Mitchell v. Collagen Corp.

Decision Date23 September 1997
Docket NumberNo. 94-3946,94-3946
Citation126 F.3d 902
Parties33 UCC Rep.Serv.2d 750, Prod.Liab.Rep. (CCH) P 15,079 Barbara MITCHELL and Gregory Mitchell, Plaintiffs-Appellants, v. COLLAGEN CORPORATION, Defendant-Appellee.
CourtU.S. Court of Appeals — Seventh Circuit

David Cerven, Joseph E. Costanza, Sr., Burke, Murphy, Costanza & Cuppy, East Chicago, IN, Michael M. Essmyer, Essmyer & Tritico, Houston, TX, Clinard Hanby, The Woodlands, TX, Brian Wolfman (argued), Public Citizen Litigation Group, Washington, DC, for Plaintiff-Appellant.

Gregory J. Tonner, Jon F. Schmoll, Spangler, Jennings & Dougherty, Merrillville, IN, Keith A. Jones, Joe W. Redden, Jr. (argued), Beck, Redden & Secrest, Houston, TX, Robert Neil Weiner, Steve J. Boom, Arnold & Porter, Washington, DC, Hugh Young, Product Liability Advisory Counsil, Inc., Reston, VA, for Amicus Curiae.

Before CUDAHY, RIPPLE and KANNE, Circuit Judges.

RIPPLE, Circuit Judge.

This case is before the court on remand from the Supreme Court of the United States. The Court has directed us to reconsider our earlier decision in light of the Court's intervening decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). See Mitchell v. Collagen Corp., --- U.S. ----, 116 S.Ct. 2576, 135 L.Ed.2d 1091 (1996) (granting certiorari, vacating our judgment and remanding for consideration in light of Medtronic).

In their complaint, the Mitchells alleged various state law claims arising out of collagen-based injection treatments that Mrs Mitchell received. Collagen Corporation ("Collagen") sought summary judgment, on the ground that all the Mitchells' claims were preempted by the Medical Devices Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq. The district court granted summary judgment to Collagen on the ground that the state law claims were preempted. See Mitchell v. Collagen, 870 F.Supp. 885 (N.D.Ind.1994). We affirmed the grant of summary judgment, relying, with respect to some of the claims, on Collagen's defense of preemption and, with respect to other claims, on the Mitchells' failure to meet their burden of coming forward on summary judgment with an adequate factual showing to warrant trial. See Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir.1995) ("Mitchell I"). After reconsidering this case in light of the Supreme Court's Medtronic analysis, we affirm the judgment of the district court.

I BACKGROUND
A. Facts

We shall assume familiarity with the facts set out in Mitchell I. We limit our rendition here to those matters relevant to the task at hand.

In 1988, Barbara Mitchell received several injections of Zyderm or Zyplast (collectively "Zyderm"), collagen-based products produced by Collagen. Zyderm is used to fill in soft tissue under skin or scars when tissue has been lost due to injury, trauma, age, infection or other diseases. The collagen-based product is injected into the layers of the skin where there is a depressed scar or indentation. Zyderm acts as a replacement for the soft tissue that has been lost in this area and is classified as a Class III medical device.

Class III medical devices are those that operate "to sustain human life, are of substantial importance in preventing impairment of human health, or pose a potential unreasonable risk of illness or injury." Chambers v. Osteonics Corp., 109 F.3d 1243, 1245 (7th Cir.1997). Before a Class III device may be introduced to the market, the manufacturer must provide the Food and Drug Administration ("FDA") with a reasonable assurance that the device is safe and effective under the MDA. Medtronic, 518 U.S. at ----, 116 S.Ct. at 2246. To provide that assurance, a manufacturer must obtain premarket approval ("PMA") from the FDA. This procedure is a "rigorous" process, in which the manufacturer much submit detailed information to the FDA regarding the safety and effectiveness of the device. Id. at ----, 116 S.Ct. at 2247. Manufacturers must provide the FDA with samples of the device, an outline of the device's components and properties, a description of the manufacturing process, copies of the proposed labels, various other data and information, and any other information the FDA requests. 21 C.F.R. § 814.20. The FDA spends an average of 1,200 hours per PMA application reviewing these materials.

The FDA initially approved Collagen's PMA for Zyderm in 1981. During 1991-92, the FDA conducted a reexamination of Zyderm and concluded that its decision to approve Zyderm's PMA was appropriate.

There are several exceptions to the PMA requirement. These exceptions have demonstrated a propensity for swallowing the rule. See Medtronic, 518 U.S. at ---- - ----, 116 S.Ct. at 2247-48 (cataloging the lopsidedness of Class III devices introduced under the "substantially equivalent" procedures rather than under the PMA process). First, products that were introduced into or distributed to be introduced into interstate commerce prior to May 28, 1976 are grandfathered from this requirement until the FDA initiates and completes the PMA process for such devices. 21 C.F.R. § 814.1(c)(1). Second, those devices that are "substantially equivalent" to grandfathered products are exempt from the PMA process until the FDA initiates and completes the PMA process for such products. Id. In stark contrast to the PMA process, the FDA determination of whether a Class III device is substantially equivalent to another device already on the market is completed, on average, in only 20 hours. Medtronic, 518 U.S. at ----, 116 S.Ct. at 2247.

B. Earlier Proceedings
1.

The Mitchells filed a multi-count complaint against Collagen in Indiana state court. Their complaint alleged counts of strict liability, negligence, fraud, mislabeling, misbranding, adulteration and breach of warranty. Collagen removed the case to federal court and moved for summary judgment. The district court granted Collagen's motion. It reasoned that the Mitchells' state law claims were preempted by the MDA. The court determined the scope of federal preemption by focusing on the MDA's preemption provision and the FDA's regulations. The MDA proscribes states from establishing "any requirement ... which is different from, or in addition to, any [federal] requirement" established under the MDA. 21 U.S.C. § 360k(a). 1 The regulations clarify that a state requirement can include requirements established by court decision. See 21 C.F.R. § 808.1(b). The district court concluded that Congress intended the MDA preemption provision to be read to preempt common law causes of action. It reasoned that the PMA process for Class III medical devices constitutes a requirement under the MDA and that, consequently, any state requirement that implicated the requirements imposed by the PMA process was a requirement "different from, or in addition to," the federal requirements. The district court therefore granted Collagen's motion and dismissed all the state law counts as preempted by federal law, except for Mr. Mitchell's derivative claim for loss of consortium. This claim was dismissed because the remaining claims were preempted.

2.

We affirmed the judgment of the district court, although we did not rely exclusively on preemption grounds. We began by noting that the question of whether a state cause of action is preempted by federal law " 'is a question of congressional intent.' " Mitchell I, 67 F.3d at 1274 (quoting Hawaiian Airlines, Inc. v. Norris, 512 U.S. 246, 252, 114 S.Ct. 2239, 2243-44, 129 L.Ed.2d 203 (1994)). Relying primarily on the plain wording and language of the MDA preemption clause, we concluded that "[t]he phrase 'any requirement' in 21 U.S.C. § 360k(a) is broad enough to include at least some common law causes of action within the statute's preemptive scope." Id. at 1276; cf. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (holding that state requirement under Public Health Cigarette Smoking Act of 1969 preemption provision encompasses common law causes of action). In considering the FDA's preemption regulations under the MDA and the structure of the Amendments, we also concluded that the PMA process constitutes a specific federal requirement for preemption purposes under 21 U.S.C. § 360k(a).

We then turned to the individual claims and analyzed them in light of these conclusions to determine whether they would add requirements "different from, or in addition to," the PMA process. First, we dealt with the Mitchells' strict liability claim and their negligence claims. The strict liability claim alleged that Collagen "knew or in the course of reasonable care should have known" that Zyderm was "unreasonably dangerous and had the potential for causing serious immunological and/or autoimmune reactions, damage and injuries when injected into humans for its intended use and purpose." Compl. at 2-3. The negligence claims alleged that the product was accompanied by inadequate warnings and that Collagen had been negligent in the design, testing, approval, manufacturing, marketing and sale of Zyderm. We held that these claims were preempted by the MDA. We further concluded that, to the extent that the mislabeling, misbranding and adulteration claims alleged violations of state law despite Collagen's conformity to the FDA's requirements, these claims also were preempted. However, to the extent that the Mitchells' claims for mislabeling, misbranding and adulteration alleged that Collagen had not followed the FDA requirements, the claims were not preempted because, in permitting a cause of action for non-conformity with federal requirements, state law did not impose a requirement "different from, or in addition to," the federal requirements.

Upon examination of the Mitchells' mislabeling, misbranding and adulteration claims, however, we determined that only the Mitchells' adulteration claim could be construed as...

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