma, Incorporated;
No. 12-31011.
United States Court of Appeals, Fifth Circuit.
July 11, 2014.
David Michael Gold, Esq., Attorney, Christopher Joseph Aubert, Esq., Aubert Law Firm, Covington, LA, Richard Anthony Oetheimer, Esq. (argued), Goodwin Procter, L.L.P., Boston, MA, Jonathan I. Price, Goodwin Procter, L.L.P., New York, N.Y., William F. Sheehan, Esq., Attorney, Goodwin Procter, L.L.P., Washington, DC, Stanton E. Shuler, Jr., Esq., Lauren Fajoni Bartlett, Attorney, Leake & Andersson, L.L.P., New Orleans, LA, Tammara N. Tukloff, Morris Polich & Purdy, L.L.P., San Diego, CA, Kannan K. Shanmugam (argued), Williams & Connolly, L.L.P., Washington, DC, David Michael Melancon, Esq., Irwin Fritchie Urquhart & Moore, L.L.C., New Orleans, LA, Henninger Simons Bullock, Mayer Brown, L.L.P., New York, N.Y., Andrew Jonathan Calica, Attorney, Mayer Brown, L.L.P., New York, N.Y., Megan Haggerty Guy, Gregory Fortier Rouchell, Adams & Reese, L.L.P., New Orleans, LA, Mark Cheffo, Quinn Emanuel Urquhart & Sullivan, LLP., New York, N.Y., for Defendants-Appellees.
Before SMITH, DENNIS, and HIGGINSON, Circuit Judges.
HIGGINSON, Circuit Judge:
Tina Johnson filed this products liability suit against generic and brand-name manufаcturers of the prescription drug metoclopramide. Johnson alleges that her long-term use of generic metoclopramide caused her to develop a neurological disorder known as tardive dyskinesia, and that manufacturers provided misleading and inadequate warnings as to the risks associated with long-term use of the drug. The district court dismissed Johnson‘s claims against the brand-name manufacturers under Rule 12(b)(6), granted judgment on the pleadings for the generic manufacturers under Rule 12(c), and denied Johnson leave to amend her complaint. Because all of Johnson‘s claims are either preemptеd
I. Background
Metoclopramide is a prescription drug approved by the Food and Drug Administration (“FDA“) and available in both brand (“Reglan“) and generic formulations. From July 2002 until March 2009, Johnson consumed generic metoclopramide to treat digestive problems. In prescribing metoclopramide, Johnson‘s physicians relied on the drug‘s warning labels, including the information contained in the drug‘s package inserts and the Physicians’ Desk Reference. Johnson alleges that, as a result of her long-term use of generic metoclоpramide, she developed tardive dyskinesia.
In March 2010, Johnson filed this suit against generic and brand-name manufacturers of metoclopramide, including Teva Pharmaceuticals, USA, Inc.; Qualitest Pharmaceuticals, Inc.; and Generics Bidco I, LLC (“Generic Defendants“), and also Wyeth, LLC; Schwarz Pharma, Inc.; and Alaven Pharmaceuticals, LLC (“Brand Defendants“). Johnson alleges that both Generic and Brand Defendants provided inadequate, misleading, and false warnings as to risks associated with long-term use of the drug. Johnson brought claims against Generic Defendants under the
The district court granted Brand Defendants’ motion to dismiss under
II. Claims Against Generic Defendants
On appeal, Johnson contends that the district court erred in granting Generic Defendants’
We review a district court‘s ruling on a
a. Failure-to-Warn Claims
In her original complaint, Johnson brought a claim against Generic Defen-
In Mensing, the Supreme Court held a similar failure-to-warn claim against generic manufacturers of metoclopramide preempted by federal law. Mensing, 131 S.Ct. at 2572. The Court reasoned that federal lаw demands that “generic drug labels be the same at all times as the corresponding brand-name drug labels.” Id. at 2578. This is known as the “duty of sameness.” Id. at 2576. “This duty of sameness is overlaid with the agency‘s pronouncement that ‘Dear Doctor’ letters (or other forms of warnings) from a generic manufacturer constitute labeling.” Lashley v. Pfizer, Inc., 750 F.3d 470, 474 (5th Cir.2014). Because federal law requires generic drug labels to be the same as brand-name labels, any state-law duty that requires generic manufacturers to use safer labels conflicts with the federal “duty of sameness” and is preempted by federal law. Mensing, 131 S.Ct. at 2577, 2578 (“Where state and federal law ‘directly conflict,’ state law must give way.“); Morris v. PLIVA, Inc., 713 F.3d 774, 776-77 (5th Cir.2013) (“Whether a warning is placed on the label on the bottle or in letters to distributors, any state law duty requiring generic manufacturers to act unilaterally in this area is preempted by federal law.“); see also Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 678 (5th Cir.2014); Lashley, 750 F.3d at 474.
The crux of Johnson‘s failure-to-warn claim alleged in her original complaint appears to be that the warnings accompanying generic metoclopramide were inadequate and that Generic Defendants should have provided stronger warning labels. Because Generic Defendants were unable to provide stronger warnings as a matter of federal law, Johnson‘s failure-to-warn claim is preempted. See Mensing, 131 S.Ct. at 2578. Acсordingly, the district court did not err in granting Generic Defendants’ motion for judgment on the pleadings for this claim.
Johnson also requested leave to amend her complaint to add two additional failure-to-warn claims. First, Johnson requested leave to add a claim alleging that Generic Defendants failed to adequately communicate the information contained in the FDA-approved label. In 2004, the FDA approved a label change to warn that “[t]herapy should not exceed 12 weeks in duration.” Mensing, 131 S.Ct. at 2572. Johnson alleges that Generic Defendants are liable for failing to send “Dear Doctor” letters or similar communications to alert medical providers to the 2004 label change. This claim is controlled by Morris and Lashley, in which we held nearly identical claims preempted by federal law. See Morris, 713 F.3d at 777; Lashley, 750 F.3d at 474-75. In Morris, we wrote:
Mensing forecloses such claims because failure to “communicate” extends beyond just a label change. To avoid liability, the manufacturer must take affirmative steps to alert consumers, doctors, or pharmacists of changes in the drug label. Because the duty of sameness prohibits the generic manufacturers from taking such action unilaterally, they are dependent on brand-names taking the lead. Under federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not whether the proposed warning to be disseminated contains substantially similar information as the label. Because no brand-name manufacturer sent a warning based on the 2004 label change, the
generic manufacturers were not at liberty to do so. As Mensing concluded, preemption is thus triggered since it would be impossible for [the generic manufacturer] to comply with both the state law duty to warn and the federal law duty of sameness.
Morris, 713 F.3d at 777 (internal citations omitted).
In this case, Johnson acknowledges that no brand-name manufacturer sent a warning based on the 2004 label change. Accordingly, Generic Defendants were not at liberty to do so. See id.; Lashley, 750 F.3d at 474-75; see also Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir.2013). But see Teva Pharm. USA, Inc. v. Superior Court, 217 Cal.App.4th 96, 158 Cal.Rptr.3d 150, 161–64 (2013). Following controlling рrecedent, we conclude that Johnson‘s proposed claim is preempted by federal law, and the district court did not abuse its discretion in denying Johnson leave to add this claim.
Second, Johnson requested leave to add a claim alleging that generic manufacturer Teva failed to incorporate the 2004 label change into its label until 2005. This claim is also controlled by Morris. See Morris, 713 F.3d at 777; see also Lashley, 750 F.3d at 475. In Morris, we observed that “it is logically incoherent to conclude that [the generic manufacturer] had a duty to apply the 2004 warning label when Appellants also assert repeatedly that no labels predating 2009 were adequatе. Tort liability does not arise for failure to attach an inadequate label.” Morris, 713 F.3d at 777. We further concluded that “a claim that [the generic manufacturer] breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted.” Id. In light of Morris, we hold that the district court did not abuse its discretion in denying Johnson leave to add this claim.1
b. Design-Defect Claim
In her original complaint, Johnson also brought a claim against Generic Defendants for design defect under
(1) There existed an alternative design for the product that was capable of preventing the claimant‘s damage; and (2) The likelihood that the product‘s design would cause the claimant‘s damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product.
For the reasons articulated in Bartlett, Johnson‘s design-defect claim is preempt-
Johnson contends that her design-defect claim is not preempted because Generic Defendants could have complied with their duties under both federal and state law by declining to sell metoclopramide. The Supreme Court rejected this “stop-selling” rationale in Bartlett as “incompatible with our pre-emption jurisprudence.” Bartlett, 133 S.Ct. at 2477. “Our pre-emption cases presume that an actor seeking to satisfy both his federal and state-law obligations is not required to cease acting altogether in order to avoid liability.” Id.
Johnson further contends that her design-defect claim is distinguishable from those that сourts have previously found preempted because Louisiana law allows liability for a design defect under the theory that there exists a safer alternative product, not just a safer alternative design. Even assuming this to be the case, Johnson‘s argument does not save her claim. Johnson did not allege the existence of a safer product in her complaint. Nor did Johnson move to amend on this ground.
For the reasons above, the district court did not err in finding that Johnson‘s design-defect claim, as alleged in her complaint, is preempted by federal law. The district court properly granted judgment on the pleаdings for Generic Defendants on this claim.
c. Express-Warranty Claim
Finally, Johnson brought a claim against Generic Defendants for breach of express warranty under
III. Claims Against Brand Defendants
Johnson next contends that the district court erred in dismissing her claims against Brand Defendаnts under
In dismissing Johnson‘s claims, the district court reasoned that the LPLA provides the exclusive remedy against manufacturers in products liability suits under Louisiana law, and that Johnson could not maintain claims against Brand Defendants under the LPLA because Brand Defendants did not manufacture the generic metoclopramide that caused Johnson‘s injuries. The district court further reasoned that Johnson‘s claims also fail because “brand name drug manufacturers do not owe a continuing duty to consumers of the generic drug equivalent.”
“We review a district court‘s decision on a
As a preliminary matter, Johnson moves to certify to the Louisiana Supreme Court the question of whether a brand-namе manufacturer can be held liable for injuries caused by a plaintiff‘s ingestion of a generic product that was neither manufactured nor distributed by the brand-name manufacturer. We may certify a determinative question of Louisiana law to the Louisiana Supreme Court if there is “no clear controlling precedent” of that court.
We conclude that certification is not warranted in this case. Our conclusion is informed by a number of considerations, including this court‘s prior decision 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); the numerous other decisions interpreting Louisiana law on this subject;2 Johnson‘s
Turning to the merits of Jоhnson‘s appeal, our prior decision in Demahy resolves Johnson‘s claims against Brand Defendants. In Demahy, we addressed nearly identical claims brought by a consumer of generic metoclopramide against brand-name manufacturers, including claims for misrepresentation, fraud, and violation of LUTPA. Demahy, 702 F.3d at 180-81. Demahy appealed the district court‘s denial of her Rule 59(e) motion for relief from the district court‘s dismissal of her claims against the brand-name manufacturers in light of the Supreme Court‘s decision in Mensing. Id. at 182. We affirmed the district court‘s ruling. In doing so, we reasoned that prior to Mensing, Louisiana law did not provide liability against brand-name manufacturers for injuries caused by a plaintiff‘s ingestion of a genеric product, and that nothing in Mensing altered this conclusion. Id. at 182-84. We wrote:
The
Louisiana Products Liability Act (“LPLA“) provides that it is the exclusive remedy for products liability suits, stating that “[a] claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability that is not set forth in this Chapter.”La.Rev.Stat. Ann. § 9:2800.52 . Under the LPLA, recovery is not available against a manufacturer if the manufacturer did not produce the offending product. Thus, according to pre-Mensing Louisiana caselaw, Demahy‘s claims against [the brand-name manufacturers] fail because they did not manufacture the medication she actually consumed.
Id. at 182-83 (internal quotation marks and citations omitted). We furthеr explained that “the Supreme Court‘s decision in Mensing had no effect on Louisiana state law.” Id. at 184.
Following Demahy, we conclude that Johnson‘s claims against Brand Defendants are foreclosed by the LPLA. Brand Defendants, like the brand-name manufacturers in Demahy, are “manufacturers” within the LPLA‘s exclusivity provision. See
Also consistent with Demahy, we conclude that, even if the LPLA did not apply, Johnson has not established that Brand Defendants owed Johnson a duty of care. See Demahy, 702 F.3d at 183 n. 4 (“[E]ven if the LPLA did not apply, Demahy‘s tort claims would fail since [the brand-name manufacturers] did not manufacture the generic product giving rise to Demahy‘s claims, and thus owed Demahy no duty of care.“); Stanley, 991 So.2d at 34-35 (“[A] name brand drug manufacturer owes no legal duty to the consumer of a generic equivalent of its drug.“); Fricke v. Owens-Corning Fiberglas Corp., 618 So.2d 473, 475 (La.Ct.App.1993); see also Solomon v. Walgreen Co., 975 F.2d 1086, 1089 (5th Cir.1992) (“This court is Erie-bound to apply state law as it currently exists, and may not change that law or adopt innovative theories of recovery.“). Thus, to the extent that Johnson‘s claims rely on a duty of care, these claims fail for an additional reason as well.3
Accordingly, we perceive no error in the district court‘s dismissal of Johnson‘s claims against Brand Defendants.
IV. Conclusion
For the foregoing reasons, we AFFIRM the district court‘s grant of Generic Defendants’ motion for judgment on the pleadings, grant of Brand Defendants’ motion to dismiss, and denial of leave to amend. We further DENY Johnson‘s motion for certification.
AFFIRMED.
JAMES L. DENNIS, Circuit Judge, concurring in part, dissenting in part:
Although I concur in the majority opinion‘s disposition of Plaintiff-Appellant Tina
The Louisiana Supreme Court has never addressed the extent of brand-name manufacturers’ liability to consumers of the generic equivalents. There is only one Louisiana Court of Appeals case on point and it‘s questionable whether its reasoning stands today. In Stanley v. Wyeth, Inc., 991 So.2d 31 (La.App. 1st Cir.2008), the Court of Appeal of Louisiana, First Circuit, held that the plaintiff failed to state а claim against the brand-name manufacturers for negligent misrepresentation because brand defendants do not owe a duty to consumers of the generic equivalent. Id. at 33. In holding that brand-name defendants owe no duty to consumers of the generic equivalent, the Stanley court reasoned that “a manufacturer cannot reasonably expect that consumers will rely on the information it provides when actually ingesting another company‘s drug.” Id. at 34. The court in Stanley therefore based its holding on pre-Mensing assumptions: that consumers of generic drugs do not rely upon the brand-name manufacturer‘s representations or warnings as to the risks of harm to consumers, and that a generic mаnufacturer‘s “acceptance” of the brand-name manufacturer‘s label, is something of a choice. Id. Such reasoning is belied by Mensing‘s holding that, under federal law, a generic manufacturer‘s label and communications must be the same as the brand-name equivalent, and the generic manufacturer is prohibited from unilaterally communicating to consumers any message different than that communicated by the brand name manufacturer. Thus, it is perfectly foreseeable, if not inevitable, that, post-Mensing, consumers of generic drugs and their physicians will rely exclusively upon the brand-name manufacturer‘s label to assess the safety risks of the generiс drug equivalent. Mensing thus calls Stanley—the sole Louisiana Court of Appeal decision on this issue—into ques-
Without any authoritative guidance from Louisiana courts, the majority‘s opinion completely closes the courthouse doors to Louisiana consumers injured by inadequately labeled generic pharmaceutical products. By declining to certify thе question to the Louisiana Supreme Court and affirming the district court‘s decision below, both generic and brand-name pharmaceutical companies are essentially immunized from private suits by consumers of generic drugs, who make up an overwhelming majority of pharmaceutical consumers. Today, “nearly 8 in 10 of prescriptions are filled with generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015.” See Facts About Generic Drugs, U.S. FOOD AND DRUG ADMINISTRATION, http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm (last visited July 9, 2014). Thе threat of private suits for damages provides substantial incentives to pharmaceutical manufacturers to effectively warn consumers of the safety risks associated with consumption of their products. The majority eviscerates this incentive for brand-name manufacturers, who control the content of the warning labels and communications to the public for both brand and generic drug equivalents, and thus will have “tremendous consequences” for the health and safety of consumers of pharmaceutical products in Louisiana. Jesco, 278 F.3d at 448.
Tort claims against the manufacturer of drugs that allegedly inadequately warn the consumer as to potential risks are common. Given the nature of the parties involved, ---Louisiana has many consumers of generic drugs but is home to few, if any, drug manufacturers—cases raising this issue will invariably be litigated in federal court, pursuant to diversity jurisdiction. See
Lastly, as Johnson notes in her motion to certify, an identical question was recently certified to the Alabama Supreme Court by the United States District Court for the Middle District of Alabama. Despite federal precedent interpreting Alabama law
In conclusion, because there is no precedent from the Louisiana Supreme Court on this case-dispositive issue, the prior Louisiana case law is based on reasoning now undermined by Mensing, and the question implicates significant public policy concerns with potentially severe ramifications for the people of Louisiana, I respectfully dissent from the majority opinion‘s resolution of Johnson‘s claims against the brand-name manufacturers and would grant Johnson‘s motion to certify the questiоn to the Louisiana Supreme Court.
Brenda TOLBERT; Joseph Rice Neuhaus, Jr.; and Lawrence Gift, Jr., Plaintiffs-Appellants,
v.
RBC CAPITAL MARKETS CORPORATION, now known as RBC Capital Markets, L.L.C.; RBC Centura Bank, now known as RBC Bank, (USA); RBC U.S. Insurance Services, Incorporated, Defendants-Appellees.
No. 13-20213.
United States Court of Appeals, Fifth Circuit.
July 14, 2014.