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Honda underreported potential defects to federal regulators, audit finds

Honda pilot

Honda Motor Company said Monday that an independent third-party audit of company records found it failed to report injury and death notices and claims to federal regulators more than half the time in the last 11 years. The National Highway Traffic Safety Administration (NHTSA) regards written notices submitted to automakers as “Early Warning Reports” that could help regulators detect defects and other safety trends, which could lead to recalls and possibly save lives. In 2003, Congress passed the Transportation Recall Enhancement, Accountability and Documentation (TREAD) Act, requiring motor vehicle manufacturers to provide federal regulators with Early Warning Reports and warranty or ... Read More

Trinity guardrails to be independently tested after federal jury sides with whistleblower

guard-rail - KCPQ-TV image

Federal highway regulators said they will re-test a certain guardrail system model manufactured by Trinity Highway Products LLC after the company lost a whistleblower lawsuit last month and was ordered to pay the U.S. $175 million. The new crash tests of Trinity’s ET-Plus guardrails will be conducted at an independent lab in San Antonio, Texas, in mid-January. The results are expected by the end of February. The results of the tests will determine whether the government will reimburse states that continue to use the Trinity guardrails, although the manufacturer suspended sales of the ET-Plus shortly after the verdict against it in ... Read More

Tennessee home health care company settles whistleblower allegations for $25 million


A Nashville, Tenn.-based home health care company and its affiliates have agreed to pay $25 million plus interest to settle whistleblower allegations that they violated the federal False Claims Act by submitting bills to Medicare and Medicaid that were wrongly coded and false in a scheme to boost profits. According to the U.S. Justice Department, CareAll Management LLC, one of Tennessee’s largest home health care providers, routinely overstated the severity of patients’ conditions to increase its billings. The company also billed Medicare and Medicaid for medically unnecessary services, often treating patients who were not homebound, federal prosecutors said. The alleged ... Read More

Medical device maker to pay U.S. $4.9 million in whistleblower kickback case


Biotronik Inc., an Oregon-based medical device manufacturer, has agreed to pay $4.9 million to resolve allegations made by a whistleblower under the False Claims Act that the company violated federal anti-kickback laws by paying physicians to use devices that it produced and sold. Former Biotronik employee, Brian Sant, filed a whistleblower lawsuit against the company under the qui tam or “whistleblower” provisions of the False Claims Act, which authorizes private individuals armed with evidence of fraud and other wrongdoing against federal agencies and programs to sue on behalf of the U.S. and share in any recovery. The U.S. Justice Department ... Read More

Whistleblower sues Shire Pharmaceuticals for wrongful termination


A former employee of Shire Pharmaceuticals is suing the drug company in a Pennsylvania federal court, alleging she was fired in retaliation for voicing concerns over Shire’s inappropriate, off-label marketing of Firazyr, a costly drug approved for the treatment of hereditary angioedema, a rare and potentially life-threatening immune disorder that causes swelling of the face, airway, and other parts of the body. Mary Catherin Barry, who worked in Shire’s accounting department from 2006 to 2014, monitored Medicare and Medicaid reimbursements of Firayr. She states in her lawsuit that she noticed a number of patients were using unusually high amounts of the ... Read More

GM defective ignition switch victim compensation fund has extended deadline for claim submissions

GM recall

The deadline to submit wrongful-death and personal-injury claims to a fund set up for victims of the General Motors (GM) defective ignition switches has been extended for an additional month. Attorney Kenneth Feinberg, the administrator of the special GM victim compensation fund, chose to extend the December 31 deadline to January 31 “out of an abundance of caution” to make sure everyone who may have been harmed by the ignition switch defect has a fair shot at filing a claim. The ignition switch fund began accepting claims on August 1, a few months after GM announced it was launching a ... Read More

Judges decide not to dismiss lawsuits against generic Reglan makers


A three-judge panel has found that failure-to-warn claims against makers of generic versions of the heartburn drug Reglan could move forward because the companies failed to update their warning labels when the brand name product’s label was changed to include new side effect warnings. The ruling affects a large number of the roughly 650 lawsuits consolidated in Middlesex County, where they were transferred from Atlantic County last month. The panel of judges wrestled with the 2011 ruling in Pliva v. Mensing that state tort claims against makers of generic drugs alleging inadequate warnings should be overridden by federal law, which ... Read More

Toyota recall affects 361,800 vehicles globally with variety of safety issues

toyota cars

With a Toyota recall of about 361,800 vehicles from around the globe due to the three different safety defects, 2014 continues to earn the title as the “Year of Recalls.” The largest recall of the three includes 170,000 Toyota Camrys. According to the recall announcement, the Camrys have a faulty ball joint that may result in a loss of vehicle control. The majority of the Camrys, approximately 120,000, are located in Europe. Another 40,000 are recalled in Japan. The second recall mostly affects Japan. The recall is of 105,800 Hiace, Regius Ace and Dyna vehicles, all of which were manufactured by Toyota. The vehicles ... Read More

Florida jury awards $26.7 million to four women injured by transvaginal mesh

bladder sling

A Florida federal jury determined that medical device maker Boston Scientific should pay $26.7 million to four women who claim they were injured by the company’s transvaginal mesh. The jury found Boston Scientific negligent in manufacturing the Pinnacle Pelvic Floor Repair Kit, a type of surgical mesh that is used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. Jurors found that the device was defective at the time of its sale because it didn’t meet reasonable expectations of its intended users, and that the benefits of the device were overshadowed by the risks, ... Read More

Wrongful death lawsuit filed against five talcum powder manufacturers

baby powder contains talc

Five manufacturers of talcum powder are being sued by the estate of Janice Chakalos, a longtime user of talc-containing products, claiming the products caused her to develop ovarian cancer, which took her life in 2012 at the age of 63. Johnson & Johnson, Sanofi, Imerys Talc, Valeant Pharmaceuticals and Chattem are named in the lawsuit. Chakalos allegedly used Johnson & Johnson’s Baby Powder and Shower to Shower, which was produced by Johnson & Johnson but recently sold to Valeant, and Gold Bond, which is made by Chattem. Chattem was acquired by Sanofi in 2010. Imerys mined the talc used in the ... Read More