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Conklin v. Medtronic (CA1 10/19/17)

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Federal pre-emption in a medical-device case.

Plaintiff used Defendant’s infusion pump, an implanted medical device. It allegedly malfunctioned; he sued under the usual products liability theories. Defendant moved to dismiss arguing that the federal pre-marketing approval process — which the product had passed — pre-empts state law. The trial court granted the motion.

The Court of Appeals affirms in part. The Medical Device Amendments to the Food, Drug, and Cosmetic Act prohibit state regulation that is different from or in addition to federal law. The court holds that strict-liability and warranty claims are barred because they would involve arguing that the product is defective or unsafe when the FDA’s approval process found otherwise.

But the court reverses on failure to warn. Plaintiff alleged that Defendant hadn’t reported certain adverse events to the FDA as required by federal law. The Ninth Circuit examined this issue in Stengal (2013) (also involving one of Defendant’s infusion pumps) and held that Arizona failure-to-warn law parallels the disclosure requirements of the FDCA and is therefore not preempted. This assumes that the Arizona duty to warn can be satisfied by giving notice to a third party such as the FDA. The Court of Appeals agrees that it can, treating the FDA as a learned intermediary because it “could have notified [Plaintiff’s] doctor.” (Whether that would actually have happened, and how the process actually works, the court does not discuss.) Claims that Defendant should have warned Plaintiff or his doctor directly are, however, pre-empted.

For similar reasons the court holds that negligence claims are barred except for negligent failure to report things to the FDA.

Plaintiff argued that this, as a statutory violation, is negligence per se. The court says it could be, invites Plaintiff to ask the trial court to so rule, points out which paragraphs of which case to look at, and then says ‘we express no opinion . . . on the trial court’s ultimate resolution of that issue.” There are ways for a court to opine on issues not before it that are rather less ham-handed than that.

(Opinion: Conklin v. Medtronic)

Rasor v. Northwest Hospital (10/18/17)

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We blogged the Court of Appeals Opinion here; go there first.

The Supreme Court affirms that the witness was not qualified as a standard-of-care expert: “We . . . hold that, pursuant to § 12-2604, an expert is unqualified to testify on standard of care if she did not engage in active clinical practice or teaching during the year immediately preceding the injury.” And it affirms the challange: “We hold that a defendant may move for summary judgment based on a proposed expert’s lack of requisite qualifications under A.R.S. § 12-2604 without first challenging the sufficiency of the expert affidavit under A.R.S. § 12-2603.” “[T]he proper recourse for a plaintiff whose expert’s qualifications are challenged for the first time in a summary judgment motion is to seek relief under Rule 56(d).”

However, the court vacates the portions of the Court of Appeals’ opinion remanding to allow Plaintiff to find a new expert. Its own disposition might allow that — the court says that that was justified because prior decisions on the relationship between 2603 and 2604 were in conflict and because the trial court had repeatedly told Plaintiff that she could use the expert on standard-of-care. But it adds a wrinkle. There were quesitons, apparently argued in the Court of Appeals, about whether a causation expert was necessary and, if so, if Plaintiff’s expert qualifed as such. The Supreme Court remands to the Court of Appeals to decide those things. If an expert is necessary and Plaintiff’s doesn’t qualify then the Court of Appeals “should affirm the trial court’s grant of summary judgment.” Otherwise, that court “should remand to the trial court to provide Rasor an opportunity to file a Rule 56(d) motion and for any other appropriate proceedings.”

(Opinion: Rasor v. Northwest Hospital)

Flynn v. Campell (9/22/17)

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We blogged the Court of Appeals’ opinion here; go there for the details.

The Supreme Court comes to the same conclusion but vacates that opinion. It says the two things that needed to be said: 1) “we first ask whether the defendant rather than the plaintiff knew or should have known that, absent some mistake, the action would have been brought against him or her” and 2) “We hold unrepresented litigants in Arizona to the same standards as attorneys.”

(Opinion: Flynn v. Campbell)