Boros v. Pfizer, Inc. ( 2016 )

IN SUPERIOR COURT OF THE STATE OF DELAWARE
HACAH BOROS, as Administrix of the
Estate of JONATHAN BOROS; G.'B,
an infant under the Age of 14 years,
by her guardian HACAH BOROS;
N.B, an infant under the age of 14 years,
by his Guardian HACAH BOROS;
and HACAH BOROS lndividually,
va C.A. No. N15C-04-029 JRJ
PFIZER, INC.; PFIZER
INTERNATIONAL LLC; PFIZER
PHARMACEUTICALS, INC.; TEVA
PHARMACEUTICALS USA INC.;
PLIVA, INC. a/k/a SIDMAK
LABORATORIES, INC.; and
DOES 1 through 10
£&€§&/§/&\/L/L/\/\/&/§§/§&%/\_/§/
Defendant$,-__-
Date Submitted: February 25, 2016
Date Decided: May 25, 2016
Upon Defendant Teva Pharmaceuticals USA Inc. ’s Motionfor judgment on the
Pleadz`ngs: DENIED.
James D. Heisman, Esquire, and Diane M. Coffey, Esquire, Bern Rjpka LLP,
Wilmington, DE, Hunter Shkolnik, Esquire (argued) (pro hac vice), and Staesha
Rath, Esquire (pro hac vz`ce), Napoli Shkolnik PLLC, New York City, NY.
Attorneys for Plaintiffs.
William R. Denny, Esquire, and Michael B. Rush, Esquire, Potter Anderson &
Corroon LLP, Wilmington, DE, Jeffrey Peck, Esquire (argued) (pro hac vice), and
Jennifer Snyder Heis, Esquire (pro hac vz`ce), Ulmer & Berne, LLP, Cincinnati,
OH. Attorneys for Defendant Teva Pharmaceuticals USA Inc.
I. INTRODUCTION
On April 2, 2015 , Plaintiffs filed a Complaint against Defendants Pfizer Inc.,
Pfizer Pharmaceuticals, Inc., and Pfizer Intemational LLC (collectively "Pfizer");
Teva Pharmaceuticals USA Inc. ("Teva"); Pliva, Inc. a/k/a Sidmak Laboratories,
Inc. ("Pliva"); and DOES l through 10 (collectively "Defendants"), alleging that
Plaintiff Jonathan Boros ("Decedent") was injured and died as a proximate result
of ingesting either the brand-name azithromycin drug Zithromax, manufactured
and sold by Pfizer, or the generic equivalent, manufactured and sold by one of the
other named Defendants.'
Although Plaintiffs assert seven causes of action against Defendants, the
core of the claims is the same-Defendants failed to adequately wam Decedent of
the safety issues regarding the azithromycin that he ingested.z
On May 21, 2015, Pfizer filed a Motion to Dismiss the Complaint3 and on
July 8, 2015, Teva filed a Motion for Judgment on the Pleadings.4 At oral
argument on Pfizer’s Motion to Dismiss, Plaintiffs voluntarily dismissed their
l Compl. (Trans. ID. 570l88l8). Plaintiffs in this case are as follows: Hacah Boros, as
Administrix of the Estate of Jonathan Boros; G.B, an infant under the Age of 14 years, by her
Guardian Hacah Boros; N.B, an infant under the age of 14 years, by his Guardian Hacah Boros;
and Hacah Boros, Individually. Id. 1111 l-5.
2 Plaintiffs allege: (l) Strict Liability; (2) Strict Liability Design Defect; (3) Marketing Defect
and Manufacturing Defect; (4) Negligence; (5) Breach of Warranty; (6) Breach of Implied
Warranty; and (7) Loss of Consortium.
3 Trans. ID. 57519127.
" Trans. ID. 57523364.
In contrast to the claims alleged in Mensing and Bartlett, however, the
Plaintiffs in this case do not allege that state law required Teva to vary its labeling
from the brand-name drug. Rather, Plaintiffs allege that Teva should have updated
its warning labels to match the brand-name Zithromax labels, and the labels on
Teva’s azithromycin (that Decedent ingested) failed to adequately warn about the
risk of irregular heart rhythms.47 Accordingly, Teva is not entitled to judgment on
the pleadings based on impossibility pre-emption because it was possible for Teva
to fulfill both its duty under federal law to update its labels and its duty under state
law to adequately warn consumers/18
47 See Fulgenzi v. PLIVA, Inc,, 711 F.3d 578 (6th Cir. 2013); Phelps v. Wyeth, Inc., 938 F. Supp.
2d 1055, 1061 (D. Or. 20l3) ("Unlike the failure to warn claim in Mensing, plaintiffs do not
claim that Pliva was required to use a different or stronger warning label; they merely claim that,
under Oregon law, Pliva was negligent by failing to update its label to match the name-brand
label_a requirement that is consistent with the FDCA. Thus, because plaintiffs’ state-law claim
does not make it impossible for Pliva to comply with federal law, no conflict exists and
preemption is not warranted."); Cooper v. Wyeth, Inc., 2012 WL 733846, at *4 (M.D. La. Mar. 6,
2012) ("Since, as Mensing makes clear, the FDA’s labeling regulations set the ceiling for
labeling strength, any state law purporting to impose more stringent requirements would be
preempted. However, a generic drug manufacturer’s failure to adhere to the brand-name label the
generic drug is tied to would plainly violate federal law and likely violate state law . . . . In the
latter scenario, the requirements of state law would coextend with, but would not exceed, the
requirements of federal law, rendering impossibility preemption inapplicable."); Johnson v. Teva
Pharm. USA, Inc., 2012 WL l866839, at *3 (W.D. La. May 2l, 2012), a/j"’ci, 758 F.3d 605 (5th
Cir. 2014) ("[I]mpossibility preemption would not apply to any requirement . . . that the Generic
Defendants update their product labels to reflect labeling changes made by the brand name
manufacturer."); Teva Pharm. USA, Inc. v. Superior Court, 158 Cal. Rptr. 3d 150, 158 (2013)
("In this case, as in Fulgenzi v. PLIVA, Inc., it was possible for the Teva Defendants to comply
with both a federal duty to make their labels match the Fosamax label, and a state tort law duty to
prevent harm to the consumers of alendronate sodium. Therefore, the impossibility preemption
doctrine does not bar [the] claims.").
48 Mensing, 564 U.S. at 620 ("The question for ‘impossibility’ is whether the private party could
independently do under federal law what state law requires of it.").
ll
Teva also argues that Plaintiffs’ claims are merely an attempt to enforce the
FDCA’s "sameness" duty, which requires that the generic drug’s labels be
identical to the brand-name drug’s labels. Pursuant to 21 U.S.C. § 337(a), only the
federal government may bring an action to enforce the provisions of the FDCA.
Contrary to Teva’s arguments, Plaintiffs do not allege a private federal cause of
action under the FDCA based on a failure to have the same labels as Zithromax.
Rather, Plaintiffs allege that the azithromycin labels did not adequately warn about
the risks associated with the drug.49
Finally, Teva argues it is entitled to judgment on the pleadings because the
Complaint fails to allege any facts based on a "failure to update" theory. Although
bare-boned, the Complaint alleges: (l) the FDA stated the Zithromax label would
be updated with stronger language regarding the risk of life threatening irregular
heart rhythms; (2) Teva should have revised their package inserts following
modifications initiated by Pfizer; (3) the warning about the risk of irregular heart
rhythms was not included on the label of the generic azithromycin allegedly
manufactured by Teva that Decedent ingested; and (4) Decedent died after
experiencing a prolonged QT interval, leading to an arrhythmia, the exact cardiac
risk that should have been included on the label.
35 See e.g., Compl._ 1111 33_-42.
12
The standard for granting a motion for judgment on the pleadings is strict,
and to prevail, the moving party must show that there are no issues of material fact
in existence.so Teva has failed to meet this burden because genuine issues of
material fact exist, including when Pflzer updated the Zithromax label, and what
warnings, if any, Teva provided at the time Decedent ingested azithromycin
V. CONCLUSION
For foregoing reasons, Defendant Teva Pharrnaceuticals USA Inc.’s Motion
for Judgment on the Pleadings is DENIED.
IT IS SO ORDERED.
50 Ar¢isans ’ Bank, 2010 WL 2501471, ar *1.
13
claims against Pfizer (rendering that motion moot) because it is undisputed that
Decedent never ingested Pfizer’s brand-name Zithromax product.5
Before the Court is Defendant Teva’s Motion for Judgment on the
Pleadings. For the reasons that follow, the Motion is DENIED.
II. BACKGROUND
A. Relevant Federal Regulations
The Federal Food, Drug, and Cosmetic Act ("FDCA"), provides the
statutory framework for federal regulation of prescription drugs in the United
States.6 Under the FDCA, drug manufacturers must obtain approval from the
United States Food and Drug Administration ("FDA") before marketing any drug
in interstate commerce.7 In the case of a brand-name manufacturer seeking to
market a new prescription drug, FDA approval can be secured only by submitting a
"New Drug Application" ("NDA"), which must include extensive studies of the
drug’s safety and effectiveness,g and the proposed labeling for the drug.9
Prior to l984, both brand-name manufacturers and generic manufacturers
were required to file an NDA to receive approval from the FDA to market a drug.'o
In 1984, Congress passed the Drug Price Competition and Patent Term Restoration
-_._ __
5 Trans. 1D. 58326397.
6 the FDCA is codified ar 21 U.s.c. § 301 er seq.
7 21 U.s.c. § 355(3).
8 21 U.s.c. §355(3)-(1);1\4111»1@11>11¢1¢»»1 ca v. Bar¢lerz, 133 s.c1.2466,2470~71 (2013)-._5
9 21 U.s.c. § 355(1»)(1)(11);13¢1¢¢1€1¢, 133 s. ct ar 2471.
‘° PLWA, Inc, v. Mensing, 564 U.s. 604, 612 (2011).
3
Act of 1984, known as the "Hatch-Waxman Act," which, among other things
amended the FDCA to reduce the time and cost required to obtain FDA approval
for generic drugs."
Under the Hatch-Waxman Act, a generic manufacturer can obtain FDA
approval by simply showing that the generic drug is identical to the already-
approved brand-name drug.lz Instead of an NDA, the generic manufacturer must
file an "Abbreviated New Drug Application" ("ANDA") demonstrating that the
generic product is a "bioequivalent" and chemical equivalent of the brand-name
3
drug.' Additionally, the Hatch-Waxman Act requires that the labeling and
warnings for the generic drug be identical to the labels for the FDA approved
brand-name drug.m Thus, brand-name drug manufacturers and generic drug
manufacturers have different federal drug labeling duties.l$ A brand-name
manufacturer seeking FDA approval for a new drug is responsible for the accuracy
" Barrzarr, 133 s. Cr. ar 2471.
'2 1a ar 2470-71.
13 21 U.S.C. § 355(j). "Bioequivalent" means that the generic drug must have the same "rate and
extent of absorption" as the brand-name drug. 21 U.S.C. § 355@)(8)(B). Chemically equivalent
means that the generic drug must have the same active ingredient or active ingredients, route of
administration, dosage form, and strength. Bartlett, 133 S. Ct. at 2471 (citing 21 U.S.C. §§
355@)(2)(A)(ii) and (iii)). Thus, generic drug manufacturers have a federal duty of "sameness."
Mensz`ng, 564 613.
14 21 U.S.C. § -;:Z)(A)(v); Bartletl, 133 S. Ct. at 2471.
‘5 Mansr'ng, 564 U.s. ar 613
and adequacy of its label, and a generic manufacturer must ensure that its label is
the same as the brand-name drug’s label.'6
B. Zithromax/Azithromycin
In 1981, Pliva patented the drug azithromycin, a broad-spectrum macrolide
antibiotic." In 1986, Pfizer and Pliva entered into a licensing agreement, which
gave Pfizer the exclusive rights to manufacture, label, distribute, market, and sell
azithromycin in Western Europe and the United States.lg
The FDA approved azithromycin under the brand-name Zithromax, and in
1991, Pfizer launched Zithromax in the United States.lg In December 2002,
Pfizer’s exclusive licensing rights for azithromycin lapsed, and generic
manufacturers began producing azithromycin.zo Defendant Teva manufactures,
markets, distributes, and sells azithromycin pursuant to an ANDA.Z] As such,
under federal law, Teva’s generic azithromycin product must be the bioequivalent
and chemical equivalent of the brand-name Zithromax, and the labels must be
identical w the zirhr@max 131»@13.”
16 Ia'. (internal citations omitted).
" c<>mp1.111119,21.
‘8 1a 11 22.
‘9 ld. 1111 20, 23.
20 2,7_
2’ f»_t'z§%wm 27~28.
”:;;§";11 31.
On March 12, 2013, the FDA issued a new warning regarding potentially
fatal irregular heart rhythms that can occur among patients taking Zithromax,” and
stated that the Zithromax label would be updated with stronger language regarding
the risk of life threatening irregular heart rhythms.24 The FDA warning was
prompted by the agency’s review of two studies that assessed the potential for
Zithromax to cause abnormal changes in the electrical activity of the heart.25
C. Decedent’s use of azithromycin
Plaintiffs allege that Decedent’s pharmacist dispensed to Decedent a generic
form of azithromycin allegedly manufactured and sold by one of the Defendants.%
On April 2, 2013, Decedent ingested the drug as prescribed, and the next day
collapsed in front of his wife, Plaintiff Hacah Boros.27 Decedent’s wife called 911
1.2“
and paramedics transported Decedent to the hospita Decedent underwent an
EKG, which showed a prolonged QT interval, leading to a cardiac arrhythmia.29
23 1¢1.1133.
24 1a m 33, 37.
25 Idaho 1[ 34. A May 2012 study published in the New England Journal of Medicine reported a
higher risk of cardiovascular deaths, and deaths from any cause, in persons treated with a 5-day
course of Zithromax compared to those treated with amoxicillin. Id. 11 35. The FDA also
reviewed a study that determined Zithromax can lead to a potentially fatal heart rhythm known
as prolonged QT interval, in which the timing of the heart’s contractions becomes irregular.
After approximately forty minutes of unsuccessful attempts at resuscitation,
Decedent was pronounced dead at ll:36 a.m. on April 3, 2013.30
III. STANDARD OF REVIEW
Pursuant to Superior Court Civil Rule l2(c), a party may move for judgment
on the pleadings after the pleadings are closed but within such time as not to delay
the trial. The Court must accept all well pled allegations of fact as true and all
l
. . . 3 .
reasonable inferences are construed m favor of the non-moving party. A motion
for judgment on the pleadings will be granted only when no material issues of fact
exist and the movant is entitled to judgment as a matter of law.32
IV. DISCUSSION
Teva argues that the claims against Teva are pre-empted by federal law,
which precludes a generic drug manufacturer from unilaterally altering a drug’s
warning labels. The Supremacy Clause of the United States Constitution
establishes that the laws and treaties of the United States "shall be the supreme
Law of the Land . . . any Thing in the Constitution or Laws of any State to the
113-il- .:`
3°1¢ 1111 79-30.
3‘ silver Lake 0;7¢@ Plaza, LLC v. Lanard & Axzzbunar, lnc., 2014 WL 595378, ar *6 (Del.
Super. Jan. l7, 2014); D0e v. Bradley, 2011 WL 290829, at *3 (Del. Super. Jan. 2l, 20l l)
32 Artisans’ Bank v. Seaford IR, LLC, 2010 WL 2501471, at *l (Del. Super. June 2l, 2010)
(citing Gonzales v. Apartment Cmtys. Corp., 2006 WL 2905724, at *l (Del. Super. Oct. 4,
2006)); Bradley, 20ll WL 290829, at *3 ("Indeed, when considering a motion under Rule l2(c),
the Court must decline to construe facts not clearly alleged in the complaint or to decide disputed
issues of fact, but rather must confine its review to deciding issues of law as framed by the well
pled allegations in the complaint.").
-.¢;
Contrary notwithstanding."” If a state law "directly conflicts" with a federal law,
))34
"state law must give way. Even in the absence of an express pre-emption
provision, a state law may be pre-empted "where it is impossible for a private party
1335
to comply with both state and federal requirements. "[I]mpossibility pre-
emption is a demanding defense."%
In support of its pre-emption argument, Teva relies on two decisions from
the United States Supreme Court involving generic pharmaceutical products. In
PLIVA, Inc. v. Mensz`ng, the plaintiffs brought actions against a generic drug
manufacturer alleging that the generic manufacturer knew or should have known
that the long-tenn use of its generic drug metoclopramide carried a high risk of a
severe neurological disorder and that the drug’s labels did not adequately warn of
that risk.37 Under the state law applicable to the actions in Mensing, all drug
manufacturers had a duty to adequately warn consumers and safely label their
38
products. lt was undisputed in Mensz`ng that state law required the generic drug
manufacturer to use a "different, safer" label than the brand-name manufacturer’s
35 Qon _
35 list
. omitted _:; 133 S. Ct. ar`”‘-i' ~i
36 -'_ 1~‘.’*§.‘».~._-. 555 _._-j»';'_'£§-a 573 i*i‘?.§iweese v. Nat~..E-'-i-HaB,-.- Passenger Corp. (Amtrak),
590 F.3d 239, 246 (3d Cir. 2009) (citing Czj)ollone v. Liggett Group, Inc., 505 U.S. 504, 516
(l992)).
37 Mensing, 564 U.s. ar 611.
38 Id_
label.39 The U.S. Supreme Court explained that federal regulations require that the
labels on generic drugs match the label on the corresponding brand-name drug,
thus preventing generic drug manufacturers from independently changing their
drug’s safety labels.40 The Mensing Court held that the state law failure-to-warn
claims were pre-empted by the FDCA because it was impossible for the generic
drug manufacturer to comply with both the state law duty to label its products in a _
way that rendered them reasonably safe and the federal law duty not to change the
generic drug’s safety labels from the brand-name drug.
In Mutual Pharmaceuticals, Inc. v. Bartlett, the issue was whether a state
law design-defect claim against a generic drug manufacturer was pre-empted by
federal law.‘" The plaintiff in Bartlett developed an acute case of toxic epidermal
necrolysis and suffered severe physical disabilities after taking a generic form of
an ami-inflammatory pain reliever. The plaintiff brought failure-to-warn and
design-defect claims against the generic drug manufacturer under state law, which
required drug manufacturers to ensure that the products they designed,
manufactured, and sold were not unreasonably unsafe, either because of inadequate
42
warnings or inadequate design. At the time the plaintiffs ingested the generic
drug, the FDA and brand-name manufacturer had not changed the warning labels
39 14 ar 611~12.
"°1d.ar612-13.
‘*‘ 133 s. cc. 2466 (2013)
”mmMm
.Il_
to more explicitly warn against toxic epidermal necrolysis.43 Consequently, the
state law imposed a duty on the generic manufacturer to change the labeling to
provide stronger warnings.44 The Bartlett Court found that it was impossible for
the generic manufacturer to simultaneously comply with the state law duty to
strengthen the warnings and the federal law duty prohibiting generic drug
manufacturers from making any unilateral change to the drug’s labels.45
Contrary to Teva’s argument that Plaintiffs’ claims are pre-empted by
federal law under the controlling precedents of Mensing and Bartlett, Mensing and
Bartlett do not provide generic drug manufacturers with blanket immunity against
state law waming claims. For example, the Mensz`ng Court noted that "federal law
would permit the [generic drug] [m]anufacturers to comply with the state labeling
requirements if, and only if, the FDA and the brand-name manufacturer changed
the brand-name label to do so."46 The crux of the U.S. Supreme Court’s decisions
in Mensing and Bartlett was that the plaintiffs claimed state law required generic
drug manufacturers to provide stronger warnings than the brand-name drug. Thus,
under Mensing and Bartlett, impossibility pre-emption applies to claims involving
a generic drug manufacturer’s failure to unilaterally alter its labeling to comply
with state law warning duties.
“mmmn
"" Id. ar 2470.
45 1a ar 2474-79.
46 Mensing, 564 U.S. at 620,.,._
10