09-3434 Bausch v. Stryker Corporation, et al.

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Civil Procedure
Jurisdiction; preemption; Class III medical device; dismissal with prejudice

In a diversity action where plaintiff alleges injury by a hip replacement, a Class III medical device under the federal Food Drug and Cosmetic Act, under Illinois common law for negligence and strict liability for a defective product, the trial court erred when it held that her common-law claims were preempted by federal law and dismissed the action with prejudice without allowing her the opportunity to amend.
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.

The Supreme Court has twice addressed the limited scope of this preemption provision. First, in 1996, the Supreme Court held that lawsuits brought under state law against medical device manufacturers who submit “premarket notification” to the FDA 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). Second, 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. Consistent with Lohr, we held in McMullen v. Medtronic, Inc., 421 F. 3d 482, 489 (7th Cir. 2005), quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005), that state requirements are not expressly preempted under § 360k where the plaintiff can show that the requirements are “genuinely equivalent.” We said that where there are “both state and federal requirements to [the same] effect, then the state requirements will not be different from, or in addition to, the federal requirements.” [Citations.]
“Nothing in Riegel changes our view that state law claims based on violations of federal law are not expressly preempted by section 360k. In this case, the district court erred by dismissing as preempted plaintiff’s common law claims based upon alleged violations of federal law. The district court thought Riegel and Lohr would leave room for a claim based on ‘a state regulatory enactment,’ but that common law claims would be different from or in addition to federal law and thus would be preempted. Bausch v. Stryker Corp., 2008 WL 5157940, at *5 (N.D. Ill. Dec. 9, 2008). That analysis overlooked the Supreme Court’s rejection in Lohr and Riegel of precisely that argument against common law claims. As the passage quoted above begins: ‘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.’ 518 U.S. at 495.”

With regard to the court’s decision to dismiss the complaint with prejudice, “We do not see a fatal defect in the original complaint that would have justified its dismissal, let alone entry of a final judgment dismissing the action with prejudice. The only significant issue we see with the original complaint is that it alleges not only violations of ‘regulatory’ standards, but also violations of ‘industry’ standards. To the extent that the claims are based upon violations of ‘industry standards’ that are different from or in addition to the federal regulatory standards (which have the force of law), those claims would be preempted under section 360k. Yet complaints that combine legally valid and invalid claims are common. When a complaint asserts claims that are legally valid and those that are not, the correct judicial response is not to dismiss the complaint, let alone with prejudice. It’s not even necessary to require a plaintiff to file a ‘cleaner’ amended complaint. The case may proceed under the original complaint, with the understanding, provided by the court if necessary, as to the proper scope of claims that can survive the legal challenge.”
Reversed and remanded.

09-3434 Bausch v. Stryker Corporation, et al.

Northern District of Illinois, Eastern Division, Der-Yeghiayan, J., Hamilton, J.

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