ORDER

MICAELA ALVAREZ, District Judge.

Pending before the Court is the self-styled "Motion to Dismiss by Defendants Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC" and supporting memorandum.1 Defendants Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC, the generic manufacturer defendants ("Generics"), argue that in light of PLIVA, Inc. v. Mensing,2 Plaintiffs' second amended complaint should be dismissed under Federal Rules of Civil Procedure 8, 9 and 12.3 After considering the motion, memorandum, response and relevant authorities, the Court finds that the motion should be GRANTED.

I. Background4

Plaintiffs filed their first complaint on April 13, 2011.5 On June 29, 2011, they filed an amended complaint.6 Plaintiffs filed their second amended complaint on August 26, 2011.7 The second amended complaint alleges Roy Eckhardt ("Eckhardt") developed a neurological disorder known as tardive dyskinesia in early 2008.8 Plaintiffs allege that Eckhardt's condition was caused by Reglan/metoclopramide, which his doctor began prescribing in 2007 to treat Eckhardt's gastrointestinal problems.9 Plaintiffs sued both brand-name and generic manufacturers of Reglan/metoclopramide.10 The thirty-three page complaint advances several theories of recovery ranging from negligence to fraud.11 Generics' motion to dismiss argues that all of Plaintiffs' claims against Generics should be dismissed for failure to state a claim upon which relief may be granted.

II. Dismissal Standards

"The ultimate question in a Rule 12(b)(6) motion is whether the complaint states a valid claim when all well-pleaded facts are assumed true and are viewed in the light most favorable to the plaintiff."12 "A pleading that states a claim for relief must contain: ... (2) a short and plain statement of the claim showing that the pleader is entitled to relief...."13 "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'"14 "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged."15 "[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice."16

To the extent that Plaintiffs allege fraud or misrepresentation, those claims are subject to the heightened pleading standards of Rule 9(b).17 Rule 9(b) "requires that [a plaintiff] `state with particularity the circumstances constituting the fraud.' `Put simply, Rule 9(b) requires the who, what, when, where, and how to be laid out.'"18

III. Analysis

The Court will begin its analysis by reviewing a recent Supreme Court decision that dealt with preemption of certain claims against generic manufactures of metoclopramide, then the Court will explore the interaction of Mensing and Texas products liability law, and finally the Court will evaluate whether Plaintiffs have stated any claims that are not preempted.

A. PLIVA, Inc. v. Mensing

As a threshold matter, the Court will address the elephant in the room, PLIVA, Inc. v. Mensing.19 The Supreme Court handed down this opinion on June 23, 2011,20 which was six days before Plaintiffs filed their first amended complaint and two months before Plaintiffs filed their second amended complaint.

Mensing is strikingly similar to the case now before the Court. Mensing was a consolidation of lawsuits in which Gladys Mensing and Julie Demahy sued generic manufacturers of metoclopramide.21

The defendant generic manufacturers responded by arguing "that federal law pre-empted the state tort claims."23

The Supreme Court began its preemption analysis by identifying and comparing the state tort duties with the applicable federal drug labeling requirements,24 and highlighted various differences between the approval and labeling requirements of brand-name and generic drugs.25 The opinion contrasted the complicated FDA approval process for new drugs with the approval process under the Hatch-Waxman Amendments for "`generic drugs' [which] can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA."26 The Supreme Court defined a "generic drug" as a "drug designed to be a copy of a reference listed drug (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy."27 Similarly, the majority contrasted the labeling duties of brand-name and generic drug manufacturers in seeking drug approval. "A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's."28

The Supreme Court then turned to the issue of whether generic manufacturers were permitted to change their labels "after initial FDA approval."29 The majority analyzed this issue under the principles of conflict preemption stating, "[w]here state and federal law `directly conflict,' state law must give way"30 and "[w]e have held that state and federal law conflict where it is `impossible for a private party to comply with both state and federal requirements.'"31 It is important to note that Mensing turned on the issue of conflict preemption-not express preemption. When the Supreme Court conducted a conflict preemption analysis in Mensing, it determined:

Later in the opinion the Supreme Court further developed its analysis stating, "federal law would permit the [generic manufacturers] to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label to do so."33 Mensing and Demahy argued that the generic manufacturers could not "bear their burden of proving impossibility because they did not even try to start the process that might ultimately have allowed them to use a safer label."34 The majority rejected this argument because "[t]he question for `impossibility' is whether the private party could independently do under federal law what state law requires of it."35

In the wake of Mensing, it is clear that state laws requiring generic drugs to have different labels than the FDA-approved brand-name labels are preempted. In order to understand the full implications of Mensing, it is necessary to review the definition of labeling in the prescription drug context.

Thus, Mensing covers a wide variety of communications regarding prescription drugs.

B. Mensing and Texas Products Liability Law Preclude Most Theories of Recovery

Turning to the case at bar, Plaintiffs' extensive complaint alleges several theories of recovery, but they all arise out of the alleged injury to Roy Eckhardt caused by his alleged use of metoclopramide. In Plaintiffs' motion for leave to file a second amended complaint, they stated, "[t]his is a product liability case."37 Upon review of the second amended complaint, the Court agrees that despite the multiple claims asserted by Plaintiffs, this is essentially a products liability case, with the claim arising from a failure to warn. More specifically, Plaintiffs claim that Generics failed to warn, in one form or another, that long-term use of metoclopramide caused tardive dyskinesia.

As this case is before the Court based on diversity, the Court applies Texas products liability law. In Texas,

Furthermore, Texas follows the § 402A Restatement (Second) of Torts approach to strict products liability.39 Section 402A provides:

Thus, "a product may be unreasonably dangerous because of a defect in marketing, design, or manufacturing."41

As mentioned above, this is primarily a failure to warn case. In Texas there is a statutorily created presumption in certain products liability actions involving prescription drugs where the plaintiff alleges a failure to provide adequate warnings or information:

Plaintiffs' second amended complaint apparently assumes that the warnings and information accompanying Eckhardt's metoclopramide were approved by the FDA.43 Thus, Generics appear to be statutorily protected from liability. However, the statute provides five means by which the presumption may be rebutted.44 Here, Plaintiffs specifically deny the applicability of the presumption by alleging that Generics withheld information from the FDA and misrepresented information to the FDA.45 These allegations correspond to one of the statutorily enumerated means of rebutting the presumption. But recently, the Fifth Circuit determined in Lofton v. McNeil Consumer and Specialty Pharmaceuticals that fraud-on-the-FDA claims under Texas Civil Practice and Remedies Code 82.007(b)(1) are preempted "unless the FDA itself has found fraud."46 The second amended complaint does not indicate that the FDA has itself found fraud. Therefore, in light of Lofton, the Court finds that Plaintiffs' claims that Generics provided the FDA with misinformation, however characterized, are preempted.

As noted, Plaintiffs have not disputed that Generics' warnings and information were approved by the FDA. Texas products liability law shields a manufacturer from liability for "an injury ... caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product"47 regardless of "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."48 Furthermore, as stated above, Mensing makes clear that any state laws requiring Generics' labeling to deviate from the approved brand labeling are preempted. To the extent that Generics only provided labeling and information that was approved by the FDA, Plaintiffs cannot prevail on any failure to warn theory.

Additionally, Plaintiffs cannot prevail on a theory that Generics failed to monitor the safety of metoclopramide either through testing or post-market surveillance. Simply put, there is a causation problem. Even assuming that testing by Generics would have uncovered the dangers of long-term metoclopramide use earlier, that knowledge would only be helpful to the extent that it was communicated through labeling. But Mensing establishes that Generics were not in a position to unilaterally change the labeling associated with the metoclopramide that they were producing. Therefore, like Demahy and Mensing's claim that generic manufacturers have a duty to request a strengthened label from the FDA,49 this failure to monitor claim is precluded by Mensing.

C. Theories of Recovery That Potentially Remain

The Court now considers those claims that may survive the above analysis. To survive the motion to dismiss, a claim must be both legally possible and supported by facts alleged in the complaint. The Court begins by noting that the response to the motion to dismiss adds several assertions of fact that were not included in the second amended complaint. Although the Court interprets a new theory raised in a response to a motion to dismiss as a motion to amend,50 the Court finds that such amendment should not be permitted here. Plaintiffs have already amended their complaint twice since the Supreme Court handed down Mensing51 Therefore, Plaintiffs have been afforded sufficient opportunities to make the necessary adjustments.

1. Manufacturing Defect

Plaintiffs' complaint alludes to a manufacturing defect.52 "A manufacturing defect exists 'when a product deviates, in its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous.'"53 The Court finds that the complaint contains no more than conclusory allegations that there was a manufacturing defect. Accordingly, Plaintiffs' manufacturing defect claim is dismissed.

2. Failure-to-Provide-Any-Information

In Plaintiffs' response, they argue that even if state laws requiring Generics to have different warnings than the FDA approved brand-name labeling are preempted, Generics may still be held liable for failing to provide any information whatsoever. In their response, Plaintiffs go as far as stating that "Generic Defendants never provided Plaintiff or his physicians with ANY warning or other information with regard to metoclopramide."54 Critically, Plaintiffs' second amended complaint directly contradicts the new assertion that Generics provided no information regarding metoclopramide. In the second amended complaint, Plaintiffs state:

Because the live pleading directly contradicts the failure-to-provide-any-information theory raised in the response, the Court will not consider this theory.

3. Failure-to-Update-Labeling

In both the second amended complaint and the response to the motion to dismiss, Plaintiffs complain that Generics did not properly update the labeling. But it is critical to understand that, although they are couched in similar language, the claims in the complaint and the claims in the response are based on radically different allegations. In the complaint, the claims focus on alleged failures to update the labeling to warn of the actual risks associated with metoclopramide.57 Mensing makes clear that these claims are preempted because generic manufacturers are not free to unilaterally change their labeling. For example, the Supreme Court stated, "we conclude that federal law did not permit the Manufacturers to issue additional warnings through Dear Doctor letters."58 Therefore, the failure-to-update-labeling claims in the second amended complaint are dismissed.

Turning to the failure-to-update-labeling claims in the response, they are very different from claims in the second amended complaint. In Plaintiffs' response, they assert that Generics failed to update the labeling or communicate the contents of the most up-to-date FDA approved brand labels.59 Quite simply, these claims are not supported by the second amended complaint. Therefore, the Court will not consider the novel failure-to-update-labeling claims that first appear in the response to the motion to dismiss.

4. Failure to Withdraw Metoclopramide From the Market

In Plaintiffs' response to the motion to dismiss, they argue that if Generics were prohibited by federal law from changing the label, they should have withdrawn metoclopramide from the market. First, the Court doubts that the second amended complaint supports this theory. The second amended complaint focuses on the alleged failure of Generics to adequately warn of the risks of long-term metoclopramide use. Second, the Court in Mensing found that state laws requiring the labels of generic manufacturers to differ from FDA-approved label conflicted with federal law. Similarly, a state law requirement that the drug be completely withdrawn from the market, based solely on a theory that the federally mandated label was inadequate, would also impermissibly conflict with federal law and be preempted. Therefore, any claims based on Generics' failure to withdraw metoclopramide from the market are dismissed.

5. Design Defect

The second amended complaint asserts that there was a design defect. For a plaintiff to prevail on a design defect claim under Texas law, he "must prove that there is a safer alternative design."60 "In the absence of a safer alternative, a product is not unreasonably dangerous as a matter of law."61 Here, Generics were obliged to use a certain design. In Mensing the Supreme Court stated:

Therefore, Generics were required to produce a drug that was equivalent to the brand-name drug and were not free to unilaterally pursue a safer alternative design in order to comply with state law. The design defect claim is thus preempted and therefore dismissed.

6. Participatory Liability

The Court has reviewed Plaintiffs' assertion that Generics are responsible for the brand manufacturers' actions on a theory of participatory liability under "The Restatement of Torts 2d § 876."63 It is an "open question" whether Texas law would even allow liability to be imposed based on § 876,64 and Plaintiffs have not directed the Court to any Texas cases holding a defendant liable under § 876. It is not the role of this Court, "Erie-bound," to expand Texas tort law.65 Therefore, the Court dismisses any claims that are based on a § 876 theory that Generics should be held liable for the actions of brand manufacturers.

7. Fraud

Plaintiffs allege that Generics committed fraud. Quite simply, Generics allegations of fraud fall far short of Rule 9(b)'s particularity requirement. The Court dismisses the fraud claims.

8. Suppression of Evidence

Plaintiffs allege that Generics suppressed evidence.66 The Court begins by noting that this claim is likely covered by the fraud analysis above. Nevertheless, out of an abundance of caution, the Court notes that it has found no Texas case recognizing a cause of action for suppression of evidence.67 Therefore this claim is dismissed.

9. Deceptive Trade Practices — Consumer Protection Act

Plaintiffs allege that Generics violated the Deceptive Trade Practices — Consumer Protection Act ("DTPA").68 The Court has already found that all the other claims in the complaint should be dismissed. After examining Plaintiffs' DTPA claims, it is clear that they are based on the same underlying allegations; Plaintiffs' DTPA claims are either conclusory or preempted in light of Mensing. Therefore, the DTPA claims are dismissed.

IV. CONCLUSION

After reviewing the motion, supporting memorandum, response, record and controlling authorities, the Court GRANTS Generics' motion to dismiss in its entirety. The claims against Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC, are dismissed with prejudice.

IT IS SO ORDERED.