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.
For some time, we have been following the emerging case law on whether companies, such as Amazon, that create an online marketplace for other sellers, may be held liable when products supplied by those sellers cause injury. The cases have gone both ways, but on November 30 Amazon added another ruling to its win column when a New York appellate court upheld a ruling dismissing negligence and breach-of-warranty claims based on injuries allegedly caused by a defective service from a third-party provider on a product sold by a third party on Amazon’s website.
In Wallace v. Tri-State Assembly LLC (Case No. 2020-04820), the First Department of New York’s Appellate Division affirmed an order dismissing claims against Amazon by an individual who was injured after the handlebars on his electric bike came apart, causing him to fall. His father ordered the bike on Amazon’s website from a third-party seller in China, and at the same time purchased an assembly option from an Amazon-approved service provider, Tri-State. Plaintiff alleged that Amazon and its “agents” were negligent and breached warranties of fitness and merchantability.
On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods. In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.” However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’” See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.
Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.
Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions, and multidistrict litigation. Most of this scrutiny has focused on pre-litigation or pre-resolution commercial loans to fund the litigation, and particularly whether parties are required to disclose such funding during the course of the litigation.
Continue reading “Third Circuit Tackles Third-Party Funding Issues in In Re: National Football League Players’ Concussion Injury Litigation“
Counsel drafting an order under Federal Rule of Evidence 502(d) or an agreement under Rule 502(e) generally expect to supplant the uncertainty of the privilege waiver analysis under Rule 502(b) and assure near-absolute protection against inadvertent waiver. But two recent decisions frustrate such expectations and offer lessons on how to better assure strong anti-waiver protection. Absolute Activist Value Master Fund Ltd. v. Devine, 262 F. Supp. 3d 1312 (M.D. Fla. 2017); irth Solutions, LLC v. Windstream Communications, LLC, 2018 WL 575911 (S.D. Ohio 2018) (appeal pending).
Defendants and courts have seen a variety of arguments set forth in attempts to demonstrate specific personal jurisdiction. One argument seen with increasing frequency in medical products cases is that specific jurisdiction exists over an out-of-state defendant for the claims of non-resident plaintiffs because the defendant conducted clinical trials of the product at issue in the forum state. Courts have consistently rejected this argument. Continue reading “Clinical Trial Activity Is Not an Exception to the Rule”