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claims 1826 articles

Johnson & Johnson’s Acclarent Settles Whistleblower Lawsuit With U.S. for $18 Million

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Johnson & Johnson’s California-based medical device manufacturer Acclarent will pay the U.S. government $18 million plus interest to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing its Stratus sinus spacer devices without U.S. Food and Drug Administration (FDA) approval. “The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “We will not permit companies ... Read More

Company Contracted To Train Iraqi Police Committed Fraud, U.S. Alleges in False Claims Act Suit

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The U.S. government has announced it has filed a False Claims Act lawsuit against DynCorp International, a firm contracted by the State Department to train police in Iraq. The government’s complaint alleges DynCorp knowingly allowed one of its main subcontractors to inflate the cost of a multitude of services billed to the government. The State Department’s Bureau for International Narcotics and Law Enforcement Affairs contracted DynCorp, a subsidiary of Delta Tucker Holdings Inc., in April 2004 to provide training for civilian police forces in Iraq as well as other services needed in support of the police training operations. The U.S. ... Read More

Motion filed asking for consolidation of talc suits into new MDL

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Reuters reports that on July 15 a plaintiff’s firm filed a motion asking the U.S. Judicial Panel on Multidistrict Litigation to consolidate lawsuits filed against Johnson and Johnson creating a new multidistrict litigation (MDL) for talc-powder claims. These suits all share the common allegation that the company knew of the research linking talc to ovarian cancer when used for feminine hygiene, but Johnson and Johnson failed to warn women of this risk. “The lawsuits accuse J&J of concealing a link between talc use for feminine hygiene and an increased risk of ovarian cancer, and failing to warn consumers about the ... Read More

Ship Captain Awarded $1.1 Million In Whistleblower Retaliation Case

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The captain of a cargo ship who alleged he was fired for reporting safety violations to the U.S. Coast Guard has been awarded more than $1 million in back pay, damages, and other compensation by a U.S. Labor Department administrative law judge. The award is the largest damages award ever under the whistleblower provisions of the federal Seaman’s Protection Act (SPA). According to the Connecticut Law Tribune, John Loftus, Captain of the 813-foot-long container ship Horizon Trader, filed a complaint with the U.S. Labor Department claiming he was unlawfully terminated for reporting ship malfunctions that went unfixed and other safety ... Read More

Advice for those who are taking herbs and supplements as a safer alternative to Viagra

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Several recent studies have found that sildenafil, the active ingredient in Viagra, encourages melanoma growth. As a result, many men are searching for other, safer, more natural cures for erectile dysfunction. “Herbs and supplements for erectile dysfunction are common in China and Africa,” reports Health Aim in an article called “Erectile Dysfunction Cure: See What Herbal Supplements Are Safe, Risky or Harmful.” There are a growing number of these kinds of products available to men in America, but manufacturers are not required to prove their safety and effectiveness prior to making marketing claims and selling these products, so it’s challenging for ... Read More

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