Schrock v. Wyeth Inc.

FILED
United States Court of Appeals
Tenth Circuit
PUBLISH
August 28, 2013
UNITED STATES COURT OF APPEALS
Elisabeth A. Shumaker
Clerk of Court
TENTH CIRCUIT

SUSAN SCHROCK; STEVE
SCHROCK,

Plaintiffs–Appellants,

v.
No. 12-6078
WYETH, INC.; SCHWARZ PHARMA,
INC.; PLIVA USA, INC.; QUALITEST
PHARMACEUTICALS, INC.,

Defendants–Appellees.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR
THE WESTERN DISTRICT OF OKLAHOMA
(D.C. No. 5:08-CV-00453-M)

Terrence J. Donahue, McGlynn Glisson & Mouton, Baton Rouge, Louisiana, for the
Plaintiffs-Appellants.

Jeffrey Francis Peck, Ulmer & Berne LLP, Cincinnati, Ohio (Linda E. Maichl and Joseph
P. Thomas with him on the brief) for Defendant-Appellee Pliva, Inc..

Kannon K. Schanmugam, Williams & Connolly LLP, Washington, D.C. (James M.
McDonald, Williams & Connolly LLP, Washington, D.C.; Henninger S. Bullock and
Andrew J. Calica, Mayer Brown, LLP, New York, New York, with him on the brief) for
Defendant-Appellee Wyeth, Inc. and Schwarz Pharma, Inc..
Richard H. Nakamura Jr., Morris Polich & Purdy, LLP, Los Angeles, California
(Tammara Tukloff, Morris Polich & Purdy LLP, San Diego, California; J.R. Baker and
Kim A. Tran, Hiltgen & Brewer, P.C., Oklahoma City, Oklahoma, with him on the brief)
for Defendant-Appellee Qualitest Pharmaceuticals, Inc..

Before LUCERO, HARTZ, and HOLMES, Circuit Judges.

LUCERO, Circuit Judge.

Susan and Steven Schrock filed suit against brand-name and generic

manufacturers of the drug metoclopramide, alleging that Susan Schrock’s use of generic

metoclopramide caused her to develop tardive dyskinesia, a neurological disorder

characterized by involuntary body movements. The district court dismissed all claims in

favor of the manufacturers in a series of orders. On appeal, the Schrocks challenge the

dismissal of their claims against PLIVA USA, Inc. (“PLIVA”), Qualitest

Pharmaceuticals, Inc. (“Qualitest”), Schwarz Pharma, Inc. (“Schwarz”), and Wyeth, Inc.

(“Wyeth”).

Following oral argument, we abated this appeal pending the Supreme Court’s

decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). In light

of the Court’s opinion in Bartlett, we are compelled to conclude that the Schrocks’

breach-of-warranty claims against PLIVA and Qualitest, the generic drug manufacturers,

are preempted by federal law. We also agree with the district court that the Schrocks’

non-warranty claims against the generic manufacturers are barred by Oklahoma’s two-
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year statute of limitations. Okla. Stat. tit. 12 § 95.

With respect to the Schrocks’ claims against Schwarz and Wyeth, name-brand

manufacturers of metoclopramide, we are in accord with the district court’s determination

that Oklahoma tort law would not provide a remedy. Given prior Oklahoma precedent

and the clear consensus of courts in other jurisdictions, we predict that Oklahoma would

not impose a duty on brand-name drug manufacturers to consumers of a generic

manufacturer’s products.

Finally, we reject the argument that the Schrocks’ notice of appeal was untimely

as to certain orders they seek to appeal. Exercising jurisdiction under 28 U.S.C. § 1291,

we affirm.

I

A

Under the 1962 amendments to the Federal Food, Drug, and Cosmetic Act

(“FDCA”), Pub. L. 87-781, 76 Stat. 780 (1962) (codified at 21 U.S.C. §§ 301 et seq.), a

manufacturer seeking federal approval to market a new drug “must prove that it is safe

and effective and that the proposed label is accurate and adequate.” PLIVA, Inc. v.

Mensing, 131 S. Ct. 2567, 2574 (2011) (citing 21 U.S.C. § 355(b)(1), (d)). Initially, the

same rules applied to all drug manufacturers. See Mensing, 131 S. Ct. at 2574.

However, Congress later passed the Drug Price Competition and Patent Term Restoration

Act of 1984, Pub. L. 98-417, 98 Stat. 1585 (codified as amended in scattered sections of

21 and 35 U.S.C.), known as the Hatch-Waxman Amendments, that created special rules
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for generic drug manufacturers. See Mensing, 131 S. Ct. at 2574.

These Amendments were intended “to provide a swifter route for approval of

generic drugs.” Bartlett, 133 S. Ct. at 2471. “Under Hatch-Waxman, a generic drug may

be approved without the same level of clinical testing required for approval for a new

brand-name drug, provided that the generic drug is identical to the already-approved

brand-name drug in several key respects.” Id. To be approved for sale, a generic drug

must be “identical [to its branded equivalent] in active ingredients, safety, and efficacy,”

as well as in “the safety and efficacy labeling.” Mensing, 131 S. Ct. at 2574 & n.2

(quotation and alteration omitted).

After a generic or brand-name drug is approved, “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.’” Bartlett, 133 S. Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)). Generic

manufacturers “are also prohibited from making any unilateral changes to a drug’s label,”

thus “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.” Id. (quotation and alteration

omitted) (citing 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10)).

B

Metoclopramide was first approved by the Food and Drug Administration

(“FDA”) under the brand name Reglan. Generic manufacturers began production of

metoclopramide in 1985, the same year the FDA-mandated label for all versions of
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metoclopramide was modified to warn that “tardive dyskinesia . . . may develop in

patients treated with metoclopramide.” Mensing, 131 S. Ct. at 2572. The labeling also

added that “therapy longer than 12 weeks has not been evaluated and cannot be

recommended.” Id. (alteration omitted).

Over time, evidence began to suggest that long-term use of metoclopramide can

cause tardive dyskinesia. Id. In 2004, brand-name manufacturers of the drug requested a

label change, which the FDA approved, to add that “therapy should not exceed 12 weeks

in duration.” Id. (alteration omitted). In 2009, the FDA ordered a “black box

warning”—the strongest warning issued by the agency—to be placed on the label of

metoclopramide stating, “[t]reatment with metoclopramide can cause tardive dyskinesia,

a serious movement disorder that is often irreversible . . . . Treatment with

metoclopramide for longer than 12 weeks should be avoided in all but rare cases.” Id.

Susan Schrock was prescribed brand-name metoclopramide (Reglan) on three

occasions between March 2000 and March 2005. Each time, however, she purchased

generic metoclopramide instead. On either May 2 or 3, 2005, Susan Schrock visited Dr.

Michael Tribbey, a neurologist, complaining of “neck drawing and arm weakness” that

began six to eight weeks prior. Dr. Tribbey diagnosed her with “a form of dystonia,” a

neurological movement disorder, that was “quite possib[ly] related to metoclopramide,”

and recommended that she stop taking it. Susan Schrock discontinued the drug, and

researched side effects of metoclopramide online. Following a hiatus during which her

symptoms abated, she reported a worsening of her uncontrollable neck twisting in
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October 2006. In July of 2007, she was formally diagnosed with tardive dyskinesia.

C

On April 30, 2008, the Schrocks sued Schwarz and Wyeth, former manufacturers

of Reglan, and PLIVA, a manufacturer of generic metoclopramide, along with others not

at issue in this appeal. Claims of negligence, strict products liability, breach of

warranties, misrepresentation, and fraud were advanced in the federal court proceedings.

After the district court concluded that Schwarz and Wyeth did not owe a duty to the

Schrocks because Susan Schrock used only generic versions of metoclopramide, it

granted summary judgment in favor of those companies on March 11, 2007. Schwarz

and Wyeth sought certification of the district court’s order under Fed. R. Civ. P. 54(b).

The district court entered a judgment in their favor on April 20, 2009, but did not

explicitly certify the order as final under Rule 54(b).

On April 14, 2010, the district court granted the Schrocks’ motion for leave to file

an amended complaint adding claims against Qualitest, which pharmacy records showed

had manufactured some of the generic metoclopramide that Susan Schrock used.

Qualitest promptly moved to dismiss, arguing the suit was barred by the statute of

limitations. PLIVA filed a motion for summary judgment on the same basis. On July 20,

2010, the district court granted summary judgment in favor of PLIVA, and dismissed all

but the breach-of-warranty claims against Qualitest. On December 8, 2011, the district

court dismissed the breach-of-warranty claims pursuant to a Rule 12(b)(6) motion by

Qualitest, concluding the claims were preempted. On the same date, the court entered
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final judgments in favor of PLIVA and Qualitest.

On January 5, 2012, the Schrocks filed a motion to alter or amend the December 8,

2011 judgment in favor of Qualitest. The district court denied the motion on February

24, 2012. On March 23, 2012, the Schrocks filed a notice of appeal designating the

grants of summary judgment in favor of Wyeth, Schwarz, and PLIVA, and the grants of

Qualitest’s motions to dismiss as the orders being appealed.

II

We first determine whether the Schrocks’ notice of appeal was timely. Schwarz

and Wyeth argue that the district court’s April 20, 2009 judgment in their favor was a

final judgment, thus the Schrocks’ March 23, 2012 notice of appeal is untimely under

Fed. R. App. P. 4(a)(1)(A). After the district court granted Schwarz and Wyeth’s motion

for summary judgment, those companies filed a motion under Fed. R. Civ. P. 54(b). In

granting this motion, the district court entered a judgment stating: “[i]n light of the

Court’s Order granting said defendants summary judgment and having reviewed the

parties’ submissions, the Court hereby enters judgment in favor of defendants WYETH,

INC. and SCHWARZ PHARMA, INC. . . . .”

Under Rule 54(b), a “court may direct entry of a final judgment as to one or more,

but fewer than all, claims or parties only if the court expressly determines that there is no

just reason for delay.” Fed. R. Civ. P. 54(b). Because “Rule 54(b) entries are not to be

made routinely,” we have held that:

[C]ertification under Rule 54(b) is only appropriate when a district court
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 adheres strictly to the rule’s requirement that a court make two express
determinations. First, the district court must determine that the order it is
certifying is a final order. Second, the district court must determine that
there is no just reason to delay review of the final order until it has
conclusively ruled on all claims presented by the parties to the case.

Oklahoma Tpk. Auth. v. Bruner, 259 F.3d 1236, 1242 (10th Cir. 2001).

Schwarz and Wyeth concede that the district court did not make the express

determinations required by our decision in Oklahoma Turnpike; however, they urge us to

follow an approach taken by other circuits and look beyond the text of the district court’s

order to determine whether it can be said to have made the requisite determinations. See,

e.g., Denson v. United States, 574 F.3d 1318, 1335 n.52 (11th Cir. 2009); Askanase v.

LivingWell, Inc., 981 F.2d 807, 810 (5th Cir. 1993). Under this approach, they argue that

their motion seeking Rule 54(b) certification, considered along with the judgment,

reflects the district court’s intent to allow an immediate appeal.

Regardless of the desirability of this alternative rule, “one panel cannot overrule

the judgment of another panel of this court . . . absent en banc reconsideration or a

superseding contrary decision by the Supreme Court.” Barber v. T.D. Williamson, Inc.,

254 F.3d 1223, 1229 (10th Cir. 2001) (quotation omitted). In Oklahoma Turnpike, we

noted that although Rule 54(b)’s “requirement that these determinations be stated

explicitly in the district court’s certification order is to some extent a formality, the

requirement does provide district courts with one last opportunity to discover errors in

their decision to certify an order for appeal.” 259 F.3d at 1244. We have adhered to this

formal requirement. See Stockman’s Water Co., LLC v. Vaca Partners, L.P., 425 F.3d
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1263, 1264-65 (10th Cir. 2005) (dismissing appeal for lack of jurisdiction without

considering the merits of a Rule 54(b) certification or the motion seeking certification

because district court did not make the necessary findings). Because the district court did

not make the requisite determinations under Oklahoma Turnpike, we reject the argument

that the district court’s April 10, 2009 judgment was final for purposes of appeal.

PLIVA, Schwarz, and Wyeth also claim that the March 23, 2012 appeal is

untimely on the theory that the Schrocks’ Rule 59(e) motion—which challenged only the

judgment in favor of Qualitest—did not toll the time to appeal with respect to the other

defendants. We reject this argument. Federal Rule of Appellate Procedure 4(a)(4)(A)

states: “[i]f a party timely files in the district court any of the following motions,”

including a motion to “alter or amend judgment under Rule 59,” then “the time to file an

appeal runs for all parties from the entry of the order disposing of the last such remaining

motion.” Fed. R. App. P. 4(a)(4)(A) (emphasis added).

Our opinion in TBG, Inc. v. Bendis, 36 F.3d 916 (10th Cir. 1994), is not to the

contrary. TBG holds that “a motion to reconsider one final judgment does not extend the

time to appeal another final judgment just because they are part of the same litigation.”

Id. at 921. Unlike the case at bar, however, in TBG the district court had “certified as

final and appealable under Rule 54(b)” both of the separate judgments at issue,

effectively severing the two judgments for appellate purposes. Id. We specifically

recognized that the result would have been different, if, as in the case at bar, the

judgments had not been properly certified as final and appealable. See id. (under Rule
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4(a)(4), “a motion for a new trial by one [party] also extends the time to appeal a verdict

in favor of a second [party], unless the district court certifies the judgments as separate

and final under Rule 54(b)”). Because the district court did not properly certify the

judgments at issue under Rule 54(b), we conclude that the Schrocks’ Rule 59 motion

tolled the time to appeal as to each of the orders. The notice of appeal is therefore timely

as to each order appealed.

III

“We review a grant of summary judgment de novo, applying the same standard as

the district court.” Jaramillo v. Adams Cnty. Sch. Dist. 14, 680 F.3d 1267, 1268 (10th

Cir. 2012). Summary judgment is appropriate only if “there is no genuine dispute as to

any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ.

P. 56(a). We view all facts and evidence in the light most favorable to the party opposing

summary judgment. Morris v. City of Colo. Springs, 666 F.3d 654, 660 (10th Cir. 2012).

We also review de novo a district court’s grant of a motion to dismiss under Fed.

R. Civ. P. 12(b)(6). Khalik v. United Air Lines, 671 F.3d 1188, 1190 (10th Cir. 2012).

We accept as true “all well-pleaded factual allegations in a complaint and view these

allegations in the light most favorable to the plaintiff.” Kerber v. Qwest Group Life Ins.

Plan, 647 F.3d 950, 959 (10th Cir. 2011). To survive a motion to dismiss under Rule

12(b)(6), a complaint must contain “enough facts to state a claim to relief that is plausible

on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007).

All the parties agree that Oklahoma law controls our analysis. Accordingly, “our
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task here is to interpret and apply the law of [Oklahoma] as we believe the [Oklahoma]

Supreme Court would.” High Plains Natural Gas Co. v. Warren Petroleum Co., 875 F.2d

284, 288 (10th Cir. 1989); see also United States v. DeGasso, 369 F.3d 1139, 1145 (10th

Cir. 2004) (“It is axiomatic that state courts are the final arbiters of state law.”). If a state

supreme court has not resolved a legal issue, we “may seek guidance from decisions

rendered by lower courts in the relevant state, appellate decisions in other states with

similar legal principles, district court decisions interpreting the law of the state in

question, and the general weight and trend of authority in the relevant area of law.”

Wade v. Emcasco Ins. Co., 483 F.3d 657, 666 (10th Cir. 2007) (citations and quotation

omitted).

A

The district court concluded that the Schrocks’ claims against PLIVA and

Qualitest, other than their warranty claims, were barred by Oklahoma’s two-year

limitations period. See Okla. Stat. tit. 12, § 95; Kirkland v. Gen. Motors Corp., 521 P.2d

1353, 1361 (Okla. 1974). Oklahoma follows the “discovery rule,” under which “the

statute [of limitations in product liability cases] does not begin to run until the plaintiff

knows, or as a reasonably prudent person should know, that he has the condition for

which his action is brought and that the defendant caused it.” Daugherty v. Farmers

Coop. Ass’n, 689 P.2d 947, 950 (Okla. 1984) (quotation omitted). However, a plaintiff

need not know the “extent of injury” or know that it is “permanent” for the limitations

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period to commence. Kang v. Kang, 11 P.3d 218, 219 (Okla. Civ. App. 2000);1 see also

Daugherty, 689 P.2d at 950-51 (under the discovery rule, “acquisition of sufficient

information which, if pursued, would lead to the true condition of things will be held as

sufficient knowledge to start the running of the statute of limitations”).

We agree with the district court that the Schrocks’ non-warranty claims against

PLIVA are untimely. It is undisputed that in May of 2005 Susan Schrock’s doctor

informed her that metoclopramide was “quite possib[ly]” responsible for her symptoms,

including her uncontrollable neck movement. Yet the Schrocks did not file suit until

April 30, 2008, nearly three years later.

We reject the Schrocks’ assertion that the limitations period began to run only

when Susan Schrock’s symptoms returned, sometime in mid- to late-2006, because it was

then that she developed tardive dyskinesia, rather than the previously diagnosed acute

dystonia.2 Susan Schrock admits that in May 2005 she understood that metoclopramide

was causing her symptoms, recorded by her physician as including uncontrollable neck

movements. At that time, the label for metoclopramide warned that involuntary

1
“Although we are not required to follow the dictates of an intermediate state
appellate court, we may view such a decision as persuasive as to how the state supreme
court might rule.” Sellers v. Allstate Ins. Co., 82 F.3d 350, 352 (10th Cir. 1996).
2
Both dystonia and dyskinesia refer to involuntary movement disorders. The
record indicates that acute dystonia refers to the abrupt onset of muscle spasms and often
involves involuntary twisting and abnormal postures. Dyskinesia refers to any abnormal,
involuntary movement resulting from certain drugs. “Tardive” means “tending to or
characterized by lateness esp. in development or maturity.” Webster’s Third New Int’l
Dictionary 2340 (1993). Thus, tardive dyskinesia features involuntary muscle
movements that develop or persist after a drug is discontinued.

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movement symptoms may “remit, partially or completely, within several weeks-to-

months after metoclopramide is withdrawn” but that tardive dyskinesia is nevertheless

“potentially irreversible.” This was informed by the Schrocks’ contemporaneous online

research on the side effects of metoclopramide shortly after speaking with Dr. Tribbey.

Based on these facts, we agree with the district court that the Schrocks acquired

“sufficient information which, if pursued, would lead to . . . sufficient knowledge to start

the running of the statute of limitations.” Daugherty, 689 P.2d at 951.

Although Oklahoma law might recognize that some symptoms are “too isolated or

inconsequential to trigger the running of the [s]tatute of [l]imitations,” Wetherill v. Eli

Lilly & Co. (In re N.Y. Cnty. DES Litig.), 678 N.E. 2d 474, 478 n.4 (N.Y. 1997), this is

not such a case. Susan Schrock is suing based on involuntary muscle movements caused

by metoclopramide: she was aware of both symptom and cause in May 2005. Oklahoma

courts have squarely rejected an acute versus permanent distinction. See Kang, 11 P.3d

at 219 (holding that the statute of limitations is not tolled until the discovery of

permanent, as opposed to temporary, injuries). We therefore affirm the district court’s

dismissal of the Schrocks’ non-warranty claims against PLIVA.

We reach the same conclusion as to the Schrocks’ non-warranty claims against

Qualitest.3 The Schrocks did not amend their complaint to add these claims until April

3
Qualitest argues that the Schrocks do not challenge the district court’s dismissal
of the non-warranty claims against them on appeal. In their opening brief, the Schrocks
assert only a general statute of limitations argument without stating whether they are
Continued . . .
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14, 2010, after pharmacy records indicated that Qualitest manufactured some of the

generic metoclopramide taken by Susan Schrock. Under Oklahoma law, the Schrocks are

charged with knowledge of facts they would have learned through “reasonable diligence”

in acquiring evidence that would implicate a defendant. See Daugherty, 689 P.2d at 951.

The Schrocks do not attempt to explain the reason they did not obtain Susan Schrock’s

own pharmacy records until two years after filing their complaint and approximately five

years after first learning that metoclopramide was causing her symptoms. The district

court correctly dismissed the Schrocks’ non-warranty claims against Qualitest.

B

Summary judgment in favor of Wyeth and Schwarz was granted on the ground

that the brand-name manufacturers do not owe a duty to the Schrocks because Susan

Schrock did not take brand-name metoclopramide. Although the Oklahoma Supreme

Court has not had an opportunity to speak on this issue, we predict—consistent with the

trend among courts nationally and Oklahoma tort law in general—that it would not

recognize a duty flowing from brand-name drug manufacturers to consumers of generic

drugs.

Oklahoma courts usually require that a defendant have some relationship with the

product alleged to have caused a plaintiff’s injuries, either through manufacturing,

selling, or distributing the product. This is clearly the case in strict products liability

challenging the district court’s orders in favor of Qualitest, PLIVA, or both. Due to this
ambiguity, we decline to treat the issue as waived.

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actions. See Kirkland, 521 P.2d at 1363 (to prevail on strict liability claim for a defective

product, plaintiff must show the product was defective when it left the defendant’s

“possession and control”); see also Dutsch v. Sea Ray Boats, Inc., 845 P.2d 187, 190

(Okla. 1992) (plaintiff asserting manufacturer’s product liability must establish that “the

product was defective when it left the hands of the manufacturer”). Because Wyeth and

Schwarz were never in control or possession of the metoclopramide Susan Schrock took,

the Schrocks cannot establish this element of their strict liability claim.

Several federal district court cases that have applied Oklahoma law have rejected

products liability claims on this basis. See Muniz v. Masco Corp., 744 F. Supp. 266, 267

(W.D. Okla. 1990) (“In Oklahoma, a product liability cause of action lies only against a

manufacturer, seller, or supplier of a defective product.”); Mayberry v. Akron Rubber

Mach. Corp., 483 F. Supp. 407, 412 (N.D. Okla. 1979) (rejecting a products-liability

claim based on the “critical” fact that the products at issue “were not manufactured by

[defendant]”). And we have recently emphasized in an unpublished order and judgment

that under Oklahoma tort law, “responsibility for the defect must still be traced to the

proper Defendant.” Edwards v. PepsiCo, Inc., 268 F. App’x 756, 762 (10th Cir. 2008)

(unpublished).

In addition, the Schrocks contend that Oklahoma law permits claims against an

entity that negligently designs, but does not manufacture, a product that causes harm if

the plaintiff’s resulting injury is foreseeable. They rely primarily on Keel v. Titan

Construction Corp., 639 P.2d 1228 (Okla. 1981), in which the Oklahoma Supreme Court
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held that plaintiffs could bring suit for negligent breach of contract against an architect

who designed their home, absent privity between the plaintiffs and the architect. Id. at

1232. In Keel, however, the architects designed the particular structure that resulted in

plaintiffs’ injury. See id. at 1230. Keel is simply not analogous to the present case, in

which a competitor of the brand-name manufacturers utilized a design originally

conceived by them, and the competitors’ product harmed the plaintiffs.

Oklahoma courts have also required a relationship between the defendant

company and the product at issue for other theories of liability, including negligence. In

Spence v. Brown-Minneapolis Tank, Co., 198 P.3d 395 (Okla. Civ. App. 2008), the court

rejected a negligence claim premised on the same facts as a strict liability claim because

the defendant “had nothing to do with the manufacture” of the product at issue and did

not “occupy a relationship which gives rise to a legal obligation . . . for the benefit of the”

plaintiff. Id. at 401. Similarly, in Copeland v. Admiral Pest Control, 933 P.2d 937 (Okla.

Civ. App. 1996), the court noted that for a claim in negligence, “[w]hether or not a duty

exists depends on the relationship between the parties.” Id. at 939. The brand-name

manufacturers do not have any relationship with the Schrocks.

We are directed to Independent-Eastern Torpedo Co. v. Price, 258 P.2d 189 (Okla.

1953), as supporting the Schrocks’ negligence claim. In Price, the Oklahoma Supreme

Court held that a company had a duty to warn an individual injured by a company

employee. Id. at 201. The duty, however, was based on the employer-employee

relationship between the defendant and the person who injured the plaintiff. Id. (citing
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Southland Cotton Oil Co. v. Renshaw, 299 P. 425 (Okla. 1931)). Such a relationship is

not present between the generic and brand-name manufacturers.

In support of their misrepresentation, fraud, and failure-to-warn claims, the

Schrocks advance two arguments. First, they argue that the brand-name manufacturers

concealed a latent defect in their product. However, in the Oklahoma cases they cite as

permitting such claims, the plaintiff and defendant were engaged in a buyer-seller or

other contractual relationship. See Rogers v. Meiser, 68 P.3d 967, 976 (Okla. 2003)

(“[A] vendor is guilty of fraudulent concealment of a latent defect affecting the value of

property for the purpose for which it was bought.”); Dawson v. Tindell, 733 P.2d 407,

408-09 (Okla. 1987) (suit by home buyers against realtor); O’Quinn v. Nothaff, 205 P.

498, 500 (Okla. 1922) (“[T]he defendants induced the plaintiff to enter into the contract

for the exchange of the cars by committing a fraud.”); Von Brauchitsch v. Cravens, 604

P.2d 379, 380 (Okla. Civ. App. 1978) (“A latent soil defect, known to the seller of a

house built on such soil, creates a duty of disclosure in the seller.”). See also Okland Oil

Co. v. Conoco Inc., 144 F.3d 1308, 1312 (10th Cir. 1998); Uptegraft v. Dome Petroleum

Corp., 764 P.2d 1350, 1351-52 (Okla. 1988). No authority is cited to suggest that a

manufacturer may be held liable under Oklahoma law for concealing a defect in a product

that is never purchased or used by the plaintiff.

Second, the Schrocks argue that Oklahoma law imposes a duty upon brand-name

manufacturers to speak rather than to remain silent in certain circumstances. The

Schrocks recognize, however, “[i]n determining whether there is a duty to speak,
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consideration must be given to the situation of the parties and the matters with which they

are dealing.” Silk v. Phillips Petroleum Co., 760 P.2d 174, 179 (Okla. 1988). Even

accepting the Schrocks’ assertion that the brand-name manufacturers conveyed “a false

impression by the disclosure of some facts and the concealment of others,” Deardorf v.

Rosenbusch, 206 P.2d 996, 998 (Okla. 1949), it nonetheless remains true that the brand-

name manufacturers had no relationship with the Schrocks; there were no “matters with

which they [we]re dealing,” Silk, 760 P.2d at 179.

To the same effect, the Schrocks argue that under Oklahoma law, liability may be

imposed if a defendant has knowledge of a dangerous situation yet fails to warn of that

danger. They cite two cases for this contention: one involves a relationship that clearly

requires a duty, and in the other the court held that there was no duty. Wells v. Boston

Ave. Realty, 125 F.3d 1335, 1339 (10th Cir. 1997) (holding that a “business owner is not

liable for third person assaults”); Rogers v. Hennessee, 602 P.2d 1033, 1034 (Okla. 1979)

(noting that the “parties stand in an undisputed invitor-invitee relationship”). These cases

do not persuade us that Oklahoma courts would impose a duty on drug manufacturers to

warn of dangers in their competitors’ products.

The Schrocks do not develop any specific argument regarding their breach of

warranty claims. Nonetheless, the Oklahoma Uniform Commercial Code contemplates

such claims only as against the seller of the product at issue. See Okla. Stat. tit. 12A,

§ 2-313 (express warranties are “created” by the seller with representations that become

“part of the basis of the bargain”); § 2-314 (“[A] warranty that the goods shall be
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merchantable is implied in a contract for their sale if the seller is a merchant with respect

to goods of that kind.”); § 2-315 (“Where the seller at the time of contracting has reason

to know any particular purpose for which the goods are required and that the buyer is

relying on the seller’s skill or judgment to select or furnish suitable goods, there is unless

excluded or modified under the next section an implied warranty that the goods shall be

fit for such purpose.”). This cause of action does not apply.

We are told that the brand defendants may be held liable under “traditional

theories of tort law.” Several provisions of the Restatement (Second) of Torts, which

recite general tort principles of duty and foreseeability, are relied on by the Schrocks.

See, e.g., Restatement (Second) of Torts §§ 302A; 310; 315; 324A. Although several

other provisions of the Restatement are cited by the Schrocks in response to Wyeth and

Schwarz’s motion for summary judgment, they did not bring these specific Restatement-

based theories to the attention of the district court. Arguments that were not raised below

are “waived for purposes of appeal.” Quigley v. Rosenthal, 327 F.3d 1044, 1069 (10th

Cir. 2003). This rule applies when a “litigant changes to a new theory on appeal that falls

under the same general category as an argument presented at trial or presents a theory

that was discussed in a vague and ambiguous way.” Bancamerica Comm. Corp. v.

Mosher Steel of Kan., Inc., 100 F.3d 792, 798-99 (10th Cir. 1996) (quotations omitted).

Moreover, as the foregoing discussion demonstrates, the Schrocks fail to cite

Oklahoma case law suggesting that these general tort principles impose liability with

respect to a defendant that did not sell, distribute, manufacture, or otherwise have contact
-19-
with the allegedly harmful product. Instead, they ask this court to expand the scope of

tort liability under Oklahoma law by imposing a duty under entirely unprecedented

circumstances. “As a federal court, we are generally reticent to expand state law without

clear guidance from its highest court.” Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir.

1993). And the Schrocks’ novel claims are not supported by “decisions rendered by

lower courts in the relevant state” or “district court decisions interpreting the law of the

state in question.” Wade, 483 F.3d at 666 (citations and quotation omitted).

We may also look to “appellate decisions in other states with similar legal

principles . . . and the general weight and trend of authority in the relevant area of law” in

predicting whether the Oklahoma Supreme Court would recognize a cause of action

against a brand-name drug manufacturer under the present circumstances. But the courts

of other states have overwhelmingly rejected the very theory advanced by the Schrocks.

See Mensing v. Wyeth, Inc., 588 F.3d 603, 613 (8th Cir. 2009) (the “overwhelming

majority of courts” have declined to impose liability against brand-name manufactures on

claims by consumers of a generic equivalent drug), rev’d in part on other grounds sub

nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

In Foster v. American Home Products, 29 F.3d 165 (4th Cir. 1994), the Fourth

Circuit rejected “the contention that a name brand manufacturer’s statements regarding

its drug can serve as the basis for liability for injuries caused by another manufacturer’s

drug.” Id. at 170. The court explained:

Name brand advertising benefits generic competitors because generics are
-20-
 generally sold as substitutes for name brand drugs, so the more a name
brand drug is prescribed, the more potential sales exist for its generic
equivalents. There is no legal precedent for using a name brand
manufacturer’s statements about its own product as a basis for liability for
injuries caused by other manufacturers’ products, over whose production
the name brand manufacturer had no control. This would be especially
unfair when, as here, the generic manufacturer reaps the benefits of the
name brand manufacturer’s statements by copying its labels and riding on
the coattails of its advertising.

Id. Since Foster was decided, every federal circuit court to address this issue—applying

the law of numerous states—has consistently followed. See Guarino v. Wyeth, LLC, No.

12-13263, 2013 WL 3185084, at *6, __ F.3d __ (11th Cir. June 25, 2013) (“[T]he

overwhelming national consensus—including the decisions of every court of appeal and

the vast majority of district courts around the country to consider the question—is that a

brand-name manufacturer cannot be liable for injuries caused by the ingestion of the

generic form of a product.”); Bell v. Pfizer, Inc., No. 12-1674, 2013 WL 2661189, at *3

716 F.3d 1087 (8th Cir. June 14, 2013) (“Because Bell never used Reglan the brand

defendants manufactured, Bell cannot hold them liable under Arkansas law.”); Demahy

v. Schwarz Pharma, Inc., 702 F.3d 177, 183 (5th Cir. 2012) (per curiam) (under

Louisiana law, plaintiff’s “claims against Wyeth and Schwarz fail because they did not

manufacture the medication she actually consumed”), rev’d in part on other grounds sub

nom. Mensing, 131 S. Ct. 2567; Smith v. Wyeth, Inc., 657 F.3d 420, 423-24 (6th Cir.

2011) (argument “that the name-brand defendants’ liability stems from the fact that the

regulatory structure governing name-brand and generic drugs makes it foreseeable that

patients and their physicians will rely on the name-brand labels to use and prescribe
-21-
generic drugs” was “rejected by all but one of the courts that have considered it”), cert.

denied, 132 S. Ct. 2103 (2012); Mensing, 588 F.3d at 614 (concluding that “under

Minnesota law Mensing has not shown that the name brand manufacturers owed her a

duty of care necessary to trigger liability”), rev’d in part on other grounds sub nom.

Mensing, 131 S. Ct. 2567.

Courts that have concluded brand-name manufacturers are not liable to consumers

of generic drugs relied on three principal rationales. First, they based their view on

traditional common law tort principles under which a manufacturer is liable for injuries

caused by its own product. See, e.g., Mensing, 588 F.3d at 604, 613 (holding name brand

manufacturers liable for harm caused by generic manufacturers “stretches the concept of

foreseeability too far” (quotation and alteration omitted)). Second, they reason that

brand-name manufacturers’ warnings and representations do not create a basis for

liability to consumers of competitors’ products because brand-name manufacturers only

“intend[] to communicate with their customers, not the customers of their competitors.”

Id. at 613 n.9; see also Stanley v. Wyeth, Inc., 991 So. 2d 31, 34 (La. Ct. App. 2008) (“A

manufacturer cannot reasonably expect that consumers will rely on the information it

provides when actually ingesting another company’s drug.”). Finally, they conclude that

public policy considerations weigh against holding name-brand competitors liable for

injuries caused by their generic competitor’s drug. See, e.g., Foster, 29 F.3d at 170

(citing the expense in development, research, and promotion undertaken by name-brand

manufacturers not undertaken by generic manufacturers).
-22-
 In contrast to the dozens of cases holding to the contrary, only a handful of

courts—and no federal courts of appeals—have held that brand-name manufacturers can

be held liable for injuries caused by their generic counterparts. See Kellogg v. Wyeth,

762 F. Supp. 2d 694 (D. Vt. 2010); Easter v. Aventis Pasteur, Inc., No. 5:03-CV-141,

2004 WL 3104610 (E.D. Tex. Feb. 11, 2004) (unpublished); Wyeth, Inc. v. Weeks, No.

1101397, 2013 WL 135753, __ So. 2d __ (Ala. Jan. 11, 2013); Conte v. Wyeth, Inc., 85

Cal. Rptr. 3d 299 (Cal. Ct. App. 2008).

We predict that the Oklahoma Supreme Court would not recognize this novel

theory of liability.4 Accordingly, we affirm the district court’s grant of summary

judgment in favor of Wyeth and Schwarz.

C

Finally, the Schrocks argue that the district court erred in concluding that their

breach of express and implied warranty claims against Qualitest were preempted by

federal law under the doctrine of impossibility preemption.5 The Supremacy Clause

provides that the Constitution, 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

Contrary notwithstanding.” U.S. Const., art. VI, cl. 2. State law is preempted if it is

4
Notably, the Schrocks did not request certification of this issue to the Oklahoma
Supreme Court.
5
The Schrocks do not appeal the district court’s dismissal of their breach of
warranty claims against PLIVA.

-23-
“impossible for a private party to comply with both state and federal requirements.”

English v. Gen. Elec. Co., 496 U. S. 72, 79 (1990). As the Supreme Court explained in

its recent FDCA preemption case, state tort law is preempted if it imposes a duty upon

manufacturers to take some action that is prohibited under federal law, because such a

regime “actually conflicts with federal law by making it impossible for a private party to

comply with both state and federal requirements.” Mut. Pharm. Co., Inc. v. Bartlett, 133

S. Ct. 2466, 2479 (2013) (quotation and alterations omitted).

Our analysis of whether the Schrocks’ state law warranty claims are preempted

thus “begin[s] by identifying [Qualitest’s] duties under state law.” Id. at 1473. Under

Oklahoma law, an express warranty is defined as “[a]ny affirmation of fact or promise

made by the seller to the buyer which relates to the goods and becomes part of the basis

of the bargain,” “[a]ny description of the goods which is made part of the basis of the

bargain,” or “[a]ny sample or model which is made part of the basis of the bargain.”

Okla. Stat. tit. 12A, § 2-313(1)(a)-(c). Unless excluded or modified, a warranty that

goods are “merchantable is implied in a contract for their sale if the seller is a merchant

with respect to goods of that kind.” Okla. Stat. tit. 12A, § 2-314(1). To comply with this

warranty, goods must:

(a) pass without objection in the trade under the contract description; and
(b) in the case of fungible goods, [be] of fair average quality within the
description; and
(c) [be] fit for the ordinary purposes for which such goods are used; and
(d) run, within the variations permitted by the agreement, of even kind,
quality and quantity within each unit and among all units involved; and
(e) [be] adequately contained, packaged, and labeled as the agreement may
-24-
 require; and
(f) conform to the promises or affirmations of fact made on the container or
label if any.

§ 2-314(2) (a)-(f).

Consistent with these statutory provisions, the Schrocks alleged under the “Breach

of Warranties” heading in their amended complaint that: (1) Qualitest “expressly and

impliedly warranted that . . . metoclopramide [was] not unreasonably dangerous and

instead [was] merchantable and fit for its intended use”; (2) Qualitest’s metoclopramide

“contained descriptions of the safety profile of the medication to which it did not

conform”; (3) Qualitest’s metoclopramide was “not adequately contained, packaged, and

labeled, and did not conform to the promises [and] affirmations of fact made in the label

which accompanied the drug”; and (4) Qualitest’s “metoclopramide did not conform to

express warranties present on its labeling, was not merchantable, was unfit for its

intended use, and was unreasonably dangerous.”

Both the complaint and the Oklahoma statute refer to the manner in which a

product is labeled, packaged, and otherwise described to the consumer. See Okla. Stat.

tit. 12A, § 2-313(1)(a)-(b) (“promise[s]” and “description[s]” of the goods); § 2-314(2)

(a) (“pass without objection in the trade under the contract description”); § 2-314(2)(b)

(“are of fair average quality within the description”); § 2-314(2)(e) (“are adequately

contained, packaged, and labeled as the agreement may require”); § 2-314(2)(f)

(“conform to the promises or affirmations of fact made on the container or label”).

Repeatedly, the Schrocks’ complaint refers to the “descriptions” and “labeling” of the
-25-
metoclopramide. These warranty claims are thus based on the theory that Qualitest

provided improper descriptions or warnings in the labeling and packaging of

metoclopramide or that the content of the metoclopramide Qualitest sold rendered it

unreasonably dangerous or unmerchantable.

In Mensing, the Court recognized that federal law imposes “an ongoing federal

duty of ‘sameness’” that precludes generic drug manufacturers from altering their

products labels. 131 S. Ct. at 2575 (citing Abbreviated New Drug Application

Regulations, 57 Fed. Reg. 17,950, 17,961 (1992)). Further, generic manufacturers may

not use “‘Dear Doctor’ letters to send additional warnings to prescribing physicians and

other healthcare professionals.” Id. at 2576. Deferring to the FDA’s interpretation of its

regulations, the Mensing Court held that “Dear Doctor letters qualify as ‘labeling’” and

thus such a letter “that contained substantial new warning information would not be

consistent with the drug’s approved labeling.” Id. Based on these determinations, the

Court held that state law failure-to-warn claims against generic drug manufacturers are

preempted by federal regulations because it is impossible for a generic manufacturer of

metoclopramide to unilaterally alter its drug’s label to comply with state law without

violating FDA regulations. Id. at 2577-78.

Key to the Mensing decision was the Court’s deference to the FDA’s broad-

definition of “labeling.” Id. at 2576. Under FDA regulations, the term “labeling” in the

prescription drug context is expansive, including:

[b]rochures, booklets, mailing pieces, detailing pieces, file cards, bulletins,
-26-
 calendars, price lists, catalogs, house organs, letters, motion picture films,
film strips, lantern slides, sound recordings, exhibits, literature, and reprints
and similar pieces of printed, audio, or visual matter descriptive of a drug
and references published (for example, the “Physicians’ Desk Reference”)
for use by medical practitioners, pharmacists, or nurses, containing drug
information supplied by the manufacturer, packer, or distributor of the drug
and which are disseminated by or on behalf of its manufacturer, packer, or
distributor . . . .

21 C.F.R. § 202.1(l)(2); see also Del Valle v. PLIVA, Inc., No. B:11-113, 2011 WL

7168620, at *4 (S.D. Tex. Dec. 21, 2011) (unpublished) (“In essence, virtually all

communication with medical professionals concerning a drug constitutes labeling.”)

adopted sub nom. Del Valle v. Qualitest Pharm. Inc., 2012 WL 2899406 (S.D. Tex. June

22, 2012) (unpublished)).

Plaintiffs attempt to distinguish Mensing by asserting that it only addressed

failure-to-warn claims in the context of a drug’s label, which they appear to construe

narrowly. Yet the same federal regulatory scheme that prevented generic manufacturers

from unilaterally issuing label changes and “Dear Doctor letters” at issue in Mensing

applies to a broad array of communications. No effort is made to identify a mechanism

through which Qualitest could have modified or supplemented the warranties allegedly

breached without running afoul of the duty of sameness identified in Mensing.

Accordingly, the Schrocks’ claims are preempted to the extent they rest on inadequate

labeling as broadly defined by the FDA.

It is also alleged in the complaint that Qualitest’s product “was not

merchantable, was unfit for its intended use, and was unreasonably dangerous.” See

-27-
Okla. Stat. tit. 12A, § 2-314(2)(c) (implied warranty that product is “fit for the ordinary

purposes for which such goods are used”). Under Oklahoma law, products are

“merchantable” or “fit” if they “operate for their ordinary purpose.” Perry v. Lawson

Ford Tractor Co., 613 P.2d 458, 463 (Okla. 1980). We conclude that these claims, based

on allegations of dangerousness or ineffectiveness, are also preempted because Qualitest

could not have altered the composition of the metoclopramide it manufactured without

violating federal law. In Bartlett the Supreme Court held that the reasoning of Mensing

extends to “warning-based design-defect cause[s] of action” asserted against generic

manufacturers. Bartlett, 133 S. Ct. at 2477. The Court noted that under the state law at

issue, a manufacturer has a duty to “ensure that the products they design, manufacture,

and sell are not unreasonably dangerous,” which can be “satisfied either by changing a

drug’s design or by changing its labeling.” Id. at 2474. As in Mensing, the Court

explained that labeling changes are preempted because generic manufacturers have a

“federal-law duty not to alter [a drug’s] label.” Bartlett, 133 S. Ct. at 2473.

Further, the Court extended its reasoning in Mensing to claims that a generic drug

is ineffective or unreasonably dangerous. “In the drug context, either increasing the

‘usefulness’ of a product or reducing its ‘risk of danger’ would require redesigning the

drug: A drug’s usefulness and its risk of danger are both direct results of its chemical

design and, most saliently, its active ingredients.” Bartlett, 133 S. Ct. at 2475. But “the

FDCA requires a generic drug to have the same active ingredients, route of

administration, dosage form, strength, and labeling as the brand-name drug on which it is
-28-
based.” Id. (citing 21 U.S.C. §§ 355(j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. § 320.1(c)).

Under Bartlett, a claim that a generic drug manufacturer’s product is unfit for its intended

use or unreasonably dangerous is one that would impose a duty to alter the composition

of that drug. See Bartlett, 133 S. Ct. at 2474-75; see also Bartoli v. APP Pharm., Inc., (In

re Pamidronate Prod. Liab. Litig.), 842 F. Supp. 2d 479, 485 (E.D.N.Y. 2012) (a “breach

of implied warranty claim necessarily alleges that defendants should have changed the

design of [a drug] to make it safe and fit for its intended uses” and is therefore preempted

(quotation omitted)); In re Fosamax Prods. Liab. Litig. (No. II), No. 08-008, 2011 WL

5903623, at *8 (D.N.J. Nov. 21, 2011) (unpublished) (“[B]reach of implied warranty

claim necessarily alleges that manufacturers should have changed [a drug’s] design. This

would be in violation of the federal duty of sameness, and therefore, this claim is

preempted.”).

In advancing their warranty claims, the Schrocks allege that Qualitest had a duty

under state law to alter either the composition or the labeling, as broadly defined by the

FDA, of its generic metoclopramide. Because Qualitest could not have taken either

action under federal law, we conclude these claims are preempted. The Eleventh Circuit

has reached the same conclusion. See Guarino, 2013 WL 3185084, at *1-2 (holding

claims against generic manufacturer, including breach of warranty claim, preempted

because all claims were “premised upon an allegedly inadequate warning”). And the

Ninth Circuit summarily affirmed a district court decision concluding that similar

warranty claims were preempted on remand from the Supreme Court following Mensing.
-29-
See Gaeta ex rel. A.G. v. Perrigo Pharms. Co., 469 F. App’x 556 (9th Cir. 2012)

(unpublished); see also Gaeta v. Perrigo Pharms. Co., 562 F. Supp. 2d 1091, 1097-98

(N.D. Cal. 2008) (express and implied warranty claims preempted because generic

manufacturer could not alter labeling and be consistent with federal law).6

In Metz v. Wyeth, LLC, 872 F. Supp. 2d 1335 (M.D. Fla. 2012), the Middle

6
In Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013), the Eighth Circuit reversed
a grant of summary judgment based on preemption because it was unable to determine
whether plaintiff’s “breach of implied warranty claims, other than those based on an
inadequate warning or labeling, are in essence, failure-to-warn claims.” Id. at 1096. As
noted supra, however, the Supreme Court has since extended the holding of Mensing to
cover not just failure-to-warn claims, but also those claims that would require a redesign
of a generic drug. Bartlett, 133 S. Ct. at 2476-77.
We reject the Schrocks’ reliance on the Eighth Circuit’s decision in Fullington v.
Pfizer, Inc., No. 12-2945, 2013 WL 3491060, __ F.3d __ (8th Cir. July 15, 2013). In
Fullington, the court reversed the dismissal of warranty claims against generic
manufacturers of metoclopramide because it concluded that the district court improperly
“categorized [the claims] as failure-to-warn claims,” and thus concluded the claims were
preempted under Supreme Court precedent. Id. at *4. For the reasons stated supra, we
hold that the Schrocks’ warranty claims are properly characterized as failure-to-warn
claims or as design defect claims. And as the Eighth Circuit states, “Bartlett casts doubt
on the viability of [design defect claims].” Fullington, 2013 WL 3491060, at *5.
We are similarly not persuaded by the Schrocks’ reliance on pre-Bartlett case law.
For example, they cite Wyeth v. Levine, 555 U.S. 555, 574-75 (2009), for the proposition
that the FDCA does not preempt all state torts against drug manufacturers. We are not
inclined to make such a sweeping holding; we simply construe Bartlett as indicating the
Schrocks’ warranty claims are preempted. Bartlett stressed the Court had not “ignored
Congress’ explicit efforts to preserve state common-law liability,” citing Levine.
Bartlett, 133 S. Ct. at 2480. The Schrocks also point to Bates v. Dow Agrosciences,
LLC, 544 U.S. 431 (2005), as providing the rule of decision in this case. But the majority
in Bartlett explicitly rejected the argument that Bates was dispositive, explaining that in
Bates “the design-defect claim in question was not a requirement for labeling or
packaging” and also that Bates addressed a different statutory scheme than the FDCA,
which was the relevant statute both in Bartlett and the case at bar. Bartlett, 133 S. Ct. at
2479 (quotations and emphasis omitted).

-30-
District of Florida held that metoclopramide-related warranty claims were preempted

because they stemmed from a failure to warn. Id. at 1341. We are pointed to the court’s

dicta stating that “an implied warranty claim may survive preemption” if it is based on a

claim that the generic manufacturer provided a warranty “contrary [to] the FDA approved

label.” Id. at 1342; see also Fisher v. Pelstring, 817 F. Supp. 2d 791, 820 (D.S.C. 2011)

(claim that generic manufacturer did not update label to match changes in brand-name

label not preempted); Couick v. Wyeth, Inc., No. 09-210, 2012 WL 79670, at *3-4 (W.D.

N.C. Jan. 11, 2012) (unpublished) (same). There is no allegation, however, that

Qualitest’s label deviated from the FDA-approved label.

We do not lend credence to the Schrocks’ argument that Qualitest could have

complied with its alleged duty under state tort law and with the federal requirements by

simply declining to manufacture metoclopramide. The Supreme Court squarely rejected

this contention in Bartlett, holding that the “‘stop-selling’ rationale [is] incompatible with

our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to

satisfy both his federal- and state-law obligations is not required to cease acting

altogether in order to avoid liability.” 133 S. Ct. at 2477.

Finally, we reject the argument that the state law warranty claims are not

preempted because they simply parallel requirements imposed by federal law. See Riegel

v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (federal law does not “prevent a State from

providing a damages remedy for claims premised on a violation of FDA regulations; the

state duties in such a case ‘parallel,’ rather than add to, federal requirements”). The
-31-
Schrocks argue that the requirements of Oklahoma state law regarding warranties parallel

federal law because the metoclopramide was “misbranded” under 21 U. S. C. §352(j),

and are therefore not preempted. But the Bartlett court indicated in dicta that “a drug is

misbranded under federal law only when liability is based on new and scientifically

significant information that was not before the FDA” and that allegations of

dangerousness based on “the medical literature or published FDA analyses” would not

qualify. 133 S. Ct. at 2477 n.4. A misbranding claim along these lines has not been

advanced.

IV

We recognize the catch-22 situation in which existing jurisprudence places the

Schrocks and similarly situated consumers of generic drugs. They cannot obtain relief

from brand-name drug manufacturers because, as we predict, Oklahoma would not

impose a duty on the brand-name manufacturers that flows to consumers of generic

drugs. Yet the Schrocks’ claims against generic drug manufacturers are preempted under

Mensing and Bartlett. As a federal court, however, we have limited authority to correct

this potential injustice. It is for the state courts, rather than this panel, to engage in the

delicate policy considerations predicate to the expansion of the scope of state tort law.

See Taylor, 9 F.3d at 887. Moreover, as the Mensing court acknowledged, courts are not

asked “to decide whether the statutory scheme established by Congress is unusual or even

bizarre” despite the “the unfortunate hand that federal drug regulation has dealt”

consumers of generic drugs. 131 S. Ct. at 2581-82. If consumers of generic drugs are to
-32-
obtain federal relief, it must come from Congress.

We AFFIRM. PLIVA’s motion to dismiss for lack of jurisdiction is DENIED.

-33-