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Pharmaceutical 3579 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.

Endoscope at center of superbug outbreak was never FDA approved

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The manufacturer of the specialized endoscope at the center of the deadly drug-resistant bacteria outbreak at UCLA never obtained approval from drug and medical device regulators to sell the surgical tool in the United States, CNN has learned. Olympus began selling its TJF-Q180V duodenoscope in 2010. The Food and Drug Administration (FDA), didn’t realize until late 2013 or early 2014 that Olympus had never filed for FDA approval on the device. Duodenoscopes are a type of flexible endoscope fitted with a camera that is put down throats of patients to treat a variety of gastrointestinal conditions. A half million duodenoscope ... Read More

Heart pumps recalled due to dangerous defect

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Heartware International is recalling its older Ventricular Assist System Controller, a type of miniaturized implantable heart pump, because of a defect that may have contributed to the death of one patient and a serious injury to another. The devices were distributed in the U.S. during clinical trials prior to Food and Drug Administration (FDA) approval in 2012. The ventricular assist devices are used to treat patients suffering from advanced heart failure. The affected controllers have a higher susceptibility to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or ... Read More

FDA requires cardiovascular warning for testosterone therapy products

Low T

Manufacturers of testosterone therapy products have been ordered by the Food and Drug Administration (FDA) to change the labels on their products to warn of a possible increased risk of heart attacks, strokes and death in patients using the drugs, and to better clarify for which patients the treatments are intended. The FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of testosterone therapy has not been established in the treatment of age-related low testosterone, even if a man’s symptoms appear related to low levels ... Read More

Trials underway on experimental diabetes drug

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Novo Nordisk’s new oral diabetes drug is proving to be just as effective as its injectable counterpart in clinical studies. The drug, known as OG217SC, is an oral version of the company’s experimental weekly injectable medication semaglutide, from a class of type 2 diabetes drugs known as glucagon-like peptide-1 receptor agonist, or GLP-1 drugs. The drugs work by promoting the body’s natural production of insulin, which not only helps manage insulin levels but also can with weight loss. Weight gain is a contributing factor in type 2 diabetes and many diabetic patients are encouraged to lose weight by following a ... Read More

Janssen ordered to pay $136 million for Risperdal illegal marketing

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The South Carolina Supreme Court has ordered Johnson & Johnson subsidiary Janssen Pharmacetuicals to pay $136 million to the state for deceptively marketing its antipsychotic drug Risperdal. The decision upholds penalties against the company but reduces the damages, which were originally set at $327 million by a trial court in 2011. Justices said the penalty had to be reduced because of South Carolina’s three-year statute of limitations. Risperdal, known generically as risperidone, is used to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. The drug has also been prescribed off label to treat attention deficit hyperactivity ... Read More

Analysis: Statins benefits overrated, side effects underreported

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Statin medications, such as the widely prescribed Lipitor, can drive down elevated cholesterol levels, but they have failed to substantially improve users’ chances of having a heart attack or stroke. The drugs also have numerous serious side effects that are pushed under the radar by supporters of statin therapy, according to a study published in the March edition of the medical journal Expert Review of Clinical Pharmacology. Dr. David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr. Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular ... Read More

Patient files first lawsuit in deadly superbug outbreak

duodenoscope

An 18-year-old boy who became infected with a deadly superbug after undergoing a procedure using a specialized endoscope at UCLA’s Ronald Reagan Medical Center has filed a lawsuit against the manufacturer of the surgical tool. The patient, high school student Aaron Young, remains hospitalized with carbapenem-resistant enterobacteriaceae, or CRE, a highly antibiotic-resistant bacteria that kills up to 50 percent of infected patients. The lawsuit names Olympus Corp. of Americans, manufacturers of the specialized endoscope, known as a duodenoscope. UCLA and the University of California regents may also be added as defendants following more investigations into the matter. Duodenoscopes are flexible fiber-optic ... Read More

FDA approves first wireless diabetes glucose monitoring app

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The Food and Drug Administration (FDA) has approved the first seamless diabetes glucose monitoring app, which can wirelessly transmit glucose readings directly to an iPhone, giving diabetics more flexibility when it comes to managing their disease. Federal drug and medical device regulators gave a nod to the new version of the Dexcom Share platform, which works with the Dexcom G4 continuous glucose monitor (CGM). The original Dexcom Share, which was approved by the FDA in October 2014, was a docking cradle peripheral that could transmit Dexcom’s glucose readings to a nearby iPhone. The readings were then uploaded through the cloud ... Read More

Study to look anesthesia safety in infants, children

sleeping-baby

The effect of anesthesia on infants and children has been hotly debated for years, with some animal studies suggesting the drugs can harm developing brains. But there is no clear evidence that the drugs can cause harm, such as developmental delays or behavior problems later in life. Doctors don’t want to add concern to parents whose children need general anesthesia for crucial surgery. A group of researchers has partnered with the Food and Drug Administration (FDA) to settle the matter once and for all. “Millions of kids safely undergo anesthesia,” said SmartTots co-author Dr. Beverly Orser, a professor of anesthesia ... Read More

Tracheotomy humidifiers recalled for cracks

Two recalls have been issued for Teleflex Medical’s MAQUET Servo Humidifier 163 for connector cracks and cracks in connector tubes that may result in serious health consequences including death to patients. Some connector cracks were found when preparing patients for support with a ventilator. These cracks could cause oxygen and other gasses to leak from the ventilator and not deliver sufficient treatment to patients. Cracks were also found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified. The MAQUET Servo Humidifier is a heat and moisture condenser that is placed over ... Read More