We previously posted about plaintiffs’ shenanigans in attempting to defeat diversity in a medical device case removed to the Northern District of Illinois. Plaintiffs’ antics were unsuccessful, and the federal court denied plaintiff’s motion remand.  Today’s decision addresses the defendants’ motion to dismiss plaintiffs’ third amended complaint in the same case, and it is very favorable from a preemption standpoint. Miller v. Rush University Medical Center, 2026 WL 147413 (N.D. Ill. Jan. 20, 2026).

Miller involves a cervical disc replacement device (the “Mobi-C”). The device includes an accompanying inserter with a “depth stop” mechanism used to prevent the Mobi-C from going too far into the spinal cord during insertion. Plaintiff and his spouse sued the device manufacturer, the distributor, two sales representatives, the hospital, and the treating physician based on claims that he suffered spinal cord contusions during surgery. The defendants moved to dismiss, with the manufacturer and distributor arguing that all claims against them were preempted. The court agreed.  

The FDA approved the Mobi-C device through the PMA process, so plaintiffs’ claims would be preempted if the plaintiffs’ state law claims imposed requirements that “differ from, or add to, the FDA requirements.” Id. at *5.  Plaintiffs argued that their warnings claims were parallel to the FDA requirements because they did not impose any additional requirements on the device. But the complaint alleged that the device’s warnings were insufficient to inform physicians of the risk of adverse events, contained misleading warnings about efficacy, failed to disclose inadequate testing, omitted post-market warnings, and included inadequate instructions. Those are classic “different from or in addition to” claims, and the court squarely rejected plaintiffs’ arguments:

Plaintiffs’ desired warnings . . . would constitute an addition to the warnings that the FDA approved and required. A finding of liability requiring Defendants to conform to state-law failure to warn requirements, therefore, would reflect a requirement different from, or in addition to, the standard required by federal authority. Plaintiffs’ failure to warn claim thus remains preempted.

Id. (internal citation and quotations omitted).

In an effort to avoid preemption of their design-defect claims, Plaintiffs argued that the inserter accompanying the Mobi-C was a Class I device that was separate from the Mobi-C. Whether the inserter functioned as part of the PMA approved Mobi-C was a question of law for the court, since it required statutory and regulatory interpretation. Id. at *6. A “device” is defined as an “instrument, apparatus, implement, or implant . . . including any component part, or accessory.” Id. (quoting 21 U.S.C. § 321(h)).  And a “component” is defined as “any . . .piece, part, . . . or assembly that is intended to be included as part of the finished, packaged and labeled device.” Id. (quoting 21 U.S.C. § 820.3(a)). Finally, a “finished device” is “any device or accessory to any device that is suitable for use or capable of functioning.” Id. These definitions all indicated that the inserter was part of the Mobi-C.

Plaintiffs relied on cases involving hybrid device systems, where one component part received PMA approval and another component received §510(k) clearance. But the court distinguished those cases based on the facts and the statutory definitions.  The FDA granted PMA approval to the entire Mobi-C device—which, based on the clear language of the statutory definitions, included the inserter. Id. at *7.  Plaintiffs’ claim that the Mobi-C’s inserter was in an unreasonably dangerous and defective condition was preempted, since the FDA’s PMA approval specifically incorporated the inserter’s design, testing, intended use, manufacturing methods, performance standards and labeling.

Apart from preemption, the court held that the claims against the distributor defendant should be dismissed under the Illinois distributor statute. That statute generally provides that a distributor should be dismissed from a product liability case if the manufacturer is named as a defendant, unless (i) the distributor exercised significant control over the design of the product, (ii) had actual knowledge of the defect, or (iii) created the defect. Id. at *7. Since plaintiffs’ claim was based on allegations that the distributor failed to provide additional warnings about the device, none of the exceptions applied and the statute provided separate grounds for dismissal.

The sales representatives did not fare as well on their motion to dismiss. The court evaluated the negligence claims against them under a Good Samaritan theory (by providing assistance in some way, they may have assumed a duty).  Plaintiffs levied all sorts of claims against the sales reps, including that they did not undergo adequate training and failed to assemble or set up the inserter properly. The court held that those allegations—at least at the pleadings stage—were enough to create a duty to act on their part and were sufficient to avoid dismissal.

Finally, plaintiffs alleged that the defendants were liable under a joint venture theory.  Plaintiffs tried to construe the fee structure for the hospital’s billing and the purchase of the Mobi-C as a joint venture, but the court recognized it for what it was – a typical supply chain agreement between separate business entities. Plaintiffs did not otherwise allege any formal joint venture or plead adequate facts to support the existence of an implied joint venture.  The court dismissed the joint venture count in its entirety.  Combined with the prior ruling on plaintiffs’ motion to remand, this case is off to a good start.