News & Analysis as of

Scientific Evidence

Whether by Guidance or Rule, Fundamental Changes Continue at EPA

by Burr & Forman on

Through a combination of memoranda and a recently proposed rulemaking, EPA Administrator Scott Pruitt is moving to affect longstanding and fundamental components of EPA programs. The merits (or lack thereof) may be lost as...more

Currents - Energy Industry Insights - April 2018 #4

EPA Announces a New Rule. One Likely Effect: Less Science in Policymaking - "The Environmental Protection Agency announced a new regulation that would restrict the kinds of scientific studies the agency can use when it...more

EPA Considering Ban On The Use Of Private Scientific Data

EPA Administrator Scott Pruitt is considering a plan to restrict the agency’s use of scientific data to only that data which is publicly available. The move would prevent EPA from using private studies, dubbed “secret...more

Currents - Energy Industry Insights - March 2018 #4

Trump Prepared to Hit China with $60 Billion in Annual Tariffs - "President Trump is preparing to impose a package of $60 billion in annual tariffs against Chinese products, following through on a longtime threat that he...more

The Freedom to Swim

by Wilson Elser on

In an August 2017 article, “0.44% of NFL Brains” we addressed The New York Times coverage of Dr. Ann Mckee’s report “Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football” (JAMA....more

When Scientists Sue

by LeClairRyan on

Mark Jacobson, who alleges that he is a “renowned scientist,” along with three co-authors, publishes a paper in the Proceedings of the National Academy of Sciences journal. The Jacobson paper posits that a large-scale US...more

Report Finds European Union's Assessment of High-Risk Medical Devices of Low Quality

by Knobbe Martens on

A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research) concluded that assessments of high-risk medical devices in the European...more

0.44% of NFL Brains

by Wilson Elser on

When The New York Times reports that 110 out of 111 NFL brains (99.09%) have chronic traumatic encephalopathy (CTE), everyone pays attention. Mothers worry about their kids. Some worry about their jobs. Senate subcommittees...more

Reading the Tea Leaves: Sales of Macadamia Nut Could Be Going Up!

On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between...more

Biodegradable Six Pack Rings and “Green Marketing”

by Bowditch & Dewey on

Last Summer, a Florida brewery made national headlines by announcing an innovation: biodegradable six-pack rings. The rings, co-developed by the brewery and a New York advertising agency, are made from wheat and barley waste...more

Impact of Ninth Circuit Upholding Biological Opinion for Silver State South Solar Project in Nevada

by Perkins Coie on

In Defenders of Wildlife v. Zinke, the U.S. Court of Appeals for the Ninth Circuit upheld the Biological Opinion prepared by the U.S. Fish & Wildlife Service to assess the impacts on the threatened desert tortoise from the...more

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Acknowledging Climate Change But Limiting the Role of Science?

by Burr & Forman on

The past week was not a good one for the cause of science as it relates to environmental issues and may foreshadow what might be described as an Age of Un-enlightenment....more

Update – Sweden’s Request to Ban American Lobster in the EU Risks Violating the Rules of the WTO

by King & Spalding on

In July 2016, we reported that the Swedish Government had requested that the European Union impose a ban on imports of U.S./Canadian live lobster (Homarus americanus). Sweden argues that Homarus americanus should be...more

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

by McCarter & English, LLP on

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

"Legislative, Regulatory and Judicial Challenges to the 2015 Ozone National Ambient Air Quality Standards"

President Donald Trump has expressed a strong opposition to many federal environmental regulatory programs and the work of the Environmental Protection Agency (EPA) during Barack Obama's presidency. His nominee for EPA...more

D.C. Court of Appeals Allows Prominent Climate Scientist’s Defamation Suit to Proceed

by Akin Gump - Excubitor on

Dr. Michael Mann is a prominent climate scientist who is well-known for his “hockey stick” graph depicting a dramatic increase in global temperatures during the 20th century. On July 13, 2012, Rand Simberg published a blog...more

Florida Appellate Court Reverses Verdict Against Valve Manufacturer in Asbestos Case - Decision: Trial Court Abused Discretion in...

by Holland & Knight LLP on

Manufacturers of products that contained chrysotile asbestos won a major victory in Crane Co. v. DeLisle on Sept. 14, 2016, when Florida's Fourth District Court of Appeal (Fourth DCA) reversed a verdict entered against a...more

IP Newsletter - Superintendency of Industry and Commerce orders TV advertisement pulled for unsupported claims

by Dentons on

Colombia's Superintendency of Industry and Commerce, in Resolution 59176 of 2016, issued an order that the Colombian Association of Consumer Education cease airing a TV advertisement that contained misleading statements about...more

Viagra — Developments in Litigation

There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg,...more

Florida Tightens the Reins on Proving Causation in Asbestos Claims

by Wilson Elser on

On September 14, 2016, Florida joined a growing number of jurisdictions that reject the “any exposure” theory of proving causation. Variously known as the “cumulative exposure” or “each and every exposure” theory, it is based...more

WTO Panel Report: Russia – Pigs (EU)

by White & Case LLP on

Decision: A WTO Panel has ruled that the Russian Federation violated its WTO obligations by imposing an EU-wide ban on live pigs and pork products, in breach of the food safety rules of the WTO Agreement on the...more

Advertising Law - August 2016 #2

Electric Toothbrushes Battle It Out Before NAD - In a battle over electric toothbrushes, the National Advertising Division determined that Procter & Gamble can support superiority claims for its Oral-B models challenged...more

Health Claim Substantiation Has Not Gone to the Dogs

by Kelley Drye & Warren LLP on

The FTC announced a settlement with Mars Petcare U.S. concerning allegations that the company did not have proper substantiation to support quantified health benefit claims for its Eukanuba brand dog food. The FTC’s...more

Advertising Law - July 2016 #3

Wikipedia Link Trips up Ninth Circuit False Ad Suit - Ruling that a California federal court incorrectly relied upon a Wikipedia link when considering a summary judgment motion in a false advertising suit, the Ninth...more

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