Tibbe v. Ranbaxy, Inc.

[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.

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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

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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.”

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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

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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.

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{¶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

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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