King v. Collagen Corp.

983 F.2d 1130 (1st Cir. 1993)

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Nature of the Case

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Facts

King (P) received a test dose of a Zyderm treatment. Zyderm is manufactured by Collagen (D). The treatment consists of injecting cow tissues directly under the skin. Zyderm was approved and regulated by the FDA under the MDA. MDA imposes high standards in order to provide reasonable assurances of safety and effectiveness of medical procedures and products. A provision in MDA protects manufacturers of medical devices from state law intrusion. Shortly after receiving the test dose, P suffered muscle and joint pains, as well as other symptoms. P was diagnosed as suffering from an autoimmune disease because of the Zyderm treatment. P filed a strict liability, breach of warranty, and negligence action against D. The trial court granted a summary judgment to D because the actions were preempted by MDA. P appealed.