Articles By Meghan A. McCaffrey

Today, the Supreme Court heard arguments in FTC v. Activis, Inc. on whether reverse settlement or so-called “pay for delay” agreements between branded and generic drug manufacturers violate U.S. antitrust laws.  Hinting at a ruling that could have significant legal and financial implications for the pharmaceutical industry, the justices seemed skeptical of the legality of such agreements.   Continue reading »

In a significant decision, the Supreme Court of Alabama ruled Friday that “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce[.]“  Rejecting the majority approach, Alabama now joins only two other courts — California and Vermont — in holding branded manufacturers liable for claims based on a generic drug. Continue reading »

Yesterday, Representatives Ed Markey, Jan Schakowsky and Earl Blumenauer wrote FDA commissioner Margaret Hamburg demanding that the agency investigate popular hair straightening products such as the popular Brazilian Blowout.  The letter urges the commissioner to protect salon workers and consumers from alleged adverse health concerns resulting from the products and toxic fumes which contain formaldehyde, classified in the U.S. as a known carcinogen.  The classification of formaldehyde seems to be making the news recently, as Law360 reported today that an EU chemicals watchdog panel recently proposed classifying the substance as a presumed human carcinogen, a less severe rating than that adopted by the U.S.     

The concerns surrounding the Brazilian Blowout hair straightening products first began in May 2011, when the same representatives first contacted the FDA requesting a voluntary recall of the products, institute better labeling practices (one of the Brazilian Blowout products studied had been marketed as formaldehyde free although studies showed possible formaldehyde levels between 4-10%), and to conduct a review of whether formaldehyde-containing products should be banned due to health risks.  In August 2011, the FDA warned the maker of one Brazilian Blowout treatment that its product was misbranded and falsely promoted the solution as formaldehyde-free.  In response, the company sent letters to salons reaffirming the safety of its products and released another product that it claims does not release formaldehyde.  In January 2012, the same company settled with the California Attorney General’s office and was required to stop advertising its product as formaldehyde-free and to place warning stickers on its products. 

Despite being a $50 billion industry, cosmetic products are amongst the least regulated consumer products available on the market.  Under the Food, Drug and Cosmetic Act, cosmetic products and ingredients do not require FDA approval before they go on the market.  Instead, the agency only monitors their safety through a voluntary cosmetic registration program database, inspections, product surveys, a cosmetic ingredient review expert panel, and consumer reports.  Given recent criticism over the FDA’s failure to adequately oversee and regulate the compounding industry, it remains to be seen whether other industries — like cosmetics — could be next.  Regardless, the Congressman are demanding an answer from the FDA by December 21 on the Brazilian Blowout issue and what steps the agency is taking to “protect the public health.”  We’ll continue to monitor these developments here at the Product Liability Monitor.