The federal government and the Fourth Circuit have ruled that a charitable patient assistant program conceived to increase access to cancer drugs for needy patients violated the federal Anti-Kickback Statute. In an opinion long on canons of statutory interpretation and short on compassion for sick and dying patients, the Fourth Circuit upheld an HHS advisory
Supreme Court Holds That Dismissing Federal Claims Kills Federal Jurisdiction
When a defendant removes a case to federal court on the basis that the case presents federal questions, what happens if the plaintiff amends the complaint to remove all references to federal law, leaving only state-law claims? The U.S. Supreme Court has ruled that once the plaintiff amends to delete all federal claims, a federal
“Pre-approval” Defect Claims Make No Sense
Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads. It is not because we are easily confused, at least not on most days. No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged
Federal Judge In California Burns Both Sides With Expert Rulings
The District Judge in Lin v. Solta Medical, Inc. is evidently on a year-end push. We reported just the other day on the court’s order granting summary on the plaintiff’s warnings-based claims, but denying summary judgment on design defect. A few days later, the court ruled on the parties’ motions to exclude expert opinions. This
MDL Time: Forever and a Day Later, California Law Applies To Hip Implant Claims
A case we reviewed a couple of months ago came to mind recently, not only because of its result, but also because how long it has been kicking around in our federal court system, trapped in an MDL. What refreshed our recollection? As regular blog consumers have read this week, the annual ACI Drug
Michigan Repeal Of Product Liability Protection Is Not Retroactive
The district court’s order applying Michigan law and dismissing one plaintiff’s complaint in the Tapezza MDL may be the last of a dying breed. The court faithfully enforced Michigan’s statute providing a presumption of non-defectiveness for FDA approved drugs and dismissed the plaintiffs’ case. But alas, Michigan repealed that law effective February 13, 2024, thus
First Circuit Approves Federal Officer Jurisdiction In Insulin Pricing Row
Federal officer jurisdiction is the quiet middle child of the federal jurisdiction family. We all came out of law school fully versed in federal question jurisdiction and diversity jurisdiction (and we also vividly recall our civil procedure professor using Wyoming and Colorado for all his hypotheticals on diversity of citizenship because those were the only
Medical Device Claims Preempted in Ohio
Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting—at least to us. We lamented just yesterday that many judges reflexively deny motions to dismiss on preemption, but others see the light from the get
Group Pleading, No Causation Leave Plaintiff Blue In Kentucky
We receive emails from readers fairly regularly. They are usually from other attorneys, sometimes friends or acquaintances sharing their points of view or expanding on things that we may have underplayed or overlooked. Although we don’t spend much time (or really any time) trying to predict when we might hear from others, we have noticed
Learned Intermediary Rule Still Alive and Well in California
We have a couple of updates on the learned intermediary rule in California. We reported to you three months ago on the California Supreme Court’s tweaking of the learned intermediary rule in Himes v. Somatics, and the tweaks were not good. As we wrote back then, the Court did not make any fundamental