Try This on Your Prostate, Class|Tells Supplement Maker & QB

     SACRAMENTO (CN) – With bogus endorsements from quarterback Joe Theismann, a supplement maker sold millions of bottles of a phony prostate drug invented by a felon, a class action claims in Federal Court.
     Lead plaintiff Floyd Luman sued New Vitality Corp. and Joe Theismann in Federal Court. Luman claims the defendants hawked and sold Super Beta Prostate, an unsafe and illegal drug that does nothing to alleviate prostate troubles.
     He says in the complaint that New Vitality and Theismann induced him and 2 million other men to buy Super Beta Prostate through a misleading ad campaign that promises improved urinary flow and function.
     A staple of late-night TV commercials, Super Beta Prostate assures daily users of “getting out of the bathroom and back to your life.”
     But Super Beta Prostate does nothing to alleviate symptoms of an enlarged prostate, known as benign prostate hyperplasia or BPH, Luman says.
     The complaint states: “Defendants’ marketing and promotion of Super Beta Prostate is an elaborate hoax involving a falsified medical endorsement by Dr. Jeffrey J. Zielinski, and false claims that the product will treat the symptoms of BPH. The product was created by Roger Mason, a convicted felon who pleaded guilty to conspiracy to distribute PCP. Defendant New Vitality describes Mr. Mason as a ‘research chemist.’ His latest concoction, Super Beta Prostate, is an illegal drug that contains dangerously high doses of mixed sterols, including B-sitosterol, a drug that has been marketed in Europe under the trade names Harzol and Azuprostat. These compounds are no longer considered suitable for treatment of BPH. Indeed, in 1995 a researcher studying Harzol wrote:
     “‘The effect of phytopharmaceuticals [such as B-sitosterol] on BPH is controversial because no clear mechanisms of action have been established, and their effect has been attributed to placebo responses. … Since other forms of medical treatment of BPH have been shown to be effective, it is questionable whether phytopharmaceutical drugs should continue to be prescribed.'” (Brackets and ellipsis in complaint.)
     And, Dr. Zielinski – now an actor who hasn’t practiced medicine since 2009 – said in a sworn declaration to Luman’s attorneys that his endorsement of Super Beta Prostate was an acting role, not his professional medical opinion, according to the complaint.
     “‘I was provided with a white doctor’s coat with my name on it,'” the complaint states, citing Zielinski’s “sworn declaration.” It continues: “After donning the white coat I was directed to stand in front of a green screen and to read lines from a teleprompter. After I saw the commercials air on television, I understood that a doctor’s office was superimposed on the green screen to create the illusion that I was speaking from a doctor’s office. … As far as I understood, I was hired as an actor. I was to play the role of a doctor, reading lines from a script. And that is what I did. I had no input in the creation of the script or the content of the advertisements. I did not intend to provide medical advice to anyone, or to provide a medical endorsement of the product. If I were a practicing physician, I would not recommend Super Beta Prostate for the treatment of BPH or its symptoms. … I would not recommend Super Beta Prostate to anyone for any purpose. I believe it is unsuitable for the treatment of BPH, and possibly unsafe because it is a formulation that has never been studied and it includes mixed sterols in very high doses that could cause significant adverse events.'” (Ellipses in complaint.)
     Zielinski is not a party to the lawsuit.
     Prostates – which are normally the size of a walnut – begin to grow at age 30 due to an increased number of cells, an increase in cell size, or both. When a prostate grows too large, it compresses the urethra and causes an obstruction that can block the flow of urine out of the bladder and can cause bladder, urinary tract or kidney problems.
     New Vitality markets Super Beta Prostate as containing all-natural ingredients. Theismann promises “stronger urinary flow,” “improved bladder emptying,” “healthy sleeping habits,” “healthy prostate function,” “less frequent bathroom trips,” reducing “that sudden urge to go,” “more complete bladder emptying,” “sleep through the night,” “waking up feeling more refreshed” and improved intimacy and feeing “younger and more energetic,” Luman says in the complaint.
     But Luman, who says he bought Super Beta Prostate in 2012 based on Theismann’s recommendation, claims Super Beta Prostate did note of that. He says he called New Vitality to complain, and an agent told him that the drug takes time to work and encouraged him to continue taking it.
     “Mr. Luman followed the agent’s advice and continued to take Super Beta Prostate, but the product was still ineffective,” Luman says in the complaint.
     Doctors typically prescribe medication such as Flomax and Rapaflo to treat BPH. When these are ineffective – or their side effects are intolerable – urologists perform in-office procedures in which a catheter is inserted through the urethra and into the prostate, which is blasted with heat to kill excess cells.
     Medical professionals view surgery as the final option to relieve enlarged prostate, since its complications include impotence and incontinence. Luman claims New Vitality preys on the fears of 25 million men who have BPH.
     New Vitality touts the supplement’s creator, Roger Mason, as “‘a renowned research chemist’ whose research ‘has culminated in several acclaimed formulas; most distinguished is Super Beta Prostate.’ Defendants represent that ‘Super Beta Prostate was formulated by research chemist Roger Mason.’ Defendants also represent that ‘Roger [Mason] has been an integral part of the natural health industry for more than 30 years. He has done extensive research into natural health, life extension and healing yourself naturally with whole foods, proven supplements, natural hormones and exercise,'” according to Luman’s complaint, citing the Super Beta Prostate website.
     But Luman says in the complaint: “Roger Mason is not a ‘renowned research chemist.’ He is not a doctor. He is not a physician’s assistant. He is not a nurse. He has no training, education or experience relevant to the treatment of BPH or its symptoms. He has no training, education or experience relevant to the development of drugs or dietary supplements. He has never held a job in any of these fields. Roger Mason is a convicted felon. In 1975 he pleaded guilty to conspiracy to distribute PCP. In May 1985, while on parole for his prior drug convictions, Roger Mason was arrested for manufacturing 326 counterfeit credit cards which were used to make at least $100,000 in fraudulent purchases. Roger Mason was released again on parole around 1993.”
     Mason is not a party to the complaint.
     Luman claims that Theismann fabricated his endorsement of Super Beta Prostate, by claiming that his prostate was “giving me fits.”
     “On information and belief, Mr. Theismann has never been diagnosed with BPH or its symptoms,” the complaint states. “Nor was he a bona fide user of Super Beta Prostate. His statements concerning his symptoms are completely fabricated. Instead of referring directly to BPH, Mr. Theismann describes the disease and its symptoms as those of an ‘aging prostate.’ The symptoms described by Mr. Theismann are the classic symptoms of BPH. Indeed, they are identical to the symptoms described in New Vitality’s other advertisements that expressly promote Super Beta Prostate as a treatment for BPH.”
     Luman claims that Theismann’s image appears on nearly every page of the Super Beta Prostate website. In fact, the website includes a page entitled “About Joe Theismann” where he expands on the claims he makes in the commercials.
     “He explains, ‘Even when I first started broadcasting, I’d be hit with sudden urges to go – so I always had to know where the closest bathroom was. My prostate was really getting to me. Does any of this sound familiar? That’s because many men over 40 have issues that come with an aging prostate. … There’s no reason to accept these issues that come with an aging prostate. Take Super Beta Prostate to help you support your quality of life-both during the day and at night. I’m so glad I tried it, and you will be too,'” the complaint states, citing the website.
     Luman claims that Super Beta Prostate is a drug under the Food, Drug and Cosmetic Act, since it is intended for use “in the diagnosis, cure, mitigation, treatment or prevention of disease,” specifically BPH. But he says it has not been approved by the FDA, making it illegal to distribute in interstate commerce.
     “Similarly, federal law prohibits marketers of dietary supplements from making any claim suggesting use of the supplement for the diagnosis, cure, mitigation, treatment or cure of a disease unless the claim is specifically authorized by an FDA finding that there is ‘significant scientific agreement’ to support the claim, or the claim is based on ‘authoritative statements’ from certain federal scientific bodies such as NIH and the National Academy of Sciences. The claims identified above specifically suggest the use of Super Beta Prostate to treat the symptoms of benign prostate hyperplasia. These claims have not been authorized by the FDA or any scientific body. Super Beta Prostate is thus ‘misbranded’ and bears a ‘false or misleading label’ under [federal law],” Luman says in the complaint.
     New Vitality claims on its website for Super Beta Prostate that it has shipped more than 5 million bottles of the supplement. Each page, except the checkout, includes a fine-print warning in the footer that the FDA has not evaluated the company’s claims, and that Super Beta Prostate “is not intended to diagnose, treat, cure or prevent any disease.”
     Luman seeks compensatory and punitive damages for breach of warranty, unjust enrichment, consumer law violations, unfair competition and false advertising.
     He is represented by L. Timothy Fisher with Bursor & Fisher, of Walnut Creek.

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