States cannot take over enforcement of federal requirements when Congress has entrusted that enforcement exclusively to the FDA. In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Iowa Department of Revenue, No. 4:24-cv-00448, 2025 U.S. Dist. LEXIS 85732 (S.D. Iowa May 2, 2025), the state of Iowa enacted a law imposing penalties on
No one can sell a new drug without prior approval from the FDA. That rule is codified in the federal Food, Drug, and Cosmetic Act and is not controversial (or at least should not be controversial). Less clear is whether a seller of an FDA-approved drug can sue a competitor under state unfair competition laws
Taking pot shots at “Big Pharma” is easy. Crack a joke about Big Pharma and you are sure to get a laugh. Amirite?
That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country.
Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so. Our post about the Ninth
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
We have been to Montana only once. Through various life events, we have traveled by highway from the San Francisco Bay Area to the Midwest multiple times, so we are somewhat familiar with the mountains of Utah, western railroad towns like Cheyenne and North Platte, and the long rolling expanse known as Nebraska. We never
We knew as soon as we read the Supreme Court’s opinion in Mutual Pharma v. Bartlett that its reasoning should extend beyond generic drugs and would support implied preemption in generic and innovator products alike. We were generally correct. Bartlett held that federal law preempted state law design defect claims involving a generic drug because
Our best college era summer job was working as a staffer for the New Jersey State Senate. The Abscam investigation was ongoing, and it seemed that every week there’d be another empty seat in the Senate chamber courtesy of the FBI. Good times. We doubt we personally performed any services that were useful for Garden
We have been monitoring litigation involving tenofovir-based HIV medication for some time now. We reported a few weeks ago on oral argument in the California Court of Appeal, where the parties debated a novel “duty to innovate” under California law. We also gave you our view on the 2019 order that many say kickstarted these
Thirteen years litigating the same case is a looooong time. Absurdly long. Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments. Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones