[Cite as Tibbe v. Ranbaxy, Inc., 2017-Ohio-1149.] IN THE COURT OF APPEALS FIRST APPELLATE DISTRICT OF OHIO HAMILTON COUNTY, OHIO
ASHLEY N. TIBBE, : APPEAL NO. C-16o472 TRIAL NO. A-1405563 and :
CHRISTINE TIBBE, : O P I N I O N. Plaintiffs-Appellants, :
vs. :
RANBAXY, INC., :
Defendant-Appellee, :
and :
RANBAXY LABORATORIES : LIMITED, et al.,
Defendants. :
Civil Appeal From: Hamilton County Court of Common Pleas
Judgment Appealed From Is: Affirmed
Date of Judgment Entry on Appeal: March 29, 2017
Loeb, Vollman, & Friedmann and Roger E. Friedmann, for Plaintiffs-Appellants,
Ulmer & Berne LLP, Thomas G. McIntosh and Jeffrey F. Peck, for Defendant- Appellee. OHIO FIRST DISTRICT COURT OF APPEALS
CUNNINGHAM, Judge.
{¶1} Plaintiffs-appellants Ashley and Christine Tibbe appeal the judgment
of the common pleas court granting summary judgment to defendant-appellant
Ranbaxy, Inc., (“Ranbaxy”) on the basis that the Tibbes’ claims were preempted by
federal law. We affirm the trial court’s judgment.
The Tibbes’ Claims
{¶2} Ashley Tibbe and her mother, Christine Tibbe, filed a complaint
alleging personal injury to Ashley when she was a minor from her ingestion of the
drug minocycline, which is the generic form of the brand-name or reference-listed
drug (“RLD”) Minocin. They alleged that in June 2010, Ashley began using
minocycline to treat acne, taking it until September 2011, when she developed lupus
as a result of her ingestion of the drug.
{¶3} The Tibbes further alleged that the generic form of minocycline that
Ashley had ingested had been manufactured by several companies, including
Ranbaxy,1 and that Kroger Limited Partnership I (“Kroger”) had operated the
pharmacies that filled the prescriptions for minocycline and dispensed or supplied
the generic form of the drug. They also alleged that Christine had incurred and paid
certain medical expenses and other expenses related to Ashley’s care and treatment,
and that she had also suffered emotional distress and anxiety related to Ashley’s
injuries.
{¶4} The Tibbes’ complaint included causes of action against Ranbaxy and
Kroger in products-liability negligence, common-law fraud and misrepresentation,
Ohio Consumer Sales Practices Act violations, and negligent failure to counsel. The
1The Tibbes voluntarily dismissed their claims against defendants Teva Pharmaceuticals USA, Inc., and Actavis, Inc., f.k.a. Watson Pharmaceuticals, Inc., prior to the trial court’s ruling on their motions to dismiss.
2 OHIO FIRST DISTRICT COURT OF APPEALS
gravamen of the claims was that the defendants had failed to adequately warn “the
plaintiffs and others,” including physicians, of the risks associated with the use of
minocycline, particularly the risk of developing lupus, in violation of state law. The
Tibbes further alleged that the defendants had violated federal law by failing to
report adverse events to the Food and Drug Administration (“FDA”) and by “fail[ing]
to follow FDA procedures concerning product letters of approval.”
{¶5} Kroger filed an answer and a cross-claim against Ranbaxy seeking
indemnification and contribution for any judgment that might be rendered against it.
Kroger also filed a “counterclaim” against Christine Tibbe. Kroger alleged that “its
actions or omissions, if any, were passive, remote, and secondary to the active and
primary negligence of Christine Tibbe” and that it was entitled to contribution and
indemnification from Christine Tibbe in the event any liability was assessed against
it.
Ranbaxy’s and Kroger’s Motions to Dismiss
{¶6} Ranbaxy and Kroger each filed motions to dismiss the Tibbes’
complaint. They argued that the Tibbes’ claims were predicated upon a failure-to-
warn theory and that under the United States Supreme Court’s decision in Pliva, Inc.
v. Mensing, 564 U.S. 604, 609, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), such state-
law failure-to-warn claims against generic-drug manufacturers and suppliers were
preempted by federal law because it was impossible for them to comply with their
state-law duty to adequately warn and their federal-law duty to maintain the same
labeling as their brand-name counterpart. They additionally argued that the Tibbes’
allegations that the defendants had violated federal law by failing to report adverse
events to the FDA and by failing to “follow FDA product letters of approval” failed to
assert a state-law claim because there is no private right to enforce the federal Food
3 OHIO FIRST DISTRICT COURT OF APPEALS
Drug and Cosmetic Act’s [FDCA] provisions. See 21 U.S.C. 337(a) (“proceedings for
enforcement of the FDCA shall be by and in the name of the United States”); see also
Buckman v. Plaintiff’s Legal Comm., 531 U.S. 341, 349, 121 S.Ct. 1012, 148 L.Ed.2d
854 (2001), fn. 4 (“The FDCA leaves no doubt that it is the Federal Government
rather than litigants who [is] authorized to file suit for noncompliance with the
FDCA.”).
{¶7} In their memorandum opposing the motions, the Tibbes argued that
they may have a claim that fit within what they characterized as a “narrow exception”
to preemption based on the “failure-to-update theory” articulated by the Sixth
Circuit in Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir.2013). The Tibbes contended,
however, that without discovery, they could not assert a failure-to-update claim
against Ranbaxy. Likewise, the defendants could not demonstrate that their labeling
was the same as the RLD, Minocin, as required for preemption under Mensing. The
Tibbes additionally argued for the first time that the defendants should have
accompanied their minocycline products with a warning to consumers that they have
no “recourse for any harm that may be caused by their drugs.”
{¶8} The trial court denied the defendants’ motions to dismiss. In its entry,
the trial court acknowledged the preemptive effect of federal law on the Tibbes’
claims, but found, citing Fulgenzi, that there was an “exception” to federal
preemption for a claim based on a failure-to-update theory. The trial court
concluded that Ranbaxy and Kroger “[could] not prove that they were unequivocally
entitled to federal preemption at this time” and permitted the Tibbes to conduct
“discovery to determine the facts that would support their claims against both
Ranbaxy and Kroger.”
4 OHIO FIRST DISTRICT COURT OF APPEALS
Ranbaxy’s Motion for Summary Judgment
{¶9} Following discovery, Ranbaxy moved for summary judgment on the
basis that the “Fulgenzi exception” as articulated in the trial court’s entry did not
apply and that the Tibbes’ claims were, therefore, preempted under Mensing, 564
U.S. 604, 131 S.Ct. 2567, 180 L.Ed.2d 580. In Fulgenzi, the Sixth Circuit held that a
plaintiff’s state-law failure-to-warn claim against a generic-drug manufacturer was
not preempted by federal law where the plaintiff had alleged that the generic
manufacturer had failed to update its labeling to match the updated labeling of the
brand-name manufacturer. See Fulgenzi at 585.
{¶10} The Sixth Circuit reasoned that because the generic manufacturer
could have independently updated its labeling to match that of the brand-name
manufacturer, and, in fact, had a federal duty to do so, compliance with both federal
and state-law duties was not just possible, it was required. Id. Thus, it held that the
plaintiff’s narrow argument that the generic manufacturer’s warning was inadequate
to the extent that it did not include language contained in the updated brand-name
label was not preempted under Mensing. Id.
{¶11} Ranbaxy pointed out that the FDCA defines “labeling” as “all labels
and other written, printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.” See 21 U.S.C. 321(m).
The FDA regulations define “[l]abeling [to] include all written, printed, or graphic
matter accompanying any article at any time while such article is in interstate
commerce or held for sale after shipment or delivery in interstate commerce”; and
“label means any display of written, printed, or graphic matter on the immediate
container of any article, or any such matter affixed to any consumer commodity or
5 OHIO FIRST DISTRICT COURT OF APPEALS
affixed to or appearing upon a package containing any consumer commodity.” See 21
C.F.R. 1.3.
{¶12} Ranbaxy argued that the pharmacy records produced by Kroger
showed that Ashley had received prescriptions of Ranbaxy’s generic minocycline
from June 2010 to August 2011. During that time, the warning language for lupus in
Ranbaxy’s generic minocycline package insert matched the warning language for
lupus in the package insert for the RLD, Minocin.
{¶13} Ranbaxy attached to its motion for summary judgment Ashley’s
pharmacy records, as well as the package inserts from the RLD, Minocin, and the
generic minocycline manufactured by Ranbaxy for the time period that Ashley had
allegedly consumed the drug. Ranbaxy, citing federal case law, argued that the trial
court could take judicial notice of the package insert for Minocin as set forth on the
FDA website. Ranbaxy also attached the affidavit of Usha Sankaran, the senior
director of regulatory affairs, North America, for Ranbaxy.
{¶14} Sankaran averred that Ranbaxy had submitted its abbreviated new
drug application (“ANDA”) of 100 mg minocycline hydrochloride for FDA approval
on December 27, 1999. The FDA had approved the ANDA on November 30, 2000.
The package insert for Ranbaxy’s generic 100 mg minocycline hydrochloride in effect
in June 2010 has a revision date of January 2009 and went into effect in May 2009.
The package insert for Ranbaxy’s generic 100 mg minocycline hydrochloride in effect
in April 2011 has a revision date of February 2011 and went into effect in April 2011.
There were no other package inserts in effect for Ranbaxy’s generic 100 mg
minocycline hydrochloride between June 2010 and April 2011.
6 OHIO FIRST DISTRICT COURT OF APPEALS
{¶15} Sankaran further averred that the package inserts for Ranbaxy’s 100
mg generic minocycline hydrochloride and the RLD, Minocin, contained the same
warning relating to lupus under the adverse reactions section:
Hypersensitivity reactions; Urticaria, angioneurotic edema,
polyarthralgia, anaphylaxis/anaphylactoid reaction (including
shock and fatalities), anaphylactoid purpura, myocarditisi,
pericarditis, exacerbation of systemic lupus erythemaosus and
pulmonary infiltrates with eosinophilia have been reported. A
transient lupus-like syndrome and serum sickness-likeness
reactions also have been reported.
***
Lupus-like syndrome consisting of positive antinuclear antibody;
arthralgia; arthritis, joint stiffness, or joint swelling; and one or
more of the following: fever, myalgia, hepatitis, rash and vasculitis.
{¶16} In their memorandum opposing summary judgment, the Tibbes
argued that Ranbaxy had failed to meet its burden of proof because Sankaran’s
statement, by itself, that the labels for its generic minocycline and the RLD, Minocin,
were identical was insufficient to support summary judgment where the affidavit
referred to the attached package inserts for minocycline only. They additionally
argued that summary judgment was improper because Ranbaxy had failed to warn
that it had no duty as a generic manufacturer to independently verify the warnings
on its labels. They asserted that such a warning would not be preempted under
Mensing, because it did not imply any type of therapeutic difference between the
generic minocyline and the RLD, Minocin. The Tibbes argued that because Ranbaxy
7 OHIO FIRST DISTRICT COURT OF APPEALS
had not addressed this argument in its motion for summary judgment, the trial court
could not grant it summary judgment on this claim.
{¶17} After the trial court took judicial notice of the package inserts for the
RLD, Minocin, it granted summary judgment to Ranbaxy on the basis that the
Tibbes’ claims were preempted by federal law. The trial court stated that the
“exception” to federal preemption articulated in Fulgenzi did not apply because
Ranbaxy had presented admissible evidence that the warning language for lupus on
Ranbaxy’s minocycline label was the same as the warning language on the RLD,
Minocin, label. Thus, under Mensing, any claim that Ranbaxy should have added
additional warnings to its labeling would be preempted by federal law.
{¶18} The Tibbes appealed the trial court’s order. Ranbaxy filed a motion to
dismiss the Tibbes’ appeal. It argued that because the trial court’s entry granting
summary judgment lacked Civ.R. 54(B) certification, and the Tibbes’ claims against
Kroger remained pending in the trial court, the entry was not a final appealable
order. We agreed and dismissed the Tibbes’ appeal.
{¶19} Shortly thereafter, the Tibbes voluntarily dismissed their claims
against Kroger without prejudice pursuant to Civ.R. 41(A)(1)(a). The Tibbes then
filed another notice of appeal from the trial court’s order granting summary
judgment to Ranbaxy.
Jurisdiction
{¶20} As an initial matter, we note that the Tibbes’ voluntary dismissal of
their claims against Kroger created a final appealable order. Civ.R. 41(A)(1)(a)
provides that:
[A] plaintiff, without order of court, may dismiss all claims asserted
by that plaintiff against a defendant by doing either of the
8 OHIO FIRST DISTRICT COURT OF APPEALS
following: (a) filing a notice of dismissal at any time before the
commencement of trial unless a counterclaim which cannot remain
pending for independent adjudication by the court has been served
by that defendant[.]
{¶21} While the record reflects that Kroger filed a purported “counterclaim”
against Christine Tibbe, this claim was in effect a cross-claim because it was
dependent upon a finding of liability against Kroger. Because the Tibbes’ dismissal
of their claims against Kroger precludes a finding of liability against it, Kroger’s claim
against Christine Tibbe is moot. See Wise v. Gursky, 66 Ohio St.2d 241, 243, 421
N.E.2d 150 (1981); Wisintainer v. Elcen Power Strut Co., 67 Ohio St.3d 352, 355, 617
N.E.2d 1136 (1993); see also Unternaher v. Heath, 5th Dist. Licking No. 14-CA-108,
2015-Ohio-3069, ¶ 20. Thus, the trial court’s order granting summary judgment to
Ranbaxy is a final appealable order.
Summary Judgment
{¶22} In their sole assignment of error, the Tibbes argue the trial court erred
by granting summary judgment in favor of Ranbaxy on the basis that their state-law
claims were preempted by federal law.
{¶23} We review the grant of summary judgment de novo, employing the
same standard as the trial court. Summary judgment is appropriate where there is
no genuine issue of material fact, the moving party is entitled to judgment as a
matter of law, and the evidence demonstrates that reasonable minds can come to but
one conclusion, and that conclusion is adverse to the party opposing the motion.
Comer v. Risko, 106 Ohio St.3d 185, 2005-Ohio-4559, 833 N.E.2d 712, ¶ 8.
9 OHIO FIRST DISTRICT COURT OF APPEALS
Federal Regulation of Pharmaceutical Drugs
{¶24} The marketing of pharmaceutical drugs is heavily regulated by federal
law. The FDA is the federal agency charged by Congress with regulating the
manufacture, sale, and labeling of new prescription drugs. In re Darvocet, Darvon,
and Propoxyphene Prods. Liab. Litigation, 756 F.3d 917, 922 (6th Cir.2014). To
acquire federal approval to market a drug, the 1962 Drug Amendments to the FDCA
require that a manufacturer prove that the proposed drug is “safe and effective and
that the proposed label is accurate and adequate,” which occurs by way of lengthy
and costly clinical testing. Id. For a period of time, all manufacturers had to
complete the same approval process, regardless of whether the manufacturer was
seeking to market an entirely new pharmaceutical drug or merely a new generic
version of an existing drug. Id.
{¶25} Congress, however, in the 1984 Drug Price Competition and Patent
Term Restoration Act, popularly known as the Hatch-Waxman Amendments to the
FDCA, in an effort to increase the availability of low-cost generic drugs, altered the
approval process for generic drugs. The Hatch-Waxman Amendments permit
manufacturers to obtain expedited FDA approval of a generic version of a drug where
the active ingredients of the generic drug are the same as the RLD—generally a
brand-name drug that has already been approved by the FDA—and the safety and
efficacy of the labeling proposed is the same as the labeling approved for the RLD.
Id. at 923.
{¶26} The FDA has created procedures by which manufacturers can make
changes to a drug’s approved labeling. Brand-name manufacturers may seek to
modify a drug’s labeling through a “Prior Approval Supplement,” which requires
submission to and approval by the FDA prior to distribution of the product, or
10 OHIO FIRST DISTRICT COURT OF APPEALS
through a “changes-being-effected” (CBE) supplement, which must be submitted 30
days before distribution, but does not require prior FDA approval. Label changes to
add or strengthen a contradiction, warning, precaution, or adverse reaction, may be
made through the CBE process. Id.
{¶27} In Mensing, 564 U.S. 604, 131 S.Ct. 2567, 180 L.Ed.2d 580, the United
States Supreme Court recognized that under federal regulations, generic
manufacturers have different labeling responsibilities from their brand-name
counterparts. In Mensing, the plaintiffs had argued that they had developed tardive
dyskinesia based on their long term use of the generic drug metoclopramide and that
the generic manufacturers were liable under state law for failing to provide adequate
warnings of the risk or prevalence of tardive dyskinesia. Id. at 610. The generic
manufacturers argued that the failure-to-warn claims were preempted because they,
as generic manufacturers, could not unilaterally change their labels after their initial
FDA approval to include warnings that varied from Reglan, the brand name or RLD.
Id.
{¶28} The Supreme Court agreed with the generic manufacturers. It held
that because generic manufacturers were required under federal law to maintain the
same labeling as the brand-name drug Reglan, to the extent state law would have
required the generic manufacturers to use a stronger warning label state and federal
law conflicted, making it impossible for the generic manufacturers to comply with
both laws. The Supreme Court held that federal law, therefore, preempted state law
on plaintiffs’ failure-to-warn claim. Id. at 613.
{¶29} The Supreme Court rejected the plaintiffs’ arguments that the generic
manufacturers could have utilized the FDA’s “changes-being-effected” process
11 OHIO FIRST DISTRICT COURT OF APPEALS
and/or “dear doctor” letters to unilaterally strengthen their warning labels without
waiting for FDA approval. Id. at 614-615.
{¶30} The Mensing court stated that the possibility of complying with both
state and federal law did not defeat a finding of conflict preemption. It held that the
federal duty to seek a labeling change from the FDA would not have satisfied the
state-law duty to warn, and the manufacturers were not required to prove that they
would have been prohibited from making a labeling change if they had asked the
FDA for permission to do so in order to establish conflict preemption. The court
explained:
This raises the novel question whether conflict pre-emption should
take into account these possible actions by the FDA and the brand-
name manufacturer. Here, what federal law permitted the
manufacturers to do could have changed, even absent a change in
the law itself, depending on the actions of the FDA and the brand-
name manufacturer. Federal law does not dictate the text of each
generic drug’s label, but rather ties those labels to their brand-
name counterparts. Thus, federal law would permit the generic
manufacturers 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.
Id. at 620.
{¶31} The Mensing plaintiffs had additionally argued that the manufacturers
could not establish conflict preemption because they had not tried to start the
process for seeking a label change with the FDA and the brand-name manufacturer.
The court rejected this “fair argument” stating
12 OHIO FIRST DISTRICT COURT OF APPEALS
the question for ‘impossibility’ is whether the private party could
independently do under federal law what state law requires of it.
Accepting [plaintiffs’] argument would render conflict pre-emption
largely meaningless because it would make most conflict between
state and federal law illusory.
[Citations omitted.] Id. Thus, the court found that conflict preemption had been
established. The court stated
to decide these cases, it is enough to hold that when a party cannot
satisfy its state duties without the Federal Government’s special
permission and assistance, which is dependent on the exercise of
judgment by a federal agency, that party cannot independently
satisfy those duties for pre-emption purposes.
Id. at 623-624.
{¶32} The Mensing court recognized the unfortunate hand that federal drug
regulation had dealt plaintiffs who have consumed generic drugs. The court
recognized that had the plaintiffs consumed the brand-name drug prescribed by their
doctors, instead of the generic version, their lawsuits would not be preempted by
federal law. The Mensing court held, however, that it was not “its task to decide
whether the statutory scheme established by Congress is unusual or even bizarre”
and that it would “not distort the Supremacy clause in order to create similar
preemption across a dissimilar statutory scheme.” Id. at 625. Thus, the Mensing
court concluded that Congress and the FDA retained the authority to change the law
and regulations if they desired. Id.
{¶33} In Stayhorn v. Wyeth Pharms, Inc., 737 F.3d 378, 391 (6th Cir.2013),
the Sixth Circuit rejected plaintiffs’ argument that Mensing should be read narrowly
13 OHIO FIRST DISTRICT COURT OF APPEALS
to preempt only those state-law claims based on the adequacy of the information
contained in the drug’s label and not claims based on “a manufacturer’s duty to
provide a warning beyond the label.” The Sixth Circuit noted that such a narrow
reading of Mensing had been “soundly rejected by all circuits to consider [it].” Id.
The court noted that the “circuits had interpreted Mensing to broadly preempt
claims that are, at their core, claims that the generic manufacturers failed to provide
additional warnings beyond that which was required by federal law of the brand-
name manufacturer.” Id. at 391.
Summary Judgment was Properly Granted to Ranbaxy
{¶34} In its motion for summary judgment, Ranbaxy argued that the Tibbes’
claims were preempted under Mensing because the package inserts for the brand-
name drug Minocin and its generic drug, minocycline, were identical, containing the
same warning language related to lupus at the time that Ashley had been prescribed
minocycline. In their appellate brief, the Tibbes do not dispute that Ranbaxy has a
federal-law duty as a generic manufacturer to maintain the same labeling as the
brand-name manufacturer. Nor do the Tibbes dispute the sameness of the labeling
for Ranbaxy’s generic minocycline and the brand-name RLD, Minocin, during the
time that Ashley had consumed Ranbaxy’s generic minocycline.
{¶35} Instead, they argue that the trial court erred in granting summary
judgment to Ranbaxy because there is a genuine issue of material fact as to whether
Ranbaxy had an additional duty to warn consumers of the generic version of the drug
that they cannot bring a state-law failure-to-warn claim when their prescriptions are
filled with Ranbaxy’s generic minocycline and the labeling for the drug is the same as
that of the RLD. The Tibbes argue that “Ranbaxy knows under the current landscape
that they can escape liability for any deficiencies in their product by simply
14 OHIO FIRST DISTRICT COURT OF APPEALS
maintaining the same warnings that the brand-name drug equivalent uses, yet they
do not warn consumers that they are not liable for any deficiencies in their labels,
and they failed to take precautions that a reasonable company would take in
presenting this information to the consumer.”
{¶36} The Tibbes argue that they were unaware that by purchasing the
Ranbaxy product, they would be forfeiting their right to contest the adequacy of the
warning labels that accompanied Ashley’s prescription, and that they accepted this
risk without ever knowing about it. As a result, they assert that Ranbaxy has violated
its state-law duty to warn consumers that once they purchase a generic version of the
drug, they have no right to sue the generic manufacturer if its labeling is the same as
that of the brand-name manufacturer.
{¶37} While the trial court did not directly address this argument on
summary judgment, we cannot conclude the trial court erred in granting summary
judgment to Ranbaxy on the Tibbes’ failure-to-warn claims, including this particular
one. We need not determine whether the Tibbes’ claim that Ranbaxy must warn
consumers they cannot prosecute a state-law failure-to-warn claim when its labeling
matches that of the brand-name manufacturer would be preempted by federal law.
{¶38} As Ranbaxy points out, the Tibbes did not plead this specific failure-to-
warn claim in their complaint and they cite no law to support their argument. Under
the Ohio Product Liability Act, a manufacturer, such as Ranbaxy, has a duty to warn
of the risks associated with the product. See R.C. 2307.76(A)(1)(a). There is no
corresponding duty to warn a consumer of her legal rights or the prospective
outcome of litigation should she decide to sue a drug manufacturer at a future point
in time. Thus, a claim based on that theory would not be available under Ohio law.
See R.C. 2307.71(B) (“Sections R.C. 2307.71 to 2307.80 of the Revised Code are
15 OHIO FIRST DISTRICT COURT OF APPEALS
intended to abrogate all common law product liability claims or causes of action.”).
Similarly, the Tibbes could not pursue this claim under the Ohio Consumer Sales
Practices Act because the Act does not apply to claims for personal injuries. See R.C.
1345.12(C).
{¶39} Because there are no genuine issues of material fact and Ranbaxy is
entitled to judgment as a matter of law, the trial court did not err in granting
summary judgment to Ranbaxy on the basis that the Tibbes’ claims that Ranbaxy
had failed to adequately warn the plaintiffs and others, including physicians, of the
risks of injury associated with the use of minocycline, particularly the risk of
developing lupus, were preempted by federal law. Similarly, the trial court did not
err in granting summary judgment to Ranbaxy on the Tibbes’ claim that Ranbaxy, as
a generic manufacturer, had a state-law duty to warn consumers regarding their
potential legal rights, because their claim is not supported by Ohio law. We,
therefore, overrule the sole assignment of error and affirm the judgment of the trial
court.
Judgment affirmed.
MOCK, P.J., and ZAYAS, J., concur.
Please note: The court has recorded its own entry this date.