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claims 1821 articles

Whistleblower Lawsuit Alleges West Virginia Internet Provider Squandered U.S. Stimulus Funds

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Allegations of gross misuse of federal stimulus grants for private profit are the basis of a whistleblower lawsuit filed by one West Virginia internet provider against another under the federal False Claims Act. Bridgeport, W. Va.-based provider Citynet is suing Frontier Communications, accusing the defendant of misusing $40.5 million it received in federal stimulus funds. Rather than building an open, high-speed broadband network for more than a thousand public facilities as it was supposed to do under the term of the grant, Frontier instead built a closed network connecting the public buildings to its existing fiber utility poles, Citynet claims. ... Read More

FDA sends warning letter to dietary supplement maker regarding erroneous claims

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The Food and Drug Administration (FDA) has issued a warning letter to a dietary supplement manufacturer Mc-Cor, LLC, because its promotion of “ClucoCoR” capsules makes claims to treat type 1 and 2 diabetes and other conditions, a clear violation of the Federal Food, Drug and Cosmetic Act. The product was sold on the company’s website www.metacorlic.com/en, touting claims such as: “Promote healthy glucose levels” “Promote… tissue repair” “GlucoCor is a Metabolic Corrector” “Helps maintain adequate levels of blood sugar” “Attends the biochemical origin of the disease” “Treatment for Diabetes 1 and 2 diabetes GlucoCor” “Metabolic Correction for Diabetes Type 2 ... Read More

Metal-on-Metal Hip Implant Linked to Heart Failure Risk in Men

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Men who received a large-head metal-on-metal hip implant had nearly double the risk of heart failure than men who received a metal-on-polyethylene, said Stephen Graves, M.D., at the American Academy of Orthopaedic Surgeons Annual Meeting. According to a study led by Dr. Graves, 2,115 men had total hip arthroplasties between January 2003 – December 2012. Of those men, 2,028 received metal-on-polyethylene and 87 received the ASR XL, the DePuy Synthes Joint Reconstruction. The ASR XL recipients had “significant increased risk” of heart failure – one in 10, to be exact. The study strongly suggests that the men who have received the ASR XL should have “close ... Read More

California federal court selected for Viagra MDL

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Lawsuits making similar claims that Pfizer has continued to aggressively market and advertise Viagra without warning consumers of its melanoma risk were consolidated this past spring. Researchers in Germany, Sweden and the United States have all published studies finding that sildenafil, the active ingredient in Viagra, increases melanoma risk. The U.S. study, published in 2014, found men taking Viagra were 84 percent more likely to be diagnosed with melanoma, but not other forms of skin cancer. Biochemists in Germany this year showed how exactly how sildenafil opens up metabolic pathways that cause melanoma to grow more rapidly. According to AL.com, ... Read More

FDA sends warning letters to dietary supplement makers

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A dozen companies received warning letters from the Food and Drug Administration (FDA) for selling dietary supplements promoted to treat diseases, posing a risk to public health. “The products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” said Deborah Autor, the FDA’s director of drug compliance. People swayed by these promotions could waste time taking them and delay seeking medical treatment, which could be detrimental to their health. Warning letters were sent to companies with names such as Medavir, Herpaflor and C-Cure, none of which the ... Read More

Health care professionals encouraged to report problems with defective blood monitors

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The Food and Drug Administration (FDA) is encouraging health care providers to report any errors or resulting adverse effects with blood monitors Alere INRatio and INRatio2 prothrombin time/international normalized ratio (PT/INR) because the monitors give inaccurate results. The monitoring system is used to measure the effectiveness of some blood thinning medications. The company recently announced it was recalling the devices due to the errors, which had been plaguing the company for years. In December 2014, Alere alerted its users of an “urgent correction” with the INRatio and INRatio monitors that detailed certain medical conditions that should not be tested using the ... Read More

Honda Class Action Claims Rabbits, Rodents Have Appetite For Soy-Based Wiring

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A federal class action lawsuit representing vehicle owners in three states claims soy-based electrical wire coatings have caused rats, mice, rabbits, and squirrels to munch on Honda engines like snacks, causing severe and costly damage. Lead plaintiff Daniel Dobbs, a Wyoming resident, and owners of Honda vehicles in Texas and Arizona sued Honda earlier this year for breach of warranty, alleging the biodegradable, food-based wire coatings Honda used in 2012-2015 model-year vehicles are defective in their design. The plaintiffs say Honda refuses to cover the repairs. Another plaintiff, Arizona resident Greg Delaney, took his ’14 Honda CrossTour to have wires ... Read More

The FDA puts Regulations on E-Cigarettes, Hookahs and Other Types of Electronic Nicotine Delivery Systems (ENDS)

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E-cigarettes, a form of Electronic Nicotine Delivery System (ENDS), are now regulated by the Food and Drug Administration (FDA). The FDA has classified e-cigarettes, hookahs and other ENDS products as now subjected to regulation, like other tobacco products, regarding their manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution. Manufacturers of e-cigarettes are required to immediately submit an application and obtain authorization for marketing their product. The FDA requires a listing of ingredients, as well as information about harmful and potentially harmful constituents (HPHCs). E-cigarettes and their liquids also now must have a warning statement on packaging and advertisements. The FDA was pushed toward regulation based on ... Read More

Hospice Provider Pays U.S. $18 Million To Settle False Claims Act Allegations

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A Minnesota-based hospice care provider has agreed to pay the U.S. $18 million to settle allegations that it violated the False Claims Act by billing Medicare for end-of-life care to patients who were not eligible to receive Hospice care because they weren’t terminally ill. According to the U.S. Department of Justice (DOJ), a group of former employees of Evercare Hospice, now known as Optum Palliative and Hospice Care (Palliative), sued the company under the whistleblower provisions of the False Claims Act, alleging it knowingly billed Medicare for hospice care that patients didn’t need. When a terminally ill Medicare patient enters ... Read More

Dietary supplement maker fights claims its weight loss product is unsafe

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Dietary supplement marker USPlabs LLC is seeking to fight claims made by the U.S. Department of Justice (DOJ) that weight loss product OxyElite Pro is dangerous to consumers by introducing experts to testify that the product was safe under the conditions of recommended use listed on its label. The judge overseeing the case will decide whether to hold a hearing to determine whether experts can testify on behalf of the defense regarding the safey of OxyElite Pro when the case goes to trial. The indictment unsealed last November alleges USPlabs made hundreds of millions of dollars through a criminal conspiracy ... Read More