News & Analysis as of

Scientific Evidence

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

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...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

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

by Reed Smith on

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

FTC Settles Supplement Maker Over Unsubstantiated Claims and Expert Endorsement

by Reed Smith on

On October 5, 2016, the Federal Trade Commission (FTC) settled its case with Supple, LLC over certain advertising claims regarding its Supple joint supplement. Between 2011 and 2015, the company advertised (via social media,...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

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

by Reed Smith on

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...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

Mars Settles With FTC Over Dog Lifespan Claims

by Reed Smith on

Last week, Mars Petcare U.S., Inc. (“Mars”) settled its case with the Federal Trade Commission (“FTC”) over certain advertising claims. In 2015, the FTC initiated an investigation of Mars’ advertising claims for its Eukanuba...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

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