Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
This alert was originally published on June 3, 2025, and has been revised based on recent developments. Update: On June 30, 2025, the U.S. Supreme Court denied certiorari Port of Tacoma v. Puget Soundkeeper Alliance, No....more
Key Takeaways - Federal citizen suits are likely to become more frequent as the federal government decreases its enforcement efforts. Federal courts are split on whether Clean Water Act (CWA) citizen suits can enforce...more
Earlier this week, in what almost certainly has to be the most fractured appellate decision in the history of the United States courts, the 5th Circuit Court of Appeals, sitting en banc, affirmed via per curiam decision the...more
Washington State requires ports to control stormwater discharges across their entire footprint, though federal rules cover only certain port facilities. According to a recent decision by the Ninth Circuit Court of Appeals,...more
Earlier this week, the 10th Circuit Court of Appeals vacated EPA’s disapproval of Montana’s regional haze plan for the PacifiCorp’s Wyodak power plant. The basis for the disapproval was an issue near and dear to my heart. ...more
By majority decision in Naturaland Trust v. Dakota Finance, LLC, the United States Court of Appeals for the Fourth Circuit struck a blow against one of the affirmative defenses a company may use to defend against citizen...more
Last week, the D.C. Circuit Court of Appeals granted a writ of mandamus to the Center for Biological Diversity, imposing a deadline on EPA to issue an “effects determination” concerning the potential impacts of the pesticide...more
Citizen suits begin with private parties sending “notice letters” to potential defendants apprising them that, if a specified action isn’t done within a certain period, litigation will be filed. A primary purpose of these...more
The United States Court of Appeals for the First Circuit (“Court”) addressed in an April 18th Opinion an issue involving the Clean Water Act citizen suit provision. See Blackstone Headwaters Coalition, Inc. v. Gallo Builders,...more
Last week, the First Circuit Court of Appeals ruled that a person who enters into an administrative settlement with a state is immune from citizen suits seeking civil penalties, but not immune from suits for declaratory or...more
The Court of Appeals for the 1st Circuit (“Court of Appeals”) addressed an issue arising out of a Clean Water Act (“CWA”) and Resource Conservation and Recovery Act (“RCRA”) citizen suit action. See Conservation Law...more
On April 23, the U.S. Supreme Court finally answered the question that has plagued environmental attorneys for years with its decision in County of Maui v. Hawaii Wildlife Fund (Slip Op 18-260, April 23, 2020): whether point...more
On Wednesday, September 12, 2018, the 4th Circuit Court of Appeals reversed a District Court ruling and rejected the Sierra Club’s citizen suit against Virginia Electric Power alleging that releases of arsenic from a coal ash...more
A recent ruling by the Fourth Circuit Court of Appeals signals a marked expansion of jurisdiction and potential liability under the Clean Water Act (CWA). Reversing the trial court’s dismissal for failure to state a claim,...more