The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role in pioneering and developing this concept. Indeed, the idea of courts as gatekeepers in the expert context finds its roots in the Eastern District of New York, with the late Chief Judge Weinstein coining the term in a 1985 opinion in In re Agent Orange Product Liability Litigation. Three decades later, the Southern District of New York offered one of the most thorough illustrations of careful judicial gatekeeping in In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II). Now, New York can also call itself home to the first MDL-wide decision to exclude experts under Rule 702’s new formulation.
Subject: Over-The Counter Drugs
The Zantac Rule 702 Order: TLBR (Too Long, But Read)
On opening an opinion, lawyers habitually roll their eyes when they see a table of contents. Even more so when they learn the opinion is over 300 pages. The MDL order granting defense motions to exclude experts and for summary judgment in In re Zantac (Ranitidine) Products Liability Litig. (S.D. Fla. Dec. 6, 2022), however, is a worthwhile read. The court’s analysis and prose is thorough, clearly reasoned, well-supported, … and highly readable. It reveals a court willing to roll up its judicial sleeves, tackle and explain the fundamental science in detail, and rigorously apply Rule 702 to perform its essential gatekeeping function – to insulate the jury, and the defendants, from flawed advocacy masquerading as scientific evidence and holding retained experts to reasonable standards of intellectual rigor.
The Zantac litigation involves claims that the active ingredient in popular heartburn medication ranitidine breaks down to produce excessive levels of NDMA, a probable human carcinogen, under certain storage and biological conditions. That sounds scary. FDA has set a low daily intake limit of NDMA, a byproduct of, among other things, a common diet.
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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”
FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.
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Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings
By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering food to taking the bus to work could be achieved and tracked through a simple app. During the pandemic, the reliance on electronic mediums went from preferable to necessary, as many businesses shut down and transitioned to a remote or online-only presence.
The escalation of the digital age has led some manufacturers to consider electronic warnings for their products, through the manufacturer’s website, by providing a QR code, or by recommending (or requiring) the consumer to download an app. Even the American National Standards Institute (ANSI) has bought into digital warnings. ANSI’s Z535 standards provide guidance for product manufacturers related to the size, content, and location of warnings. Recently, ANSI created a subcommittee on warnings in electronic media and is in the process of developing a new standard, ANSI Z535.7, for safety information in electronic media. This new standard is expected to be published by December 2022. The FDA has also recently utilized electronic means to communicate information regarding the COVID-19 vaccines. In October 2021, the FDA published three Consumer Fact Sheets for the three currently authorized vaccines on its website and included a QR Code linked to the “most recent” COVID-19 Vaccine Fact Sheets.
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Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL
A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law. The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.
The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020. The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.
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