Subject: Statutory Interpretation

Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

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A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.

In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn.  She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

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Can a Person Marry Into Consortium Damages in a Wrongful Death Claim? Florida’s Fourth and Fifth District Courts of Appeal Are in Conflict

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As things stand, a spouse who marries a decedent post-injury cannot recover wrongful death damages in the Fourth District but can recover such damages in the Fifth District. All eyes are on the Florida Supreme Court to resolve the confusion, contradiction and uncertainty facing some Florida litigants related to wrongful death claims.

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The California Supreme Court Shrugs Off a Settlement to Provide Important Guidance on Admissibility of Former Deposition Testimony by Company Witnesses

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We reported back in December [California Supreme Court Set to Decide How Defense Counsel Approach Defending Company Witness Depositions] on a case then pending before the California Supreme Court, Berroteran v. Superior Court. The case involves the former testimony exception to the hearsay rule, Evidence Code section 1291(a)(2), as applied to the deposition testimony of company witnesses taken in prior litigation. [Disclaimer: I wrote an amicus brief in support of the petition for review and another on the merits.]

Oral argument did not go well for the plaintiff. Consequently, it was not surprising that within a few days the parties notified the Court that they had reached a settlement. The Supreme Court could have dismissed the appeal at that point and left the issue unresolved. But because its core mission is “to secure uniformity of decision” and to settle important questions of law, Cal. Rule of Court 8.500(b), the Court went ahead and decided the appeal. 2022 WL 664719 (Cal. Mar. 7, 2022). And, as Larry David might say, the decision is pretty, pretty good.

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Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

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Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with whether to consider software a product and have largely found that it is not. However, a recent decision in the Western District of Michigan holds that software is a product—Holbrook v. Prodomax Automation Ltd., No. 1:17-cv-219, 2021 U.S. Dist. LEXIS 178325 (W.D. Mich. Sept. 20, 2021). While Holbrook may be an outlier, it is significant. It bucks the trend, and potential defendants should be aware of it.

Background: Holbrook involved a wrongful death suit arising out of an accident on a robotic assembly line. The decedent’s estate (Plaintiff) brought a common-law negligence claim against multiple defendants, including the manufacturer who designed, built, and installed the assembly line. Plaintiff’s claim was based, among other things, on the software controlling the robots.

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California Supreme Court Set to Decide How Defense Counsel Approach Defending Company Witness Depositions

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The California Supreme Court will soon decide an evidentiary issue that could significantly impact how company witnesses are defended at deposition.

The Court heard argument December 7 in Berroteran v. Ford Motor Co., No. S259522, a class action opt-out case alleging consumer fraud claims based on purported defects in a Ford truck engine. The appeal involves interpretation and operation of California Evidence Code section 1291 — an exception to the hearsay rule for former testimony — and specifically how it applies to the deposition testimony of company employees taken in prior cases.

Ford moved in limine to exclude as hearsay the deposition testimony of nine current and former Ford employees taken in similar cases. In response, Plaintiff relied on section 1291.

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510(k) Clearance Precludes Punitive Damages in Arizona

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We know the plaintiffs’ bar’s feelings about the FDA’s 510(k) clearance process. They tell the jury and the court it is antiquated. They say it does not constitute a finding of safety or efficacy. They do all they can to paint the FDA’s regulatory clearance process as meaningless and not worthy of consideration by a judge or jury. Such arguments may have some vitality in some jurisdictions. But, as we learned twice again in the last month, not in Arizona.

Back in 2012, the Arizona legislature passed a law stating that a manufacturer may not be held liable for exemplary or punitive damages if “[t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented . . . according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” A.R.S. § 12-689(A)(1). The statute broadly defined “manufacturer” to include those engaged in designing, manufacturing, or formulating a product. A.R.S. § 12-689(D)(3). And it further defined “government agency” to mean any federal or Arizona agency with authority “to issue rules, regulations, orders or standards concerning the design, manufacture, packaging, labeling or advertising of a product[.]” A.R.S. § 12-689(D)(2).

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