Tagged Articles

personal injury lawsuits 19 articles

FDA opens up adverse event files for food, supplements, cosmetics

More than 25,000 adverse event reports were linked to dietary supplements since 2004, according to a new report by the Food and Drug Administration (FDA). Last month, the FDA announced that it was publicly releasing adverse event data it had received related to cosmetics and food, including conventional foods and dietary supplements. The adverse events include any negative reaction or complaints experienced after using or consuming a product, including serious illness, severe allergic reactions or other major medical events, as well as issues such as defective packaging or quality problems. The first report reached back to Jan. 1, 2004, through ... Read More

Johnson and Johnson to pay Oregon $4 million for deceptively marketing metal hip implants

Johnson & Johnson will pay $4 million to settle a lawsuit with the State of Oregon over claims that the company failed to warn doctors and patients that its artificial hip had a high failure rate. The settlement is being called the first of its kind by the Oregon Department of Justice. The settlement involves Johnson & Johnson’s subsidiary DePuy Orthopaedics’ ASR metal-on-metal hip replacement system, which was recalled in 2010 after mounting reports of premature failure. Not only were the devices failing at a higher than expected rate, in some cases the metal devices were corroding inside the body, ... Read More

FDA rejects consumer group’s request for black box warning on statin drugs

Cholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys. Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The ... Read More

Wrongful death lawsuit filed against dialysis provider Fresenius Medical Care

Immediately after Beverly Stockton received hemodialysis treatment at Fresenius Medical Care in Charleston, W.Va., she suffered cardiac arrest and died. Her husband James Stockton is suing Fresenius, the largest provider of dialysis products and services, for her wrongful death. James’ lawsuit alleges that his wife was given the dialysis concentrate GranuFlo, which had confusing dosing instructions that caused his wife to receive toxic levels of bicarbonate, an ingredient in GranuFlo. Elevated bicarbonate can cause heart problems including sudden cardiac arrest. The complaint claims that long before his wife received her fatal dose of GranuFlo, Fresenius executives had received, but disregarded, ... Read More

Fresenius recalls 49 lots of NaturaLyte due to bacterial contamination

Fresenius Medical Care, the world’s largest distributor of dialysis products and services, is issuing an urgent medical device recall on 49 lots of NaturaLyte Liquid Bicarbonate Concentrate due to high levels of bacterial contamination found in the product. The company says it is currently conducting an investigation to identify the organism(s) in its dialysis concentrate and, when testing is complete, will announce the identity of those bacteria. NaturaLyte is used to regulate electrolytes in patients undergoing dialysis treatment. The company says no pyrogenic reactions, bacterial infections or related adverse events have been reported to date in connection with the recall. ... Read More

Physicians question safety of testosterone replacement therapy

Increasing numbers of physicians are questioning whether testosterone replacement therapy to boost libido, muscle mass and mood may do more harm than good. Recent studies have linked testosterone therapy to an increased risk of heart attack, stroke and death. News of the study results rang loudly throughout America, where nearly 3 percent of men older than 40 are using prescription testosterone supplements as a “fountain of youth.” And they didn’t come blindly to their doctors in search of a cure. Many were swayed by heavy marketing campaigns waged by drug companies concocting a disorder they called “Low T,” and urging men ... Read More

FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device. Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence. The mesh was widely used in women ... Read More

Justice group supports holding generic drug companies liable for side effects

Authorizing manufacturers of generic drugs to update safety labels independently, without waiting for Food and Drug Administration (FDA) approval or for the brand name equivalent to change its label, is a sensible rule proposed by the FDA and will give both patients and doctors more timely warnings of emerging risks and allow patients to hold generic drug companies liable in court, said Sarah Rooney, Director of Regulatory Affairs for the American Association for Justice, in a recent New York Times editorial. The opinion piece was prompted by strong opposition to the plan by generic drug makers who fear lawsuits from ... Read More

Batches of Paxil recalled due to possible contamination

GlaxoSmithKline (GSK) received a warning letter from the Food and Drug Administration (FDA) regarding a potentially contaminated shipment of the company’s antidepressant Paxil and its failure to warn consumers of quality problems. The action stems from an October inspection of its plant in Ireland during which the FDA found several violations of good manufacturing practices. GSK announced it will issue a Class III recall of Paxil made at the facility in question, meaning it is of less serious nature. The company says the issue is nothing consumers should be concerned about and that they believe there is no risk for ... Read More

Short-term use, lower doses of Actos linked to increased bladder cancer risk

People who have been treated with the type 2 diabetes medication Actos (pioglitazone) for more than six months may be at greater risk of developing bladder cancer, even if they were on a low dose, according to a new study published in the Journal of Korean Medical Science and reported by Cancer Monthly. In 2011, studies showed long-term use (12 months or greater) of Actos increased the risk for bladder cancer. As a result, some countries banned the drug. The U.S. Food and Drug Administration (FDA) ordered that Actos and its generic equivalents include a warning on their safety labels ... Read More