REVISED May 15, 2014

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 13-40151

ROY ECKHARDT; YOLANDA C. ECKHARDT,

Plaintiffs – Appellants

v.

QUALITEST PHARMACEUTICALS, INCORPORATED; WYETH, 

INCORPORATED, individually and as Successor-in-Interest to A.H. ROBINS 

COMPANY, INCORPORATED and AMERICAN HOME PRODUCTS; 

SCHWARZ PHARMA, INCORPORATED; VINTAGE PHARMACEUTICALS, 

L.L.C.,

Defendants – Appellees

Appeal from the United States District Court

for the Southern District of Texas

Before JOLLY, HIGGINBOTHAM, and SOUTHWICK, Circuit Judges.

E. GRADY JOLLY, Circuit Judge:

The plaintiff, Roy Eckhardt,1 appeals the judgment of the district court 

dismissing his claims again Wyeth and Schwarz Pharma (together, the “Brand 

Defendants”) under Rule 12(b)(6) and granting summary judgment to 

1 Although both Roy and Yolanda Eckhardt are plaintiffs in this case, this opinion will 

treat Roy Eckhardt as the sole plaintiff because all of the claims before us arise out of Roy’s 

use of metoclopramide. 

United States Court of Appeals

Fifth Circuit

FILED

May 13, 2014

Lyle W. Cayce

Clerk

 

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Qualitest Pharmaceuticals and Vintage Pharmaceuticals (together, the 

“Generic Defendants”). Eckhardt alleges that as a result of his prolonged use 

of the drug metoclopramide, he developed tardive dyskinesia, a severe 

neurological disorder. Eckhardt brought various products liability and general 

tort claims against the Brand Defendants – who initially developed and 

received FDA approval for metoclopramide – and the Generic Defendants –

who manufactured and sold the product that Eckhardt used. Because we hold 

that Eckhardt’s claims against both the Brand and the Generic Defendants are

all either preempted, not adequately pleaded, or not recognized under Texas 

law, we AFFIRM the judgment of the district court. 

I.

In order to provide the necessary background regarding Eckhardt’s 

claims and the defenses asserted, we will begin with a general discussion of

the FDA approval process for pharmaceuticals and a brief history of 

metoclopramide specifically. We then turn to Eckhardt’s factual allegations. 

A.

Before a manufacturer can market a new drug, the FDA must approve

“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). In 1984, 

through the Hatch-Waxman Amendments, Congress modified these 

procedures for generic drug manufacturers, creating an expedited process for 

approving generic drugs. See Drug Price Competition and Patent Term 

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

sections of 21 and 35 U.S.C.). In essence, these amendments allow a generic 

drug manufacturer to piggy-back on the FDA approval of a brand name drug –

greatly accelerating the process for receiving approval – provided that the 

generic drug has active ingredients and labeling identical to that of the FDAapproved brand name drug. Mensing, 131 S. Ct. at 2574 & n.2.

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After the generic drug receives approval, the generic manufacturer is 

prohibited from making changes to the drug itself or from unilaterally 

changing the drug’s label. See Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 

S. Ct. 2466, 2471 (2013). In receiving FDA approval for their generic 

metoclopramide, the Generic Manufacturers used this expedited process.

Metoclopramide was first approved by the FDA in 1980 under the brand 

name Reglan for use in treating various gastrointestinal problems by speeding 

the movement of food through the digestive track. Since 1985, when Reglan’s 

patent exclusivity expired, several companies have manufactured a generic 

version of the drug. Beginning in 1985, the label for metoclopramide was 

modified to warn that “tardive dyskinesia . . . may develop in patients treated 

with metoclopramide,” and the package insert included with the drug indicated 

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

recommended.” Mensing, 131 S. Ct. at 2572 (citing Physician’s Desk Reference 

1635–36 (41st ed. 1987)). In 2004, brand-name manufacturers of 

metoclopramide requested that the FDA approve a change to the labeling of 

metoclopramide to state that therapy using the drug should not exceed twelve 

weeks. The FDA granted the request. Subsequently, in 2009, the FDA 

mandated that a “black box” warning – the strongest warning the FDA can 

mandate on a drug – be added to metoclopramide making clear the risk of 

developing tardive dyskinesia. 

B.

From late 2007 until at least July 2009, Eckhardt’s physician prescribed 

Reglan, the brand name for metoclopramide, to treat his gastrointestinal 

problems. When filling this prescription, Eckhardt’s pharmacy substituted a 

less-expensive generic version of metoclopramide manufactured by the Generic 

Defendants. It is undisputed that Eckhardt never used metoclopramide

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manufactured by the Brand Defendants. As a result of his prolonged use of

metoclopramide, Eckhardt alleges that he developed tardive dyskinesia.

In 2011, Eckhardt filed his original complaint against Endo 

Pharmaceutical Holdings and Qualitest. The complaint asserted causes of 

action for negligence, strict liability, breach of implied warranties, 

misrepresentation, fraud, and under the Texas Deceptive Practices –

Consumer Protection Act. In June 2011, Eckhardt amended his complaint to 

add Wyeth and Schwarz as defendants, alleging misrepresentations by them

to the medical community in their status as owners of the marketing 

application for Reglan. Eckhardt and Endo later filed a stipulation of dismissal 

as to the claims against Endo, and the district court granted leave to Eckhardt 

to add Vintage in Endo’s place as a defendant. Eckhardt did so in his second 

amended complaint. In September, the Generic Defendants moved to dismiss 

for failure to state a claim. The Brand Defendants subsequently filed a motion 

for summary judgment. The district court eventually granted both motions 

and entered a final judgment dismissing all of Eckhardt’s claims against all 

defendants. 

Eckhardt then filed a motion to alter or amend the judgment. The 

district court denied the motion, and Eckhardt brought this appeal.

II.

We will first examine, de novo, the district court’s Rule 12(b)(6) dismissal 

of Eckhardt’s claims against the Generic Defendants. BP Exploration Libya 

Ltd. v. ExxonMobil Libya Ltd., 689 F.3d 481, 490 (5th Cir. 2012). To survive a

Rule 12(b)(6) motion, a plaintiff must plead enough facts to state a claim for 

relief that is plausible on its face. Bell Atlantic Corp. v. Twombly, 127 S. Ct. 

1955, 1974 (2007).

Eckhardt brings a number of different claims against the Generic 

Defendants. And although it is at times difficult to construe precisely what 

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cause of action Eckhardt is asserting against the Generic Defendants, the 

claims fit into one of a few categories: products liability claims, strict liability

design defect claims, failure-to-warn claims, breach of warranty claims, and 

consumer protection claims. We analyze each claim in turn.

A.

Though Eckhardt fails to classify it as such, his main claim against the

Generic Defendants is a products liability claim for a failure to warn about the 

dangers of metoclopramide. As the district court correctly pointed out, the 

Texas Products Liability statute is intentionally broad; that is, it is written to 

cover products liability claims, even in situations where the plaintiffs do not 

label their claims thusly. See Tex. Civ. Prac. & Rem. Code Ann. § 82.001(2) 

(“‘Products liability action’ means any action against a manufacturer or seller 

for recovery of damages arising out of personal injury, death, or property 

damage allegedly caused by a defective product whether the action is based in 

strict tort liability, strict products liability, negligence, misrepresentation, 

breach of express or implied warranty, or any other theory or combination of 

theories.”).

It is not mind-taxing to discern why Eckhardt shies from labeling his 

claims as products liability claims: A products liability claim against the 

Generic Defendants simply cannot succeed. In Mensing, the Supreme Court 

explained the extent to which federal law regarding pharmaceuticals 

preempted state laws applicable to those same products. Mensing establishes 

two points relevant to Eckhardt’s claims. First, under federal law, generic 

manufacturers of a prescription drug are not permitted unilaterally to change 

the labeling on that drug, even if that change “strengthens” the warnings. 

Mensing, 131 S. Ct. at 2575 (accepting FDA’s interpretation of regulations that 

“changes unilaterally made to strengthen a generic drug’s warning label would 

violate” laws requiring a generic drug label to match the brand name 

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counterparts). Second, it follows that any state law tort claim that is based on 

a generic manufacturer’s failure to update the labeling on its drug directly 

conflicts with this federal law requirement and is therefore preempted. See id.

at 2577–78. 

Those two linked principles dispose of Eckhardt’s products liability 

claims against the Generic Manufacturers: Eckhardt’s products liability claims

are premised on the Generic Defendants’ failure to warn adequately about the 

dangers associated with metoclopramide. More specifically, Eckhardt alleges 

that Texas state law imposed a duty on the Generic Manufacturers to provide 

stronger warnings on their product. But Mensing makes clear the Generic 

Defendants were estopped from unilaterally doing so under federal law. See 

also Lashley v. Pfizer, Inc., Nos. 12-60861 & 12-41148, 2014 WL 661058, at *2–

3 (5th Cir. Feb. 21, 2014) (holding failure-to-warn claims in identical factual 

setting preempted). The district court’s dismissal of Eckhardt’s products

liability claims against the Generic Defendants was therefore proper.

B.

Moving next to Eckhardt’s strict liability design defect claim, we find 

that Eckhardt is again on the wrong side of the Supreme Court. In Bartlett, a 

quite recent decision, the Supreme Court analyzed whether a strict liability

claim under New Hampshire law was preempted by federal law. Once again, 

the Supreme Court found that the state law was trumped by the federal 

regulatory regime. And while Eckhardt argues that the Texas law is different 

from New Hampshire law, he simply cannot escape Bartlett’s application to 

this case.

The Court in Bartlett held that a New Hampshire strict liability claim 

was preempted because, as an element of the claim, the fact-finder, in 

considering the product’s labeling, was required to balance the product’s harms 

and benefits. Bartlett, 133 S. Ct. at 2474–75. Because generic manufacturers 

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are, as a matter of federal law, forbidden from changing the labeling of the 

product regardless of the cost-benefit analysis, the Supreme Court held that

the claim was preempted. Id. at 2477.

Eckhardt attempts to distinguish Texas law on the basis that Texas law 

does not require a cost-benefit analysis as a factor in proving a strict liability 

cause of action. Although this fact is true, it will not save Eckhardt’s claim. 

To prove a strict liability design defect claim under Texas law as alleged here, 

the plaintiff must prove that “a safer alternative design existed.” Timpte 

Indus., Inc. v. Gish, 286 S.W.3d 306, 311 (Tex. 2009). Thus, a fact finder must 

not only conclude that a safer alternative design existed, but further that the 

Generic Defendants breached their duty by failing to adopt that alternative 

design. But the Generic Defendants were prohibited by federal law from 

changing the design of the drug, and, therefore, no alternative design existed. 

As in Bartlett, the state law claim against the Generic Defendants is preempted 

because the state law claim is in direct conflict with the federal law. See 

Lashley, 2014 WL 661058, *3 (holding that strict liability claims under Texas 

law are preempted).

C.

Eckhardt raises additional failure-to-warn claims, which are of a slightly 

different kind than the products liability claims discussed above. Specifically, 

Eckhardt asserts that he has alleged that the Generic Defendants failed to 

provide Eckhardt or his physician with any of the FDA-approved warnings. As 

failing to provide FDA-approved warnings would be a violation of both state 

and federal law, this is a parallel claim that is not preempted. Nevertheless, 

the district court was correct in dismissing the claim.

Eckhardt simply does not adequately allege that the Generic Defendants 

failed to provide him with FDA-approved warnings. As the district court noted, 

this allegation was most clearly stated in Eckhardt’s response to the Generic 

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Defendants’ motion to dismiss below. In that filing, Eckhardt alleges, “Generic 

Defendants never provided Plaintiff or his physicians with ANY warning or 

other information with regard to metoclopramide.” The district court held that 

this was a new factual allegation that was directly contradicted by Eckhardt’s 

second amended complaint. The district court interpreted the addition of a

new factual allegation as a motion to amend and denied the motion, 

considering only the factual allegations in the second amended complaint. This 

denial was not an abuse of discretion. See Mayeaux v. La. Health Serv. and 

Indem. Co., 376 F.3d 420, 425 (5th Cir. 2004) (“We review the district court’s 

denial of leave to amend a complaint . . . for abuse of discretion).

And looking at the factual allegations in the second amended complaint,

it is clear that this untimely factual allegation is contradicted. In the second 

amended complaint, Eckhardt alleges several times that he was provided 

warnings by the Generic Defendants. He has thus failed adequately to plead 

the Generic Defendants’ failure to provide any information, and the argument 

lacks merit.

D.

Turning to the breach of warranty claims, Eckhardt argues that the 

district court failed to address these claims in its opinion. The Generic 

Defendants respond that the district court only failed to discuss these claims 

because Eckhardt failed to press them in opposition to the Generic Defendants’ 

motion to dismiss. Regardless of which party is correct, this court has 

previously held that such breach of warranty claims are preempted. See Morris 

v. PLIVA, Inc., 713 F.3d 774, 778 (5th Cir. 2013) (“A breach of warranty claim 

that goes directly to the sufficiency of the generic manufacturer’s labeling is 

clearly unacceptable. . . . This claim is preempted.”). This precedent makes 

clear that Eckhardt’s breach of warranty claims are preempted, and thus 

meritless.

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E.

Finally, Eckhardt argues that his claims under the Deceptive Trade 

Practices – Consumer Protection Act (“DTPA”) should have survived the 

motion to dismiss. Again, it is clear that the district court’s dismissal was 

proper. Eckhardt’s claim under the DTPA is based on the same factual 

allegations as his other claims – namely, that the Generic Defendants failed 

sufficiently to warn consumers of the harms associated with metoclopramide. 

As discussed in the foregoing sections, the Generic Defendants’ labeling was 

FDA-approved, and federal law forbade the Generic Defendants from making 

any changes. Because these actions were mandated by federal law, any state 

law claim based on these actions is in direct conflict with the federal law and 

thus preempted. Accordingly, Eckhardt’s DTPA claim was properly dismissed.

III.

We turn now to Eckhardt’s claims against the Brand Defendants. The 

district court granted summary judgment to the Brand Defendants on all of 

Eckhardt’s claims. We review a grant of summary judgment de novo. Royal v. 

CCC&R Tres Arboles, L.L.C., 736 F.3d 396, 400 (5th Cir. 2013). 

As with the Generic Defendants, Eckhardt alleges a number of different 

claims against the Brand Defendants and, again, the parties disagree over how 

the claims should be categorized. In the view of the Brand Defendants, 

Eckhardt’s various allegations are merely superficial glosses on a products

liability action. Eckhardt denies that his complaint alleges a products liability 

claim at all. Although it is clear to us that the essence of Eckhardt’s claim 

sounds in products liability, we will analyze Eckhardt’s claims against the 

Brand Defendants both as a single products liability claim, and as various 

general tort claims.

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A.

To the extent Eckhardt raises products liability claims against the Brand

Defendants, those claims may be quickly rejected. A prior panel of this court 

held that Texas products liability law does not impose liability in this exact 

factual situation. Lashley, 2014 WL 661058, at *5 (“[The plaintiff] admits that 

she did not ingest the Schwarz brand defendants’ product; thus, we find that 

Schwarz brand defendants are not liable under Texas products liability law.”).2 

We are bound by this determination.

In post-argument submissions, Eckhardt argues that Lashley did not 

discuss the possibility that “the control Brand Defendants exercised over 

metoclopramide’s design rendered them manufacturers of the metoclopramide 

ingested by Plaintiff in this case for purposes of Texas product liability law.”

This contention is contradicted by the filings in Lashley. The plaintiff in 

Lashley advanced this precise argument, and Lashley considered the 

possibility of liability under the Texas products liability statute and rejected 

any such argument. Lashley, 2014 WL 661058, *5. Thus, to the extent that 

Eckhardt raises products liability claims against the Brand Defendants, the 

district court properly granted summary judgment to the Brand Defendants 

on those claims.

B.

Analyzing Eckhardt’s claims against the Brand Defendants as general 

tort claims, we address the three causes of action he asserts: fraud, negligence, 

and negligent misrepresentation. 

2 Lashley was released after oral arguments were heard in this case. It was originally 

released as an unpublished decision, but the Lashley panel has since granted a motion for 

the opinion to be published. The opinion is thus now binding precedent for this panel.

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1.

Reviewing first Eckhardt’s fraud claim, we find that Eckhardt fails to 

allege sufficient facts for his fraud claim to survive. In his second amended 

complaint, Eckhardt provides only two factual allegations that could support a 

fraud claim: (1) The predecessor in interest to Wyeth told physicians that 

Reglan was safe for long-term use, and these statements were intentionally 

misleading; and (2) Wyeth intentionally disseminated misleading information 

about the risk of long-term ingestion of Reglan. These two allegations, without 

any additional factual support in Eckhardt’s complaint, are not sufficient to 

support a fraud charge under the heightened pleading standard of Rule 9. See 

Benchmark Elecs., Inc. v. J.M. Huber Corp., 343 F.3d 719, 724 (5th Cir. 2003) 

(“Put simply, Rule 9(b) requires the who, what, when, where, and how to be 

laid out.”) (internal quotation marks omitted). The district court’s grant of 

summary judgment on these claims must therefore be affirmed.

2.

Next, Eckhardt advances claims of negligence and negligent 

misrepresentation against the Brand Defendants. To establish a claim for 

negligence under Texas law, the plaintiff “must establish a duty, a breach of 

that duty, and damages proximately caused by the breach.” Kroger Co. v. 

Elwood, 197 S.W.3d 793, 794 (Tex. 2006). At this stage of the litigation, the 

parties now focus their dispute on whether the Brand Defendants owe a duty 

to consumers of generic versions of Brand Defendants’ drugs. 

Although Eckhardt concedes that he has never used a product 

manufactured by the Brand Defendants, he argues that given the structure of 

the pharmaceutical industry as a result of federal law, the Brand Defendants 

owe a duty to eventual consumers of the drugs they design, even if those 

consumers use a generic version of the drug. Several courts have faced this

question. Every circuit court has held (under the laws of several different 

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states) that a brand-name manufacturer does not owe a duty to consumers who 

use a generic version of the drug. See Schrock v. Wyeth, Inc., 727 F.3d 1273, 

1285 (10th Cir. 2013) (holding that no duty is owed under Oklahoma law); 

Guarino v. Wyeth, LLC, 719 F.3d 1245, 1251–52 (11th Cir. 2013) (same under 

Florida law); Bell v. Pfizer, Inc., 716 F.3d 1087, 1093 (8th Cir. 2013) (same 

under Arkansas law); Smith v. Wyeth, Inc., 657 F.3d 420, 423–24 (6th Cir. 

2011) (same under Kentucky law); Foster v. Am. Home Prods. Corp., 29 F.3d 

165, 170–71 (4th Cir. 1994) (same under Maryland law). These authorities 

were recently joined by an opinion from this court. See Lashley, 2014 WL 

661058, at *4–5 (finding no duty under Mississippi or Texas law). 

Lashley holds that “because [plaintiffs] did not ingest the brand 

manufacturers’ products, these defendants have no common-law duty to them.” 

Id. at *4. Here, Eckhardt advances the same claims, under the same state law, 

against the same Brand Defendants, for the same reasons as the plaintiffs in 

Lashley. We see no grounds for distinguishing this binding authority. 

Consequently, Eckhardt’s negligence claim cannot survive because the 

Brand Defendants do not owe a duty to Eckhardt. And because a duty must

also exist for a claim of negligent misrepresentation to succeed, this analysis 

applies equally to that claim. See Fed. Land Bank Ass’n of Tyler v. Sloane, 825 

S.W.2d 439, 442 (Tex. 1991). The district court’s grant of summary judgment 

to the Brand Defendants on these claims is therefore affirmed. 

IV.

We sum up: We hold that Eckhardt’s products liability claims against 

the Generic Defendants are preempted under the holdings and reasoning of 

Mensing and Bartlett, and that Eckhardt has failed to adequately plead any 

parallel claims. Similarly, we hold that Eckhardt’s claims against the Brand 

Defendants fail because Eckhardt did not use the Brand Defendants’ products 

and because Texas does not recognize a duty to a consumer who uses a 

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competitor’s products. For those reasons, the judgment of the district court 

dismissing Eckhardt’s claims against the Generic Defendants and granting 

summary judgment to the Brand Defendants is AFFIRMED.

AFFIRMED.

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