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McNair v. Johnson & Johnson

Supreme Court of West Virginia

May 11, 2018

KIMMY MCNAIR AND LARRY MCNAIR, Petitioners
v.
JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INCORPORATED; AND ORTHO-MCNEIL PHARMACEUTICAL, INCORPORATED, Respondents

          Submitted: January 17, 2018

          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.

          Elbert Lin, Esq., Hutton & Williams 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, And Allison M. Zieve, Esq. (pro hac vice), Public Citizen Litigation Group Washington, D.C. Counsel for Amicus Curiae Public Citizen, Inc., 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.

         SYLLABUS

         1. "Product liability actions may be premised on three independent theories - strict liability, negligence, and warranty. Each theory contains different elements which plaintiffs must prove in order to recover." Syl. Pt. 6, in part, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d 603 (1983).

         2. "For the duty to warn to exist, the use of the product must be foreseeable to the manufacturer or seller." Syl. Pt. 3, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d 603 (1983).

         3. "In order to establish a prima facie case of negligence in West Virginia, it must be shown that the defendant has been guilty of some act or omission in violation of a duty owed to the plaintiff. No action for negligence will lie without a duty broken." Syl. Pt. 1, Parsley v. Gen. Motors Acceptance Corp., 167 W.Va. 866, 280 S.E.2d 703 (1981).

         4. There is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested was produced by a generic drug manufacturer.

          OPINION

          LOUGHRY JUSTICE.

         This matter is before this Court upon a June 9, 2017, order of the United States 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 (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 (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. Specifically, once the patent expires on a 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 (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.[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 (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, 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 (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. 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. 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. Thus, concluded the Supreme Court, it is impossible for the generic drug manufacturers to comply with both state and federal law. Id. at 624.

         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 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) (indicating that "[h]ad [plaintiffs] taken Reglan, the brand-name drug prescribed by their doctors . . . their lawsuits would not be preempted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits." (additional citation omitted)). We now turn to the specific facts of this case.

         II. Facts and Procedural Background

         The petitioners, the McNairs, filed an action in the Circuit Court of Kanawha County against the respondent, Janssen Pharmaceuticals ("Janssen"), alleging that in March 2012, Mrs. McNair developed acute respiratory distress ("ARDS") after ingesting the generic drug levofloxacin[5] that was manufactured by Dr. Reddy's Laboratories Limited ("Dr. Reddy's"). Janssen originally trademarked and sold levofloxacin under the brand Levaquin®. Thus, Janssen produced the warnings on the label that accompanied the distribution of Levaquin, which were subsequently used by generic manufacturers of levofloxacin. The McNairs alleged in their complaint that Janssen was aware that ARDS had been linked to the use of levofloxacin but negligently failed to include a warning, knowing this omission would exist not only in its distribution of Levaquin, but also in the warnings accompanying generic versions of the drug. Asserting several products liability claims, the McNairs' general theory of liability is that even though Mrs. McNair took a generic version of the drug, Janssen had exclusive control of the content of the warnings that were published to the public and to health care providers for both the brand-name and the generic forms of the drug. Therefore, the McNairs conclude that Janssen is liable for their alleged injuries.

         Janssen removed the action to federal court on diversity grounds. Janssen then moved for summary judgment, arguing that it could not be liable for a drug it did not manufacture or distribute because, under West Virginia law, a manufacturer's culpability in a products liability case is tied to conduct associated with designing, manufacturing or selling a defective product. The McNairs conceded that Janssen did not manufacture or sell the generic drug that Mrs. McNair ingested, but nonetheless urged the federal district court to deny Janssen's motion, averring that Janssen alone made the decision not to warn about ARDS in its labeling. The McNairs also pointed out that federal law precluded an action against Dr. Reddy's based on a failure to warn because the generic manufacturer was prohibited from changing the warning on its label in any way from the warning label prepared by Janssen. Finally, the McNairs argued that granting Janssen's motion would mean no party is liable for the alleged misinformation that purportedly caused Mrs. McNair's injury.

         The federal district court granted summary judgment to Janssen. The district court reasoned that every federal court of appeals to consider the issue, both before and after Mensing, has rejected the contention that a brand-name drug manufacturer's statements regarding its drug could serve as the basis of liability for injuries caused by another manufacturer's drug. The district court observed that in West Virginia, "[p]roduct liability law . . . allows for recovery when the plaintiff can prove that 'a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff's injuries.'" McNair, 2015 WL 3935787, at *6 (citing Meade v. Parsley, No. 09-388, 2009 WL 3806716, at *3 (S.D.W.Va. Nov. 13, 2009) (quoting Dunn v. Kanawha Co. Bd. of Educ., 194 W.Va. 40, 46, 459 S.E.2d 151, 157 (1995)). The district court found that because Janssen did not manufacture the product that Mrs. McNair ingested, there is no proximate cause and no basis on which to hold Janssen liable. The district court further ruled that the McNairs' breach of express and implied warranty claim failed because Janssen did not sell to the McNairs the product that allegedly injured Mrs. McNair and made no warranty of any kind regarding the specific product the McNairs purchased.[6]

         The McNairs appealed the district court's ruling to the Fourth Circuit Court of Appeals. The Court of Appeals certified to this Court the question set forth above.

         III. Standard of Review

         We have consistently held that "[a] de novo standard is applied by this Court in addressing the legal issues presented by a certified question from a federal district or appellate court." Syl. Pt. 1, Light v. Allstate Ins. Co., 203 W.Va. 27, 506 S.E.2d 64 (1998). With this standard to guide us, we proceed to consider the certified question.

         IV. Discussion

         We have recognized that "[p]roduct liability actions may be premised on three independent theories - strict liability, negligence, and warranty. Each theory contains different elements which plaintiffs must prove in order to recover." Syl. Pt. 6, in part, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d 603 (1983). ...


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