Mills v. Warner-Lambert Co., Civil Action No. 1:07-CV-264-TH.

CourtUnited States District Courts. 5th Circuit. United States District Court of Eastern District Texas
Writing for the CourtThad Heartfield
Citation581 F.Supp.2d 772
PartiesKatherine MILLS, individually and on behalf of all others similarly situated, and Veronica Evans, individually and on behalf of all others similarly situated, Plaintiffs, v. WARNER-LAMBERT COMPANY, Pfizer, Inc., Bayer Corporation, Del Pharmaceuticals, Inc., Del Laboratories Inc., and Care Technologies, Inc., and Insight Pharmaceutical Corporation, Defendants.
Decision Date30 September 2008
Docket NumberCivil Action No. 1:07-CV-264-TH.
581 F.Supp.2d 772
Katherine MILLS, individually and on behalf of all others similarly situated, and Veronica Evans, individually and on behalf of all others similarly situated, Plaintiffs,
v.
WARNER-LAMBERT COMPANY, Pfizer, Inc., Bayer Corporation, Del Pharmaceuticals, Inc., Del Laboratories Inc., and Care Technologies, Inc., and Insight Pharmaceutical Corporation, Defendants.
Civil Action No. 1:07-CV-264-TH.
United States District Court, E.D. Texas, Beaumont Division.
September 30, 2008.

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Mikal C. Watts, Edward William Allred, Francisco Guerra, IV, Watts Law Firm, San Antonio, TX, for Plaintiffs.

Jack Edward Urquhart, Laura E. DeSantos, Urquhart & DeSantos, Austin, TX, Richard A. De Sevo, Thomas A. Smart, Kaye Scholar, New York, NY, Rex Wayne Peveto, Peveto Law Firm, Wayne Peveto, Attorney at Law, Orange, TX, for Warner-Lambert Company, Pfizer, Inc.

Gerry Lowry, Fulbright & Jaworski, Houston, TX, for Bayer Corporation.

James Gregory Waller, Richard H. Caldwell, Andrews & Kurth, Houston, TX, for Del Pharmaceutical, Inc., Del Laboratories, Inc.

Gerald J. Pels, Sutherland Asbill & Brennan, LLP, Houston, TX, Matthew Gatewood, Richard G. Murphy, Jr., Sutherland Asbill & Brennan LLP, Washington, DC, for Insight Pharmaceuticals Corporation.

MEMORANDUM OPINION & ORDER GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

THAD HEARTFIELD, District Judge.


Before the Court is the Motion for Summary Judgment and Supporting Memorandum of Defendants Warner-Lambert Company LLC, Pfizer Inc., Bayer Corporation, Del Pharmaceuticals, Inc., Del Laboratories, Inc. and Insight Pharmaceuticals Corporation [Clerk's Docket No. 41], filed September 28, 2007. Having considered the motion, the responsive pleadings, and the applicable law, the Court is of the opinion that the motion should be granted.

I. INTRODUCTION

Plaintiffs Katherine Mills and Veronica Evans (collectively "Plaintiffs") bring this putative class action against the manufacturers of various lice treatment medications. Plaintiffs challenge the effectiveness of those medications, and seek recovery of the money they spent purchasing them. This opinion considers whether federal law preempts such a challenge to a drug when it has previously been approved by the FDA. The Court concludes that it does. Because this is not a products liability action (under

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Texas law), Plaintiffs' claims are expressly barred by Section 379r of the Federal Food, Drug and Cosmetic Act, (21 U.S.C. § 301 et. seq.) (the "FDCA"), the preemption clause of the statute, that relates to nonprescription drugs.

II. BACKGROUND

A. Plaintiffs' Lawsuit

Plaintiffs purchased lice treatment medications manufactured by the defendants in this case, and now claim that they are ineffective—that they do not kill lice. Plaintiffs do not just claim that these medications failed in specific instances, or for specific individuals. Rather, they claim that lice are resistant to the products, and that the medications do not work for anyone at any time.

This suit specifically concerns three non-prescription lice treatment medications: (1) NIX Lice Treatment, sold by defendant Insight Pharmaceuticals Corporation1 ("Insight"), and previously sold by defendant Warner-Lambert Company LLC2 ("Warner-Lambert"); (2) RID Lice Killing Shampoo, sold by defendant Bayer Corporation ("Bayer"), and previously sold by defendant Pfizer, Inc. ("Pfizer"); and (3) PRONTO Lice Treatment, sold by defendant Del Pharmaceuticals, Inc.3 ("Del").4 All of these products are generically known by the scientific name "pediculicides."5

To be clear about the nature of this suit: Plaintiffs do not allege a negligent manufacturing defect, a design defect sounding in strict liability, or a failure to warn. They do not claim that the lice treatments have caused any personal injury or any damage to property. And, they do not claim that the treatments are potentially unsafe. Their sole contention is that the products are ineffective. In Plaintiffs' own words:

The plaintiffs are contending that defendants' products amount to snake oil. The products are inherently useless and worthless. They do not kill lice. They do not cure lice infestations.

Warner-Lambert v. Mills, 2005 WL 2088366, at *1, 2005 Tex.App. LEXIS 7105, *34 (Tex.App.-Beaumont, August 31, 2005) (quoting Plaintiffs' briefs).

On this basis, Plaintiffs assert two causes of action under Texas law. First, Plaintiffs claim that by selling ineffective medications Defendants breached the implied warranty of merchantability codified by the Texas UCC, Tex. Bus. & Comm. Code § 2.314. Under Texas law, a warranty of merchantability is implied in every contract for the sale of goods by a merchant, unless the warranty is properly excluded or modified. Tex. Bus. & Comm. Code § 2.314(a) (Vernon 2007); Hininger v. Case Corp., 23 F.3d 124, 128 (5th Cir. 1994). Second, Plaintiffs claim that by

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selling ineffective medications, Defendants violated the Texas Deceptive Trade Practices Act, Tex. Bus. & Comm.Code § 17.50(a)(2) (the "DTPA"). While this DTPA claim is a distinct cause of action, the DTPA does not actually create an independent claim for breach of warranty. See Hininger, 23 F.3d at 129 (citing La Sara Grain Co. v. First Nat'l Bank of Mercedes, 673 S.W.2d 558, 565 (Tex.1984) (the DTPA "does not create any warranties")); Parkway Co. v. Woodruff, 901 S.W.2d 434, 438 (Tex.1995). Instead, the DTPA simply provides additional monetary remedies for a breach of the implied warranty of merchantability. Id. So, the two claims are substantively the same.

Rather than attack the merits of these allegations, Defendants argue that all of Plaintiffs' claims are preempted by federal law; and, therefore, must be dismissed.

B. Federal Preemption

The doctrine of federal preemption is based on the Supremacy Clause of the United States Constitution. Fid. Fed. Sav. & Loan Ass'n v. dela Cuesta, 458 U.S. 141, 152, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). The Supremacy Clause provides that United States law is "the supreme Law of the Land; ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. CONST. Art. VI, Cl. 2. As such, any State law that conflicts with the exercise of federal power is preempted and has no effect. Maryland v. Louisiana, 451 U.S. 725, 747, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981); See McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316, 4 L.Ed. 579 (1819).

Supreme Court case law has established that State law is preempted under the Supremacy Clause in three circumstances. English v. General Electric Co., 496 U.S. 72, 78-79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990). First, Congress may expressly preempt State law. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992); English, 496 U.S. at 79, 110 S.Ct. 2270. Second, in the absence of explicit statutory language, "state law is preempted where it regulates conduct in a field that Congress intended the Federal Government to occupy exclusively." English, 496 U.S. at 79, 110 S.Ct. 2270; Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995). Finally, preemption may also be implied to the extent that State law actually conflicts with federal law. English, 496 U.S. at 79, 110 S.Ct. 2270. The Supreme Court has found such implied conflict preemption where "(1) it is impossible for a private party to comply with both State and federal requirements; or (2) State law obstructs accomplishing and executing Congress' full purposes and objectives." Freightliner, 514 U.S. at 287, 115 S.Ct. 1483.

C. FDCA Preemption

In this case, Defendants argue that Plaintiffs' claims are preempted for two reasons: (1) they are expressly preempted by Section 379r of the Federal Food, Drug and Cosmetic Act ("FDCA") (21 U.S.C. § 301 et. seq.); and (2) they are impliedly preempted because they conflict with the FDCA and the Food and Drug Administration ("FDA") regulations governing the sale of Defendants' Medications. (Def.s' Mot. for Summ. J. at 9). This opinion only addresses Defendants' first argument: express preemption under Section 379r.

Section 379r is the preemption provision of the FDCA that applies to nonprescription drugs. 21 U.S.C. § 379r.6 It provides that any State requirement relating

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to drug regulation that is not identical to a federal requirement under the FDCA is expressly preempted. 21 U.S.C. § 379r(a). Here, Defendants argue that Plaintiffs' claims are preempted by Section 379r because they would impose a drug labeling "requirement" different from that required by the FDA. Essentially (the argument goes), the FDCA specifies that Defendants' drug labels must state that they are effective in the treatment of head lice. However, Plaintiffs' suit is based on the notion that the medications are not effective. It would punish Defendants for selling their products with the labeling language required by the FDCA. So according to Defendants, Plaintiffs' claims would impose a requirement on the marketing and sale of their products that differs from the FDCA's. Plaintiffs admit that a jury verdict in this lawsuit "might effect or induce" Defendants to change their conduct. Nevertheless, Plaintiff maintain that their claims do not constitute a "requirement," under the meaning of the statute.

Alternatively, Plaintiffs argue that their claims are `saved' from preemption by Section 379(e), the FDCA's `saving clause.' Section 379(e) provides that nothing in the preemption provision "shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State." 21 U.S.C. § 379r(e). As such, Plaintiffs argue that their claims brought under the product liability law of Texas and are therefore exempt from preemption.

These preemption arguments have been part of this case for more than seven years.

D. Procedural...

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37 practice notes
  • Note Inv. Grp., Inc. v. Assocs. First Capital Corp., CIVIL ACTION NO. 1:12–CV–419
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • March 16, 2015
    ...“only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); accor......
  • Brooks v. Firestone Polymers, LLC, CIVIL ACTION NO. 1:12–CV–325
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • October 8, 2014
    ...“only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); accor......
  • Gellhaus v. Wal–mart Stores Inc., Civil Action No. 1:10–CV–123.
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • March 10, 2011
    ...Nevertheless, “only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (......
  • Bitco Gen. Ins. Corp. v. Acadia Ins. Co., CIVIL ACTION NO. 1:18-CV-526
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • December 16, 2019
    ..."only reasonable inferences in favor of the nonmoving party can be drawn from the evidence." Mills v. Warner-Lambert Co. , 581 F. Supp. 2d 772, 779 (E.D. Tex. 2008) (citing Eastman Kodak Co. v. Image Tech. Servs., Inc. , 504 U.S. 451, 469 n.14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); see ......
  • Request a trial to view additional results
36 cases
  • Note Inv. Grp., Inc. v. Assocs. First Capital Corp., CIVIL ACTION NO. 1:12–CV–419
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • March 16, 2015
    ...“only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); accor......
  • Brooks v. Firestone Polymers, LLC, CIVIL ACTION NO. 1:12–CV–325
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • October 8, 2014
    ...“only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); accor......
  • Gellhaus v. Wal–mart Stores Inc., Civil Action No. 1:10–CV–123.
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • March 10, 2011
    ...Nevertheless, “only reasonable inferences in favor of the nonmoving party can be drawn from the evidence.” Mills v. Warner–Lambert Co., 581 F.Supp.2d 772, 779 (E.D.Tex.2008) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 469 n. 14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (......
  • Bitco Gen. Ins. Corp. v. Acadia Ins. Co., CIVIL ACTION NO. 1:18-CV-526
    • United States
    • United States District Courts. 5th Circuit. United States District Court of Eastern District Texas
    • December 16, 2019
    ..."only reasonable inferences in favor of the nonmoving party can be drawn from the evidence." Mills v. Warner-Lambert Co. , 581 F. Supp. 2d 772, 779 (E.D. Tex. 2008) (citing Eastman Kodak Co. v. Image Tech. Servs., Inc. , 504 U.S. 451, 469 n.14, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ); see ......
  • Request a trial to view additional results

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