Rojas v. Teva Pharmaceuticals USA, Inc.
Rojas v. Teva Pharmaceuticals USA, Inc.
Opinion of the Court
OPINION AND ORDER
Pending before the Court is a self-styled motion to dismiss filed by Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth, LLC.
1. Background
This case was originally filed in the 389th District Court, Hidalgo County, Tex
Plaintiff did not serve some of the named defendants. Importantly, Plaintiff only served two manufacturers of generic metoclopramide: Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth, LLC (collectively, “Generics”).
The state court, upon the agreement of all counsel, abated the case by order dated November 22, 2011.
On August 17, 2012, Generics filed a motion to dismiss.
Finally, on October 31, 2012, the parties who had appeared signed a stipulation of dismissal as to “Wyeth LLC; Wyeth Pharmaceuticals Inc., Individually and d/b/a ESI Lederle, Inc.; Wyeth Inc.; and Pfizer Inc.”
II. Legal Standards
Because Generics filed their motion to dismiss after they answered, the Court will construe it as a motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). “A motion for judgment on the pleadings under Rule 12(c) is subject to the same standard as a motion to dismiss under Rule 12(b)(6).”
To the extent that Plaintiff alleges fraud or misrepresentation, those claims are subject to the heightened pleading standards of Rule 9(b).
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 Plaintiff has 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.
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.
Each alleged, as relevant here, that long-term metoclopramide use caused her tardive dyskinesia and that the Manufacturers were liable under state tort law (specifically, that of Minnesota and Louisiana) for failing to provide adequate warning labels. They claimed that ‘despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label,’ none of the [generic manufacturers] had changed their labels to adequately warn of that danger.26
The defendant generic manufacturers responded by arguing “that federal law preempted the state tort claims.”
The Supreme Court began its preemption analysis by identifying and comparing the state tort duties with the applicable
The Supreme Court then turned to the issue of whether generic manufacturers were permitted to change their labels “after initial FDA approval.”
We find impossibility here. It was not lawful under federal law for the [generic manufacturers] to do what state law required of them. And even if they had fulfilled their federal duty to ask for FDA assistance, they would not have satisfied the requirements of state law.
If the [generic manufacturers] had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking Mensing and Demahy’s allegations as true, state law imposed on the [generic manufacturers] a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the [generic manufacturers] to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.36
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.”
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.
Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, 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 are hereby determined to be labeling as defined in section 201(m) of the act.40
Thus, Mensing covers a wide variety of communications regarding prescription drugs.
B. Plaintiffs Claims
The Court will now consider whether Plaintiff has stated any claims that survive the motion for judgment on the pleadings. The Court notes that Plaintiffs complaint is lacking in factual details and is conclusory. Even separate and apart from the preemption issues, it is doubtful the complaint would survive judgment on the pleadings. Furthermore, Plaintiffs response to the motion for judgment on the pleadings suffers from the same problem yet adds allegations that are not supported by the original petition. Nonetheless, in Plaintiffs response, she explicitly seeks leave to amend the complaint. Because Plaintiff has not previously amended her complaint, the Court interprets the response as both a motion to amend the complaint and a proposed amendment. Therefore, the Court will consider whether any of Plaintiffs claims, as amended by Plaintiffs response, survive the motion for judgment on the pleadings.
1. Mensing Preempts Most Theories of Recovery
Turning to the case at bar, Plaintiffs complaint (as amended by the response) alleges several theories of recovery, but they all arise out of the alleged injury to Petra Rojas caused by her alleged use of metoclopramide. In an “Agreed Order to Abate” the parties characterized this case as a “product liability case.”
As this case is before the Court based on diversity, the Court applies Texas products liability law. In Texas,
‘[pjroducts 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.42
Furthermore, Texas follows the § 402A Restatement (Second) of Torts approach to strict products liability.
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
(2) The rule stated in Subsection (1) applies although
(a) the seller has exercised all possible care in the preparation and sale of his product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.44
The Texas Supreme Court has explained the ways a product may be unreasonably dangerous. “[A] product may be unreasonably dangerous because of a defect in marketing, design, or manufacturing.”
A failure to warn, the focus of this case, is a type of marketing defect.
Furthermore, Plaintiff cannot prevail on a theory that Generics failed to adequately test their product. 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,
2. Theories of Recovery That Potentially Remain
The Court now considers those claims that may survive the above analysis. To survive the motion for judgment on the pleadings, a claim must be both legally possible and supported by facts alleged in the complaint.
a. Manufacturing Defect
Plaintiffs complaint alludes to a manufacturing defect.
b. Failure to Withdraw Metoclopramide From the Market
In Plaintiffs response to the motion for judgment on the pleadings, she directs the Court to Bartlett v. Mutual Pharmaceutical Co., Inc. in which the First Circuit found that a generic defendant “certainly can choose not to make the drug at all.”
c.Design Defect
Plaintiff also asserts that there was design defect. For a plaintiff to prevail on a design defect claim under Texas law, she “must prove that there is a safer alternative design.”
[Gjeneric drugs can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA. This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug. A generic drug application must also show that the [safety and efficacy] labeling proposed*780 ... is the same as the labeling approved for the [brand-name] drug.55
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. Above, the Court noted that it was not persuaded by the First Circuit’s recent opinion in Bartlett v. Mutual Pharmaceutical Co., Inc.
d. Fraud and Misrepresentation
Plaintiff alleges that Generics committed fraud. Quite simply, Plaintiffs allegations of fraud and misrepresentations fall far short of Rule 9(b)’s particularity requirement. The Court grants judgment on the pleadings for Generics on Plaintiffs fraud and misrepresentation claims.
e. Off-Label Promotion
In her response, Plaintiff asserts that Generics promoted and marketed metoclopramide “in a manner inconsistent with the FDA-mandated label and for off-label purposes[.]”
f.Failure to Update the Labeling
In Plaintiffs response, she alleges that Mensing does not preempt all of her claims because she has made state law claims that are not in conflict with federal law. In particular, Plaintiff alleges that Generics failed to update their labeling in 2004 as required by the FDA and failed to communicate that change to prescribers.
Recently in Centocor, Inc. v. Hamilton, a prescription drug case, the Texas Supreme Court found: “In sum, the crux of the [Plaintiffs]’ claims rests on [Defendant’s] alleged failure to provide an adequate warning of the potential risks and side effects associated with [the prescription drug].”
Specifically, Plaintiffs allegations are deficient because they fail to address the learned intermediary doctrine. In Centocor, the Texas Supreme Court explained the following about the learned intermediary doctrine:
Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a ‘learned intermediary,’ who then assumes the duty to pass on the necessary warnings to the end user. In this case, we consider the applicability of the learned intermediary doctrine to a patient’s claims against a prescription drug manufacturer, whose product allegedly caused a serious injury. We hold that the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician. We further hold that the court of appeals erred by creating an exception to the learned intermediary doctrine for direct-to-consumer (DTC) advertising. Although the patient alleged various common law causes of action, all of the patient’s claims turn on the prescription drug manufacturer’s failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient’s claims, and the patient was required to show that an inadequate warning to the prescribing physicians caused the patient’s injuries. Because the patient presented no evidence that the allegedly inadequate warning was a producing cause of her physicians’ decisions to prescribe the prescription drug, her claims fail as a matter of law.62
In Centocor, The Texas Supreme Court also elaborated on the “producing cause” requirement. “But when the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries.”
In this case, Plaintiffs failure-to-update-the-labeling and any other remaining failure to warn claims are inadequate. First, in her response, Plaintiff fails to mention her doctor in relation to her failure-to-update-the-labeling allegations. Instead she makes global allegations that Generics did not communicate the 2004 labels to the medical community. In short, she makes nothing more than conclusory allegations that Generics breached a duty to her doctor. Furthermore, Plaintiff makes no allegations that her doctor was unaware of the side effects of metoelopramide. On the contrary, in her original complaint, Plaintiff alleges that Dr. Behara knew or should have known of the side effects of metoclopramide. Thus, even if Plaintiff had sufficiently alleged that Ge
The Court finds that the learned intermediary doctrine applies in this case, but that Plaintiff has failed to plead facts that would allow her to prevail. Therefore, the Court grants judgment on the pleadings for Generics on Plaintiffs failure-to-update-the-labeling claims and any other claims that are not explicitly addressed elsewhere in this opinion.
g. Implied Warranty
In Plaintiffs response she states:
The Generic Defendants were aware that chronic MCP usage was unsafe and that their label was not compliant with the FDA-mandated label change. However, the Generic Defendants allowed the drug to be continued to be sold, which is tantamount to warranting that the drug was safe and effective for long-term usage. By failing to do what federal law required it to do (change their labels to conform with the 2004 version), the Generic Defendants warranted something that was not true.66
After considering Plaintiffs allegations, the Court finds that Plaintiffs implied warranty claims are indistinguishable from the failure to warn claims addressed earlier in this opinion. To the extent Plaintiffs implied warranty claim is not preempted, it is subject to the learned intermediary doctrine and inadequately pleaded. Therefore, the Court grants judgment on the pleadings for Generics on Plaintiffs implied warranty claims.
h. DTPA
Plaintiff alleges that Generics violated the Deceptive Trade Practices — Consumer Protection Act (“DTPA”).
IV. Conclusion
After considering the motion, response, reply, record, and governing authorities, the Court GRANTS Generics’ motion for judgment on the pleadings in its entirety.
IT IS SO ORDERED.
. Dkt. No. 32.
. The Court notes at the outset that the Supreme Court in PLIVA, Inc. v. Mensing, -
. Dkt. No. 1-2.
. Dkt. No. 1-4.
. Dkt. No. 1-4.
. Dkt. No. 1-2.
. Dkt. No. 1-14.
. Dkt. No. 1-20.
. Dkt. No. 1.
. Dkt. Nos. 18 & 38.
. Dkt. No. 32.
. Dkt. Nos. 35, 37 & 48.
. Dkt. Nos. 50, 51 & 52.
. Dkt. No. 53.
. Doe v. MySpace, Inc., 528 F.3d 413, 418 (5th Cir. 2008) (citations omitted).
. Shandong Yinguang Chem. Indus. Joint Stock Co., Ltd. v. Potter, 607 F.3d 1029, 1032 (5th Cir. 2010) (citation omitted).
. Fed.R.Civ.P. 8(a).
. Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)).
. Id. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955).
. Id. (citing Twombly, 550 U.S. at 555, 127 S.Ct. 1955).
. Fed.R.Civ.P. 9(b).
. Shandong Yinguang Chem. Indus. Joint Stock Co., Ltd. v. Potter, 607 F.3d 1029, 1032 (5th Cir. 2010) (quoting Fed.R.Civ.P. 9(b); Benchmark Elec., Inc. v. J.M. Huber Corp., 343 F.3d 719, 724 (5th Cir. 2003)).
. -U.S.-, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011).
. Id.
. Id. at 2572-73.
. Id. at 2573.
. Id.
. Id. at 2573-75.
. Id. at 2573-76.
. Id. at 2574 (citation omitted).
. Id. at 2574 n. 2 (citations omitted) (emphasis added).
. Id. at 2574 (citations omitted).
. Id.
. Id. at 2577 (citation omitted).
. Id. (citation omitted).
. Id. at 2577-78 (internal citations omitted).
. Id. at 2578.
. Id. at 2578-79.
. Id. at 2579 (citing Wyeth v. Levine, 555 U.S. 555, 573, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009)).
. 21 C.F.R. § 202.1(1 )(2); see also, Del Valle v. PLLVA, Inc., Civ. No. B:11-113, 2011 WL 7168620, at *4 (S.D.Tex. Dec. 21, 2011) ("In essence, virtually all communication with medical professionals concerning a drug constitutes labeling.”) (citing 21 C.F.R. § 202.1(0(2), adopted sub nom. Del Valle v. Qualitest Pharm. Inc., 2012 WL 2899406 (S.D.Tex. June 22, 2012)).
. Dkt. No. 1-14 at p. 2.
. Tex. Civ. Prac & Rem.Code Ann. § 82.001(2) (Vernon Supp.2011-2012).
. FFE Transp. Servs., Inc. v. Futgham, 154 S.W.3d 84, 87 (Tex. 2004).
. Restatement (Second) of Torts § 402A (1965).
. Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 426 (Tex. 1997) (citations omitted).
. Id. at 426 (citations omitted).
. PLIVA, Inc. v. Mensing,-U.S.-, 131 S.Ct. 2567, 2576-77, 180 L.Ed.2d 580 (2011).
. Dkt. No. 48 atp. 10.
. Dkt. No. 48 at p. 10.
. Dkt. No. 1-4 at p. 9.
. BIC Pen Corp. v. Carter, 346 S.W.3d 533, 540 (Tex. 2011) (internal quotation and citation omitted).
. Dkt. No. 48 at p. 6 (citing Bartlett v. Mut. Pharm. Co. Inc., 678 F.3d 30, 37 (1st Cir. 2012)).
. Brockert v. Wyeth Pharm. Inc., 287 S.W.3d 760, 769 (Tex.App.-Hous. [14th Dist.] April 14, 2009, no pet.) (citing Gen. Motors Corp. v. Sanchez, 997 S.W.2d 584, 588 (Tex. 1999); Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995)).
. Id. (citing Caterpillar, 911 S.W.2d at 384).
. PLIVA, Inc. v. Mensing, —U.S.—, 131 S.Ct. 2567, 2574, 180 L.Ed.2d 580 (2011) (internal citations and quotation marks omitted).
. 678 F.3d 30 (1st Cir. 2012).
. Id. at 35-36.
. Dkt. No. 48 at p. 9.
. Civ. No. 10-1552, 2011 WL 6056546 (E.D.La. Dec. 6, 2011).
. Dkt. No. 48 at pp. 7-10.
. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 169 (Tex. 2012).
. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 142-43 (Tex. 2012) (internal citation omitted).
. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 170 (Tex. 2012), reh’g denied (Aug. 17, 2012) (citation omitted).
. Id. at 166 & n. 26.
. Id. at 164-66.
. Dkt. No. 48 atp. 10 (emphasis added).
. Dkt. No. 1-4 at p. 9.
Reference
- Full Case Name
- Petra ROJAS v. TEVA PHARMACEUTICALS USA, INC.
- Cited By
- 2 cases
- Status
- Published