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lawsuit 2050 articles

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

FDA adds strongest warning to power morcellators for hysterectomies, myomectomies

morcellator

The Food and Drug Administration (FDA) has slapped its most serious warning possible on a surgical tool used to perform hysterectomies and remove uterine fibroids because the devices can spread undetected cancer throughout the abdomen and worsen long-term survival. The warning was applied to laparoscopic power morcellators, surgical tools that are used to grind away uterine growths or entire uteruses inside the body and remove the bits through small incisions in the abdomen. Morcellation is often preferred for hysterectomies or myomectomies (removal of uterine fibroids) over open surgery because it is less invasive, offers less recovery time, and is less scarring. ... Read More

Complications with transvaginal mesh can occur years after implantation

bladder sling

Women who have undergone transvaginal mesh procedures to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) can experience complications from the defective devices years after implantation. Pelvic organ prolapse is a common condition in women in which muscles and ligaments supporting pelvic organs weaken, which can allow organs such as the bladder, uterus, rectum, and small bowel to slip out of place, or prolapse, into the vagina. It can cause discomfort, painful intercourse, and incontinence. Since 2004, polypropylene mesh kits have been used to lift prolapsed organs back into the correct anatomical position. Stress urinary incontinence is the ... 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

Walmart truck crash left Tracy Morgan with traumatic brain injury

Tracy Morgan limo bus - KYW, CNN photo

Actor-Comedian Tracy Morgan sustained a severe traumatic brain injury (TBI) when a Walmart truck crashed into the back of his limousine van in New Jersey June 7, his lawyer told NJ.com. The crash that critically injured Mr. Morgan and his other companions and killed his friend James McNair has generated much publicity, including speculation as to whether Mr. Morgan, who starred on Saturday Night Live and 30 Rock, among other shows, would ever return to his busy career in acting and stand-up after the debilitating crash. Previously it had been reported that Mr. Morgan’s critical injuries included a broken nose, ... Read More

Patients taking experimental cholesterol-lowering drug reported fewer side effects

lipitor

An experimental cholesterol-lowering drug from a new class of medications focused on taking a bite out of the billion-dollar statin market has outperformed Zetia, the most widely used alternative to statins on the market, according to a clinical trial presented at the American Heart Association annual meeting. Alirocumab drove down LDL, or bad, cholesterol levels in study participants by 45 percent, compared to just 14.6 percent in patients who were treated with Zetia. The main drawback is that alirocumab is administered by injection once every two weeks, while Zetia and statins are take by mouth in the form of a pill. ... Read More

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

whistleblower

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

whistleblower

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

Researchers warn energy drinks are dangerous to children

redbull

Energy drinks such as Red Bull, Monster and 5-Hour Energy are not safe for children because kids 6 years old and younger have suffered seizures and heart problems after drinking the highly caffeinated drinks, a new study reveals. Researchers also warn that the drinks should be avoided by people with heart conditions because the effects could be dangerous. Researchers with Wayne State University in Detroit reviewed 5,156 calls to U.S. poison control centers from October 2010 to September 2013, focusing on ones involving energy drinks. The most common cause for the calls was because children accidentally drank an energy drink. ... Read More

Mother concerned about Risperdal side effects

risperdal

Joelle Kendle is struggling with whether to fill the prescription her doctor has given her for Risperdal for her 6-year-old son, Matthias. He is already taking the stimulant Adderall for attention deficit hyperactivity disorder (ADHD), but it barely controls his outbursts. Joelle is concerned about Risperdal side effects, and rightfully so. The drug has been associated with weight gain and diabetes. More recent studies have linked the drug to gynecomastia, a condition in which boys grow breasts. Risperdal, known generically as risperidone, is an antipsychotic medication that is approved in the United States to treat adults and children with schizophrenia, ... Read More