Friday, November 30, 2012

November 30, 2012 Meningitis Recall News Update

The Framingham pharmacy linked to the fungal meningitis outbreak blamed for the deaths of dozens of pain sufferers has been told by a federal judge not to tamper with or attempt to destroy anything within the company’s walls — or even stored on personal cellphones and home computers.

My office is lead counsel on the Green v. NECC case, and there were hearings held in that case this past week. We sought for preservation of evidence and asked for permission to inspect the facilities where the recalled products were compounded. 

U.S. District Court Judge F. Dennis Saylor IV today told lawyers for  New England Compounding Center and its sister operation Ameridose he intends to issue an evidence-preservation order on behalf of 12 civil suits pending against one or both of the pharmacies in Boston’s federal court alone.

At a hearing this, Saylor also temporarily consolidated the 12 lawsuits for the convenience of pre-trial discovery and proceedings. Saylor is juggling just a handful of the 70 cases that have been filed federally against NECC and Ameridose nationwide, and which he noted may all be brought under one umbrella here or in another district early next year.

Wednesday, November 28, 2012

FDA Issues Warning Letter to Mushroom Supplements Company

Here's the warning letter to this company:

The products are labeled for conditions that cause them to be drugs. Also the dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation. Although the firm sent out samples of finished product lots to outside laboratories for testing, the laboratories only tested for heavy metals (mercury, lead, arsenic, and cadmium) and food chemistry (ash, total calories, total carbohydrates, fat, moisture, and protein); instead of conducting assay tests to determine that the components were consistent with your firm’s established specifications, etc. (Amyloban 3399 From Lion’s Mane, Grifron Maitake, and Super Shiitake); FDCA 505(a), 21 CFR 111.75, 111.560(a)(2), 111.325(b)(1), 111.535(b)(2), 111.160(d)(1), 111.160(c)(3), 111.35(b)(4).

Warnings of suffocation risk from infant sleep positioners

A new report however from the Centers for Disease Control and Prevention finds the products have caused 13 suffocation deaths in young infants since 1997.  Unintentional suffocation is the leading cause of injury death for U.S. children younger than 1-year-old, according to the CDC.

For the CDC's report, researchers reviewed information collected by the U.S. Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC) between 1997 and 2011 on the natures of deaths associated with infant sleep positioners. The devices aim to keep a baby in a specific position while sleeping.

Read more here

Thursday, November 15, 2012

US regulators report possible link between 5 Hour Energy & deaths

 The U.S. Food and Drug Administration confirmed on Wednesday the receipt of reports that another caffeine drink, 5-hour Energy, may have been involved in a number of deaths - in this case 13 over the past four years.

The reports were first detailed by the New York Times on Wednesday.

The news follows the FDA's disclosure last month that it was investigating reports of five deaths that may be related to Monster Beverage's namesake drinks.

The highly caffeinated beverages are the fastest-growing type of soft drink in the United States, with sales increasing 17 percent last year to about $9 billion, according to Beverage Digest.

FDA spokeswoman Shelly Burgess said that 5-hour Energy, sold by Living Essentials, has been mentioned in some 90 FDA filings since 2009, including more than 30 that involved serious or life-threatening events likeheart attacks, convulsions, and in one case, a spontaneous abortion, the New York Times reported.

The Times said another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone.

But Elaine Lutz, spokeswoman for Living Essentials, the company that distributes 5-hour Energy, said in a statement that the product "is not an energy drink" (the so-called shot comes in a bottle that holds less than 2 ounces).,0,4904784.story
"Living Essentials," the statement went on, "takes reports of any potential adverse event tied to our products very seriously. We fully comply with all of our reporting requirements." The company was "unaware of any deaths proven to have been caused by the consumption of 5-hour Energy."

Sunday, November 11, 2012

Nesquik Recall

Nestlé USA announced the voluntary recall of limited quantities of Nestlé NESQUIK® Chocolate Powder in the 10.9, 21.8 and 40.7 ounce canisters. The voluntary recall is limited to only NESQUIK Chocolate Powder, which was distributed nationally. No other varieties of NESQUIK powder or any sizes or flavors of NESQUIK ready-to-drink are affected by this recall.
Nestlé is removing the canisters from distribution because the company was notified by an ingredient supplier, Omya Inc. that it has issued a recall of certain lots of its ingredient, calcium carbonate due to possible presence of Salmonella. Calcium carbonate is used in NESQUIK as an ingredient. There have been no reports of any illnesses or adverse health effects associated with the affected product.
To ensure the safety of consumers, Nestlé is recalling selected NESQUIK Chocolate Powder. The recall is limited to the following sizes, UPC and production codes of NESQUIK Chocolate Powder:
SizeUPC CodeProduction Codes
40.7 oz. Chocolate (72 servings)0 28000 68230 92282574810
21.8 oz. Chocolate (38 servings)0 28000 68090 92278574810
10.9 oz. Chocolate (19 servings)0 28000 67990 32278574810
The affected NESQUIK Chocolate Powder was produced during early October, 2012. To locate the production code, consumers should look on the bottom of the canister, adjacent to the consumer expiration date. All affected products have an expiration date of BEST BEFORE Oct 2014.
Consumers who may have purchased the affected NESQUIK Chocolate Powder should not consume it, but instead should return it to the place of purchase for a full refund or contact Nestlé Consumer Services at (800) 628-7679.
The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating or drinking contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.