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Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
Date:6/14/2012

SAN DIEGO, June 14, 2012 /PRNewswire/ -- Millennium Laboratories today applauded the decision of a federal jury and confirming order by United States District Court Judge Benson Everett Legg that Ameritox's claims in advertisements promoting its Rx Guardian and Rx Guardian CD medication monitoring system are literally false, and the court's determination that the ads are material and "actually deceive or have the tendency to deceive" physicians. After the court concurred with the jury verdict that the ads were literally false, Ameritox consented to an order entered by the court prohibiting the dissemination of any advertisements claiming that Ameritox's Urine Drug Tests (UDT) can determine dosage compliance or adherence. In addition, the order requires Ameritox's CEO Ancelmo Lopes to promptly send to all current Ameritox customers, and post to Ameritox's website, a letter explaining the jury's verdict and the court's conclusion that Ameritox's challenged Rx Guardian advertisements contained the literally false statements that Rx Guardian can "determine dosage compliance," "verify dosage compliance," and other phrases that convey such meaning.    

(Logo:  http://photos.prnewswire.com/prnh/20120516/LA07836LOGO )

The jury verdict and concurring finding by Judge Legg also determined that an advertisement concerning Ameritox's so-called "Compliance Database" – introduced in June 2011 as Rx Guardian CD – was literally false because the patients in the purported "Compliance Database," described by Ameritox as "known adherent" patients, were not in fact known to be adherent. By the court's order, Ameritox is permanently prohibited from advertising that its services can determine, verify, or confirm the dosage taken by the patient. The order also prohibits Ameritox from using the term "known" adherent when describing patients in the so-called "Compliance Database."

"This case has always been about putting patient care first by dispelling the myth perpetrated by Ameritox about Rx Guardian and Rx Guardian CD," said James Slattery, CEO of Millennium Laboratories. "The jury's verdict and court's order should put an end to Ameritox's practice of using false claims and advertising practices to mislead physicians into believing they could use the Rx Guardian service to determine whether their patients were taking the proper dosage of their prescribed medications, potentially leading to damaging outcomes for patients and their physicians."  

Slattery continued: "Based on statements by Ameritox's own witnesses under oath, Rx Guardian and Rx Guardian CD simply do not do what the company promises. As a result, patients can be wrongfully labeled as adherent or non-adherent based on the Rx Guardian reference ranges and their results could be erroneously reported in the physicians' records as reflecting aberrant behaviors, when in fact the patient may be taking their medications as prescribed. You cannot falsely advertise that your services can do something they cannot do. And you should not advertise that you know things about your database that you do not know. Ameritox has done both. That is why we stood up for healthcare providers and patients to challenge Ameritox's false claims."

Judge Legg established at the outset of the trial that UDT, including Rx Guardian and Rx Guardian CD, cannot determine whether or not a patient is taking the prescribed dosage of a drug. It was the testimony of Ameritox's own executives that doomed its efforts to defend the ads. During rigorous cross-examination, Ameritox's Chief Medical Officer, Dr. Harry Leider, admitted to Rx Guardian's failings in the following exchange: "Dr. Leider, you would agree with me that Rx Guardian cannot determine the dosage of a medication that a patient has taken; isn't that correct?" He answered, "Yes." Dr. Leider was then asked, "And you would agree with me that Rx Guardian cannot determine the frequency with which a patient actually is taking a prescribed medication; isn't that correct?" He answered, "Yes." Moreover, Dr. Leider conceded that patients who were excluded from Ameritox's "Compliance Database" could in fact be compliant with their regimens, while those abusing or misusing their medications could actually be included. "This," according to Slattery, "is what makes the Rx Guardian product so dangerous."

Millennium's case was supported by Howard A. Heit, MD, FACP, FASAM, who provided expert testimony on the adverse consequences that may occur when clinicians rely on Rx Guardian to determine how the patient has been taking their medications, both in terms of overall dosage and frequency of medication use. Commenting on the outcome, Dr. Heit stated: "The decision to alter a patient's medication regimen based on false scientific data can easily lead to patient harm through dose reduction and a worsening of the patient's complaints of pain. Worse still, we know that some clinicians discharge their patients based on urine drug test results. Any clinical decision based on unsound laboratory testing can expose the patient as well as the prescriber to significant risk and potentially devastating adverse outcomes. It is only a matter of time before an injured patient holds their prescriber legally accountable for actions taken against them based on UDT results that claim more than they can deliver."

Slattery added, "Urine drug testing provides significant clinical value in improving patient care, but only if the results of the test can be trusted. Yet for years, Ameritox propagated a false message about what its service could do. When you do that, you can hurt healthcare providers. You can hurt patients. You can hurt our industry. This was a long and difficult fight, but ultimately the truth prevailed."

NOTE: Consent Order is available at http://millenniumlabs.com/consent-order/

About Millennium Laboratories:

Located in San Diego's life sciences cluster, Millennium Laboratories (www.millenniumlabs.com) is the leading research-based clinical diagnostic company dedicated to improving the lives of people suffering from pain. The company provides healthcare professionals with scientific data, clinical tools and services that help personalize treatment plans to improve clinical outcomes and patient safety.

The company utilizes leading technology and proprietary methodologies to provide some of the fastest and most reliable medication monitoring and drug detection results via both urine drug testing (UDT) and oral fluid testing. Test results are backed by expert toxicologists, clinical guidance and dedicated customer service.

Millennium's commitment to advancing the science and the field of pain management also includes a strong focus on the advancement of industry research, education and advocacy. Through its association with the Millennium Research Institute, a nonprofit national research center, it quickly has gained respect as a leader in toxicology, pharmacology and pain management research and education, providing healthcare professionals with innovative research to advance the assessment and management of chronic pain.


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