Chicago Accident and Injury Lawyer Blog

You may not be aware that Congress has in place a regulatory scheme, which establishes various levels of oversight for medical devices, depending on the risks that the devices present. Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). The levels of oversight are broken down into three classes of devices. Class I devices, which include items such as elastic bandages and examination gloves, are subject to the lowest level of oversight. Class II devices, which include powered wheelchairs and surgical drapes, are subject to additional "special controls," such as performance standards and postmarket surveillance measures. Id. Class III devices, which are subject to the highest form of federal oversight, include devices used “in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." Bausch v. Stryker Corp., 630 F.3d 546, 550 (7th Cir. 2010).

Although there are some preemption issues in this area of the law -- meaning, in the simplest form, that federal law takes precedence over state law when it comes to how these devices are regulated -- courts must allow claims to proceed when they are premised on the theory that the manufacturer of the device violated federal law. The U.S. Supreme Court specifically stated in Riegel: Section “360k [of the federal Food, Drug and Cosmetic Act] does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations…." 522 U.S. 312, 330.

This was exactly the case in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), where plaintiff claimed she was injured by a medical device, specifically the Trident hip replacement system (“Trident system”), a Class III medical device. In her complaint, plaintiff alleged defendants manufactured the device in violation of federal law. Unfortunately, doctors implanted the device in plaintiff’s body six days after the FDA informed defendants that a component of the Trident system was “adulterated” and that the companies’ manufacturing process failed to comply with federal standards. Id. at 549.

Once implanted in plaintiff, the Trident system failed, requiring surgical removal and replacement of the product and leading to a host of serious and painful medical problems for the plaintiff. Plaintiff filed suit under Illinois common law for negligence and strict liability for a defective product. Id.

The United States District Court for the Northern District of Illinois dismissed the suit pursuant to Rule 12(b)(6) of the Federal Rules of Procedure, holding that the plaintiff’s common law claims were preempted by federal law. Id.

The United States Court of Appeals for the Seventh Circuit reversed the judgment, finding the District Court erred, and holding that plaintiff stated a legally viable claim based on an alleged violation of federal law. The Court firmly stated:

The central issue in this appeal is whether federal law preempts product liability claims against manufacturers of Class III medical devices where a patient claims that she was harmed by the manufacturer’s violation of federal law. That statement of the issue may be a little startling. The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive. Nevertheless, manufacturers in this case and in others have asserted this theory of defense.... [T]he manufacturer's theory tries to stretch the Supreme Court's decisions in this field beyond the boundaries that were made clear in those decisions. Medical device manufacturers who subject their Class III devices to the rigorous premarket approval process are protected by federal law from civil liability so long as they comply with federal law. That protection does not apply where the patient can prove that she was hurt by the manufacturer's violation of federal law.

Id. at 549-550.