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FDA panel to address injuries, deaths with Essure birth control device


Reported health problems – including at least four deaths – not listed on the safety label of the implantable permanent birth control Essure have prompted the Food and Drug Administration (FDA) to conduct an investigation into the safety of the devices. Essure is a nonsurgical permanent birth control implant shaped in a spiral that is inserted through the cervix and through the uterus into the fallopian tubes to block fertilization. Bayer Healthcare’s unit Conceptus Inc., received FDA approval to market the device in 2002. Since then, nearly 5,100 reports of complications have been associated with the device, including four deaths. ... Read More

U.S. government asks court to block immunity shield in Alegrity Whistleblower Case


The U.S. government motioned Friday to block a former security contractor’s bid to shield itself and its executives from liability in a whistleblower lawsuit accusing it of fraudulently overcharging the government and billing it tens of millions of dollars for work it never performed. Alegrity Inc., the bankrupt parent company of U.S. Investigations Services (USIS) which used to provide top-level security screenings for the government, plans to emerge from bankruptcy with all of its businesses except USIS intact. Alegrity is currently liquidating USIS amid a False Claims Act lawsuit that accuses the company of “flushing” or “dumping” unfinished security investigations ... Read More

Attorneys request consolidation of power morcellator lawsuits


Attorneys for six women suing Johnson & Johnson over injuries they claim to have suffered after undergoing gynecological procedures with the company’s power morcellator device have filed a request with the U.S. Judicial Panel on Multidistrict Litigation to consolidate with at least 22 similar lawsuits pending in 16 different federal district courts. The motion seeks to transfer the cases to U.S. District Judge Kathryn Vratil in Kansas. The request comes just weeks after the Wall Street Journal reported that Johnson & Johnson was being investigated by the Federal Bureau of Investigation (FBI) about how much the company knew about cancer ... Read More

Law firm takes on FDA over gynecomastia risks with Risperdal


A law firm is going head-to-head with the Food and Drug Administration (FDA) over documents the agency refused to make public about specific side effects in children taking the antipsychotic drug Risperdal. Sheller PC claims it was stifled in its efforts to advocate on behalf of children injured by Risperdal when it was barred from turning over to the FDA confidential documents it had obtained through discovery in litigation against the makers of the drug. The firm petitioned the FDA in November to change the safety labels on Risperdal and revoke its pediatric indication because of reports that the drug caused ... Read More

Oregon doctor faces sanctions for overprescribing testosterone treatments, opioids

Nebido injectable testosterone therapy

A Redmond, Ore., physician could lose her license and be fined thousand of dollars for a long list of violations including prescribing unnecessary and excessive testosterone treatments to a man who developed side effects. The Oregon Medical Review Board’s report claims Dr. Rose Kenny, a family practice physician at a Family Care Center was “grossly negligent” in her treatment of patients. In one case, she over prescribed narcotics to a truck driver who reported having six alcoholic drinks per day. She also prescribed excessive and contraindicated medication to treat diaper rash, and doled out several months of antibiotics to pediatric ... Read More

Attorneys request moving hundreds of transvaginal mesh lawsuits to PA

transvaginal mesh

Plaintiffs in more than 500 lawsuits spread across two separate multidistrict litigations alleging defectively designed transvaginal mesh made by Bard Inc. and Ethicon Inc. caused serious injuries have requested their cases be moved out of West Virginia and into Pennsylvania federal court so that their claims could be dealt with faster. More than 70,000 lawsuits in seven separate multidistrict litigations alleging injuries with transvaginal mesh from various manufacturers are pending in West Virginia. At least 23,000 of those are waged against Johnson & Johnson’s Ethicon, and another 10,000 have been filed against Bard. This week, U.S. District Judge Joseph Goodwin, ... Read More

The Fraud List: Boston Scientific puts profits above patients

The Fraud List

Healthcare fraud is one of the most egregious forms of corporate misconduct, often manifest in schemes that that prey upon tax-payer funded insurance programs for the nation’s elderly, poor, and veterans while putting those patients at risk with drugs used for unapproved purposes, unnecessary treatments, defective medical devices, and medical decisions made more the interest of profit than patient care. The Boston Scientific Corporation (Boston Scientific), a global developer of medical devices that are used in a spectrum of surgeries and procedures, is one of the healthcare industry giants that has been implicated repeatedly in fraud schemes designed to boost profits on ... Read More

Investor files potential class-action against guardrail maker Trinity

guard-rail - KCPQ-TV image

A lawsuit filed Friday by an investor against guardrail manufacturer Trinity Industries seeks to represent other investors whose stakes in the company plummeted in value after a federal jury found it had defrauded the U.S. government by secretly modifying its already-approved guardrail systems. The case, filed in federal court in Dallas on behalf of Trinity investor Richard Isolde, alleges that the company made false statements in 2012 and 2013 in an effort to conceal the risks posed by its ET-Plus guardrail systems. Trinity shares were at a five-year high last September, closing at more than $50 mid-month. But company shares have ... Read More

District judge consolidates 26 transvaginal mesh lawsuits against Ethicon

transvaginal mesh

Twenty-six lawsuits in a massive multidistrict against Johnson & Johnson unit Ethicon, Inc., alleging the company sold defectively designed transvaginal mesh resulting in serious injuries will be consolidated and go to trial, a West Virginia federal judge ruled. The lawsuits are among about 23,000 filed against Ethicon over transvaginal mesh that will likely go to trial in November. The 26 all involve West Virginia plaintiffs who underwent procedures in the state to have Ethicon’s mesh implanted for the treatment of pelvic organ prolapse or stress urinary incontinence. Thus, all 26 lawsuits are subject to the state’s relevant laws. After the ... Read More

243 Professionals Charged in Record Medicare Fraud Crackdown

Pills - Stethoscope on Money

A nationwide sweep by the federal government’s Medicare Fraud Strike Force resulted in criminal charges against 243 individuals, including 46 doctors, nurses, and other health care professionals for their suspected participation in a multitude of Medicare and Medicaid fraud schemes that cost U.S. taxpayers $712 million, the Department of Health and Human Services (HHS) announced Thursday. U.S. Attorney General Loretta Lynch said the sweep, which encompassed 17 metropolitan areas throughout the U.S., was the “largest criminal health care fraud takedown in the history of the Department of Justice,” both in the number of individuals charged and the amount of federal ... Read More