Saturday, December 28, 2013

OTC Thyroid ‘Boosters’ May Harm

From the Dietary Supplement Reporter this post:

Over-the-counter thyroid supplements are not supposed to contain any thyroid hormone,” Lee told MedPage Today. “But there’s no truth-in-labeling in these supplements.”
“People who are unsuspecting, or who are already on thyroid medications … can become significantly and severely hyperthyroid,” Lee said.
Lee said thyroid supplements have gained popularity because the symptoms of hypothyroidism — especially fatigue and weight gain — are so common in normal aging. Women looking for a quick fix to those problems may be attracted to supplements that promise to boost thyroid function.

Friday, December 27, 2013

FDA warns consumers not to use muscle growth product Bluntforce-Mass Destruction

The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances. The product’s ingredients are undergoing further analysis by the FDA.
Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet. An investigation is underway to identify the product’s manufacturer. Consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine, or any other unexplained changes in their health.
Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”  
In general, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.  
Health care professionals and consumers are encouraged to report adverse events that may be related to this or similar products to FDA’s MedWatch Adverse Event Reporting program by:

FDA: Recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy

The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.  

Contaminated sterile drugs put patients at risk of serious infection. Health care professionals who have received the affected products should stop using them and follow Abrams’ recall instructions.

The FDA is aware of one adverse event associated with mineral IV injection produced by Abrams’ lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive forStenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection. 

“Patient safety is our top priority, and giving a patient a contaminated drug could result in a serious infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Using these products puts patients at an unacceptable risk, and we urge health care professionals to follow recall instructions issued by the firm.”

Patients who were administered any sterile drug products produced and distributed by Abrams and have concerns should contact their health care professional.

Adverse reactions experienced with the use of any Abrams products should be reported to FDA’s MedWatch Adverse Event Reporting program by:
• completing and submitting the report online at; or 
• downloading and completing the form, then submitting it via fax to 800-FDA-0178.

Monday, December 23, 2013

Preliminary Settlement Agreements Exceeding $100M in NECC Deadly Meningitis Outbreak Litigation Announced By Plaintiffs' Steering Committee

I'm one of the seven lawyers appointed by Judge Saylor in the tainted epidural steroid litigation, currently before the Court in Boston, Massachusetts.

There is news today that gives the victims of this tragedy some small measure of good news:

The Court-appointed Plaintiffs' Steering Committee (PSC), charged with speaking for hundreds of victims of tainted steroids produced by the New England Compounding Pharmacy, Inc. (NECC), today announced a preliminary settlement with the owners, operators and insurers of the bankrupt NECC.

A conditional agreement has been reached between bankruptcy trustee Paul D. Moore, the PSC and the Unsecured Creditors Committee under which the Cadden and Conigliaro families, the insurers of NECC and related company Ameridose, have promised to pay to a compensation fund an amount that may exceed $100 million. This fund will allow victims who received injections of tainted steroids made by NECC to seek a measure of justice against those wrongdoers.

The agreements are not final, require due diligence on the part of the PSC to ensure the rights to victims are protected under these agreements, and will be conditional upon approval by creditors and a federal court for fairness and adequacy.

Thomas M. Sobol, lead counsel for the PSC in the national litigation pending before a federal court in Boston, said, "The PSC has worked hard over the last several months to evaluate the liability of everyone involved in this tragedy and the tentative agreements are a big step forward in getting justice for victims. However, we must all be mindful that the agreements still require much work in order to protect the rights of victims. We also recognize that any amount of money would be grossly inadequate to compensate the families of those persons killed and others grievously injured by the callous conduct of those in charge of NECC."

Sobol said, "This is but one chapter in this saga; litigation will continue against medical clinics, doctors, hospitals and other companies who were hired by NECC that bear responsibility to those who were badly injured or who died horrible and painful deaths as a result of having the injection of the tainted product into their bodies. This case is not over until all the wrongdoers have been brought to justice."

"The proposed settlement does not resolve families' claims against the corporate-owned clinics that sold and injected these contaminated medications, such as St. Thomas Outpatient Neurosurgery Clinic in Nashville, Tenn., and other related St. Thomas companies. Numerous St. Thomas patients died or suffered serious illnesses as a result of receiving contaminated medications sold and administered at St. Thomas' Nashville facility," said PSC Member Gerard Stranch.

"These corporate-owned companies chose to put profits over patient safety, as detailed in the hundreds of lawsuits filed against these companies, including St. Thomas, by families whose loved ones died or suffered serious injuries," said PSC Member Mark Chalos, who also represents a number of affected families. "Any corporation that endangers our families by breaking patient safety rules should be held accountable for their conduct - no matter how rich or powerful those corporations are," said Chalos.

There is no deadline set for when details of the proposal will be made public.

The next court hearing in connection with this case is scheduled for January 10, 2014, at which point further due diligence will have been undertaken and additional details can likely be released. Full and complete information will be released to the public in due course and all victims who file a proof of claim in the Bankruptcy Court will have the opportunity to support or oppose the settlement.

Stay tuned

Monday, December 16, 2013

Red Bull Litigation

Quick reads this week: Lawyers on both sides of Red Bull Litigation:

FDA Scientists Find Amphetamine-Like Ingredient In 9 Diet Supplements… So Where’s The Warning?

An interesting read here:

Extracts of Acacia rigidula leaves are used in weight-loss products sold in vitamin shops and over the internet with little or no published data about their potential biological effects. In our chemical investigations on authenticated A. rigidula plant material, we established a rapid and sensitive LC–MS/MS method for the quantitative determination of several phenethylamine, tyramine and tryptamine derivatives. Stable isotopically labeled compounds were used as internal standards for quantitative analysis. We found total calculated contents of 6 biogenic amines in A. rigidula leaf of 18.6 and 32.9 μg/g. The content of selected amines in 21 dietary supplements labeled as containing A. rigidula was determined by a second LC–MS/MS method. Our study revealed significant differences in the amine profiles of authenticated plant materials and dietary supplements. β-Methylphenethylamine, a non-natural compound, was found in 9 of the 21 dietary supplement products. β-Methylphenethylamine was found at levels of 960–60,500 μg/g while phenethylamine was found at levels of 710–171,620 μg/g. β-Methylphenethylamine is a positional isomer of amphetamine and our results showed that it can be misidentified as amphetamine during LC–MS analysis. An independent GC–MS analysis was used to confirm the presence of β-methylphenethylamine and the absence of amphetamine in dietary supplements labeled as containing A. rigidula. This study demonstrates that confirmations by independent analytical methods are essential to verify findings of unusual or unexpected compounds in dietary supplements.

Ingredient spurs firm to recall two sports supplements

Physique Enhancing Science, also called PES, this week launched a recall of certain lots of Enhanced, a pre-workout supplement, and Alphamine, which is sold as a fat burner.
Both products contain aegeline, an ingredient flagged by the U.S. Food and Drug Administration during its investigation of an outbreak of dozens of liver injuries linked to a weight-loss supplement made by a different company: USPlabs' OxyElite Pro. 
Return of Alphamine and Enhanced products
     From PES: 
     If customers have unused or opened containers of these products, we request that you to return them to where it was purchased. A full refund will be provided for all returned product.
     These products contain “aegeline”, an unapproved New Dietary Ingredient according to the FDA. PES has received no serious adverse events from either of these products, but out of an abundance of caution we are requesting their return.
Alphamine Lot #’s (Distributed between 09/09/2013 – 11/12/2013)
Enhanced Lot #’s (Distributed between 2/4/13 – 11/5/13)
  •   • N09474   EXP: 08/2015
  •   • N08447-B   EXP: 08/2015
  •   • N08448   EXP: 08/2015
  •   • N08447-A   EXP: 08/2015
  •   • N07398   EXP: 07/2015
  •   • N07397   EXP: 07/2015
  •   • N04238   EXP: 04/2015
  •   • N01047   EXP: 03/2015
  •   • N01046   EXP: 03/2015
  •   • M11589   EXP: 02/2015
  •   • M11588   EXP: 02/2015
- See more at:

FDA Issues Warning on Recalled Medtronic Device

Regulators have determined that defects in some medical devices made by Medtronic Inc.have the potential to cause serious harm or death, according to statements issued by the company and the U.S. Food and Drug Administration Friday night.
The FDA's determination relates to a recall initiated by Medtronic last month of nearly 15,000 guidewires manufactured since April that are used in heart procedures. The FDA has now designated the action as a Class I recall, the most serious classification given to product recalls.

FDA: Idaho knew about mold in yogurt at Chobani factory before recall


A report by the FDA says the Idaho State Department of Agriculture detected abnormalities in yogurt at a Chobani facility two months before the company issued a recall, but state officials say that’s not true.

This stems from an issue earlier this year:

The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.
The potentially affected product was distributed nationwide from its Twin Falls, Idaho facility and was delivered to consumers through retail and club stores.
The products subject to recall are identified as follows:
Best By Date CodesIMS NumberChobani Branded ProductsUPC Codes
Sep 11 –13 (four digit time stamp)
Oct 07-13 (four digit time stamp)
16-012 (three digit line number)Chobani 6 oz. cups – all flavors
Chobani 16 oz. tubs – all flavors
Chobani 32 oz. tubs – all flavors
Chobani 3.5 oz. cups – all flavors
Chobani Bite™ 3.5 oz. cups – all flavors
Chobani Flip™ 5.3 oz. containers – all flavors
Chobani Champions® cups 3.5 oz. – all flavors
Chobani Champions® tubes 2.25 oz., 8, 16 and 36 count – all flavors
See attached list.
Consumers who have purchased the product should discard the product and may contact the company's Customer Loyalty Team at or call us at 877-847-6181 between the hours of 9am and 5pm ET. Our team is diligently working to coordinate replacements or refunds and will be in touch as soon as possible during this time of very high contact volumes.

The quality of Chobani products and the trust of its consumers are the company's primary concern, and it sincerely apologizes to its consumers impacted by this issue. Chobani holds itself to the highest standards and is committed to fully transparent and decisive action to rectify any identified issues.