Wednesday, October 21, 2015

October 20, 2015 Tampa FL VW Recall Lawyers

There  is lots of talk across the south about VW and how it rigged its cars to test emissions lower.  Volkswagen has admitted to lying to government agencies and the people who bought or leased their diesel cars. By now, it's almost impossible to read about this on the Internet and read "class actions" filed. 

Is a class action case in Florida the best or only way to go. NO. So where does the anaylsis start? It starts with who claims to be first in line. 

VW has said they will pay for their illegal activity and false marketing claims. Who will be compensated?
  1. Federal and state governments. In similar cases, the mandatory penalties are paid first.
  2. VW Diesel Owners and Leasees. VW has already broken the trust their customers had in them. Prepare to stand in line.
Don’t forget about the VW Shareholders, who want to make sure their dividends stay intact. Bottom line: If you bought or leased a diesel-fueled 
Volkswagen JettaGolfBeetle,Passat, or Audi A3 sedan manufactured between 2009 and 2015, you need to be represented to fully and fairly recover losses from your devalued vehicle and other potential damages. The list of the named vehicles include:
  • VW Jetta TDI (model years 2009 – 2015)
  • VW Jetta SportWagen TDI (model years 2009-2014)
  • VW Golf TDI (model years 2010-2015)
  • VW Golf SportWagen TDI (model year 2015)
  • VW Beetle TDI and VW Beetle Convertible TDI (model years 2012-2015)
  • VW Passat TDI (model years 2012-2015)
  • Audi A3 TDI models using the 2.0L 4-cylinder TDI engine (model years 2010-2013)

    VW Diesel Owners -Florida Law Protects You

    The only way affected customers can help ensure they will be fully compensated for their losses is to sue Volkswagen.  What can one person claim - outside of a class action?
    • Overpayment of up to $6,000 for their vehicles.
    • Substantial loss of value in their vehicles.
    • Great difficulty in reselling their vehicles.
    • Potential loss of fuel efficiency and/or performance as the result of “fixing ” their vehicles.
  • contact us at 813-513-1381

Dietary Supplements Send 23,000 to ER Yearly

From Study: 

On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement–related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits.

More than a quarter of the ER visits documented in the study involved young adults between the age of 20 and 34 years.

Sunday, October 04, 2015

Sunset Natural Products ordered to stop making or selling dietary supplement products

A Florida judge has barred a Florida dietary supplements maker from doing business until it cleans up its act.

The consent decree of permanent injunction was issued against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.

The decree was entered by U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida on the strength of a complaint filed by the U.S. Department of Justice, which alleged the company operates under conditions that do not meet the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP) requirements.

Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act.

Novartis issues voluntary recall of ADHD drug manufactured in Georgia

Novartis  has issued a voluntary recall of more than 10,000 bottles of a drug used to treat attention deficit hyperactivity disorder (ADHD) that were manufactured at a plant in Georgia.
According to a FDA enforcement report, the Class III recall was for 10,767 bottles of prescription-only 10-milligram dexmethylphenidate HCI extended-release capsules that were manufactured by Alkermes Gainesville in Gainesville, GA. 

The reason cited for the recall was an "out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing."

VW Recall Information

Trying to get to the full understanding of the VW scandal. VW's problems have continued to escalate in recent days, and even as prosecutors in both the U.S. and Germany look into the scandal, the automaker's top U.S. executive has been summoned to Capitol Hill, where he will testify before a congressional oversight panel on Oct. 8.

"The American people want to know why these devices were in place, how the decision was made to install them, and how they went undetected for so long. We will get them those answers," said Rep. Tim Murphy, the Pennsylvania Republican who serves as chairman of the Energy and Commerce Subcommittee on Oversight and Investigations.

Only Diesel Vehicles are Subject to the Recall & Subject to Possible Compensation for Owners/Lessees:

  • 2010 - 2015 Audi A3
  • 2012 - 2015 Volkswagen Beetle
  • 2012 - 2015 Volkswagen Beetle Convertible
  • 2010 - 2015 Volkswagen Golf
  • 2009 - 2015 Volkswagen Jetta
  • 2009 - 2014 Volkswagen Jetta SportWagen
  • 2012 - 2015 Volkswagen Passat

Friday, October 02, 2015

Some Brain & Workout Supplements Contain Unapproved Drugs

The Study is here:

The newly developed UHPLC-PDA method facilitated the detection of vinpocetine and picamilon. This method exhibited excellent performance in terms of sensitivity and is a suitable method for rapid analysis of vinpocetine and picamilon in dietary supplements. The developed method was validated for all the parameters tested and successfully applied to the identification of vinpocetine in authenticated plant samples and dietary supplements.
As expected, vinpocetine was not detected in 2 authenticated samples of Vinca minor. Of the 23 vinpocetine dietary supplements tested, 17 contained vinpocetine and the quantity of vinpocetine in these supplements ranged from 0.3 to 32 mg per recommended daily serving. No vinpocetine was detected in 26% (6/23) of the sampled supplements. Vinpocetine was sold as if it were a constituent of lesser periwinkle in 13% (3/23) of the supplements. In summary, 39% (9/23) of the vinpocetine supplements were misbranded, and 74% (17/23) of vinpocetine supplement labels did not provide any information on the quantity of vinpocetine.
Of the 31 picamilon supplements tested, 30 contained picamilon and the quantity of picamilon ranged from 2.7 to 721.5 mg per maximum recommended daily serving. In the supplements providing a specific quantity of picamilon on the label, actual quantity of picamilon ranged from 99.6 to 157.9% of labelled quantity.

New York Advisory Position Regarding Juror Research and Social Media

Definitely worth a read:

TOPIC: Jury Research and Social Media
DIGEST: Attorneys may use social media websites for juror research as long as no communication occurs between the lawyer and the juror as a result of the research. Attorneys may not research jurors if the result of the research is that the juror will receive a communication. If an attorney unknowingly or inadvertently causes a communication with a juror, such conduct may run afoul of the Rules of Professional Conduct. The attorney must not use deception to gain access to a juror’s website or to obtain information, and third parties working for the benefit of or on behalf of an attorney must comport with all the same restrictions as the attorney. Should a lawyer learn of juror misconduct through otherwise permissible research of a juror’s social media activities, the lawyer must reveal the improper conduct to the court.
RULES: 3.5(a)(4); 3.5(a)(5); 3.5(d); 8.4
Read more here:

Imported Dietary Supplements Recalled for Elevated Lead and Mercury Levels

Butala Emporium Inc., of Jackson Heights, NY, is voluntarily recalling 11 Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders.
The products were distributed in NY through retail stores and to consumers as single-unit purchases via the firm’s Internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, Washington, D.C., and PR.
Butala EmporiumThe recall was initiated after it was discovered that the products contain high levels of lead and mercury based on testing by the New York City Department of Health laboratory and the U.S. Food and Drug Administration (FDA). No complaints or illnesses have been received to date.
The concentration of lead exceeds the recommended daily lead exposure for children younger than 6 years of age and women of childbearing age and would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a protracted period of time (e.g., weeks to months), permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The problems that might occur are dependent on the duration and degree of exposure.

Sunday, August 23, 2015

Iowa Dietary Supplement Firm Shuts Down Under Consent Decree

U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.  
The company and its owners marketed their products online at and through online marketplace websites, such as eBay, Amazon and They also sold their products through a retail location in Cedar Rapids, Iowa. 
“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”

FDA: CBD oil not a dietary supplement

A warning letter went to a seller of CBD Oil: 

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops,” which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
Examples of claims observed on your website that establish the intended use of your products include, but may not be limited to: 
On the “CBD oil – Pure Vape E-Drops 50mG” product webpage,
• “A literature review from 2009 recapped CBD’s documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . .”
On the “Hemp oil – Dixie Botanicals Dew Drops” product webpage,
• “EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries)”
On the “CBD Oil” webpage,
Under the heading, “Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment”:
 “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer.”
 “[T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . ..”
Under the heading, “CBD May Help Reduce Psychotic Symptoms of Schizophrenia”:
 “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . ..”
 “[Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both ‘safe and effective’ but they declared CBD superior . . . .”
It is clear from the claims above that your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
Additionally, your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Your marketed products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115.  For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:

Friday, July 31, 2015

Akttive High Performance Fat Burner Gold capsules recalled

783 bottles of Akttive High Performance Fat Burner Gold capsules weight loss supplements have been recalled. 

The product contains Sibutramine, desmethylsibutramine and Phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States. These undeclared ingredients make the product an unapproved new drug for which safety and efficacy have not been established.

No illnesses or injuries have been reported to the company to date in connection with this product.

The product, marketed as a dietary supplement for weight loss, is packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17.

Teva recalls Adrucil cancer drug for a second time

Teva has issued a voluntary recall for its intravenous cancer medicine Adrucil because of the potential presence of impurities.
As Philadelphia Business Journal reported, Teva recalled six lots of Adrucil because they may contain small amounts of silicone rubber pieces and fluorouracil crystals. In May, it recalled eight lots of the cancer medicine for the same reason.
No adverse events have been reported, but a company statement on the FDA website said “administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.”

Bexco recalls DaVinci brand cribs

Bexco recalled about 11,700 DaVinci brand cribs in the United States and Canada because a metal bracket that connects the mattress support to the crib can break, creating an uneven sleeping surface or a gap. If this occurs, a baby can become entrapped in the crib, fall, or suffer lacerations from the broken metal bracket.

The recall includes DaVinci brand full-size cribs including the Reagan crib (model #M2801), the Emily crib, (model #M4791), the Jamie crib (model #M7301), and the Jenny Lind crib (model #M7391) manufactured from May 2012 through December 2012.

The company has received 10 reports of the mattress support brackets detaching. No injuries have been reported. For more information, go to the U.S. Consumer Product Safety Commission websit


Monday, July 27, 2015

Bard IVC Filters and Potential Claims (July 2015)

Inferior vena cava (IVC) filters sold by Bard have been found to have a high failure rate in a study published in  the Archives of Internal Medicine.
IVC filters are implanted in patients to help prevent pulmonary embolism due to blood clots moving into the lungs. Patients who receive IVC filters such as the Bard Recovery and the G2 by Bard are often patients who are either unresponsive or unqualified due to other medical problems for anti-coagulant drugs.
The tiny vena cava filters are shaped similarly to a cone with legs that extend to catch blood clots. When these legs break off the pieces or the entire filter can migrate through the body to affect other body parts, perforate veins and even cause sudden death. The result of this study caused the FDA to take notice of the dangers involved in using IVC filters and issued a warning to physicians to monitor their patients and remove the filters once the risk of blood clotting has passed.  
The FDA issued a communication on this: 
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided. 
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.

If you have been harmed by one of these products, call us at 866.373.1800 and ask for Ms. Cragin.

Xarelto Trials Set for 2016

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Now, more than 500 Xarelto lawsuits have been consolidated and are currently pending in federal district court in the Eastern District of Louisiana, and District Court Judge Fallon recently announced that the first bellwether trial is scheduled for August 1, 2016.
Besides the Xarelto trial set for August 1, 2016, the court also scheduled three more bellwether trials for August 22, September 12, and October 17, 2016. The first two trials will take place in the Eastern District of Louisiana, the third will be held in the Southern District of Texas, and the fourth is scheduled for the Southern District of Mississippi.
You can also find the Order regarding case-specific discovery here:

Friday, June 19, 2015

Lumber Liquidators MDL Goes to Alexandria Virginia United States District Court Judge

Nationwide there is litigation involving Lumber Liquidators over claims of formaldehyde in several of the company's laminated flooring products. You can read more about the claims here.

Lawyers working on the cases asked to have the many different lawsuits centralized in one Court. Lumber Liquidators, based in Virginia asked to have all related cases sent to its home state. After hearing from various lawyers, the Judicial Panel on Multi District Litigation chose Alexandra Virginia. Here's the Order  

St. Mary's Hospital: Children's Deaths from Open Heart Surgeries at St. Mary's Hospital in West Palm Beach Prompt Federal Investigation

A West Palm Beach, Florida hospital, St. Mary’s Medical Center, is the subject of an investigation from The Centers for Medicare & Medicaid Services, as the hospital reportedly has one of the highest rates of death from open heart surgeries on children. Between the years 2011 and 2013, the mortality rate had risen as high as 12.5% among surgery recipients, according to reports.
CNN managed to obtain the data that the hospital is required to report to the state in order to calculate the 12.5% mortality rate.. This means that the death rate is nearly three times higher than the national average in hospitals around the country who perform heart surgery on infants and children. There is large concern among parents who have lost their children, as well as federal authorities, that the facility may be neglecting the basics of care, especially with regard to their Medicaid and Medicare patients.

The majority of patients who underwent open heart surgery at St. Mary’s Hospital were Medicaid patients. St. Mary’s Medical Center’s parent company, Tenet Healthcare, has declined to comment further on the claims that have been made about its program which opened in December 2011. This raises concerns over whether or not the hospital has been withholding its facts and figures.
CNN discovered after reviewing the information the hospital supplied to the State of Florida that 12.5% of the babies who underwent heart surgery since the progam’s beginning died. Heart surgery is often necessary to correct congenital heart defects. In centers which perform the highest number of surgeries to correct these defects, he mortality rate is very low regardless of the difficulty of the surgery.

According to physicians hired by the State of Florida to look into its program, St. Mary’s did not perform enough surgeries each year to become proficient. In fact, they did not perform even two surgeries per month over the life of the program. In fact, these investigators determined that St. Mary’s needed to stop all surgeries on infants immediately. St. Mary’s ignored the recommendations in this report and continued to operate on babies some of whom were injured or died.

Thursday, May 07, 2015

FDA Warns 14 Sports Supplement Companies Of Illegal DMBA (AMP Citrate)

BMPEA is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.
BMPEA is also known as:
  • ╬▓MePEA
  • R-beta-methylphenethylamine
  • R-beta-methylphenethylamine HCl
  • Beta-methylphenethylamine
  • ╬▓-methylphenylethylamine
  • 1-amino-2-phenylpropane 
  • 2-phenylpropan-1-amine 
  • 2-phenylpropylamine
  • alpha-benzylethylamine
  • 1-phenyl-1-methyl-2-aminoethane
  • beta-methylbenzeneethanamine
  • beta-phenylpropylamine
  • 2- phenyl-1-propanamine 
On April 23, 2015, the FDA issued warning letters to five companies regarding a total of eight products for which the product labeling lists BMPEA as a dietary ingredient. Two of the companies further identified the source of this stimulant as the botanical Acacia rigidula.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
While BMPEA was listed as a dietary ingredient on the product labels, the substance does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement. Additionally, relating to the two companies that identified the botanical Acacia rigidula as the source of the BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula.  FDA considers these specific products to be misbranded for this reason, as well.
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law.

Saturday, April 25, 2015

Toxic Diet Pills Kill a 21 Year Old DNP

News of a tragic death this week involving a diet pill with DNP.

2,4-Dinitrophenol (2,4-DNP, DNP) is an organic compound with the formula HOC6H3(NO2)2. It is a yellow, crystalline solid that has a sweet, musty odor. It sublimes, is volatile with steam, and is soluble in most organic solvents as well as aqueous alkaline solutions. It is a precursor to other chemicals and is biochemically active, inhibiting energy (ATP) production in cells with mitochondria. DNP is considered an important environmental contaminant by the United States Environmental Protection Agency.

From various news sites:

The tablets that Parry is believed to have taken shortly before her death are being tested for a toxic substance called dinitrophenol or DNP, police said. Generally described as a yellow, powdery substance in medical literature, dinitrophenol has been used as a black market weight-loss drug for decades, authorities said.
The substance is illegal for use in a diet drug or supplement in the United States, according to a spokeswoman for the U.S. Food and Drug Administration.
Parry's mother, Fiona Parry, recounted the details leading up to her daughter's death on a post on the police department's website.
Fiona Parry said her daughter became ill after taking the diet pills but didn't initially realize the gravity of her situation. Even after taking herself to a local hospital, her daughter said she did not initially feel gravely ill, Fiona Parry recalled.

Saturday, April 18, 2015

NECC Litigation News

I'm one of seven lawyers appointed by a Federal Court Judge to prosecute the civil case involving New England Compounding Pharmacy. I'm NOT a class action lawyer. An interesting and compelling read from Newsweek this week:

2015_04_17_Cover_600 x 800

Monday, April 13, 2015

Lumber Liquidators: Litigation and News for April 2015

Concerned?  Contact us today using the form to the right of this post. 
Certified laboratory testing performed on laminate wood flooring purchased from Lumber Liquidators locations in Virginia, Florida, Texas, Illinois, and New York revealed levels of formaldehyde, a known carcinogen, that exceed those permitted by the California Air Resources Board (CARB) and the Formaldehyde Emissions Standards for Composite Wood Products Act, which will take effect nationwide this year. According to this testing, certain laminate flooring samples contained up to 20 times the legal level of formaldehyde. The 60 Minutes report indicates that these extreme levels of formaldehyde raised concern among laboratory employees, who suspected that their testing equipment may be faulty.
A certain amount of formaldehyde is present and legally permissible in laminate flooring manufactured by Lumber Liquidators in America, and by other companies. Lumber Liquidators laminate flooring sold at Home Depot and Lowes stores is CARB-compliant, as it contains levels of formaldehyde which the California Air Resources Board has deemed safe. 

These Lumber Liquidators lumber products  may contain excessive and illegal amounts of formaldehyde

  • 8 mm Bristol County Cherry Laminate Flooring
  • 8 mm Dream Home Nirvana French Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Antique Bamboo Laminate Flooring
  • 12 mm Dream Home St. James Oceanside Plank Bamboo Laminate Flooring
  • 12 mm Dream Home Kensington Manor Warm Springs Chestnut Laminate Flooring
  • 15 mm Dream Home St. James Sky Lakes Pine Laminate Flooring
  • 12 mm Dream Home Ispiri Chimney Tops Smoked Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Imperial Teak Laminate Flooring
  • 12 mm Dream Home St. James Vintner’s Reserve Laminate Flooring
  • 12 mm Dream Home Kensington Manor Cape Doctor Laminate Flooring
  • 12 mm Dream Home St. James Cumberland Mountain Oak Laminate Flooring
  • 12 mm Dream Home Ispiri Americas Mission Olive Laminate Flooring
  • 12 mm Dream Home Kensington Manor Glacier Peak Poplar Laminate Flooring
  • 12 mm Dream Home Kensington Manor Golden Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Handscraped Imperial Teak Laminate Flooring (SKU 10029601)
  • 12 mm Dream Home Kensington Manor Handscraped Summer Retreat Teak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Sandy Hills Hickory Laminate Flooring
  • 12 mm Dream Home Kensington Manor Tanzanian Wenge Laminate Flooring
  • 8 mm Dream Home Nirvana Royal Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Blacksburg Barn Board Laminate Flooring
  • 12 mm Dream Home St. James Brazilian Koa Laminate Flooring
  • 12 mm Dream Home St. James Golden Acacia Laminate Flooring
  • 12 mm Dream Home Ispiri Poplar Forest Oak Laminate Flooring
  • 12 mm Dream Home Kensington Manor Fumed African Ironwood Laminate Flooring
  • 12 mm Dream Home St. James African Mahogany Laminate Flooring
  • 12 mm Dream Home St. James Chimney Rock Charcoal Laminate Flooring
At high levels, formaldehyde is considered a known human carcinogen because it can cause various types of cancer, including myeloid leukemia and nasopharyngeal cancer. At low levels, formaldehyde exposure can cause a number of additional problems such as respiratory issues, asthma and irritation of the eyes, nose and throat. According to the 60 Minutes report, children may be most susceptible to these issues, as they are often in close contact with the flooring.

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. This type of cancer usually gets worse quickly if it is not treated. It is the most common type of acute leukemia in adults. AML is also called acute myelogenous leukemia, acute myeloblastic leukemia, acute granulocytic leukemia, and acute nonlymphocytic leukemia.

Nasopharynx cancer or nasopharyngeal carcinoma (NPC) is the most common cancer originating in the nasopharynx, the uppermost region of the pharynx ("throat"), behind the nose where the nasal passages and auditory tubes join the remainder of the upper respiratory tract. NPC occurs in children and adults. NPC differs significantly from other cancers of the head and neck in its occurrencecauses, clinical behavior, and treatment. It is vastly more common in certain regions of East Asia and Africa than elsewhere, with viraldietary and genetic factors implicated in its causation. It is most common in males. It is a squamous cell carcinoma or an undifferentiated type. Squamous epithelial cells are a flat type of cell found in the skin and the membranes that line some body cavities. Differentiation means how different the cancer cells are from normal cells. Undifferentiated is a word used to describe cells that do not have their mature features or functions.

Tuesday, March 10, 2015

Herbal Supplements, their Safety and Marketing: State Prosecutors to Form Coalition

The states are getting their respective acts together. This report today:

 A group of attorneys general is expected to announce on Tuesday that they are forming a coalition to crack down on fraud and quality control issues in the herbal supplement industry.

The coalition would signal a shift in the way law enforcement agencies ensure the safety of herbal supplements, a $5 billion-a-year industry that has been plagued by complaints of mislabeling. An investigation by the New York State attorney general’s office led to accusations last month that four national retailers were selling supplements that contained either little or none of the medicinal herbs advertised on their labels or, in many cases, included cheap fillers and contaminants like powdered rice, wheat and houseplants.

The retailers — GNC, Target, Walmart and Walgreens — were forced to pull the products from their shelves. The state attorney general, Eric T. Schneiderman, later issued subpoenas to the manufacturers of the products, demanding that they explain how they verify the quality of their products and what testing they do to support a variety of claims on their labels, like “gluten free” and “hypoallergenic.”

Critics of the industry have argued that the Food and Drug Administration does not have enough power to keep fraudulent or dangerous products from reaching store shelves. The F.D.A. is restricted by a 1994 federal law — sponsored by Senator Orrin G. Hatch, Republican of Utah, who has strong financial ties to the industry — that prevents it from subjecting supplements to the strict approval process applied to prescription drugs.

As a result, unsafe herbal products generally are pulled from stores only after they have caused harm. But Dr. Arthur P. Grollman, an expert on herbal supplements at Stony Brook University, said he believed that greater action at the state level might pressure the supplement industry to address some of its safety issues.
Dr. Grollman was among the experts who more than a decade ago led calls for a ban on ephedra, an herbal supplement that was linked to many heart attacks, strokes and deaths. The F.D.A. eventually banned ephedra in 2004, only after several states and counties had introduced legislation outlawing its sale in their local stores.

Monday, March 09, 2015

New York AG asks Retailers to Halt Sales (GNC, Target, Walgreens), Round 2

Round 2 continues, as a number of companies have received letters. These include Pharmavite (the Nature Made brand); NBTV - which makes Sundown Naturals, Nature's Bounty, Met-Rx and Solgar. Also named were Nature's Way, and Nutraceuticals Corp.  

Previously, these companies were sent letters: 


  • Six “Herbal Plus” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from four locations with representative stores in Binghamton, Harlem, Plattsburgh & Suffolk.
  • Only one supplement consistently tested for its labeled contents: Garlic. One bottle of Saw Palmetto tested positive for containing DNA from the saw palmetto plant, while three others did not. The remaining four supplement types yielded mixed results, but none revealed DNA from the labeled herb.
  • Of 120 DNA tests run on 24 bottles of the herbal products purchased, DNA matched label identification 22% of the time.
  • Contaminants identified included asparagus, rice, primrose, alfalfa/clover, spruce, ranuncula, houseplant, allium, legume, saw palmetto, and Echinacea.
  • Six “Up & Up” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Valerian Root, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Nassau County, Poughkeepsie, and Syracuse.
  • Three supplements showed nearly consistent presence of the labeled contents: Echinacea (with one sample identifying rice), Garlic, and Saw Palmetto. The remaining three supplements did not revealed DNA from the labeled herb.
  • Of 90 DNA tests run on 18 bottles of the herbal products purchased, DNA matched label identification 41% of the time.
  • Contaminants identified included allium, French bean, asparagus, pea, wild carrot and saw palmetto.
  • Six “Finest Nutrition” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Brooklyn, Rochester and Watertown.
  • Only one supplement consistently tested for its labeled contents: Saw Palmetto. The remaining five supplements yielded mixed results, with one sample of garlic showing appropriate DNA. The other bottles yielded no DNA from the labeled herb.
  • Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 18% of the time.
  • Contaminants identified included allium, rice, wheat, palm, daisy, and dracaena (houseplant).
  • Six “Spring Valley” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three geographic locations with representative stores in Buffalo, Utica and Westchester.
  • None of the supplements tested consistently revealed DNA from the labeled herb. One bottle of garlic had a minimal showing of garlic DNA, as did one bottle of Saw Palmetto. All remaining bottles failed to produce DNA verifying the labeled herb.
  • Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 4% of the time.
  • Contaminants identified included allium, pine, wheat/grass, rice mustard, citrus, dracaena (houseplant), and cassava (tropical tree root).
The Attorney General’s investigation follows an important study conducted by the University of Guelph in 2013 that also found contamination and substitution in herbal products in most of the products tested. As was said at the time by a spokesperson for the University of Guelph, “The industry suffers from unethical activities by some manufacturers.”
The market for herbal supplements is significant. The Natural Products Foundation estimates that the dietary supplement industry contributes $61 billion dollars to the national economy. A 2013 study from the Canadian Institutes of Health Research estimated there are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.
That same study also found that more than half of Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012 were dietary supplements. Class I recalls are reserved for drugs or supplements for which there is a “reasonable probability that [their use] will cause serious adverse health consequences or death.”
The Attorney General thanks Dr. James A. Schulte II of Clarkson University in Potsdam, N.Y. for providing his expertise in DNA barcode testing for this investigation.
The case is being handled by Executive Deputy Attorney General Marty Mack and Assistant Attorney General Deanna Nelson with the assistance of NYAG’s thirteen regional offices.