King v. Collagen Corp.

Decision Date11 September 1992
Docket NumberNo. 92-1278,92-1278
Citation983 F.2d 1130
Parties, 21 UCC Rep.Serv.2d 568, Prod.Liab.Rep. (CCH) P 13,401 Jane KING, Plaintiff, Appellant, v. COLLAGEN CORPORATION, Defendant, Appellee. . Heard
CourtU.S. Court of Appeals — First Circuit

Clinard J. Hanby, with whom Susan A. Allinger, John O'Quinn, O'Quinn, Kerensky & McAninch, Michael M. Essmyer, Michael M. Essmyer & Associates, Houston, TX, Frank Lynch and LeComte, Emanuelson, Tick & Doyle, Boston, MA, were on brief, for appellant.

Bob Gibbins, Austin, TX, and Jeffrey R. White, Washington, DC, were on brief, for the Ass'n of Trial Lawyers of America, amicus curiae.

Joseph J. Leghorn, with whom Peter T. Wechsler, Warner & Stackpole, Joe W. Redden, Jr., W. Curtis Webb, and Beck, Redden & Secrest, Houston, TX, were on brief, for appellee.

Bruce N. Kuhlik, Lars Noah, Covington & Burling, Edwin H. Allen, and Retta M. Riordan, Washington, DC, were on brief, for Health Industry Mfrs. Ass'n, amicus curiae.

Before TORRUELLA, Circuit Judge, ALDRICH and CAMPBELL, Senior Circuit Judges.

TORRUELLA, Circuit Judge.

Jane King appeals from a grant of summary judgment entered in favor of Collagen Corporation ("Collagen") by the United States District Court for the District of Massachusetts. The district court determined that plaintiff's claims were preempted by the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360c et seq. Because the district court correctly construed the preemption provision of the MDA, we affirm.

FACTS

Defendant Collagen manufactures and distributes Zyderm, a cosmetic medical device used to correct wrinkles and other skin deformities. Zyderm treatment consists of injecting processed cow tissue directly under the skin. Zyderm then supports the skin from underneath, smoothing out deformities on the surface of the skin. The course of treatment may run for several weeks and requires up to six applications. Researchers at Stanford University developed Zyderm in the early 1970's and Collagen placed it on the market in the early 1980's.

As a medical device, Zyderm falls within the scope of the MDA and thus must be approved and regulated by the Food and Drug Administration ("FDA"). As a Class III medical device under the MDA scheme, it is subject to the most extensive pre-marketing approval requirements imposed by the MDA and to similarly extensive regulation post-approval. The premarket approval process is designed to provide a "reasonable assurance of ... safety and effectiveness" for medical devices which are too dangerous or unknown to permit less regulation. 21 U.S.C. § 360c(a)(1)(C). Post-approval regulation is designed to keep the FDA apprised of ongoing safety findings or any other information about the device as it becomes available. Id. §§ 360e(e) & 360i(a).

Pursuant to the pre-marketing approval process, the FDA requires applicants to submit proposed labeling, extensive safety testing data and descriptions of manufacturing methods and materials. Id. § 360e(c)(1). Upon reviewing the materials in a comprehensive manner, the FDA may approve the device for sale or return the application to the applicant for further information or testing. Id. § 360e(d)(1). When the FDA returns an application to Appellant Jane King sought Zyderm treatment in 1987. Following the normal procedure, Ms. King's physician administered a test dose of Zyderm before proceeding with the full treatment. Shortly after receiving this test dose, Ms. King suffered muscle and joint pains, as well as other symptoms. Her doctor subsequently diagnosed her as having dermatomyositis/polymyositis ("DM/PM"), an autoimmune disease in which the immune system attacks skin and muscle tissue as if it were a foreign substance.

                the applicant, the FDA must apprise the applicant of how to correct all deficiencies.   Id. § 360e(d)(2).   Once the device is approved, the FDA retains the power to withdraw approval of the product permanently or suspend its approval temporarily if it determines that the device has become unsafe or its labeling inadequate.   Id. § 360e(e)(1)-(3).   To assist the FDA in making these determinations, manufacturers must maintain records and make reports to the FDA on information pertinent to the device.   Id. § 360i(a).   Zyderm passed through the Class III approval process prior to marketing, and underwent revisions to the original approval afterwards
                

When Ms. King received Zyderm, Zyderm's FDA-approved labeling contraindicated use by those with a personal history of autoimmune disease. Since that time, however, the FDA has gradually allowed Collagen to change the labeling as it related to autoimmune disease. By 1991, Zyderm was no longer contraindicated for persons with a history of autoimmune disease. The FDA required a warning in 1991, however, that some recipients have suffered from unwanted autoimmune reactions, but that no causal connection between Zyderm and these reactions has been shown.

Ms. King subsequently filed a first amended complaint detailing seven claims against Collagen. 1 First, she claimed that Collagen was strictly liable for her injuries because Zyderm was unsafe for its intended purpose and unreasonably dangerous to users. Second, she alleged that Zyderm was not safe and fit for the purpose intended and therefore was sold in breach of the warranty of merchantability. Third, Ms. King alleged that negligence in the design, manufacture, marketing and sale of Zyderm, including negligence in not revealing dangerous propensities of the product, led to her injury. Fourth, she maintained that Collagen misbranded and/or mislabeled Zyderm. Fifth, she asserted that Collagen made misrepresentations of material fact to Ms. King in selling Zyderm to her. Sixth, she alleged that Collagen failed to warn her of any defective condition. Finally, Ms. King alleged that Collagen fraudulently obtained FDA approval.

Collagen moved for summary judgment shortly after Ms. King filed her amended complaint, arguing that FDA regulation of Zyderm under the MDA preempted all of the causes of action alleged in the complaint. The district court granted this motion, relying on a similar case from the Southern District of Texas. This case, Stamps v. Collagen Corp., No. H-90-2242, 1991 WL 352421, 1991 U.S.Dist. LEXIS 20666 (S.D.Tex.1991), held that plaintiff's various products liability claims arising out of Zyderm treatment were preempted by FDA regulation under the MDA.

LEGAL ANALYSIS
I.

Article VI of the Constitution dictates that federal law "shall be the supreme Law Congress may express its intent to preempt state law explicitly in the language of the statute. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977). Congress may express its intent implicitly by passing an extensive statutory scheme that extensively covers the field of regulation. Fidelity Federal Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982). Implied preemption also occurs when a conflict between state and federal law makes compliance with both impossible, or when state law would frustrate the purpose and objectives of the federal law. Id. (citing Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 83 S.Ct. 1210, 1217-18, 10 L.Ed.2d 248 (1963); Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941)).

                of the Land;  and the judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State notwithstanding."   U.S. Const. art.  VI, cl. 2.   State laws that conflict with federal laws and regulations, therefore, are preempted.   E.g., Malone v. White Motor Corp., 435 U.S. 497, 98 S.Ct. 1185, 55 L.Ed.2d 443 (1978).   In determining whether such a conflict exists, it is well settled that the intent of Congress governs.   That is, preemption does not occur unless Congress so intended.  Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947)
                

We are aided in our determination of preemption in this case by the Supreme Court's recent treatment of the subject in Cipollone v. Liggett Group, Inc., --- U.S. ----, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). In Cipollone, a victim of lung cancer sued several cigarette manufacturers for breach of warranties contained in cigarette advertisements, for failure to warn of health hazards related to smoking, for fraudulently misrepresenting those hazards to the public, and for conspiracy to deprive the public of important health information. Id., --- U.S. at ----, 112 S.Ct. at 2613. The cigarette manufacturers contended that petitioner's claims were preempted by the federal law requiring a health warning to appear on all cigarette advertisements and containers. 2 Id., --- U.S. at ----, 112 S.Ct. at 2614.

In analyzing preemption, the Court relied only on the specific language of the provision regarding preemption. The Court reasoned that "Congress' enactment of a provision defining the preemptive reach of a statute implies that matters beyond that reach are not preempted." Id., --- U.S. at ----, 112 S.Ct. at 2618. The opinion thus analyzed each of petitioner's claims in light of the express language of the preemption provision in the cigarette warning statute.

The plurality held that the provision preempted failure to warn claims as to advertising practices, but not as to testing or research practices. Id., --- U.S. at ---- - ----, 112 S.Ct. at 2621-22. The plurality reasoned that the Act only preempted state law claims arising out of cigarette advertising and promotion, and that appellant's claims arising out of testing and research did not relate to advertising and promotion. The provision preempted petitioner's fraudulent misrepresentation claim that cigarette advertising neutralized the effect of the warning in a similar fashion. Id., --- U.S. at ---- - ----, 112 S.Ct. at 2623-24. The provision, however, did not preempt fraud claims arising out...

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