Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-almd-2_10-cv-00973/USCOURTS-almd-2_10-cv-00973-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF ALABAMA

NORTHERN DIVISION

ROSALYN BELL,

Plaintiff,

v.

WYETH, INC., et al.,

Defendants.

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CASE NO. 2:10-CV-973-WKW

 [WO]

MEMORANDUM OPINION AND ORDER

This lawsuit is one in a long line of actions alleging inadequate and illegal 

conduct on the part of the various pharmaceutical companies that “innovated, 

made, promoted, and sold” the prescription drug Reglan® or its generic 

counterpart, Metoclopramide (“MCP”). (Doc. # 105, at 1.) Plaintiff Rosalyn Bell 

contends that she ingested MCP in accordance with a prescription from her treating 

physician and developed a severe and incurable neurological disorder as a result. 

Ms. Bell alleges that her diagnosis is the proximate result of Defendants Wyeth, 

Inc. (“Wyeth”),

1

Pfizer, Inc. (“Pfizer”), Schwarz Pharma, Inc. (“Schwarz”),2Pliva 

 

1 As noted in Ms. Bell’s Amended Complaint, Pfizer acquired Wyeth in a cash and stock 

merger on October 15, 2009. As a result of the merger, Pfizer acquired all of Wyeth’s assets and 

assumed the full extent of Wyeth’s liabilities. Pfizer is named in Ms. Bell’s Amended Complaint 

solely as the successor to Wyeth’s liability.

2

Schwarz entered an Asset Purchase Agreement with Wyeth on December 27, 2001, 

whereby Schwarz purchased the rights and liabilities associated with Reglan subject to an 

indemnification provision.

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USA, Inc. (“Pliva”), Watson Laboratories, Inc. (“Watson Laboratories”), Watson 

Pharmaceuticals, Inc. (“Watson Pharmaceuticals”), and Teva Pharmaceuticals 

USA’s (“Teva”) dissemination of “inaccurate, misleading, materially incomplete, 

false, and otherwise inadequate information concerning the potential effects of 

exposure to Reglan/MCP.” (Doc. # 105, at 8.) She brings the following claims 

against each Defendant: strict liability (Count I), negligence and wantonness 

(Count II), breach of implied warranty (Count III), breach of express warranty 

(Count IV), fraud by misrepresentation (Count V), fraud by concealment, 

suppression, or omission of material facts (Count VI), and failure to adequately 

warn (Count VII). 

Presently before the court is Defendants Pliva and Watson Laboratories’ 

(“Generic Defendants”)3 Motion for Judgment on the Pleadings, in which they 

argue that Ms. Bell’s claims against them are preempted by federal law. (Doc. # 

117). The motion has been fully briefed. (Docs. # 118, 133, 144.) Upon 

consideration of the parties’ arguments, the record, and the relevant case law, the 

court finds that the Generic Defendants’ motion is due to be granted. 

I. JURISDICTION AND VENUE

Subject-matter jurisdiction is proper pursuant to 28 U.S.C. § 1332. The 

parties do not contest personal jurisdiction or venue.

 

3 Defendants Activis, Inc., f/k/a Watson Pharmaceuticals, and Teva – the other Generic 

Defendants – did not join in the present motion. 

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II. BACKGROUND

A. Facts

The FDA approved Reglan® in 1980 as a short-term therapy4for adults 

suffering from gastroesophageal reflux who did not respond to conventional 

therapy and to relieve the symptoms associated with acute and recurrent diabetic 

gastric stasis. Simply put, Reglan® was designed to increase the speed at which 

food travels through the digestive system. In 1985, pharmaceutical manufacturers 

began producing MCP – a generic version of Reglan®. MCP is equivalent to 

Reglan® in all therapeutically relevant aspects, including dosage, strength, and 

active ingredients. 

Ms. Bell’s physician prescribed her MCP in 2005, and she took the drug for 

approximately two years. In 2009, Ms. Bell was diagnosed with tardive dyskinesia 

(“TD”). TD is a neurological disorder that commonly causes “involuntary, 

repetitive movements of the extremities, lip smacking, grimacing, tongue 

protrusion, teeth grinding, rapid eye movements or blinking, puckering and pursing 

of the lips, and/or impaired and involuntary movement of the fingers.” (Doc. # 

105, at 9.) Ms. Bell suffers from one or more of these symptoms. At present, there 

is no known cure for TD, and its effects are rarely reversible. 

Ms. Bell alleges that it was her prolonged ingestion of MCP that caused her

to develop TD. The active ingredient in MCP works to block the transfer of 

 

4 Reglan® was never approved for use longer than twelve weeks.

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dopamine within the brain, which in turn causes the brain to produce additional 

dopamine receptors. Ultimately, prolonged MCP ingestion may lead the areas 

within the brain that control movement to become hypersensitive to dopamine, 

potentially resulting in the development of a neurological movement disorder. 

“Studies have shown that up to 29% of patients who take [MCP] for several years 

develop [TD].” PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011). 

In her complaint, Ms. Bell alleges that Defendants had actual knowledge that 

the risk of developing TD or another neurological side effect from long-term use of 

Reglan® or MCP was “approximately 100 times greater” than the risk that 

Defendants disclosed to medical professionals. (Doc. # 105, at 10.) Ms. Bell 

contends that Defendants failed to warn doctors and patients of the risks associated 

with long-term use and even “encouraged long term use of the drug,” concealing 

the drug’s “true risks and the true prevalence of side effects.” (Doc. # 105, at 10.) 

Had her treating physician been warned of the true risks of MCP, Ms. Bell asserts 

that her physician would have adjusted the prescription to avoid the risks

associated with long-term use or not prescribed the drug at all. 

B. Procedural History

This case has a protracted procedural history. Ms. Bell filed her initial 

complaint in November 2010. The Brand-Name Defendants5responded with a 

motion to dismiss. In the motion, they argued that Ms. Bell only ingested the 

 

5

The Brand-Name Defendants are Wyeth, Pfizer, and Schwarz. 

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generic MCP, and accordingly, she could not maintain products-liability claims 

against them as the manufacturers and sellers of Reglan®. After briefing the 

motion to dismiss, the Brand-Name Defendants moved to stay the action to allow 

the Eleventh Circuit to issue its opinion in Simpson v. Wyeth, Inc., No. 11-11197 

(11th Cir.). The Brand-Name Defendants argued that Simpson presented the same 

issue existing in this case – namely, whether brand-name drug manufacturers can 

be held liable for harm caused by a generic drug manufactured and distributed by 

an unrelated generic manufacturer. The motion to stay was unopposed, and the 

court entered the stay on April 15, 2011. 

Before the Eleventh Circuit issued its opinion, however, the Simpson

plaintiffs moved to dismiss their appeal. As a result, the Brand-Name Defendants 

requested that this court certify the unresolved question to the Alabama Supreme 

Court. However, in another action pending in this court in which an identical legal 

issue was presented, the following question was certified to the Supreme Court of 

Alabama: “Under Alabama law, may a drug company be held liable for fraud or 

misrepresentation (by misstatement or omission), based on statements it made in 

connection with the manufacture or distribution of a brand-name drug, by a 

plaintiff claiming physical injury from a generic drug manufactured and distributed 

by a different company?” Weeks v. Wyeth, Inc., No 1:10-CV-602-MEF, at 5 (M.D. 

Ala. Aug. 25, 2011) (Order certifying question to the Alabama Supreme Court). 

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Accordingly, this court kept the April 15, 2011 stay in place pending the 

conclusion of the certification process in Weeks.

On October 17, 2011, the Alabama Supreme Court agreed to answer the 

question certified in Weeks. On January 11, 2013, the Alabama Supreme Court 

issued its opinion, concluding that liability could extend to brand-name 

manufacturers and developers for fraud or misrepresentations made in connection 

with the manufacture and sale of a brand-name drug, by a plaintiff who was injured 

by the generic drug manufactured and distributed by a different company. The 

brand-name defendants in Weeks, however, timely moved for a rehearing, which

the Alabama Supreme Court granted. 

On August 15, 2014, the Alabama Supreme Court withdrew its January 11, 

2013 opinion and issued a new opinion. Despite the issuance of a new opinion, the 

Alabama Supreme Court’s legal determination largely was the same. For a second 

time, it concluded that liability could extend to brand-name manufacturers and 

developers for fraud or misrepresentations made in connection with the 

manufacture and sale of a brand-name drug, by a plaintiff who was injured by the 

generic drug manufactured and distributed by a different company. The brandname defendants in Weeks again applied for rehearing, but the Alabama Supreme 

Court denied their application, and on September 3, 2014, a certificate of judgment 

was issued, making the determination as to the certified question final.

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Upon the conclusion of the certification process in Weeks, the stay in this 

case was lifted, and a new scheduling order was entered. Ms. Bell filed an 

amended complaint on December 16, 2014. After the pleadings closed, the

Generic Defendants responded with the now pending motion for judgment on the 

pleadings. 

III. STANDARD OF REVIEW

The Federal Rules of Civil Procedure provide that “[a]fter the pleadings are 

closed—but early enough not to delay trial—a party may move for judgment on 

the pleadings.” Fed. R. Civ. P. 12(c). A judgment on the pleadings is limited to 

consideration of “the substance of the pleadings and any judicially noticed facts.” 

Bankers Ins. Co. v. Fla. Residential Prop. & Cas. Joint Underwriting Ass’n, 137 

F.3d 1293, 1295 (11th Cir. 1998). In evaluating a motion for judgment on the 

pleadings, the court must review the factual allegations in the light most favorable 

to the non-moving party. Cannon v. City of W. Palm Beach, 250 F.3d 1299, 1301 

(11th Cir. 2001). However, the court need not credit a nonmoving party’s legal 

contentions. See CompuCredit Holdings Corp. v. Akanthos Capital Mgmt., LLC, 

661 F.3d 1312, 1314 (11th Cir. 2011). A judgment on the pleadings pursuant to 

Rule 12(c) is appropriate when “no issues of material fact exist, and the movant is 

entitled to judgment as a matter of law[,]” Ortega v. Christian, 85 F.3d 1521, 1524 

(11th Cir. 1996), or when “the complaint lacks sufficient factual matter to state a 

facially plausible claim for relief that allows the court to draw a reasonable 

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inference that the defendant is liable for the alleged misconduct.” Jiles v. United 

Parcel Serv., Inc., 413 F. App’x 173, 174 (11th Cir. 2011) (citing Bell Atl. Corp. v. 

Twombly, 550 U.S. 544, 556, 570 (2007)).

IV. DISCUSSION

The Generic Defendants’ motion for judgment on the pleadings is grounded

singularly upon an assertion that Ms. Bell’s state-law tort claims are preempted by 

federal law. They specifically contend that the federal-labeling requirements

imposed on generic-pharmaceutical manufacturers directly conflict with state-tort 

liabilities and that these conflicting obligations mandate the dismissal of Ms. Bell’s 

claims against them on the basis of preemption. In response, Ms. Bell argues that 

the preemption doctrine is not applicable because the Generic Defendants chose 

not to comply with federal law. Because the Generic Defendants failed to comply 

with the federal requirements, Ms. Bell asserts that they could have complied with 

the state laws, avoiding true conflict and bringing this action outside the scope of 

federal preemption. 

A. Federal Pharmaceutical Regulations

The labeling of pharmaceuticals is heavily regulated by federal law. Before 

a pharmaceutical manufacturer may market any new drug to the public, it must 

first acquire federal approval. To acquire federal approval, the 1962 Drug 

Amendments to the Federal Food, Drug, and Cosmetic Act require that a

manufacturer prove that the new drug “is safe and effective and that the proposed 

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label is accurate and adequate.” 21 U.S.C. §§ 301 et seq.; Mensing, 131 S. Ct. at 

2574. 

For a period of time, all manufacturers had to complete the same approval 

process, whether the manufacturer was seeking to market an entirely new 

pharmaceutical or merely a new, generic version of an existing drug. Mensing, 

131 S. Ct. at 2574. Because successfully completing the approval process 

inherently required “costly and lengthy clinical testing” ill-suited to the 

development of a thriving generic-pharmaceutical industry, in 1984 Congress 

enacted the Drug Price Competition and Patent Term Restoration Act, commonly 

known as the Hatch-Waxman Amendments, which drastically altered the approval 

process for new generic pharmaceuticals. 21 U.S.C. § 355(j); Mensing, 131 S. Ct. 

at 2574.

Pursuant to the Hatch-Waxman Amendments, manufacturers of brand-name 

drugs and manufacturers of generic drugs face two different sets of obligations 

when seeking federal approval of new pharmaceuticals. Brand-name drug 

manufacturers must prove that the proposed label is “accurate and adequate.” 21 

U.S.C. § 355(b)(1), (d); Mensing, 131 S. Ct. at 2574. The manufacturers of 

generic drugs, on the other hand, are not independently required to demonstrate the 

accuracy or adequacy of their labels. Rather, generic-drug manufacturers are 

obligated to ensure that their proposed warning label is identical to the label of the 

corresponding brand-name drug. 

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B. The Arguments of the Parties

It is upon this “sameness” requirement that the Generic Defendants rest their 

federal-preemption argument. They contend that each of Ms. Bell’s claims is 

grounded upon a theory that the Generic Defendant failed to adequately warn 

and/or properly design MCP. The Generic Defendants argue, however, that they 

were unable to strengthen MCP’s warning labels or alter the drug’s design without 

violating federal law. In conclusion, the Generic Defendants assert that, because 

the state-tort laws conflict with their federal-law obligations, the state laws are 

preempted and Ms. Bell’s claims against them are due to be dismissed. 

Ms. Bell counters the Generic Defendants’ arguments by contending that the 

Generic Defendants cannot rely on federal preemption because they “chose not to 

comply with the applicable federal law” when they failed to update their labels. 

Because the Generic Defendants did not comply with the federal labeling 

requirements, Ms. Bell asserts that they could have complied with Alabama’s tort 

laws. Accordingly, she argues that there is no real conflict and, therefore, no 

preemption defense available. 

C. Analysis

A defense of federal preemption is grounded upon the Supremacy Clause of 

the United States Constitution. The Supremacy Clause states that “the Laws 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., 

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art. VI, cl. 2. The Supreme Court has interpreted this constitutional mandate to 

require any state law, including those creating state-tort duties, to give way when 

the state law is in direct conflict with a federal law. Mensing, 131 S. Ct. at 2577. 

(“Where state and federal law ‘directly conflict,’ state law must give way.” 

(quoting Wyeth v. Levine, 555 U.S. 555, 583 (2009))). The Supreme Court has 

explained that state and federal law directly conflict for preemption purposes when 

it is “impossible for a private party to comply with both state and federal 

requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995). 

To be sure, this is not the first case in which a court has been tasked with 

determining whether state-tort laws directly conflict with the federal laws 

regulating pharmaceuticals. The Supreme Court addressed a similar preemption 

defense brought on behalf of the generic manufacturers of MCP in 2011. In 

Mensing, plaintiffs similarly situated to Ms. Bell alleged that the long-term use of 

MCP had caused them to develop TD and that the generic manufacturers of MCP 

were liable under state-tort laws “for failing to provide adequate warning labels.” 

131 S. Ct. at 2573. Specifically, they contended that, “despite mounting evidence 

that long term [MCP] use carries a risk of [TD] far greater than that indicated on 

the label, none of the [m]anufacturers had changed their labels to adequately warn 

of that danger.” Id. (internal quotation marks omitted). 

The Mensing defendants countered the plaintiffs’ claims with a theory of 

federal preemption. Like the Generic Defendants in the present action, the 

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Mensing defendants explained that “federal statutes and FDA regulations required 

them to use the same safety and efficacy labeling as their brand-name 

counterparts,” and, accordingly, it was impossible for them “to simultaneously 

comply with both federal law and any state tort-law duty that required them to use 

a different label.” Id. With these contentions in place, the Supreme Court 

examined whether the Mensing defendants had an avenue by which they could 

comply with both federal drug regulations and state-tort laws. 

Relying heavily on the FDA’s interpretations of the federal requirements 

imposed upon generic pharmaceutical manufacturers, the Supreme Court 

determined that the Mensing defendants were without a viable means of complying 

with both state and federal law. Specifically, the Supreme Court determined that 

federal law prohibited the generic manufacturers from unilaterally changing their 

labels via the “changes-being effected” process or providing heightened warnings 

directly to physicians via “Dear Doctor” letters. Id. at 2575. Accordingly, the 

Supreme Court concluded that federal law preempted the Mensing plaintiffs’ 

failure-to-warn state-tort claims. 

Two years later, the Supreme Court extended its holding in Mensing, 

concluding that federal pharmaceutical regulations also preempted state-tort claims

against generic manufacturers based upon design-defect theories. See Mut. Pharm. 

Co. v. Bartlett, 133 S. Ct. 2466 (2013). The Supreme Court neglected the First 

Circuit’s rationale that Mensing was distinguishable because the generic 

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manufacturer could have complied with state design-defect laws and federal 

regulations simultaneously by choosing to not make the drug at all. It determined 

that a “stop-selling” rationale was “incompatible with . . . pre-emption 

jurisprudence.” Id. at 2477. The Court ultimately concluded that state-tort laws 

that require generic manufacturers to “render a drug safer by either altering its 

composition or altering its labeling are in conflict with federal laws” and 

preempted accordingly. Id. at 2479. 

Recently, the Eleventh Circuit applied the Supreme Court’s holdings in 

Mensing and Bartlett. In Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013), 

a plaintiff appealed from a district court’s dismissal of her claims in favor of a 

generic manufacturer of MCP. The district court had explicitly relied upon the 

Supreme Court’s decision in Mensing, and on appeal, the plaintiff argued that 

Mensing was distinguishable because her negligence claim was based upon a 

“failure to communicate” theory. Id. at 1247–48. Addressing the plaintiff’s artful 

attempt to overcome federal preemption, the Eleventh Circuit spoke to the scope of 

Mensing, explaining that any state law cause of action grounded upon a generic 

manufacturer’s taking unilateral action is preempted because the federal law “duty 

of sameness” makes generic manufacturers dependent upon brand-name 

manufacturers. Id. at 1249. 

The Generic Defendants argue that Mensing, Bartlett, and Guarino control 

the entirety of Ms. Bell’s action against them. Ms. Bell asserts, however, that her 

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claims against the Generic Defendants are easily distinguishable from the claims 

asserted in Mensing and the related cases. She argues that the Generic Defendants, 

on their own, “prior to [her] ingestion of [MCP], chose not to fulfill federal law” 

when they failed to update the package inserts to match the inserts that 

accompanied the name-brand Reglan®. (Doc. # 133, at 8.) Accordingly, she 

contends that by unilaterally deciding to ignore the federal duty of “sameness,” the 

Generic Defendants should not now be able to cloak themselves in that duty for 

preemption purposes. As support for this argument, Ms. Bell highlights the Sixth 

Circuit’s analysis in Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013).

6

In Fulgenzi, the Sixth Circuit was tasked with applying Mensing to facts 

largely analogous to those presented in this case. Specifically, the plaintiff in 

Fulgenzi argued that federal preemption was not available to the generic 

manufacturer because it “failed to update its labels as required by federal law—

rendering compliance with both federal and state duties no longer impossible.” 

711 F.3d at 580. Finding the plaintiff’s argument persuasive, the Sixth Circuit

concluded that the generic manufacturer not only could have acted unilaterally to 

update its labeling to conform to that of the brand-name manufacturer, but it was 

required to do so under federal law. Id. at 584. Accordingly, it held that the 

 

6

The Eleventh Circuit addressed Fulgenzi when rendering its decision in Guarino. In a 

footnote, the Eleventh Circuit explained that its decision “was not to the contrary” of the Sixth 

Circuit’s holding in Fulgenzi. Guarino, 719 F.3d at n.2. Rather, it noted that the plaintiff in 

Guarino had failed to allege that the generic manufacturer had not updated its label, as allowed 

by federal law. Id.

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plaintiff’s claims were allowed to go forward in a limited fashion. While the 

plaintiff could not proceed as to any claims based upon the generic manufacturer’s 

failure to act independently of the brand-name manufacturers, her claims 

challenging the generic manufacturer’s warning survived “to the extent that [the 

warning] did not include the language contained in the updated Reglan label from 

2004.” Id. 

While Ms. Bell hinges her opposition to the Generic Defendants’ motion for 

judgment on the pleadings upon the Sixth Circuit’s reasoning in Fulgenzi, she fails 

to appreciate the limited nature of Fulgenzi’s holding. The Fulgenzi court did not 

conclude that federal preemption was inapplicable to the entirety of the plaintiff’s 

claims. Rather, the Sixth Circuit determined that federal-preemption law did not 

prohibit the plaintiff from pursuing a single, narrow state-tort law claim. 

Specifically, the plaintiff was able to proceed on her claim that the generic 

manufacturers violated state-tort law when they failed to provide a durational 

warning on the labeling, as was allowed (even required) under federal regulations 

because the brand-name manufacturers already had added the language to their 

labels. 

Accordingly, while Ms. Bell argues that the Generic Defendants’ failure to 

comply with federal law should leave her claims entirely outside the scope of 

federal preemption, the Supreme Court, the Eleventh and Sixth Circuits, and the 

Supreme Court of Alabama all make clear that generic manufacturers cannot be 

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held liable for violating state-tort laws in failing to take unilateral actions that 

would be prohibited by federal law. Mensing, 131 S. Ct. at 2577–78 (“We find 

impossibility here. It was not lawful under federal law for the Manufacturers to do 

what state law required of them.”); Guarino, 719 F.3d at 1249 (agreeing with the 

Fifth Circuit, that “[w]hether a warning is placed on the label on the bottle or in 

letters to distributors, any state law duty requiring generic manufacturers to act 

unilaterally in this area is preempted by federal law” (quoting Morris v. PLIVA, 

Inc., 713 F.3d 774, 776–77 (5th Cir. 2013))); Fulgenzi, 711 F. 3d at 588 (“Under 

Mensing, [the plaintiff’s] claims are viable only to the extent [the generic 

manufacturer’s] actions were permitted by federal law.”); Wyeth, Inc. v. Weeks, 

159 So. 3d 649, 677 (Ala. 2014) (“The Supreme Court in [Mensing] held that it 

would have been impossible for the generic manufacturers to change their warning 

labels without violating the federal requirement that the warning on a generic drug 

must match the warning on the brand-name version, preempting failure-to-warn 

claims against generic manufacturers.”). Applying that principle, to the extent Ms. 

Bell seeks to hold the Generic Defendants liable for actions that would have been 

prohibited by federal law, her claims are due to be dismissed under a 

straightforward application of Mensing. 

This court is left with the singular task of determining whether Ms. Bell may 

proceed on a claim that the Generic Defendants violated state-tort law when they 

failed to provide a durational warning on the labeling. As discussed in Guarino, 

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such a claim could potentially survive Mensing and federal preemption because the 

Generic Defendants were allowed (even required) under the federal regulations to 

incorporate the durational warning since the brand-name manufacturers already 

had added that language to their labeling. A close review of Ms. Bell’s Amended 

Complaint, however, makes clear that, unlike the Guarino plaintiffs, Ms. Bell has 

not pled a failure-to-update claim sufficiently narrow to escape federal preemption.

As Ms. Bell has acknowledged, preemption will attach when “it is 

‘impossible for a private party to comply with both state and federal 

requirements.’” Mensing, 131 S. Ct. at 2577 (quoting Freightliner Corp. v. 

Myrick, 514 U.S. 280, 287 (1995)). Stated differently, if complying with a state’s 

laws would require a “party to violate federal law,” then the state laws “are preempted and, thus, are ‘without effect.’” Bartlett, 133 S. Ct. at 2470 (quoting 

Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). In turn, to present a viable 

state-tort claim that falls outside the scope of federal preemption, Ms. Bell would 

have to allege that (1) the Generic Defendants violated their state-tort duties, and 

that (2) the Generic Defendants could have taken actions in line with their federallaw obligations that would have also allowed them to discharge their state-law 

duties. More specifically, she would have to allege that, if the Generic Defendants 

had updated their labels in accordance with federal law to incorporate a durational 

warning, then they would have been able to comply fully with their state tort-law 

obligations. 

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Ms. Bell, however, does not make such a claim. Rather, throughout her 

Amended Complaint, Ms. Bell repeatedly asserts that the federally compliant 

labeling, as implemented by the Brand-Name Defendants in 2004, failed to fully 

comply with state law. As a result, Ms. Bell contends that, even if the Generic 

Defendants had fulfilled their federal updating obligation, they would not have 

satisfied state law. Because Ms. Bell’s claims, all of which are grounded upon

failure-to-warn and defective-design theories,7allege state-law violations that the 

Generic Defendants could not have remedied without violating federalpharmaceutical obligations, the claims are preempted. See Mensing, 131 S. Ct. at 

2577 (“We find impossibility here. It was not lawful under federal law for the 

Manufacturers to do what state law required of them. And even if they had 

fulfilled their federal duty . . . , they would not have satisfied the requirements of 

state law.”); Morris, 713 F.3d at 777 (“[I]t is logically incoherent to contend that 

[the generic manufacturer] had a duty to apply the 2004 warning label when 

appellants also assert repeatedly that no labels predating 2009 were adequate.”). 

 

7

In responding to the Generic Defendants’ motion for judgment on the pleadings, Ms. 

Bell clarifies that she is not seeking to hold the Generic Defendants accountable for failing to 

comply with the federal law that requires generic manufactures to maintain the same labeling as 

that of their brand-name counterparts. She repeatedly emphasizes that all of her claims are based 

upon alleged violations of state law and that she is not pursuing a “failure-to-update” claim. Ms. 

Bell explains that the Generic Defendants’ failure to update its labeling was discussed only 

tangentially as a means of establishing why her claims were outside the reach of a preemption 

defense. 

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V. CONCLUSION

Based on the foregoing analysis, it is ORDERED that Defendants Pliva and 

Watson Laboratories’ Motion for Judgment on the Pleadings (Doc. # 117) is 

GRANTED. 

DONE this 3rd day of August, 2015. 

 /s/ W. Keith Watkins 

CHIEF UNITED STATES DISTRICT JUDGE

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