858 F. Supp. 2d 792 | S.D. Tex. | 2012
ORDER
Pending before the Court is the self-styled “Motion to Dismiss by Defendants Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC” and supporting memorandum.
I. Background
Plaintiffs filed their first complaint on April 13, 2011.
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.”
To the extent that Plaintiffs allege 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 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.
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.22
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 federal drug labeling requirements,
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*797 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 them 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.32
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.36
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
As this case is before the Court based on diversity, the Court applies Texas products liability law. In Texas,
‘[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.38
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.40
Thus, “a product may be unreasonably dangerous because of a defect in marketing, design, or manufacturing.”
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:
(a) In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescribe!’, are not liable with respect to the allegations involving failure to provide adequate warnings or information if:
(1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended, or Section 351, Public Health Service Act (42 U.S.C. Section 262), as amended;42
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”
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,
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
1. Manufacturing Defect
Plaintiffs’ complaint alludes to a manufacturing defect.
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.”
Qualitest and Vintage expressly warranted to physicians that Reglan/metoclopramide was safe for long term use.55 Each of the generic drug company defendants adopted, in substance, as the text of the “package insert” for its generic metoclopramide product, the verbatim content of the package insert for Reglan, as revised from time to time, modified only to reflect therapeutically non-relevant differences among the products, such as color[,] shape, inactive ingredients, and source of manufacture.56
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.
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.
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.”
[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 ... is the same as the labeling approved for the [brand-name] drug.62
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.
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.”
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.
9. Deceptive Trade Practices — Consumer Protection Act
Plaintiffs allege that Generics violated the Deceptive Trade Practices- — Consumer Protection Act (“DTPA”).
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.
. Dkt. No. 47; Dkt. No. 47, Attach. 1.
. - U.S.-, 131 S.Ct. 2567, 180 L.Ed.2d 580(2011).
. Dkt. No. 47, Attach. 1.
. The Court notes at the outset that the Supreme Court in Mensing expressly limited its analysis of federal law to the law as it existed prior to the 2007 amendments. Mensing, 131 S.Ct. at 2574 n. 1. Here, Generics assert that the 2007 amendments do not alter the outcome in this case and Plaintiffs have not directed the Court to anything that indicates otherwise.
. Dkt. No. 1.
. Dkt. No. 10.
. Dkt. No. 22.
. Dkt. No. 22, at ¶ 3.48.
. Id. at ¶¶ 3.15, 3.48-3.50.
. Id. at ¶¶ 1.06-1.07; 3.02-3.03, 3.10.
. Id.
. 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, 129 S.Ct. 1937, 1949, 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. at 1949-1950 (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 2572-2573.
. Id. at 2573.
. Id.
. Id. at 2574-2575.
. Id.
. 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 2577-2578 (internal citation omitted).
. Id. at 2578.
. Id. at 2578-2579.
. 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(l)(2); see also, Del Valle v. PLIVA, 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(l)(2)).
. Dkt. No. 20.
. Tex. Civ. Prac. & Rem.Code Ann. § 82.001(2) (Vernon Supp.2011-2012).
. FFE Transp. Servs., Inc. v. Fulgham, 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).
. Tex Civ. Prac. & Rem.Code Ann. § 82.007(a) (Vernon Supp.2011-2012).
. Dkt. No. 22 at p. 32.
. Tex. Civ. Prac. & Rem Code Ann. § 82.007(b) (Vernon Supp.2011-2012).
. Dkt. No. 22 at p. 32.
. 672 F.3d 372, 380 (5th Cir.2012).
. Tex. Civ. Prac. & Rem.Code Ann. § 82.007(a) (Vernon Supp.2011-2012).
. Tex. Civ. Prac. & Rem.Code Ann. § 82.001(2) (Vernon Supp.2011-2012).
. PLIVA, Inc. v. Mensing, - U.S. -, 131 S.Ct. 2567, 2576-2577, 180 L.Ed.2d 580 (2011).
. See Stover v. Hattiesburg Pub. Sch. Dist., 549 F.3d 985, 989 n. 2 (5th Cir.2008).
. Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962) (listing “repeated failure to cure deficiencies by amendments previously allowed" among valid reasons for denying leave to amend).
. Dkt. No. 22 at ¶ 4.03(a).
. BIC Pen Corp. v. Carter, 346 S.W.3d 533, 540 (Tex.,2011) (internal quotation and citation omitted).
. Dkt. No. 54 at p. 3.
. Dkt. No. 22 at ¶ 3.04.
. Id. at ¶ 3.18 (emphasis added).
. See, e.g., id. at ¶¶ 3.73, 3.81, 3.94.
. PLIVA, Inc. v. Mensing, - U.S. -, 131 S.Ct. 2567, 2576, 180 L.Ed.2d 580 (2011).
. See, e.g., Dkt. No. 54 at pp. 7-9.
. Brockert v. Wyeth Pharm. Inc., 287 S.W.3d 760, 769 (Tex.App.-Hous. [14th Dist.] 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).
. Mensing, 131 S.Ct. at 2574 (internal citations and quotation marks omitted).
. Dkt. No. 22 at ¶ 6.01.
. Navarro v. Grant Thornton, LLP, 316 S.W.3d 715, 727 n. 12 (Tex.App.-Hous. [14th Disl.] 2010, no pet.) (citing Juhl v. Airington, 936 S.W.2d 640, 643 (Tex. 1996)).
. City Pub. Serv. Bd. v. Gen. Elec. Co., 947 F.2d 747, 748 (1991).
. Dkt. No. 22 at ¶¶ 4.16-4.21.
. Even spoliation of evidence is not recognized as an independent tort in Texas. Trevino v. Ortega, 969 S.W.2d 950, 952-53 (Tex.1998).
. Dkt. No. 22 at ¶¶ 4.32-4.35.