FDA Makes a Welcome Return to Courtroom Advocacy for Uniform, National Regulation

FDAThrough the Food, Drug & Cosmetic Act (FDCA) and its amendments, Congress put the Food and Drug Administration (FDA) in charge of establishing uniform, national regulation of consumer products. In the past decade, private litigants and state officials have increasingly undercut regulatory uniformity through state tort and consumer-protection lawsuits. Rather than defend its congressional mandate through amicus briefs or other courtroom advocacy, FDA remained mostly silent during that period.

This year, under the leadership of Commissioner Scott Gottlieb and Chief Counsel Rebecca Wood, FDA has stepped off the sidelines and is once again promoting uniformity by defending its regulatory role in several third-party legal action. That is a positive development for the producers and purchasers of FDA-regulated goods, which comprise nearly 25% of U.S. consumer spending. Continue reading “FDA Makes a Welcome Return to Courtroom Advocacy for Uniform, National Regulation”

A River Runs to Court: Environmental Activists Circumvent Democracy to Impose Agenda

colorado river gorgeThis is a frustrating time for environmental special-interest activists. Their cause is not one the public rates as a national priority. Their allies are no longer in leadership positions in federal agencies. And though they still have friends at the state and local levels, shrinking budgets prevent those regulators and elected officials from pursuing the activists’ agenda. With waning influence in other branches, many environmental organizations now increasingly look to a long-standing and reliable tool of advocacy—the lawsuit—to achieve their ends.

Some groups have gone well beyond such traditional environmental litigation as citizen suits under state or federal laws, and are instead seeking judicial injunctions that would force government regulators to implement activists’ preferred policies. These lawsuits suffer from a number of infirmities, not the least of which is they turn the entire democratic process on its head. Continue reading “A River Runs to Court: Environmental Activists Circumvent Democracy to Impose Agenda”

Change in Law of Patent Venue May Not Be Get Out of Texas Card

Kaminski_Jeffri_LRFeatured Expert Contributor, Intellectual Property—Patents

Jeffri A. Kaminski, Venable LLP

In In re: Micron Technology, Inc., the U.S. Court of Appeals for the Federal Circuit resolved a disagreement among various district courts as to when the U.S. Supreme Court’s ruling in TC Heartland LLC v. Kraft Food Group Brands LLC has changed patent venue law.  The Federal Circuit ruled the law had changed, but each federal district court maintains discretion to apply the new rule in accordance with each court’s respective procedures. Continue reading “Change in Law of Patent Venue May Not Be Get Out of Texas Card”

New First Amendment Challenge Takes Aim at California’s Listing of Glyphosate as a Potential Carcinogen Under Prop 65

warningLong the subject of much controversy, California’s Proposition 65 law prohibits businesses from exposing Californians to chemicals “known to the State of California to cause cancer” without first providing a warning. California’s Office of Environmental Health Hazard Assessment (OEHHA) publishes a list of chemicals “known to the State of California to cause cancer.” By statute, that list must include substances designated as potential carcinogens by the International Agency for Research on Cancer (IARC), an international non-governmental entity. Continue reading “New First Amendment Challenge Takes Aim at California’s Listing of Glyphosate as a Potential Carcinogen Under Prop 65”

Ninth Circuit Permits Interest-Group Enforcement of RCRA after EPA Exercises Non-Enforcement Discretion on Stormwater

sboxermanFeatured Expert Column—Environmental Law and Policy

By Samuel B. Boxerman, Sidley Austin LLP

Can an environmental organization file suit under the Resource Conservation and Recovery Act’s (“RCRA”) citizen-suit provision claiming harm from stormwater runoff which could be, but was not, subject to limits under a Clean Water Act (“CWA”) permit? In a November 2, 2017 decision, Ecological Rights Foundation v. Pacific Gas and Electric Company, the U.S. Court of Appeals for the Ninth Circuit held that it could. The ruling, which also rejected the defendant’s arguments opposing Article III standing, is a portentous development at a time when environmental groups are actively seeking out litigation opportunities to enforce federal regulations. Continue reading “Ninth Circuit Permits Interest-Group Enforcement of RCRA after EPA Exercises Non-Enforcement Discretion on Stormwater”

WLF Webinar to Feature Two Seasoned FCPA Compliance Practitioners

LowmoyerThe FCPA Approaches Middle Age: Is the Anti-Corruption Law Slowing Down or as Spirited as Ever?

Tuesday, November 14, 1:00-2:00 p.m. EST

Live webcast, click here to view

Speakers: Homer E. Moyer, Jr., Miller & Chevalier and Lucinda A. Low, Steptoe & Johnson

Description: For 40 years, the Foreign Corrupt Practices Act has kept business interaction with overseas government officials on a short leash. But four decades of federal enforcement dominated by voluntary disclosures and widely disparate settlements has deprived FCPA targets of clear standards and guidance. Our speakers will derive lessons and trends from recent DOJ and SEC actions, forecast what the law’s next decade may bring, and identify possible vulnerabilities ripe for judicial review.

High Stakes for Patent Holders, Challengers in SCOTUS “Oil States” Case

Kaminski_Jeffri_LRFeatured Expert Contributor, Intellectual Property—Patents

Jeffri A. Kaminski, Venable LLP

The U.S. Supreme Court is set to hear arguments in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, which could strike a devastating blow to extant patent procedure. On November 27, the Court will consider Oil States’ challenge to the constitutionality of the Inter Partes Review (“IPR”) process used by the Patent and Trademark Office (“PTO”) to scrutinize the validity of already-issued patents. While this is not the first constitutional challenge to IPRs, Oil States marks the first time the Supreme Court will confront the issue. Continue reading “High Stakes for Patent Holders, Challengers in SCOTUS “Oil States” Case”