Consumer Lawyers

Archive for November, 2011|Monthly archive page

FDA sues dietary supplement maker ATF Fitness

In Uncategorized on November 29, 2011 at 5:16 pm

From ageorgialawyer.blogspot.com

 

The FDA has sued a dietary supplement manufacturer, ATF Fitness Products and Manufacturing ATF Dedicated Excellence (MADE), for non-compliance with the Federal Food, Drug, and Cosmetic Act.
The company has been charged with, by the US Department of Justice, adulteration and mislabeling of its products, besides violation of current Good Manufacturing Practice (cGMP) regulations.

ATF buys dietary supplements including vitamins and minerals from MADE which markets them across the US under the brands Sci-Fit, Nature’s Science and For Store Only.

Source:  http://otc.pharmaceutical-business-review.com/news/fda-sues-dietary-supplement-maker-for-violating-laws-281111

 

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Ocean Spray Original Flavor Craisins Recalled, Hair-like Metal Fragments Found

In Uncategorized on November 28, 2011 at 8:00 pm

Small hair-like fragments were found in certain lots of Original Flavor Craisins Dried cranberries, triggering a voluntary recall, the FDA (Food and Drug Administration) and Ocean Spray Cranberries Inc. have announced. The affected produce comes in 5-ounce, 10-ounce and 48-ounce packages. The company emphasized that the hair-like metal fragments are extremely unlikely to cause any harm or injury to consumers, it added that this current recall is a precautionary measure.

Craisins are fresh cranberries that have been partially dehydrated, a process similar to making raisins from grapes. Craisins are popular for making salads, added to bread, cereals, or simply eaten on their own. The word craisin is a registered trademark of Ocean Spray Cranberries Inc. Other manufacturers who make partially dried cranberries are not allowed to use the term “craisins” for their products.

The FDA and the makers of craisins say they have received no reports of consumer complaints.

Ocean Spray Craisins brand dried cranberries

Image via Wikipedia

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Four Star Import & Distribution Inc. Issues An Alert On Uneviscerated Fish

In Uncategorized on November 24, 2011 at 1:28 pm

-Four Star Import & Distribution Inc, 1075 Flushing Avenue, Brooklyn, New York, 11237 is recalling Noya Brand Boyal Dry Fish discovered by New York State Department of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of the product by New York State Food Laboratory personnel confirming that the product was not properly eviscerated prior to processing.

This product may be contaminated with Clostridium botulinum spores, which can cause botulism, a serious and potentially fatal food–borne illness.

The sale of this type of fish is prohibited under New York State Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning; symptoms of botulism include blurred or double vision, general weakness, poor reflexes, difficulty swallowing and respiratory paralysis.

The recalled Noya Brand Boyal Dry Fish comes in 200 gram plastic bags coded Best Before Dec. 2012 and is a product of Bangladesh.  Noya Brand Boyal Dry Fish was sold nationwide.

No illnesses have been reported to date in connection with this problem.

Ready Pac Foods, Inc. Announces Voluntary Product Recall Because Of Possible Health Risk

In Uncategorized on November 20, 2011 at 10:36 pm

Ready Pac Foods, Inc. of Irwindale, CA is recalling a total of 5,379 cases of  bagged salad products containing Romaine lettuce, as listed below, with the Use-by Date of November 18, 2011 because they may be contaminated with E. coli (E.coli O157:H7).   E.coli O157:H7 is an organism that may cause diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

The recall extends only to the listed products with this Use-by Date and sold in the following states: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nebraska, Nevada, New Mexico, Oregon, South Dakota, Texas, Washington, and Wyoming.  No other Ready Pac Foods, Inc. products are included in the recall.

PRODUCT DESCRIPTION UPC # BEST IF USED BY
10oz. Ready Pac Caesar Romaine 0-77745-00202-6 NOV 18
9.25oz Ready Pac Santa Fe Caesar Complete Salad 0-77745-21404-7 NOV 18
10oz. Ready Pac Classic Caesar Complete Salad 0-77745-20566-3 NOV 18
10oz. Ready Pac Bella Romaine 0-77745-21407-8 NOV 18
10oz. Dining In Classic Caesar Salad Kit 0-11225-02530-3 NOV 18
10oz. Raley’s Caesar Romaine 0-46567-71642-8 NOV 18
10oz. Trader Joe’s Romaine Salad 0013-2145 NOV 18
16oz. Trader Joe’s Very American Salad 0020-7225 NOV 18
10oz. Safeway Farms Caesar Romaine 0-21130-98350-6 NOV 18
9oz. Safeway Farms Hearts of Romaine 0-21130-98358-2 NOV 18
10oz. Safeway Farms Complete Caesar Supreme 0-21130-33677-7 NOV 18
10.25oz Safeway Farms Complete Southwestern Ranch 0-21130-33679-1 NOV 18

 

No illnesses related to these products have been reported.

The voluntary recall was initiated based on a single positive random sample result for E.coli O157:H7 reported to Ready Pac by the FDA. Ready Pac is fully cooperating with the FDA on the recall.

Because it is still possible that products bearing the Use-by Date of November 18, 2011 could be on store shelves, this recall extends to retailers as well as consumers. Ready Pac believes that it is important to alert consumers and retailers who might still possess one of the potentially affected salads to dispose of it immediately.

Additional Trial Dates For Fosamax Lawsuits Scheduled For February 2012

In Uncategorized on November 19, 2011 at 11:49 pm

Carol E. Higbee, who is overseeing the consolidated Fosamax lawsuits, In re: Fosamax Litigation (No. 282 NJ. Super. Ct.)) pending in the Superior Court of New Jersey, Atlantic County, issued a Case Management Order regarding four Fosamax lawsuits.* Because Fosamax side effects include femur fractures and osteonecrosis of the jaw, both types of lawsuits have been consolidated into one mass tort action. On November 1, 2011, Judge Higbee ordered that the group of Fosamax lawsuits alleging that Fosamax caused plaintiffs to develop osteonecrosis of the jaw will proceed to trial on February 27, 2012. In issuing the Case Management Order, Judge Higbee outlined detailed deadlines that both plaintiffs and Merck, the defendant in the Fosamax litigation, must adhere to in anticipation of the February 2012 trial date. Although the Fosamax femur fracture lawsuits have been consolidated with lawsuits alleging that Fosamax caused osteonecrosis of the jaw, none of the femur fracture lawsuits have gone to trial yet. Judge Higbee is trying the osteonecrosis of the jaw cases first; trials for the Fosamax femur fracture lawsuits will follow. Because Merck, the manufacturer of Fosamax, is defending both groups of cases, there is overlapping discovery. For example, many documents produced by Merck will be used by plaintiffs in both types of lawsuits. Therefore, the lawyers at Bernstein Liebhard LLP have been carefully monitoring developments in both litigations.

Deadlines Established In The Fosamax Litigation Case Management Order

According to the order, plaintiff and defendant expert reports are due by November 4, 2011 and December 5, 2011, respectively. These reports contain the opinions of expert witnesses chosen by both plaintiffs and defendants in order to support their respective claims. Typically, expert reports state facts and provide detailed explanations in order to justify the experts’ conclusions and opinions. Experts for both sides are then deposed by opposing counsel. According to the order, these depositions as well as all expert discovery must be completed by January 9, 2012. In addition to expert discovery, the order outlined deadlines for various motions the parties are entitled to make before trial begins. These pretrial motions are expected to be argued in early February. If all progresses as planned in the current scheduling order, on February 27, 2012, these four Fosamax lawsuits will proceed to trial.

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/11/07/prweb8945227.DTL#ixzz1eBd07rZA

Actos and a Bladder Cancer Risk?

In Uncategorized on November 19, 2011 at 11:40 pm

Our office is investigating the link between Actos and Bladder Cancer, 404-451-7781.

Recent Studies by the FDA has  linked the diabetes medication Actos, which contains pioglitazone, to an increased risk of bladder cancer compared to other anti-diabetesdrugs. Actos is prescribed, along with diet and exercise, to control Type 2 Diabetes.

Between January 2010 and October 2010, approximately 2.3 million patients filled a prescription for Actos, which is manufactured in San Diego, California by Takeda Pharmaceuticals North America, at outpatient pharmacies across America.

In September of 2010, following a five-year review and analysis of patient data, the FDA reported that while there was no major increased risk of bladder cancer with pioglitazone use, the agency did note an increased risk of bladder cancer among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dosage.

 

http://www.usrecallnews.com/2011/11/actos-bladder-cancer.html

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Georgia November 2011: Should Transvaginal Mesh Devices Be Recalled?

In Uncategorized on November 19, 2011 at 8:30 pm

Call us at 404-451-7781 or email us to discuss your legal rights.

 

An FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.

According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:

  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation

Less frequent problems included

  • Return of POP
  • Neuro-muscular problems
  • Vaginal scarring/shrinkage
  • Emotional problemsMore than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:
    • C.R. Bard
    • Johnson & Johnson’s Ethicon
    • American Medical Systems

    Complications have been reported for several other manufacturers of surgical mesh as well including:

    • Boston Scientific Scimmed
    • Sofradim
    • Caldera
    • Mentor Corporation

    What Should You Do?

    If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

 

Kimberly-Clark Recalls Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency

In Uncategorized on November 19, 2011 at 8:14 pm

Kimberly-Clark announced a product recall of a limited number of its Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency distributed to specific stores in the United States.

This recall is limited to two product SKUs (carton codes), 15063 (18 count) and 15068 (36 count). The tampons were manufactured with a raw material contaminated with a bacterium, Enterobacter sakazakii, which may cause health risks, including vaginal infections, urinary tract infections (UTIs), pelvic inflammatory disease or infections that can be life-threatening.  Women with serious existing illnesses, cancer or immune-compromised conditions, such as HIV, are at increased risk.  There is limited evidence of transfer between individuals with this bacterium.

The impacted product includes both 18-count and 36-count packages of the Kotex Natural Balance* Security ® Unscented Tampons Regular Absorbency that were shipped to retail customers between October 29, 2011 and November 2, 2011 in specific Walmart stores in Iowa, Kansas, Missouri, Nebraska, New Mexico and Texas; specific Fry’s stores in Arizona; and specific Smith’s stores in Utah and Arizona.  More information about the specific product SKUs and lot numbers are noted below.  Not all stores in the above mentioned states were impacted. All impacted stores have been alerted to remove the recalled product SKUs from shelves. A listing of stores impacted and the latest information can also be found on the Kimberly-Clark website at www.kimberly-clark.com  and the Kotex brand website atwww.kotex.com.

Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency Affected Lot Numbers:

Product SKU numbers 15063 and 15068 are the last five digits of the product’s barcode and can be found on the bottom of the package. Specific lot numbers can be found inside the red box located on the bottom of the package.

Kimberly-Clark Kotex Natural Balance* Security® Regular Uncented Tampons
Carton Lot Number Cartoon Count SKU
AC129321X 18 Count 15063
AC129325X 36 Count 15068
AC129321X 18 Count 15063
AC129325X 36 Count 15068
AC129321X 18 Count 15063
AC129325X 36 Count 15068
AC129321X 18 Count 15063
AC129325X 36Count 15068
AC129321X 18 Count 15063
AC129325X 36 Count 15068
AC129321X 18 Count 15063
AC129325X 36 Count 15068
AC129321X 18 Count 15063
AC129325X 36 Count 15068

Photographs of the recalled packages are included.

Consumers should contact a physician immediately if they have used the impacted Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency product and experience unusual vaginal discharge, rash, fever, headache, vomiting or abdominal pains, particularly if they are HIV positive, have AIDS, cancer, an existing serious illness or may be pregnant.

If any consumer has the impacted Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency in their possession, they should stop using the product immediately.  They should also contact Kimberly-Clark’s Consumer Services Division at 1-800-335-6839 so the necessary information and arrangements can be made to retrieve the unused product.

While no reports of any adverse reactions from consumers using the recalled product have been received by Kimberly-Clark to date, this product recall is to maintain Kimberly-Clark’s expected high level of quality in all its products.

No other Kotex-branded products are subject to this recall, and Kotex Natural Balance* Security® Tampons that don’t contain the SKU numbers or lot numbers described in this announcement should be considered safe to use by consumers.

 

Hallmark Sued for House Fire Linked to Snow Globe

In Uncategorized on November 19, 2011 at 8:06 pm

An insurance company has filed a lawsuit seeking $1.8 million from Hallmark Cards and another company over a defective snow globe blamed for a fire that destroyed a home in northern Michigan.

The Jumbo Snowman snow globe was recalled in December 2008, weeks after a fire destroyed the Petoskey home of Stephen and Florence Hajek, who own two card stores. Federal regulators at the time said the globe could act as a magnifying glass in the sun and cause a fire.

Auto-Owners Insurance paid $1.8 million after the Hajek home was destroyed. Snow globes and other store inventory were at their home.

The lawsuit, filed Nov. 2 in federal court in Grand Rapids, accuses Hallmark and a Taiwan company of negligence and product liability. It claims “inappropriate materials in the shell and interior fluid” of the globe caused an unsafe medium for sunlight to pass through.

Read more: http://www.foxnews.com/us/2011/11/16/hallmark-sued-for-house-fire-linked-to-snow-globe/#ixzz1eAihqbbn

Hallmark logo

Image via Wikipedia

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Dutailier Group Recalls Drop-Side Cribs Due to Entrapment and Fall Hazards

In Uncategorized on November 19, 2011 at 8:04 pm

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Drop-side cribs

Units: About 440 cribs

ImporterDutailier Group Inc., of Quebec, Canada

Hazard: The slats on the drop side can detach from the top and bottom rails creating a space between the slats. An infant or toddler’s body can become entrapped in the space, which can lead to strangulation and/or suffocation. A child can also fall out of the crib.

Incidents/Injuries: The firm is aware of 16 reports in which the slats on the drop side became detached from the top or bottom of the drop side rails of a crib. No injuries have been reported.

Description: This recall involves full-size, drop-side wooden cribs with part numbers that begin with E1230C2, E3500C2, E3540C2, E5100C2, E5140C2, E5530C2, E9000C2 and E9100C2. The Dutailier logo and the part number can be found on labels on the inside of the end panels.

Sold at: Children’s products stores and other baby specialty stores from January 2009 through February 2010 for between $425 and $775.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled cribs and contact Dutailier Group to receive a free repair kit which consists of a new fixed side to replace the drop-side of the crib. In the meantime, parents are urged to find an alternate, safe sleeping environment for the child, such as a bassinet, play yard or toddler bed depending on the child’s age.

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