Perspectives on Life Sciences

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

Arent Fox filed an amici brief on behalf of the Wisconsin Alumni Research Foundation, the Indiana University Research and Technology Corporation, and San Diego Intellectual Property Law Association. Our brief focused on the following three errors in the Federal Circuit’s rationale.

The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the Controlled Substances Act, which could allow more research into its potential medicinal benefits. A decision is expected this summer.  

The Federal Trade Commission announced on April 12 that it reached settlement agreements with four companies that market skin care products, shampoos, and sunscreens online over charges that they falsely claimed that their products are “ALL NATURAL” or “100% NATURAL,” despite the fact that they cont

As in previous years, 2015 brought a combination of expected and unexpected holdings by the Supreme Court and the Federal Circuit.

Last week, the Department of Health and Human Services (HHS) and Department of Agriculture (USDA) released the federal government’s 2015-2020 Dietary Guidelines.

The TPP will undoubtedly increase the volume of food choices within the twelve nation pact. Congress is well aware of this anticipated increase in competition and will work to ensure that US border agencies have the resources to enforce regulations to guard against unsafe and counterfeit products.

On Monday, November 30, 2015, Nordstrom and denim manufacturer AG Adriano Goldschmied filed a motion to approve a settlement in California federal court, agreeing to pay more than $4 million to settle a consumer class action suit that accused them of falsely labeling jeans as “Made in USA.”

Recently, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after reality TV star Kim Kardashian endorsed the company’s morning sickness drug, Diclegis, on her Instagram account.

Jawbone and Fitbit, both billion-dollar leaders in the “wearable” technology category of fitness bands, are warming up for what may become a test of legal endurance.

Thirty-nine Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2016.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

On August 3, 2015, the New York Attorney General announced settlements with five retailers who violated state law that prohibits the sales of realistic-looking toy guns. As part of the agreement, the retailers will halt sales of the violative products and pay more than $300,000 in penalties.

Nike Inc. (Nike) recently agreed to pay more than $2.4 million to settle a class action lawsuit related to the Nike FuelBand activity tracker.

On July 27, 2015, the Food and Drug Administration published a Supplemental Proposed Rule (SPR) that amends its Proposed Rule on Nutritional Labeling published on March 3, 2014.

On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

After a two-year bipartisan effort, the US House of Representatives approved the 21st Century Cures Act (H.R. 6), by an overwhelming vote of 344-77. 

In April, Senator Byron Dorgan published an article with Automotive Law360 following Toyota’s recent launch of the Mirai, a new hydrogen fuel cell car.

Automotive suppliers should take note that California’s Proposition 65 now imposes a duty on suppliers to warn consumers about risks associated with exposure to several plasticizers or softeners added to certain soft plastics that are commonly used in automotive products.

An Arent Fox team led by noted commercial litigator Hunter T. Carter prevailed at the US Court of Appeals for the Second Circuit.

Earlier this week, the owners of the egg distribution firm, Quality Egg, LLC (Quality Egg), were sentenced to three months in prison, given one year of supervised probation, and required to each pay a $100,000 fine after pleading guilty to selling eggs in 2010 that were contaminated with salmonella.

Last week, 14 state attorneys general sent a letter to Congress requesting that it investigate the herbal supplements industry, as well as consider giving the US Food and Drug Administration (FDA) stronger oversight authority over the marketing of such products in the US.

Recently, the US Food and Drug Administration issued a Warning Letter to L’Oreal USA for marketing its cosmetic products, “Rosalic AR Intense” and “Mela-D Pigment Control,” with claims deemed by FDA to be drug claims.

On January 28, 2015, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) introduced respective companion food safety legislation in the Senate (S.287, the “Safe Food Act of 2015”) and House (HR.609).

The US Food and Drug Administration (FDA) recently issued a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers — Draft Guidance for Industry and Food and Drug Administration Staff.”