McNair v. Johnson & Johnson

Decision Date11 May 2018
Docket NumberNo. 17-0519,17-0519
CourtWest Virginia Supreme Court
Parties Kimmy MCNAIR and Larry McNair, Petitioners v. JOHNSON & JOHNSON; Janssen Pharmaceuticals, Incorporated; and Ortho-McNeil Pharmaceutical, Incorporated, Respondents

818 S.E.2d 852

Kimmy MCNAIR and Larry McNair, Petitioners
JOHNSON & JOHNSON; Janssen Pharmaceuticals, Incorporated; and Ortho-McNeil Pharmaceutical, Incorporated, Respondents

No. 17-0519

Supreme Court of Appeals of West Virginia.

Submitted: January 17, 2018
Filed: May 11, 2018

818 S.E.2d 855

Leslie A. Brueckner, Esq. (pro hac vice ), Public Justice, P.C., Oakland, California And Richard D. Lindsay, Esq., Tabor Lindsay & Associates, Charleston, West Virginia, Counsel for the Petitioners

Anthony J. Majestro, Esq., Powell & Majestro, PLLC, Charleston, West Virginia And Allison M. Zieve, Esq. (pro hac vice ), Public Citizen Litigation Group, Washington, D.C., Counsel for Amicus Curiae, Public Citizen, Inc.

Elbert Lin, Esq., Hunton Andrews Kurth LLP, Richmond, Virginia And David B. Thomas, Esq., Daniel R. Higginbotham, Esq., Thomas Combs & Spann LLP, Charleston, West Virginia And John D. Winter, Esq. (pro hac vice ), Jonah M. Knobler, Esq. (pro hac vice ), Patterson Belknap Webb & Tyler LLP, New York, New York, Counsel for the Respondents

Anthony J. Majestro, Esq., Powell & Majestro, PLLC, Charleston, West Virginia, Counsel for Amici Curiae, AARP and AARP Foundation

Forrest H. Roles, Esq., Mark A. Carter, Esq., Dinsmore & Shohl, LLP, Charleston, West Virginia, Counsel for Amicus Curiae, Washington Legal Foundation

Ancil G. Ramey, Esq., Steptoe & Johnson PLLC, Huntington, West Virginia And Russell D. Jessee, Esq., Steptoe & Johnson PLLC, Charleston, West Virginia And Michael X. Imbroscio, Esq. (pro hac vice ), Paul W. Schmidt, Esq. (pro hac vice ), Gregory L. Halperin, Esq. (pro hac vice ), Covington & Burling LLP, Washington, D.C., Counsel for Amicus Curiae, Pharmaceutical Research and Manufacturers of America

Kannon K. Shanmugam, Esq. (pro hac vice ), Williams & Connolly LLP, Washington, D.C. And John M. Canfield, Esq., West Virginia Chamber of Commerce, Charleston, West Virginia, Counsel for Amici Curiae, Chamber of Commerce of the United States of America, West Virginia Chamber of Commerce, American Tort Reform Association

LOUGHRY, Justice:

This matter is before this Court upon a June 9, 2017, order of the United States

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Court of Appeals for the Fourth Circuit certifying the following question:

Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.

By order dated August 30, 2017, this Court accepted the certified question and docketed the matter for resolution.1 Upon review of the parties' briefs, arguments, the appendix record, and the pertinent law, we answer the certified question in the negative.2

I. Regulatory Background

We begin our analysis with a brief discussion of federal prescription drug regulations to provide the necessary background for addressing the question before us. A manufacturer seeking federal approval to market a new drug in interstate commerce must prove that the drug is safe and effective and that the manufacturer's proposed label is accurate and adequate. PLIVA, Inc. v. Mensing , 564 U.S. 604, 612, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (citations and footnote omitted). The United States Supreme Court has explained the approval of a new prescription drug as follows:

In the case of a new brand-name drug, FDA approval can be secured only by submitting a new-drug application (NDA). An NDA is a compilation of materials that must include full reports of all clinical investigations, relevant nonclinical studies, and any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source. The NDA must also include the labeling proposed to be used for such drug and a discussion of why the drug's benefits exceed the risks under the conditions stated in the labeling. The FDA may approve an NDA only if it determines that the drug in question is safe for use under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. In order for the FDA to consider a drug safe, the drug's probable therapeutic benefits must outweigh its risk of harm.

The process of submitting an NDA is both onerous and lengthy. A typical NDA spans thousands of pages and is based on clinical trials conducted over several years.

Mut. Pharm. Co. v. Bartlett , 570 U.S. 472, 476-77, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013) (internal quotation marks, brackets, and citations omitted).

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, which is commonly known as the Hatch-Waxman Act ("Hatch-Waxman" or "the Act"), in order to get prescription drugs to market in a speedier and less expensive manner. Abbott Labs. v. Young, 920 F.2d 984, 985 (D.C. Cir. 1990). The Act was also intended to improve the affordability of prescription drugs while encouraging innovation of new drugs. Id. Under the Act, generic drugs can gain approval of the Federal Food and Drug Administration ("FDA") merely by showing equivalence to a brand-name drug that has already been approved by the FDA. Mensing , 564 U.S. at 612, 131 S.Ct. 2567. Specifically, once the patent expires on a

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brand-name drug, a pharmaceutical company seeking to market a generic version of the drug can submit an "Abbreviated New Drug Application" ("ANDA") which requires the following:

First, the proposed generic drug must be chemically equivalent to the approved brand-name drug. It must have the same active ingredient or active ingredients, route of administration, dosage form, and strength as its brand-name counterpart. Second, a proposed generic must be bioequivalent to an approved brand-name drug. That is, it must have the same rate and extent of absorption as the brand name drug. Third, the generic drug manufacturer must show that the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.

Bartlett , 570 U.S. at 479, 133 S.Ct. 2466 (quotations marks and citations omitted). Further, generic manufacturers are prohibited from making any unilateral changes to their drug labels once those labels have been approved by the FDA, and they may alter a warning label only when necessary to duplicate a change in a brand-name label or to follow the FDA's instructions.3 See Mensing , 564 U.S. at 613-615, 131 S.Ct. 2567.4 The Supreme Court has characterized the fact that generic drug labels must match brand-name drug labels as an "ongoing federal duty of ‘sameness.’ " Mensing , 564 U.S. at 613, 131 S.Ct. 2567 (citations omitted). In return for granting generic drugs an expedited path to approval, Hatch-Waxman authorized the FDA to extend the length of brand-name manufacturers' patents for a period of up to five years, depending on the length of the review period, so that brand-name manufacturers have a monopoly over their newly-developed drugs for a longer period of time. Sergeants Benevolent Assoc. Health and Welfare Fund v. Acta Vis, PLC , Nos. 15-cv-6549, 15-cv-7488, 2016 WL 4992690, at *3 (S.D.N.Y. Sept. 13, 2016).

In 2009, the United States Supreme Court held in Wyeth v. Levine , 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), that, generally, plaintiffs may bring state failure-to-warn claims against manufacturers of brand-name drugs. The Supreme Court reasoned that such a claim was not preempted by federal law because it is possible for a brand-name manufacturer to comply with both state and federal law under the FDA's regulations. Id. at 573, 129 S.Ct. 1187. However, two years later in Mensing, the Supreme Court determined that federal labeling law for generic drugs generally preempts state failure-to-warn claims brought by plaintiffs alleging that manufacturers of generic drugs failed to warn of the risks of taking its drug. Mensing , 564 U.S. at 624, 131 S.Ct. 2567. The Supreme Court reasoned that if the generic drug manufacturers had independently changed their labels to meet state law requirements to attach a safer label to the drug, the generic manufacturers would have violated the federal requirement that generic drug labels must correspond verbatim to brand-name drug labels. 564 U.S. at 618, 131 S.Ct. 2567. Thus, concluded the Supreme Court, it is impossible for the generic drug manufacturers to comply with both state and federal law. Id. at 624, 131 S.Ct. 2567.

This preemption of state failure-to-warn claims against generic drug manufacturers has, in the words of the federal district court in the case at bar,

[c]reated what the Supreme Court has acknowledged as an "unfortunate" quirk: plaintiffs who ingest a brand-name drug may well have a cause of action against the
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brand-name manufacturer, but those who ingest a generic drug with the same composition and same label as the brand-name drug have no similar recourse against the generic manufacturer.

McNair v. Johnson & Johnson , No. 2:14-17463, 2015 WL 3935787, at *4 (S.D.W.Va. June 26, 2015) (citing Mensing , 564 U.S. at 625, 131 S.Ct. 2567 ) (indicating that "[h]ad [plaintiffs] taken Reglan, the brand-name drug...

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