Blanchard v. Collagen Corp.

• Decision Date: 12 December 1995
• Docket Number: Civ. A. No. 94-1177.
• Citation: 909 F. Supp. 427
• Parties: Dr. Annelle C. BLANCHARD v. COLLAGEN CORPORATION.
• Court: U.S. District Court — Eastern District of Louisiana

909 F. Supp. 427

Dr. Annelle C. BLANCHARD v. COLLAGEN CORPORATION.

Civ. A. No. 94-1177.

United States District Court, E.D. Louisiana.

December 12, 1995.

COPYRIGHT MATERIAL OMITTED

Patrick M. Amedee, Alton Jeorld Hall, Jr., Vosbein, Delise, Amedee & Bertrand, New Orleans, LA, for plaintiff.

Lawrence A. Mann, Leake & Andersson, New Orleans, LA, William Curt Webb, Joe W. Redden, Jr., Beck, Redden & Secrest, Houston, TX, William Paul Wilkins, O'Neal, Walsh & Associates, Baton Rouge, LA, for defendant.

ORDER AND REASONS

MENTZ, District Judge.

I. FACTUAL BACKGROUND

The plaintiff, Dr. Annelle C. Blanchard, brought this product liability action under Louisiana state tort laws against Collagen Corporation as the manufacturer and distributer of Zyplast Collagen Implant. Zyplast is a product made from bovine collagen. It is injected under the skin to correct soft tissue deficiencies resulting from disease, trauma, or age. Blanchard received a series of injections of Zyplast into her lower lip. Within a few days of receiving one of these injections, she began to experience the onset of craniofacial varicella zoster, a recurring viral condition that causes lesions and disfiguring scars. Blanchard alleges that her condition was caused by an injection of collagen contaminated with a bovine herpes virus. She claims that Collagen is strictly liable and/or negligent for failure to warn and improper design, construction, manufacture, and testing of the collagen.

Before the court is Collagen's motion for summary judgment. Collagen seeks to dismiss plaintiff's suit on the ground of federal preemption based on the MDA's preemption statute, 21 U.S.C. § 360k(a), and the undisputed fact that Zyplast received pre-market approval from the Food and Drug Administration (FDA).

Under the Medical Device Amendments of 1976 (MDA), 21 U.S.C. §§ 360(c), et seq., to the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. §§ 301, et seq. (as amended by the Safe Medical Devices Act of 1990, Pub.L. No. 101-629, 104 Stat. 4511-30 (1990)), medical devices are subject to different degrees of regulation depending on the nature of the device and its risks to health, if any. The FDA, which has comprehensive regulatory authority over medical devices, has classified Zyplast as a Class III device.¹ With certain exceptions not relevant here, Class III devices must undergo a rigorous pre-market approval process (PMA).² PMA requires the applicant to present the FDA with "all information" known or reasonably knowable about the device, including proposed labeling, testing data, descriptions of design, manufacturing methods and materials, and proposed uses. 21 U.S.C. § 360e(c)(1)(A-G).³

The issue before the court is whether the MDA, and in particular, the FDA's pre-market approval of Zyplast, preempts any of Blanchard's state law claims. For the reasons that follow, the court grants partial summary judgment dismissing all claims, except for strict liability and negligence based on the alleged contamination of the product.

II. ANALYSIS

A. Standard for Summary Judgment

Summary judgment is appropriate where the record shows no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Fed. R.Civ.P. 56(c). The facts must be viewed in the light most favorable to the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 2513-14, 91 L.Ed.2d 202 (1986). The non-moving party bears the burden of placing at least one material fact into dispute after the moving party shows the absence of any disputed material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 324-25, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986).

B. General Principles of Federal Preemption Analysis

The foundation for federal preemption of state laws is found in the Supremacy Clause of the United States Constitution, which mandates that "this Constitution, and the Laws of the United States ... shall be 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. "State laws that conflict with federal laws and regulations, therefore, are preempted." King v. Collagen Corp., 983 F.2d 1130, 1133 (1st Cir.), cert. denied, ___ U.S. ___, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) (citing Malone v. White Motor Corp., 435 U.S. 497, 98 S.Ct. 1185, 55 L.Ed.2d 443 (1978)).

Whether a federal statute preempts state law is a question of congressional intent. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947). There is a presumption against preemption unless congressional intent to preempt is clear and manifest. See Department of Revenue of Oregon v. ACF Industries, Inc., ___ U.S. ___, ___, 114 S.Ct. 843, 851, 127 L.Ed.2d 165 (1994); CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 662-63, 113 S.Ct. 1732, 1737, 123 L.Ed.2d 387 (1993); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 515-16, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992); Rice, 331 U.S. at 229-31, 67 S.Ct. at 1152. This presumption is based on principles of federalism which include a deference for state historic police powers, such as the regulation of health and safety matters, and the provision of tort remedies to compensate for personal injuries, particularly when there is no federal remedy for the plaintiff's injury. See Hawaiian Airlines, Inc. v. Norris, ___ U.S. ___, ___, 114 S.Ct. 2239, 2243, 129 L.Ed.2d 203 (1994) (quoting Fort Halifax Packing Co., Inc. v. Coyne, 482 U.S. 1, 21, 107 S.Ct. 2211, 2222, 96 L.Ed.2d 1 (1987)); Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251-52, 104 S.Ct. 615, 623, 78 L.Ed.2d 443 (1984) ("it is difficult to believe that Congress would, without comment, remove all means of recourse for those injured by illegal conduct"); Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (D.C.Cir.), cert. denied, 469 U.S. 1062, 105 S.Ct. 545, 83 L.Ed.2d 432 (1984).

Blanchard's claims concern rights and remedies regarded as within the scope of traditional state powers, namely, tort compensation and health and safety. See W. Prosser, Handbook of the Law of Torts, § 5 at 23 (4th ed. 1971) (state tort law unquestionably relates to matters of health and safety). In addition, Blanchard will be left without a remedy if her claims are preempted because there is no private right of action to recover damages or other relief under the MDA. See Stamps v. Collagen Corp., 984 F.2d 1416, 1425 (5th Cir.), cert. denied, ___ U.S. ___, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993). Therefore, Collagen, who as defendant bears the burden of demonstrating preemption, see Silkwood, 464 U.S. at 254-56, 104 S.Ct. at 625, must establish that Congress has spoken clearly and made its intention to preempt unmistakable.

Congressional intent to preempt state law may be stated expressly in statutory language. In the absence of an express preemption, Congressional intent to preempt a state law may be inferred where comprehensive federal law entirely occupies a given regulatory field to the exclusion of state law, or where the state law actually conflicts with a federal law. See English v. General Elec. Co., 496 U.S. 72, 78-79, 110 S.Ct. 2270, 2275, 110 L.Ed.2d 65 (1990).

The United States Supreme Court recently addressed express and implied preemption in Cipollone:

When Congress has considered the issue of preemption and has included in the enacted legislation a provision explicitly addressing that issue, and when that provision provides a "reliable indicium of congressional intent with respect to state authority," "there is no need to infer congressional intent to pre-empt state laws from the substantive provisions" of the legislation.

505 U.S. at 517, 112 S.Ct. at 2618. "There is a presumption that a pre-emption clause is a reliable indicium of congressional intent." Myrick v. Freuhauf Corp., 13 F.3d 1516, 1525 (11th Cir.1994), aff'd sub nom. Freightliner Corp. v. Myrick, ___ U.S. ___, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995).

In order to discern congressional intent, the starting place is the statute itself. CSX Transp., 507 U.S. at 662-63, 113 S.Ct. at 1737. "Where ... the statute's language is plain, `the sole function of the courts is to enforce it according to its terms.'" United States v. Ron Pair Enterprises, Inc., 489 U.S. 235, 241, 109 S.Ct. 1026, 1030, 103 L.Ed.2d 290 (1989). In addition, the courts must attempt to give effect to all sections of an act of Congress where possible, rather than enforce one section at the expense of another. See American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 513, 101 S.Ct. 2478, 2492, 69 L.Ed.2d 185 (1981); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1120 (3rd Cir.1990).

In cases in which Congress has provided express preemption, the courts must give the preemption statute a "fair but narrow reading" which will give effect to Congress' purpose without undermining "the strong presumption against pre-emption." Cipollone, 505 U.S. at 522-24, 112 S.Ct. at 2621. The predicate legal duty of each common law claim must be examined in light of the specific language of the preemption provision to determine whether it is in fact preempted. Id.

If the statute is silent or ambiguous regarding congressional intent, then the court may look to an agency's regulations for guidance concerning interpretation of congressional intent. The court should defer to a federal agency's construction of such a statute, unless the agency's interpretation is not reasonable. Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).

First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at

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