Posts Tagged ‘FDA’

$4.69 BILLION VERDICT LINKING BABY POWDER, ASBESTOS & OVARIAN CANCER!

Thursday, July 12th, 2018

A jury has awarded $4.69 billion to 22 women and their families who alleged that decades of daily use of Johnson & Johnson’s asbestos-laden talcum powder products caused their ovarian cancer.  After six weeks of testimony, the twelve-person jury deliberated eight hours before returning the verdict. The jury award includes $550 million in compensatory damages and $4.14 billion in punitive damages against the company.

While there have been other trials in which juries have determined that talc products contained asbestos and caused mesothelioma cancer, this case marks the first talc/asbestos-induced ovarian cancer verdict in the United States. Jurors heard evidence that Johnson & Johnson’s Baby Powder and Shower to Shower products have been laced with asbestos for decades, in spite of the representations J&J made to the FDA and others. Medical experts testified that microscopic asbestos fibers enter the body when talcum powder is inhaled or applied to the genital area.  Asbestos fibers and talc particles were found in the ovarian tissues of many of the women.

“For over 40 years, Johnson & Johnson has covered up the evidence of asbestos in their products,” said Mark Lanier, lead trial counsel for the plaintiffs. “We hope this verdict will get the attention of the J&J board and that it will lead them to better inform the medical community and the public about the connection between asbestos, talc, and ovarian cancer. The company should pull talc from the market before causing further anguish, harm, and death from a terrible disease. J&J sells the same powders in a marvelously safe corn starch variety. If J&J insists on continuing to sell talc, they should mark it with a serious warning.”

BUYER BEWARE: ZYLAST TOPICAL ANTISEPTICS!

Wednesday, June 6th, 2018

photo: Shutterstock

The U.S. Food and Drug Administration on Wednesday filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.

“Despite being warned by the FDA about their unproven claims, this company has continued to market their products as a tool for preventing infection from serious disease-related pathogens, without adequate evidence to support these uses,” said FDA Commissioner Scott Gottlieb, M.D. “We’re concerned that people potentially exposed to pathogens may use these products with a false sense of safety. This may result in infrequent hand washing, or the substitution of these products for protective gloves and clothing or hand washing, which are the principal methods for protecting against the spread of diseases. Today’s action reflects the FDA’s continued efforts to take appropriate enforcement action against those who market products with inappropriate or unproven claims that could potentially put patients’ health at risk.”

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STEM CELL RESEARCH ON DIABETES-RELATED WOUNDS

Sunday, October 29th, 2017

The Food and Drug Administration recently approved a trial to use adipose-derived stem cells to treat non-healing leg ulcers, a common complication of diabetes, in a study conducted by researchers at Sanford Health.  “This clinical trial can help explore treatments for people with non-healing wounds, including people who have diabetes and others with conditions that affect their quality of life,” according to David Pearce, Ph.D., executive vice president of innovation and research at Sanford Health. According to the World Health Organization, in 2014 more than 422 million people have been living with diabetes globally.  The trials, which began in September, followed a similar study in which stem cells were tested for the treatment of shoulder injuries.

While the study has not yet been completed, the FDA’s support indicates growing interest in this arena.  According to Marissa Brassfield of Abundance 360, “this is a great example of how we can use exponential technology advances to tackle large-scale problems — like the 2 to 5 million people living with chronic wounds in the United States alone — which serves to fund a larger vision, refine the technical details, and explore adjacent applications.”