Image Credit: Mylan(R)
Pharma Bro Martin Shkreli isn’t the only one charging new prices for old medicine. It appears that Mylan, the manufacturer of the EpiPen, has increased the price of its emergency epinephrine injection 5-6X over the last 12 years, according to this article in Slate.
It is true that EpiPen can be a lifesaver in a food allergy emergency that causes anaphylaxis. However, this was also true 12 years ago, and it appears that the technology and medication have changed little in the interim.
So what changed? Marketing that turned this modest medication into a billion-dollar profit center. (Mylan offers a co-pay coupon for prescriptions, but many people still pay too high a price and risk their lives with cheaper and riskier ways to inject emergency epinephrine.)
Please see my recently-published article in Plaintiff Magazine regarding the liability standards that apply in California for food-related personal injuries.
The Mexicali Rose decision allows plaintiffs to state some previously non-cognizable negligence claims against restaurants that serve injury-causing food. Mexicali Rose v. Sup. Ct. (Clark), 1 Cal.4th 617, 621 (1992) (“Mexicali Rose”). However, if the injury resulted from a substance that was “natural to the preparation of the food,” then strict liability and breach of warranty claims remain barred. Id. at 630.
In light of food processing and safety changes that have occurred since this 1992 decision, the artificial, vague, and unworkable distinction between foreign and purportedly natural substances should be overruled. A fair measure of justice should be available for all consumers, based on their reasonable expectations for the food served.
“Do you really know what kind of fish you’re eating?” And why that’s such an important question?
As recently reported in Food Safety News, food fraud (by way of species substitution) presents more than a risk of ripping off consumers. Pregnant women may be unwittingly exposed to toxins, gastric distress, and allergens from consuming seafood that is not what it purports to be. Honest employees of fishing companies, distributors, and retailers that sell genuine products can lose sales and their jobs.
U.S. Senator Barbara Boxer (D-CA) recently asked the FDA to increase its efforts to reduce seafood mislabeling. For bad actors, increased “traceability and enforcement . . . from bait to plate” presents risks of criminal prosecution and civil damages from class action litigation. However, for seafood companies that adopt best practices, it also provides promotional and marketing opportunities.
The Journal of the American Academy of Pediatrics published a new study today which concluded that “the prevalence and severity of childhood food allergy is greater than previously reported.” Some six million children in the U.S. have food allergies, and almost 40 percent of food allergy reactions are “severe.”
Although there is some research indicating that a novel food processing method may reduce peanut allergenicity, until there is a highly-effective treatment or cure for food allergies, food-allergic consumers must avoid foods that cause their reactions.
When accommodating a food-allergic consumer, restaurants may want to consider whether their staff are aware of not just the potentially life-threatening allergic reactions, but also some persistent myths about food allergies. Troublingly, some people believe that eating just a little bit of an allergic food may be okay, or that cooking makes a food less allergenic.
Food Allergy Awareness Week is May 8-14, 2011.
Have you considered whether this is an opportunity for your restaurant to reach out to the community of food-allergic consumers? If not, why not? Food-allergic consumers are loyal, repeat customers. Restaurants that accommodate them can grow their business.
Perhaps your staff are not sufficiently trained to handle requests from allergic customers? The Food Allergy and Anaphylaxis Network and the National Restaurant Association published Welcoming Guests with Food Allergies, a free guide to help restaurants train staff to serve food safely to their food-allergic patrons.
Recently, Paul Seelig, the owner of Great Specialty Products, was arrested for allegedly representing that its bread was “gluten free,” even though it allegedly tested positive for gluten. (Seelig denied the allegations, and he is currently on trial in North Carolina.) According to his defense counsel, the company was misled by its suppliers.
The purpose of this post is not to discuss the substantive merits of this dispute or pick sides; defendants are innocent until proven guilty. I will, however, address some risk management issues for companies that are trying to do the right thing, such as identifying simple steps one can take to minimize the risk of litigation, and when necessary, be better prepared to defend itself in a court of law (and the court of public opinion).
What is Gluten?
Gluten is a type of protein found in some grains. When people with celiac disease eat gluten, they may experience gastric distress and other symptoms. (The FDA estimates that up to 1% of the population may have celiac disease.) Some research has shown that gluten consumption may also contribute to other health problems. Accordingly, many consumers are now seeking “gluten-free” products.
What does “Gluten Free” Mean?
At this time, there is no standard for this term in the U.S. However, the FDA has proposed setting a threshold of 20 ppm for a product to claim that it is “gluten free.” The FDA also publishes a list of questions and answers about its proposed gluten-free labeling rule. That site also identifies several foods that naturally contain no gluten.
How Can My Company Tell Consumers About its Gluten-Free Products?
Good communication is important in any relationship, personal or business. Talk to your customers about their needs and interests. Are foods with low gluten levels acceptable, or does their diet have stricter requirements?
If you are buying purportedly gluten-free products from your suppliers, how are they testing and documenting that? Who performs their testing? How long do they (and you) keep records?
Be realistic about what you can do for your customers. Above all, it goes without saying that one should not exaggerate a product’s gluten-free status or flat-out lie to customers, as at least one chef allegedly did.
The Food Allergy and Anaphylaxis Network provides a form where you can sign up to receive email notifications about manufacturers recalling foods that may contain undisclosed allergens. Notices pertain to the top eight food allergens.