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Potential Embarrassment Insufficient to Enable Plaintiffs to Litigate Anonymously in Breast Implant MDL

A New Jersey federal court has held that potential embarrassment is not enough to permit plaintiffs to litigate anonymously in a fight over breast implants.

In an August 13, 2020 letter order, the Hon. Joseph A. Dickson, U.S.M.J., ruled that the plaintiffs alleging that defendant Allergan Inc. hid health risks associated with its textured breast implants must reveal their identifies in court filings in the MDL litigation captioned In re: Allergan BIOCELL Textured Breast Implant Prods. Liab. Litig., No. 19-MD-2121.

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Dire Consequences: Avoiding Waiver in Pennsylvania Jury Selection

Practicing law at a socially appropriate distance has forced many litigators to broadly consider the value of face-to-face interaction—and what may be lost in its absence. A recent Pennsylvania Supreme Court opinion highlights the importance of face-to-face interaction between a trial court judge and prospective jurors during voir dire. It also unfolds a cautionary tale about waiver for counsel who would challenge a prospective juror based on actual bias.

In Trigg v. Children’s Hospital of Pittsburgh of UPMC, 2020 WL 1932639 (Pa. Apr. 22, 2020), the Court found a medical malpractice plaintiff waived her objection to the procedure by which the trial court had evaluated an objection to a juror’s actual bias. The plaintiff challenged the juror for cause at trial, but argued for the first time in post-trial motions that the judge did not have the chance to observe the person’s “demeanor” because jury selection was overseen by the court clerk, with the challenge evaluated by the judge based only on the transcript record.

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

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”

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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Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.

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Parties Face New Discovery Obligations Under Proposed Rule 30(B)(6) Amendment

A proposed amendment to Federal Rule of Civil Procedure 30(b)(6) – the rule governing deposition notices directed to organizations – seeks to impose a new meet-and-confer requirement on parties.

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