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Margaret J. Bausch v. Strykercorporation

December 23, 2010


Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. No. 08 C 4248-Samuel Der-Yeghiayan, Judge.

The opinion of the court was delivered by: Hamilton, Circuit Judge.


Before EASTERBROOK, Chief Judge, and MANION and HAMILTON, Circuit Judges.

This diversity jurisdiction case presents issues concerning federal preemption and sufficient pleading of a plaintiff's claim that she has been injured by a medical device-a hip replacement- allegedly manufactured in violation of federal law. Plaintiff Margaret J. Bausch appeals the district court's dismissal of her case against defendants Stryker Corpora- tion, HOC, and Stryker Ireland, Ltd. (collectively "Stryker"), who have manufactured, distributed, and sold the Trident-brand ceramic-on-ceramic hip replacement system ("the Trident") in the United States since 2003. The Trident is a Class III medical device under federal law, the class of devices that are most critical to human health and subject to the most extensive federal regulation.

Bausch alleged that the defendants violated federal law in manufacturing the Trident. The device was im-planted in her body six days after the United States Food and Drug Administration informed the defendants that a component of the Trident hip system was "adulterated" and that the companies' manufacturing processes failed to comply with federal standards. The Trident implanted in Bausch failed, requiring surgical removal and replacement of the product and leading to a host of serious and painful medical problems. The defendants later recalled a component of the Trident bearing the same catalogue number as the one that had been implanted in Bausch's body. Bausch brought this suit under Illinois common law for negligence and strict liability for a defective product.

The district court granted defendants' motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, holding that Bausch's common law claims were preempted by federal law. In an unusual step, the district court did not allow plaintiff a requested opportunity to amend her complaint, but immediately entered final judgment dismissing the action with preju-dice. The district court then denied Bausch's motion to vacate the judgment and for leave to file an amended complaint.

We conclude that the district court erred. Bausch's claims that she was injured by defendants' alleged violations of federal law are not preempted. Her original complaint should not have been dismissed. Even if the original complaint had been defective, the district court abused its discretion by dismissing the action with preju-dice and denying Bausch leave to file an amended complaint. We address first the preemption issue and then the pleading issues.

I. The Scope of Federal Preemption for Class III Medical Devices

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. As we explain below, the 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. We begin by analyzing defendants' asserted defense of express preemption and then their defense of implied preemption.

A. Express Preemption-The Limited Scope of 21 U.S.C. § 360k

Defendants' hip implants are so important to patients' health that they are treated as "Class III Medical Devices" under the federal Food, Drug, and Cosmetic Act. Class III medical devices are those used "in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" and those that "present[ ] a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(c). Under the federal act, the Food and Drug Administration (FDA) subjects new Class III medical devices to a rigorous process of federal review for safety and effectiveness called "premarket approval." See 21 U.S.C. § 360e; Riegel v. Medtronic, Inc., 552 U.S. 312, 317-20 (2008) (describing process and requirements).

The Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act include an express, but limited, preemption provision for product liability claims against manufacturers of Class III medical devices:

[N]o 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. § 360k(a).

The Supreme Court has twice addressed the limited scope of this preemption provision. Its decisions show that plaintiff Bausch has stated a legally viable claim based on alleged violations of federal law. First, in 1996, the Supreme Court held that lawsuits brought under state law against medical device manufacturers who submit "premarket notification" to the FDA-a process described below-are not preempted by 21 U.S.C. § 360k(a) when liability is premised on theories that the device was defective and unreasonably dangerous and that the manufacturer failed to use reasonable care in the device's design, manufacture, assembly, and sale. Medtronic, Inc. v. Lohr, 518 U.S. 470, 481, 494-95 (1996). In 2008, the Supreme Court held that lawsuits brought under state law against medical device manufacturers who obtain the full federal "premarket approval" are preempted by section 360k(a) when liability is premised on violations of state law requirements that are in addition to or different from federal requirements regulating the devices. Riegel, 552 U.S. at 330. Neither case held that state lawsuits premised on violations of federal law are preempted under section 360k(a). In fact, the Court's opinions in Lohr and Riegel expressly left the door open for state law claims based on violations of federal law.

In Lohr, the Court rejected a preemption defense as applied to another medical device (pacemaker leads) where the plaintiff based her claims on allegations that the manufacturer had violated federal regulations. The Court explained that the federal preemption provision allows claims under a state's common law based on the defendant's violation of federal law:

Nothing in § 360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be "different from" the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different "requirement" that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing "requirements" under federal law.

Lohr, 518 U.S. at 495 (reversing dismissal of complaint).

The pacemaker leads at issue in Lohr had not been approved through the FDA's premarket approval process. Instead, the FDA confirmed that the leads were "substantially equivalent" to a device that was already on the market through what is known as a "premarket notification" or "§ 510(k) process." Id. at 478-80. The section 510(k) process is less rigorous than the pre-market approval process, so much so that Lohr held that such generally applicable standards are not "requirements" sufficient even to trigger preemption under section 360k(a). Id. at 492-93. The Court went on to explain that section 360k(a) does not preempt state rules that merely duplicate federal requirements. Id. at 494-95. Thus, the above quoted language in Lohr discussing parallel claims also applies to products that have gone through premarket approval.

Nothing in the more recent Riegel case calls into question the ability of a patient to sue a Class III device manufacturer under state law for violations of federal law. In fact, the Riegel Court went out of its way to explain that such claims are not ...

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