A federal jury has just found (unanimously in a 12-0 decision) that Ameritox repeatedly lied to physicians about the abilities of its Rx Guardian and Rx Guardian CD urine drug testing system to determine whether patients adhere to and are compliant with their prescribed pain medication regimens. The suit was brought against Ameritox by Millennium Laboratories (ML), Ameritox’s biggest competitor in the urine drug testing industry. The legal fights between the two have been heating up recently (Ameritox sues ML for illegal inducements, ML sues Ameritox for libel, ML sues Ameritox for trade dress infringement).
Ameritox claimed to measure compliance by comparing patient drug test results to a reference database of 1,000 chronic pain patients that are “known adherents” to their pain medication regimen using a proprietary algorithm. Well, it turns out that Ameritox did not actually know whether the patients in their reference database were actually adherent or not.
Here is a brief exchange between a plaintiff attorney and the Ameritox CMO:
“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.”
Essentially, in that 30 second exchange, ML won its case, in my opinion.
The judge did not impose a financial penalty, but instead told Ameritox it must never again advertise that Rx Guardian can measure regimen compliance. In addition, Ameritox is to send a letter to all of its current customers and post on its website an admission that it falsely advertised from 2008-2012. As of 7 AM CST on June 14, 2012, the Ameritox website still advertised Rx Guardian CD’s ability to “…identify whether your patients are taking their medication correctly”, so I’m not sure when the injunction is to begin.
After reading about this case, I am left to simply wonder what difficulties or harm befell patients that were tested by this methodology. I also am left to wonder how many pain doctors out there that generate revenue for themselves from urine drug tests actually care.
Millennium Labs may have won this battle, but the war between ML and Ameritox is far from over. As I mentioned above, there are still several lawsuits pending. Stay tuned.
Courtesy of PRNewswire:
SAN DIEGO, June 13, 2012 /PRNewswire/ — Millennium Laboratories today applauded the unanimous 12-0 decision of a Federal jury and confirming order by United States District Court Judge Benson Everett Legg finding Ameritox’s advertising claims about its Rx Guardian and Rx Guardian CD medication monitoring system to be literally false and material, and “actually deceives or had the tendency to deceive” physicians. The court found that monetary damages would be insufficient to correct the harm imposed by Ameritox’s ad campaign and that the public interest would be served by a permanent injunction prohibiting the dissemination of any advertisements promoting the ability of Ameritox’s Urine Drug Tests (UDT) to determine dosage compliance or adherence. In addition, the Court ordered Ameritox’s CEO Ancelmo Lopes to promptly send a “corrective advertising” letter to all current Ameritox customers, and post to its website, conceding Ameritox’s false advertising campaign from 2008 through 2012.
The unanimous jury verdict and concurring finding by Judge Legg also determined that Ameritox’s re-introduction of Rx Guardian as Rx Guardian CD – or “Compliance Database” in June 2011 – was literally false and deceptive because the patients in the “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 claiming or implying its product can determine, verify, or confirm compliance or adherence with a prescription regimen. 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 should put an end to Ameritox’s nearly decade-long 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, leading to damaging outcomes for patients and their physicians.”
Slattery continued: “Based on the judge’s determinations and 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 CD ranges; 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 can’t falsely advertise that your services can do something you know they cannot do. And you shouldn’t advertise that you know things about your database that you do not know. Ameritox has done both. That is why we stood up for physicians 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 dosages of a prescribed pain management 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. According to Dr. Heit, “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 his prescriber legally accountable for actions taken against him 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 lied in its advertisements by misleading doctors about its products. It hurt physicians. It hurt patients. It hurt this industry. This was a long and difficult fight, but ultimately the truth prevailed.”