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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Listen Up Class: The Role of Daubert at the Class Certification Stage in the Ninth Circuit

Class certification is the feature fight of any putative class action lawsuit. If granted, it can multiply the stakes of a case several hundred- or thousand-fold. If denied, it can signal the end of the litigation. Because of its importance, parties often invest heavily in the class certification fight, including by offering – and challenging – expert testimony.

As this trend has become more common, more focus has been devoted to answering a key question – to what extent should Rule 702 apply at this critical juncture? A number of circuits have held that Rule 702 applies in full force and that opinions deemed inadmissible under Rule 702 should not be considered in regard to class certification; others, such as the Ninth Circuit, have taken a somewhat different approach. Recently, the Southern District of California, in Stewart v. Quest Diagnostics Clinical Labs., Inc., 2022 WL 5236821 (S.D. Cal. Oct. 5, 2022), weighed in on this question.

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Experts’ Disagreement with Medical Literature Leads to Exclusion

Peer-reviewed literature can be a powerful tool in attacking an opposing expert’s opinions.  A solid, on-point article can do more than merely satisfy several of the so-called Daubert factors for assessing reliability – by showing a court that others in a challenged expert’s field disagree with his or her opinions, literature can remove any expert “aura” that might discourage a lay judge from discharging his or her duty as a gatekeeper.  Presenting literature that directly undermines the expert’s opinion can make the difference between winning and losing a motion to exclude, especially where the expert’s opinion is not supported by other literature accepted in the field.

A recent example is U.G. v. United States, 2022 WL 7426212 (S.D.N.Y. Oct. 13, 2022), a medical malpractice action under the Federal Tort Claims Act in which plaintiff suffered a shoulder injury during his birth and was later diagnosed with permanent Erb’s palsy, or brachial plexus injury.  He alleged that the obstetrician caused the injury by using excessive force on his head and shoulders during delivery.  In support of his claims, he offered two causation experts – an obstetrician/gynecologist and a pediatric neurologist– both of whom claimed the “totality of the circumstances” ruled out several possible alternate causes and thus showed that the defendant caused the injury.

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Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device manufacturing, drug discovery and manufacturing, industrial manufacturing, smart home and wearable devices, and vehicles. AI has the potential to benefit society in a number of ways, including by boosting efficiency, providing invaluable insights, and informing decisions. But to borrow from the likes of Winston Churchill (or Spider-man), with great AI capabilities comes great responsibility.

Many of the risks and benefits of AI systems are unique in comparison to other technologies. Regulators, governmental agencies, and consumer advocates are keenly focused on addressing unintended consequences that may result from the development and use of algorithms and AI. These issues, like the technology, are complex, and policymakers, stakeholders, and regulators are grappling with how best to address them.

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“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims.  While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.

There are two theories under which a failure-to-warn claim may be brought in the products liability context:  a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”).  Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim.  See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).

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European Commission Updates Liability Rules to the Digital Age

The European Commission adopted two proposals that adapt liability rules to the digital age, circular economy and the impact of global value chains. These proposals are related to the Revised Product Liability Directive, fit for the green and digital transition and global value chains, and the AI Liability Directive to provide easier access to redress.

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