Coffee – a health risk or a health promoter? “Private attorneys general” or the British Journal of Medicine?

There have been a variety of media reports of late regarding the health effects of coffee. Two almost simultaneous news articles demonstrate how our regulatory environment can lead to puzzling contradictions. These same articles illuminate the vast reach and potential impact of California’s Prop. 65.

For those not familiar with Prop. 65, it is a California regulatory scheme whereby producers and distributors of any products and foods used or consumed in California must apply a cancer/birth defect warning on their products if they contain any of 800 different identified substances in levels that might lead to an exposure in excess of the mandated permissible levels. The regulations allow any attorney in California to act as a “private attorney general” to bring suit against anyone who has not properly warned. These suits can lead to injunctive relief, fines and penalties, and perhaps most importantly, an award of plaintiff’s (but not defendant’s) attorneys’ fees.

As a habitual coffee drinker, I was pleased to see that Sam Meredith of CNBC reported on November 23rd about a study from the University of Southampton, published in the British Journal of Medicine, that a review of some 200 previously published medical studies led the authors to conclude that drinking 3 to 4 cups of coffee each day was “more often associated with benefit than harm” from a health perspective. Consuming coffee can reduce the risk of numerous ailments from heart disease to dementia, and even some cancers it is reported.

Yet literally the next day, Bob Egelko in the San Francisco Chronicle reported that 7- Eleven had just obtained court approval of a settlement of a case brought against it alleging that their sale of prepared coffee without warnings was a violation of Proposition 65 as coffee contains an unsafe level of acrylamide, a substance identified as a human carcinogen by the State of California. 7-Eleven had apparently decided that it was wiser to settle this case for $900,000 than risk a court trial on the issue of whether or not consuming coffee truly presents a cancer risk to consumers in the Golden State. No doubt much of the settlement will go to Raphael Metzger, plaintiffs’ counsel in this matter.

The settlement will thus have the effect of giving Mr. Metzger more resources to continue prosecuting the same case against Starbucks and many other defendants that have been sued in the same case. If Starbucks wins its case, presumably customers will not see a Prop. 65 warning plaque on the wall behind their favorite barista, nor a Prop. 65 warning on the new Holiday Season cups. If Starbucks loses its case, those warnings may join the legions of other such warnings that have proliferated across the state. One would be left to wonder whether the citizens of California would be rendered more safe by such warnings, or instead as the University of Southampton and the British Journal of Medicine seem to feel, safer by drinking more coffee?

More Chemicals (DBAs) Slated for Warnings – But Where Will They Put the Warning Labels?

On November 19, 2014, California’s OEHHA will conduct a meeting to determine whether a group of chemicals known as Dibenzanthracenes (DBAs) should be listed as known  to cause cancer. For those of you not familiar with the OEHHA, it describes its authority and function thusly:

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Carcinogen Identification Committee (CIC) advises and assists OEHHA in compiling the list of chemicals known to the State to cause cancer as required by Health and Safety Code section 25249.8. The Committee serves as the State’s qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

OEHHA’s treatment of DBAs lends some insight into the workings of this agency with far-reaching authority.  It is OEHHA that mandates the use of the ubiquitous “Prop. 65 Warnings” that adorn products and buildings throughout the Golden State.

First, DBAs are five-ring polycyclic aromatic hydrocarbons (PAHs) that contain an anthracene core (three linear benzene rings). DB[a,h]A has been listed by Prop. 65 since 1988.  The same chemical was listed as “probably carcinogenic to humans” by the International Agency for Research on Cancer in 1987.  The National Toxicology Program classified DB[a,h]A as “reasonably anticipated to be a human carcinogen” in its Second Report on Carcinogens in 1981, and the U.S. Environmental Protection Agency listed it as a “probable human carcinogen” based on experimental animal evidence.   But none of these authorities have so listed DB[a,c]A or DB[a,j]A, which OEHHA now proposes to add to its list of carcinogens.

Like many other PAHs, DBAs are produced as products of incomplete combustion or pyrolysis of organic matter (e.g., cigarette and marijuana smoke, gasoline engine exhaust, and industrial emissions such as fuel combustion, coke oven operations, and coal-tar distillation) and during high temperature cooking (e.g., grilling, broiling, roasting, baking, frying).  DBAs are known to be included in the smoke of forest fires and even the campground fires one might use to toast marshmallows.

With the exception of smokers and occupationally exposed workers, most individuals are exposed to PAHs predominately from dietary sources.  DBAs are present in the air (ambient and indoor, in occupational settings and cooking fumes); in water (drinking and fresh); in dried sediments; and in food (fresh and cooked).  OEHHA reports that DBAs are present in cigarette smoke and marijuana smoke, slightly more so in marijuana smoke (0.00115 μg/ tobacco  cigarette; 0.00141 μg/ marijuana cigarette ).

DBAs have been aggressively studied for decades.  OEHHA has a page on its website titled “Evidence on the Carcinogenicity of Dibenzanthracenes,”  which has a section of references covering 10 pages.  Despite that, OEHHA notes that “[n]o data on the long-term effects of human exposure to pure DBAs were identified in the literature search conducted by OEHHA” and that “[n]o epidemiology studies were identified that investigated the risk of cancer associated with exposure specifically to DBAs.”  Nevertheless, relying on animal studies, in vivo studies and mechanistic analyses, OEHHA proposes to list the chemicals found in marijuana smoke, fresh vegetables and forest fire smoke as having been “clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.”

Perhaps such a determination can be justified, but where will they put the warning labels?

PS – At the same November meeting, OEHHA will consider expanding its listing of N- nitrosomethyl-n-alkylamines (NMAs).  According to OEHHA, NMAs have been detected in personal care products, such as shampoos and conditioners, and household cleaning products, such as dishwashing liquids and surface cleaners. NMAs are not intentionally added to these products, but may form as a result of the reaction of nitrite with amine compounds.  However, the challenge as to locating warning labels on these products is perhaps somewhat lesser than that relating to DBAs.

The public has until October 13 to comment on two hazard identification documents: “Evidence on the Carcinogenicity of Dibenzanthracenes” and “Evidence on the Carcinogenicity of N-Nitrosomethyl-n-alkylamines.”

Physician’s Failure To Read Trumps Drug Company’s Failure To Warn

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the drug, plaintiff’s claim that the label should have contained a stronger warning is rendered moot.

Often the physician, a trained clinician, will testify that she was familiar with the risks in question and did not need to be provided a warning. Alternatively, the physician may testify that a stronger warning would not have influenced her decision to prescribe the drug and that she still prescribes the drug. Under either scenario, it may be argued on summary judgment that the learned intermediary did not rely on the allegedly inadequate warning and that, therefore, the plaintiff cannot establish that the alleged failure to warn was a proximate cause of plaintiff’s injury.

In an article on his Drug and Device Law blog on October 17, 2013 titled, “Don’t Forget About a Prescribing Physician’s Failure to Read Warnings,” James M. Beck, Counsel resident in the Philadelphia office of Reed Smith, provides an exhaustive survey of cases dismissing claims where the learned intermediary physician failed to read the warnings. Beck reports on and provides summaries of decisions from 42 jurisdictions.

As Beck observed in another blog post on October 28, 2011, “After all, there is a causation element to every warning claim – the defect (whatever is allegedly wrong with the warning) has to cause the injury. If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.”