Legal Look: Love, Opioids & Dana Baiocco

From the FDA declaring a war on love (at least, as an ingredient…) to painkiller pharma companies facing large payments to those who became addicted to their products, this issue of the Legal Look runs the gamut of recent consumer safety litigation and regulatory updates.

FDA Declares “Love” Is Not an Ingredient

“Love” is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.

Ronald PaceU.S. Food & Drug Administration

In September, the U.S. Food & Drug Administration wrote a warning letter to Nashoba Brook Bakery in Massachusetts. The bakery had listed the first ingredient in their granola as “Love,” but the regulatory agency stated that the L-word is “not a common or usual name of an ingredient.” Therefore, the bakery must remove “Love” from the list of ingredients on its products.

The baker commented to Bloomberg that he felt like the warning was “silly.” (We note that ingredient list for Campbell’s Goldfish still begins with “Made with smiles.”)

AbbVie Pays Up in Second AndroGel Case

In a second loss surrounding their testosterone therapies, AbbVie now owes $140M to Jeffrey Konrad, an AndroGel user who suffered a heart attack just two months into treatment. The plaintiff’s counsel argued that AbbVie neglected to warn patients about the increased risk of cardiac events and other side effects.

The plaintiffs also asserted that AbbVie targeted a wider population of men than the drug was intended for. Their marketing centered on the question, “Is it Low-T?,” which Konrad said made men seek out the treatment without adequate need. This summer, AbbVie lost a similar case, paying out $150 million.

Opioid Drug Maker Sued for its Role in Deadly Epidemic

Pharmaceutical company, Insys, is staring down the lawsuit barrel. Just last week, the company was ordered to pay $500,000 to Massachusetts, and now a new suit is being presented by the state of New Jersey. The suits target the drug Subsys, a powerful and addictive painkiller.

While the drug was originally intended only for use by cancer patients in extreme pain, plaintiffs argue that Insys marketed the drug to a broader audience, and marketed higher doses than allowed by the FDA. In doing so, they allegedly contributed to the massive opioid epidemic across America. Similar complaints against other drugmakers in West Virginia are looking to pull together more than 60 plaintiffs and gain multidistrict litigation (MDL) status.

P&G Reaches $30 Million Consumer Fraud Settlement

In a lawsuit against the popular probiotic Align, consumer products company Proctor & Gamble is paying for misleading marketing. Previous advertising had claimed that Align was “clinically proven,” to improve digestive health.

In addition to paying up to $15 million in refunds to a huge class of users, encompassing anyone who purchased Align between March 2009 and June 2016, P&G will also make changes to its marketing strategy. The company has agreed to remove the “clinically proven” wording, unless the chemical formula is changed and/or supported by new, reliable clinical data.

Poland Spring Suit Drowns Nestle

Nestle, the parent company of Poland Spring water, is being sued for claiming its bottled products are sourced from “100% spring water.” The suit argues that consumers are receiving “common groundwater” from Maine instead. Federal regulations on the nomenclature of bottled water products are very strict, and with good reason. The FDA dictates that “the name of water derived from an underground formation from which water flows naturally to the surface of the earth may be ‘spring water.’” That same document goes on for a full paragraph, describing the exact scenario that must be present to legally call a product “spring water.”

Plaintiffs in this case argued that it is impossible to prove a connection between Poland Spring plants and naturally occurring springs– an important part of the naming requirements. They also have made allegations the company may have used an executive position at the state level to slide under the regulatory radar. Nestle has also failed to have an external agency verify the existence of the natural springs, like the ones they market on their labels, connecting to the plants in Maine.

Trump Nominates New CPSC Commissioner

Dana Baiocco has been nominated by President Trump to lead the Consumer Protection Safety Commission starting in late October. The resulting shift in power would result in a GOP majority on the Commission. Ms. Baiocco is a graduate of Ohio University, and received her law degree from Duquesne University. She is also a Partner at Jones Day law firm.

While Baiocco is a seasoned lawyer with significant experience in mass torts and product liability, her nomination has raised concerns because of the nature of her previous work. As a Commissioner for the CPSC, Baiocco’s first responsibility would be to the consumer. However, her previous work history lists, exclusively, defense on the part of corporations against consumer action.

The next step in Baiocco’s nomination is to sit for a confirmation hearing; she must then be confirmed by the Senate, before ascending to her new role.