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Theoretical Injury Won’t Hack It: Illinois Federal Court Dismisses Jeep Drivers’ Class Action for Lack of Standing

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An Illinois federal judge dismissed a trio of certified putative class actions involving 220,000 Jeep Cherokee drivers from Missouri, Michigan, and Illinois for lack of standing. The decision underscored a key principle: Theoretical injury is not enough for purposes of standing.

In Flynn, et al. v. FCA US LLC, et al., Case No. 15-cv-855, the plaintiffs alleged that defendants FCA US LLC and Harman International Industries Inc. installed defective “UConnect” infotainment systems in Jeep Cherokees and other vehicles which could be hacked by outsiders and subsequently remotely controlled. The class actions arose from a single 2015 hack of the UConnect system executed by two highly skilled researchers in a controlled experiment, as reported by Wired magazine. None of the other “1.2 million subject vehicles with the purported defects” had been hacked.

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FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional”

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The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional.” The FOA relates to the FDA’s RWE Framework published in December 2018, and is issued “to support research projects that examine real-world data (RWD), real-world evidence (RWE), and related issues such as data analytics, the use of digital health tools, and innovative trial designs utilizing healthcare settings.”

The FOA specifically seeks the submission of proposed projects that explore the utility of RWD and RWE in the generation of evidence supporting regulatory approval of new indications of use or post-approval study requirements for approved medicines. The FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is “clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD.”

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Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

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The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed here and here addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to clarify the standard arising from Wyeth v. Levine, 555 US 555 (2009) that a labeling claim against a manufacturer is preempted for “impossibility” if there is “clear evidence” that the FDA would have rejected a manufacturer’s proposed label change. Albrecht explained that impossibility preemption requires the “manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.” But Albrecht left unclear what the “clear evidence” showing entails and left open several important questions about how it is to be applied.

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All in the Corporate Family: Attorney-Client Privilege Applies Between Parent and Subsidiaries

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The District of New Jersey confirmed that members of a corporate family all are represented by the same in-house counsel, whether that counsel occupies an office within the parent company or within a subsidiary, because corporate family members are considered joint clients. Accordingly, emails sent between in-house counsel employed by a subsidiary and an executive or representative from a parent company are protected by the attorney-client privilege. See Trzaska v. L’Oreal USA, Inc., No. 2:15cv-02713 (D.N.J. January 6, 2020).

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Hierarchy of Scientific Evidence Reigns Supreme: NJ Appellate Division Affirms Exclusion of Experts in Accutane Litigation

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In In re: Accutane Litigation (A-4952-16T1) — an appeal decided just 10 days after oral argument — the New Jersey Appellate Division applied the New Jersey Supreme Court’s landmark decision In re Accutane Litigation, 234 N.J. 340 (2018) (Accutane 2018), arising from the same multicounty litigation, to affirm exclusion of two of plaintiffs’ experts and dismissal of more than 3,000 cases.

The Accutane multicounty litigation involves thousands of cases in which plaintiffs claim the prescription acne medication caused inflammatory bowel disease (IBD). The litigation has been divided into two parts, based on the sub-type of IBD injury alleged: cases in which plaintiffs claim Accutane caused Crohn’s disease (CD) and cases in which plaintiffs claim it caused ulcerative colitis (UC).

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A Failure of Leakage Linkage: The District of New Jersey Sinks a Proposed Class Action under Tennessee and California Laws over Leaky Water Heaters

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A New Jersey federal judge recently applied Tennessee and California law in dismissing a proposed class action concerning allegedly leaky water heater sensors/valves (valves) made by Honeywell International Inc. The decision provides a point-by-point explanation of how superficial allegations of product defect fail to satisfy federal pleading standards under the substantive product liability laws of both states.

In Butera v. Honeywell International, Inc., Civil Action No. 18-13417, the named plaintiffs were a resident of Tennessee and a resident of California whose water heaters began leaking six years after purchase. The plaintiffs filed a putative class action claiming that Honeywell’s hot water heater valves were defective. The plaintiffs alleged that the valves featured a plastic (thermowell) casing that “prematurely erodes” and deteriorates, allowing water leakage. They asserted claims under Tennessee’s Products Liability Act (TPLA) and causes of action under California common law, the California Commercial Code, and California’s Unfair Competition Law statute (UCL), sounding in breach of express and implied warranty, negligence, strict product liability and consumer fraud. Honeywell moved to dismiss for failure to state a claim. The court applied the laws of each plaintiff’s home state to their respective claims.

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