ARTICLES FROM IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

King v. Collagen Corp.[index]

The medical device in this case, Zyderm, is a modified cow protein that is injected under the skin to correct wrinkles. The FDA regulates Zyderm as a Class III medical device. (We will not discuss the rationale the FDA used to determine that this was a device and not a drug.) As with all injections of foreign protein, Zyderm carries the risk of an allergic reaction. To limit this risk, patients are given a test injection of Zyderm prior to the full course of treatment. Shortly after this test dose, and before the full course of treatment, Ms. King was diagnosed with an autoimmune disease, dermatomyositis/ polymyositis. Ms. King claimed that this disease was caused by Zyderm and sued Collagen Corp. for selling a defective product and for failure to properly warn her and her physician of the risks of using the product.

As a Class III medical device, the marketing of Zyderm was regulated under the Medical Device Amendments (MDA) of 1976.[6] Since Zyderm was not functionally equivalent to an existing device, it was rigorously evaluated and was subjected to both premarket approval and post-market regulation. Section 360k of the MDA, as quoted by the King Court provides:

"(a) Except as provided in subsection (b) of this section, no 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. s 360k."

Under subsection (b) of section 360k, a state may petition the FDA in certain circumstances to allow state requirements to continue in force. Because no such petition was made in the King case, the Court was concerned only with the preemptive effect of subsection (a).

Crucial in the King case was the fact that the FDA had considered and strictly regulated the labeling, design, manufacturing, and other aspects of the device. In effect, the FDA had legally prescribed the product and marketing of this device. The King Court determined that this posed the same issue as in Cipollone, the cigarette case, and applied the reasoning of the Cipollone Court to Ms. King's claims. (The following discussion is drawn from the King Court's own language.)

A. Strict Liability

First, the Court considered Ms. King's claim that Zyderm is unsafe for its intended purpose and unreasonably dangerous to users. The Court pointed out,

"Indeed, class III devices such as Zyderm are those that present a "potential unreasonable risk of illness or injury" such that extensive regulation is required to ensure reasonably safe use. 21 U.S.C. s 360c(a)(1)(C). The FDA must evaluate these devices with regard to those for whose use the device is intended. Id. s 360c(a)(2)(A). The entire MDA scheme for such Class III devices as Zyderm, therefore, is aimed at determining and regulating the intended purpose of the device, and at ensuring a reasonable level of safety for its users."

The Court concluded,

"It is clear that appellant's strict liability claim would impose requirements related to the safety and effectiveness of Zyderm. If successful, the claim would require Collagen to redesign Zyderm, remove it from the market, or be subject to strict liability. The MDA does not permit this. Appellant's claim would force us to determine that Zyderm is unsafe and dangerous, in opposition to the contrary determination made by the FDA under the MDA. Subsection (a) protects manufacturers of medical devices approved by the FDA under the MDA from such state law intrusion."

B. Breach of Warranty

The Court next considered Ms. King's claim that Collagen breached express and implied warranties of merchantability and fitness for a particular purpose. After pointing out that the express warranty claims arise from the labeling and packaging of Zyderm, all of which are regulated by the FDA, the Court concluded,

"In labeling and packaging, Collagen could not say any less than what the FDA required, and appellee could only add extra warnings or safety information, but not warranties, without FDA approval. Appellant's express warranty claims therefore are preempted because any such warranties only could arise out of the FDA-approved labeling and packaging. Allowing appellant's express warranty claims effectively would impose additional or different requirements on Zyderm's labeling and packaging."

C. Negligence

The Court next considered Ms. King's claim of negligence in the design, manufacture, marketing and sale of Zyderm. The Court concluded that this claim also is preempted by the MDA because the design, manufacture, marketing and sale of Zyderm is regulated by the FDA. The Court pointed out,

"Otherwise, a finding of negligence would force Collagen to alter these aspects of Zyderm in response to the finding of liability, or be subject to liability. Either result impermissibly would impose an additional or different state requirement upon the design, manufacture, marketing and sale of Zyderm.

D. Product Misbranding, Misrepresentation & Failure to Warn

Ms. King's next claim was that Zyderm was misbranded or mislabeled. This claim was found to be preempted because misbranding generally occurs when labeling is "false or misleading" in any particular, and under the MDA, the FDA must reject proposed labeling when the labeling is "false or misleading in any particular." 21 U.S.C. ss 352(a) and 360e(d)(2)(D).

Ms. King's claims of misrepresentation and failure to warn were found to be preempted for similar reasons. A finding that Collagen misrepresented Zyderm to appellant would impose a requirement on Collagen to change its packaging or labeling in order to correct the misrepresentation. The failure to warn claims similarly challenge the adequacy of Zyderm's FDA-regulated packaging and labeling. The Court concluded that the MDA forecloses these claims because Collagen cannot be forced to change Zyderm's packaging and labeling by virtue of these state law damage claims.

E. Fraud

Ms. King's final claim alleged that Collagen fraudulently obtained FDA approval at the premarketing stage of the MDA process. The Court found that this claim was also preempted by the MDA because it too was a failure to warn claim in that it attempted to show that Collagen had a duty to provide different information in Zyderm's packaging and labeling than that which was approved by the FDA. Thus, the claims in B, D, and E were all basically failure to warn claims preempted by the FDA.

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