We write a lot about the learned intermediary rule. There are 50 state surveys and summaries of helpful decisions, as well as numerous posts on state-specific decisions. We tracked the development of the rule in jurisdictions like West Virginia and Arizona, and we’ve generally been pleased to report positive developments. At the end of 2024, though, we flagged the Himes case from California as one of the ten worst decisions of the year based on its novel approach to warnings causation. Given our criticisms of Himes, we found it both bizarre and troubling to see the case cited recently by an MDL court in Massachusetts applying Pennsylvania law. Our colleagues in the plaintiffs’ bar are clearly advocating to expand Himes into other jurisdictions, and the defense bar should be ready to counter those efforts.Continue Reading Himes Makes a Sneak Appearance on the East Coast
Jingle Jangle, California OTC Preemption
It’s the holiday season, and we’re getting in the festive spirit. We like old-school jingle in our jangle (even though that’s not necessarily holiday themed), more recent, unquestionably holiday-focused jingle jangle, and even first-gift of Christmas jingle, But there may be nothing more festive than a rock-solid preemption win—particularly one from California. We think this one will put a spring in your step and a sparkle in your smile. Continue Reading Jingle Jangle, California OTC Preemption
Package Inserts Are Not Admissible to Establish Standard of Care
We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject. Not surprisingly, we follow medical malpractice decisions that address off label use. Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care
Another Blood and Tissue Statute Win
This has been a big year for blood and tissue statute decisions. Given their subject matter, we’ve previously lamented that the decisions didn’t fall closer to Halloween. While not quite coinciding with our doorbells ringing and handing out candy to the little ones, today’s decision is close enough for a little seasonal digression.Continue Reading Another Blood and Tissue Statute Win
Litigation Funding Discovery from Secondary Payor Troll
If you’ve been practicing in mass torts for any length of time, you’ve probably dealt with MSP Recovery. We’ve posted about this Medicare Secondary Payor Troll many times (most recently here). One of MSP’s typical litigation approaches is to claim it has assignments of rights from certain Medicare Advantage Plans and then assert claims
Litigation Funding Agreements Discoverable in Delaware
We’ve all heard that “what’s good for the goose is good for the gander.” Some of us describe it as “the rule of poultry equivalents.” However you phrase it, we’ve always thought that if a defendant’s insurance is routinely discoverable, a plaintiff’s litigation financing agreement should be as well. Today’s decision from Delaware, Burkhart v. Genworth Financial, Inc., 2024 WL 3888109 (Del. Ch. Aug. 21, 2024), isn’t a pharmaceutical or medical device case, but it is the fourth decision out of the Delaware state courts holding that a plaintiff’s litigation funding agreement is discoverable. The decision adds to some of the positive case law and local rules related to litigation funding that we’ve addressed here, here and here. Continue Reading Litigation Funding Agreements Discoverable in Delaware
Pennsylvania Federal Court Holds Online Marketplace Has No Duty to Inspect Goods
Although today’s decision involves a medical product, it focuses on an online marketplace rather than a drug or device manufacturer. And by online marketplace we mean the delivery service that has become ubiquitous in almost all of our lives—Amazon. The decision is significant because it finds Amazon, as a shipper rather than a seller, does not have an independent duty to investigate risks of the products it ships.Continue Reading Pennsylvania Federal Court Holds Online Marketplace Has No Duty to Inspect Goods
More from the Zantac MDL – Census Registries and Enforcement of Forum Selection Certifications
This post is not from the Reed Smith, Dechert, or Holland & Knight side of the blog.
We’re pretty sure no one teaches about MDL census registries in law school. They’re a relatively new creation, and we previously blogged about them here. Essentially, registries create a mechanism where plaintiffs’ counsel can park potential claims without paying a filing fee while records are collected to determine if the claimant can establish Rule 11 basics like product use and injury. Records are typically collected by a vendor—for which the MDL defendants pay half the costs. The benefit defendants receive is a commitment that, if the claim is ultimately filed, it has to be filed in the MDL or other federal court.Continue Reading More from the Zantac MDL – Census Registries and Enforcement of Forum Selection Certifications
Mixed Bag Rule 702 Ruling from D. Mass.
We like decisions applying Fed. R. Evid. 702 that recognize the recent amendment’s impact on judicial gatekeeping. A status update on post-amendment decisions is here, and there’s a lot to like. We don’t like post-amendment decisions that barely recognize the amendments to Rule 702 and instead parrot pre-amendment case law. As key proponents of the recent rule amendments continue to emphasize, “Don’t Say Daubert.” Hunt v. Covidien, 2024 WL 2724144 (D. Mass. May 28, 2024) says a lot about Daubert and pre-amendment case law, but very little about the recent rule amendments. Nonetheless, the decision excludes entirely the opinions of an expert regularly disclosed by plaintiffs on FDA regulatory issues—Dr. Laura Plunkett. Continue Reading Mixed Bag Rule 702 Ruling from D. Mass.
North Carolina and Post-Dobbs Regulation of Mifepristone
Last year Bexis was lead author on a law review article in the Food and Drug Law Journal titled Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier. The article expands on themes previously raised in this blog, including here, here and here. It discusses the application of federal preemption under the Food Drug and Cosmetic Act (FDCA) to state-law medication abortion restrictions after Dobbs. The article recognized that, following Dobbs, it was inevitable that FDCA preemption would become embroiled in the abortion controversy. That prediction was accurate. Today’s decision addresses the impact of preemption on a North Carolina law that imposed significant restrictions on an FDA approved medication taken to terminate a pregnancy.Continue Reading North Carolina and Post-Dobbs Regulation of Mifepristone