Kimmy McNair v. Johnson & Johnson

Filing

OPINION/ORDER CERTIFYING QUESTION to state court in West Virginia. Originating case number: 2:14-cv-17463 Copies to all parties and district court. [1000089887] [15-1806]

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UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 15-1806

KIMMY MCNAIR; LARRY MCNAIR,
Plaintiffs – Appellants,
v.
JOHNSON
&
JOHNSON,
a
foreign
corporation;
JANSSEN
PHARMACEUTICALS, INCORPORATED, a foreign corporation; ORTHOMCNEIL PHARMACEUTICAL, INCORPORATED, a foreign corporation,
Defendants – Appellees.

Appeal from the United States District Court for the Southern District of West Virginia,
at Charleston. John T. Copenhaver, Jr., District Judge. (2:14-cv-17463)

Argued: January 25, 2017

Decided: May 30, 2017

Before NIEMEYER, TRAXLER, and WYNN, Circuit Judges.

Question certified to the Supreme Court of Appeals of West Virginia by unpublished
order. Judge Traxler prepared the order, in which Judge Niemeyer and Judge Wynn
joined.

ARGUED: Richard David Lindsay, TABOR LINDSAY & ASSOCIATES, Charleston,
West Virginia, for Appellants. John Winter, PATTERSON BELKNAP WEBB &
TYLER LLP, New York, New York, for Appellees. ON BRIEF: Matthew C. Lindsay,
TABOR LINDSAY & ASSOCIATES, Charleston, West Virginia, for Appellants. Daniel

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R. Higginbotham, THOMAS COMBS & SPANN, PLLC, Charleston, West Virginia, for
Appellees.

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ORDER OF CERTIFICATION TO THE
SUPREME COURT OF APPEALS OF WEST VIRGINIA

TRAXLER, Circuit Judge:
Pursuant to West Virginia’s Uniform Certification of Questions of Law Act, see
W. Va. Code § 51-1A-1 et seq., we hereby request that the Supreme Court of Appeals of
West Virginia exercise its discretion to answer the following certified question of law:
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.
The answer to the foregoing question of West Virginia law may be determinative of
the action presently before us. As set forth below, there appears to be no controlling
precedent in West Virginia that directly addresses this issue or provides sufficient
guidance for us to dispose of this question. In support of our request, we briefly describe
the relevant facts and legal issues in the matter before us.
I.
This case involves the drug levofloxacin. The patent for this drug had been held
by Janssen Pharmaceuticals and marketed under the trade name of Levaquin®. 1 Janssen
produced the warnings that accompanied the distribution of Levaquin. When Janssen’s

1

The McNairs also named as defendants Ortho-McNeil Pharmaceutical, Inc.,
which originally held the patent for levofloxacin before transferring its assets to Janssen,
and Johnson & Johnson, Janssen’s parent company.

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patent expired, other companies began manufacturing and distributing generic versions of
levofloxacin. When they did so, federal law required the generic manufacturers to use
the exact same warnings Janssen produced. No additions or subtractions were permitted
by the generic manufacturers.
Kimmy and Larry McNair filed an action in West Virginia state court against
Janssen Pharmaceuticals, alleging that in March 2012, Kimmy developed acute
respiratory distress syndrome ("ARDS") after taking the drug levofloxacin, which had
been given to her along with warning information prepared by Janssen. The McNairs
assert that Janssen was aware that ARDS had been linked to the use of levofloxacin but
negligently failed to include this fact in its warnings, knowing that this omission would
exist not only in its own distribution of Levaquin, but also in the warnings accompanying
the distribution of the generic versions. The McNairs’ theory of liability is that even
though Kimmy took a generic version manufactured by Dr. Reddy's Laboratories,
Janssen had exclusive control of the content of the warnings that went out to the public
and to health care providers for both the name brand drug and the generic forms and
therefore Janssen is liable for injuries caused by the lack of warning that levofloxacin
might induce ARDS.
Janssen removed the action to federal court on diversity grounds. See 28 U.S.C. §
1332(a)(1); 28 U.S.C. § 1441(b). 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 product liability case is tied to
conduct associated with designing or manufacturing a defective product.”
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J.A. 70

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(internal quotation marks omitted).

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The McNairs conceded that Janssen did not

manufacture or distribute the generic drug that Kimmy ingested, but they nonetheless
urged the district court to hold Janssen liable, alleging that Janssen alone made the
decision to omit the warning about ARDS and no one else had the power to put it into the
labeling.
The McNairs also pointed out that federal law precluded a suit against Dr. Reddy’s
Laboratories based on a lack of warning because the generic manufacturer was forbidden
to change the warning in any way from that which Janssen prepared. Dismissal of the
case against Janssen, which drafted the warning information to start with, would mean no
one would ever be liable for the misinformation that allegedly caused Kimmy’s injury.
The district court concluded that West Virginia law does not permit “a plaintiff
who consumes a generic [to] instead sue the brand-name manufacturer that produced the
[original] formula for the drug and warning label in the first instance.” J.A. 107. The
district court noted that this court twenty years ago “rejected ‘the contention [under
Maryland law] that a name brand manufacturer’s statements regarding its drug c[ould]
serve as the basis for liability for injuries caused by another manufacturer’s drug.’” J.A.
107 (quoting Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994)). The
district court further observed that every other circuit court of appeals to consider this
issue had arrived at the same conclusion—a brand-name manufacturer cannot be held
liable for injuries caused by the ingestion of a generic produced by a third party. Finally,
having compared this weight of authority to West Virginia law, the district court held that

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“[t]here is no reason to think the outcome would be any different under West Virginia
law.” J.A. 109. The court dismissed the McNairs’ action, and they appealed.
II.
Pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”), “drug
manufacturers must gain approval from the United States Food and Drug Administration
(FDA) before marketing any drug in interstate commerce.”

Mutual Pharm. Co. v.

Bartlett, 133 S. Ct. 2466, 2470 (2013); see 21 U.S.C. § 355(a). A company that creates
and develops a new brand-name drug must submit a new drug application (“NDA”) to
obtain FDA approval. See 21 U.S.C. § 355(b).

The Supreme Court has described the

“process of submitting an NDA” as “both onerous and lengthy,” Bartlett, 133 S. Ct. at
2471, requiring the presentation of complete reports of clinical trials and nonclinical
studies, as well as any other relevant information regarding the effectiveness and safety
of the new drug, see 21 U.S.C. § 355(b)(1); Bartlett, 133 S. Ct. at 2470-71.
manufacturer must also submit proposed labeling for the drug.

The

See 21 U.S.C. §

355(b)(1)(F); 21 C.F.R. §§ 314.50(c)(2)(i), (e). Before approving an NDA, the FDA
must find that the new branded drug is “safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling thereof.” 21 U.S.C. § 355(d). The
FDA will reject the proposed labeling if “based on a fair evaluation of all material facts,
such labeling is false or misleading in any particular.” Id.; 21 C.F.R. § 314.105(b).
The approval process required of generic drugs is far less demanding. Once the
patent expires for a pioneer drug, a pharmaceutical company seeking to market a generic
version of the drug must submit an Abbreviated New Drug Application (“ANDA”), in
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which they may “rely on the clinical studies performed by the pioneer drug
manufacturer” instead of having “to prove the safety and effectiveness of its generic drug
from scratch.” aaiPharma, Inc. v. Thompson, 296 F.3d 227, 231 (4th Cir. 2002). All a
generic manufacturer must show is that: (1) the generic drug is “chemically equivalent to
the approved brand-name drug,” (2) the generic drug is “bioequivalent” to the brandname drug, and (3) “the labeling proposed for the new drug is the same as the labeling
approved for the . . . brand-name drug.” Bartlett, 133 S. Ct. at 2471 (internal quotation
marks and alterations omitted); see 21 U.S.C. § 355(j)(2)(A)(ii)-(v).
After a drug is approved by the FDA, “the manufacturer is prohibited from making
any major changes to the qualitative or quantitative formulation of the drug product,
including active ingredients, or in the specifications provided in the approved application.
Generic manufacturers are also prohibited from making any unilateral changes to a
drug's label.”

Bartlett, 133 S. Ct. at 2471 (emphasis added; internal citation and

quotation marks omitted); see 21 C.F.R. §§ 314.94(a)(8)(iii); 314.150(b)(10) (approval
for a generic drug may be withdrawn if the generic drug's label “is no longer consistent
with that for [the brand-name] drug”). Federal law “require[s] that the warning labels of
a brand-name drug and its generic copy must always be the same—thus, generic drug
manufacturers have an ongoing federal duty of sameness.” PLIVA, Inc. v. Mensing, 564
U.S. 604, 613 (2011) (internal quotation marks omitted).
This ongoing duty of sameness makes it impossible for a generic manufacturer to
comply with any state law duty to strengthen the warnings on its labels. And, “where it is
impossible for a private party to comply with both state and federal requirements,” then
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state law is preempted to the extent it conflicts with federal law. Id. at 618 (internal
quotation marks omitted); see Bartlett, 133 S. Ct. at 2477 (“Because it is impossible for
[the manufacturer of a generic drug] . . . to comply with both state and federal law, New
Hampshire's warning-based design-defect cause of action is pre-empted with respect to
FDA-approved drugs sold in interstate commerce.”); see also Drager v. PLIVA USA,
Inc., 741 F.3d 470, 476 (4th Cir. 2014). But while a state law failure-to-warn claim
against a generic manufacturer is preempted, such claims are not preempted as to the
warnings on a brand-name drug distributed by a brand-name manufacturer, which can
“unilaterally strengthen its warning.” Wyeth v. Levine, 555 U.S. 555, 573 (2009).
III.
With these principles in mind, we turn to the question at issue in this case—
whether, under West Virginia law, a brand-name manufacturer can be held liable on a
failure-to-warn claim where the plaintiff ingested a generic substitute and therefore has
no remedy against the manufacturer of the generic drug. The Supreme Court of Appeals
of West Virginia has not decided this issue, and the parties reasonably disagree as to how
the Supreme Court of Appeals would resolve the question.
The McNairs argue that under West Virginia products liability law, a manufacturer
can be held liable where the product at issue was defective when it left the manufacturer.
See Dunn v. Kanawha County Bd. of Educ., 459 S.E.2d 151, 157 (W. Va. 1995)
(“Product liability law in this State permits a plaintiff to recover where the plaintiff can
prove a product was defective when it left the manufacturer and the defective product
was the proximate cause of the plaintiff’s injuries.”). The McNairs describe the product
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at issue in this case as the generic levofloxacin Mrs. McNair ingested and its
accompanying warning label, which Janssen produced. The McNairs contend that under
the FDCA, brand-name manufacturers are solely responsible for the content of the
branded drug’s label, which, in turn, establishes the content of the generic drug’s label as
a result of the “sameness” requirement. The warning label produced by Janssen, the
McNairs argue, contained inadequate warnings and, thus, was defective when it left the
generic manufacturer.
Moreover, the McNairs argue that the “duty of sameness” results in physicians
relying upon Janssen’s warning label when prescribing the generic drug and individuals
doing the same when deciding to ingest the generic drug, giving rise to Janssen’s
responsibility to warn those physicians and consumers adequately. The McNairs note
that this responsibility is all the more important due to state laws, like that in West
Virginia, which compel pharmacists to fill prescriptions for brand-name drugs with
generic equivalents. See, e.g., W. Va. Code § 30-5-12b(b) (“A pharmacist who receives a
prescription for a brand name drug . . . shall substitute a less expensive generic name
drug . . . unless in the exercise of his or her professional judgment the pharmacist
believes that the less expensive drug is not suitable for the particular patient [or] . . . the
prescribing practitioner indicates that . . . a specific brand name drug is medically
necessary.”). The McNairs allege that Janssen failed to warn consumers of the generic
drug of the risk of ARDS, proximately causing Mrs. McNair’s injury. Thus, the McNairs
ask us to find that Janssen can be held liable under West Virginia law because Janssen
was solely responsible for the inadequate warning label that accompanied the generic
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levofloxacin, and the generic manufacturer was powerless to change it, rendering the
product that injured Mrs. McNair defective when it left the manufacturer.
The McNairs’ theory of liability is not entirely without support. A few courts
have held that the brand-name manufacturer may be liable for failure to warn when the
plaintiff’s injury was caused by the generic drug, basing their decisions largely on the
foreseeability of physicians’ and patients’ reliance upon the brand-name manufacturer’s
warning label. See Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 320–21 (Cal. Ct. App.
2008) (holding that, under California law, the brand-name manufacturer owes a duty of
care to patients who ingest the generic drug); 2 Kellogg v. Wyeth, 762 F. Supp. 2d 694,
708–09 (D. Vt. 2010) (concluding, under Vermont law, that brand-name manufacturers
owe a duty of care to physicians who prescribe and patients who ingest the generic drug);
Wyeth, Inc. v. Weeks, 159 So. 3d 649, 676–77 (Ala. 2014) (holding that a brand-name
manufacturer could be liable for failure to warn claims brought by plaintiffs who ingested
the generic drug), superseded by statute, Ala. Code § 6-5-530(a) (“In any civil action for
personal injury, death, or property damage caused by a product, regardless of the type of
claims alleged or the theory of liability asserted, the plaintiff must prove, among other
elements, that the defendant designed, manufactured, sold, or leased the particular
product the use of which is alleged to have caused the injury on which the claim is based,
and not a similar or equivalent product.”).
2

The rule announced in Conte is at issue in a separate appeal pending before the
Supreme Court of California. H. (T.) v. Novartis Pharm. Corp., 371 P.3d 241 (Cal.
2016).

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Our court addressed this issue well before the Supreme Court decided Mensing
and Bartlett, which preempted state-law failure to warn and design defect claims against
generic drug manufacturers. In Foster v. American Home Products Corporation, we held
that under Maryland law, “a name brand manufacturer cannot be held liable on a
negligent misrepresentation theory for injuries resulting from use of another
manufacturer’s [generic substitute].”

29 F.3d 165, 167 (4th Cir. 1994).

Foster’s

reasoning, in large part, was that
a manufacturer of generic products is responsible for the accuracy of labels
placed on its products. Although generic manufacturers must include the
same labeling information as the equivalent name brand drug, they are also
permitted to add or strengthen warnings and delete misleading statements
on labels, even without prior FDA approval. 21 C.F.R.§ 314.70 (1993). The
statutory scheme governing premarketing approval for drugs simply does
not evidence Congressional intent to insulate generic drug manufacturers
from liability for misrepresentations made regarding their products, or to
otherwise alter state products liability law. Manufacturers of generic drugs,
like all other manufacturers, are responsible for the representations they
make regarding their products.
Id. at 170 (emphasis added). Of course, after Mensing and Bartlett, it is no longer the
case that generic manufacturers can alter FDA-approved labels. See Drager, 741 F.3d at
476 (“[Mensing and Bartlett] establish that under the FDCA a generic may not
unilaterally change its labeling or change its design or formulation.”). This court has not
revisited the question presented today since Foster.
Nonetheless, as the district court recognized, even after Mensing and Bartlett, the
overwhelming weight of federal precedent favors no liability against the brand-name
manufacturer, leaving plaintiffs who ingest generic drugs with no legal recourse for
injuries caused by inadequate warning labels or defective drug designs.
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See, e.g.,

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Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605, 616 n.3 (5th Cir. 2014) (“Our decision
is consistent with other circuit decisions that have held (under the laws of several
different states) that brand-name manufacturers are not liable for injuries caused by a
plaintiff[’]s ingestion of generic products.”); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1286
(10th Cir. 2013) (predicting the Oklahoma Supreme Court would not hold that “brandname manufacturers can be held liable for injuries caused by their generic counterparts”);
Guarino v. Wyeth, LLC, 719 F.3d 1245, 1253 (11th Cir. 2013) (“Florida law does not
permit an injured consumer to recover from the brand manufacturer of a prescription drug
if the consumer is known to have ingested only the generic form of that drug.”);
Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 405 (6th Cir. 2013) (“The plaintiffs have
presented no authority indicating that manufacturers of a brand-name drug have a duty
under Tennessee law to consumers of the brand-name manufacturers’ competitors, and
we are loath to expand Tennessee’s substantive law without direction from the Tennessee
Supreme Court.”); Bell v. Pfizer, Inc., 716 F.3d 1087, 1093 (8th Cir. 2013) (“Because
Bell never used . . . the brand defendants manufactured, Bell cannot hold them liable
under Arkansas law.”).
IV.
For us to decide this issue, we would have to speculate as to how the Supreme
Court of Appeals of West Virginia would rule in an area of law where it has not spoken
directly and where its precedent leaves open the possibility that brand-name
manufacturers may be liable for failure to warn when a plaintiff ingests the generic drug.
Therefore, pursuant to the certification process provided by the State of West Virginia,
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we seek guidance from the Supreme Court of Appeals of West Virginia on the controlling
question of West Virginia law, which we identify as follows:
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.
We acknowledge that the Supreme Court of Appeals of West Virginia may
reformulate the question. All of the parties in this matter are represented by counsel,
whose names and addresses are provided hereunder.
For the Plaintiffs–Appellants:

For the Defendants–Appellees:

Matthew C. Lindsay
Richard D. Lindsay
Tabor Lindsay & Assocs.
1223 Virginia St. E.
Charleston, WV 25301
P.O. Box 1269
Charleston, WV 25325

Daniel R. Higginbotham
Thomas Combs & Spann, PLLC
300 Summers Street, Suite 1380
Charleston, WV 25301
P.O. Box 3824
Charleston, WV 25338-3824
John D. Winter
Patterson Belknap Webb & Tyler LLP
1133 Avenue of the Americas
New York, NY 10036-6710
V.

Accordingly, pursuant to the privilege made available under West Virginia law as
described above, we hereby order: (1) that the question set forth herein be certified to the
Supreme Court of Appeals of West Virginia for answer; (2) that the Clerk of this Court
transmit to the Supreme Court of Appeals of West Virginia, under the official seal of this
Court, a copy of this Order of Certification; and (3) that the Clerk of this Court forward in
addition the original or copies of the record before this Court, in all or in part, as
requested by the Supreme Court of Appeals of West Virginia, any and all such requests
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being effective upon notification by ordinary means from the Clerk of the Supreme Court
of Appeals of West Virginia.
QUESTION CERTIFIED

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