PLIVA v. Mensing: A Poor Outcome for Consumers

By Mark Apostolos, Albany Government Law Review[1]

Product manufacturers are generally required by state law to sell a product that: (1) is free of design or manufacturing defects, and (2) carries appropriate warnings putting customers on notice as to the reasonably foreseeable risks of using the product.[2]  Prescription drug products require “reasonable instructions or warnings regarding foreseeable risks of harm,”[3] which are to be provided to either “prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings”[4] or “the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.”[5]  In addition, like any other negligence claim, a plaintiff may have a cause of action if that duty is breached and they are injured as a result of the manufacturer’s failure to warn the consumer with an adequate label.[6]

In the recent case of Pliva v. Mensing,[7] the Supreme Court rendered a decision whose holding undermines the well-established principles of product liability.  The Court held that generic drug manufacturers can no longer be liable for failure to warn claims where state law conflicts with federal law,[8] effectively rendering generic drug manufacturers immune from state law failure-to-warn tort claims.[9]

Mensing included facts that are typical to a failure-to-warn claim: the plaintiffs in this consolidated case[10] developed tardive dyskinesia from long-term use of the generic drug metoclopramide and alleged manufacturer liability for failure to provide adequate warning labels.[11]  The case was fought around whether or not federal legislation, the Hatch-Waxman amendments,[12] allowed a generic drug manufacture to strengthen their label to comply with state law tort duties.[13]  The Hatch-Waxman amendments allow a generic drug manufacture to apply for an “abbreviated new drug application” (“ANDA”), which allows for FDA approval “simply by showing equivalence to a reference listed drug that has already been approved by the FDA.”[14] Under ANDA—in order to speed up the process and efficiency of putting the generic drug on the market—the generic drug manufacture must “show that the [safety and efficacy] labeling proposed for the new drug is the same as the labeling approved for the listed [brand name] drug.”[15]

Therefore, the main issue of Mensing was whether or not a state product liability law, which requires a drug manufacturer to have an adequate warning label, is preempted by the Hatch-Waxman Amendments, which require the generic drug to have the same label as the brand name.[16]  The Supreme Court came to the conclusion that the Hatch-Waxman amendments preempt state law-based failure-to-warn claims against generic drug manufacturers because it is impossible for drug manufacturers to comply with the ANDA requirements—which require generic labels resemble their brand name equivalent—and at the same time modify their labels to comply with state law tort duties.[17]  Quite simply, a generic drug manufacturer is now provided with complete immunity from liability for a state law claim of this type.[18]  As a result, approximately seventy-five percent of all prescription drug users now have no claim of failure-to-warn.[19]

Not only is this holding contrary to American tort law jurisprudence generally,[20] but it is contrary to the specific principle of tort law that manufacturers should have monetary incentives to make sure that the warnings they place on their products are diligently crafted and all-encompassing.  As was said by the Supreme Court in Wyeth v. Levine,[21] “[s]tate tort suits uncover unknown drug hazards and provide an incentive for drug manufactures to disclose safety risks promptly.”[22]  If the Mensing decision is allowed to stand, inadequate labels may very likely become an issue, because Mensing only allows the generic label to be strengthened in accordance with the brand name’s label.[23]  But, if the brand name manufacturer will not be held liable for the generic’s defective label,[24] coupled with the fact that the overwhelming majority (ninety percent) of drugs with a generic option available are filled using the generic option,[25] the brand name manufactures will have less incentive to update their labels—or even continue long term research—when their sales have been dramatically reduced by the increased availability of the generic.

Because the Mensing decision is contrary to public policy and well-established principles of American tort law, the appropriate governing federal statutes and/or regulations need to be modified to allow generic drug manufacturers to absorb liability when their product labels fail to adequately warn consumers of the risks of using their product.  As Maryland District Court Judge C. Blake stated in the Grinage decision, “[p]recedent constrains this court.  Unless and until the FDA modifies its regulations or Congress further amends the governing statute, there is no authority to allow similar failure-to-warn claims to proceed against generic drug manufactures.”[26]

A possible legislative solution could be an amendment that specifically addresses the Mensing opinion, declaring that the Hatch-Waxman Amendments do not preempt state product liability law.  Another possibility is legislation specifically declaring that generic drug manufactures are liable for the products they produce, and have a duty to adequately warn a consumer equivalent to a brand name manufacturer.  The Hatch-Waxman Amendments expressly speak to keeping the generic label the same as the brand name, with the intention of making the generic as safe as the brand name.[27]  Therefore, there is little logical argument that could be made against allowing the generic to strengthen that label, as this will only further protect consumers.

If legislation is implemented as I propose, one could reasonably argue that generic manufactures may incur higher costs if they are under the same duty to alter their labels as brand name manufactures.  This would translate to higher costs to consumers, thereby undermining the primary reason for having generic drugs in the first place: to offer consumers a cheaper alternative.  However, up until the Mensing decision, generic drug manufactures were effectively operating under this duty,[28] and continued to produce generic drugs at affordable prices.[29]

It is apparent that courts have struggled on where to place liability with generic drugs[30] because federal legislation does not adequately address it.[31]  As a result of this lack of clarity, Mensing was able to create the aforementioned tort immunity.[32]  What is clear, however, is that reduced tort liability diminishes the incentive for generic companies to ensure the safety of their label, particularly when that label may be outdated and present imminent dangers to consumers.[33]  But until some sort of change is instituted consumers will bear the burden of the negligence of drug manufacturers—whether brand name or generic—without any form of legal recourse.

[1] J.D. Candidate (2013), Albany Law School.

[2]Restatement (Third) of Torts: Prod. Liab. § 2 (1998); see Frey v. Montgomery Ward & Co., 258 N.W.2d 782, 788 (Minn. 1977) (“[W]here the manufacturer  . . . of a product has actual or constructive knowledge of danger to users, the . . . manufacturer has a duty to give warning of such dangers.”); Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 269–70 (5th Cir. 2002) (“[A] manufacturer’s duty to warn includes a duty to provide adequate instructions for safe use of a product.”); Voss v. Black & Decker Mfg. Co., 450 N.E.2d 204, 204 (1983) (“[A] plaintiff may assert that the product is defective . . . because the manufacturer failed to provide adequate warnings regarding the use of the product.”); see also Colo. Rev. Stat. Ann. § 13-21-401 (West 2011); Kan. Stat. Ann. § 60-3305 (West 2011); La. Rev. Stat. Ann. § 9:2800.57 (West 2009); N.J. Stat. Ann. § 2A:58C-4 (West 2000); N.C. Gen. Stat. Ann. § 99B-5 (West 2011); Or. Rev. Stat. Ann. § 30.900 (West 2011); Tenn. Code Ann. § 29-28-102 (West 2011).

[3] Restatement (Third) of Torts: Prod. Liab. § 6(d) (1998).

[4] Id. § 6(d)(1).

[5] Id. § 6(d)(2).

[6] Restatement (Second) of Torts § 282 (1965).

[7] 131 S. Ct. 2567 (2011).

[8] Id. at 2572.

[9] See id. at 2582 (Sotomayor, J., dissenting) (stating that the court’s holding “immunizes generic-drug manufacturers from all failure-to-warn claims . . .”).

[10] Certiorari was granted on a condolidated basis.  Id. at 2573.

[11] Id.

[12] 21 U.S.C.A. § 355(j)(2)(A).

[13] Mensing, 131 S. Ct. at 2573.

[14] Id. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)).

[15] 21 U.S.C.A. §355(j)(2)(A)(v).

[16] Mensing, 131 S. Ct. at 2573.

[17] Id. at 2577–78.

[18] See Grinage v. Mylan Pharm., Inc., CCB-11-1436, 2011 WL 6951962, at *8 (D. Md. Dec. 30, 2011).

[19] Mensing at 2592 (Sotomayor, J., dissenting).

[20] See supra note 2.

[21] 555 U.S. 555 (2009).

[22] Id. at 579.

[23] See Couick v. Wyeth, Inc., No. 3:09 CV 210 RJC DSC, 2012 WL 79670, at *5–6 (W.D. N.C. Jan. 11, 2012); Fisher v. Pelstring, 817 F. Supp. 2d 791, 801(D.S.C. 2011).

[24] See Moretti v. Wyeth, Inc., 2009 WL 749532 (Nev. Dist. 2009); Dietrich v. Wyeth Inc., 2009 WL 4924722 (Fla. Cir. Ct. 2009); Mensing v. Wyeth Inc., 588 F.3d 603 (8th Cir. 2009); Foster v. Am. Home Prod. Corp. 29 F.3d 165 (4th Cir. 1994). Flynn v. Am. Home Prod. Corp. 627 N.W.2d 342 (Minn. App. 2001) (all refusing to extend the brand name drug manufactures liability to injuries caused by the generic).

[25] Mensing, 131 S. Ct. at 2584.

[26] Grinage, 2011 WL 6951962, at *8.

[27] See 21 U.S.C.A. § 355(j)(2)(A).

[28] See Kelly v Wyeth, 22 Mass. L. Rptr. 384 (Sup. Ct. 2007) (denying Teva’s—a generic manufacturer—motion for summary judgment claiming no liability for failing to change the label); Stacel, 620 F. Supp. 2d 899 (denying Teva’s motion to dismiss based upon preemption).

[29] See Somnath Pal, Trends in Drug Pricing, U.S. Pharmacist, (June 20, 2011), available at (last visited Jan. 27, 2012) (stating that generic drug price index decreased at a rate of .6 percent per quarter between 2006 and 2010).

[30] Compare Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 304–05 (Ct. App. 2008) (extending liability to the brand name manufacture when a consumer is injured from a generic drug’s failure to warn), with Mensing v. Wyeth Inc., 588 F.3d 603 (8th Cir. 2009) (declining to follow Conte, instead placing liability on generic manufacture (pre Mensing Supreme Court decision)).

[31] See 21 U.S.C. §360.

[32] See Mensing, 131 S. Ct. at 2572 (2011).

[33] See Nate Raymond, Supreme Court’s Mensing Ruling Isn’t Silver Bullet for Generic Drug Makers,, (last visited Jan. 27, 2012) (stating that presently, there are approximately 2,000 failure to warn cases against generic drug manufactures for the generic version of Reglan).

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