Pharmaceutical 4166 articles

Beasley Allen has one of the largest and most technologically advanced Mass Torts practices in the country. The Mass Torts division represents numerous people in claims against companies that manufacture and/or market defective pharmaceuticals and/or medical devices. The resources devoted to this division allow the firm to competently and conscientiously handle any group of cases, no matter how large, along with particular catastrophic injury cases.

Our firm was recently involved in one of the greatest victories in Mass Torts history, against drug manufacturer Merck regarding the drug Vioxx. After more than five years of hard-fought and difficult litigation, Merck agreed to pay $4.85 billion, the largest pharmaceutical settlement in U.S. history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack, including sudden cardiac death, or a stroke.

Victoza fails to improve health in heart failure patients


Novo Nordisk has made great strides to expand the indication of its type 2 diabetes drug Victoza by gaining approval for a high-dose version as a weight loss treatment, marketed as Saxenda. The company is also testing the drug as a treatment for nonalcoholic fatty liver disease. But a new study found the drug ineffective in patients with advanced heart failure. Heart failure is a chronic condition in which the heart does not pump enough blood through the body. About 5 million Americans have heart failure. The study sought to find whether Victoza, known chemically as liraglutide, could correct defects in ... Read More

Congressman introduces legislation to ban Essure permanent birth control


A Pennsylvania congressman has made good on his promise to introduce legislation to ban the permanent birth control implant Essure in response to complaints from thousands of women who say they have been harmed by the device. U.S. Rep. Mike Fitzpatrick introduced the bipartisan bill aimed at revoking the Food and Drug Administration’s (FDA) premarket approval status of Essure and requiring the manufacturer, Bayer Healthcare, to pull the device from the market. Essure was approved by the FDA in 2002, and remains the only FDA-approved non-surgical permanent birth control method available in the United States. Essure is a flexible, nickel-titanium ... Read More

Zofran for morning sickness linked to birth defects

Pregnant Girl

Lawsuits in a multidistrict litigation (MDL) alleging birth defects from anti-nausea drug Zofran have increased substantially according to a Reuters analysis of statistics from the U.S. Judicial Panel on Multidistrict litigation. Zofran, known chemically as ondansetron, is manufactured by GlaxoSmithKline. It is approved to treat nausea for patients undergoing chemotherapy and following surgery, and works by blocking serotonin in the areas of the brain that trigger nausea and vomiting. From 2002 to 2004, GlaxoSmithKline began marketing Zofran for the treatment of morning sickness in pregnant women, an indication the drug was not approved to treat. Doctors have the discretion of ... Read More

Viagra may prevent diabetes, but increase melanoma risk


The erectile dysfunction drug Viagra may help prevent type 2 diabetes in people at risk for the disease, but it may also put them at risk for a deadly form of skin cancer. A small clinical trial published in the Journal of Clinical Endocrinology & Metabolism found that Viagra, known chemically as sildenafil, improved insulin sensitivity on overweight people with pre-diabetes. Viagra was also found not to increase the risk of heart or kidney disease. The trial involved just 42 patients, both men and women who were overweight and had been diagnosed with pre-diabetes, a condition in which blood sugar ... Read More

Patients with Type 2 diabetes sought for clinical trial comparing medications


More than 50 medical centers associated with universities across the country are recruiting patients with type 2 diabetes to participate in a five-year study to determine the best prescription drug to treat high blood sugar. The study is being conducted by National Institute of Diabetes and Digestive and Kidney Diseases. A total of 5,000 participants is being sought. Those who wish to join the clinical trial should have been diagnosed with type 2 diabetes within the past 10 years and currently be taking the widely used anti-diabetes drug Metformin. Those who are accepted into the program will receive compensation for their ... Read More

FDA warns intravascular medical device coatings may peel, cause injuries


The Food and Drug Administration (FDA) is warning of problems with the coatings on intravascular medical devices, including intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems, that can cause serious injury to patients. The FDA Safety Alert comes after nearly a dozen recalls and 500 reports of defects with the devices. “The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients,” the FDA said in the Safety Alert. “Coating separation ... Read More

FDA issues warning letter to medical device maker C.R. Bard

IVC filter

Medical device manufacturer C R. Bard was slapped with a warning letter from the Food and Drug Administration (FDA) over misfiling customer complaints that included one patient death, manufacturing a high-risk medical device without required agency approval, and failing to notify the FDA of serious device malfunctions. The FDA letter addresses Bard’s manufacturing and marketing of the Recovery Cone Removal System, used to retrieve inferior vena cava filters, also known as Retrievable IVC filters. The cage-like filters are implanted in the body’s largest vein, called the vena cava, to capture blood clots before they reach the heart and lungs. The devices ... Read More

Victoza studied in obese patients with pre-diabetes

bathroom scale

People who are obese and pre-diabetic can lose weight and delay the onset of type 2 diabetes by more than three years if they take a newer diabetes medication, according to a study presented at ObesityWeek 2015. However, the medication puts users at risk for dangerous side effects. The study involved the type 2 diabetes drug liraglutide, known by the brand name Victoza, which was approved by the Food and Drug Administration (FDA) in 2010. In December 2014, the agency approved a higher dose of the drug, marketed as Saxenda, for weight loss in obese non-diabetics, and for overweight patients ... Read More

Diabetes drug tested as treatment for non-alcoholic fatty liver disease


Researchers are testing type 2 diabetes drug Victoza as a possible treatment for non-alcoholic fatty liver disease, the most common form of liver disease in the United States, affecting about 20 percent of the population. The condition describes a wide range of conditions that are caused when fat builds up within the liver. Non-alcoholic steathohepatitis, or NASH, is the most serious form of the disease, and can lead to total liver failure requiring liver transplant. NASH is known as a silent killer because it does not present with many symptoms and those affected generally feel well. Risk factors include obesity, ... Read More

Warming blanket linked to infection risk in joint replacement patients

Bair Hugger

More than 50 patients who have undergone orthopedic surgery have filed lawsuits against the makers of a popular warming blanket used to keep patients warm during surgery, claiming the machine can circulate contaminated air and cause debilitating infections deep inside joints. The Bair Hugger, manufactured by 3M Company and its subsidiary Arizant Healthcare, pushes warm air through a flexible hose into a blanket that is draped over a patient during surgery. Researchers have found that the air within the blankets can become contaminated, and as the air blows over surgical sites, it can cause infections including MRSA and sepsis. Patients ... Read More