Faegre Drinker on Products

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The Zantac Rule 702 Order: TLBR (Too Long, But Read)

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

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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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District of New Jersey Finds Amazon to be “Seller” of Hoverboard under NJ Product Liability Act

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The District of New Jersey has held that Amazon may be sued under New Jersey law for defective products sold by third-party sellers through its online marketplace.

The dispute in New Jersey Manufacturers Insurance Group v. Amazon.com Inc., Civil Action No. 16-cv-9014, involved an allegedly defective hoverboard purchased from a third-party seller by an insured of plaintiff New Jersey Manufacturers Insurance Group (“NJM”) via Amazon.com.  NJM filed suit as subrogee of the insured, asserting a strict lability claim under the New Jersey Product Liability Act (NJPLA), in addition to claims for breach of implied warranty and negligence.

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Ninth Circuit Adheres to Precedent and Finds That Subverting Express Warranties Simply Does Not Compute

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On May 19, 2022, in an unpublished decision, a Ninth Circuit panel reaffirmed that under California law manufacturers do not have a duty to disclose defects in their products that manifest after the expiration of the product’s warranty unless the defect poses an unreasonable safety risk.  Taleshpour v. Apple, Inc., 2022 WL 1577802 (9th Cir. May 19, 2022).  The court affirmed dismissal of a proposed class action against Apple Inc., holding that California consumer protection laws were not violated as a matter of law because the alleged defect in MacBook Pro laptop computers arose after the expiration of the warranty and the complaint did not allege any safety issue.  The court followed existing Circuit precedent, even though there is some conflicting authority in the California courts of appeal.

Plaintiffs alleged that in certain MacBook Pro models, the backlight ribbon cables used to connect the display screen to the display control tear because the cables do not provide enough slack when the laptops open and close.  Apple agreed to replace the display of all 13-inch MacBook Pros that suffer from the alleged defect, but not the 15-inch model or any model released after 2016.  Plaintiffs alleged on behalf of the class that the excluded models suffered from the same backlight defect as the pre-2016 13-inch version.  Plaintiffs conceded the backlight ribbon issues arose after the expiration of Apple’s one-year warranty.

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Pathologist Stopped Short of Offering Could-Have, Should-Have Opinions

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In personal injury and wrongful death cases, the plaintiff bears the burden of proving medical causation, which almost universally requires testimony from a competent expert.  Some plaintiffs offer testimony from forensic pathologists—also known as medical examiners, or physicians specializing in postmortem cause-of-death determinations—to prove causation.  These forensic pathologists (or the parties proffering their testimony) may push evidentiary boundaries with respect to opinions corollary to their cause of death determinations. While some courts have allowed juries to hear these questionable corollary opinions, relying on cross examination to level the playing field, others have excluded such testimony on the basis of insufficient qualifications or lack of reliable methodology.  Recently, the Southern District of Georgia excluded a forensic pathologist’s opinions on both grounds in a wrongful death action. Although not a product liability case, the court’s well-reasoned holding is sure to affect product cases going forward.

In Griffin v. Coffee County et al., 2022 WL 2045650 (S.D. Ga. June 7, 2022), a man in custody at a county jail in Georgia died from a methamphetamine overdose. His estate brought claims for deprivation of rights and medical malpractice against the jail, the hospital, and various individuals associated with those entities. In support of its claims, the estate proffered testimony from a forensic pathologist who offered opinions about medical treatment.

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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

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Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.

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