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Baker v. St. Jude Medical6/30/2005
This appeal involves the issue of federal preemption of state law causes of action arising out of the implantation of an allegedly defective heart valve in the deceased, Jean Baker. Specifically, we must decide whether state common--law causes of action asserted by Baker's heirs against the valve manufacturer are preempted by the manufacturer's compliance with the Food and Drug Administration's premarket approval procedures for certain medical devices. Because we hold that state product-liability claims are preempted by federal law in this case, we affirm the summary judgment granted in the manufacturer's favor.
BACKGROUND
Legislative Background of Medical Devices Act
In 1976, in response to mounting consumer concern over, among other things, defective intrauterine devices, Congress passed the Medical Device Amendments (MDA) to allow the Food and Drug Administration (FDA) to regulate medical devices. The MDA creates three categories of medical devices. The most stringent FDA control is over Class III devices, which are devices that either "presen a potential or unreasonable risk of illness or injury," or which are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." See 21 U.S.C. § 360c(a)(1)(C)(ii)(I-II). It is undisputed that a heart valve is a Class III medical device.
Obtaining FDA Approval to Market Class III Devices
1. Full PMA Approval
Before marketing a Class III device, the manufacturer must either submit its product to the FDA for premarket approval (PMA) or qualify for one of two exceptions to the premarket approval process. To obtain PMA approval, the manufacturer must provide the FDA with "reasonable assurance" that the device is safe and effective. See 21 U.S.C. § 360e(d)(2). To do so, manufacturers submit detailed information regarding their device, which the FDA then reviews for an average of 1200 hours before approving or disapproving the device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 2247 (1996).
2. § 510(k) Exemption to PMA Approval
In addition to the "rigorous" PMA process, there are two exemptions by which a manufacturer may gain the FDA's permission to market a device. Id. at 477-78, 116 S.Ct. at 2247. One of these exemptions permits devices that are "substantially equivalent" to devices existing in 1976 to be marketed and sold without full PMA approval. See 21 U.S.C. § 360j(g)(1). This review is known as a section 510(k) review (after the number of the section in the original act) and is "by no means comparable to the PMA process." Lohr, 518 U.S. at 479, 116 S.Ct. at 2247. As opposed to the PMA's average review time of 1200 hours, a § 510(k) review takes an average of only 20 hours to complete. " Lohr, 518 U.S. at 478, 116 S.Ct. at 2247.
3. PMA Supplementation for Modifications to PMA--Approved Devices
If a manufacturer wants to modify a Class III device that already has PMA approval, the manufacturer may submit a PMA supplement, rather than obtain an entirely new PMA approval. See U.S. v. Prigmore, 243 F.3d 1, 5 (1st Cir. 2001) (describing PMA supplement process). The PMA supplement "must contain scientific information that provides a basis for approval of the modified device." Id. (quoting 21 C.F.R. § 814.39(c)). The procedures for a PMA supplement are the same as those for an original PMA, although the FDA requires only that the manufacturer provide materials supporting the proposed modification. Worthy v. Collagen Corp., 967 S.W.2d 360, 364-65 (Tex. 1998); Kemp v. Medtronic., Inc., 231 F.3d 216, 222 (6th Ci
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