Bartlett v. Mutual Pharmaceutical Co., Inc.

Decision Date30 September 2009
Docket NumberCivil No. 08-cv-358-JL.
Citation659 F.Supp.2d 279,2009 DNH 144
PartiesKaren L. BARTLETT and Gregory S. Bartlett v. MUTUAL PHARMACEUTICAL COMPANY, INC., et al.
CourtU.S. District Court — District of New Hampshire

Bryan Ballew, Keith M. Jensen, Patrick J. O'Neal, Jensen Belew & Gonzalez PLLC, Fort Worth, TX, Christine M. Craig, Timothy P. Beaupre, Shaheen & Gordon, Dover, NH, for Plaintiff.

Jeffrey D. Geoppinger, Joseph P. Thomas, Linda E. Maichl, Paul J. Cosgrove, Ulmer & Berne LLP, Cincinnati, OH, Stephen J. Judge, Wadleigh Starr & Peters PLLC, Manchester, NH, for Defendant.

ORDER

JOSEPH N. LAPLANTE, District Judge.

This case presents a question currently pending before three different federal courts of appeal: whether state-law tort claims alleging the defective labeling of generic drugs are preempted by federal law. See Morris v. Wyeth, Inc., No. 09-5509 (6th Cir. Apr. 27, 2009); Demahy v. Wyeth, Inc., No. 08-31204 (5th Cir. Dec. 16, 2008); Mensing v. Wyeth, Inc., No. 08-3850 (8th Cir. Dec. 10, 2008). The defendants, Mutual Pharmaceutical Company, Inc. and United Research Laboratories, Inc., move for judgment on the pleadings, see Fed.R.Civ.P. 12(c), on claims by the plaintiffs, Karen L. and Gregory S. Bartlett, alleging that Karen suffered serious injuries from Sulindac, a generic drug manufactured by the defendants. The defendants argue that all of the plaintiffs' state-law causes of action are pre-empted by Title I of the Drug Price Competition and Patent Term Restoration Act of 1984,1 part of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act ("FDCA").2 This court has subject-matter jurisdiction under 28 U.S.C. § 1332(a)(1) (diversity).

After considering the parties' extensive briefing and oral argument, the court denies the defendants' motion for judgment on the pleadings. The Bartletts' claims do not present an obstacle to the accomplishment and execution of the full purposes and objectives of Congress in the Hatch-Waxman Amendments, nor does complying with the state law underlying those claims make it impossible to comply with the Hatch-Waxman Amendments or any other federal law identified by the defendants. The Supreme Court's recent decision on the pre-emptive effect of federal drug regulation on state tort law in Wyeth v. Levine, ___ U.S. ___, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), makes that result clear. Accordingly, the Bartletts' claims are not pre-empted.

I. Applicable legal standard

Federal "preemption is an affirmative defense on which [the] defendant bears the burden of proof." Cambridge Literary Props., Ltd. v. W. Goebel Porzellanfabrik G.m.b.H. & Co. KG., 510 F.3d 77, 102 (1st Cir.2007), cert. denied, ___ U.S. ___, 129 S.Ct. 58, 172 L.Ed.2d 25 (2008); see also Wyeth, 129 S.Ct. at 1193 (characterizing a manufacturer's argument that federal drug law pre-empted the plaintiff's claims as a defense). While an affirmative defense can support a Rule 12(c) motion for judgment on the pleadings, it can do so "only where it is (1) definitively ascertainable from the complaint and other sources of information that are reviewable at [the pleadings] stage, and (2) [these] facts establish the affirmative defense with certitude." Citibank Global Mkts., Inc. v. Rodriguez Santana, 573 F.3d 17, 23 (1st Cir. 2009).

II. Background
A. The Bartletts' allegations

For purposes of the defendants' motion for judgment on the pleadings, the court accepts the following allegations of the Bartletts' complaint as true. See Gray v. Evercore Restructuring L.L.C., 544 F.3d 320, 324 (1st Cir.2008). In December 2004, Karen Bartlett's physician prescribed her Sulindac, a non-steroidal anti-inflammatory drug manufactured by the defendants, for pain in her right shoulder. Within weeks of filling the prescription, she went to a local emergency room complaining of "pimple like bumps, spots or blisters on her face, a fever, eye irritation," and other symptoms. She was soon diagnosed with Stevens-Johnson syndrome progressing to toxic epidermal necrolysis, a serious and potentially fatal condition characterized by large areas of lesions on and necrosis of the skin and mucous membranes. See Dorland's Illustrated Medical Dictionary 1872 (31st ed.2007). She spent approximately three months in the hospital recovering, including two months in a medically induced coma, and emerged with permanent injuries.

Sulindac is the generic version of a drug originally approved by the FDA in 1978; the generic version at issue here was approved in 1991. The Bartletts allege that, following this approval, the defendants "had an ongoing duty to conduct post-marketing safety surveillance for any reports of serious adverse events associated with Sulindac including any such report in the medical literature" and that, had they done so, they would have uncovered information compelling them "to warn physicians about the dangers" of the drug, including associations with Stevens-Johnson syndrome and toxic epidermal necrolysis.

The Bartletts' complaint asserts seven counts:

• strict product liability—failure to warn (count 1);

• strict product liability—defective in design or manufacture (count 2);

• fraud, in the sense that the defendants "made misrepresentations of material facts . . . and omitted and/or concealed material facts" about the risks of Sulindac (count 3);

• breach of implied warranty that Sulindac was "of merchantable quality and safe and fit for [its intended] use" (count 4);

• breach of express warranty that Sulindac "was safe and well accepted by patients and was safe for long-term use" (count 5);

• negligence in failing "to use reasonable care in designing, testing, labeling, marketing, supplying, distribution [sic] and selling" Sulindac (count 6);

• gross negligence based on the same omissions (count 7).

B. The statutory and regulatory scheme
1. Overview of the FDA approval process

The FDCA prohibits the "introduction into interstate commerce [of] any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug."3 21 U.S.C. § 355(a). As discussed in detail below, those two subsections provide two different procedures for obtaining the requisite approval from the Secretary of Health and Human Services to distribute a new drug. The Secretary oversees the Food and Drug Agency in carrying out these procedures. See id. § 393(b)(2)(A).

Subsection (b) authorizes a new drug application ("NDA") containing certain specified data, e.g., "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective for use," "a full list of the articles used as components of such drug," and "specimens of the labeling proposed to be used for such drug." Id. § 355(b)(1). The Secretary shall approve such an application absent specified grounds for denial. See id. § 355(c)(1)(A). These grounds include, e.g., that the required investigations "do not include adequate tests . . . to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof," that "results of such tests show that such drug is unsafe for use under such conditions," and that "based on a fair evaluation of all material facts, such labeling is unsafe or misleading in any particular." Id. § 355(d).

Subsection (j), the Hatch-Waxman Amendments, sets forth a process under which "[a]ny person may file with the Secretary [of HHS] an abbreviated application for the approval of a new drug." Id. § 355(j)(1) (emphasis added). Rather than the data required of a full-blown NDA by subsection (b), an abbreviated application ("ANDA") must show that "the conditions of use prescribed, recommended, or suggested in the labeling have been previously approved for . . . a listed drug," id. §§ 355(j)(2)(A)(i) (internal quotation marks and parentheses omitted), and that each of a number of specified characteristics of the new drug is "the same as that of the listed drug." Id. §§ 355(j)(2)(A)(ii)-(v). These characteristics include the drug's active ingredient, route of administration, dosage form, strength, and labeling. See id.

A "listed drug" is a "drug which has been approved for safety and effectiveness under subsection (c) of this section," id. § 355(j)(7)(A)(i)(I), which, as just discussed, governs the approval of applications submitted under subsection (b). The Secretary must approve an ANDA absent certain specified grounds, e.g., "information submitted with the application is insufficient to show that each of the proposed conditions of use have been previously approved for the listed drug," id. § 355(j)(4)(B), or "information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug,"4 id. § 355(j)(4)(G).

The Hatch-Waxman Amendments, then, authorize the approval of a new drug without demanding the information that would otherwise be required in an application under subsection (b), i.e., the reports of safety and effectiveness investigations and the like, provided the same drug has been previously approved for the same conditions under that more rigorous process. As one committee report on the Amendments noted, their "focus . . . is to provide the Food and Drug Administration with sufficient information to assure that the generic drug is the same as the listed drug that has previously been determined to be safe and effective." H.R.Rep. No. 98-857, pt. 1, at 21 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2654 (footnote and parenthetical omitted). The term "generic drug," in this context, refers to a "listed drug" not covered by a patent, whether because that patent has expired or otherwise. See 21 U.S.C. § 355(j)(2)(A)(vii).

2. ANDA procedures before Hatch-Waxman

As this committee report also noted, the FDA had, at that point, already...

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