Redwood operates forensic drug testing facilities, including EtG/EtS urine tests for alcohol. These tests measure EtG (ethyl glucuronide) and EtS (ethyl sulfate), two direct metabolites from ethanol that can be found in urine up to three to four days after ethanol is ingested. Ethanol is found in various fermented alcohol products; EtG/EtS can only be in someone’s urine if that person ingested alcohol, but ingestion doesn’t necessarily mean drinking. “An EtG level over 100 ng/mL and EtS level over 25 ng/mL indicate exposure to ethanol but is not dispositive of intentional consumption of alcohol.”
Redwood's customers specify the EtG and EtS cut-off levels they want for positive findings. Tri-County Community Corrections, a customer, selected the above cutoff for a positive finding of recent ethanol ingestion. Redwood “does not offer a definitive opinion on alcohol consumption,” and in response to a question about accuracy and reliability states:
EtG/EtS are direct metabolites of alcohol (ethanol), and their detection in urine is highly specific, similar to testing for other drugs.... This methodology provides highly accurate results. As is the case with any laboratory test, it is also very important to obtain clinical correlation.Clinical correlation means "knowledge of a test subject's medical history, alcohol consumption history and/or abuse, DUI convictions and/or alcohol related convictions and other indicators of alcohol abuse."Incidental exposure to alcohol can result in EtG concentrations over 100 ng/ml, a possibility that is discussed in Redwood's materials as a result of “chronic use of food products (vanilla extract), hygiene products, mouthwash, or OTC medications (cough syrups), which contain ethanol.” Redwood continues that “if measurable ethanol is detected (>.04 gm %) in the urine, and EtG is detected in excess of 100 ng/mL and EtS is also detected in excess of 25 ng/mL, then this is very strong evidence that beverage alcohol was ingested.” In addition, the court noted, most alcohol abstinence programs require an agreement to avoid consuming such products.
Miller is a recovering alcoholic on supervised probation, one condition of which is that he may not use or possess alcohol. He’s subject to random alcohol testing. He suffered a relapse, in violation of his probation, which he first denied and later admitted; his probation was later reinstated. A month later, he was tested again, and Redwood returned a positive result: EtG at 1130 ng/mL and EtS t 603 ng/mL.
At his hearing, he testified that in the days before he provided his sample, he assisted his mother in closing up a gift shop by cleaning metal shelving with a lacquer thinner which contained an alcohol substance, that there were heavy fumes and no ventilation, and that he also used hand sanitizer containing an alcohol substance at the hospital where he was visiting his father several times.
The state’s witness, a toxicologist and a technical consultant and certifying scientist at Redwood, testified to the debate over what a good cut-off for determining alcohol consumption, but also testified that the higest value he’d seen for EtG levels from incidental use was 713. Miller’s witness, who uses EtG/EtS testing as a tool to ensure compliance for doctors in the Alabama Physician Health program, testified that a study that involved using hand gel every two minutes for an hour in a closed room resulted in levels up to nearly 800 ng/mL, that a pharmacist using hand gel every half hour throughout the day produced a result of 770, and that a doctor "that fairly certainly had only used topical alcohol on joints" had a level of 1500. In the Alabama program, a positive test coupled with a denial of drinking results in a second test. About 10-15% of positive EtG/EtS tests have negative results on this second test, but that test only produces a positive result if a person has consumed about 7 standard drinks in a week. The state court found that Miller had credibly presented evidence of incidental exposure to alcohol and that the state hadn’t proven that Miller violated his probation by clear and convincing evidence.
Miller sued Redwood for false advertising under state law and negligence. He alleged that Redwood’s website and other advertising materials misrepresent (1) that Redwood's test uses the "most sophisticated, sensitive and specific equipment and technology available"; (2) that the EtG/EtS test was "ideal for zero tolerance and abstinence situations"; (3) that the test could produce "highly accurate results for up to 80 hours after ingestion"; (4) that Redwood's analytical methods "are accepted and approved by the U.S. Department of Health and Human Services"; and (5) that EtG "is only detected in urine when ethanol has been ingested" and that any EtG level over 100 ng/mL is the "most definitive" indicator that the specimen came from a person who has ingested alcohol.
The court found that the state law claims were subject to Lanham Act analysis, as is common in this circuit despite the structural differences between state consumer protection law and the Lanham Act.
The claims were dismissed. Redwood’s material explain the importance of obtaining clinical correlation to a positive test and recognize the potential that incidental exposure to products containing ethanol could trigger a positive test result. The statement that Redwood’s testing is “ideal” for zero tolerance and abstinence situations and is "the best and most definitive test available" are simply expressions of opinion and thus nonactionable puffery.
The claim of “highly accurate” results was also non-actionable. Miller argued that the cut-off values didn’t correlate with proof of drinking alcohol, but the cited ads did not show that Redwood claimed such proof. Its materials explained that different cut-offs varied, even as it stated that “[i]n order to provide alcohol abstinence programs with the most clinically relevant answer to whether or not recent ethanol ingestion has occurred, using a 100 ng/mL cut-off for EtG and a 25 ng/mL cut-off for EtS detection is the best and most definitive test available to answer his question.... In addition, using a 100/25 ng/mL cut-off nearly doubles the time of detection of recent ethanol detection versus the use of a 250 ng/mL cut-off. In summary, the 100/25 ng/mL EtG/EtS cut-off is superior for monitoring purposes, and provides the most sensitive and definitive indicator of recent ethanol ingestion.”
Miller also challenged Redwood's claims that the EtG/EtS test is "approved by the U.S. Department of Health and Human Services" and utilizes the "most sophisticated, sensitive, and specific equipment and technology available." The Department of Health and Human Services licenses Redwood's scientific procedures, documentation and personnel every two years. Miller didn’t allege facts showing that these claims were false or misleading.
Miller’s negligence claim also failed. He alleged that Redwood owed him a duty of being objective because it tested his specimen, which he was required to take and pay for as a condition of his freedom and because his results determined whether or not he’d go to jail. Though there are cases imposing a duty of care on drug testing labs with respect to the actual collection and/or testing of the specimen, there was no broader duty and Miller didn’t allege that Redwood failed to act with reasonble care in its collection or testing. It was Tri-County that interpreted Redwood’s results.
Miller’s class claims also failed, obviously.
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