December 1 marks an important and long-awaited change to Federal Rule of Evidence 702. The Rule, pertaining to the testimony of expert witnesses, has not received a substantive update since 2000, when it was amended in the wake of the Daubert decision. Now, more than 20 years later—and after years of study—the Rule has been amended to make two issues clear: (1) that the proponent of an expert’s testimony must establish the admissibility of that testimony by a preponderance of the evidence; and (2) that an expert’s opinion must reflect a reliable application of his or her methodology to the case. These changes reinforce the key gatekeeping role that courts play in ensuring that only helpful, reliable expert testimony is heard by the factfinder.
CPPA Releases Draft Automated Decisionmaking Technology Regulations
Ahead of its December 8 board meeting, the California Privacy Protection Agency (CPPA) has issued draft “automated decisionmaking technology” (ADMT) regulations. The CPPA has yet to initiate the formal rulemaking process and has stated that it expects to begin formal rulemaking next year. Accordingly, the draft ADMT regulations are subject to change. Below are the key takeaways:
Recent Developments in Mexico’s Supreme Court
- Mexico’s Supreme Court (“SCJN”) has decided or will decide on the fate of key policies promoted by President López Obrador.
- Lacking a super majority in Congress to amend the Constitution, López Obrador has seen several of his legislative bills declared unconstitutional, like an overhaul of the electoral system, while others are still pending full review by the SCJN, such as the Electric Power Industry Law.
- Open confrontation between the President and the SCJN has become more evident this year. A slate of candidates summited early November by the President to fill an open seat in the SCJN heralds closer alignment with Morena—the President’s party—and reflects how the SCJN is central for cementing the future of López Obrador’s self-described “Fourth Transformation of Mexico.”
- The composition of the SCJN will play a decisive role well beyond the end of the López Obrador administration (September 2024) in areas that are critical for the overall business climate, such as energy, tax policy, antitrust, the role of the armed forces in public security, telecom, cybersecurity and artificial intelligence regulation, among others.
López Obrador and the SCJN
On November 7, 2023, the former President of Mexico’s SCJN, Arturo Zaldívar resigned prematurely, a year before the end of his term and after serving in the Court for 14 years. The day after his resignation, Mr. Zaldívar joined the campaign of López Obrador’s favored candidate to succeed him as president, Claudia Sheinbaum. Mr. Zaldívar’s resignation caused a political uproar and was widely perceived as a move that allows López Obrador to get a new SCJN Minister for a full new term. The Constitution only permits ministers to resign for “serious reasons,” and it is expected that Zaldívar will have a prominent role in a future Morena administration, including that of Attorney General after the two-year cool-off period required by the Constitution.
Out of 11 magistrates on the SCJN, four have entered the bench during López Obrador’s tenure, following Senate confirmation: Juan Luis González Alcántara y Carrancá (12/2018), Yasmín Esquivel Mossa (03/2019), Ana Margarita Ríos Farjat (12/2019), and Loretta Ortiz Ahlf (12/2021). This new vacancy in the Court allows the President to nominate a fifth Supreme Court minister, who will serve for a 15-year term.
The President accepted Zaldívar’s resignation and, on November 15, 2023, sent to the Senate his slate of candidates to replace him. The candidates are all women who currently work in his administration, are members of his Morena party and are aligned to his political ideology and government program. Two of them are also related to important members of the party (one is the sister of the Interior Minister and the other is the sister of the Major of Mexico City).
VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)
On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced a new 5-year voluntary scheme for branded medicines pricing, access and growth (“VPAG”).
Although the parties have announced agreement upon heads of terms, it is already clear this is very significant news for the pricing and reimbursement of branded medicines in the UK. It is likely to represent a paradigm-shift in the way the innovative pharmaceutical industry will view reimbursement.
German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications
Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).
2023 Legislative Session Wrap-Up: New California Workplace Laws for 2024 and Beyond
As we enter the final months of 2023, California employers should turn their attention to the employment-related bills that Governor Newsom recently signed into law, many of which take effect on January 1, 2024. Summaries of key developments are below.
A Closer Look: Second Circuit Steps In to Reverse Decision Refusing To Enforce “Click-Wrap” Mandatory Arbitration Agreement
On November 3, the Second Circuit reversed a lower court decision denying a motion to compel arbitration in a putative class action against Klarna. See Edmundson v. Klarna, Inc., 85 F.4th 695 (2d Cir. 2023). The decision offers guidance (and support) for companies looking to enforce similar “click-wrap” agreements with mandatory arbitration provisions.
Sixth Circuit Pumps the Brakes on Class Certification Alleging Common Defects in Ford F-150 Pickup Trucks
The Sixth Circuit vacated an order certifying five statewide classes alleging a common brake defect in Ford Motor Company’s F-150 pickup trucks, remanding the case to the district court “for more searching consideration” of whether commonality under Federal Rule of Civil Procedure 23(a)(2) was satisfied.
In Weidman v. Ford Motor Co., 2022 WL 1071289 (E.D. Mich. Apr. 8, 2022), plaintiffs had filed a putative class action against Ford over an alleged defective brake cylinder in their F-150 pickup trucks. The district court certified five statewide classes on three issues under Rule 23(c)(4): (1) whether the trucks’ brake systems were defective; (2) whether Ford possessed pre-sale knowledge of the defect; and (3) whether concealed information about the defect would be material to a reasonable buyer.
On a Rule 23(f) petition for interlocutory review, the Sixth Circuit vacated the class certification order, finding that the district court’s “cursory treatment of commonality, one of the four necessary class action ingredients, failed to meet Rule 23’s stringent requirements.” In Re Ford Motor Co., 2023 WL 7877971, at *1 (6th Cir. Nov. 16, 2023).
China Issues Draft Rules Governing the Discretion of Administrative Penalties for Drugs, Devices, and Cosmetics
On October 19, 2023, China’s National Medical Products Administration (“NMPA”) published the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration (the “Proposed Rules”) for public comment. The Proposed Rules largely retain the overall structure of the 2012 Rules for the Applicable Discretion of Administrative Penalties in Drugs and Medical Devices (the
FTC Announces Voice Cloning Challenge
On November 16, 2023, the Federal Trade Commission (the “FTC”) announced a competition seeking solutions to protect consumers from voice cloning technology harms. Voice cloning technology can create a nearly identical clone of someone’s voice based on a short audio clip and is becoming more sophisticated as text-to-speech AI advances. The FTC cited concerns about