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Third Circuit Holds State Law Claims Of Defective Design Of Medical Device Were Pre-Empted By FDA Requirements


HLD, v. 32, n. 9 (September 2004)

Third Circuit Holds State Law Claims Of Defective Design Of Medical Device Were Pre-Empted By FDA Requirements

In 1998, while Daniel Horn was awaiting a heart transplant, surgeons implanted a medical device known as a HeartMate in Horn to provide circulatory support because Horn's cardiac condition continued to deteriorate. The HeartMate is surgically attached to the heart and helps to pump blood through the heart. A few months after the surgery to implant the HeartMate Horn began bleeding through a tube where the HeartMate exited his body and exploratory surgery revealed that the pump from the HeartMate had become disconnected. Surgeons reattached the pump but it was too late because air entered the opening and traveled to Horn's brain and caused a brain hemorrhage resulting in his death. In 2000, Horn's wife Barbara (plaintiff) as executrix of Horn's estate, sued Thoratec Corporation (defendant), the manufacturer of the HeartMate, alleging that the HeartMate was defectively designed and manufactured and that defendant failed to warn of the alleged defects. Defendant filed a motion for summary judgment on the ground that under the Food and Drug Administration's (FDA's) Pre-Market Approval (PMA) process plaintiff's state law claims were expressly pre-empted by 21 U.S.C. � 360k(a). The district court applied the two-prong test of FDA pre-emption in which it had to determine if the FDA had established specific requirements that applied to the device and if the state law claims are "different from, or in addition to, the specific federal requirements" and determined that plaintiff's state common law claims were pre-empted. The district court determined that the PMA process imposed specific requirements on the HeartMate device and any judgment on plaintiff's claims would be in direct conflict with the FDA's approval of the device. Plaintiff appealed.

The Third Circuit affirmed the district court's judgment that federal law pre-empted plaintiff's state law claims. Section 360k(a) provides for express pre-emption for any state laws that impose requirements that are different from, or in addition to, the specific federal requirements, and defendant argued that plaintiff's state law claims would impose different requirements on the HeartMate. Plaintiff argued her state law claims would only impose generally applicable duties of good care and fair warning that are not specific requirements that conflict with federal requirements. The FDA medical device approval process provides that a device that is "substantially equivalent" to an existing device that was already approved will not undergo a rigorous approval process under � 510(k) and that devices that are not substantially equivalent to an existing device will go through a more rigorous approval process involving requirements specific to that product under � 360e(c). Plaintiff argued the HeartMate came within the � 510(k) approval process and defendant argued the device came within the � 360e(c) approval process. Plaintiff argued that under Medtronic v. Lohr, 518 U.S. 470 (1996) the high court held that FDA approval of a pacemaker did not pre-empt the plaintiff's state law claims. The HeartMate device was approved by the FDA under � 360e(c). In Lohr the high court concluded that the � 510(k) approval process did not impose "specific" federal requirements on a product, but did not address whether the � 360e(c) approval process imposed specific federal requirements on a device. The appeals court determined that, based on the FDA's lengthy approval process for the HeartMate under � 360e(c) and the imposition by the FDA of certain mandatory conditions on the manufacture, packaging, storage, labeling, distribution, and advertising of the device the HeartMate underwent the type of approval that gives rise to specific federal requirements. In Lohr the high court specifically noted that an FDA pre-emption determination should be accorded deference, and the FDA has expressed its view that plaintiff's state law claims were pre-empted. The appeals court determined that because the HeartMate can only be manufactured and sold in compliance with strict requirements specifically imposed on it by the FDA the plaintiff's claims were pre-empted.

The appeals court then turned to the issue of whether plaintiff's state law claims impose requirements on the HeartMate, which are different from, or in addition to, the federal requirements. Plaintiff did not allege any specific claims based on the design of the device, said the appeals court, and the claims were generally that the device was defective and defendant failed to warn about the dangerousness of the device. The appeals court determined that, while one claim appeared to be general because it merely alleged a negligent design, if plaintiff prevailed on that claim the design that was approved by the FDA would be subject to redesign, and therefore, the claim conflicted with specific FDA requirements. The FDA also gave its opinion that plaintiff's claims would impose specific requirements that were different from the requirements it imposed under its approval process. Plaintiff did not allege that defendant had deviated from the FDA requirements for the HeartMate and any finding on plaintiff's state law claims would impose different requirements than the federal requirements, said the appeals court.

Therefore, the appeals court held plaintiff's state law claims were completely pre-empted and affirmed the district court's judgment. A dissenting opinion said that FDA regulations clarify that pre-emption only occurs when a specific federal requirement conflicts with a specific state requirement and not a general state requirement, and therefore in this case plaintiff's state law claims were not pre-empted.

Horn v. Thoratec Corp., No. 02-4597 (3d Cir. July 20, 2004). To read the case, go to

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