Stamps v. Collagen Corp.

Decision Date19 February 1993
Docket NumberNo. 92-2084,92-2084
Citation984 F.2d 1416
Parties, Prod.Liab.Rep. (CCH) P 13,404 Jennifer STAMPS, Plaintiff-Appellant, v. COLLAGEN CORPORATION, Defendant-Appellee.
CourtU.S. Court of Appeals — Fifth Circuit

Clinard J. Hanby, Houston, TX, Martha K. Wivell, Robins, Kaplan, Miller & Ciresi, Minneapolis, MN, Priscilla Budeiri, Arthur H. Bryant, Trial Lawyers for Public Justice, Washington, DC, John O'Quinn, O'Quinn, Kerensky, McAninch & Riebschlager, Houston, TX, for plaintiff-appellant.

James C. Todd, Craig Jordan, Asst. Attys. Gen., Austin, TX, for amicus-State of Tex.

Joe W. Redden, Jr., William Curtis Webb, Beck, Redden & Secrest, Houston, TX, for defendant-appellee.

Jeffrey Robert White, Washington, DC, for amicus-ATLA.

Bruce N. Kuhlik, Covington & Burling, Washington, DC, for amicus-(HIMA) on behalf of Collagen.

David M. Bernick, Marion B. Adler, Chicago, IL, amicus-(PLAC) on behalf of Collagen.

Appeals from the United States District Court for the Southern District of Texas.

Before GOLDBERG, SMITH, and EMILIO M. GARZA, Circuit Judges.

JERRY E. SMITH, Circuit Judge:

Contending that she contracted a rare autoimmune disease from being injected with defendant Collagen Corporation's ("Collagen") products, Jennifer Stamps filed suit to recover damages in state court, alleging causes of action based upon defective design, inadequate warnings, and negligent failure to warn. Collagen timely removed and thereafter moved for summary judgment. The district court found all of Stamps's state law claims to be preempted by federal law and granted summary judgment. We affirm.


Zyderm and Zyplast are so-called Class III medical devices regulated under the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. §§ 360c-360l, pursuant to which the Food and Drug Administration ("FDA") classifies all medical devices in one of three categories. See 21 U.S.C. § 360c. Class I devices generally pose little or no threat to public health and safety; tongue depressors are an example. Accordingly, Class I devices are subject only to general controls on manufacturing processes.

Class II items are more complex than Class I and include such devices as oxygen masks used in anesthesiology and tampons. These may be subject to recommendations, guidelines, post-marketing surveillance, the development of patient registries, and even the promulgation of specific performance standards, should the FDA deem them a sufficient health hazard as to require strict product specifications or warnings. See 21 U.S.C. § 360c(a)(1)(B).

Class III devices, such as Zyderm, require premarket approval ("PMA"), which process permits the FDA to determine whether a proposed product provides "reasonable assurance of its safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C). Such devices are subject to the more stringent PMA process because they "present[ ] a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii)(II).

The PMA process requires a manufacturer to submit a detailed application to the FDA, including information pertaining to product specifications, intended use, manufacturing methods, and proposed labeling. See 21 U.S.C. § 360e(c). The FDA refers each application to a panel of qualified experts that prepares a report and recommendation. Within six months, the FDA must either accept or reject the application. 21 U.S.C. § 360e(d).


In March and April 1988, Stamps was injected with Zyderm and Zyplast, which contain processed bovine collagen that Collagen markets as an anti-wrinkle treatment for middle-aged women. A typical treatment consists of a series of injections directly under the skin, the collagen then remaining to smooth out any wrinkles or deformities on the skin's surface.

Shortly after receiving her injections, Stamps began complaining of muscle and joint pains that subsequently were diagnosed as dermatomyositis/polymyositis ("DM/PM"). DM/PM is a relatively rare autoimmune disease in which an individual's immune system identifies one's own skin and muscle tissue as foreign and attacks them. Stamps claims that Collagen's products attached to her tissues and provoked an immune response that destroyed her body tissue.


In granting summary judgment, the district court likened the instant case to Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir.1989), in which we found a plaintiff's state-law-based failure-to-warn and labeling claims regarding a Class II medical device (tampons) to be preempted, although her defective construction and design claims survived. Reasoning that collagen implants are regulated under Class III, which requires FDA pre-market approval of not just labeling and packaging, but manufacturing methods as well, see, e.g., 21 C.F.R. §§ 814.20, 814.80, the court concluded that Stamps's claims are completely preempted.

Appellant Stamps disputes the district court's interpretation of the MDA and its application of Moore, contending that the MDA neither expressly nor impliedly preempts general state tort law and that Moore must be limited to the Class II regulatory context it describes. As a final matter, Stamps argues that even if we find Moore compelling precedent in the Class III context as well, the most it can be said to require is the preemption of her defective labeling and negligent failure-to-warn claims; her products liability, fraud, and negligence per se causes of action, as in Moore, should be reinstated.


The question is whether the MDA preempts Stamps's state law claims. The Supremacy Clause of the Constitution invalidates state laws that "interfere with, or are contrary to" federal law. U.S. CONST. art. VI, cl. 2. When "the field which Congress is said to have pre-empted has been traditionally occupied by the States ... 'we start with the assumption that the historic police powers of the States [are] not to be superseded by the Federal Act unless that [is] the clear and manifest purpose of Congress.' " Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)) (citations omitted); see also Hillsborough County v. Automated Medical Lab., 471 U.S. 707, 715, 105 S.Ct. 2371, 2376, 85 L.Ed.2d 714 (1985) (recognizing a "presumption that state or local regulation of matters related to health and safety is not invalidated under the Supremacy Clause"). Accordingly, " '[t]he purpose of Congress is the ultimate touchstone' " of preemption analysis. Malone v. White Motor Corp., 435 U.S. 497, 504, 98 S.Ct. 1185, 1190, 55 L.Ed.2d 443 (1978) (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 222, 11 L.Ed.2d 179 (1963)).

Congress's intention to preempt may be either express or implied from the statutory text. Absent an express declaration, Congressional intent to preempt state law may be inferred only if state law actually conflicts with federal law, see Pacific Gas & Elec. Co. v. Energy Resources Conservation & Dev. Comm'n, 461 U.S. 190, 204, 103 S.Ct. 1713, 1722, 75 L.Ed.2d 752 (1983), or where the scheme of federal legislation is so comprehensive " 'as to make reasonable the inference that Congress left no room for the States to supplement it.' " Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982) (quoting Rice, 331 U.S. at 230, 67 S.Ct. at 1152).


The Supreme Court's most recent and authoritative treatment of preemption doctrine is Cipollone v. Liggett Group, Inc., --- U.S. ----, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). In Cipollone, a plurality held that a lung cancer victim's suit against cigarette manufacturers alleging breach of warranty, failure to warn, fraudulent misrepresentation, and conspiracy to deprive the public of medical information regarding smoking was not preempted by the 1965 Federal Cigarette Labeling and Advertising Act; certain of her failure to warn and fraudulent misrepresentation claims were, however, preempted by the language added by Congress to the Public Health Cigarette Smoking Act of 1969. Id. at ----, 112 S.Ct. at 2625.

In Cipollone, the Court relied exclusively upon the express language of the statutory provision regarding preemption. Reasoning that "Congress' enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not pre-empted," the Court concluded,

When Congress has considered the issue of pre-emption 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.... Therefore, we need only identify the domain expressly pre-empted by [the statute].

--- U.S. at ----, 112 S.Ct. at 2618 (citations omitted). See also id. at ----, 112 S.Ct. at 2625 (Blackmun, J., concurring) (same).

The MDA was enacted in 1976 as an amendment to the Federal Food, Drug and Cosmetic Act of 1938. Like the Public Health Cigarette Smoking Act addressed in Cipollone, it contains a provision expressly addressing its intended preemptive scope:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a) (Supp.1992).


Applying Cipollone, we reject, at the outset, Collagen's contention that we may resort to the doctrine of implied preemption to uphold the district court. The existence in the MDA of an...

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