United States: Parallel Claims In PMA Medical Device Complaint Warrant Federal Question Removal

Last Updated: April 3 2017
Article by James Beck

We were wondering when the courts would catch on to this Catch 22. In order to survive preemption, plaintiffs suing the manufacturers of pre-market approved ("PMA") medical devices have to allege "parallel claims" in which all "common-law" claims must be genuinely equivalent to violations of FDA regulations. But under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), and Gunn v. Minton, 133 S. Ct. 1059 (2013), the more "federal" looking the cause of action, the more likely it is to support federal question jurisdiction.

Less than two weeks ago we blogged about an "analogous" GMO case where an agency fraud claim sufficed to support G-G federal question jurisdiction. Now comes the real thing. In Burrell v. Bayer Corp., 2017 WL 1032504 (W.D.N.C. March 17, 2017), we no longer need to speak of analogies in considering G-G PMA preemption removal. To paraphrase Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Burrell IS PMA preemption removal.

Burrell involved the Essure contraceptive device – the other side's current target in its quest to impose a tort tax on every new form of contraceptive (a phenomenon we discussed here). Because this product is a pre-market approved medical device, the plaintiff filed a complaint consisting of almost entirely parallel violation claims. Defendant removed the claim to federal court despite the presence of non-diverse prescribing physicians. Not even bothering with fraudulent joinder and diversity jurisdiction, the defendant relied solely on federal question jurisdiction under G-G.

G-G jurisdiction involves a three-part test.

First, the action must involve a federal question that was "necessarily raised" as well as "actually disputed." Not hard at all. The plaintiff's parallel claim "necessarily raises federal law." Burrell, 2017 WL 1032504, at *2.

The Complaint is replete with references to the FDA. Federal oversight of the . . . defendants is a necessary part of this case, and plaintiff raises the question of the[ir] . . . duties under the FDCA, as amended by the MDA, and whether they complied with such responsibilities. Accordingly, the plaintiff's Complaint necessarily raises federal issues, particularly agency action and the MDA, and the actions of the . . . defendants and health providers under such federal oversight are the subject of this and the related suit.

Id. The issue was not whether the FDCA created a cause of action itself, but only whether federal law was "necessarily implicated." Id.

In order to succeed, the plaintiff must demonstrate that the device or defendants' conduct deviated from prevailing law. In the case of the device's marketing and manufacture, those relevant laws are federal in nature. Accordingly, they are implicated here and in dispute.

Id. at *3.

Second, the question must be substantial. Another variant of the prior plaintiff's argument based on lack of a federal cause of action again failed. Absence of a cause of action did not mean that the federal aspects of plaintiff's parallel claim were insubstantial. The G-G test "explicitly rejected" that equation. Id. at *3. Rather,

If the Supreme Court actually intended there to be two pathways to federal question jurisdiction (federally-created or "arising from" federal law), it simply cannot be that the lack of a federal cause of action would foreclose the second pathway. The lack of a private, federally-created cause of action . . . is far from dispositive if the second pathway ("arising from" federal law) is to be of any real-world application.

Id. Thus "that there is no private right of action under the FDCA is not dispositive." Id. at*4. Rather, "the dispute is indeed substantial as it challenges the federal oversight of Class III medical device products." Id.

Third, and finally, the federal question must be capable of review "without disrupting the federal-state balance." The fact of extensive express preemption established where that balance properly lies. "Congress in this case passed the MDA, explicitly pre-empting state law as a general rule. It would be farcical to override that explicit Congressional act." Id. at *3.

In setting up the MDA, Congress acted with the intent that medical devices would be regulated exclusively by the FDA and state law would be generally preempted. See 21 U.S.C. § 360k. Accordingly, it would not upset the federal-state balance to have such claims be brought in federal court.

Id. "Federal law governs those duties" that plaintiff alleged, such as the supposed "continuing duty to monitor and disclose the true character, quality and nature" of the product. Id. at *4 (quoting complaint). All plaintiff's references to the FDA, necessary to plead a parallel claim under TwIqbal, also tipped the balance in favor of exercising federal jurisdiction. Id. "It does not upset the federal-state balance to allow federally-approved medical devices to be sued for alleged safety risks and labeling defects in federal court." Id.

That's how it is done.

The existence of extensive federal preemption, in and of itself, is a strong indication that Congress preferred federal to state court jurisdiction in this aspect of the FDCA. That plaintiff pleaded claims brimming with FDA standards and allegations of violations of federal law further demonstrated the propriety of federal jurisdiction. Federal-state balance is not a code word for shrinking federal court dockets, but rather entails balancing the federal and state aspects of the plaintiff's allegations.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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