Hi Tech Pharmaceuticals Ordered to Pay $40M in Sanctions

A USDCT Judge in Georgia has imposed a $40 million sanctions against Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), Jared Wheat, Sean Smith, and Dr. Terrell Mark Wright. The sanction arose from the defendants’ failure to comply with orders obtained by the U.S. Federal Trade Commission (FTC) requiring that they cease making unsubstantiated claims about their products and include a health-risk warning on products containing yohimbe.

On November 11, 2004, the FTC filed a complaint alleging that several defendants had violated Sections 5 and 12 of the Federal Trade Commission Act (hereinafter “the FTC Act”), 15 U.S.C. §§ 45(a) and 52, by making false
and unsubstantiated claims in connection with their advertising and sale of various dietary supplements.

The court entered two separate final judgment and permanent injunctions against the defendants on December 16, 2008, enjoining them from several activities related to their previous violations of the FTC Act. The first final judgment and permanent injunction is against National Urological Group, Inc., Hi-Tech, Wheat, Thomasz Holda, and Smith hereinafter “the Hi-Tech Order”). The second final judgment and permanent injunction is against Wright (hereinafter “the Wright Order.”) Section II of each of the injunction orders prohibied the defendants from advertising weight-loss products using claims that the products cause rapid or substantial weight loss and fat loss or claims that the products affect metabolism, appetite, or fat unless those claims are substantiated with “competent and reliable scientific evidence.”

Here's the Order:

Ftc national from mzamoralaw

Eugene Oregon, Inc. Issues Nationwide Expansion Of The Recall Of All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients

English: Logo of the . (Photo credit: Wikipedia)

May 28, 2014 (Revised from May 5, 2014) Press Release - Eugene Oregon, Inc. of Levittown, Pennsylvania is voluntarily expanding the recall of the following products to the consumer level:

Product Name	Lot Number	Packaging	Packaging Coloring	Quantity Per Package
African Black Ant	All lots	Small boxes inside large box	Red, black, and silver	6 capsules per box, 8 boxes per display unit.
Black Ant	All lots	Small boxes / tins inside large box	Green	4 capsules per small box, 20 boxes display unit. Also packaged in 10 tablets and 10 capsules in a metal tin.
Mojo Risen	All lots	Envelopes inside box	Red and white	2 capsules per envelope, 24 envelopes per display box.

This recall is a revised version of the recall issued on May 5, 2014 and is revised to reflect the recall of ALL LOTS of the recalled products. Misinformation about the Black Ant product codes and packaging description may have been included in the original press release and this information is intended to clarify any ambiguity and expand the recall to all lots of all recalled products.

Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat erectile dysfunction. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure.

Sildenafil and tadalafil can pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, and heart disease often take nitrates. To date, Eugene Oregon, Inc. has not received any reports of adverse events related to this recall.

These products are marketed as dietary supplements for sexual enhancement and packaged in tins, envelopes, and/or boxes and were distributed to consumers nationwide at retail stores. Eugene Oregon, Inc. has discontinued the distribution of these products and is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately.

http://www.fda.gov/Safety/Recalls/ucm399144.htm?utm_source=twitterfeed&utm_medium=twitter

Synthetic Street Drug Dangers Emerge

A report on synthetic street drugs from a Kansas newspaper is worth a read:

'Many of the synthetic drugs are illegal and can be very toxic, highly variable in dosage and quality control and heavily marketed over the Internet with colorful packaging targeting young people, said Tim Rohrig, director of the Sedgwick County Regional Forensic Science Center. Besides conducting autopsies, the center does drug identification testing for area law enforcement.

The center recorded 115 instances of synthetic cannnabinoid in 2013, Rohrig told law enforcement officers meeting Thursday at the Midwest Law Enforcement Gangs & Drugs Conference at the DoubleTree by Hilton Hotel Wichita Airport.'

http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html

.http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html'
Read more here: http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html#storylink=cpy

Gencor's Testofen an Issue in Litigation

If you've been reading about LowT litigation, here is an offshoot of the cases. The class case alleges that defendants have violated the federal Racketeer Influenced and Corrupt Organizations Act and several California laws, including the Consumer Legal Remedies Act, Unfair Competition Law and False Advertising Law. The lawsuit also alleged breaches of express warranty, implied warranty of merchantability and implied warranty of fitness for a particular purpose.  Testofen is not a drug, but an over the counter product, which is represented this way in the company website:

Testofen® is a fenugreek extract standardized for 50% Fenuside™. 

Testofen is the branded name for Gencor’s fenugreek extract. Fenugreek is a well-known, versatile herb that contains over 100 phytochemical constituents, including Furostanol Saponins and Steroidal Saponins.  While fenugreek has multiple health applications, Testofen has been shown to increase sexual desire, help maintain sexual health and muscle mass and support the immune system.* The group of saponin glycosides that Testofen is standardized to is named Fenuside.

After age 30, most men begin to experience a natural and gradual decline in testosterone levels, which can result in reduced desire and a slow loss of muscle tone and definition. Testofen has been shown to promote free testosterone, up to 98 percent, in an eight-week trial (see below).* 

Incorporate Testofen in product formulations designed to support healthy sexual function and performance in adult males.* 

Clinical research

Both animal and human clinical studies have been conducted on Testofen®.

Animal study

Study results: The 2010 study of Testofen on the reproductive systems of rats demonstrated that Testofen supported an increase in the weight of the ani-levator muscle, which led to support for muscle mass and body weight.* 

Citation: Urmila Aswar et.al, 2010. Effect of Furostanol Glycosides from Trigonella foenum –graecum on the reproductive system of Male Albino Rats. Phytotherapy Research, 24, 1482–1488.

http://www.gencorpacific.com/index.php/featured-ingredients/testofen

Lansal Recalls Hummus and Dip Products

Prepared Foods manufacturer, Lansal, Inc.( d.b.a Hot Mama’s Foods) has announced it is recalling approximately 14,860 pounds of hummus and dip products.The products were sold at Trader Joes and Target, and the recall is based on worries about possible Listeria contamination.  

 

The potential for contamination was found during a routine test of Target Archer Farms Traditional Hummus (10 ounce) by the Texas Department of Health. No illness has been reported.

 

 Here are the UPC codes: 

  

UPC: 85239233405

Target Archer Farms Traditional Hummus 10oz.

JUN/11/2014

National

 

UPC: 8968630 01823

Target Archer Farms Traditional Hummus 2lb. 

(Non-retail item; Ingredient item used in SuperTarget store production of 2 items, Archer Farms Mediterranean Veggie Hummus Wrap and Archer Farms Hummus Veggie Snacker)

JUN/11/2014

National

 

UPC: 85239233498

Target Archer Farms Roasted Garlic with Roasted Garlic Tapenade 17 oz.

JUN/9/14 & JUN/12/14

National

 

UPC: 85239233481

Target Archer Farms Roasted Red Pepper with Roasted Red Pepper Topping 17 oz.

JUN/12/2014

National

 

UPC: 988582 Trader Joe’s Edamame Hummus 8oz.

APR/28/14 & APR/29/14 & MAY/9/24

Arizona, California, Colorado, Florida, Georgia, Idaho, Louisiana, North Carolina, Nevada, New Mexico, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia (Southern), Washington.

Dietary Supplement "Lean Slow Motion" gets an FDA Warning Letter

In a key  first warning letter on issue since FDA liquid dietary supplements guidance was finalized in January, the FDA warned a manufacturer that the beverage drinks are adulterated under federal law because they contain melatonin, which is not approved for use in food

Marco Moran, President

Dewmar International BMC, Inc.

101 Convention Center Drive, Suite 700

Las Vegas, Nevada 89109

 

Dear Mr. Moran:

 

The Food and Drug Administration (FDA) has reviewed the regulatory status of the ingredients declared on the label of your beverage products, Lean Slow Motion…Potion (Easta Pink, Purp, and Yella varieties) and has determined your products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)] because they bear or contain an unsafe food additive.  Specifically, the products contain melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).

 

Additionally, based on our review of your product labels, your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov. 

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are represented for use as conventional foods, and accordingly are not dietary supplements, as defined under Section 201(ff) of the Act [21 USC 321(ff)].  The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 USC 321(ff)(2)(B)].  Your use of the term “dietary supplement” below the Nutrition Facts panel on your product labels does not make your products dietary supplements, because your Lean Slow Motion…Potion products are represented for use as conventional foods.  Examples of factors and information that establish that the products are represented for use as conventional foods are as follows:

 

• Your products are described as beverages on the information panels of the cans.
• The “Products” page on your website describes your Yella product as for people who like “pineapple-based Fanta” carbonated soft drink, your Purp product as for people who “like it raw mixed with Sprite” carbonated soft drink and your Easta Pink product as inspired by “Sprite Easta Pink.”
• The homepage of your website, www.slowmotionpotion.com, refers to your line of products as, “#1 relaxation beverage” and “the most potent relaxation drink.”
• The “Products” page on your website describes the flavor of your Yella product as having a “hint of red Jolly Rancher flavor” and “unique flavor combination that is ranked number 1 in blind taste tests.” The page describes the flavor of your Purp product as including “grape Jolly Rancher candy.” The page describes the flavor of your Easta Pink product as “a secret flavor combination” that “creates the sweetest of the Leans.”
• Your products, sold in single-serving pop-top aluminum cans, have the appearance and packaging of carbonated soft drinks.
• Your products contain a Nutrition Facts label.
• Your products are comprised of typical ingredients for carbonated soft drinks (carbonated water, sugar, citric acid, natural flavor, potassium sorbate, sodium benzoate) plus melatonin and extracts.
• The president’s message on your company website at www.dewmarinternational.com/presidents-message/ refers to your products as “relaxation beverages” and a “beverage brand.”

 

Unapproved Food Additive

 

Any substance added to a conventional food, such as your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) beverage products, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as General Recognized As Safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin.  We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.

 

FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts.  The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

 

• Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.”  Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.”  Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
• Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.”  Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.”  Importantly, however, the fact a substance was added to food before 1958 does not, in itself, demonstrate such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
• Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”  The regulation provides that, in determining safety, the following factors are to be considered:  (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).1

 

We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.  In assessing the GRAS status of melatonin for use in a conventional food such as “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella),” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products does not satisfy the criteria for GRAS status under 21 CFR 170.30.

 

FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your beverage product. Therefore, melatonin added to a conventional food is a food additive under Section 201(s) of the Act [21 USC 321(s)] and is subject to the provisions of Section 409 of the Act [21 USC 348].  Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Melatonin is not approved for use in any food, including beverages.  Therefore, your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products are adulterated within the meaning of Section 402(a)(2)(C) of the Act [21 USC 342(a)(2)(C)].

 

Misbranded Food

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. As discussed above, the products are represented for use as conventional foods, however, below the Nutrition Facts panel, the labels state:  “DIETARY SUPPLEMENT.”

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 (i)(1) of the Act [21 USC 343(i)(1)] because they fail to bear a statement of identity in accordance with 21 CFR 101.3.

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition information is not in an appropriate format, as specified in 21 CFR 101.9. For example:

 

• A declaration of “Acai Berry Extract” is not allowed within the nutrition label (e.g., Nutrition Facts panel). According to 21 CFR 101.9(c), no nutrients or food components other than those listed in 21 CFR 101.9(c) as either mandatory or voluntary may be included within the nutrition label.
• The amounts of saturated fat and trans fat are not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(2)(i) and 21 CFR 101.9(c)(2)(ii) or 21 CFR 101.9(f)(4).  Further, the amount of cholesterol is not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(3) or 21 CFR 101.9(f)(4).
• The label uses the simplified Nutrition Facts labeling format under 21 CFR 101.9(f). When using this format, the declaration of voluntary nutrients triggers the requirement that the statement “Not a significant source of ___” be included at the bottom of the nutrition label. We note the labels fail to use this statement to declare trans fat, saturated fat, cholesterol, vitamins A and C, iron and calcium.

 

This letter is not intended to be an all-inclusive list of violations in your products. It is your responsibility to ensure all of your products comply with the Act and other applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.

 

(b)(4)

 

 

 

You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.

 

Your response should be sent to:  Ms. Kimberly Dutzek, Compliance Officer, at the address above.  If you have any questions about the content of this letter, please contact Ms. Dutzek at (615) 366-7826.

 

                                                                       

Sincerely,

/S/ 

Patricia K. Schafer

District Director

New Orleans District

 

May News - Morcellator Warning from the FDA

The FDA has discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.

Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.

The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.

“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Maisel. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.” 

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm

From FDA Safety communication:

Summary of Problem and Scope:

Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.

A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

From  the American Cancer Society:

Sarcomas are cancers that start from tissues such as muscle, fat, bone, and fibrous tissue (the material that forms tendons and ligaments). Cancers that start in epithelial cells, the cells that line or cover most organs, are calledcarcinomas.

More than 95% of cancers of the uterus are carcinomas. If a carcinoma starts in the cervix, it is called a cervical carcinoma. Carcinomas starting in the endometrium, the lining of the uterus, are called endometrial carcinomas. These cancers are discussed in our other documents Cervical Cancer and Endometrial (Uterine) Cancer. This document is only about uterine sarcomas.

Most uterine sarcomas are put into categories, based on the type of cell they developed from:

• Endometrial stromal sarcomas develop in the supporting connective tissue (stroma) of the endometrium. These cancers are rare, representing less than 1% (1 in 100) of all uterine cancers. These tumors are low grade -- the cancer cells do not look very abnormal and they tend to grow slowly. Patients with these tumors have a better outlook than those with other uterine sarcomas .
• Undifferentiated sarcomas used to be considered a type of endometrial stromal sarcoma, but since they are more aggressive and are treated differently from low-grade tumors, they are now considered separately. These cancers make up less than 1% of all uterine cancers and tend to have a poor outlook.
• Uterine leiomyosarcomas start in the muscular wall of the uterus known as the myometrium. These tumors make up about 2% of cancers that start in the uterus.

Another type of cancer that starts in the uterus is called carcinosarcoma. These cancers start in the endometrium and have features of both sarcomas and carcinomas. They can be classified with uterine sarcomas, but many doctors now believe they are more closely related to carcinomas. These cancers are also known as malignant mixed mesodermal tumors or malignant mixed mullerian tumors. Uterine carcinosarcomas are discussed in detail in the American Cancer Society document Endometrial (Uterine) Cancer.

http://www.cancer.org/cancer/uterinesarcoma/detailedguide/uterine-sarcoma-what-is-uterine-sarcoma

Georgia Low Testosterone Complaint filed, May 2014

Law partner Roger Orlando has taken the lead in investigating a claimed link between Androgel and other Low T drugs with claimed heart attacks. He has now filed the first case in GA: 

First LowT Complaint filed in Georgia Punitive Damages from mzamoralaw

Recent research has found that testosterone treatments for men could cause an increased risk of stroke, heart attack or even death. Men with signs of heart problems were more likely to suffer a stroke, heart attack or die compared to healthy men who didn’t take testosterone supplements, according to the study, which followed 8,700 men taking testosterone for three years.

The study was published in the Journal of the American Medical Association in November 2013 and is the second major study that has reported an elevated health risk when taking testosterone supplements.

In 2011, more than 5 million prescriptions for testosterone were written in the United States, according to news reports. Testosterone therapy is most often administered as a gel, patch or injection.

A Lonely Death, but Justice for a Wife

Our lawyer Craig Jones just finished a jury trial this week that gives some comfort to the family of a man who was prematurely taken from his family.

Craig worked for a woman whose husband was walking along a roadway near his home, in the rain, just before the sun came up that morning. He was without warning hit by a car; he landed (alive) on the roadway, when a Mack truck with an inattentive driver ran over him, snuffing out his life.  The drivers of each vehicle blamed the deceased.   The case was brought in a conservative venue in Metro Atlanta. 

Craig claimed that that the driver of the car failed to maintain a proper lookout and that the truck followed too closely, not giving the driver enough time to perceive and react.  He had no expert.  The entire case was based on cross examining the defendant drivers.  

According to Craig: "I used the trucking company’s corporate representative (the division safety manager) to prove the safety rules on proper following distance (4 seconds) and the need to increase that to as much as 7 seconds under hazardous conditions (it was rainy).  According to the truck driver’s testimony – which the police said was consistent with all the evidence – he was only maintaining a 3 second following distance.   

The wrongful death award was not based on income, but upon testimony from friends and family about his quality of life.  There were no settlement offers.  The jury found the deceased was 35% at fault and awarded $1,633,000 to his widow. The jury put 23% on the driver of the car and 42% on the truck driver. 

In Georgia tonight, a widow is able to have closure because a jury has spoken.   

Maker Of Erectile Dysfunction Products Admits To Misbranding And Selling Drugs As "All-Natural" Herbal Supplements

An North Carolina  man pleaded guilty in federal court defrauding consumers of nearly $5 million by misbranding erectile dysfunction drugs and selling them as “all natural” herbal supplements, announced Anne M. Tompkins, U.S. Attorney for the Western District of North Carolina.

Kamran Rezapour, 52, of Creston, N.C. pleaded guilty before U.S. Magistrate Judge David C. Keesler to one count of wire fraud and two counts of drug misbranding. At today’s plea hearing, Rezapour admitted that from 2009 through April 2013, he defrauded consumers of nearly $5 million, by fraudulently and falsely claiming that his erectile dysfunction products were “100 % safe and natural.” Rezapour admitted that his products, in fact, contained ingredients similar to prescription drugs such as Viagra, which require FDA approval to market and distribute. According to court documents, Rezapour was the owner and operator of Nutrition for Health, Inc. and Mojo Risen, LLC. Through these companies, Rezapour sold dietary supplements, male enhancement drugs and erectile dysfunction drugs, including Mojo Risen, Mojo Sensation and VajiVedic. Court documents indicate that Rezapour advertised Mojo Risen and the other erectile dysfunction pills as non-prescription, “all natural” herbal supplements. As part of his plea, Rezapour admitted that in order to induce consumers to purchase his Mojo Risen, Rezapour made multiple and repeated false claims that the sexual enhancement products were “100% safe and natural” and without “harsh and dangerous side effects.”

Rezapour admitted in court today that these claims were false. Court documents indicate that Mojo Risen, Mojo Sensation and VajiVedic contained pharmaceutical and prescription compounds, including sildenafil (the active ingredient in Viagra) and its chemical analogue noracetildinafil, which Rezapour smuggled into the United States from China. Rezapour did not list sildenafil, noracetildenafil or any another prescription ingredient in the packaging and advertising material for the supplements and did not provide any warnings about the possible adverse side effects of sildenafil and noracetildenafil. Court documents indicate that these products also did not bear the symbol “Rx only” on their labels, as is required for all prescription drugs.

According to court records, Rezapour and his Chinese supplier evaded detection of the pharmaceutical and prescription compounds by U.S. Customs authorities and the FDA by falsely labeling the packages as “paint products,” “care product[s]” and “gift[s].” Rezapour ultimately distributed his products nationwide, including to customers located in Charlotte, and received approximately $4,944,939 in payments for the fraud scheme.

During the course of the investigation, law enforcement agents seized approximately $1.5 million in funds, and gold and silver coins in connection with the fraud. Rezapour has agreed to forfeit all of these assets as part of his plea agreement in this case.

“Rezapour’s customers bought his mislabeled drugs as safe alternatives to prescription medications,” said U.S. Attorney Tompkins. “What’s particularly troubling is that Rezapour knew his products contained certain ingredients that could cause serious health consequences, yet he marketed and sold his supplements without appropriate warning labels. My office and our federal partners will prosecute those who profit from the reckless sale of misbranded drugs to unsuspecting consumers.”

“Protecting the American public from those utilizing the mail for illegal purposes is of primary concern to the Postal Inspection Service,” said Keith Fixel, Inspector in Charge of USPIS’s Charlotte Division. “Working with our law enforcement partners, we will vigorously pursue those who attempt to use the mail for unlawful gain and who prey upon unsuspecting consumers.”

At sentencing, Rezapour faces a maximum prison term of 20 years and a $250,000 fine for the wire fraud charge and a maximum prison term of three years and a $250,000 fine for each count of misbranding drugs. In his plea agreement, Rezapour has agreed to pay full restitution for any losses resulting from his criminal scheme. The final restitution amount will be determined by the Court at Rezapour’s sentencing hearing, which has not been scheduled yet. Rezapour has been detained since April 17, 2013.

The investigation into Rezapour was conducted by FDA-OCI and USPIS, with the assistance of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives. The prosecution is handled by Assistant U.S. Attorney Kelli Ferry and Special Assistant U.S. Attorney Erin Comerford of the U.S. Attorney’s Office in Charlotte.

$100 Million Settlement for Victims in NECC Meningitis Outbreak

English: Logo of the Centers for Disease Control and Prevention, an agency within the United States Department of Health and Human Services. White on blue background with white rays but no white "burst". No detailed wording. (Photo credit: Wikipedia)

I've been working on the NECC Meningitis tragedy since November, 2012. As a member of the seven lawyer Plaintiffs' Steering Committee, it's been some of the most tragic litigation I've been a part of in more than 20 years of practice.  The reason? The many deaths and grievous harm that so many have suffered through or died from, through 0% fault of their own. Here's part of the news reports: 

Today,  the Plaintiffs’ Steering Committee, the legal committee representing victims in federal court, today announced a $100 million settlement for victims who were exposed to tainted epidural steroid injections manufactured by New England Compounding Center (NECC), which caused a recorded 64 deaths. The tentative settlement announced late last year has now been reduced to writing, signed by the parties and filed with the bankruptcy court. 

The 2012 outbreak was the worst such outbreak in U.S. history. The CDC ultimately recorded 751 cases of fungal meningitis and infections in 20 states, linked to tainted injections compounded and distributed by NECC.

The settlement involves NECC, NECC’s owners, related companies and insurers. The settlement is pending approval from the bankruptcy court. Given the timing of the settlement, it is possible that victims could receive compensation as early as next year.

“The job that we are duty bound to complete is far from over. We will continue with our efforts to hold other wrongdoers accountable, including companies like UniFirst, who was responsible for controlling contamination,” Mark Zamora, a member of the Plaintiffs’ Steering Committee said. 

The terms of the settlement includes personal contributions of almost $50 million from NECC owners Barry Cadden, Lisa Cadden, Carla Conigliaro and Greg Conigliaro. According to the settlement, insiders will also assign 90 percent of their expected tax refunds, which the insiders estimate will amount to an additional $20 million contribution.

Ameridose, the insurers for NECC and a related company, Pharmacists Mutual and Maxum, are contributing more than $25 million. Other insurers, including Lloyd’s of London and Ironshores, have not contributed to the settlement.

An additional contribution will be made if and when the sale of Ameridose is completed, estimated to be valued at about $10 million.